Title 21 C.F.R. — Food and Drugs

8370 sections

PART 1

• § 1.1 — General
• § 1.3 — Definitions
• § 1.4 — Authority citations
• § 1.20 — Presence of mandatory label information
• § 1.21 — Failure to reveal material facts
• § 1.23 — Procedures for requesting variations and exemptions from required label statements
• § 1.24 — Exemptions from required label statements
• § 1.70 — Scope
• § 1.71 — Definitions
• § 1.72 — Data elements that must be submitted in ACE for articles regulated by FDA
• § 1.73 — Food
• § 1.74 — Human drugs
• § 1.75 — Animal drugs and veterinary devices
• § 1.76 — Medical devices
• § 1.77 — Radiation-emitting electronic products
• § 1.78 — Biological products, HCT/Ps, and related drugs and medical devices
• § 1.79 — Tobacco products
• § 1.80 — Cosmetics
• § 1.81 — Rejection of entry filing
• § 1.83 — Definitions
• § 1.90 — Notice of sampling
• § 1.91 — Payment for samples
• § 1.94 — Hearing on refusal of admission or destruction
• § 1.95 — Application for authorization to relabel and recondition
• § 1.96 — Granting of authorization to relabel and recondition
• § 1.97 — Bonds
• § 1.99 — Costs chargeable in connection with relabeling and reconditioning inadmissible imports
• § 1.101 — Notification and recordkeeping
• § 1.225 — Who must register under this subpart?
• § 1.226 — Who does not have to register under this subpart?
• § 1.227 — What definitions apply to this subpart?
• § 1.230 — When must you register or renew your registration?
• § 1.231 — How and where do you register or renew your registration?
• § 1.232 — What information is required in the registration?
• § 1.233 — Are there optional items included in the registration form?
• § 1.234 — How and when do you update your facility's registration information?
• § 1.235 — How and when do you cancel your facility's registration information?
• § 1.240 — What other registration requirements apply?
• § 1.241 — What are the consequences of failing to register, update, renew, or cancel your registration?
• § 1.242 — What does assignment of a registration number mean?
• § 1.243 — Is food registration information available to the public?
• § 1.245 — Waiver request
• § 1.276 — What definitions apply to this subpart?
• § 1.277 — What is the scope of this subpart?
• § 1.278 — Who is authorized to submit prior notice?
• § 1.279 — When must prior notice be submitted to FDA?
• § 1.280 — How must you submit prior notice?
• § 1.281 — What information must be in a prior notice?
• § 1.282 — What must you do if information changes after you have received confirmation of a prior notice from FDA?
• § 1.283 — What happens to food that is imported or offered for import without adequate prior notice?
• § 1.284 — What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?
• § 1.285 — What happens to food that is imported or offered for import from unregistered facilities that are required to register under subpart H of this part?
• § 1.326 — Who is subject to this subpart?
• § 1.327 — Who is excluded from all or part of the regulations in this subpart?
• § 1.328 — What definitions apply to this subpart?
• § 1.329 — Do other statutory provisions and regulations apply?
• § 1.330 — Can existing records satisfy the requirements of this subpart?
• § 1.337 — What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food?
• § 1.345 — What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?
• § 1.352 — What information must transporters establish and maintain?
• § 1.360 — What are the record retention requirements?
• § 1.361 — What are the record availability requirements?
• § 1.362 — What records are excluded from this subpart?
• § 1.363 — What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?
• § 1.368 — What are the compliance dates for this subpart?
• § 1.377 — What definitions apply to this subpart?
• § 1.378 — What criteria does FDA use to order a detention?
• § 1.379 — How long may FDA detain an article of food?
• § 1.380 — Where and under what conditions must the detained article of food be held?
• § 1.381 — May a detained article of food be delivered to another entity or transferred to another location?
• § 1.382 — What labeling or marking requirements apply to a detained article of food?
• § 1.383 — What expedited procedures apply when FDA initiates a seizure action against a detained perishable food?
• § 1.384 — When does a detention order terminate?
• § 1.391 — Who approves a detention order?
• § 1.392 — Who receives a copy of the detention order?
• § 1.393 — What information must FDA include in the detention order?
• § 1.401 — Who is entitled to appeal?
• § 1.402 — What are the requirements for submitting an appeal?
• § 1.403 — What requirements apply to an informal hearing?
• § 1.404 — Who serves as the presiding officer for an appeal and for an informal hearing?
• § 1.405 — When does FDA have to issue a decision on an appeal?
• § 1.406 — How will FDA handle classified information in an informal hearing?
• § 1.500 — What definitions apply to this subpart?
• § 1.501 — To what foods do the requirements in this subpart apply?
• § 1.502 — What foreign supplier verification program (FSVP) must I have?
• § 1.503 — Who must develop my FSVP and perform FSVP activities?
• § 1.504 — What hazard analysis must I conduct?
• § 1.505 — What evaluation for foreign supplier approval and verification must I conduct?
• § 1.506 — What foreign supplier verification and related activities must I conduct?
• § 1.507 — What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation?
• § 1.508 — What corrective actions must I take under my FSVP?
• § 1.509 — How must the importer be identified at entry?
• § 1.510 — How must I maintain records of my FSVP?
• § 1.511 — What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?
• § 1.512 — What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers?
• § 1.513 — What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system?
• § 1.514 — What are some consequences of failing to comply with the requirements of this subpart?
• § 1.600 — What definitions apply to this subpart?
• § 1.601 — Who is subject to this subpart?
• § 1.610 — Who is eligible to seek recognition?
• § 1.611 — What legal authority must an accreditation body have to qualify for recognition?
• § 1.612 — What competency and capacity must an accreditation body have to qualify for recognition?
• § 1.613 — What protections against conflicts of interest must an accreditation body have to qualify for recognition?
• § 1.614 — What quality assurance procedures must an accreditation body have to qualify for recognition?
• § 1.615 — What records procedures must an accreditation body have to qualify for recognition?
• § 1.620 — How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?
• § 1.621 — How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?
• § 1.622 — How must a recognized accreditation body monitor its own performance?
• § 1.623 — What reports and notifications must a recognized accreditation body submit to FDA?
• § 1.624 — How must a recognized accreditation body protect against conflicts of interest?
• § 1.625 — What records requirements must an accreditation body that has been recognized meet?
• § 1.630 — How do I apply to FDA for recognition or renewal of recognition?
• § 1.631 — How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?
• § 1.632 — What is the duration of recognition?
• § 1.633 — How will FDA monitor recognized accreditation bodies?
• § 1.634 — When will FDA revoke recognition?
• § 1.635 — What if I want to voluntarily relinquish recognition or do not want to renew recognition?
• § 1.636 — How do I request reinstatement of recognition?
• § 1.640 — Who is eligible to seek accreditation?
• § 1.641 — What legal authority must a third-party certification body have to qualify for accreditation?
• § 1.642 — What competency and capacity must a third-party certification body have to qualify for accreditation?
• § 1.643 — What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?
• § 1.644 — What quality assurance procedures must a third-party certification body have to qualify for accreditation?
• § 1.645 — What records procedures must a third-party certification body have to qualify for accreditation?
• § 1.650 — How must an accredited third-party certification body ensure its audit agents are competent and objective?
• § 1.651 — How must an accredited third-party certification body conduct a food safety audit of an eligible entity?
• § 1.652 — What must an accredited third-party certification body include in food safety audit reports?
• § 1.653 — What must an accredited third-party certification body do when issuing food or facility certifications?
• § 1.654 — When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?
• § 1.655 — How must an accredited third-party certification body monitor its own performance?
• § 1.656 — What reports and notifications must an accredited third-party certification body submit?
• § 1.657 — How must an accredited third-party certification body protect against conflicts of interest?
• § 1.658 — What records requirements must a third-party certification body that has been accredited meet?
• § 1.660 — Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application?
• § 1.661 — What is the duration of accreditation by a recognized accreditation body?
• § 1.662 — How will FDA monitor accredited third-party certification bodies?
• § 1.663 — How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?
• § 1.664 — When would FDA withdraw accreditation?
• § 1.665 — What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?
• § 1.666 — How do I request reaccreditation?
• § 1.670 — How do I apply to FDA for direct accreditation or renewal of direct accreditation?
• § 1.671 — How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application?
• § 1.672 — What is the duration of direct accreditation?
• § 1.680 — How and when will FDA monitor eligible entities?
• § 1.681 — How frequently must eligible entities be recertified?
• § 1.690 — How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?
• § 1.691 — How do I request reconsideration of a denial by FDA of an application or a waiver request?
• § 1.692 — How do I request internal agency review of a denial of an application or waiver request upon reconsideration?
• § 1.693 — How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?
• § 1.694 — Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
• § 1.695 — Are the records obtained by FDA under this subpart subject to public disclosure?
• § 1.700 — Who is subject to a user fee under this subpart?
• § 1.705 — What user fees are established under this subpart?
• § 1.710 — How will FDA notify the public about the fee schedule?
• § 1.715 — When must a user fee required by this subpart be submitted?
• § 1.720 — Are user fees under this subpart refundable?
• § 1.725 — What are the consequences of not paying a user fee under this subpart on time?
• § 1.900 — Who is subject to this subpart?
• § 1.902 — How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act?
• § 1.904 — What definitions apply to this subpart?
• § 1.906 — What requirements apply to vehicles and transportation equipment?
• § 1.908 — What requirements apply to transportation operations?
• § 1.910 — What training requirements apply to carriers engaged in transportation operations?
• § 1.912 — What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations?
• § 1.914 — Under what circumstances will we waive a requirement of this subpart?
• § 1.916 — When will we consider whether to waive a requirement of this subpart?
• § 1.918 — What must be included in the Statement of Grounds in a petition requesting a waiver?
• § 1.920 — What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available?
• § 1.922 — Who will respond to a petition requesting a waiver?
• § 1.924 — What process applies to a petition requesting a waiver?
• § 1.926 — Under what circumstances may we deny a petition requesting a waiver?
• § 1.928 — What process will we follow when waiving a requirement of this subpart on our own initiative?
• § 1.930 — When will a waiver that we grant become effective?
• § 1.932 — Under what circumstances may we modify or revoke a waiver?
• § 1.934 — What procedures apply if we determine that a waiver should be modified or revoked?
• § 1.980 — Administrative detention of drugs
• § 1.1101 — What documents are incorporated by reference in this subpart
• § 1.1102 — What definitions apply to this subpart?
• § 1.1103 — Who is subject to this subpart?
• § 1.1107 — When must food testing be conducted under this subpart?
• § 1.1108 — When and how will FDA issue a directed food laboratory order?
• § 1.1109 — How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?
• § 1.1110 — What are the general requirements for submitting information to FDA under this subpart?
• § 1.1113 — What are the eligibility requirements for a recognized accreditation body?
• § 1.1114 — How does an accreditation body apply to FDA for recognition or renewal of recognition?
• § 1.1115 — How will FDA evaluate applications for recognition and renewal of recognition?
• § 1.1116 — What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?
• § 1.1117 — How may an accreditation body request reinstatement of recognition?
• § 1.1119 — What are the conflict of interest requirements for a recognized accreditation body?
• § 1.1120 — How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
• § 1.1121 — When must a recognized accreditation body require corrective action, suspend a LAAF-accredited laboratory, or reduce the scope of or withdraw the LAAF-accreditation of a laboratory?
• § 1.1122 — What procedures must a recognized accreditation body provide for appeals of decisions to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation?
• § 1.1123 — What reports, notifications, and documentation must a recognized accreditation body submit to FDA?
• § 1.1124 — What are the records requirements for a recognized accreditation body?
• § 1.1125 — What are the internal audit requirements for a recognized accreditation body?
• § 1.1130 — How will FDA oversee recognized accreditation bodies?
• § 1.1131 — When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?
• § 1.1138 — What are the eligibility requirements for a LAAF-accredited laboratory?
• § 1.1139 — How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?
• § 1.1140 — What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?
• § 1.1141 — What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?
• § 1.1142 — How does a laboratory request reinstatement of LAAF-accreditation?
• § 1.1147 — What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?
• § 1.1149 — What oversight standards apply to sampling?
• § 1.1150 — What are the requirements for analysis of samples by a LAAF-accredited laboratory?
• § 1.1151 — What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?
• § 1.1152 — What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?
• § 1.1153 — What are the requirements for submitting abridged analytical reports?
• § 1.1154 — What other records requirements must a LAAF-accredited laboratory meet?
• § 1.1159 — How will FDA oversee LAAF-accredited laboratories?
• § 1.1160 — How will FDA review test results and analytical reports?
• § 1.1161 — When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports?
• § 1.1162 — What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?
• § 1.1171 — How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?
• § 1.1173 — How does an accreditation body or laboratory request a regulatory hearing on FDA's decision to revoke the accreditation body's recognition or disqualify a LAAF-accredited laboratory?
• § 1.1174 — How does an owner or consignee request a regulatory hearing on a directed food laboratory order?
• § 1.1199 — Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
• § 1.1200 — Are the records obtained by FDA under this subpart subject to public disclosure?
• § 1.1300 — Who is subject to this subpart?
• § 1.1305 — What foods and persons are exempt from this subpart?
• § 1.1310 — What definitions apply to this subpart?
• § 1.1315 — What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?
• § 1.1320 — When must I assign traceability lot codes to foods on the Food Traceability List?
• § 1.1325 — What records must I keep and provide when I harvest or cool a raw agricultural commodity on the Food Traceability List?
• § 1.1330 — What records must I keep when I am performing the initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List?
• § 1.1335 — What records must I keep when I am the first land-based receiver of a food on the Food Traceability List that was obtained from a fishing vessel?
• § 1.1340 — What records must I keep and provide when I ship a food on the Food Traceability List?
• § 1.1345 — What records must I keep when I receive a food on the Food Traceability List?
• § 1.1350 — What records must I keep when I transform a food on the Food Traceability List?
• § 1.1360 — Under what circumstances will FDA modify the requirements in this subpart that apply to a food or type of entity or exempt a food or type of entity from the requirements of this subpart?
• § 1.1365 — When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?
• § 1.1370 — What must be included in a petition requesting modified requirements or an exemption from the requirements?
• § 1.1375 — What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available?
• § 1.1380 — What process applies to a petition requesting modified requirements or an exemption?
• § 1.1385 — What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?
• § 1.1390 — When will modified requirements that we adopt or an exemption that we grant become effective?
• § 1.1395 — Under what circumstances may FDA revise or revoke modified requirements or an exemption?
• § 1.1400 — What procedures apply if FDA tentatively determines that modified requirements or an exemption should be revised or revoked?
• § 1.1405 — Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?
• § 1.1410 — When will FDA consider whether to waive a requirement of this subpart?
• § 1.1415 — How may I request a waiver for an individual entity?
• § 1.1420 — What process applies to a request for a waiver for an individual entity?
• § 1.1425 — What must be included in a petition requesting a waiver for a type of entity?
• § 1.1430 — What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available?
• § 1.1435 — What process applies to a petition requesting a waiver for a type of entity?
• § 1.1440 — What process will FDA follow when waiving a requirement of this subpart on our own initiative?
• § 1.1445 — Under what circumstances may FDA modify or revoke a waiver?
• § 1.1450 — What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?
• § 1.1455 — How must records required by this subpart be maintained and made available?
• § 1.1460 — What consequences could result from failing to comply with the requirements of this subpart?
• § 1.1465 — How will FDA update the Food Traceability List?

PART 2

• § 2.5 — Imminent hazard to the public health
• § 2.10 — Examination and investigation samples
• § 2.19 — [Reserved]
• § 2.25 — Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food
• § 2.35 — Use of secondhand containers for the shipment or storage of food and animal feed
• § 2.110 — Definition of ammonia under Federal Caustic Poison Act
• § 2.125 — Use of ozone-depleting substances in foods, drugs, devices, or cosmetics

PART 3

• § 3.1 — Purpose
• § 3.2 — Definitions
• § 3.3 — Scope
• § 3.4 — Designated agency component
• § 3.5 — Procedures for identifying the designated agency component
• § 3.6 — Product jurisdiction officer
• § 3.7 — Request for designation
• § 3.8 — Letter of designation
• § 3.9 — Effect of letter of designation
• § 3.10 — Stay of review time

PART 4

• § 4.1 — What is the scope of this subpart?
• § 4.2 — How does FDA define key terms and phrases in this subpart?
• § 4.3 — What current good manufacturing practice requirements apply to my combination product?
• § 4.4 — How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?
• § 4.100 — What is the scope of this subpart?
• § 4.101 — How does the FDA define key terms and phrases in this subpart?
• § 4.102 — What reports must you submit to FDA for your combination product or constituent part?
• § 4.103 — What information must you share with other constituent part applicants for the combination product?
• § 4.104 — How and where must you submit postmarketing safety reports for your combination product or constituent part?
• § 4.105 — What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?

PART 5

• § 5.1100 — Headquarters
• § 5.1105 — Chief Counsel, Food and Drug Administration
• § 5.1110 — FDA public information offices

PART 7

• § 7.1 — Scope
• § 7.3 — Definitions
• § 7.12 — Guaranty
• § 7.13 — Suggested forms of guaranty
• § 7.40 — Recall policy
• § 7.41 — Health hazard evaluation and recall classification
• § 7.42 — Recall strategy
• § 7.45 — Food and Drug Administration-requested recall
• § 7.46 — Firm-initiated recall
• § 7.49 — Recall communications
• § 7.50 — Public notification of recall
• § 7.53 — Recall status reports
• § 7.55 — Termination of a recall
• § 7.59 — General industry guidance
• § 7.84 — Opportunity for presentation of views before report of criminal violation
• § 7.85 — Conduct of a presentation of views before report of criminal violation
• § 7.87 — Records related to opportunities for presentation of views conducted before report of criminal violation

PART 10

• § 10.1 — Scope
• § 10.3 — Definitions
• § 10.10 — Summaries of administrative practices and procedures
• § 10.19 — Waiver, suspension, or modification of procedural requirements
• § 10.20 — Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure
• § 10.25 — Initiation of administrative proceedings
• § 10.30 — Citizen petition
• § 10.31 — Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications
• § 10.33 — Administrative reconsideration of action
• § 10.35 — Administrative stay of action
• § 10.40 — Promulgation of regulations for the efficient enforcement of the law
• § 10.45 — Court review of final administrative action; exhaustion of administrative remedies
• § 10.50 — Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing
• § 10.55 — Separation of functions; ex parte communications
• § 10.60 — Referral by court
• § 10.65 — Meetings and correspondence
• § 10.70 — Documentation of significant decisions in administrative file
• § 10.75 — Internal agency review of decisions
• § 10.80 — Dissemination of draft Federal Register notices and regulations
• § 10.85 — Advisory opinions
• § 10.90 — Food and Drug Administration regulations, recommendations, and agreements
• § 10.95 — Participation in outside standard-setting activities
• § 10.100 — Public calendar
• § 10.105 — Representation by an organization
• § 10.110 — Settlement proposals
• § 10.115 — Good guidance practices
• § 10.200 — Scope
• § 10.203 — Definitions
• § 10.204 — General
• § 10.205 — Electronic media coverage of public administrative proceedings
• § 10.206 — Procedures for electronic media coverage of agency public administrative proceedings

PART 11

• § 11.1 — Scope
• § 11.2 — Implementation
• § 11.3 — Definitions
• § 11.10 — Controls for closed systems
• § 11.30 — Controls for open systems
• § 11.50 — Signature manifestations
• § 11.70 — Signature/record linking
• § 11.100 — General requirements
• § 11.200 — Electronic signature components and controls
• § 11.300 — Controls for identification codes/passwords

PART 12

• § 12.1 — Scope
• § 12.20 — Initiation of a hearing involving the issuance, amendment, or revocation of a regulation
• § 12.21 — Initiation of a hearing involving the issuance, amendment, or revocation of an order
• § 12.22 — Filing objections and requests for a hearing on a regulation or order
• § 12.23 — Notice of filing of objections
• § 12.24 — Ruling on objections and requests for hearing
• § 12.26 — Modification or revocation of regulation or order
• § 12.28 — Denial of hearing in whole or in part
• § 12.30 — Judicial review after waiver of hearing on a regulation
• § 12.32 — Request for alternative form of hearing
• § 12.35 — Notice of hearing; stay of action
• § 12.37 — Effective date of a regulation
• § 12.38 — Effective date of an order
• § 12.40 — Appearance
• § 12.45 — Notice of participation
• § 12.50 — Advice on public participation in hearings
• § 12.60 — Presiding officer
• § 12.62 — Commencement of functions
• § 12.70 — Authority of presiding officer
• § 12.75 — Disqualification of presiding officer
• § 12.78 — Unavailability of presiding officer
• § 12.80 — Filing and service of submissions
• § 12.82 — Petition to participate in forma pauperis
• § 12.83 — Advisory opinions
• § 12.85 — Disclosure of data and information by the participants
• § 12.87 — Purpose; oral and written testimony; burden of proof
• § 12.89 — Participation of nonparties
• § 12.90 — Conduct at oral hearings or conferences
• § 12.91 — Time and place of prehearing conference
• § 12.92 — Prehearing conference procedure
• § 12.93 — Summary decisions
• § 12.94 — Receipt of evidence
• § 12.95 — Official notice
• § 12.96 — Briefs and arguments
• § 12.97 — Interlocutory appeal from ruling of presiding officer
• § 12.98 — Official transcript
• § 12.99 — Motions
• § 12.100 — Administrative record of a hearing
• § 12.105 — Examination of record
• § 12.120 — Initial decision
• § 12.125 — Appeal from or review of initial decision
• § 12.130 — Decision by Commissioner on appeal or review of initial decision
• § 12.139 — Reconsideration and stay of action
• § 12.140 — Review by the courts
• § 12.159 — Copies of petitions for judicial review

PART 13

• § 13.1 — Scope
• § 13.5 — Notice of a hearing before a Board
• § 13.10 — Members of a Board
• § 13.15 — Separation of functions; ex parte communications; administrative support
• § 13.20 — Submissions to a Board
• § 13.25 — Disclosure of data and information by the participants
• § 13.30 — Proceedings of a Board
• § 13.40 — Administrative record of a Board
• § 13.45 — Examination of administrative record
• § 13.50 — Record for administrative decision

PART 14

• § 14.1 — Scope
• § 14.5 — Purpose of proceedings before an advisory committee
• § 14.7 — Administrative remedies
• § 14.10 — Applicability to Congress
• § 14.15 — Committees working under a contract with FDA
• § 14.20 — Notice of hearing before an advisory committee
• § 14.22 — Meetings of an advisory committee
• § 14.25 — Portions of advisory committee meetings
• § 14.27 — Determination to close portions of advisory committee meetings
• § 14.29 — Conduct of a hearing before an advisory committee
• § 14.30 — Chairperson of an advisory committee
• § 14.31 — Consultation by an advisory committee with other persons
• § 14.33 — Compilation of materials for members of an advisory committee
• § 14.35 — Written submissions to an advisory committee
• § 14.39 — Additional rules for a particular advisory committee
• § 14.40 — Establishment and renewal of advisory committees
• § 14.55 — Termination of advisory committees
• § 14.60 — Minutes and reports of advisory committee meetings
• § 14.61 — Transcripts of advisory committee meetings
• § 14.65 — Public inquiries and requests for advisory committee records
• § 14.70 — Administrative record of a public hearing before an advisory committee
• § 14.75 — Examination of administrative record and other advisory committee records
• § 14.80 — Qualifications for members of standing policy and technical advisory committees
• § 14.82 — Nominations of voting members of standing advisory committees
• § 14.84 — Nominations and selection of nonvoting members of standing technical advisory committees
• § 14.86 — Rights and responsibilities of nonvoting members of advisory committees
• § 14.90 — Ad hoc advisory committee members
• § 14.95 — Compensation of advisory committee members
• § 14.100 — List of standing advisory committees
• § 14.120 — Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC)
• § 14.122 — Functions of TEPRSSC
• § 14.125 — Procedures of TEPRSSC
• § 14.127 — Membership of TEPRSSC
• § 14.130 — Conduct of TEPRSSC meeting; availability of TEPRSSC records
• § 14.140 — Establishment of a color additive advisory committee
• § 14.142 — Functions of a color additive advisory committee
• § 14.145 — Procedures of a color additive advisory committee
• § 14.147 — Membership of a color additive advisory committee
• § 14.155 — Fees and compensation pertaining to a color additive advisory committee
• § 14.160 — Establishment of standing technical advisory committees for human prescription drugs
• § 14.171 — Utilization of an advisory committee on the initiative of FDA
• § 14.172 — Utilization of an advisory committee at the request of an interested person
• § 14.174 — Advice and recommendations in writing

PART 15

• § 15.1 — Scope
• § 15.20 — Notice of a public hearing before the Commissioner
• § 15.21 — Notice of participation; schedule for hearing
• § 15.25 — Written submissions
• § 15.30 — Conduct of a public hearing before the Commissioner
• § 15.40 — Administrative record
• § 15.45 — Examination of administrative record

PART 16

• § 16.1 — Scope
• § 16.5 — Inapplicability and limited applicability
• § 16.22 — Initiation of regulatory hearing
• § 16.24 — Regulatory hearing required by the act or a regulation
• § 16.26 — Denial of hearing and summary decision
• § 16.40 — Commissioner
• § 16.42 — Presiding officer
• § 16.44 — Communication to presiding officer and Commissioner
• § 16.60 — Hearing procedure
• § 16.62 — Right to counsel
• § 16.80 — Administrative record of a regulatory hearing
• § 16.85 — Examination of administrative record
• § 16.95 — Administrative decision and record for decision
• § 16.119 — Reconsideration and stay of action
• § 16.120 — Judicial review

PART 17

• § 17.1 — Scope
• § 17.2 — Maximum penalty amounts
• § 17.3 — Definitions
• § 17.5 — Complaint
• § 17.7 — Service of complaint
• § 17.9 — Answer
• § 17.11 — Default upon failure to file an answer
• § 17.13 — Notice of hearing
• § 17.15 — Parties to the hearing
• § 17.17 — Summary decisions
• § 17.18 — Interlocutory appeal from ruling of presiding officer
• § 17.19 — Authority of the presiding officer
• § 17.20 — Ex parte contacts
• § 17.21 — Prehearing conferences
• § 17.23 — Discovery
• § 17.25 — Exchange of witness lists, witness statements, and exhibits
• § 17.27 — Hearing subpoenas
• § 17.28 — Protective order
• § 17.29 — Fees
• § 17.30 — Computation of time
• § 17.31 — Form, filing, and service of papers
• § 17.32 — Motions
• § 17.33 — The hearing and burden of proof
• § 17.34 — Determining the amount of penalties and assessments
• § 17.35 — Sanctions
• § 17.37 — Witnesses
• § 17.39 — Evidence
• § 17.41 — The administrative record
• § 17.43 — Posthearing briefs
• § 17.45 — Initial decision
• § 17.47 — Appeals
• § 17.48 — Harmless error
• § 17.51 — Judicial review
• § 17.54 — Deposit in the Treasury of the United States

PART 19

• § 19.1 — Scope
• § 19.5 — Reference to Department regulations
• § 19.6 — Code of ethics for government service
• § 19.10 — Food and Drug Administration Conflict of Interest Review Board
• § 19.21 — Duty to report violations
• § 19.45 — Temporary disqualification of former employees
• § 19.55 — Permanent disqualification of former employees

PART 20

• § 20.1 — Testimony by Food and Drug Administration employees
• § 20.2 — Production of records by Food and Drug Administration employees
• § 20.3 — Certification and authentication of Food and Drug Administration records
• § 20.20 — Policy on disclosure of Food and Drug Administration records
• § 20.21 — Uniform access to records
• § 20.22 — Partial disclosure of records
• § 20.23 — Request for existing records
• § 20.24 — Preparation of new records
• § 20.25 — Retroactive application of regulations
• § 20.26 — Electronic availability and indexes of certain records
• § 20.27 — Submission of records marked as confidential
• § 20.28 — Food and Drug Administration determinations of confidentiality
• § 20.29 — Prohibition on withdrawal of records from Food and Drug Administration files
• § 20.30 — Food and Drug Administration Division of Freedom of Information
• § 20.31 — Retention schedule of requests for Food and Drug Administration records
• § 20.32 — Disclosure of Food and Drug Administration employee names
• § 20.33 — Form or format of response
• § 20.34 — Search for records
• § 20.40 — Filing a request for records
• § 20.41 — Time limitations
• § 20.42 — Aggregation of certain requests
• § 20.43 — Multitrack processing
• § 20.44 — Expedited processing
• § 20.45 — Fees to be charged
• § 20.46 — Waiver or reduction of fees
• § 20.47 — Situations in which confidentiality is uncertain
• § 20.48 — Judicial review of proposed disclosure
• § 20.49 — Denial of a request for records
• § 20.50 — Nonspecific and overly burdensome requests
• § 20.51 — Referral to primary source of records
• § 20.52 — Availability of records at National Technical Information Service
• § 20.53 — Use of private contractor for copying
• § 20.54 — Request for review without copying
• § 20.55 — Indexing trade secrets and confidential commercial or financial information
• § 20.60 — Applicability of exemptions
• § 20.61 — Trade secrets and commercial or financial information which is privileged or confidential
• § 20.62 — Inter- or intra-agency memoranda or letters
• § 20.63 — Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy
• § 20.64 — Records or information compiled for law enforcement purposes
• § 20.65 — National defense and foreign policy
• § 20.66 — Internal personnel rules and practices
• § 20.67 — Records exempted by other statutes
• § 20.80 — Applicability of limitations on exemptions
• § 20.81 — Data and information previously disclosed to the public
• § 20.82 — Discretionary disclosure by the Commissioner
• § 20.83 — Disclosure required by court order
• § 20.84 — Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees
• § 20.85 — Disclosure to other Federal Government departments and agencies
• § 20.86 — Disclosure in administrative or court proceedings
• § 20.87 — Disclosure to Congress
• § 20.88 — Communications with State and local government officials
• § 20.89 — Communications with foreign government officials
• § 20.90 — Disclosure to contractors
• § 20.91 — Use of data or information for administrative or court enforcement action
• § 20.100 — Applicability; cross-reference to other regulations
• § 20.101 — Administrative enforcement records
• § 20.102 — Court enforcement records
• § 20.103 — Correspondence
• § 20.104 — Summaries of oral discussions
• § 20.105 — Testing and research conducted by or with funds provided by the Food and Drug Administration
• § 20.106 — Studies and reports prepared by or with funds provided by the Food and Drug Administration
• § 20.107 — Food and Drug Administration manuals
• § 20.108 — Agreements between the Food and Drug Administration and other departments, agencies, and organizations
• § 20.109 — Data and information obtained by contract
• § 20.110 — Data and information about Food and Drug Administration employees
• § 20.111 — Data and information submitted voluntarily to the Food and Drug Administration
• § 20.112 — Voluntary drug experience reports submitted by physicians and hospitals
• § 20.113 — Voluntary product defect reports
• § 20.114 — Data and information submitted pursuant to cooperative quality assurance agreements
• § 20.115 — Product codes for manufacturing or sales dates
• § 20.116 — Drug and device registration and listing information
• § 20.117 — New drug information
• § 20.118 — Advisory committee records
• § 20.119 — Lists of names and addresses
• § 20.120 — Records available in Food and Drug Administration Public Reading Rooms

PART 21

• § 21.1 — Scope
• § 21.3 — Definitions
• § 21.10 — Policy concerning records about individuals
• § 21.20 — Procedures for notice of Food and Drug Administration Privacy Act Record Systems
• § 21.21 — Changes in systems and new systems
• § 21.30 — Records of contractors
• § 21.31 — Records stored by the National Archives and Records Administration
• § 21.32 — Personnel records
• § 21.33 — Medical records
• § 21.40 — Procedures for submitting requests for notification and access
• § 21.41 — Processing of requests
• § 21.42 — Responses to requests
• § 21.43 — Access to requested records
• § 21.44 — Verification of identity
• § 21.45 — Fees
• § 21.50 — Procedures for submitting requests for amendment of records
• § 21.51 — Responses to requests for amendment of records
• § 21.52 — Administrative appeals of refusals to amend records
• § 21.53 — Notation and disclosure of disputed records
• § 21.54 — Amended or disputed records received from other agencies
• § 21.60 — Policy
• § 21.61 — Exempt systems
• § 21.65 — Access to records in exempt systems
• § 21.70 — Disclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required
• § 21.71 — Disclosure of records in Privacy Act Record Systems; accounting required
• § 21.72 — Individual consent to disclosure of records to other persons
• § 21.73 — Accuracy, completeness, timeliness, and relevance of records disclosed from Privacy Act Record Systems
• § 21.74 — Providing notice that a record is disputed
• § 21.75 — Rights of legal guardians

PART 25

• § 25.1 — Purpose
• § 25.5 — Terminology
• § 25.10 — Policies and NEPA planning
• § 25.15 — General procedures
• § 25.16 — Public health and safety emergencies
• § 25.20 — Actions requiring preparation of an environmental assessment
• § 25.21 — Extraordinary circumstances
• § 25.22 — Actions requiring the preparation of an environmental impact statement
• § 25.30 — General
• § 25.31 — Human drugs and biologics
• § 25.32 — Foods, food additives, and color additives
• § 25.33 — Animal drugs
• § 25.34 — Devices and electronic products
• § 25.35 — Tobacco product applications
• § 25.40 — Environmental assessments
• § 25.41 — Findings of no significant impact
• § 25.42 — Environmental impact statements
• § 25.43 — Records of decision
• § 25.44 — Lead and cooperating agencies
• § 25.45 — Responsible agency official
• § 25.50 — General information
• § 25.51 — Environmental assessments and findings of no significant impact
• § 25.52 — Environmental impact statements
• § 25.60 — Environmental effects abroad of major agency actions

PART 50

• § 50.1 — Scope
• § 50.3 — Definitions
• § 50.20 — General requirements for informed consent
• § 50.22 — Exception from informed consent requirements for minimal risk clinical investigations
• § 50.23 — Exception from general requirements
• § 50.24 — Exception from informed consent requirements for emergency research
• § 50.25 — Elements of informed consent
• § 50.27 — Documentation of informed consent
• § 50.50 — IRB duties
• § 50.51 — Clinical investigations not involving greater than minimal risk
• § 50.52 — Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects
• § 50.53 — Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition
• § 50.54 — Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children
• § 50.55 — Requirements for permission by parents or guardians and for assent by children
• § 50.56 — Wards

PART 54

• § 54.1 — Purpose
• § 54.2 — Definitions
• § 54.3 — Scope
• § 54.4 — Certification and disclosure requirements
• § 54.5 — Agency evaluation of financial interests
• § 54.6 — Recordkeeping and record retention

PART 56

• § 56.101 — Scope
• § 56.102 — Definitions
• § 56.103 — Circumstances in which IRB review is required
• § 56.104 — Exemptions from IRB requirement
• § 56.105 — Waiver of IRB requirement
• § 56.106 — Registration
• § 56.107 — IRB membership
• § 56.108 — IRB functions and operations
• § 56.109 — IRB review of research
• § 56.110 — Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research
• § 56.111 — Criteria for IRB approval of research
• § 56.112 — Review by institution
• § 56.113 — Suspension or termination of IRB approval of research
• § 56.114 — Cooperative research
• § 56.115 — IRB records
• § 56.120 — Lesser administrative actions
• § 56.121 — Disqualification of an IRB or an institution
• § 56.122 — Public disclosure of information regarding revocation
• § 56.123 — Reinstatement of an IRB or an institution
• § 56.124 — Actions alternative or additional to disqualification

PART 58

• § 58.1 — Scope
• § 58.3 — Definitions
• § 58.10 — Applicability to studies performed under grants and contracts
• § 58.15 — Inspection of a testing facility
• § 58.29 — Personnel
• § 58.31 — Testing facility management
• § 58.33 — Study director
• § 58.35 — Quality assurance unit
• § 58.41 — General
• § 58.43 — Animal care facilities
• § 58.45 — Animal supply facilities
• § 58.47 — Facilities for handling test and control articles
• § 58.49 — Laboratory operation areas
• § 58.51 — Specimen and data storage facilities
• § 58.61 — Equipment design
• § 58.63 — Maintenance and calibration of equipment
• § 58.81 — Standard operating procedures
• § 58.83 — Reagents and solutions
• § 58.90 — Animal care
• § 58.105 — Test and control article characterization
• § 58.107 — Test and control article handling
• § 58.113 — Mixtures of articles with carriers
• § 58.120 — Protocol
• § 58.130 — Conduct of a nonclinical laboratory study
• § 58.185 — Reporting of nonclinical laboratory study results
• § 58.190 — Storage and retrieval of records and data
• § 58.195 — Retention of records
• § 58.200 — Purpose
• § 58.202 — Grounds for disqualification
• § 58.204 — Notice of and opportunity for hearing on proposed disqualification
• § 58.206 — Final order on disqualification
• § 58.210 — Actions upon disqualification
• § 58.213 — Public disclosure of information regarding disqualification
• § 58.215 — Alternative or additional actions to disqualification
• § 58.217 — Suspension or termination of a testing facility by a sponsor
• § 58.219 — Reinstatement of a disqualified testing facility

PART 60

• § 60.1 — Scope
• § 60.2 — Purpose
• § 60.3 — Definitions
• § 60.10 — FDA assistance on eligibility
• § 60.20 — FDA action on regulatory review period determinations
• § 60.22 — Regulatory review period determinations
• § 60.24 — Revision of regulatory review period determinations
• § 60.26 — Final action on regulatory review period determinations
• § 60.28 — Time frame for determining regulatory review periods
• § 60.30 — Filing, format, and content of petitions
• § 60.32 — Applicant response to petition
• § 60.34 — FDA action on petitions
• § 60.36 — Standard of due diligence
• § 60.40 — Request for hearing
• § 60.42 — Notice of hearing
• § 60.44 — Hearing procedures
• § 60.46 — Administrative decision

PART 70

• § 70.3 — Definitions
• § 70.5 — General restrictions on use of color additives
• § 70.10 — Color additives in standardized foods and new drugs
• § 70.11 — Related substances
• § 70.19 — Fees for listing
• § 70.20 — Packaging requirements for straight colors (other than hair dyes)
• § 70.25 — Labeling requirements for color additives (other than hair dyes)
• § 70.40 — Safety factors to be considered
• § 70.42 — Criteria for evaluating the safety of color additives
• § 70.45 — Allocation of color additives
• § 70.50 — Application of the cancer clause of section 721 of the act
• § 70.51 — Advisory committee on the applicability of the anticancer clause
• § 70.55 — Request for scientific studies

PART 71

• § 71.1 — Petitions
• § 71.2 — Notice of filing of petition
• § 71.4 — Samples; additional information
• § 71.6 — Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice
• § 71.15 — Confidentiality of data and information in color additive petitions
• § 71.18 — Petition for exemption from certification
• § 71.20 — Publication of regulation
• § 71.22 — Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued
• § 71.25 — Condition for certification
• § 71.26 — Revocation of exemption from certification
• § 71.27 — Listing and exemption from certification on the Commissioner's initiative
• § 71.30 — Procedure for filing objections to regulations
• § 71.37 — Exemption of color additives for investigational use

PART 73

• § 73.1 — Diluents in color additive mixtures for food use exempt from certification
• § 73.30 — Annatto extract
• § 73.32 — Antarctic krill meal
• § 73.35 — Astaxanthin
• § 73.37 — Astaxanthin dimethyldisuccinate
• § 73.39 — xxx
• § 73.40 — Dehydrated beets (beet powder)
• § 73.50 — Ultramarine blue
• § 73.69 — Butterfly pea flower extract
• § 73.70 — Calcium carbonate
• § 73.75 — Canthaxanthin
• § 73.80 — Calcium phosphate
• § 73.85 — Caramel
• § 73.90 — β-Apo-8′-carotenal
• § 73.95 — β-Carotene
• § 73.100 — Cochineal extract; carmine
• § 73.125 — Sodium copper chlorophyllin
• § 73.140 — Toasted partially defatted cooked cottonseed flour
• § 73.160 — Ferrous gluconate
• § 73.165 — Ferrous lactate
• § 73.167 — Galdieria extract blue
• § 73.168 — Gardenia (genipin) blue
• § 73.169 — Grape color extract
• § 73.170 — Grape skin extract (enocianina)
• § 73.185 — Haematococcus algae meal
• § 73.200 — Synthetic iron oxide
• § 73.225 — Jagua (genipin-glycine) blue
• § 73.250 — Fruit juice
• § 73.260 — Vegetable juice
• § 73.275 — Dried algae meal
• § 73.295 — Tagetes (Aztec marigold) meal and extract
• § 73.297 — Myoglobin
• § 73.300 — Carrot oil
• § 73.315 — Corn endosperm oil
• § 73.340 — Paprika
• § 73.345 — Paprika oleoresin
• § 73.350 — Mica-based pearlescent pigments
• § 73.352 — Paracoccus pigment
• § 73.355 — Phaffia yeast
• § 73.450 — Riboflavin
• § 73.500 — Saffron
• § 73.520 — Soy leghemoglobin
• § 73.530 — Spirulina extract
• § 73.575 — Titanium dioxide
• § 73.585 — Tomato lycopene extract; tomato lycopene concentrate
• § 73.600 — Turmeric
• § 73.615 — Turmeric oleoresin
• § 73.1001 — Diluents in color additive mixtures for drug use exempt from certification
• § 73.1010 — Alumina (dried aluminum hydroxide)
• § 73.1015 — Chromium-cobalt-aluminum oxide
• § 73.1025 — Ferric ammonium citrate
• § 73.1030 — Annatto extract
• § 73.1070 — Calcium carbonate
• § 73.1075 — Canthaxanthin
• § 73.1085 — Caramel
• § 73.1095 — β-Carotene
• § 73.1100 — Cochineal extract; carmine
• § 73.1125 — Potassium sodium copper chloropyhllin (chlorophyllin-copper complex)
• § 73.1150 — Dihydroxyacetone
• § 73.1162 — Bismuth oxychloride
• § 73.1200 — Synthetic iron oxide
• § 73.1298 — Ferric ammonium ferrocyanide
• § 73.1299 — Ferric ferrocyanide
• § 73.1326 — Chromium hydroxide green
• § 73.1327 — Chromium oxide greens
• § 73.1329 — Guanine
• § 73.1350 — Mica-based pearlescent pigments
• § 73.1375 — Pyrogallol
• § 73.1400 — Pyrophyllite
• § 73.1410 — Logwood extract
• § 73.1496 — Mica
• § 73.1530 — Spirulina extract
• § 73.1550 — Talc
• § 73.1575 — Titanium dioxide
• § 73.1645 — Aluminum powder
• § 73.1646 — Bronze powder
• § 73.1647 — Copper powder
• § 73.1991 — Zinc oxide
• § 73.2030 — Annatto
• § 73.2085 — Caramel
• § 73.2087 — Carmine
• § 73.2095 — β-Carotene
• § 73.2110 — Bismuth citrate
• § 73.2120 — Disodium EDTA-copper
• § 73.2125 — Potassium sodium copper chlorophyllin (chlorophyllin-copper complex)
• § 73.2150 — Dihydroxyacetone
• § 73.2162 — Bismuth oxychloride
• § 73.2180 — Guaiazulene
• § 73.2190 — Henna
• § 73.2250 — Iron oxides
• § 73.2298 — Ferric ammonium ferrocyanide
• § 73.2299 — Ferric ferrocyanide
• § 73.2326 — Chromium hydroxide green
• § 73.2327 — Chromium oxide greens
• § 73.2329 — Guanine
• § 73.2400 — Pyrophyllite
• § 73.2496 — Mica
• § 73.2500 — Silver
• § 73.2550 — Silver nitrate
• § 73.2575 — Titanium dioxide
• § 73.2645 — Aluminum powder
• § 73.2646 — Bronze powder
• § 73.2647 — Copper powder
• § 73.2725 — Ultramarines
• § 73.2775 — Manganese violet
• § 73.2991 — Zinc oxide
• § 73.2995 — Luminescent zinc sulfide
• § 73.3100 — 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers
• § 73.3105 — 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione
• § 73.3106 — 1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone copolymers
• § 73.3107 — Carbazole violet
• § 73.3110 — Chlorophyllin-copper complex, oil soluble
• § 73.3110a — Chromium-cobalt-aluminum oxide
• § 73.3111 — Chromium oxide greens
• § 73.3112 — C.I. Vat Orange 1
• § 73.3115 — 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol
• § 73.3117 — 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone
• § 73.3118 — N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide
• § 73.3119 — 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone
• § 73.3120 — 16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione
• § 73.3121 — Poly(hydroxyethyl methacrylate)-dye copolymers
• § 73.3122 — 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one
• § 73.3123 — 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one
• § 73.3124 — Phthalocyanine green
• § 73.3125 — Iron oxides
• § 73.3126 — Titanium dioxide
• § 73.3127 — Vinyl alcohol/methyl methacrylate-dye reaction products
• § 73.3128 — Mica-based pearlescent pigments
• § 73.3129 — Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate

PART 74

• § 74.101 — FD&C Blue No. 1
• § 74.102 — FD&C Blue No. 2
• § 74.203 — FD&C Green No. 3
• § 74.250 — Orange B
• § 74.302 — Citrus Red No. 2
• § 74.303 — FD&C Red No. 3
• § 74.340 — FD&C Red No. 40
• § 74.705 — FD&C Yellow No. 5
• § 74.706 — FD&C Yellow No. 6
• § 74.1101 — FD&C Blue No. 1
• § 74.1102 — FD&C Blue No. 2
• § 74.1104 — D&C Blue No. 4
• § 74.1109 — D&C Blue No. 9
• § 74.1203 — FD&C Green No. 3
• § 74.1205 — D&C Green No. 5
• § 74.1206 — D&C Green No. 6
• § 74.1208 — D&C Green No. 8
• § 74.1254 — D&C Orange No. 4
• § 74.1255 — D&C Orange No. 5
• § 74.1260 — D&C Orange No. 10
• § 74.1261 — D&C Orange No. 11
• § 74.1303 — FD&C Red No. 3
• § 74.1304 — FD&C Red No. 4
• § 74.1306 — D&C Red No. 6
• § 74.1307 — D&C Red No. 7
• § 74.1317 — D&C Red No. 17
• § 74.1321 — D&C Red No. 21
• § 74.1322 — D&C Red No. 22
• § 74.1327 — D&C Red No. 27
• § 74.1328 — D&C Red No. 28
• § 74.1330 — D&C Red No. 30
• § 74.1331 — D&C Red No. 31
• § 74.1333 — D&C Red No. 33
• § 74.1334 — D&C Red No. 34
• § 74.1336 — D&C Red No. 36
• § 74.1339 — D&C Red No. 39
• § 74.1340 — FD&C Red No. 40
• § 74.1602 — D&C Violet No. 2
• § 74.1705 — FD&C Yellow No. 5
• § 74.1706 — FD&C Yellow No. 6
• § 74.1707 — D&C Yellow No. 7
• § 74.1707a — Ext. D&C Yellow No. 7
• § 74.1708 — D&C Yellow No. 8
• § 74.1710 — D&C Yellow No. 10
• § 74.1711 — D&C Yellow No. 11
• § 74.2052 — D&C Black No. 2
• § 74.2053 — D&C Black No. 3
• § 74.2101 — FD&C Blue No. 1
• § 74.2104 — D&C Blue No. 4
• § 74.2151 — D&C Brown No. 1
• § 74.2203 — FD&C Green No. 3
• § 74.2205 — D&C Green No. 5
• § 74.2206 — D&C Green No. 6
• § 74.2208 — D&C Green No. 8
• § 74.2254 — D&C Orange No. 4
• § 74.2255 — D&C Orange No. 5
• § 74.2260 — D&C Orange No. 10
• § 74.2261 — D&C Orange No. 11
• § 74.2304 — FD&C Red No. 4
• § 74.2306 — D&C Red No. 6
• § 74.2307 — D&C Red No. 7
• § 74.2317 — D&C Red No. 17
• § 74.2321 — D&C Red No. 21
• § 74.2322 — D&C Red No. 22
• § 74.2327 — D&C Red No. 27
• § 74.2328 — D&C Red No. 28
• § 74.2330 — D&C Red No. 30
• § 74.2331 — D&C Red No. 31
• § 74.2333 — D&C Red No. 33
• § 74.2334 — D&C Red No. 34
• § 74.2336 — D&C Red No. 36
• § 74.2340 — FD&C Red No. 40
• § 74.2602 — D&C Violet No. 2
• § 74.2602a — Ext. D&C Violet No. 2
• § 74.2705 — FD&C Yellow No. 5
• § 74.2706 — FD&C Yellow No. 6
• § 74.2707 — D&C Yellow No. 7
• § 74.2707a — Ext. D&C Yellow No. 7
• § 74.2708 — D&C Yellow No. 8
• § 74.2710 — D&C Yellow No. 10
• § 74.2711 — D&C Yellow No. 11
• § 74.3045 — [Phthalocyaninato(2-)] copper
• § 74.3054 — D&C Black No. 4
• § 74.3102 — FD&C Blue No. 2
• § 74.3106 — D&C Blue No. 6
• § 74.3206 — D&C Green No. 6
• § 74.3230 — D&C Red No. 17
• § 74.3602 — D&C Violet No. 2
• § 74.3708 — D&C Yellow No. 8
• § 74.3710 — D&C Yellow No. 10

PART 80

• § 80.10 — Fees for certification services
• § 80.21 — Request for certification
• § 80.22 — Samples to accompany requests for certification
• § 80.31 — Certification
• § 80.32 — Limitations of certificates
• § 80.34 — Authority to refuse certification service
• § 80.35 — Color additive mixtures; certification and exemption from certification
• § 80.37 — Treatment of batch pending certification
• § 80.38 — Treatment of batch after certification
• § 80.39 — Records of distribution

PART 81

• § 81.1 — Provisional lists of color additives
• § 81.10 — Termination of provisional listings of color additives
• § 81.30 — Cancellation of certificates

PART 82

• § 82.3 — Definitions
• § 82.5 — General specifications for straight colors
• § 82.6 — Certifiable mixtures
• § 82.50 — General
• § 82.51 — Lakes (FD&C)
• § 82.101 — FD&C Blue No. 1
• § 82.102 — FD&C Blue No. 2
• § 82.203 — FD&C Green No. 3
• § 82.304 — FD&C Red No. 4
• § 82.705 — FD&C Yellow No. 5
• § 82.706 — FD&C Yellow No. 6
• § 82.1050 — General
• § 82.1051 — Lakes (D&C)
• § 82.1104 — D&C Blue No. 4
• § 82.1205 — D&C Green No. 5
• § 82.1206 — D&C Green No. 6
• § 82.1254 — D&C Orange No. 4
• § 82.1255 — D&C Orange No. 5
• § 82.1260 — D&C Orange No. 10
• § 82.1261 — D&C Orange No. 11
• § 82.1306 — D&C Red No. 6
• § 82.1307 — D&C Red No. 7
• § 82.1317 — D&C Red No. 17
• § 82.1321 — D&C Red No. 21
• § 82.1322 — D&C Red No. 22
• § 82.1327 — D&C Red No. 27
• § 82.1328 — D&C Red No. 28
• § 82.1330 — D&C Red No. 30
• § 82.1331 — D&C Red No. 31
• § 82.1333 — D&C Red No. 33
• § 82.1334 — D&C Red No. 34
• § 82.1336 — D&C Red No. 36
• § 82.1602 — D&C Violet No. 2
• § 82.1707 — D&C Yellow No. 7
• § 82.1708 — D&C Yellow No. 8
• § 82.1710 — D&C Yellow No. 10
• § 82.2050 — General
• § 82.2051 — Lakes (Ext. D&C)
• § 82.2707a — Ext. D&C Yellow No. 7

PART 99

• § 99.1 — Scope
• § 99.3 — Definitions
• § 99.101 — Information that may be disseminated
• § 99.103 — Mandatory statements and information
• § 99.105 — Recipients of information
• § 99.201 — Manufacturer's submission to the agency
• § 99.203 — Request to extend the time for completing planned studies
• § 99.205 — Application for exemption from the requirement to file a supplemental application
• § 99.301 — Agency action on a submission
• § 99.303 — Extension of time for completing planned studies
• § 99.305 — Exemption from the requirement to file a supplemental application
• § 99.401 — Corrective actions and cessation of dissemination of information
• § 99.403 — Termination of approvals of applications for exemption
• § 99.405 — Applicability of labeling, adulteration, and misbranding authority
• § 99.501 — Recordkeeping and reports

PART 100

• § 100.1 — Petitions requesting exemption from preemption for State or local requirements
• § 100.2 — State enforcement of Federal regulations
• § 100.100 — Misleading containers
• § 100.155 — Salt and iodized salt

PART 101

• § 101.1 — Principal display panel of package form food
• § 101.2 — Information panel of package form food
• § 101.3 — Identity labeling of food in packaged form
• § 101.4 — Food; designation of ingredients
• § 101.5 — Food; name and place of business of manufacturer, packer, or distributor
• § 101.7 — Declaration of net quantity of contents
• § 101.8 — Vending machines
• § 101.9 — Nutrition labeling of food
• § 101.10 — Nutrition labeling of restaurant foods whose labels or labeling bear nutrient content claims or health claims
• § 101.11 — Nutrition labeling of standard menu items in covered establishments
• § 101.12 — Reference amounts customarily consumed per eating occasion
• § 101.13 — Nutrient content claims—general principles
• § 101.14 — Health claims: general requirements
• § 101.15 — Food; prominence of required statements
• § 101.17 — Food labeling warning, notice, and safe handling statements
• § 101.18 — Misbranding of food
• § 101.22 — Foods; labeling of spices, flavorings, colorings and chemical preservatives
• § 101.30 — Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice
• § 101.36 — Nutrition labeling of dietary supplements
• § 101.42 — Nutrition labeling of raw fruit, vegetables, and fish
• § 101.43 — Substantial compliance of food retailers with the guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish
• § 101.44 — What are the 20 most frequently consumed raw fruits, vegetables, and fish in the United States?
• § 101.45 — Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish
• § 101.54 — Nutrient content claims for “good source,” “high,” “more,” and “high potency.”
• § 101.56 — Nutrient content claims for “light” or “lite.”
• § 101.60 — Nutrient content claims for the calorie content of foods
• § 101.61 — Nutrient content claims for the sodium content of foods
• § 101.62 — Nutrient content claims for fat, fatty acid, and cholesterol content of foods
• § 101.65 — Implied nutrient content claims and related label statements
• § 101.67 — Use of nutrient content claims for butter
• § 101.69 — Petitions for nutrient content claims
• § 101.70 — Petitions for health claims
• § 101.71 — Health claims: claims not authorized
• § 101.72 — Health claims: calcium, vitamin D, and osteoporosis
• § 101.73 — Health claims: dietary lipids and cancer
• § 101.74 — Health claims: sodium and hypertension
• § 101.75 — Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease
• § 101.76 — Health claims: fiber-containing grain products, fruits, and vegetables and cancer
• § 101.77 — Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease
• § 101.78 — Health claims: fruits and vegetables and cancer
• § 101.79 — Health claims: Folate and neural tube defects
• § 101.80 — Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries
• § 101.81 — Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD)
• § 101.82 — Health claims: Soy protein and risk of coronary heart disease (CHD)
• § 101.83 — Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD)
• § 101.91 — Gluten-free labeling of food
• § 101.93 — Certain types of statements for dietary supplements
• § 101.95 — “Fresh,” “freshly frozen,” “fresh frozen,” “frozen fresh.”
• § 101.100 — Food; exemptions from labeling
• § 101.108 — Temporary exemptions for purposes of conducting authorized food labeling experiments

PART 102

• § 102.5 — General principles
• § 102.19 — Petitions
• § 102.22 — Protein hydrolysates
• § 102.23 — Peanut spreads
• § 102.26 — Frozen “heat and serve” dinners
• § 102.28 — Foods packaged for use in the preparation of “main dishes” or “dinners.”
• § 102.33 — Beverages that contain fruit or vegetable juice
• § 102.37 — Mixtures of edible fat or oil and olive oil
• § 102.39 — Onion rings made from diced onion
• § 102.41 — Potato chips made from dried potatoes
• § 102.45 — Fish sticks or portions made from minced fish
• § 102.46 — Pacific whiting
• § 102.47 — Bonito
• § 102.49 — Fried clams made from minced clams
• § 102.50 — Crabmeat
• § 102.54 — Seafood cocktails
• § 102.55 — Nonstandardized breaded composite shrimp units
• § 102.57 — Greenland turbot (Reinhardtius hippoglossoides)

PART 104

• § 104.5 — General principles
• § 104.20 — Statement of purpose
• § 104.47 — Frozen “heat and serve” dinner

PART 105

• § 105.3 — Definitions and interpretations
• § 105.62 — Hypoallergenic foods
• § 105.65 — Infant foods
• § 105.66 — Label statements relating to usefulness in reducing or maintaining body weight

PART 106

• § 106.1 — Status and applicability of the regulations in part 106
• § 106.3 — Definitions
• § 106.5 — Current good manufacturing practice
• § 106.6 — Production and in-process control system
• § 106.10 — Controls to prevent adulteration by workers
• § 106.20 — Controls to prevent adulteration caused by facilities
• § 106.30 — Controls to prevent adulteration caused by equipment or utensils
• § 106.35 — Controls to prevent adulteration due to automatic (mechanical or electronic) equipment
• § 106.40 — Controls to prevent adulteration caused by ingredients, containers, and closures
• § 106.50 — Controls to prevent adulteration during manufacturing
• § 106.55 — Controls to prevent adulteration from microorganisms
• § 106.60 — Controls to prevent adulteration during packaging and labeling of infant formula
• § 106.70 — Controls on the release of finished infant formula
• § 106.80 — Traceability
• § 106.90 — Audits of current good manufacturing practice
• § 106.91 — General quality control
• § 106.92 — Audits of quality control procedures
• § 106.94 — Audit plans and procedures
• § 106.96 — Requirements for quality factors for infant formulas
• § 106.100 — Records
• § 106.110 — New infant formula registration
• § 106.120 — New infant formula submission
• § 106.121 — Quality factor assurances for infant formulas
• § 106.130 — Verification submission
• § 106.140 — Submission concerning a change in infant formula that may adulterate the product
• § 106.150 — Notification of an adulterated or misbranded infant formula
• § 106.160 — Incorporation by reference

PART 107

• § 107.1 — Status and applicability of the regulations in part 107
• § 107.3 — Definitions
• § 107.10 — Nutrient information
• § 107.20 — Directions for use
• § 107.30 — Exemptions
• § 107.50 — Terms and conditions
• § 107.100 — Nutrient specifications
• § 107.200 — Food and Drug Administration-required recall
• § 107.210 — Firm-initiated product removals
• § 107.220 — Scope and effect of infant formula recalls
• § 107.230 — Elements of an infant formula recall
• § 107.240 — Notification requirements
• § 107.250 — Termination of an infant formula recall
• § 107.260 — Revision of an infant formula recall
• § 107.270 — Compliance with this subpart
• § 107.280 — Records retention

PART 108

• § 108.3 — Definitions
• § 108.5 — Determination of the need for a permit
• § 108.6 — Revocation of determination of need for permit
• § 108.7 — Issuance or denial of permit
• § 108.10 — Suspension and reinstatement of permit
• § 108.12 — Manufacturing, processing, or packing without a permit, or in violation of a permit
• § 108.19 — Establishment of requirements for exemption from section 404 of the act
• § 108.25 — Acidified foods
• § 108.35 — Thermal processing of low-acid foods packaged in hermetically sealed containers

PART 109

• § 109.3 — Definitions and interpretations
• § 109.4 — Establishment of tolerances, regulatory limits, and action levels
• § 109.6 — Added poisonous or deleterious substances
• § 109.7 — Unavoidability
• § 109.15 — Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials
• § 109.16 — Ornamental and decorative ceramicware
• § 109.30 — Tolerances for polychlorinated biphenyls (PCB's)

PART 110

• § 110.3 — Definitions
• § 110.5 — Current good manufacturing practice
• § 110.10 — Personnel
• § 110.19 — Exclusions
• § 110.20 — Plant and grounds
• § 110.35 — Sanitary operations
• § 110.37 — Sanitary facilities and controls
• § 110.40 — Equipment and utensils
• § 110.80 — Processes and controls
• § 110.93 — Warehousing and distribution
• § 110.110 — Natural or unavoidable defects in food for human use that present no health hazard

PART 111

• § 111.1 — Who is subject to this part?
• § 111.3 — What definitions apply to this part?
• § 111.5 — Do other statutory provisions and regulations apply?
• § 111.8 — What are the requirements under this subpart B for written procedures?
• § 111.10 — What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?
• § 111.12 — What personnel qualification requirements apply?
• § 111.13 — What supervisor requirements apply?
• § 111.14 — Under this subpart B, what records must you make and keep?
• § 111.15 — What sanitation requirements apply to your physical plant and grounds?
• § 111.16 — What are the requirements under this subpart C for written procedures?
• § 111.20 — What design and construction requirements apply to your physical plant?
• § 111.23 — Under this subpart C, what records must you make and keep?
• § 111.25 — What are the requirements under this subpart D for written procedures?
• § 111.27 — What requirements apply to the equipment and utensils that you use?
• § 111.30 — What requirements apply to automated, mechanical, or electronic equipment?
• § 111.35 — Under this subpart D, what records must you make and keep?
• § 111.55 — What are the requirements to implement a production and process control system?
• § 111.60 — What are the design requirements for the production and process control system?
• § 111.65 — What are the requirements for quality control operations?
• § 111.70 — What specifications must you establish?
• § 111.73 — What is your responsibility for determining whether established specifications are met?
• § 111.75 — What must you do to determine whether specifications are met?
• § 111.77 — What must you do if established specifications are not met?
• § 111.80 — What representative samples must you collect?
• § 111.83 — What are the requirements for reserve samples?
• § 111.87 — Who conducts a material review and makes a disposition decision?
• § 111.90 — What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with § 111.70 is not met?
• § 111.95 — Under this subpart E, what records must you make and keep?
• § 111.103 — What are the requirements under this subpart F for written procedures?
• § 111.105 — What must quality control personnel do?
• § 111.110 — What quality control operations are required for laboratory operations associated with the production and process control system?
• § 111.113 — What quality control operations are required for a material review and disposition decision?
• § 111.117 — What quality control operations are required for equipment, instruments, and controls?
• § 111.120 — What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
• § 111.123 — What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?
• § 111.127 — What quality control operations are required for packaging and labeling operations?
• § 111.130 — What quality control operations are required for returned dietary supplements?
• § 111.135 — What quality control operations are required for product complaints?
• § 111.140 — Under this subpart F, what records must you make and keep?
• § 111.153 — What are the requirements under this subpart G for written procedures?
• § 111.155 — What requirements apply to components of dietary supplements?
• § 111.160 — What requirements apply to packaging and labels received?
• § 111.165 — What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier)?
• § 111.170 — What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement?
• § 111.180 — Under this subpart G, what records must you make and keep?
• § 111.205 — What is the requirement to establish a master manufacturing record?
• § 111.210 — What must the master manufacturing record include?
• § 111.255 — What is the requirement to establish a batch production record?
• § 111.260 — What must the batch record include?
• § 111.303 — What are the requirements under this subpart J for written procedures?
• § 111.310 — What are the requirements for the laboratory facilities that you use?
• § 111.315 — What are the requirements for laboratory control processes?
• § 111.320 — What requirements apply to laboratory methods for testing and examination?
• § 111.325 — Under this subpart J, what records must you make and keep?
• § 111.353 — What are the requirements under this subpart K for written procedures?
• § 111.355 — What are the design requirements for manufacturing operations?
• § 111.360 — What are the requirements for sanitation?
• § 111.365 — What precautions must you take to prevent contamination?
• § 111.370 — What requirements apply to rejected dietary supplements?
• § 111.375 — Under this subpart K, what records must you make and keep?
• § 111.403 — What are the requirements under this subpart L for written procedures?
• § 111.410 — What requirements apply to packaging and labels?
• § 111.415 — What requirements apply to filling, assembling, packaging, labeling, and related operations?
• § 111.420 — What requirements apply to repackaging and relabeling?
• § 111.425 — What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?
• § 111.430 — Under this subpart L, what records must you make and keep?
• § 111.453 — What are the requirements under this subpart for M written procedures?
• § 111.455 — What requirements apply to holding components, dietary supplements, packaging, and labels?
• § 111.460 — What requirements apply to holding in-process material?
• § 111.465 — What requirements apply to holding reserve samples of dietary supplements?
• § 111.470 — What requirements apply to distributing dietary supplements?
• § 111.475 — Under this subpart M, what records must you make and keep?
• § 111.503 — What are the requirements under this subpart N for written procedures?
• § 111.510 — What requirements apply when a returned dietary supplement is received?
• § 111.515 — When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?
• § 111.520 — When may a returned dietary supplement be salvaged?
• § 111.525 — What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?
• § 111.530 — When must an investigation be conducted of your manufacturing processes and other batches?
• § 111.535 — Under this subpart N, what records must you make and keep?
• § 111.553 — What are the requirements under this subpart O for written procedures?
• § 111.560 — What requirements apply to the review and investigation of a product complaint?
• § 111.570 — Under this subpart O, what records must you make and keep?
• § 111.605 — What requirements apply to the records that you make and keep?
• § 111.610 — What records must be made available to FDA?

PART 112

• § 112.1 — What food is covered by this part?
• § 112.2 — What produce is not covered by this part?
• § 112.3 — What definitions apply to this part?
• § 112.4 — Which farms are subject to the requirements of this part?
• § 112.5 — Which farms are eligible for a qualified exemption and associated modified requirements based on average monetary value of all food sold and direct farm marketing?
• § 112.6 — What modified requirements apply to me if my farm is eligible for a qualified exemption in accordance with § 112.5?
• § 112.7 — What records must I establish and keep if my farm is eligible for a qualified exemption in accordance with § 112.5?
• § 112.11 — What general requirements apply to persons who are subject to this part?
• § 112.12 — Are there any alternatives to the requirements established in this part?
• § 112.21 — What requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces?
• § 112.22 — What minimum requirements apply for training personnel who conduct a covered activity?
• § 112.23 — What requirements apply regarding supervisors?
• § 112.30 — Under this subpart, what requirements apply regarding records?
• § 112.31 — What measures must I take to prevent ill or infected persons from contaminating covered produce with microorganisms of public health significance?
• § 112.32 — What hygienic practices must personnel use?
• § 112.33 — What measures must I take to prevent visitors from contaminating covered produce and food contact surfaces with microorganisms of public health significance?
• § 112.40 — What requirements of this subpart apply to my covered farm?
• § 112.41 — What requirements apply to the quality of my agricultural water?
• § 112.42 — What requirements apply to inspecting and maintaining my agricultural water systems?
• § 112.43 — What requirements apply to assessing agricultural water used in growing covered produce (other than sprouts)?
• § 112.44 — What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce?
• § 112.45 — What measures must I take for agricultural water to reduce the potential for contamination of covered produce or food contact surfaces with known or reasonably foreseeable hazards?
• § 112.46 — What requirements apply to treating agricultural water?
• § 112.47 — Who must perform the tests required under this subpart?
• § 112.48-112.49 — 112.48-112.49 [Reserved]
• § 112.50 — Under this subpart, what requirements apply regarding records?
• § 112.51 — What requirements apply for determining the status of a biological soil amendment of animal origin?
• § 112.52 — How must I handle, convey, and store biological soil amendments of animal origin?
• § 112.53 — What prohibitions apply regarding use of human waste?
• § 112.54 — What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce?
• § 112.55 — What microbial standards apply to the treatment processes in § 112.54?
• § 112.56 — What application requirements and minimum application intervals apply to biological soil amendments of animal origin?
• § 112.60 — Under this subpart, what requirements apply regarding records?
• § 112.81 — How do the requirements of this subpart apply to areas where covered activities take place?
• § 112.83 — What requirements apply regarding grazing animals, working animals, and animal intrusion?
• § 112.84 — Does this regulation require covered farms to take actions that would constitute a “taking” of threatened or endangered species; to take measures to exclude animals from outdoor growing areas; or to destroy animal habitat or otherwise clear farm borders around outdoor growing areas or drainages?
• § 112.111 — What measures must I take if I grow, harvest, pack or hold both covered and excluded produce?
• § 112.112 — What measures must I take immediately prior to and during harvest activities?
• § 112.113 — How must I handle harvested covered produce during covered activities?
• § 112.114 — What requirements apply to dropped covered produce?
• § 112.115 — What measures must I take when packaging covered produce?
• § 112.116 — What measures must I take when using food-packing (including food packaging) material?
• § 112.121 — What equipment and tools are subject to the requirements of this subpart?
• § 112.122 — What buildings are subject to the requirements of this subpart?
• § 112.123 — What general requirements apply regarding equipment and tools subject to this subpart?
• § 112.124 — What requirements apply to instruments and controls used to measure, regulate, or record?
• § 112.125 — What requirements apply to equipment that is subject to this subpart used in the transport of covered produce?
• § 112.126 — What requirements apply to my buildings?
• § 112.127 — What requirements apply regarding domesticated animals in and around a fully-enclosed building?
• § 112.128 — What requirements apply regarding pest control in buildings?
• § 112.129 — What requirements apply to toilet facilities?
• § 112.130 — What requirements apply for hand-washing facilities?
• § 112.131 — What must I do to control and dispose of sewage?
• § 112.132 — What must I do to control and dispose of trash, litter, and waste in areas used for covered activities?
• § 112.133 — What requirements apply to plumbing?
• § 112.134 — What must I do to control animal excreta and litter from domesticated animals that are under my control?
• § 112.140 — Under this subpart, what requirements apply regarding records?
• § 112.141 — What commodities are subject to this subpart?
• § 112.142 — What requirements apply to seeds or beans used to grow sprouts?
• § 112.143 — What measures must I take for growing, harvesting, packing, and holding sprouts?
• § 112.144 — What testing must I do during growing, harvesting, packing, and holding sprouts?
• § 112.145 — What requirements apply to testing the environment for Listeria species or L. monocytogenes?
• § 112.146 — What actions must I take if the growing, harvesting, packing, or holding environment tests positive for Listeria species or L. monocytogenes?
• § 112.147 — What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens?
• § 112.148 — What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen?
• § 112.150 — Under this subpart, what requirements apply regarding records?
• § 112.151 — What methods must I use to test the quality of water to satisfy the requirements of subpart E of this part?
• § 112.152 — What methods must I use to test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes to satisfy the requirements of § 112.144(a)?
• § 112.153 — What methods must I use to test spent sprout irrigation water (or sprouts) from each production batch of sprouts for pathogens to satisfy the requirements of § 112.144(b) and (c)?
• § 112.161 — What general requirements apply to records required under this part?
• § 112.162 — Where must I store records?
• § 112.163 — May I use existing records to satisfy the requirements of this part?
• § 112.164 — How long must I keep records?
• § 112.165 — What formats are acceptable for the records I keep?
• § 112.166 — What requirements apply for making records available and accessible to FDA?
• § 112.167 — Can records that I provide to FDA be disclosed to persons outside of FDA?
• § 112.171 — Who may request a variance from the requirements of this part?
• § 112.172 — How may a State, tribe, or foreign country request a variance from one or more requirements of this part?
• § 112.173 — What must be included in the Statement of Grounds in a petition requesting a variance?
• § 112.174 — What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?
• § 112.175 — Who responds to a petition requesting a variance?
• § 112.176 — What process applies to a petition requesting a variance?
• § 112.177 — Can an approved variance apply to any person other than those identified in the petition requesting that variance?
• § 112.178 — Under what circumstances may FDA deny a petition requesting a variance?
• § 112.179 — When does a variance approved by FDA become effective?
• § 112.180 — Under what circumstances may FDA modify or revoke an approved variance?
• § 112.181 — What procedures apply if FDA determines that an approved variance should be modified or revoked?
• § 112.182 — What are the permissible types of variances that may be granted?
• § 112.192 — What is the applicability and status of this part?
• § 112.193 — What are the provisions for coordination of education and enforcement?
• § 112.201 — Under what circumstances can FDA withdraw a qualified exemption in accordance with the requirements of § 112.5?
• § 112.202 — What procedure will FDA use to withdraw an exemption?
• § 112.203 — What information must FDA include in an order to withdraw a qualified exemption?
• § 112.204 — What must I do if I receive an order to withdraw a qualified exemption applicable to my farm?
• § 112.205 — Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm?
• § 112.206 — What is the procedure for submitting an appeal?
• § 112.207 — What is the procedure for requesting an informal hearing?
• § 112.208 — What requirements are applicable to an informal hearing?
• § 112.209 — Who is the presiding officer for an appeal and for an informal hearing?
• § 112.210 — What is the timeframe for issuing a decision on an appeal?
• § 112.211 — When is an order to withdraw a qualified exemption applicable to a farm revoked?
• § 112.213 — If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption?

PART 113

• § 113.3 — Definitions
• § 113.5 — Current good manufacturing practice
• § 113.10 — Personnel
• § 113.40 — Equipment and procedures
• § 113.60 — Containers
• § 113.81 — Product preparation
• § 113.83 — Establishing scheduled processes
• § 113.87 — Operations in the thermal processing room
• § 113.89 — Deviations in processing, venting, or control of critical factors
• § 113.100 — Processing and production records

PART 114

• § 114.3 — Definitions
• § 114.5 — Current good manufacturing practice
• § 114.10 — Personnel
• § 114.80 — Processes and controls
• § 114.83 — Establishing scheduled processes
• § 114.89 — Deviations from scheduled processes
• § 114.90 — Methodology
• § 114.100 — Records

PART 115

• § 115.50 — Refrigeration of shell eggs held for retail distribution

PART 117

• § 117.1 — Applicability and status
• § 117.3 — Definitions
• § 117.4 — Qualifications of individuals who manufacture, process, pack, or hold food
• § 117.5 — Exemptions
• § 117.7 — Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food
• § 117.8 — Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities
• § 117.9 — Records required for this subpart
• § 117.10 — Personnel
• § 117.20 — Plant and grounds
• § 117.35 — Sanitary operations
• § 117.37 — Sanitary facilities and controls
• § 117.40 — Equipment and utensils
• § 117.80 — Processes and controls
• § 117.93 — Warehousing and distribution
• § 117.95 — Holding and distribution of human food by-products for use as animal food
• § 117.110 — Defect action levels
• § 117.126 — Food safety plan
• § 117.130 — Hazard analysis
• § 117.135 — Preventive controls
• § 117.136 — Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control
• § 117.137 — Provision of assurances required under § 117.136(a)(2), (3), and (4)
• § 117.139 — Recall plan
• § 117.140 — Preventive control management components
• § 117.145 — Monitoring
• § 117.150 — Corrective actions and corrections
• § 117.155 — Verification
• § 117.160 — Validation
• § 117.165 — Verification of implementation and effectiveness
• § 117.170 — Reanalysis
• § 117.180 — Requirements applicable to a preventive controls qualified individual and a qualified auditor
• § 117.190 — Implementation records required for this subpart
• § 117.201 — Modified requirements that apply to a qualified facility
• § 117.206 — Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food
• § 117.251 — Circumstances that may lead FDA to withdraw a qualified facility exemption
• § 117.254 — Issuance of an order to withdraw a qualified facility exemption
• § 117.257 — Contents of an order to withdraw a qualified facility exemption
• § 117.260 — Compliance with, or appeal of, an order to withdraw a qualified facility exemption
• § 117.264 — Procedure for submitting an appeal
• § 117.267 — Procedure for requesting an informal hearing
• § 117.270 — Requirements applicable to an informal hearing
• § 117.274 — Presiding officer for an appeal and for an informal hearing
• § 117.277 — Timeframe for issuing a decision on an appeal
• § 117.280 — Revocation of an order to withdraw a qualified facility exemption
• § 117.284 — Final agency action
• § 117.287 — Reinstatement of a qualified facility exemption that was withdrawn
• § 117.301 — Records subject to the requirements of this subpart
• § 117.305 — General requirements applying to records
• § 117.310 — Additional requirements applying to the food safety plan
• § 117.315 — Requirements for record retention
• § 117.320 — Requirements for official review
• § 117.325 — Public disclosure
• § 117.330 — Use of existing records
• § 117.335 — Special requirements applicable to a written assurance
• § 117.405 — Requirement to establish and implement a supply-chain program
• § 117.410 — General requirements applicable to a supply-chain program
• § 117.415 — Responsibilities of the receiving facility
• § 117.420 — Using approved suppliers
• § 117.425 — Determining appropriate supplier verification activities (including determining the frequency of conducting the activity)
• § 117.430 — Conducting supplier verification activities for raw materials and other ingredients
• § 117.435 — Onsite audit
• § 117.475 — Records documenting the supply-chain program

PART 118

• § 118.1 — Persons covered by the requirements in this part
• § 118.3 — Definitions
• § 118.4 — Salmonella Enteritidis (SE) prevention measures
• § 118.5 — Environmental testing for Salmonella Enteritidis (SE)
• § 118.6 — Egg testing for Salmonella Enteritidis (SE)
• § 118.7 — Sampling methodology for Salmonella Enteritidis (SE)
• § 118.8 — Testing methodology for Salmonella Enteritidis (SE)
• § 118.9 — Administration of the Salmonella Enteritidis (SE) prevention plan
• § 118.10 — Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan
• § 118.11 — Registration requirements for shell egg producers covered by the requirements of this part
• § 118.12 — Enforcement and compliance

PART 119

• § 119.1 — Dietary supplements containing ephedrine alkaloids

PART 120

• § 120.1 — Applicability
• § 120.3 — Definitions
• § 120.5 — Current good manufacturing practice
• § 120.6 — Sanitation standard operating procedures
• § 120.7 — Hazard analysis
• § 120.8 — Hazard Analysis and Critical Control Point (HACCP) plan
• § 120.9 — Legal basis
• § 120.10 — Corrective actions
• § 120.11 — Verification and validation
• § 120.12 — Records
• § 120.13 — Training
• § 120.14 — Application of requirements to imported products
• § 120.20 — General
• § 120.24 — Process controls
• § 120.25 — Process verification for certain processors

PART 121

• § 121.1 — Applicability
• § 121.3 — Definitions
• § 121.4 — Qualifications of individuals who perform activities under subpart C of this part
• § 121.5 — Exemptions
• § 121.126 — Food defense plan
• § 121.130 — Vulnerability assessment to identify significant vulnerabilities and actionable process steps
• § 121.135 — Mitigation strategies for actionable process steps
• § 121.138 — Mitigation strategies management components
• § 121.140 — Food defense monitoring
• § 121.145 — Food defense corrective actions
• § 121.150 — Food defense verification
• § 121.157 — Reanalysis
• § 121.301 — Records subject to the requirements of this subpart
• § 121.305 — General requirements applying to records
• § 121.310 — Additional requirements applying to the food defense plan
• § 121.315 — Requirements for record retention
• § 121.320 — Requirements for official review
• § 121.325 — Public disclosure
• § 121.330 — Use of existing records
• § 121.401 — Compliance

PART 123

• § 123.3 — Definitions
• § 123.5 — Current good manufacturing practice
• § 123.6 — Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan
• § 123.7 — Corrective actions
• § 123.8 — Verification
• § 123.9 — Records
• § 123.10 — Training
• § 123.11 — Sanitation control procedures
• § 123.12 — Special requirements for imported products
• § 123.15 — General
• § 123.16 — Process controls
• § 123.20 — General
• § 123.28 — Source controls

PART 129

• § 129.1 — Current good manufacturing practice
• § 129.3 — Definitions
• § 129.20 — Plant construction and design
• § 129.35 — Sanitary facilities
• § 129.37 — Sanitary operations
• § 129.40 — Equipment and procedures
• § 129.80 — Processes and controls

PART 130

• § 130.3 — Definitions and interpretations
• § 130.5 — Procedure for establishing a food standard
• § 130.6 — Review of Codex Alimentarius food standards
• § 130.8 — Conformity to definitions and standards of identity
• § 130.9 — Sulfites in standardized food
• § 130.10 — Requirements for foods named by use of a nutrient content claim and a standardized term
• § 130.11 — Label designations of ingredients for standardized foods
• § 130.12 — General methods for water capacity and fill of containers
• § 130.14 — General statements of substandard quality and substandard fill of container
• § 130.17 — Temporary permits for interstate shipment of experimental packs of food varying from the requirements of definitions and standards of identity
• § 130.20 — Food additives proposed for use in foods for which definitions and standards of identity are established

PART 131

• § 131.3 — Definitions
• § 131.25 — Whipped cream products containing flavoring or sweetening
• § 131.110 — Milk
• § 131.111 — Acidified milk
• § 131.112 — Cultured milk
• § 131.115 — Concentrated milk
• § 131.120 — Sweetened condensed milk
• § 131.125 — Nonfat dry milk
• § 131.127 — Nonfat dry milk fortified with vitamins A and D
• § 131.130 — Evaporated milk
• § 131.147 — Dry whole milk
• § 131.149 — Dry cream
• § 131.150 — Heavy cream
• § 131.155 — Light cream
• § 131.157 — Light whipping cream
• § 131.160 — Sour cream
• § 131.162 — Acidified sour cream
• § 131.170 — Eggnog
• § 131.180 — Half-and-half
• § 131.200 — Yogurt

PART 133

• § 133.3 — Definitions
• § 133.5 — Methods of analysis
• § 133.10 — Notice to manufacturers, packers, and distributors of pasteurized blended cheese, pasteurized process cheese, cheese food, cheese spread, and related foods
• § 133.102 — Asiago fresh and asiago soft cheese
• § 133.103 — Asiago medium cheese
• § 133.104 — Asiago old cheese
• § 133.106 — Blue cheese
• § 133.108 — Brick cheese
• § 133.109 — Brick cheese for manufacturing
• § 133.111 — Caciocavallo siciliano cheese
• § 133.113 — Cheddar cheese
• § 133.114 — Cheddar cheese for manufacturing
• § 133.116 — Low sodium cheddar cheese
• § 133.118 — Colby cheese
• § 133.119 — Colby cheese for manufacturing
• § 133.121 — Low sodium colby cheese
• § 133.123 — Cold-pack and club cheese
• § 133.124 — Cold-pack cheese food
• § 133.125 — Cold-pack cheese food with fruits, vegetables, or meats
• § 133.127 — Cook cheese, koch kaese
• § 133.128 — Cottage cheese
• § 133.129 — Dry curd cottage cheese
• § 133.133 — Cream cheese
• § 133.134 — Cream cheese with other foods
• § 133.136 — Washed curd and soaked curd cheese
• § 133.137 — Washed curd cheese for manufacturing
• § 133.138 — Edam cheese
• § 133.140 — Gammelost cheese
• § 133.141 — Gorgonzola cheese
• § 133.142 — Gouda cheese
• § 133.144 — Granular and stirred curd cheese
• § 133.145 — Granular cheese for manufacturing
• § 133.146 — Grated cheeses
• § 133.147 — Grated American cheese food
• § 133.148 — Hard grating cheeses
• § 133.149 — Gruyere cheese
• § 133.150 — Hard cheeses
• § 133.152 — Limburger cheese
• § 133.153 — Monterey cheese and monterey jack cheese
• § 133.154 — High-moisture jack cheese
• § 133.155 — Mozzarella cheese and scamorza cheese
• § 133.156 — Low-moisture mozzarella and scamorza cheese
• § 133.157 — Part-skim mozzarella and scamorza cheese
• § 133.158 — Low-moisture part-skim mozzarella and scamorza cheese
• § 133.160 — Muenster and munster cheese
• § 133.161 — Muenster and munster cheese for manufacturing
• § 133.162 — Neufchatel cheese
• § 133.164 — Nuworld cheese
• § 133.165 — Parmesan and reggiano cheese
• § 133.167 — Pasteurized blended cheese
• § 133.168 — Pasteurized blended cheese with fruits, vegetables, or meats
• § 133.169 — Pasteurized process cheese
• § 133.170 — Pasteurized process cheese with fruits, vegetables, or meats
• § 133.171 — Pasteurized process pimento cheese
• § 133.173 — Pasteurized process cheese food
• § 133.174 — Pasteurized process cheese food with fruits, vegetables, or meats
• § 133.175 — Pasteurized cheese spread
• § 133.176 — Pasteurized cheese spread with fruits, vegetables, or meats
• § 133.178 — Pasteurized neufchatel cheese spread with other foods
• § 133.179 — Pasteurized process cheese spread
• § 133.180 — Pasteurized process cheese spread with fruits, vegetables, or meats
• § 133.181 — Provolone cheese
• § 133.182 — Soft ripened cheeses
• § 133.183 — Romano cheese
• § 133.184 — Roquefort cheese, sheep's milk blue-mold, and blue-mold cheese from sheep's milk
• § 133.185 — Samsoe cheese
• § 133.186 — Sap sago cheese
• § 133.187 — Semisoft cheeses
• § 133.188 — Semisoft part-skim cheeses
• § 133.189 — Skim milk cheese for manufacturing
• § 133.190 — Spiced cheeses
• § 133.191 — Part-skim spiced cheeses
• § 133.193 — Spiced, flavored standardized cheeses
• § 133.195 — Swiss and emmentaler cheese
• § 133.196 — Swiss cheese for manufacturing

PART 135

• § 135.3 — Definitions
• § 135.110 — Ice cream and frozen custard
• § 135.115 — Goat's milk ice cream
• § 135.130 — Mellorine
• § 135.140 — Sherbet
• § 135.160 — Water ices

PART 136

• § 136.3 — Definitions
• § 136.110 — Bread, rolls, and buns
• § 136.115 — Enriched bread, rolls, and buns
• § 136.130 — Milk bread, rolls, and buns
• § 136.160 — Raisin bread, rolls, and buns
• § 136.180 — Whole wheat bread, rolls, and buns

PART 137

• § 137.105 — Flour
• § 137.155 — Bromated flour
• § 137.160 — Enriched bromated flour
• § 137.165 — Enriched flour
• § 137.170 — Instantized flours
• § 137.175 — Phosphated flour
• § 137.180 — Self-rising flour
• § 137.185 — Enriched self-rising flour
• § 137.190 — Cracked wheat
• § 137.195 — Crushed wheat
• § 137.200 — Whole wheat flour
• § 137.205 — Bromated whole wheat flour
• § 137.211 — White corn flour
• § 137.215 — Yellow corn flour
• § 137.220 — Durum flour
• § 137.225 — Whole durum flour
• § 137.250 — White corn meal
• § 137.255 — Bolted white corn meal
• § 137.260 — Enriched corn meals
• § 137.265 — Degerminated white corn meal
• § 137.270 — Self-rising white corn meal
• § 137.275 — Yellow corn meal
• § 137.280 — Bolted yellow corn meal
• § 137.285 — Degerminated yellow corn meal
• § 137.290 — Self-rising yellow corn meal
• § 137.300 — Farina
• § 137.305 — Enriched farina
• § 137.320 — Semolina
• § 137.350 — Enriched rice

PART 139

• § 139.110 — Macaroni products
• § 139.115 — Enriched macaroni products
• § 139.117 — Enriched macaroni products with fortified protein
• § 139.120 — Milk macaroni products
• § 139.121 — Nonfat milk macaroni products
• § 139.122 — Enriched nonfat milk macaroni products
• § 139.125 — Vegetable macaroni products
• § 139.135 — Enriched vegetable macaroni products
• § 139.138 — Whole wheat macaroni products
• § 139.140 — Wheat and soy macaroni products
• § 139.150 — Noodle products
• § 139.155 — Enriched noodle products
• § 139.160 — Vegetable noodle products
• § 139.165 — Enriched vegetable noodle products
• § 139.180 — Wheat and soy noodle products

PART 145

• § 145.3 — Definitions
• § 145.110 — Canned applesauce
• § 145.115 — Canned apricots
• § 145.120 — Canned berries
• § 145.125 — Canned cherries
• § 145.130 — Canned figs
• § 145.135 — Canned fruit cocktail
• § 145.145 — Canned grapefruit
• § 145.170 — Canned peaches
• § 145.175 — Canned pears
• § 145.180 — Canned pineapple
• § 145.185 — Canned plums
• § 145.190 — Canned prunes

PART 146

• § 146.3 — Definitions
• § 146.114 — Lemon juice
• § 146.120 — Frozen concentrate for lemonade
• § 146.121 — Frozen concentrate for artificially sweetened lemonade
• § 146.126 — Frozen concentrate for colored lemonade
• § 146.132 — Grapefruit juice
• § 146.135 — Orange juice
• § 146.137 — Frozen orange juice
• § 146.140 — Pasteurized orange juice
• § 146.141 — Canned orange juice
• § 146.145 — Orange juice from concentrate
• § 146.146 — Frozen concentrated orange juice
• § 146.148 — Reduced acid frozen concentrated orange juice
• § 146.150 — Canned concentrated orange juice
• § 146.151 — Orange juice for manufacturing
• § 146.152 — Orange juice with preservative
• § 146.153 — Concentrated orange juice for manufacturing
• § 146.154 — Concentrated orange juice with preservative
• § 146.185 — Pineapple juice
• § 146.187 — Canned prune juice

PART 150

• § 150.110 — Fruit butter
• § 150.140 — Fruit jelly
• § 150.160 — Fruit preserves and jams

PART 155

• § 155.3 — Definitions
• § 155.120 — Canned green beans and canned wax beans
• § 155.130 — Canned corn
• § 155.170 — Canned peas
• § 155.190 — Canned tomatoes
• § 155.191 — Tomato concentrates
• § 155.194 — Catsup
• § 155.200 — Certain other canned vegetables
• § 155.201 — Canned mushrooms

PART 156

• § 156.3 — Definitions
• § 156.145 — Tomato juice

PART 158

• § 158.3 — Definitions
• § 158.170 — Frozen peas

PART 160

• § 160.100 — Eggs
• § 160.105 — Dried eggs
• § 160.110 — Frozen eggs
• § 160.115 — Liquid eggs
• § 160.140 — Egg whites
• § 160.145 — Dried egg whites
• § 160.150 — Frozen egg whites
• § 160.180 — Egg yolks
• § 160.185 — Dried egg yolks
• § 160.190 — Frozen egg yolks

PART 161

• § 161.30 — Declaration of quantity of contents on labels for canned oysters
• § 161.130 — Oysters
• § 161.136 — Olympia oysters
• § 161.145 — Canned oysters
• § 161.170 — Canned Pacific salmon
• § 161.173 — Canned wet pack shrimp in transparent or nontransparent containers
• § 161.175 — Frozen raw breaded shrimp
• § 161.176 — Frozen raw lightly breaded shrimp
• § 161.190 — Canned tuna

PART 163

• § 163.5 — Methods of analysis
• § 163.110 — Cacao nibs
• § 163.111 — Chocolate liquor
• § 163.112 — Breakfast cocoa
• § 163.113 — Cocoa
• § 163.114 — Lowfat cocoa
• § 163.117 — Cocoa with dioctyl sodium sulfosuccinate for manufacturing
• § 163.123 — Sweet chocolate
• § 163.124 — White chocolate
• § 163.130 — Milk chocolate
• § 163.135 — Buttermilk chocolate
• § 163.140 — Skim milk chocolate
• § 163.145 — Mixed dairy product chocolates
• § 163.150 — Sweet cocoa and vegetable fat coating
• § 163.153 — Sweet chocolate and vegetable fat coating
• § 163.155 — Milk chocolate and vegetable fat coating

PART 164

• § 164.110 — Mixed nuts
• § 164.120 — Shelled nuts in rigid or semirigid containers
• § 164.150 — Peanut butter

PART 165

• § 165.3 — Definitions
• § 165.110 — Bottled water

PART 166

• § 166.40 — Labeling of margarine
• § 166.110 — Margarine

PART 168

• § 168.110 — Dextrose anhydrous
• § 168.111 — Dextrose monohydrate
• § 168.120 — Glucose sirup
• § 168.121 — Dried glucose sirup
• § 168.122 — Lactose
• § 168.130 — Cane sirup
• § 168.140 — Maple sirup
• § 168.160 — Sorghum sirup
• § 168.180 — Table sirup

PART 169

• § 169.3 — Definitions
• § 169.140 — Mayonnaise
• § 169.150 — Salad dressing
• § 169.175 — Vanilla extract
• § 169.176 — Concentrated vanilla extract
• § 169.177 — Vanilla flavoring
• § 169.178 — Concentrated vanilla flavoring
• § 169.179 — Vanilla powder
• § 169.180 — Vanilla-vanillin extract
• § 169.181 — Vanilla-vanillin flavoring
• § 169.182 — Vanilla-vanillin powder

PART 170

• § 170.3 — Definitions
• § 170.6 — Opinion letters on food additive status
• § 170.10 — Food additives in standardized foods
• § 170.15 — Adoption of regulation on initiative of Commissioner
• § 170.17 — Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals
• § 170.18 — Tolerances for related food additives
• § 170.19 — Pesticide chemicals in processed foods
• § 170.20 — General principles for evaluating the safety of food additives
• § 170.22 — Safety factors to be considered
• § 170.30 — Eligibility for classification as generally recognized as safe (GRAS)
• § 170.35 — Affirmation of generally recognized as safe (GRAS) status
• § 170.38 — Determination of food additive status
• § 170.39 — Threshold of regulation for substances used in food-contact articles
• § 170.45 — Fluorine-containing compounds
• § 170.50 — Glycine (aminoacetic acid) in food for human consumption
• § 170.60 — Nitrites and/or nitrates in curing premixes
• § 170.100 — Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA)
• § 170.101 — Information in a premarket notification for a food contact substance (FCN)
• § 170.102 — Confidentiality of information related to premarket notification for a food contact substance (FCN)
• § 170.103 — Withdrawal without prejudice of a premarket notification for a food contact substance (FCN)
• § 170.104 — Action on a premarket notification for a food contact substance (FCN)
• § 170.105 — The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective
• § 170.106 — Notification for a food contact substance formulation (NFCSF)
• § 170.203 — Definitions
• § 170.205 — Opportunity to submit a GRAS notice
• § 170.210 — How to send your GRAS notice to FDA
• § 170.215 — Incorporation into a GRAS notice
• § 170.220 — General requirements applicable to a GRAS notice
• § 170.225 — Part 1 of a GRAS notice: Signed statements and certification
• § 170.230 — Part 2 of a GRAS notice: Identity, method of manufacture, specifications, and physical or technical effect
• § 170.235 — Part 3 of a GRAS notice: Dietary exposure
• § 170.240 — Part 4 of a GRAS notice: Self-limiting levels of use
• § 170.245 — Part 5 of a GRAS notice: Experience based on common use in food before 1958
• § 170.250 — Part 6 of a GRAS notice: Narrative
• § 170.255 — Part 7 of a GRAS notice: List of supporting data and information in your GRAS notice
• § 170.260 — Steps you may take before FDA responds to your GRAS notice
• § 170.265 — What FDA will do with a GRAS notice
• § 170.270 — Procedures that apply when the intended conditions of use of a notified substance include use in a product or products subject to regulation by the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture
• § 170.275 — Public disclosure of a GRAS notice
• § 170.280 — Submission of a supplement
• § 170.285 — Disposition of pending GRAS affirmation petitions

PART 171

• § 171.1 — Petitions
• § 171.6 — Amendment of petition
• § 171.7 — Withdrawal of petition without prejudice
• § 171.8 — Threshold of regulation for substances used in food-contact articles
• § 171.100 — Regulation based on petition
• § 171.102 — Effective date of regulation
• § 171.110 — Procedure for objections and hearings
• § 171.130 — Procedure for amending and repealing tolerances or exemptions from tolerances

PART 172

• § 172.5 — General provisions for direct food additives
• § 172.105 — Anoxomer
• § 172.110 — BHA
• § 172.115 — BHT
• § 172.120 — Calcium disodium EDTA
• § 172.130 — Dehydroacetic acid
• § 172.133 — Dimethyl dicarbonate
• § 172.135 — Disodium EDTA
• § 172.140 — Ethoxyquin
• § 172.145 — Heptylparaben
• § 172.150 — 4-Hydroxymethyl-2,6-di-tert-butylphenol
• § 172.155 — Natamycin (pimaricin)
• § 172.160 — Potassium nitrate
• § 172.165 — Quaternary ammonium chloride combination
• § 172.167 — Silver nitrate and hydrogen peroxide solution
• § 172.170 — Sodium nitrate
• § 172.175 — Sodium nitrite
• § 172.177 — Sodium nitrite used in processing smoked chub
• § 172.180 — Stannous chloride
• § 172.185 — TBHQ
• § 172.190 — THBP
• § 172.210 — Coatings on fresh citrus fruit
• § 172.215 — Coumarone-indene resin
• § 172.225 — Methyl and ethyl esters of fatty acids produced from edible fats and oils
• § 172.230 — Microcapsules for flavoring substances
• § 172.235 — Morpholine
• § 172.250 — Petroleum naphtha
• § 172.255 — Polyacrylamide
• § 172.260 — Oxidized polyethylene
• § 172.270 — Sulfated butyl oleate
• § 172.275 — Synthetic paraffin and succinic derivatives
• § 172.280 — Terpene resin
• § 172.310 — Aluminum nicotinate
• § 172.315 — Nicotinamide-ascorbic acid complex
• § 172.320 — Amino acids
• § 172.325 — Bakers yeast protein
• § 172.330 — Calcium pantothenate, calcium chloride double salt
• § 172.335 — D-Pantothenamide
• § 172.340 — Fish protein isolate
• § 172.345 — Folic acid (folacin)
• § 172.350 — Fumaric acid and salts of fumaric acid
• § 172.365 — Kelp
• § 172.370 — Iron-choline citrate complex
• § 172.372 — N-Acetyl-L-methionine
• § 172.375 — Potassium iodide
• § 172.379 — Vitamin D2
• § 172.380 — Vitamin D3
• § 172.381 — Vitamin D2 bakers yeast
• § 172.382 — Vitamin D2 mushroom powder
• § 172.385 — Whole fish protein concentrate
• § 172.395 — Xylitol
• § 172.399 — Zinc methionine sulfate
• § 172.410 — Calcium silicate
• § 172.430 — Iron ammonium citrate
• § 172.480 — Silicon dioxide
• § 172.490 — Yellow prussiate of soda
• § 172.510 — Natural flavoring substances and natural substances used in conjunction with flavors
• § 172.515 — Synthetic flavoring substances and adjuvants
• § 172.520 — Cocoa with dioctyl sodium sulfosuccinate for manufacturing
• § 172.530 — Disodium guanylate
• § 172.535 — Disodium inosinate
• § 172.540 — DL-Alanine
• § 172.560 — Modified hop extract
• § 172.575 — Quinine
• § 172.580 — Safrole-free extract of sassafras
• § 172.585 — Sugar beet extract flavor base
• § 172.590 — Yeast-malt sprout extract
• § 172.610 — Arabinogalactan
• § 172.615 — Chewing gum base
• § 172.620 — Carrageenan
• § 172.623 — Carrageenan with polysorbate 80
• § 172.626 — Salts of carrageenan
• § 172.655 — Furcelleran
• § 172.660 — Salts of furcelleran
• § 172.665 — Gellan gum
• § 172.695 — Xanthan gum
• § 172.710 — Adjuvants for pesticide use dilutions
• § 172.712 — 1,3-Butylene glycol
• § 172.715 — Calcium lignosulfonate
• § 172.720 — Calcium lactobionate
• § 172.723 — Epoxidized soybean oil
• § 172.725 — Gibberellic acid and its potassium salt
• § 172.730 — Potassium bromate
• § 172.735 — Glycerol ester of rosin
• § 172.736 — Glycerides and polyglycides of hydrogenated vegetable oils
• § 172.755 — Stearyl monoglyceridyl citrate
• § 172.765 — Succistearin (stearoyl propylene glycol hydrogen succinate)
• § 172.770 — Ethylene oxide polymer
• § 172.775 — Methacrylic acid-divinylbenzene copolymer
• § 172.780 — Acacia (gum arabic)
• § 172.785 — Listeria-specific bacteriophage preparation
• § 172.800 — Acesulfame potassium
• § 172.802 — Acetone peroxides
• § 172.803 — Advantame
• § 172.804 — Aspartame
• § 172.806 — Azodicarbonamide
• § 172.808 — Copolymer condensates of ethylene oxide and propylene oxide
• § 172.809 — Curdlan
• § 172.810 — Dioctyl sodium sulfosuccinate
• § 172.811 — Glyceryl tristearate
• § 172.812 — Glycine
• § 172.814 — Hydroxylated lecithin
• § 172.816 — Methyl glucoside-coconut oil ester
• § 172.818 — Oxystearin
• § 172.820 — Polyethylene glycol (mean molecular weight 200-9,500)
• § 172.822 — Sodium lauryl sulfate
• § 172.824 — Sodium mono- and dimethyl naphthalene sulfonates
• § 172.826 — Sodium stearyl fumarate
• § 172.828 — Acetylated monoglycerides
• § 172.829 — Neotame
• § 172.830 — Succinylated monoglycerides
• § 172.831 — Sucralose
• § 172.832 — Monoglyceride citrate
• § 172.833 — Sucrose acetate isobutyrate (SAIB)
• § 172.834 — Ethoxylated mono- and diglycerides
• § 172.836 — Polysorbate 60
• § 172.838 — Polysorbate 65
• § 172.840 — Polysorbate 80
• § 172.841 — Polydextrose
• § 172.842 — Sorbitan monostearate
• § 172.844 — Calcium stearoyl-2-lactylate
• § 172.846 — Sodium stearoyl lactylate
• § 172.848 — Lactylic esters of fatty acids
• § 172.850 — Lactylated fatty acid esters of glycerol and propylene glycol
• § 172.852 — Glyceryl-lacto esters of fatty acids
• § 172.854 — Polyglycerol esters of fatty acids
• § 172.856 — Propylene glycol mono- and diesters of fats and fatty acids
• § 172.858 — Propylene glycol alginate
• § 172.859 — Sucrose fatty acid esters
• § 172.860 — Fatty acids
• § 172.861 — Cocoa butter substitute from coconut oil, palm kernel oil, or both oils
• § 172.862 — Oleic acid derived from tall oil fatty acids
• § 172.863 — Salts of fatty acids
• § 172.864 — Synthetic fatty alcohols
• § 172.866 — Synthetic glycerin produced by the hydrogenolysis of carbohydrates
• § 172.867 — Olestra
• § 172.868 — Ethyl cellulose
• § 172.869 — Sucrose oligoesters
• § 172.870 — Hydroxypropyl cellulose
• § 172.872 — Methyl ethyl cellulose
• § 172.874 — Hydroxypropyl methylcellulose
• § 172.876 — Castor oil
• § 172.878 — White mineral oil
• § 172.880 — Petrolatum
• § 172.882 — Synthetic isoparaffinic petroleum hydrocarbons
• § 172.884 — Odorless light petroleum hydrocarbons
• § 172.886 — Petroleum wax
• § 172.888 — Synthetic petroleum wax
• § 172.890 — Rice bran wax
• § 172.892 — Food starch-modified
• § 172.894 — Modified cottonseed products intended for human consumption
• § 172.896 — Dried yeasts
• § 172.898 — Bakers yeast glycan

PART 173

• § 173.5 — Acrylate-acrylamide resins
• § 173.10 — Modified polyacrylamide resin
• § 173.20 — Ion-exchange membranes
• § 173.21 — Perfluorinated ion exchange membranes
• § 173.25 — Ion-exchange resins
• § 173.40 — Molecular sieve resins
• § 173.45 — Polymaleic acid and its sodium salt
• § 173.50 — Polyvinylpolypyrrolidone
• § 173.55 — Polyvinylpyrrolidone
• § 173.60 — Dimethylamine-epichlorohydrin copolymer
• § 173.65 — Divinylbenzene copolymer
• § 173.70 — Chloromethylated aminated styrene-divinylbenzene resin
• § 173.73 — Sodium polyacrylate
• § 173.75 — Sorbitan monooleate
• § 173.110 — Amyloglucosidase derived from Rhizopus niveus
• § 173.115 — Alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis
• § 173.120 — Carbohydrase and cellulase derived from Aspergillus niger
• § 173.130 — Carbohydrase derived from Rhizopus oryzae
• § 173.135 — Catalase derived from Micrococcus lysodeikticus
• § 173.140 — Esterase-lipase derived from Mucor miehei
• § 173.145 — Alpha-Galactosidase derived from Mortierella vinaceae var. raffinoseutilizer
• § 173.150 — Milk-clotting enzymes, microbial
• § 173.160 — Candida guilliermondii
• § 173.165 — Candida lipolytica
• § 173.170 — Aminoglycoside 3′-phosphotransferase II
• § 173.210 — Acetone
• § 173.220 — 1,3-Butylene glycol
• § 173.228 — Ethyl acetate
• § 173.230 — Ethylene dichloride
• § 173.240 — Isopropyl alcohol
• § 173.250 — Methyl alcohol residues
• § 173.255 — Methylene chloride
• § 173.270 — Hexane
• § 173.275 — Hydrogenated sperm oil
• § 173.280 — Solvent extraction process for citric acid
• § 173.290 — Trichloroethylene
• § 173.300 — Chlorine dioxide
• § 173.310 — Boiler water additives
• § 173.315 — Chemicals used in washing or to assist in the peeling of fruits and vegetables
• § 173.320 — Chemicals for controlling microorganisms in cane-sugar and beet-sugar mills
• § 173.322 — Chemicals used in delinting cottonseed
• § 173.325 — Acidified sodium chlorite solutions
• § 173.340 — Defoaming agents
• § 173.342 — Chlorofluorocarbon 113 and perfluorohexane
• § 173.345 — Chloropentafluoroethane
• § 173.350 — Combustion product gas
• § 173.355 — Dichlorodifluoromethane
• § 173.356 — Hydrogen peroxide
• § 173.357 — Materials used as fixing agents in the immobilization of enzyme preparations
• § 173.360 — Octafluorocyclobutane
• § 173.368 — Ozone
• § 173.370 — Peroxyacids
• § 173.375 — Cetylpyridinium chloride
• § 173.385 — Sodium methyl sulfate
• § 173.395 — Trifluoromethane sulfonic acid
• § 173.400 — Dimethyldialkylammonium chloride
• § 173.405 — Sodium dodecylbenzenesulfonate

PART 174

• § 174.5 — General provisions applicable to indirect food additives
• § 174.6 — Threshold of regulation for substances used in food-contact articles

PART 175

• § 175.105 — Adhesives
• § 175.125 — Pressure-sensitive adhesives
• § 175.210 — Acrylate ester copolymer coating
• § 175.230 — Hot-melt strippable food coatings
• § 175.250 — Paraffin (synthetic)
• § 175.260 — Partial phosphoric acid esters of polyester resins
• § 175.270 — Poly(vinyl fluoride) resins
• § 175.300 — Resinous and polymeric coatings
• § 175.320 — Resinous and polymeric coatings for polyolefin films
• § 175.350 — Vinyl acetate/crotonic acid copolymer
• § 175.360 — Vinylidene chloride copolymer coatings for nylon film
• § 175.365 — Vinylidene chloride copolymer coatings for polycarbonate film
• § 175.380 — Xylene-formaldehyde resins condensed with 4,4′-isopropylidenediphenol-epichlorohydrin epoxy resins
• § 175.390 — Zinc-silicon dioxide matrix coatings

PART 176

• § 176.110 — Acrylamide-acrylic acid resins
• § 176.120 — Alkyl ketene dimers
• § 176.130 — Anti-offset substances
• § 176.150 — Chelating agents used in the manufacture of paper and paperboard
• § 176.160 — Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine
• § 176.170 — Components of paper and paperboard in contact with aqueous and fatty foods
• § 176.180 — Components of paper and paperboard in contact with dry food
• § 176.200 — Defoaming agents used in coatings
• § 176.210 — Defoaming agents used in the manufacture of paper and paperboard
• § 176.230 — 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione
• § 176.250 — Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane
• § 176.260 — Pulp from reclaimed fiber
• § 176.300 — Slimicides
• § 176.320 — Sodium nitrate-urea complex
• § 176.350 — Tamarind seed kernel powder

PART 177

• § 177.1010 — Acrylic and modified acrylic plastics, semirigid and rigid
• § 177.1020 — Acrylonitrile/butadiene/styrene co-polymer
• § 177.1030 — Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer
• § 177.1040 — Acrylonitrile/styrene copoly-mer
• § 177.1050 — Acrylonitrile/styrene copoly-mer modified with butadiene/styrene elastomer
• § 177.1060 — n-Alkylglutarimide/acrylic copolymers
• § 177.1200 — Cellophane
• § 177.1210 — Closures with sealing gaskets for food containers
• § 177.1211 — Cross-linked polyacrylate copolymers
• § 177.1240 — 1,4-Cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate copolymer
• § 177.1310 — Ethylene-acrylic acid copolymers
• § 177.1312 — Ethylene-carbon monoxide copolymers
• § 177.1315 — Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers
• § 177.1320 — Ethylene-ethyl acrylate copolymers
• § 177.1330 — Ionomeric resins
• § 177.1340 — Ethylene-methyl acrylate copolymer resins
• § 177.1345 — Ethylene/1,3-phenylene oxyethylene isophthalate/ terephthalate copolymer
• § 177.1350 — Ethylene-vinyl acetate copolymers
• § 177.1360 — Ethylene-vinyl acetate-vinyl alcohol copolymers
• § 177.1380 — Fluorocarbon resins
• § 177.1390 — Laminate structures for use at temperatures of 250 °F and above
• § 177.1395 — Laminate structures for use at temperatures between 120 °F and 250 °F
• § 177.1400 — Hydroxyethyl cellulose film, water-insoluble
• § 177.1420 — Isobutylene polymers
• § 177.1430 — Isobutylene-butene copolymers
• § 177.1440 — 4,4′-Isopropylidenediphenol-epichlorohydrin resins minimum molecular weight 10,000
• § 177.1460 — Melamine-formaldehyde resins in molded articles
• § 177.1480 — Nitrile rubber modified acrylonitrile-methyl acrylate copolymers
• § 177.1500 — Nylon resins
• § 177.1520 — Olefin polymers
• § 177.1550 — Perfluorocarbon resins
• § 177.1555 — Polyarylate resins
• § 177.1556 — Polyaryletherketone resins
• § 177.1560 — Polyarylsulfone resins
• § 177.1570 — Poly-1-butene resins and butene/ethylene copolymers
• § 177.1580 — Polycarbonate resins
• § 177.1585 — Polyestercarbonate resins
• § 177.1590 — Polyester elastomers
• § 177.1595 — Polyetherimide resin
• § 177.1600 — Polyethylene resins, carboxyl modified
• § 177.1610 — Polyethylene, chlorinated
• § 177.1615 — Polyethylene, fluorinated
• § 177.1620 — Polyethylene, oxidized
• § 177.1630 — Polyethylene phthalate polymers
• § 177.1632 — Poly(phenyleneterephthalamide) resins
• § 177.1635 — Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene)
• § 177.1637 — Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins
• § 177.1640 — Polystyrene and rubber-modified polystyrene
• § 177.1650 — Polysulfide polymer-polyepoxy resins
• § 177.1655 — Polysulfone resins
• § 177.1660 — Poly (tetramethylene terephthalate)
• § 177.1670 — Polyvinyl alcohol film
• § 177.1680 — Polyurethane resins
• § 177.1810 — Styrene block polymers
• § 177.1820 — Styrene-maleic anhydride copolymers
• § 177.1830 — Styrene-methyl methacrylate copolymers
• § 177.1850 — Textryls
• § 177.1900 — Urea-formaldehyde resins in molded articles
• § 177.1950 — Vinyl chloride-ethylene copolymers
• § 177.1960 — Vinyl chloride-hexene-1 copolymers
• § 177.1970 — Vinyl chloride-lauryl vinyl ether copolymers
• § 177.1980 — Vinyl chloride-propylene copolymers
• § 177.1990 — Vinylidene chloride/methyl acrylate copolymers
• § 177.2000 — Vinylidene chloride/methyl acrylate/methyl methacrylate polymers
• § 177.2210 — Ethylene polymer, chlorosulfonated
• § 177.2250 — Filters, microporous polymeric
• § 177.2260 — Filters, resin-bonded
• § 177.2280 — 4,4′-Isopropylidenediphenolepichlorohydrin thermosetting epoxy resins
• § 177.2355 — Mineral reinforced nylon resins
• § 177.2400 — Perfluorocarbon cured elastomers
• § 177.2410 — Phenolic resins in molded articles
• § 177.2415 — Poly(aryletherketone) resins
• § 177.2420 — Polyester resins, cross-linked
• § 177.2430 — Polyether resins, chlorinated
• § 177.2440 — Polyethersulfone resins
• § 177.2450 — Polyamide-imide resins
• § 177.2460 — Poly(2,6-dimethyl-1,4-phenylene) oxide resins
• § 177.2465 — Polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers
• § 177.2470 — Polyoxymethylene copolymer
• § 177.2480 — Polyoxymethylene homopolymer
• § 177.2490 — Polyphenylene sulfide resins
• § 177.2500 — Polyphenylene sulfone resins
• § 177.2510 — Polyvinylidene fluoride resins
• § 177.2550 — Reverse osmosis membranes
• § 177.2600 — Rubber articles intended for repeated use
• § 177.2710 — Styrene-divinylbenzene resins, cross-linked
• § 177.2800 — Textiles and textile fibers
• § 177.2910 — Ultra-filtration membranes

PART 178

• § 178.1005 — Hydrogen peroxide solution
• § 178.1010 — Sanitizing solutions
• § 178.2010 — Antioxidants and/or stabilizers for polymers
• § 178.2550 — 4-Hydroxymethyl-2,6-di-tert-butylphenol
• § 178.2650 — Organotin stabilizers in vinyl chloride plastics
• § 178.3010 — Adjuvant substances used in the manufacture of foamed plastics
• § 178.3120 — Animal glue
• § 178.3125 — Anticorrosive agents
• § 178.3130 — Antistatic and/or antifogging agents in food-packaging materials
• § 178.3280 — Castor oil, hydrogenated
• § 178.3290 — Chromic chloride complexes
• § 178.3295 — Clarifying agents for polymers
• § 178.3297 — Colorants for polymers
• § 178.3300 — Corrosion inhibitors used for steel or tinplate
• § 178.3400 — Emulsifiers and/or surface-active agents
• § 178.3450 — Esters of stearic and palmitic acids
• § 178.3480 — Fatty alcohols, synthetic
• § 178.3500 — Glycerin, synthetic
• § 178.3505 — Glyceryl tri-(12-acetoxystearate)
• § 178.3520 — Industrial starch-modified
• § 178.3530 — Isoparaffinic petroleum hydrocarbons, synthetic
• § 178.3570 — Lubricants with incidental food contact
• § 178.3600 — Methyl glucoside-coconut oil ester
• § 178.3610 — α-Methylstyrene-vinyltoluene resins, hydrogenated
• § 178.3620 — Mineral oil
• § 178.3650 — Odorless light petroleum hydrocarbons
• § 178.3690 — Pentaerythritol adipate-stearate
• § 178.3700 — Petrolatum
• § 178.3710 — Petroleum wax
• § 178.3720 — Petroleum wax, synthetic
• § 178.3725 — Pigment dispersants
• § 178.3730 — Piperonyl butoxide and pyrethrins as components of bags
• § 178.3740 — Plasticizers in polymeric substances
• § 178.3750 — Polyethylene glycol (mean molecular weight 200-9,500)
• § 178.3760 — Polyethylene glycol (400) monolaurate
• § 178.3770 — Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids
• § 178.3780 — Polyhydric alcohol esters of long chain monobasic acids
• § 178.3790 — Polymer modifiers in semirigid and rigid vinyl chloride plastics
• § 178.3800 — Preservatives for wood
• § 178.3850 — Reinforced wax
• § 178.3860 — Release agents
• § 178.3870 — Rosins and rosin derivatives
• § 178.3900 — Sodium pentachlorophenate
• § 178.3910 — Surface lubricants used in the manufacture of metallic articles
• § 178.3930 — Terpene resins
• § 178.3940 — Tetraethylene glycol di-(2-ethylhexoate)
• § 178.3950 — Tetrahydrofuran

PART 179

• § 179.21 — Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing
• § 179.25 — General provisions for food irradiation
• § 179.26 — Ionizing radiation for the treatment of food
• § 179.30 — Radiofrequency radiation for the heating of food, including microwave frequencies
• § 179.39 — Ultraviolet radiation for the processing and treatment of food
• § 179.41 — Pulsed light for the treatment of food
• § 179.43 — Carbon dioxide laser for etching food
• § 179.45 — Packaging materials for use during the irradiation of prepackaged foods

PART 180

• § 180.1 — General
• § 180.22 — Acrylonitrile copolymers
• § 180.25 — Mannitol
• § 180.37 — Saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin

PART 181

• § 181.1 — General
• § 181.5 — Prior sanctions
• § 181.22 — Certain substances employed in the manufacture of food-packaging materials
• § 181.23 — Antimycotics
• § 181.24 — Antioxidants
• § 181.25 — Driers
• § 181.26 — Drying oils as components of finished resins
• § 181.27 — Plasticizers
• § 181.28 — Release agents
• § 181.29 — Stabilizers
• § 181.30 — Substances used in the manufacture of paper and paperboard products used in food packaging
• § 181.32 — Acrylonitrile copolymers and resins
• § 181.33 — Sodium nitrate and potassium nitrate
• § 181.34 — Sodium nitrite and potassium nitrite

PART 182

• § 182.1 — Substances that are generally recognized as safe
• § 182.10 — Spices and other natural seasonings and flavorings
• § 182.20 — Essential oils, oleoresins (solvent-free), and natural extractives (including distillates)
• § 182.40 — Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings
• § 182.50 — Certain other spices, seasonings, essential oils, oleoresins, and natural extracts
• § 182.60 — Synthetic flavoring substances and adjuvants
• § 182.70 — Substances migrating from cotton and cotton fabrics used in dry food packaging
• § 182.90 — Substances migrating to food from paper and paperboard products
• § 182.99 — Adjuvants for pesticide chemicals
• § 182.1045 — Glutamic acid
• § 182.1047 — Glutamic acid hydrochloride
• § 182.1057 — Hydrochloric acid
• § 182.1073 — Phosphoric acid
• § 182.1087 — Sodium acid pyrophosphate
• § 182.1125 — Aluminum sulfate
• § 182.1127 — Aluminum ammonium sulfate
• § 182.1129 — Aluminum potassium sulfate
• § 182.1131 — Aluminum sodium sulfate
• § 182.1180 — Caffeine
• § 182.1217 — Calcium phosphate
• § 182.1235 — Caramel
• § 182.1320 — Glycerin
• § 182.1480 — Methylcellulose
• § 182.1500 — Monoammonium glutamate
• § 182.1516 — Monopotassium glutamate
• § 182.1711 — Silica aerogel
• § 182.1745 — Sodium carboxymethylcellulose
• § 182.1748 — Sodium caseinate
• § 182.1778 — Sodium phosphate
• § 182.1781 — Sodium aluminum phosphate
• § 182.1810 — Sodium tripolyphosphate
• § 182.2122 — Aluminum calcium silicate
• § 182.2227 — Calcium silicate
• § 182.2437 — Magnesium silicate
• § 182.2727 — Sodium aluminosilicate
• § 182.2729 — Sodium calcium aluminosilicate, hydrated
• § 182.2906 — Tricalcium silicate
• § 182.3013 — Ascorbic acid
• § 182.3041 — Erythorbic acid
• § 182.3089 — Sorbic acid
• § 182.3109 — Thiodipropionic acid
• § 182.3149 — Ascorbyl palmitate
• § 182.3169 — Butylated hydroxyanisole
• § 182.3173 — Butylated hydroxytoluene
• § 182.3189 — Calcium ascorbate
• § 182.3225 — Calcium sorbate
• § 182.3280 — Dilauryl thiodipropionate
• § 182.3616 — Potassium bisulfite
• § 182.3637 — Potassium metabisulfite
• § 182.3640 — Potassium sorbate
• § 182.3731 — Sodium ascorbate
• § 182.3739 — Sodium bisulfite
• § 182.3766 — Sodium metabisulfite
• § 182.3795 — Sodium sorbate
• § 182.3798 — Sodium sulfite
• § 182.3862 — Sulfur dioxide
• § 182.3890 — Tocopherols
• § 182.6085 — Sodium acid phosphate
• § 182.6197 — Calcium diacetate
• § 182.6203 — Calcium hexametaphosphate
• § 182.6215 — Monobasic calcium phosphate
• § 182.6285 — Dipotassium phosphate
• § 182.6290 — Disodium phosphate
• § 182.6757 — Sodium gluconate
• § 182.6760 — Sodium hexametaphosphate
• § 182.6769 — Sodium metaphosphate
• § 182.6778 — Sodium phosphate
• § 182.6787 — Sodium pyrophosphate
• § 182.6789 — Tetra sodium pyrophosphate
• § 182.6810 — Sodium tripolyphosphate
• § 182.7255 — Chondrus extract
• § 182.8013 — Ascorbic acid
• § 182.8159 — Biotin
• § 182.8217 — Calcium phosphate
• § 182.8223 — Calcium pyrophosphate
• § 182.8250 — Choline bitartrate
• § 182.8252 — Choline chloride
• § 182.8778 — Sodium phosphate
• § 182.8890 — Tocopherols
• § 182.8892 — α-Tocopherol acetate
• § 182.8985 — Zinc chloride
• § 182.8988 — Zinc gluconate
• § 182.8991 — Zinc oxide
• § 182.8994 — Zinc stearate
• § 182.8997 — Zinc sulfate

PART 184

• § 184.1 — Substances added directly to human food affirmed as generally recognized as safe (GRAS)
• § 184.1005 — Acetic acid
• § 184.1007 — Aconitic acid
• § 184.1009 — Adipic acid
• § 184.1011 — Alginic acid
• § 184.1012 — α-Amylase enzyme preparation from Bacillus stearothermophilus
• § 184.1021 — Benzoic acid
• § 184.1024 — Bromelain
• § 184.1025 — Caprylic acid
• § 184.1027 — Mixed carbohydrase and protease enzyme product
• § 184.1033 — Citric acid
• § 184.1034 — Catalase (bovine liver)
• § 184.1061 — Lactic acid
• § 184.1063 — Enzyme-modified lecithin
• § 184.1065 — Linoleic acid
• § 184.1069 — Malic acid
• § 184.1077 — Potassium acid tartrate
• § 184.1081 — Propionic acid
• § 184.1090 — Stearic acid
• § 184.1091 — Succinic acid
• § 184.1095 — Sulfuric acid
• § 184.1097 — Tannic acid
• § 184.1099 — Tartaric acid
• § 184.1101 — Diacetyl tartaric acid esters of mono- and diglycerides
• § 184.1115 — Agar-agar
• § 184.1120 — Brown algae
• § 184.1121 — Red algae
• § 184.1133 — Ammonium alginate
• § 184.1135 — Ammonium bicarbonate
• § 184.1137 — Ammonium carbonate
• § 184.1138 — Ammonium chloride
• § 184.1139 — Ammonium hydroxide
• § 184.1140 — Ammonium citrate, dibasic
• § 184.1141a — Ammonium phosphate, monobasic
• § 184.1141b — Ammonium phosphate, dibasic
• § 184.1143 — Ammonium sulfate
• § 184.1148 — Bacterially-derived carbohydrase enzyme preparation
• § 184.1150 — Bacterially-derived protease enzyme preparation
• § 184.1155 — Bentonite
• § 184.1157 — Benzoyl peroxide
• § 184.1165 — n-Butane and iso-butane
• § 184.1185 — Calcium acetate
• § 184.1187 — Calcium alginate
• § 184.1191 — Calcium carbonate
• § 184.1193 — Calcium chloride
• § 184.1195 — Calcium citrate
• § 184.1199 — Calcium gluconate
• § 184.1201 — Calcium glycerophosphate
• § 184.1205 — Calcium hydroxide
• § 184.1206 — Calcium iodate
• § 184.1207 — Calcium lactate
• § 184.1210 — Calcium oxide
• § 184.1212 — Calcium pantothenate
• § 184.1221 — Calcium propionate
• § 184.1229 — Calcium stearate
• § 184.1230 — Calcium sulfate
• § 184.1240 — Carbon dioxide
• § 184.1245 — Beta-carotene
• § 184.1250 — Cellulase enzyme preparation derived from Trichoderma longibrachiatum
• § 184.1257 — Clove and its derivatives
• § 184.1259 — Cocoa butter substitute
• § 184.1260 — Copper gluconate
• § 184.1261 — Copper sulfate
• § 184.1262 — Corn silk and corn silk extract
• § 184.1265 — Cuprous iodide
• § 184.1271 — L-Cysteine
• § 184.1272 — L-Cysteine monohydrochloride
• § 184.1277 — Dextrin
• § 184.1278 — Diacetyl
• § 184.1282 — Dill and its derivatives
• § 184.1287 — Enzyme-modified fats
• § 184.1293 — Ethyl alcohol
• § 184.1295 — Ethyl formate
• § 184.1296 — Ferric ammonium citrate
• § 184.1297 — Ferric chloride
• § 184.1298 — Ferric citrate
• § 184.1301 — Ferric phosphate
• § 184.1304 — Ferric pyrophosphate
• § 184.1307 — Ferric sulfate
• § 184.1307a — Ferrous ascorbate
• § 184.1307b — Ferrous carbonate
• § 184.1307c — Ferrous citrate
• § 184.1307d — Ferrous fumarate
• § 184.1308 — Ferrous gluconate
• § 184.1311 — Ferrous lactate
• § 184.1315 — Ferrous sulfate
• § 184.1316 — Ficin
• § 184.1317 — Garlic and its derivatives
• § 184.1318 — Glucono delta-lactone
• § 184.1321 — Corn gluten
• § 184.1322 — Wheat gluten
• § 184.1323 — Glyceryl monooleate
• § 184.1324 — Glyceryl monostearate
• § 184.1328 — Glyceryl behenate
• § 184.1329 — Glyceryl palmitostearate
• § 184.1330 — Acacia (gum arabic)
• § 184.1333 — Gum ghatti
• § 184.1339 — Guar gum
• § 184.1343 — Locust (carob) bean gum
• § 184.1349 — Karaya gum (sterculia gum)
• § 184.1351 — Gum tragacanth
• § 184.1355 — Helium
• § 184.1366 — Hydrogen peroxide
• § 184.1370 — Inositol
• § 184.1372 — Insoluble glucose isomerase enzyme preparations
• § 184.1375 — Iron, elemental
• § 184.1386 — Isopropyl citrate
• § 184.1387 — Lactase enzyme preparation from Candida pseudotropicalis
• § 184.1388 — Lactase enzyme preparation from Kluyveromyces lactis
• § 184.1400 — Lecithin
• § 184.1408 — Licorice and licorice derivatives
• § 184.1409 — Ground limestone
• § 184.1415 — Animal lipase
• § 184.1420 — Lipase enzyme preparation derived from Rhizopus niveus
• § 184.1425 — Magnesium carbonate
• § 184.1426 — Magnesium chloride
• § 184.1428 — Magnesium hydroxide
• § 184.1431 — Magnesium oxide
• § 184.1434 — Magnesium phosphate
• § 184.1440 — Magnesium stearate
• § 184.1443 — Magnesium sulfate
• § 184.1443a — Malt
• § 184.1444 — Maltodextrin
• § 184.1445 — Malt syrup (malt extract)
• § 184.1446 — Manganese chloride
• § 184.1449 — Manganese citrate
• § 184.1452 — Manganese gluconate
• § 184.1461 — Manganese sulfate
• § 184.1472 — Menhaden oil
• § 184.1490 — Methylparaben
• § 184.1498 — Microparticulated protein product
• § 184.1505 — Mono- and diglycerides
• § 184.1521 — Monosodium phosphate derivatives of mono- and diglycerides
• § 184.1530 — Niacin
• § 184.1535 — Niacinamide
• § 184.1537 — Nickel
• § 184.1538 — Nisin preparation
• § 184.1540 — Nitrogen
• § 184.1545 — Nitrous oxide
• § 184.1553 — Peptones
• § 184.1555 — Rapeseed oil
• § 184.1560 — Ox bile extract
• § 184.1563 — Ozone
• § 184.1583 — Pancreatin
• § 184.1585 — Papain
• § 184.1588 — Pectins
• § 184.1595 — Pepsin
• § 184.1610 — Potassium alginate
• § 184.1613 — Potassium bicarbonate
• § 184.1619 — Potassium carbonate
• § 184.1622 — Potassium chloride
• § 184.1625 — Potassium citrate
• § 184.1631 — Potassium hydroxide
• § 184.1634 — Potassium iodide
• § 184.1635 — Potassium iodate
• § 184.1639 — Potassium lactate
• § 184.1643 — Potassium sulfate
• § 184.1655 — Propane
• § 184.1660 — Propyl gallate
• § 184.1666 — Propylene glycol
• § 184.1670 — Propylparaben
• § 184.1676 — Pyridoxine hydrochloride
• § 184.1685 — Rennet (animal-derived) and chymosin preparation (fermentation-derived)
• § 184.1695 — Riboflavin
• § 184.1697 — Riboflavin-5′-phosphate (sodium)
• § 184.1698 — Rue
• § 184.1699 — Oil of rue
• § 184.1702 — Sheanut oil
• § 184.1721 — Sodium acetate
• § 184.1724 — Sodium alginate
• § 184.1733 — Sodium benzoate
• § 184.1736 — Sodium bicarbonate
• § 184.1742 — Sodium carbonate
• § 184.1751 — Sodium citrate
• § 184.1754 — Sodium diacetate
• § 184.1763 — Sodium hydroxide
• § 184.1764 — Sodium hypophosphite
• § 184.1768 — Sodium lactate
• § 184.1769a — Sodium metasilicate
• § 184.1784 — Sodium propionate
• § 184.1792 — Sodium sesquicarbonate
• § 184.1801 — Sodium tartrate
• § 184.1804 — Sodium potassium tartrate
• § 184.1807 — Sodium thiosulfate
• § 184.1835 — Sorbitol
• § 184.1845 — Stannous chloride (anhydrous and dihydrated)
• § 184.1848 — Starter distillate
• § 184.1851 — Stearyl citrate
• § 184.1854 — Sucrose
• § 184.1857 — Corn sugar
• § 184.1859 — Invert sugar
• § 184.1865 — Corn syrup
• § 184.1866 — High fructose corn syrup
• § 184.1875 — Thiamine hydrochloride
• § 184.1878 — Thiamine mononitrate
• § 184.1890 — α-Tocopherols
• § 184.1901 — Triacetin
• § 184.1903 — Tributyrin
• § 184.1911 — Triethyl citrate
• § 184.1914 — Trypsin
• § 184.1923 — Urea
• § 184.1924 — Urease enzyme preparation from Lactobacillus fermentum
• § 184.1930 — Vitamin A
• § 184.1945 — Vitamin B12
• § 184.1950 — Vitamin D
• § 184.1973 — Beeswax (yellow and white)
• § 184.1976 — Candelilla wax
• § 184.1978 — Carnauba wax
• § 184.1979 — Whey
• § 184.1979a — Reduced lactose whey
• § 184.1979b — Reduced minerals whey
• § 184.1979c — Whey protein concentrate
• § 184.1983 — Bakers yeast extract
• § 184.1984 — Zein
• § 184.1985 — Aminopeptidase enzyme preparation derived from lactococcus lactis

PART 186

• § 186.1 — Substances added indirectly to human food affirmed as generally recognized as safe (GRAS)
• § 186.1093 — Sulfamic acid
• § 186.1256 — Clay (kaolin)
• § 186.1275 — Dextrans
• § 186.1300 — Ferric oxide
• § 186.1316 — Formic acid
• § 186.1374 — Iron oxides
• § 186.1555 — Japan wax
• § 186.1557 — Tall oil
• § 186.1673 — Pulp
• § 186.1750 — Sodium chlorite
• § 186.1756 — Sodium formate
• § 186.1770 — Sodium oleate
• § 186.1771 — Sodium palmitate
• § 186.1797 — Sodium sulfate
• § 186.1839 — Sorbose

PART 189

• § 189.1 — Substances prohibited from use in human food
• § 189.5 — Prohibited cattle materials
• § 189.110 — Calamus and its derivatives
• § 189.113 — Cinnamyl anthranilate
• § 189.120 — Cobaltous salts and its derivatives
• § 189.130 — Coumarin
• § 189.135 — Cyclamate and its derivatives
• § 189.140 — Diethylpyrocarbonate (DEPC)
• § 189.145 — Dulcin
• § 189.155 — Monochloroacetic acid
• § 189.165 — Nordihydroguaiaretic acid (NDGA)
• § 189.175 — P-4000
• § 189.180 — Safrole
• § 189.190 — Thiourea
• § 189.191 — Chlorofluorocarbon propellants
• § 189.220 — Flectol H
• § 189.240 — Lead solders
• § 189.250 — Mercaptoimidazoline and 2-mercaptoimidazoline
• § 189.280 — 4,4′-Methylenebis (2-chloroanaline)
• § 189.300 — Hydrogenated 4,4′-isopropylidene-diphenolphosphite ester resins
• § 189.301 — Tin-coated lead foil capsules for wine bottles

PART 190

• § 190.6 — Requirement for premarket notification

PART 200

• § 200.5 — Mailing of important information about drugs
• § 200.7 — Supplying pharmacists with indications and dosage information
• § 200.10 — Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers
• § 200.11 — Use of octadecylamine in steam lines of drug establishments
• § 200.15 — Definition of term “insulin.”
• § 200.50 — Ophthalmic preparations and dispensers
• § 200.51 — Aqueous-based drug products for oral inhalation
• § 200.200 — Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers

PART 201

• § 201.1 — Drugs; name and place of business of manufacturer, packer, or distributor
• § 201.2 — Drugs and devices; National Drug Code numbers
• § 201.5 — Drugs; adequate directions for use
• § 201.6 — Drugs; misleading statements
• § 201.10 — Drugs; statement of ingredients
• § 201.15 — Drugs; prominence of required label statements
• § 201.16 — Drugs; Spanish-language version of certain required statements
• § 201.17 — Drugs; location of expiration date
• § 201.18 — Drugs; significance of control numbers
• § 201.19 — Drugs; use of term “infant”
• § 201.20 — Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use
• § 201.21 — Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use
• § 201.22 — Prescription drugs containing sulfites; required warning statements
• § 201.23 — Required pediatric studies
• § 201.24 — Labeling for systemic antibacterial drug products
• § 201.25 — Bar code label requirements
• § 201.26 — Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile
• § 201.50 — Statement of identity
• § 201.51 — Declaration of net quantity of contents
• § 201.55 — Statement of dosage
• § 201.56 — Requirements on content and format of labeling for human prescription drug and biological products
• § 201.57 — Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1)
• § 201.58 — Waiver of labeling requirements
• § 201.60 — Principal display panel
• § 201.61 — Statement of identity
• § 201.62 — Declaration of net quantity of contents
• § 201.63 — Pregnancy/breast-feeding warning
• § 201.64 — Sodium labeling
• § 201.66 — Format and content requirements for over-the-counter (OTC) drug product labeling
• § 201.67 — Labeling requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU)
• § 201.70 — Calcium labeling
• § 201.71 — Magnesium labeling
• § 201.72 — Potassium labeling
• § 201.80 — Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1)
• § 201.100 — Prescription drugs for human use
• § 201.105 — Veterinary drugs
• § 201.115 — New drugs or new animal drugs
• § 201.116 — Drugs having commonly known directions
• § 201.117 — Inactive ingredients
• § 201.119 — In vitro diagnostic products
• § 201.120 — Prescription chemicals and other prescription components
• § 201.122 — Drugs for processing, repacking, or manufacturing
• § 201.125 — Drugs for use in teaching, law enforcement, research, and analysis
• § 201.127 — Drugs; expiration of exemptions
• § 201.128 — Meaning of “intended uses”
• § 201.129 — Drugs; exemption for radioactive drugs for research use
• § 201.130 — Exemption from adequate directions for use for a nonprescription drug product with an additional condition for nonprescription use (ACNU)
• § 201.150 — Drugs; processing, labeling, or repacking
• § 201.161 — Medical gases
• § 201.200 — Disclosure of drug efficacy study evaluations in labeling and advertising
• § 201.300 — Notice to manufacturers, packers, and distributors of glandular preparations
• § 201.301 — Notice to manufacturers, packers, and distributors of estrogenic hormone preparations
• § 201.302 — Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil
• § 201.303 — Labeling of drug preparations containing significant proportions of wintergreen oil
• § 201.304 — Tannic acid and barium enema preparations
• § 201.305 — Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings
• § 201.306 — Potassium salt preparations intended for oral ingestion by man
• § 201.307 — Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale
• § 201.308 — Ipecac syrup; warnings and directions for use for over-the-counter sale
• § 201.309 — Acetophenetidin (phenacetin)-containing preparations; necessary warning statement
• § 201.310 — Phenindione; labeling of drug preparations intended for use by man
• § 201.311 — [Reserved]
• § 201.312 — Magnesium sulfate heptahydrate; label declaration on drug products
• § 201.313 — Estradiol labeling
• § 201.314 — Labeling of drug preparations containing salicylates
• § 201.315 — Over-the-counter drugs for minor sore throats; suggested warning
• § 201.316 — Drugs with thyroid hormone activity for human use; required warning
• § 201.317 — Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning
• § 201.319 — Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil tragacanth, and xanthan gum) as active ingredients; required warnings and directions
• § 201.320 — Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances
• § 201.323 — Aluminum in large and small volume parenterals used in total parenteral nutrition
• § 201.325 — Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information
• § 201.326 — Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling
• § 201.327 — Over-the-counter sunscreen drug products; required labeling based on effectiveness testing
• § 201.328 — Labeling of medical gas containers

PART 202

• § 202.1 — Prescription-drug advertisements

PART 203

• § 203.1 — Scope
• § 203.2 — Purpose
• § 203.3 — Definitions
• § 203.10 — Restrictions on reimportation
• § 203.11 — Applications for reimportation to provide emergency medical care
• § 203.12 — An appeal from an adverse decision by the district office
• § 203.20 — Sales restrictions
• § 203.22 — Exclusions
• § 203.23 — Returns
• § 203.30 — Sample distribution by mail or common carrier
• § 203.31 — Sample distribution by means other than mail or common carrier (direct delivery by a representative or detailer)
• § 203.32 — Drug sample storage and handling requirements
• § 203.33 — Drug sample forms
• § 203.34 — Policies and procedures; administrative systems
• § 203.35 — Standing requests
• § 203.36 — Fulfillment houses, shipping and mailing services, comarketing agreements, and third-party recordkeeping
• § 203.37 — Investigation and notification requirements
• § 203.38 — Sample lot or control numbers; labeling of sample units
• § 203.39 — Donation of drug samples to charitable institutions
• § 203.50 — Requirements for wholesale distribution of prescription drugs
• § 203.60 — Request and receipt forms, reports, and records
• § 203.70 — Application for a reward

PART 205

• § 205.1 — Scope
• § 205.2 — Purpose
• § 205.3 — Definitions
• § 205.4 — Wholesale drug distributor licensing requirement
• § 205.5 — Minimum required information for licensure
• § 205.6 — Minimum qualifications
• § 205.7 — Personnel
• § 205.8 — Violations and penalties
• § 205.50 — Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records

PART 206

• § 206.1 — Scope
• § 206.3 — Definitions
• § 206.7 — Exemptions
• § 206.10 — Code imprint required

PART 207

• § 207.1 — What definitions and interpretations of terms apply to this part?
• § 207.3 — Bulk drug substance
• § 207.5 — What is the purpose of this part?
• § 207.9 — Who does this part cover?
• § 207.13 — Who is exempt from the registration and listing requirements?
• § 207.17 — Who must register?
• § 207.21 — When must initial registration information be provided?
• § 207.25 — What information is required for registration?
• § 207.29 — What are the requirements for reviewing and updating registration information?
• § 207.33 — What is the National Drug Code (NDC), how is it assigned, and what are its requirements?
• § 207.35 — What changes require a new NDC?
• § 207.37 — What restrictions pertain to the use of the NDC?
• § 207.41 — Who must list drugs and what drugs must they list?
• § 207.45 — When, after initial registration of an establishment, must drug listing information be submitted?
• § 207.49 — What listing information must a registrant submit for a drug it manufactures?
• § 207.53 — What listing information must a registrant submit for a drug that it repacks or relabels?
• § 207.54 — What listing information must a registrant submit for a drug that it salvages?
• § 207.55 — What additional drug listing information may FDA require?
• § 207.57 — What information must registrants submit when updating listing information and when?
• § 207.61 — How is registration and listing information provided to FDA?
• § 207.65 — How can a waiver of the electronic submission requirement be obtained?
• § 207.69 — What are the requirements for an official contact and a United States agent?
• § 207.77 — What legal status is conferred by registration and listing?
• § 207.81 — What registration and listing information will FDA make available for public disclosure?

PART 208

• § 208.1 — Scope and purpose
• § 208.3 — Definitions
• § 208.20 — Content and format of a Medication Guide
• § 208.24 — Distributing and dispensing a Medication Guide
• § 208.26 — Exemptions and deferrals

PART 209

• § 209.1 — Scope and purpose
• § 209.2 — Definitions
• § 209.10 — Content and format of the side effects statement
• § 209.11 — Dispensing and distributing the side effects statement

PART 210

• § 210.1 — Status of current good manufacturing practice regulations
• § 210.2 — Applicability of current good manufacturing practice regulations
• § 210.3 — Definitions

PART 211

• § 211.1 — Scope
• § 211.3 — Definitions
• § 211.22 — Responsibilities of quality control unit
• § 211.25 — Personnel qualifications
• § 211.28 — Personnel responsibilities
• § 211.34 — Consultants
• § 211.42 — Design and construction features
• § 211.44 — Lighting
• § 211.46 — Ventilation, air filtration, air heating and cooling
• § 211.48 — Plumbing
• § 211.50 — Sewage and refuse
• § 211.52 — Washing and toilet facilities
• § 211.56 — Sanitation
• § 211.58 — Maintenance
• § 211.63 — Equipment design, size, and location
• § 211.65 — Equipment construction
• § 211.67 — Equipment cleaning and maintenance
• § 211.68 — Automatic, mechanical, and electronic equipment
• § 211.72 — Filters
• § 211.80 — General requirements
• § 211.82 — Receipt and storage of untested components, drug product containers, and closures
• § 211.84 — Testing and approval or rejection of components, drug product containers, and closures
• § 211.86 — Use of approved components, drug product containers, and closures
• § 211.87 — Retesting of approved components, drug product containers, and closures
• § 211.89 — Rejected components, drug product containers, and closures
• § 211.94 — Drug product containers and closures
• § 211.100 — Written procedures; deviations
• § 211.101 — Charge-in of components
• § 211.103 — Calculation of yield
• § 211.105 — Equipment identification
• § 211.110 — Sampling and testing of in-process materials and drug products
• § 211.111 — Time limitations on production
• § 211.113 — Control of microbiological contamination
• § 211.115 — Reprocessing
• § 211.122 — Materials examination and usage criteria
• § 211.125 — Labeling issuance
• § 211.130 — Packaging and labeling operations
• § 211.132 — Tamper-evident packaging requirements for over-the-counter (OTC) human drug products
• § 211.134 — Drug product inspection
• § 211.137 — Expiration dating
• § 211.142 — Warehousing procedures
• § 211.150 — Distribution procedures
• § 211.160 — General requirements
• § 211.165 — Testing and release for distribution
• § 211.166 — Stability testing
• § 211.167 — Special testing requirements
• § 211.170 — Reserve samples
• § 211.173 — Laboratory animals
• § 211.176 — Penicillin contamination
• § 211.180 — General requirements
• § 211.182 — Equipment cleaning and use log
• § 211.184 — Component, drug product container, closure, and labeling records
• § 211.186 — Master production and control records
• § 211.188 — Batch production and control records
• § 211.192 — Production record review
• § 211.194 — Laboratory records
• § 211.196 — Distribution records
• § 211.198 — Complaint files
• § 211.204 — Returned drug products
• § 211.208 — Drug product salvaging

PART 212

• § 212.1 — What are the meanings of the technical terms used in these regulations?
• § 212.2 — What is current good manufacturing practice for PET drugs?
• § 212.5 — To what drugs do the regulations in this part apply?
• § 212.10 — What personnel and resources must I have?
• § 212.20 — What activities must I perform to ensure drug quality?
• § 212.30 — What requirements must my facilities and equipment meet?
• § 212.40 — How must I control the components I use to produce PET drugs and the containers and closures I package them in?
• § 212.50 — What production and process controls must I have?
• § 212.60 — What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?
• § 212.61 — What must I do to ensure the stability of my PET drug products through expiry?
• § 212.70 — What controls and acceptance criteria must I have for my finished PET drug products?
• § 212.71 — What actions must I take if a batch of PET drug product does not conform to specifications?
• § 212.80 — What are the requirements associated with labeling and packaging PET drug products?
• § 212.90 — What actions must I take to control the distribution of PET drug products?
• § 212.100 — What do I do if I receive a complaint about a PET drug product produced at my facility?
• § 212.110 — How must I maintain records of my production of PET drugs?

PART 213

• § 213.1 — Scope
• § 213.3 — Definitions
• § 213.22 — Responsibilities of quality unit
• § 213.25 — Personnel qualifications and responsibilities
• § 213.34 — Consultants
• § 213.42 — Design and construction features
• § 213.63 — Equipment design, size, and location
• § 213.65 — Equipment construction
• § 213.67 — Equipment maintenance and cleaning
• § 213.68 — Automatic, mechanical, and electronic equipment
• § 213.80 — General requirements
• § 213.82 — Receipt and storage of incoming designated medical gases
• § 213.84 — Testing and approval or rejection of components, containers, and closures
• § 213.89 — Rejected components, incoming designated medical gases, and medical gas containers and closures
• § 213.94 — Medical gas containers and closures
• § 213.100 — Written procedures; deviations
• § 213.101 — Charge-in of components and incoming designated medical gases
• § 213.110 — Sampling and testing of in-process materials
• § 213.122 — Materials examination and usage criteria
• § 213.125 — Labeling issuance
• § 213.130 — Packaging and labeling operations
• § 213.150 — Warehousing and distribution procedures
• § 213.160 — General requirements
• § 213.165 — Testing and release for distribution
• § 213.166 — Stability testing and expiration dating for medical gases marketed under applications submitted under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act
• § 213.180 — General requirements
• § 213.182 — Equipment cleaning and use log
• § 213.184 — Records for components, medical gas containers and closures, and labeling
• § 213.186 — Master production and control records
• § 213.189 — Batch production and control records
• § 213.192 — Production record review
• § 213.194 — Laboratory records
• § 213.196 — Distribution records
• § 213.198 — Complaint files
• § 213.204 — Returned medical gases
• § 213.208 — Salvaging of medical gases

PART 216

• § 216.23 — Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act
• § 216.24 — Drug products withdrawn or removed from the market for reasons of safety or effectiveness

PART 225

• § 225.1 — Current good manufacturing practice
• § 225.10 — Personnel
• § 225.20 — Buildings
• § 225.30 — Equipment
• § 225.35 — Use of work areas, equipment, and storage areas for other manufacturing and storage purpose
• § 225.42 — Components
• § 225.58 — Laboratory controls
• § 225.65 — Equipment cleanout procedures
• § 225.80 — Labeling
• § 225.102 — Master record file and production records
• § 225.110 — Distribution records
• § 225.115 — Complaint files
• § 225.120 — Buildings and grounds
• § 225.130 — Equipment
• § 225.135 — Work and storage areas
• § 225.142 — Components
• § 225.158 — Laboratory assays
• § 225.165 — Equipment cleanout procedures
• § 225.180 — Labeling
• § 225.202 — Formula, production, and distribution records

PART 226

• § 226.1 — Current good manufacturing practice
• § 226.10 — Personnel
• § 226.20 — Buildings
• § 226.30 — Equipment
• § 226.40 — Production and control procedures
• § 226.42 — Components
• § 226.58 — Laboratory controls
• § 226.80 — Packaging and labeling
• § 226.102 — Master-formula and batch-production records
• § 226.110 — Distribution records
• § 226.115 — Complaint files

PART 230

• § 230.1 — Scope of this part
• § 230.2 — Purpose
• § 230.3 — Definitions
• § 230.50 — General requirements for all submission types
• § 230.65 — Withdrawal by the applicant of a certification request before it is deemed granted
• § 230.70 — Supplements and other changes to a granted certification
• § 230.72 — Change in ownership of a granted certification
• § 230.80 — Annual report
• § 230.100 — FDA review of submissions
• § 230.105 — When a submission is deemed granted
• § 230.150 — Withdrawal or revocation of approval of an application
• § 230.205 — Field alert reports
• § 230.210 — General reporting requirements for designated medical gas adverse events
• § 230.220 — Human designated medical gas ICSR requirements
• § 230.230 — Animal designated medical gas adverse event reporting requirements

PART 250

• § 250.11 — Thyroid-containing drug preparations intended for treatment of obesity in humans
• § 250.12 — Stramonium preparations labeled with directions for use in self-medication regarded as misbranded
• § 250.100 — Amyl nitrite inhalant as a prescription drug for human use
• § 250.101 — Amphetamine and methamphetamine inhalers regarded as prescription drugs
• § 250.102 — Drug preparations intended for human use containing certain “coronary vasodilators”
• § 250.103-250.104 — 250.103-250.104 [Reserved]
• § 250.105 — Gelsemium-containing preparations regarded as prescription drugs
• § 250.106-250.107 — 250.106-250.107 [Reserved]
• § 250.108 — Potassium permanganate preparations as prescription drugs
• § 250.201 — Preparations for the treatment of pernicious anemia
• § 250.250 — Hexachlorophene, as a component of drug and cosmetic products

PART 251

• § 251.1 — Scope of the part
• § 251.2 — Definitions
• § 251.3 — SIP proposal submission requirements
• § 251.4 — Review and authorization of importation program proposals
• § 251.5 — Pre-Import Request
• § 251.6 — Termination of authorized importation programs
• § 251.7 — Suspension and revocation of authorized importation programs
• § 251.8 — Modification or extension of authorized importation programs
• § 251.9 — Registration of Foreign Sellers
• § 251.10 — Reviewing and updating registration information for Foreign Sellers
• § 251.11 — Official contact and U.S. agent for Foreign Sellers
• § 251.12 — Importer responsibilities
• § 251.13 — Labeling of eligible prescription drugs
• § 251.14 — Supply chain security requirements for eligible prescription drugs
• § 251.15 — Qualifying laboratory requirements
• § 251.16 — Laboratory testing requirements
• § 251.17 — Importation requirements
• § 251.18 — Post-importation requirements
• § 251.19 — Reports to FDA
• § 251.20 — Severability
• § 251.21 — Consequences for violations

PART 290

• § 290.1 — Controlled substances
• § 290.2 — Exemption from prescription requirements
• § 290.5 — Drugs; statement of required warning
• § 290.6 — Spanish-language version of required warning
• § 290.10 — Definition of emergency situation

PART 299

• § 299.3 — Definitions and interpretations
• § 299.4 — Established names for drugs
• § 299.5 — Drugs; compendial name

PART 300

• § 300.50 — Fixed-combination prescription drugs for humans
• § 300.100 — Chlorofluorocarbon propellants
• § 300.200 — Annual summary requirements under the Right to Try Act

PART 310

• § 310.3 — Definitions and interpretations
• § 310.4 — Biologics; products subject to license control
• § 310.6 — Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products
• § 310.100 — New drug status opinions; statement of policy
• § 310.103 — New drug substances intended for hypersensitivity testing
• § 310.200 — Prescription-exemption procedure
• § 310.201 — Exemption for certain drugs limited by new-drug applications to prescription sale
• § 310.305 — Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications
• § 310.306 — Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications
• § 310.501 — Patient package inserts for oral contraceptives
• § 310.502 — Certain drugs accorded new drug status through rulemaking procedures
• § 310.503 — Requirements regarding certain radioactive drugs
• § 310.509 — Parenteral drug products in plastic containers
• § 310.515 — Patient package inserts for estrogens
• § 310.517 — Labeling for oral hypoglycemic drugs of the sulfonylurea class
• § 310.518 — Drug products containing iron or iron salts
• § 310.519 — Drug products marketed as over-the-counter (OTC) daytime sedatives
• § 310.527 — Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention
• § 310.528 — Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac
• § 310.529 — Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents
• § 310.530 — Topically applied hormone-containing drug products for over-the-counter (OTC) human use
• § 310.531 — Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils
• § 310.532 — Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy
• § 310.533 — Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products
• § 310.534 — Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents
• § 310.536 — Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent
• § 310.537 — Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores
• § 310.538 — Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief
• § 310.540 — Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers
• § 310.541 — Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia
• § 310.542 — Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia
• § 310.543 — Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency
• § 310.544 — Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent
• § 310.545 — Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses
• § 310.546 — Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps
• § 310.547 — Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria
• § 310.548 — Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease

PART 312

• § 312.1 — Scope
• § 312.2 — Applicability
• § 312.3 — Definitions and interpretations
• § 312.6 — Labeling of an investigational new drug
• § 312.7 — Promotion of investigational drugs
• § 312.8 — Charging for investigational drugs under an IND
• § 312.10 — Waivers
• § 312.20 — Requirement for an IND
• § 312.21 — Phases of an investigation
• § 312.22 — General principles of the IND submission
• § 312.23 — IND content and format
• § 312.30 — Protocol amendments
• § 312.31 — Information amendments
• § 312.32 — IND safety reporting
• § 312.33 — Annual reports
• § 312.38 — Withdrawal of an IND
• § 312.40 — General requirements for use of an investigational new drug in a clinical investigation
• § 312.41 — Comment and advice on an IND
• § 312.42 — Clinical holds and requests for modification
• § 312.44 — Termination
• § 312.45 — Inactive status
• § 312.47 — Meetings
• § 312.48 — Dispute resolution
• § 312.50 — General responsibilities of sponsors
• § 312.52 — Transfer of obligations to a contract research organization
• § 312.53 — Selecting investigators and monitors
• § 312.54 — Emergency research under § 50.24 of this chapter
• § 312.55 — Informing investigators
• § 312.56 — Review of ongoing investigations
• § 312.57 — Recordkeeping and record retention
• § 312.58 — Inspection of sponsor's records and reports
• § 312.59 — Disposition of unused supply of investigational drug
• § 312.60 — General responsibilities of investigators
• § 312.61 — Control of the investigational drug
• § 312.62 — Investigator recordkeeping and record retention
• § 312.64 — Investigator reports
• § 312.66 — Assurance of IRB review
• § 312.68 — Inspection of investigator's records and reports
• § 312.69 — Handling of controlled substances
• § 312.70 — Disqualification of a clinical investigator
• § 312.80 — Purpose
• § 312.81 — Scope
• § 312.82 — Early consultation
• § 312.83 — Treatment protocols
• § 312.84 — Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses
• § 312.85 — Phase 4 studies
• § 312.86 — Focused FDA regulatory research
• § 312.87 — Active monitoring of conduct and evaluation of clinical trials
• § 312.88 — Safeguards for patient safety
• § 312.110 — Import and export requirements
• § 312.120 — Foreign clinical studies not conducted under an IND
• § 312.130 — Availability for public disclosure of data and information in an IND
• § 312.140 — Address for correspondence
• § 312.145 — Guidance documents
• § 312.160 — Drugs for investigational use in laboratory research animals or in vitro tests
• § 312.300 — General
• § 312.305 — Requirements for all expanded access uses
• § 312.310 — Individual patients, including for emergency use
• § 312.315 — Intermediate-size patient populations
• § 312.320 — Treatment IND or treatment protocol

PART 314

• § 314.1 — Scope of this part
• § 314.2 — Purpose
• § 314.3 — Definitions
• § 314.50 — Content and format of an NDA
• § 314.52 — Notice of certification of invalidity, unenforceability, or noninfringement of a patent
• § 314.53 — Submission of patent information
• § 314.54 — Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
• § 314.55 — Pediatric use information
• § 314.56 — Nonprescription drug product with an additional condition for nonprescription use (ACNU)
• § 314.60 — Amendments to an unapproved NDA, supplement, or resubmission
• § 314.65 — Withdrawal by the applicant of an unapproved application
• § 314.70 — Supplements and other changes to an approved NDA
• § 314.71 — Procedures for submission of a supplement to an approved application
• § 314.72 — Change in ownership of an application
• § 314.80 — Postmarketing reporting of adverse drug experiences
• § 314.81 — Other postmarketing reports
• § 314.90 — Waivers
• § 314.92 — Drug products for which abbreviated applications may be submitted
• § 314.93 — Petition to request a change from a listed drug
• § 314.94 — Content and format of an ANDA
• § 314.95 — Notice of certification of invalidity, unenforceability, or noninfringement of a patent
• § 314.96 — Amendments to an unapproved ANDA
• § 314.97 — Supplements and other changes to an approved ANDA
• § 314.98 — Postmarketing reports
• § 314.99 — Other responsibilities of an applicant of an ANDA
• § 314.100 — Timeframes for reviewing applications and abbreviated applications
• § 314.101 — Filing an NDA and receiving an ANDA
• § 314.102 — Communications between FDA and applicants
• § 314.103 — Dispute resolution
• § 314.104 — Drugs with potential for abuse
• § 314.105 — Approval of an NDA and an ANDA
• § 314.106 — Foreign data
• § 314.107 — Date of approval of a 505(b)(2) application or ANDA
• § 314.108 — New drug product exclusivity
• § 314.110 — Complete response letter to the applicant
• § 314.120 — [Reserved]
• § 314.122 — Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed
• § 314.125 — Refusal to approve an NDA
• § 314.126 — Adequate and well-controlled studies
• § 314.127 — Refusal to approve an ANDA
• § 314.150 — Withdrawal of approval of an application or abbreviated application
• § 314.151 — Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act
• § 314.152 — Notice of withdrawal of approval of an application or abbreviated application for a new drug
• § 314.153 — Suspension of approval of an abbreviated new drug application
• § 314.160 — Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn
• § 314.161 — Determination of reasons for voluntary withdrawal of a listed drug
• § 314.162 — Removal of a drug product from the list
• § 314.170 — Adulteration and misbranding of an approved drug
• § 314.200 — Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing
• § 314.201 — Procedure for hearings
• § 314.235 — Judicial review
• § 314.410 — Imports and exports of new drugs
• § 314.420 — Drug master files
• § 314.430 — Availability for public disclosure of data and information in an application or abbreviated application
• § 314.440 — Addresses for applications and abbreviated applications
• § 314.445 — Guidance documents
• § 314.500 — Scope
• § 314.510 — Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity
• § 314.520 — Approval with restrictions to assure safe use
• § 314.530 — Withdrawal procedures
• § 314.540 — Postmarketing safety reporting
• § 314.550 — Promotional materials
• § 314.560 — Termination of requirements
• § 314.600 — Scope
• § 314.610 — Approval based on evidence of effectiveness from studies in animals
• § 314.620 — Withdrawal procedures
• § 314.630 — Postmarketing safety reporting
• § 314.640 — Promotional materials
• § 314.650 — Termination of requirements

PART 315

• § 315.1 — Scope
• § 315.2 — Definition
• § 315.3 — General factors relevant to safety and effectiveness
• § 315.4 — Indications
• § 315.5 — Evaluation of effectiveness
• § 315.6 — Evaluation of safety

PART 316

• § 316.1 — Scope of this part
• § 316.2 — Purpose
• § 316.3 — Definitions
• § 316.4 — Address for submissions
• § 316.10 — Content and format of a request for written recommendations
• § 316.12 — Providing written recommendations
• § 316.14 — Refusal to provide written recommendations
• § 316.20 — Content and format of a request for orphan-drug designation
• § 316.21 — Verification of orphan-drug status
• § 316.22 — Permanent-resident agent for foreign sponsor
• § 316.23 — Timing of requests for orphan-drug designation; designation of already approved drugs
• § 316.24 — Deficiency letters and granting orphan-drug designation
• § 316.25 — Refusal to grant orphan-drug designation
• § 316.26 — Amendment to orphan-drug designation
• § 316.27 — Change in ownership of orphan-drug designation
• § 316.28 — Publication of orphan-drug designations
• § 316.29 — Revocation of orphan-drug designation
• § 316.30 — Annual reports of holder of orphan-drug designation
• § 316.31 — Scope of orphan-drug exclusive approval
• § 316.34 — FDA recognition of exclusive approval
• § 316.36 — Insufficient quantities of orphan drugs
• § 316.40 — Treatment use of a designated orphan drug
• § 316.50 — Guidance documents
• § 316.52 — Availability for public disclosure of data and information in requests and applications

PART 317

• § 317.1 — [Reserved]
• § 317.2 — List of qualifying pathogens that have the potential to pose a serious threat to public health

PART 320

• § 320.1 — Definitions
• § 320.21 — Requirements for submission of bioavailability and bioequivalence data
• § 320.22 — Criteria for waiver of evidence of in vivo bioavailability or bioequivalence
• § 320.23 — Basis for measuring in vivo bioavailability or demonstrating bioequivalence
• § 320.24 — Types of evidence to measure bioavailability or establish bioequivalence
• § 320.25 — Guidelines for the conduct of an in vivo bioavailability study
• § 320.26 — Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study
• § 320.27 — Guidelines on the design of a multiple-dose in vivo bioavailability study
• § 320.28 — Correlation of bioavailability with an acute pharmacological effect or clinical evidence
• § 320.29 — Analytical methods for an in vivo bioavailability or bioequivalence study
• § 320.30 — Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration
• § 320.31 — Applicability of requirements regarding an “Investigational New Drug Application.”
• § 320.32 — Procedures for establishing or amending a bioequivalence requirement
• § 320.33 — Criteria and evidence to assess actual or potential bioequivalence problems
• § 320.34 — Requirements for batch testing and certification by the Food and Drug Administration
• § 320.35 — Requirements for in vitro testing of each batch
• § 320.36 — Requirements for maintenance of records of bioequivalence testing
• § 320.38 — Retention of bioavailability samples
• § 320.63 — Retention of bioequivalence samples

PART 328

• § 328.1 — Scope
• § 328.3 — Definitions
• § 328.10 — Alcohol
• § 328.50 — Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol

PART 329

• § 329.100 — Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act

PART 330

• § 330.1 — General conditions for general recognition as safe, effective and not misbranded
• § 330.2 — Pregnancy-nursing warning
• § 330.3 — Imprinting of solid oral dosage form drug products
• § 330.5 — Drug categories
• § 330.10 — Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs
• § 330.11 — NDA deviations from applicable monograph
• § 330.12 — Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI)
• § 330.13 — Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review
• § 330.14 — Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded
• § 330.15 — Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions

PART 331

• § 331.1 — Scope
• § 331.10 — Antacid active ingredients
• § 331.11 — Listing of specific active ingredients
• § 331.15 — Combination with nonantacid active ingredients
• § 331.20 — Determination of percent contribution of active ingredients
• § 331.21 — Test modifications
• § 331.30 — Labeling of antacid products
• § 331.80 — Professional labeling

PART 332

• § 332.1 — Scope
• § 332.3 — Definitions
• § 332.10 — Antiflatulent active ingredients
• § 332.15 — Combination with non-antiflatulent active ingredients
• § 332.30 — Labeling of antiflatulent drug products
• § 332.31 — Professional labeling

PART 333

• § 333.101 — Scope
• § 333.103 — Definitions
• § 333.110 — First aid antibiotic active ingredients
• § 333.120 — Permitted combinations of active ingredients
• § 333.150 — Labeling of first aid antibiotic drug products
• § 333.160 — Labeling of permitted combinations of active ingredients
• § 333.201 — Scope
• § 333.203 — Definitions
• § 333.210 — Antifungal active ingredients
• § 333.250 — Labeling of antifungal drug products
• § 333.280 — Professional labeling
• § 333.301 — Scope
• § 333.303 — Definitions
• § 333.310 — Acne active ingredients
• § 333.320 — Permitted combinations of active ingredients
• § 333.350 — Labeling of acne drug products

PART 335

• § 335.1 — Scope
• § 335.3 — Definitions
• § 335.10 — Antidiarrheal active ingredients
• § 335.50 — Labeling of antidiarrheal drug products

PART 336

• § 336.1 — Scope
• § 336.3 — Definition
• § 336.10 — Antiemetic active ingredients
• § 336.50 — Labeling of antiemetic drug products
• § 336.80 — Professional labeling

PART 338

• § 338.1 — Scope
• § 338.3 — Definition
• § 338.10 — Nighttime sleep-aid active ingredients
• § 338.50 — Labeling of nighttime sleep-aid drug products

PART 340

• § 340.1 — Scope
• § 340.3 — Definition
• § 340.10 — Stimulant active ingredient
• § 340.50 — Labeling of stimulant drug products

PART 341

• § 341.1 — Scope
• § 341.3 — Definitions
• § 341.12 — Antihistamine active ingredients
• § 341.14 — Antitussive active ingredients
• § 341.16 — Bronchodilator active ingredients
• § 341.18 — Expectorant active ingredient
• § 341.20 — Nasal decongestant active ingredients
• § 341.40 — Permitted combinations of active ingredients
• § 341.70 — Labeling of OTC drug products containing ingredients that are used for treating concurrent symptoms (in either a single-ingredient or combination drug product)
• § 341.72 — Labeling of antihistamine drug products
• § 341.74 — Labeling of antitussive drug products
• § 341.76 — Labeling of bronchodilator drug products
• § 341.78 — Labeling of expectorant drug products
• § 341.80 — Labeling of nasal decongestant drug products
• § 341.85 — Labeling of permitted combinations of active ingredients
• § 341.90 — Professional labeling

PART 343

• § 343.1 — Scope
• § 343.3 — Definitions
• § 343.10 — [Reserved]
• § 343.12 — Cardiovascular active ingredients
• § 343.13 — Rheumatologic active ingredients
• § 343.20 — [Reserved]
• § 343.22 — Permitted combinations of active ingredients for cardiovascular-rheumatologic use
• § 343.50-343.60 — 343.50-343.60 [Reserved]
• § 343.80 — Professional labeling
• § 343.90 — Dissolution and drug release testing

PART 344

• § 344.1 — Scope
• § 344.3 — Definitions
• § 344.10 — Earwax removal aid active ingredient
• § 344.12 — Ear drying aid active ingredient
• § 344.50 — Labeling of earwax removal aid drug products
• § 344.52 — Labeling of ear drying aid drug products

PART 346

• § 346.1 — Scope
• § 346.3 — Definitions
• § 346.10 — Local anesthetic active ingredients
• § 346.12 — Vasoconstrictor active ingredients
• § 346.14 — Protectant active ingredients
• § 346.16 — Analgesic, anesthetic, and antipruritic active ingredients
• § 346.18 — Astringent active ingredients
• § 346.20 — Keratolytic active ingredients
• § 346.22 — Permitted combinations of anorectal active ingredients
• § 346.50 — Labeling of anorectal drug products
• § 346.52 — Labeling of permitted combinations of anorectal active ingredients

PART 347

• § 347.1 — Scope
• § 347.3 — Definitions
• § 347.10 — Skin protectant active ingredients
• § 347.12 — Astringent active ingredients
• § 347.20 — Permitted combinations of active ingredients
• § 347.50 — Labeling of skin protectant drug products
• § 347.52 — Labeling of astringent drug products
• § 347.60 — Labeling of permitted combinations of active ingredients

PART 348

• § 348.1 — Scope
• § 348.3 — Definitions
• § 348.10 — Analgesic, anesthetic, and antipruritic active ingredients
• § 348.50 — Labeling of external analgesic drug products

PART 349

• § 349.1 — Scope
• § 349.3 — Definitions
• § 349.10 — Ophthalmic astringent
• § 349.12 — Ophthalmic demulcents
• § 349.14 — Ophthalmic emollients
• § 349.16 — Ophthalmic hypertonicity agent
• § 349.18 — Ophthalmic vasoconstrictors
• § 349.20 — Eyewashes
• § 349.30 — Permitted combinations of active ingredients
• § 349.50 — Labeling of ophthalmic drug products
• § 349.55 — Labeling of ophthalmic astringent drug products
• § 349.60 — Labeling of ophthalmic demulcent drug products
• § 349.65 — Labeling of ophthalmic emollient drug products
• § 349.70 — Labeling of ophthalmic hypertonicity drug products
• § 349.75 — Labeling of ophthalmic vasoconstrictor drug products
• § 349.78 — Labeling of eyewash drug products
• § 349.79 — Labeling of permitted combinations of active ingredients
• § 349.80 — Professional labeling

PART 350

• § 350.1 — Scope
• § 350.3 — Definition
• § 350.10 — Antiperspirant active ingredients
• § 350.50 — Labeling of antiperspirant drug products
• § 350.60 — Guidelines for effectiveness testing of antiperspirant drug products

PART 352

• § 352.1 — Scope
• § 352.3 — Definitions
• § 352.10 — Sunscreen active ingredients
• § 352.20 — Permitted combinations of active ingredients
• § 352.50 — Principal display panel of all sunscreen drug products
• § 352.52 — Labeling of sunscreen drug products
• § 352.60 — Labeling of permitted combinations of active ingredients
• § 352.70 — Standard sunscreen
• § 352.71 — Light source (solar simulator)
• § 352.72 — General testing procedures
• § 352.73 — Determination of SPF value
• § 352.76 — Determination if a product is water resistant or very water resistant
• § 352.77 — Test modifications

PART 355

• § 355.1 — Scope
• § 355.3 — Definitions
• § 355.10 — Anticaries active ingredients
• § 355.20 — Packaging conditions
• § 355.50 — Labeling of anticaries drug products
• § 355.55 — Principal display panel of all fluoride rinse drug products
• § 355.60 — Professional labeling
• § 355.70 — Testing procedures for fluoride dentifrice drug products

PART 357

• § 357.101 — Scope
• § 357.103 — Definition
• § 357.110 — Anthelmintic active ingredient
• § 357.150 — Labeling of anthelmintic drug products
• § 357.152 — Package inserts for anthelmintic drug products
• § 357.180 — Professional labeling
• § 357.201 — Scope
• § 357.203 — Definition
• § 357.210 — Cholecystokinetic active ingredients
• § 357.250 — Labeling of cholecystokinetic drug products
• § 357.280 — Professional labeling
• § 357.801 — Scope
• § 357.803 — Definitions
• § 357.810 — Active ingredients for deodorant drug products for internal use
• § 357.850 — Labeling of deodorant drug products for internal use

PART 358

• § 358.101 — Scope
• § 358.103 — Definitions
• § 358.110 — Wart remover active ingredients
• § 358.150 — Labeling of wart remover drug products
• § 358.301 — Scope
• § 358.303 — Definitions
• § 358.310 — Ingrown toenail relief active ingredient
• § 358.350 — Labeling of ingrown toenail relief drug products
• § 358.501 — Scope
• § 358.503 — Definitions
• § 358.510 — Corn and callus remover active ingredients
• § 358.550 — Labeling of corn and callus remover drug products
• § 358.601 — Scope
• § 358.603 — Definition
• § 358.610 — Pediculicide active ingredients
• § 358.650 — Labeling of pediculicide drug products
• § 358.701 — Scope
• § 358.703 — Definitions
• § 358.710 — Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis
• § 358.720 — Permitted combinations of active ingredients
• § 358.750 — Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis
• § 358.760 — Labeling of permitted combinations of active ingredients for the control of dandruff

PART 361

• § 361.1 — Radioactive drugs for certain research uses

PART 369

• § 369.1 — Purpose of issuance
• § 369.2 — Definitions
• § 369.3 — Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C)
• § 369.4 — Warnings suggested for drugs by formal or informal statements of policy
• § 369.6 — [Reserved]
• § 369.7 — Warnings required by official compendia
• § 369.8 — Warning statements in relation to conditions for use
• § 369.9 — General warnings re accidental ingestion by children
• § 369.10 — Conspicuousness of warning statements
• § 369.20 — Drugs; recommended warning and caution statements
• § 369.21 — Drugs; warning and caution statements required by regulations

PART 500

• § 500.23 — Thermally processed low-acid foods packaged in hermetically sealed containers
• § 500.24 — Emergency permit control
• § 500.25 — Anthelmintic drugs for use in animals
• § 500.26 — Timed-release dosage form drugs
• § 500.27 — Methylene blue-containing drugs for use in animals
• § 500.29 — Gentian violet for use in animal feed
• § 500.30 — Gentian violet for animal drug use
• § 500.45 — Use of polychlorinated biphenyls (PCB's) in the production, handling, and storage of animal feed
• § 500.46 — Hexachlorophene in animal drugs
• § 500.50 — Propylene glycol in or on cat food
• § 500.51 — Labeling of animal drugs; misbranding
• § 500.52 — Use of terms such as “tonic”, “tone”, “toner”, or “conditioner” in the labeling of preparations intended for use in or on animals
• § 500.55 — Exemption from certain drug-labeling requirements
• § 500.65 — Epinephrine injection 1:1,000 in 10-milliliter containers for emergency treatment of anaphylactoid shock in cattle, horses, sheep, and swine
• § 500.80 — Scope of this subpart
• § 500.82 — Definitions
• § 500.84 — Conditions for approval of the sponsored compound
• § 500.86 — Marker residue and target tissue
• § 500.88 — Regulatory method
• § 500.90 — Waiver of requirements
• § 500.92 — Implementation
• § 500.1410 — N-methyl-2-pyrrolidone

PART 501

• § 501.1 — Principal display panel of package form animal food
• § 501.2 — Information panel of package for animal food
• § 501.3 — Identity labeling of animal food in package form
• § 501.4 — Animal food; designation of ingredients
• § 501.5 — Animal food; name and place of business of manufacturer, packer, or distributor
• § 501.8 — Labeling of animal food with number of servings
• § 501.15 — Animal food; prominence of required statements
• § 501.17 — Animal food labeling warning statements
• § 501.18 — Misbranding of animal food
• § 501.22 — Animal foods; labeling of spices, flavorings, colorings, and chemical preservatives
• § 501.100 — Animal food; exemptions from labeling
• § 501.103 — Petitions requesting exemptions from or special requirements for label declaration of ingredients
• § 501.105 — Declaration of net quantity of contents when exempt
• § 501.110 — Animal feed labeling; collective names for feed ingredients

PART 502

• § 502.5 — General principles
• § 502.19 — Petitions

PART 507

• § 507.1 — Applicability and status
• § 507.3 — Definitions
• § 507.4 — Qualifications of individuals who manufacture, process, pack, or hold animal food
• § 507.5 — Exemptions
• § 507.7 — Requirements that apply to a qualified facility
• § 507.10 — Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food
• § 507.12 — Applicability of this part to the holding and distribution of human food by-products for use as animal food
• § 507.14 — Personnel
• § 507.17 — Plant and grounds
• § 507.19 — Sanitation
• § 507.20 — Water supply and plumbing
• § 507.22 — Equipment and utensils
• § 507.25 — Plant operations
• § 507.27 — Holding and distribution
• § 507.28 — Holding and distribution of human food by-products for use as animal food
• § 507.31 — Food safety plan
• § 507.33 — Hazard analysis
• § 507.34 — Preventive controls
• § 507.36 — Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control
• § 507.37 — Provision of assurances required under § 507.36(a)(2), (3), and (4)
• § 507.38 — Recall plan
• § 507.39 — Preventive control management components
• § 507.40 — Monitoring
• § 507.42 — Corrective actions and corrections
• § 507.45 — Verification
• § 507.47 — Validation
• § 507.49 — Verification of implementation and effectiveness
• § 507.50 — Reanalysis
• § 507.51 — Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food
• § 507.53 — Requirements applicable to a preventive controls qualified individual and a qualified auditor
• § 507.55 — Implementation records required for this subpart
• § 507.60 — Circumstances that may lead FDA to withdraw a qualified facility exemption
• § 507.62 — Issuance of an order to withdraw a qualified facility exemption
• § 507.65 — Contents of an order to withdraw a qualified facility exemption
• § 507.67 — Compliance with, or appeal of, an order to withdraw a qualified facility exemption
• § 507.69 — Procedure for submitting an appeal
• § 507.71 — Procedure for requesting an informal hearing
• § 507.73 — Requirements applicable to an informal hearing
• § 507.75 — Presiding officer for an appeal and for an informal hearing
• § 507.77 — Timeframe for issuing a decision on an appeal
• § 507.80 — Revocation of an order to withdraw a qualified facility exemption
• § 507.83 — Final agency action
• § 507.85 — Reinstatement of a qualified facility exemption that was withdrawn
• § 507.105 — Requirement to establish and implement a supply-chain program
• § 507.110 — General requirements applicable to a supply-chain program
• § 507.115 — Responsibilities of the receiving facility
• § 507.120 — Using approved suppliers
• § 507.125 — Determining appropriate supplier verification activities (including determining the frequency of conducting the activity)
• § 507.130 — Conducting supplier verification activities for raw materials and other ingredients
• § 507.135 — Onsite audit
• § 507.175 — Records documenting the supply-chain program
• § 507.200 — Records subject to the requirements of this subpart
• § 507.202 — General requirements applying to records
• § 507.206 — Additional requirements applying to the food safety plan
• § 507.208 — Requirements for record retention
• § 507.212 — Use of existing records
• § 507.215 — Special requirements applicable to a written assurance

PART 509

• § 509.3 — Definitions and interpretations
• § 509.4 — Establishment of tolerances, regulatory limits, and action levels
• § 509.5 — Petitions
• § 509.6 — Added poisonous or deleterious substances
• § 509.7 — Unavoidability
• § 509.15 — Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials
• § 509.30 — Temporary tolerances for polychlorinated biphenyls (PCB's)

PART 510

• § 510.3 — Definitions and interpretations
• § 510.4 — Biologics; products subject to license control
• § 510.7 — Consignees of new animal drugs for use in the manufacture of animal feed
• § 510.95 — [Reserved]
• § 510.105 — Labeling of drugs for use in milk-producing animals
• § 510.106 — Labeling of antibiotic and antibiotic-containing drugs intended for use in milk-producing animals
• § 510.110 — Antibiotics used in food-producing animals
• § 510.112 — Antibiotics used in veterinary medicine and for nonmedical purposes; required data
• § 510.201 — Scope
• § 510.202 — Definitions
• § 510.203 — Initiation of a proceeding to establish or amend an import tolerance
• § 510.205 — Content and administration of a request
• § 510.206 — Review of information supporting actions to establish or amend an import tolerance
• § 510.207 — Disclosure of information submitted in a request
• § 510.209 — Establishment, denial, or amendment of an import tolerance
• § 510.210 — Revocation of an import tolerance
• § 510.212 — Administrative reconsideration of action
• § 510.213 — Administrative stay of action
• § 510.301 — Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect
• § 510.305 — Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs
• § 510.410 — Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling requirements
• § 510.440 — Injectable iron preparations
• § 510.455 — Requirements for free-choice medicated feeds
• § 510.600 — Names, addresses, and drug labeler codes of sponsors of approved applications

PART 511

• § 511.1 — New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act
• § 511.3 — Definitions

PART 514

• § 514.1 — Applications
• § 514.3 — Definitions
• § 514.4 — Substantial evidence
• § 514.5 — Presubmission conferences
• § 514.6 — Amended applications
• § 514.7 — Withdrawal of applications without prejudice
• § 514.8 — Supplements and other changes to an approved application
• § 514.11 — Confidentiality of data and information in a new animal drug application file
• § 514.12 — Confidentiality of data and information in an investigational new animal drug notice
• § 514.15 — Untrue statements in applications
• § 514.80 — Records and reports concerning experience with approved new animal drugs
• § 514.87 — Annual reports for antimicrobial animal drug sales and distribution
• § 514.100 — Evaluation and comment on applications
• § 514.105 — Approval of applications
• § 514.106 — Approval of supplemental applications
• § 514.110 — Reasons for refusing to file applications
• § 514.111 — Refusal to approve an application
• § 514.115 — Withdrawal of approval of applications
• § 514.116 — Notice of withdrawal of approval of application
• § 514.117 — Adequate and well-controlled studies
• § 514.120 — Revocation of order refusing to approve an application or suspending or withdrawing approval of an application
• § 514.121 — Service of notices and orders
• § 514.200 — Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing
• § 514.201 — Procedures for hearings
• § 514.235 — Judicial review

PART 515

• § 515.10 — Medicated feed mill license applications
• § 515.11 — Supplemental medicated feed mill license applications
• § 515.20 — Approval of medicated feed mill license applications
• § 515.21 — Refusal to approve a medicated feed mill license application
• § 515.22 — Suspension and/or revocation of approval of a medicated feed mill license
• § 515.23 — Voluntary revocation of medicated feed mill license
• § 515.24 — Notice of revocation of a medicated feed mill license
• § 515.25 — Revocation of order refusing to approve a medicated feed mill license application or suspending or revoking a license
• § 515.26 — Services of notices and orders
• § 515.30 — Contents of notice of opportunity for a hearing
• § 515.31 — Procedures for hearings
• § 515.40 — Judicial review

PART 516

• § 516.1 — Scope
• § 516.2 — Purpose
• § 516.3 — Definitions
• § 516.11 — Scope of this subpart
• § 516.12 — Purpose
• § 516.13 — Definitions
• § 516.14 — Submission of requests for designation
• § 516.16 — Eligibility to request designation
• § 516.20 — Content and format of a request for MUMS-drug designation
• § 516.21 — Documentation of minor use status
• § 516.22 — Permanent-resident U.S. agent for foreign sponsor
• § 516.23 — Timing of requests for MUMS-drug designation
• § 516.24 — Granting MUMS-drug designation
• § 516.25 — Refusal to grant MUMS-drug designation
• § 516.26 — Amendment to MUMS-drug designation
• § 516.27 — Change in sponsorship
• § 516.28 — Publication of MUMS-drug designations
• § 516.29 — Termination of MUMS-drug designation
• § 516.30 — Annual reports for a MUMS-designated drug
• § 516.31 — Scope of MUMS-drug exclusive marketing rights
• § 516.34 — FDA recognition of exclusive marketing rights
• § 516.36 — Insufficient quantities of MUMS-designated drugs
• § 516.52 — Availability for public disclosure of data and information in requests
• § 516.111 — Scope of this subpart
• § 516.115 — Definitions
• § 516.117 — Submission of correspondence under this subpart
• § 516.119 — Permanent-resident U.S. agent for foreign requestors and holders
• § 516.121 — Meetings
• § 516.123 — Informal conferences regarding agency administrative actions
• § 516.125 — Investigational use of minor species new animal drugs to support indexing
• § 516.129 — Content and format of a request for determination of eligibility for indexing
• § 516.131 — Refuse to file a request for determination of eligibility for indexing
• § 516.133 — Denying a request for determination of eligibility for indexing
• § 516.135 — Granting a request for determination of eligibility for indexing
• § 516.137 — Notification of decision regarding eligibility for indexing
• § 516.141 — Qualified expert panels
• § 516.143 — Written report
• § 516.145 — Content and format of a request for addition to the index
• § 516.147 — Refuse to file a request for addition to the index
• § 516.149 — Denying a request for addition to the index
• § 516.151 — Granting a request for addition to the index
• § 516.153 — Notification of decision regarding index listing
• § 516.155 — Labeling of indexed drugs
• § 516.157 — Publication of the index and content of an index listing
• § 516.161 — Modifications to indexed drugs
• § 516.163 — Change in ownership of an index file
• § 516.165 — Records and reports
• § 516.167 — Removal from the index
• § 516.171 — Confidentiality of data and information in an index file
• § 516.498 — Crofelemer
• § 516.570 — Doramectin
• § 516.1012 — Fuzapladib
• § 516.1287 — Lotilaner, moxidectin, praziquantel, and pyrantel
• § 516.1449 — Molidustat oral suspension
• § 516.1760 — Phenobarbital
• § 516.1780 — Pimobendan
• § 516.1858 — Potassium bromide
• § 516.2106 — Sirolimus
• § 516.2475 — Torsemide

PART 520

• § 520.23 — Acepromazine
• § 520.28 — Acetazolamide
• § 520.35 — Afoxolaner, moxidectin, and pyrantel
• § 520.38 — Albendazole oral dosage forms
• § 520.38a — Albendazole suspension
• § 520.38b — Albendazole paste
• § 520.43 — Afoxolaner
• § 520.48 — Altrenogest
• § 520.62 — Aminopentamide
• § 520.82 — Aminopropazine oral dosage forms
• § 520.82a — Aminopropazine
• § 520.82b — Aminopropazine and neomycin
• § 520.88 — Amoxicillin oral dosage forms
• § 520.88a — Amoxicillin trihydrate film-coated tablets
• § 520.88b — Amoxicillin trihydrate for oral suspension
• § 520.88c — Amoxicillin trihydrate oral suspension
• § 520.88d — Amoxicillin trihydrate soluble powder
• § 520.88e — Amoxicillin trihydrate boluses
• § 520.88f — Amoxicillin trihydrate tablets
• § 520.88g — Amoxicillin and clavulanate potassium tablets
• § 520.88h — Amoxicillin trihydrate and clavulanate potassium for oral suspension
• § 520.90 — Ampicillin oral dosage forms
• § 520.90a — Ampicillin tablets
• § 520.90b — Ampicillin capsules
• § 520.90c — Ampicillin boluses
• § 520.100 — Amprolium
• § 520.110 — Apramycin sulfate soluble powder
• § 520.154 — Bacitracin oral dosage forms
• § 520.154a — Bacitracin methylenedisalicylate
• § 520.154b — Bacitracin methylenedisalicylate and streptomycin sulfate powder
• § 520.154c — Bacitracin zinc soluble powder
• § 520.170 — Bexagliflozin
• § 520.222 — Bunamidine hydrochloride
• § 520.246 — Butorphanol tablets
• § 520.260 — n-Butyl chloride
• § 520.292 — Capromorelin
• § 520.301 — Caramiphen ethanedisulfonate and ammonium chloride tablets
• § 520.302 — Carnidazole tablets
• § 520.304 — Carprofen
• § 520.314 — Cefadroxil
• § 520.370 — Cefpodoxime tablets
• § 520.376 — Cephalexin
• § 520.390 — Chloramphenicol oral dosage forms
• § 520.390a — Chloramphenicol tablets
• § 520.390b — Chloramphenicol capsules
• § 520.390c — Chloramphenicol palmitate oral suspension
• § 520.434 — Chlorphenesin carbamate tablets
• § 520.441 — Chlortetracycline powder
• § 520.443 — Chlortetracycline tablets and boluses
• § 520.445 — Chlortetracycline and sulfamethazine powder
• § 520.446 — Clindamycin capsules and tablets
• § 520.447 — Clindamycin solution
• § 520.452 — Clenbuterol syrup
• § 520.455 — Clomipramine
• § 520.462 — Clorsulon drench
• § 520.522 — Cyclosporine
• § 520.530 — Cythioate oral liquid
• § 520.531 — Cythioate tablets
• § 520.534 — Decoquinate
• § 520.538 — Deracoxib
• § 520.540 — Dexamethasone oral dosage forms
• § 520.540a — Dexamethasone powder
• § 520.540b — Dexamethasone tablets and boluses
• § 520.540c — Dexamethasone chewable tablets
• § 520.563 — Diatrizoate
• § 520.580 — Dichlorophene and toluene
• § 520.581 — Dichlorophene tablets
• § 520.596 — Dichlorvos powder
• § 520.598 — Dichlorvos tablets
• § 520.600 — Dichlorvos capsules and pellets
• § 520.602 — Dichlorvos gel
• § 520.606 — Diclazuril
• § 520.608 — Dicloxacillin
• § 520.620 — Diethylcarbamazine oral dosage forms
• § 520.622 — Diethylcarbamazine citrate oral dosage forms
• § 520.622a — Diethylcarbamazine citrate tablets
• § 520.622b — Diethylcarbamazine citrate syrup
• § 520.622c — Diethylcarbamazine citrate chewable tablets
• § 520.623 — Diethylcarbamazine and oxibendazole chewable tablets
• § 520.666 — Dirlotapide
• § 520.763 — Dithiazanine oral dosage forms
• § 520.763a — Dithiazanine tablets
• § 520.763b — Dithiazanine powder
• § 520.763c — Dithiazanine iodide and piperazine citrate suspension
• § 520.766 — Domperidone
• § 520.784 — Doxylamine
• § 520.812 — Enrofloxacin
• § 520.816 — Epsiprantel
• § 520.823 — Erythromycin
• § 520.852 — Estriol
• § 520.863 — Ethylisobutrazine
• § 520.903 — Febantel oral dosage forms
• § 520.903a — Febantel paste
• § 520.903b — Febantel suspension
• § 520.903c — Febantel and praziquantel paste
• § 520.903d — Febantel tablets
• § 520.905 — Fenbendazole oral dosage forms
• § 520.905a — Fenbendazole suspension
• § 520.905b — Fenbendazole granules
• § 520.905c — Fenbendazole paste
• § 520.905d — Fenbendazole powder
• § 520.928 — Firocoxib tablets
• § 520.929 — Firocoxib solution
• § 520.930 — Firocoxib paste
• § 520.955 — Florfenicol
• § 520.960 — Flumethasone
• § 520.970 — Flunixin
• § 520.980 — Fluoxetine
• § 520.998 — Fluralaner chewable tablets
• § 520.999 — Fluralaner oral solution
• § 520.1010 — Furosemide
• § 520.1044 — Gentamicin sulfate oral dosage forms
• § 520.1044a — Gentamicin sulfate oral solution
• § 520.1044b — Gentamicin sulfate pig pump oral solution
• § 520.1044c — Gentamicin sulfate powder
• § 520.1060 — Glucose and glycine
• § 520.1084 — Grapiprant
• § 520.1100 — Griseofulvin
• § 520.1120 — Haloxon oral dosage forms
• § 520.1120a — Haloxon drench
• § 520.1120b — Haloxon boluses
• § 520.1136 — Ilunocitinib
• § 520.1150 — Imepitoin
• § 520.1156 — Imidacloprid
• § 520.1157 — Iodinated casein
• § 520.1158 — Iodochlorhydroxyquin
• § 520.1189 — Itraconazole
• § 520.1192 — Ivermectin paste
• § 520.1193 — Ivermectin tablets and chewables
• § 520.1194 — Ivermectin meal
• § 520.1195 — Ivermectin liquid
• § 520.1196 — Ivermectin and pyrantel tablets
• § 520.1197 — Ivermectin sustained-release bolus
• § 520.1198 — Ivermectin and praziquantel paste
• § 520.1199 — Ivermectin, pyrantel, and praziquantel tablets
• § 520.1200 — Ivermectin, fenbendazole, and praziquantel tablets
• § 520.1204 — Kanamycin, bismuth subcarbonate, activated attapulgite
• § 520.1242 — Levamisole
• § 520.1242a — Levamisole powder
• § 520.1242b — Levamisol boluses or oblets
• § 520.1242c — Levamisol and piperazine
• § 520.1242d — Levamisole resinate
• § 520.1242e — Levamisole hydrochloride effervescent tablets
• § 520.1242f — Levamisol gel
• § 520.1242g — Levamisole resinate and famphur paste
• § 520.1248 — Levothyroxine
• § 520.1263 — Lincomycin
• § 520.1263a — Lincomycin tablets and syrup
• § 520.1263b — Lincomycin hydrochloride soluble powder
• § 520.1265 — Lincomycin and spectinomycin powder
• § 520.1284 — Liothyronine
• § 520.1286 — Lotilaner
• § 520.1287 — Lotilaner, moxidectin, praziquantel, and pyrantel
• § 520.1288 — Lufenuron tablets
• § 520.1289 — Lufenuron suspension
• § 520.1310 — Marbofloxacin
• § 520.1315 — Maropitant
• § 520.1320 — Mebendazole
• § 520.1326 — Mebendazole and trichlorfon oral dosage forms
• § 520.1326a — Mebendazole and trichlorfon powder
• § 520.1326b — Mebendazole and trichlorfon paste
• § 520.1330 — Meclofenamic acid granules
• § 520.1331 — Meclofenamic acid tablets
• § 520.1341 — Megestrol
• § 520.1367 — Meloxicam
• § 520.1375 — Methimazole tablets
• § 520.1376 — Methimazole solution
• § 520.1380 — Methocarbamol
• § 520.1408 — Methylprednisolone
• § 520.1409 — Methylprednisolone and aspirin
• § 520.1422 — Metoserpate hydrochloride
• § 520.1425 — Metronidazole
• § 520.1430 — Mibolerone
• § 520.1441 — Milbemycin
• § 520.1443 — Milbemycin oxime and lufenuron
• § 520.1445 — Milbemycin oxime and praziquantel
• § 520.1447 — Milbemycin oxime, lufenuron, and praziquantel tablets
• § 520.1450 — Morantel tartrate oral dosage forms
• § 520.1450a — Morantel tartrate bolus
• § 520.1450b — Morantel tartrate cartridge
• § 520.1450c — Morantel tartrate sustained-release trilaminate cylinder/sheet
• § 520.1451 — Moxidectin tablets
• § 520.1452 — Moxidectin gel
• § 520.1453 — Moxidectin and praziquantel gel
• § 520.1454 — Moxidectin solution
• § 520.1468 — Naproxen
• § 520.1484 — Neomycin
• § 520.1510 — Nitenpyram
• § 520.1604 — Oclacitinib
• § 520.1615 — Omeprazole
• § 520.1616 — Orbifloxacin tablets
• § 520.1618 — Orbifloxacin suspension
• § 520.1628 — Oxfendazole powder and pellets
• § 520.1629 — Oxfendazole paste
• § 520.1630 — Oxfendazole suspension
• § 520.1631 — Oxfendazole and trichlorfon paste
• § 520.1638 — Oxibendazole
• § 520.1660 — Oxytetracycline
• § 520.1660a — [Reserved]
• § 520.1660b — Oxytetracycline capsules
• § 520.1660c — Oxytetracycline tablets
• § 520.1660d — Oxytetracycline powder
• § 520.1664 — Oxytetracycline and carbomycin
• § 520.1696 — Penicillin
• § 520.1696a — Penicillin G powder
• § 520.1696c — Penicillin V tablets
• § 520.1705 — Pergolide
• § 520.1720 — Phenylbutazone oral dosage forms
• § 520.1720a — Phenylbutazone tablets and boluses
• § 520.1720b — Phenylbutazone granules
• § 520.1720c — Phenylbutazone paste
• § 520.1720d — Phenylbutazone gel
• § 520.1720e — Phenylbutazone powder
• § 520.1760 — Phenylpropanolamine
• § 520.1780 — Pimobendan tablets
• § 520.1782 — Pimobendan solution
• § 520.1802 — Piperazine-carbon disulfide complex oral dosage forms
• § 520.1802a — Piperazine-carbon disulfide complex suspension
• § 520.1802b — Piperazine-carbon disulfide complex boluses
• § 520.1802c — Piperazine-carbon disulfide complex with phenothiazine suspension
• § 520.1803 — Piperazine citrate capsules
• § 520.1805 — Piperazine phosphate with thenium closylate tablets
• § 520.1806 — Piperazine suspension
• § 520.1840 — Poloxalene
• § 520.1855 — Ponazuril
• § 520.1860 — Pradofloxacin
• § 520.1870 — Praziquantel tablets
• § 520.1871 — Praziquantel and pyrantel
• § 520.1872 — Praziquantel, pyrantel pamoate, and febantel tablets
• § 520.1880 — Prednisolone
• § 520.1892 — Pregabalin
• § 520.1900 — Primidone
• § 520.1920 — Prochlorperazine and isopropamide
• § 520.1921 — Prochlorperazine, isopropamide, and neomycin
• § 520.1962 — Promazine
• § 520.2002 — Propiopromazine
• § 520.2041 — Pyrantel pamoate chewable tablets
• § 520.2042 — Pyrantel pamoate tablets
• § 520.2043 — Pyrantel pamoate suspension
• § 520.2044 — Pyrantel pamoate paste
• § 520.2045 — Pyrantel tartrate powder
• § 520.2046 — Pyrantel tartrate pellets
• § 520.2075 — Robenacoxib
• § 520.2086 — Sarolaner
• § 520.2090 — Sarolaner, moxidectin, and pyrantel
• § 520.2098 — Selegiline
• § 520.2100 — Selenium and vitamin E
• § 520.2123 — Spectinomycin oral dosage forms
• § 520.2123a — Spectinomycin tablets
• § 520.2123b — Spectinomycin powder
• § 520.2123c — Spectinomycin solution
• § 520.2130 — Spinosad
• § 520.2134 — Spinosad and milbemycin
• § 520.2138 — Spironolactone and benazepril
• § 520.2150 — Stanozolol
• § 520.2158 — Streptomycin
• § 520.2184 — Sulfachloropyrazine
• § 520.2200 — Sulfachlorpyridazine
• § 520.2215 — Sulfadiazine/pyrimethamine suspension
• § 520.2218 — Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder
• § 520.2220 — Sulfadimethoxine oral dosage forms
• § 520.2220a — Sulfadimethoxine oral solution and soluble powder
• § 520.2220b — Sulfadimethoxine suspension
• § 520.2220c — Sulfadimethoxine tablet
• § 520.2220d — Sulfadimethoxine bolus
• § 520.2220e — Sulfadimethoxine extended-release bolus
• § 520.2220f — Sulfadimethoxine and ormetoprim tablet
• § 520.2240 — Sulfaethoxypyridazine
• § 520.2240a — Sulfaethoxypyridazine solution
• § 520.2240b — Sulfaethoxypyridazine tablets
• § 520.2260 — Sulfamethazine oral dosage forms
• § 520.2260a — Sulfamethazine oblets and boluses
• § 520.2260b — Sulfamethazine sustained-release boluses
• § 520.2260c — Sulfamethazine sustained-release tablets
• § 520.2261 — Sulfamethazine sodium oral dosage forms
• § 520.2261a — Sulfamethazine solution
• § 520.2261b — Sulfamethazine powder
• § 520.2280 — Sulfamethizole and methenamine
• § 520.2325 — Sulfaquinoxaline oral dosage forms
• § 520.2325a — Sulfaquinoxaline powder and solution
• § 520.2325b — Sulfaquinoxaline drench
• § 520.2330 — Sulfisoxazole tablets
• § 520.2335 — Telmisartan
• § 520.2340 — Tepoxalin
• § 520.2345 — Tetracycline
• § 520.2345a — Tetracycline capsules
• § 520.2345b — Tetracycline tablets
• § 520.2345c — Tetracycline boluses
• § 520.2345d — Tetracycline powder
• § 520.2345e — Tetracycline solution
• § 520.2345f — Tetracycline phosphate complex and sodium novobiocin capsules
• § 520.2345g — Tetracycline hydrochloride and sodium novobiocin tablets
• § 520.2345h — Tetracycline hydrochloride, sodium novobiocin, and prednisolone tablets
• § 520.2362 — Thenium closylate
• § 520.2382 — Thiabendazole and triclorfon
• § 520.2455 — Tiamulin
• § 520.2471 — Tilmicosin
• § 520.2473 — Tioxidazole oral dosage forms
• § 520.2473a — Tioxidazole granules
• § 520.2473b — Tioxidazole paste
• § 520.2475 — Toceranib
• § 520.2520 — Trichlorfon oral dosage forms
• § 520.2520a — Trichlorfon and atropine
• § 520.2520b — Trichlorfon boluses
• § 520.2520c — Trichlorfon granules
• § 520.2520d — Trichlorfon, phenothiazine, and piperazine
• § 520.2582 — Triflupromazine
• § 520.2598 — Trilostane
• § 520.2604 — Trimeprazine and prednisolone tablets
• § 520.2605 — Trimeprazine and prednisolone capsules
• § 520.2610 — Trimethoprim and sulfadiazine tablets
• § 520.2611 — Trimethoprim and sulfadiazine paste
• § 520.2612 — Trimethoprim and sulfadiazine suspension
• § 520.2613 — Trimethoprim and sulfadiazine powder
• § 520.2640 — Tylosin
• § 520.2645 — Tylvalosin
• § 520.2654 — Velagliflozin
• § 520.2700 — Verdinexor tablets

PART 522

• § 522.23 — Acepromazine
• § 522.52 — Alfaxalone
• § 522.56 — Amikacin
• § 522.62 — Aminopentamide
• § 522.82 — Aminopropazine
• § 522.88 — Amoxicillin
• § 522.90 — Ampicillin injectable dosage forms
• § 522.90a — Ampicillin trihydrate suspension
• § 522.90b — Ampicillin trihydrate powder for injection
• § 522.90c — Ampicillin sodium
• § 522.144 — Arsenamide
• § 522.147 — Atipamezole
• § 522.150 — Azaperone
• § 522.158 — Bedinvetmab
• § 522.161 — Betamethasone
• § 522.163 — Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension
• § 522.167 — Betamethasone sodium phosphate and betamethasone acetate
• § 522.204 — Boldenone
• § 522.224 — Bupivacaine
• § 522.230 — Buprenorphine
• § 522.234 — Butamisole
• § 522.246 — Butorphanol
• § 522.275 — N-Butylscopolammonium
• § 522.304 — Carprofen
• § 522.311 — Cefovecin
• § 522.313 — Ceftiofur injectable dosage forms
• § 522.313a — Ceftiofur crystalline free acid
• § 522.313b — Ceftiofur hydrochloride
• § 522.313c — Ceftiofur sodium
• § 522.380 — Chloral hydrate, pentobarbital, and magnesium sulfate
• § 522.390 — Chloramphenicol
• § 522.454 — Clodronate
• § 522.460 — Cloprostenol
• § 522.468 — Colistimethate sodium powder for injection
• § 522.480 — Corticotropin
• § 522.500 — Cosyntropin injection
• § 522.522 — Danofloxacin
• § 522.533 — Deslorelin
• § 522.535 — Desoxycorticosterone
• § 522.536 — Detomidine
• § 522.540 — Dexamethasone solution
• § 522.558 — Dexmedetomidine
• § 522.563 — Diatrizoate
• § 522.650 — Dihydrostreptomycin sulfate injection
• § 522.690 — Dinoprost
• § 522.723 — Diprenorphine
• § 522.728 — Dipyrone
• § 522.770 — Doramectin
• § 522.772 — Doramectin and levamisole
• § 522.784 — Doxylamine
• § 522.800 — Droperidol and fentanyl
• § 522.810 — Embutramide, chloroquine, and lidocaine solution
• § 522.812 — Enrofloxacin
• § 522.814 — Eprinomectin
• § 522.820 — Erythromycin
• § 522.840 — Estradiol
• § 522.850 — Estradiol valerate and norgestomet in combination
• § 522.863 — Ethylisobutrazine
• § 522.883 — Etorphine
• § 522.914 — Fenprostalene
• § 522.930 — Firocoxib
• § 522.955 — Florfenicol
• § 522.956 — Florfenicol and flunixin
• § 522.960 — Flumethasone injectable dosage forms
• § 522.960a — Flumethasone suspension
• § 522.960b — Flumethasone acetate solution
• § 522.960c — Flumethasone solution
• § 522.970 — Flunixin
• § 522.995 — Fluprostenol
• § 522.998 — Fluralaner
• § 522.1002 — Follicle stimulating hormone
• § 522.1008 — Frunevetmab
• § 522.1010 — Furosemide
• § 522.1014 — Gamithromycin
• § 522.1020 — Gelatin
• § 522.1044 — Gentamicin
• § 522.1055 — Gleptoferron
• § 522.1066 — Glycopyrrolate
• § 522.1077 — Gonadorelin
• § 522.1079 — Serum gonadotropin and chorionic gonadotropin
• § 522.1081 — Chorionic gonadotropin
• § 522.1083 — Gonadotropin releasing factor analog-diphtheria toxoid conjugate
• § 522.1085 — Guaifenesin powder for injection
• § 522.1086 — Guaifenesin solution
• § 522.1125 — Hemoglobin glutamer-200 (bovine)
• § 522.1145 — Hyaluronate
• § 522.1155 — Imidocarb powder for injection
• § 522.1156 — Imidocarb solution
• § 522.1160 — Insulin
• § 522.1182 — Iron injection
• § 522.1185 — Isoflupredone
• § 522.1192 — Ivermectin
• § 522.1193 — Ivermectin and clorsulon
• § 522.1204 — Kanamycin
• § 522.1222 — Ketamine
• § 522.1223 — Ketamine, promazine, and aminopentamide
• § 522.1225 — Ketoprofen
• § 522.1242 — Levamisole
• § 522.1260 — Lincomycin
• § 522.1289 — Lufenuron
• § 522.1290 — Luprostiol
• § 522.1315 — Maropitant
• § 522.1335 — Medetomidine
• § 522.1338 — Medetomidine and vatinoxan
• § 522.1350 — Melatonin implant
• § 522.1362 — Melarsomine powder for injection
• § 522.1367 — Meloxicam
• § 522.1372 — Mepivacaine
• § 522.1380 — Methocarbamol
• § 522.1410 — Methylprednisolone
• § 522.1450 — Moxidectin solution
• § 522.1451 — Moxidectin microspheres for injection
• § 522.1452 — Nalorphine
• § 522.1465 — Naltrexone
• § 522.1468 — Naproxen for injection
• § 522.1484 — Neomycin
• § 522.1503 — Neostigmine
• § 522.1610 — Oleate sodium
• § 522.1660 — Oxytetracycline injectable dosage forms
• § 522.1660a — Oxytetracycline solution, 200 milligrams/milliliter
• § 522.1660b — Oxytetracycline solution, 300 milligrams/milliliter
• § 522.1662 — Oxytetracycline
• § 522.1663 — Oxytetracycline hydrochloride with lidocaine injection
• § 522.1664 — Oxytetracycline and flunixin
• § 522.1680 — Oxytocin
• § 522.1684 — Pegbovigrastim
• § 522.1696 — Penicillin G procaine injectable dosage forms
• § 522.1696a — Penicillin G benzathine and penicillin G procaine suspension
• § 522.1696b — Penicillin G procaine aqueous suspension
• § 522.1696c — Penicillin G procaine in oil
• § 522.1698 — Pentazocine
• § 522.1700 — Pentobarbital and phenytoin
• § 522.1703 — Pentobarbital
• § 522.1704 — Pentosan polysulfate sodium
• § 522.1720 — Phenylbutazone
• § 522.1820 — Pituitary luteinizing hormone powder for injection
• § 522.1850 — Polysulfated glycosaminoglycan
• § 522.1860 — Pradofloxacin
• § 522.1862 — Pralidoxime powder for injection
• § 522.1870 — Praziquantel
• § 522.1881 — Prednisolone acetate
• § 522.1883 — Prednisolone sodium phosphate
• § 522.1884 — Prednisolone sodium succinate
• § 522.1890 — Prednisone suspension
• § 522.1920 — Prochlorperazine and isopropamide
• § 522.1940 — Progesterone and estradiol benzoate
• § 522.1962 — Promazine
• § 522.2002 — Propiopromazine
• § 522.2005 — Propofol
• § 522.2012 — Prostalene
• § 522.2063 — Pyrilamine
• § 522.2065 — Rabacfosadine
• § 522.2075 — Robenacoxib
• § 522.2076 — Romifidine
• § 522.2092 — Secobarbital and dibucaine
• § 522.2100 — Selenium and vitamin E
• § 522.2112 — Sometribove zinc suspension
• § 522.2120 — Spectinomycin hydrochloride
• § 522.2121 — Spectinomycin sulfate
• § 522.2150 — Stanozolol
• § 522.2220 — Sulfadimethoxine
• § 522.2240 — Sulfaethoxypyridazine
• § 522.2260 — Sulfamethazine
• § 522.2340 — Sulfomyxin
• § 522.2343 — Testosterone propionate and estradiol benzoate
• § 522.2404 — Thialbarbitone sodium for injection
• § 522.2424 — Thiamylal
• § 522.2444 — Thiopental injectable dosage forms
• § 522.2444a — Thiopental powder for injection
• § 522.2444b — Thiopental and pentobarbital powder for injection
• § 522.2450 — Tigilanol
• § 522.2460 — Tildipirosin
• § 522.2470 — Tiletamine and zolazepam
• § 522.2471 — Tilmicosin
• § 522.2473 — Tiludronate
• § 522.2474 — Tolazoline
• § 522.2476 — Trenbolone acetate
• § 522.2477 — Trenbolone acetate and estradiol
• § 522.2478 — Trenbolone acetate and estradiol benzoate
• § 522.2483 — Triamcinolone
• § 522.2582 — Triflupromazine
• § 522.2610 — Trimethoprim and sulfadiazine
• § 522.2615 — Tripelennamine
• § 522.2630 — Tulathromycin
• § 522.2632 — Tulathromycin and ketoprofen
• § 522.2640 — Tylosin
• § 522.2662 — Xylazine
• § 522.2670 — Yohimbine
• § 522.2680 — Zeranol
• § 522.2690 — Zinc gluconate
• § 522.2694 — Zinc, copper, manganese, and selenium

PART 524

• § 524.86 — Amitraz
• § 524.154 — Bacitracin, neomycin, and polymyxin B ophthalmic ointment
• § 524.155 — Bacitracin, neomycin, polymyxin B, and hydrocortisone ophthalmic ointment
• § 524.230 — Buprenorphine
• § 524.390 — Chloramphenicol ophthalmic ointment
• § 524.402 — Chlorhexidine
• § 524.450 — Clotrimazole
• § 524.463 — Copper naphthenate
• § 524.575 — Cyclosporine ophthalmic ointment
• § 524.590 — Diclofenac
• § 524.660 — Dimethyl sulfoxide
• § 524.770 — Doramectin
• § 524.775 — Emodepside and praziquantel
• § 524.802 — Enrofloxacin and silver sulfadiazine otic emulsion
• § 524.814 — Eprinomectin
• § 524.815 — Eprinomectin and praziquantel
• § 524.838 — Esafoxolaner, eprinomectin, and praziquantel
• § 524.900 — Famphur
• § 524.920 — Fenthion
• § 524.955 — Florfenicol, terbinafine, and betamethasone acetate otic gel
• § 524.957 — Florfenicol, terbinafine, and mometasone otic solution
• § 524.960 — Flumethasone, neomycin, and polymyxin B ophthalmic solution
• § 524.970 — Flunixin
• § 524.981 — [Reserved]
• § 524.981a — Fluocinolone cream
• § 524.981b — Fluocinolone solution
• § 524.981c — Fluocinolone and neomycin cream
• § 524.981d — Fluocinolone and dimethyl sulfoxide solution
• § 524.981e — Fluocinolone and dimethyl sulfoxide otic solution
• § 524.998 — Fluralaner
• § 524.1001 — Fluralaner and moxidectin
• § 524.1005 — Furazolidone powder
• § 524.1044 — Gentamicin ophthalmic and topical dosage forms
• § 524.1044a — Gentamicin ophthalmic solution
• § 524.1044b — Gentamicin and betamethasone otic solution
• § 524.1044c — Gentamicin ophthalmic ointment
• § 524.1044d — Gentamicin and betamethasone ointment
• § 524.1044e — Gentamicin spray
• § 524.1044f — Gentamicin and betamethasone spray
• § 524.1044g — Gentamicin, betamethasone, and clotrimazole ointment
• § 524.1044h — Gentamicin, mometasone, and clotrimazole otic suspension
• § 524.1044i — Gentamicin and betamethasone ophthalmic solution
• § 524.1132 — Hydrocortisone, miconazole, and gentamicin otic suspension
• § 524.1140 — Imidacloprid and ivermectin
• § 524.1144j — Gentamicin, posaconazole, and mometasone furoate otic suspension
• § 524.1146 — Imidacloprid and moxidectin
• § 524.1193 — Ivermectin topical solution
• § 524.1195 — Ivermectin otic suspension
• § 524.1200 — Kanamycin ophthalmic and topical dosage forms
• § 524.1200a — Kanamycin ophthalmic ointment
• § 524.1200b — Kanamycin ophthalmic solution
• § 524.1204 — Kanamycin, amphomycin, and hydrocortisone ointment
• § 524.1240 — Levamisole
• § 524.1312 — Marbofloxacin, terbinafine, and dexamethasone otic suspension
• § 524.1376 — 2-Mercaptobenzothiazole solution
• § 524.1443 — Miconazole
• § 524.1445 — Miconazole, polymixin B, and prednisolone suspension
• § 524.1446 — Milbemycin otic solution
• § 524.1448 — Mirtazapine transdermal ointment
• § 524.1450 — Moxidectin
• § 524.1465 — Mupirocin
• § 524.1484 — Neomycin ophthalmic and topical dosage forms
• § 524.1484b — Neomycin, isoflupredone, and tetracaine powder
• § 524.1484c — Neomycin, isoflupredone, and tetracaine ointment
• § 524.1484d — Neomycin, hydrocortisone, and tetracaine otic ointment
• § 524.1484e — Neomycin and polymyxin B ophthalmic solution
• § 524.1484f — Neomycin, prednisolone, and tetracaine otic suspension
• § 524.1484g — Neomycin, thiabendazole, and dexamethasone solution
• § 524.1484h — Neomycin, penicillin, polymyxin B, and hydrocortisone suspension
• § 524.1484i — Neomycin and hydrocortisone ointment
• § 524.1484k — Neomycin and prednisolone suspension
• § 524.1580 — Nitrofurazone topical dosage forms
• § 524.1580a — Nitrofurazone ointment
• § 524.1580b — Nitrofurazone soluble powder
• § 524.1600 — Nystatin ophthalmic and topical dosage forms
• § 524.1600a — Nystatin, neomycin, thiostrepton, and triamcinolone ointment
• § 524.1600b — Nystatin, neomycin, thiostrepton, and triamcinolone ophthalmic ointment
• § 524.1610 — Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension
• § 524.1662 — Oxytetracycline ophthalmic and topical dosage forms
• § 524.1662a — Oxytetracycline and hydrocortisone spray
• § 524.1662b — Oxytetracycline and polymyxin B ophthalmic ointment
• § 524.1742 — Phosmet emulsifiable liquid
• § 524.1982 — Proparacaine ophthalmic solution
• § 524.2080 — Ropinirole
• § 524.2098 — Selamectin
• § 524.2099 — Selamectin and sarolaner
• § 524.2101 — Selenium disulfide suspension
• § 524.2338 — Terbinafine and betamethasone acetate
• § 524.2350 — Tolnaftate cream
• § 524.2482 — Triamcinolone spray
• § 524.2620 — Liquid crystalline trypsin, Peru balsam, castor oil

PART 526

• § 526.88 — Amoxicillin
• § 526.313 — Ceftiofur
• § 526.363 — Cephapirin benzathine
• § 526.365 — Cephapirin sodium
• § 526.464 — Cloxacillin benzathine
• § 526.465 — Cloxacillin sodium
• § 526.820 — Erythromycin
• § 526.1130 — Hetacillin
• § 526.1590 — Novobiocin
• § 526.1696 — Penicillin G procaine
• § 526.1697 — Penicillin G procaine and dihydrostreptomycin
• § 526.1698 — Penicillin G procaine and novobiocin
• § 526.1810 — Pirlimycin

PART 528

• § 528.1080 — Bc2371 recombinant deoxyribonucleic acid construct
• § 528.1092 — opAFP-GHc2 recombinant deoxyribonucleic acid construct
• § 528.2000 — Deletion of exon 7 of CD163 gene in domestic pigs
• § 528.2001 — pPL657 recombinant deoxyribonucleic acid construct
• § 528.2010 — Human lysosomal acid lipase recombinant deoxyribonucleic acid construct

PART 529

• § 529.56 — Amikacin
• § 529.382 — Chloramine-T
• § 529.400 — Chlorhexidine tablets and suspension
• § 529.443 — Ciclesonide
• § 529.536 — Detomidine
• § 529.539 — Dexmedetomidine
• § 529.778 — Doxycycline
• § 529.1004 — Formalin
• § 529.1044 — Gentamicin in certain other dosage forms
• § 529.1044a — Gentamicin solution for infusion
• § 529.1044b — Gentamicin solution for dipping eggs
• § 529.1115 — Halothane
• § 529.1150 — Hydrogen peroxide
• § 529.1186 — Isoflurane
• § 529.1350 — Meloxicam
• § 529.1660 — Oxytetracycline
• § 529.1940 — Progesterone intravaginal inserts
• § 529.2110 — Sevoflurane
• § 529.2464 — Ticarcillin
• § 529.2503 — Tricaine methanesulfonate
• § 529.2620 — Triptorelin

PART 530

• § 530.1 — Scope
• § 530.2 — Purpose
• § 530.3 — Definitions
• § 530.4 — Advertising and promotion
• § 530.5 — Veterinary records
• § 530.10 — Provision permitting extralabel use of animal drugs
• § 530.11 — Limitations
• § 530.12 — Labeling
• § 530.13 — Extralabel use from compounding of approved new animal and approved human drugs
• § 530.20 — Conditions for permitted extralabel animal and human drug use in food-producing animals
• § 530.21 — Prohibitions for food-producing animals
• § 530.22 — Safe levels and analytical methods for food-producing animals
• § 530.23 — Procedure for setting and announcing safe levels
• § 530.24 — Procedure for announcing analytical methods for drug residue quantification
• § 530.25 — Orders prohibiting extralabel uses for drugs in food-producing animals
• § 530.30 — Extralabel drug use in nonfood animals
• § 530.40 — Safe levels and availability of analytical methods
• § 530.41 — Drugs prohibited for extralabel use in animals

PART 556

• § 556.1 — Scope
• § 556.3 — Definitions
• § 556.5 — General considerations
• § 556.34 — Albendazole
• § 556.36 — Altrenogest
• § 556.38 — Amoxicillin
• § 556.40 — Ampicillin
• § 556.50 — Amprolium
• § 556.52 — Apramycin
• § 556.60 — Avilamycin
• § 556.68 — Azaperone
• § 556.70 — Bacitracin
• § 556.75 — Bambermycins
• § 556.100 — Carbadox
• § 556.110 — Carbomycin
• § 556.113 — Ceftiofur
• § 556.115 — Cephapirin
• § 556.118 — Chloramine-T
• § 556.120 — Chlorhexidine
• § 556.150 — Chlortetracycline
• § 556.160 — Clopidol
• § 556.163 — Clorsulon
• § 556.165 — Cloxacillin
• § 556.167 — Colistimethate
• § 556.168 — Coumaphos
• § 556.169 — Danofloxacin
• § 556.170 — Decoquinate
• § 556.180 — Dichlorvos
• § 556.185 — Diclazuril
• § 556.200 — Dihydrostreptomycin
• § 556.222 — Doramectin
• § 556.224 — Efrotomycin
• § 556.226 — Enrofloxacin
• § 556.227 — Eprinomectin
• § 556.230 — Erythromycin
• § 556.240 — Estradiol and related esters
• § 556.260 — Ethopabate
• § 556.273 — Famphur
• § 556.275 — Fenbendazole
• § 556.277 — Fenprostalene
• § 556.280 — Fenthion
• § 556.283 — Florfenicol
• § 556.286 — Flunixin
• § 556.290 — Fluralaner
• § 556.292 — Gamithromycin
• § 556.300 — Gentamicin
• § 556.304 — Gonadotropin
• § 556.308 — Halofuginone
• § 556.310 — Haloxon
• § 556.316 — Hetacillin
• § 556.330 — Hygromycin B
• § 556.344 — Ivermectin
• § 556.345 — Ketoprofen
• § 556.346 — Laidlomycin
• § 556.347 — Lasalocid
• § 556.350 — Levamisole
• § 556.360 — Lincomycin
• § 556.370 — Lubabegron
• § 556.375 — Maduramicin
• § 556.380 — Melengestrol
• § 556.410 — Metoserpate
• § 556.420 — Monensin
• § 556.425 — Morantel
• § 556.426 — Moxidectin
• § 556.428 — Narasin
• § 556.430 — Neomycin
• § 556.445 — Nicarbazin
• § 556.460 — Novobiocin
• § 556.470 — Nystatin
• § 556.490 — Ormetoprim
• § 556.495 — Oxfendazole
• § 556.500 — Oxytetracycline
• § 556.510 — Penicillin
• § 556.515 — Pirlimycin
• § 556.517 — Poloxalene
• § 556.530 — Pradofloxacin
• § 556.540 — Progesterone
• § 556.560 — Pyrantel
• § 556.570 — Ractopamine
• § 556.580 — Robenidine
• § 556.592 — Salinomycin
• § 556.597 — Semduramicin
• § 556.600 — Spectinomycin
• § 556.610 — Streptomycin
• § 556.625 — Sulfachloropyrazine
• § 556.630 — Sulfachlorpyridazine
• § 556.640 — Sulfadimethoxine
• § 556.650 — Sulfaethoxypyridazine
• § 556.660 — Sulfamerazine
• § 556.670 — Sulfamethazine
• § 556.685 — Sulfaquinoxaline
• § 556.700 — Sulfomyxin
• § 556.710 — Testosterone
• § 556.720 — Tetracycline
• § 556.732 — Tiamulin
• § 556.733 — Tildipirosin
• § 556.735 — Tilmicosin
• § 556.739 — Trenbolone
• § 556.741 — Tripelennamine
• § 556.745 — Tulathromycin
• § 556.746 — Tylosin
• § 556.748 — Tylvalosin
• § 556.750 — Virginiamycin
• § 556.760 — Zeranol
• § 556.765 — Zilpaterol
• § 556.770 — Zoalene

PART 558

• § 558.3 — Definitions and general considerations applicable to this part
• § 558.4 — Requirement of a medicated feed mill license
• § 558.5 — Requirements for liquid medicated feed
• § 558.6 — Veterinary feed directive drugs
• § 558.55 — Amprolium
• § 558.58 — Amprolium and ethopabate
• § 558.59 — Apramycin
• § 558.68 — Avilamycin
• § 558.76 — Bacitracin methylenedisalicylate
• § 558.78 — Bacitracin zinc
• § 558.95 — Bambermycins
• § 558.115 — Carbadox
• § 558.128 — Chlortetracycline
• § 558.140 — Chlortetracycline and sulfamethazine
• § 558.175 — Clopidol
• § 558.185 — Coumaphos
• § 558.195 — Decoquinate
• § 558.198 — Dichlorvos
• § 558.205 — Diclazuril
• § 558.235 — Efrotomycin
• § 558.248 — Erythromycin
• § 558.254 — Famphur
• § 558.258 — Fenbendazole
• § 558.261 — Florfenicol
• § 558.265 — Halofuginone
• § 558.274 — Hygromycin B
• § 558.295 — Iodinated casein
• § 558.300 — Ivermectin
• § 558.305 — Laidlomycin propionate potassium
• § 558.311 — Lasalocid
• § 558.325 — Lincomycin
• § 558.330 — Lubabegron
• § 558.340 — Maduramicin
• § 558.342 — Melengestrol
• § 558.348 — Mibolerone
• § 558.355 — Monensin
• § 558.360 — Morantel
• § 558.363 — Narasin
• § 558.364 — Narasin and nicarbazin
• § 558.365 — Neomycin sulfate
• § 558.366 — Nicarbazin
• § 558.415 — Novobiocin
• § 558.430 — Nystatin
• § 558.450 — Oxytetracycline
• § 558.455 — Oxytetracycline and neomycin
• § 558.464 — Poloxalene
• § 558.470 — Polyoxyethylene
• § 558.485 — Pyrantel
• § 558.500 — Ractopamine
• § 558.515 — Robenidine
• § 558.550 — Salinomycin
• § 558.555 — Semduramicin
• § 558.575 — Sulfadimethoxine and ormetoprim
• § 558.582 — Sulfamerazine
• § 558.586 — Sulfaquinoxaline
• § 558.612 — Tiamulin
• § 558.618 — Tilmicosin
• § 558.625 — Tylosin
• § 558.630 — Tylosin and sulfamethazine
• § 558.633 — Tylvalosin
• § 558.635 — Virginiamycin
• § 558.665 — Zilpaterol
• § 558.680 — Zoalene

PART 570

• § 570.3 — Definitions
• § 570.6 — Opinion letters on food additive status
• § 570.13 — Indirect food additives resulting from packaging materials prior sanctioned for animal feed and pet food
• § 570.14 — Indirect food additives resulting from packaging materials for animal feed and pet food
• § 570.15 — Adoption of regulation on initiative of Commissioner
• § 570.17 — Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals
• § 570.18 — Tolerances for related food additives
• § 570.19 — Pesticide chemicals in processed foods
• § 570.20 — General principles for evaluating the safety of food additives
• § 570.30 — Eligibility for classification as generally recognized as safe (GRAS)
• § 570.35 — Affirmation of generally recognized as safe (GRAS) status
• § 570.38 — Determination of food additive status
• § 570.203 — Definitions
• § 570.205 — Opportunity to submit a GRAS notice
• § 570.210 — How to send your GRAS notice to FDA
• § 570.215 — Incorporation into a GRAS notice
• § 570.220 — General requirements applicable to a GRAS notice
• § 570.225 — Part 1 of a GRAS notice: Signed statements and certification
• § 570.230 — Part 2 of a GRAS notice: Identity, method of manufacture, specifications, and physical or technical effect
• § 570.235 — Part 3 of a GRAS notice: Target animal and human exposures
• § 570.240 — Part 4 of a GRAS notice: Self-limiting levels of use
• § 570.245 — Part 5 of a GRAS notice: Experience based on common use in food before 1958
• § 570.250 — Part 6 of a GRAS notice: Narrative
• § 570.255 — Part 7 of a GRAS notice: List of supporting data and information in your GRAS notice
• § 570.260 — Steps you may take before FDA responds to your GRAS notice
• § 570.265 — What FDA will do with a GRAS notice
• § 570.275 — Public disclosure of a GRAS notice
• § 570.280 — Submission of a supplement

PART 571

• § 571.1 — Petitions
• § 571.6 — Amendment of petition
• § 571.7 — Withdrawal of petition without prejudice
• § 571.100 — Regulation based on petition
• § 571.102 — Effective date of regulation
• § 571.110 — Procedure for objections and hearings
• § 571.115 — Application of the cancer clause of section 409 of the act
• § 571.130 — Procedure for amending and repealing tolerances or exemptions from tolerances

PART 573

• § 573.120 — Acrylamide-acrylic acid resin
• § 573.130 — Aminoglycoside 3′-phospho- transferase II
• § 573.140 — Ammoniated cottonseed meal
• § 573.160 — Ammoniated rice hulls
• § 573.170 — Ammonium formate
• § 573.180 — Anhydrous ammonia
• § 573.200 — Condensed animal protein hydrolysate
• § 573.210 — Benzoic acid
• § 573.220 — Feed-grade biuret
• § 573.225 — 1,3-Butylene glycol
• § 573.230 — Calcium formate
• § 573.240 — Calcium periodate
• § 573.260 — Calcium silicate
• § 573.280 — Feed-grade calcium stearate and sodium stearate
• § 573.300 — Choline xanthate
• § 573.304 — Chromium propionate
• § 573.310 — Crambe meal, heat toasted
• § 573.320 — Diammonium phosphate
• § 573.340 — Diatomaceous earth
• § 573.360 — Disodium EDTA
• § 573.380 — Ethoxyquin in animal feeds
• § 573.400 — Ethoxyquin in certain dehydrated forage crops
• § 573.420 — Ethyl cellulose
• § 573.440 — Ethylene dichloride
• § 573.450 — Fermented ammoniated condensed whey
• § 573.460 — Formaldehyde
• § 573.480 — Formic acid
• § 573.485 — Fumonisin esterase
• § 573.490 — Gamma-linolenic acid safflower meal
• § 573.492 — Gamma-linolenic acid safflower oil
• § 573.496 — Guanidinoacetic acid
• § 573.500 — Condensed, extracted glutamic acid fermentation product
• § 573.520 — Hemicellulose extract
• § 573.530 — Hydrogenated corn syrup
• § 573.540 — Hydrolyzed leather meal
• § 573.550 — 25-hydroxyvitamin D3
• § 573.560 — Iron ammonium citrate
• § 573.580 — Iron-choline citrate complex
• § 573.587 — Komagataella pastoris dried yeast
• § 573.600 — Lignin sulfonates
• § 573.615 — Marine microalgae
• § 573.620 — Menadione dimethylpyrimidinol bisulfite
• § 573.625 — Menadione nicotinamide bisulfite
• § 573.637 — Methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-10, cis-12-octadecadienoic acids)
• § 573.640 — Methyl esters of higher fatty acids
• § 573.660 — Methyl glucoside-coconut oil ester
• § 573.680 — Mineral oil
• § 573.685 — Natamycin
• § 573.696 — Feed grade sodium formate
• § 573.700 — Sodium nitrite
• § 573.720 — Petrolatum
• § 573.740 — Odorless light petroleum hydrocarbons
• § 573.760 — Poloxalene
• § 573.780 — Polyethylene
• § 573.800 — Polyethylene glycol (400) mono- and dioleate
• § 573.820 — Polyoxyethylene glycol (400) mono- and dioleates
• § 573.840 — Polysorbate 60
• § 573.860 — Polysorbate 80
• § 573.870 — Poly(2-vinylpyridine-co-styrene)
• § 573.880 — Normal propyl alcohol
• § 573.900 — Pyrophyllite
• § 573.914 — Salts of volatile fatty acids
• § 573.920 — Selenium
• § 573.940 — Silicon dioxide
• § 573.960 — Sorbitan monostearate
• § 573.980 — Taurine
• § 573.1000 — Verxite
• § 573.1010 — Xanthan gum
• § 573.1020 — Yellow prussiate of soda

PART 579

• § 579.12 — Incorporation of regulations in part 179
• § 579.22 — Ionizing radiation for treatment of animal diets
• § 579.40 — Ionizing radiation for the treatment of poultry feed and poultry feed ingredients

PART 582

• § 582.1 — Substances that are generally recognized as safe
• § 582.10 — Spices and other natural seasonings and flavorings
• § 582.20 — Essential oils, oleoresins (solvent-free), and natural extractives (including distillates)
• § 582.30 — Natural substances used in conjunction with spices and other natural seasonings and flavorings
• § 582.40 — Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings
• § 582.50 — Certain other spices, seasonings, essential oils, oleoresins, and natural extracts
• § 582.60 — Synthetic flavoring substances and adjuvants
• § 582.80 — Trace minerals added to animal feeds
• § 582.99 — Adjuvants for pesticide chemicals
• § 582.1005 — Acetic acid
• § 582.1009 — Adipic acid
• § 582.1033 — Citric acid
• § 582.1057 — Hydrochloric acid
• § 582.1061 — Lactic acid
• § 582.1069 — Malic acid
• § 582.1073 — Phosphoric acid
• § 582.1077 — Potassium acid tartrate
• § 582.1087 — Sodium acid pyrophosphate
• § 582.1091 — Succinic acid
• § 582.1095 — Sulfuric acid
• § 582.1099 — Tartaric acid
• § 582.1125 — Aluminum sulfate
• § 582.1127 — Aluminum ammonium sulfate
• § 582.1129 — Aluminum potassium sulfate
• § 582.1131 — Aluminum sodium sulfate
• § 582.1135 — Ammonium bicarbonate
• § 582.1137 — Ammonium carbonate
• § 582.1139 — Ammonium hydroxide
• § 582.1141 — Ammonium phosphate
• § 582.1143 — Ammonium sulfate
• § 582.1155 — Bentonite
• § 582.1165 — Butane
• § 582.1191 — Calcium carbonate
• § 582.1193 — Calcium chloride
• § 582.1195 — Calcium citrate
• § 582.1199 — Calcium gluconate
• § 582.1205 — Calcium hydroxide
• § 582.1207 — Calcium lactate
• § 582.1210 — Calcium oxide
• § 582.1217 — Calcium phosphate
• § 582.1235 — Caramel
• § 582.1240 — Carbon dioxide
• § 582.1275 — Dextrans
• § 582.1320 — Glycerin
• § 582.1324 — Glyceryl monostearate
• § 582.1355 — Helium
• § 582.1366 — Hydrogen peroxide
• § 582.1400 — Lecithin
• § 582.1425 — Magnesium carbonate
• § 582.1428 — Magnesium hydroxide
• § 582.1431 — Magnesium oxide
• § 582.1480 — Methylcellulose
• § 582.1500 — Monoammonium glutamate
• § 582.1516 — Monopotassium glutamate
• § 582.1540 — Nitrogen
• § 582.1585 — Papain
• § 582.1613 — Potassium bicarbonate
• § 582.1619 — Potassium carbonate
• § 582.1625 — Potassium citrate
• § 582.1631 — Potassium hydroxide
• § 582.1643 — Potassium sulfate
• § 582.1655 — Propane
• § 582.1666 — Propylene glycol
• § 582.1685 — Rennet
• § 582.1711 — Silica aerogel
• § 582.1721 — Sodium acetate
• § 582.1736 — Sodium bicarbonate
• § 582.1742 — Sodium carbonate
• § 582.1745 — Sodium carboxymethylcellulose
• § 582.1748 — Sodium caseinate
• § 582.1751 — Sodium citrate
• § 582.1763 — Sodium hydroxide
• § 582.1775 — Sodium pectinate
• § 582.1778 — Sodium phosphate
• § 582.1781 — Sodium aluminum phosphate
• § 582.1792 — Sodium sesquicarbonate
• § 582.1804 — Sodium potassium tartrate
• § 582.1810 — Sodium tripolyphosphate
• § 582.1901 — Triacetin
• § 582.1973 — Beeswax
• § 582.1975 — Bleached beeswax
• § 582.1978 — Carnauba wax
• § 582.2122 — Aluminum calcium silicate
• § 582.2227 — Calcium silicate
• § 582.2437 — Magnesium silicate
• § 582.2727 — Sodium aluminosilicate
• § 582.2729 — Hydrated sodium calcium aluminosilicate
• § 582.2906 — Tricalcium silicate
• § 582.3013 — Ascorbic acid
• § 582.3021 — Benzoic acid
• § 582.3041 — Erythorbic acid
• § 582.3081 — Propionic acid
• § 582.3089 — Sorbic acid
• § 582.3109 — Thiodipropionic acid
• § 582.3149 — Ascorbyl palmitate
• § 582.3169 — Butylated hydroxyanisole
• § 582.3173 — Butylated hydroxytoluene
• § 582.3189 — Calcium ascorbate
• § 582.3221 — Calcium propionate
• § 582.3225 — Calcium sorbate
• § 582.3280 — Dilauryl thiodipropionate
• § 582.3336 — Gum guaiac
• § 582.3490 — Methylparaben
• § 582.3616 — Potassium bisulfite
• § 582.3637 — Potassium metabisulfite
• § 582.3640 — Potassium sorbate
• § 582.3660 — Propyl gallate
• § 582.3670 — Propylparaben
• § 582.3731 — Sodium ascorbate
• § 582.3733 — Sodium benzoate
• § 582.3739 — Sodium bisulfite
• § 582.3766 — Sodium metabisulfite
• § 582.3784 — Sodium propionate
• § 582.3795 — Sodium sorbate
• § 582.3798 — Sodium sulfite
• § 582.3845 — Stannous chloride
• § 582.3862 — Sulfur dioxide
• § 582.3890 — Tocopherols
• § 582.4101 — Diacetyl tartaric acid esters of mono- and diglycerides of edible fats or oils, or edible fat-forming fatty acids
• § 582.4505 — Mono- and diglycerides of edible fats or oils, or edible fat-forming acids
• § 582.4521 — Monosodium phosphate derivatives of mono- and diglycerides of edible fats or oils, or edible fat-forming fatty acids
• § 582.4666 — Propylene glycol
• § 582.5013 — Ascorbic acid
• § 582.5017 — Aspartic acid
• § 582.5049 — Aminoacetic acid
• § 582.5065 — Linoleic acid
• § 582.5118 — Alanine
• § 582.5145 — Arginine
• § 582.5159 — Biotin
• § 582.5191 — Calcium carbonate
• § 582.5195 — Calcium citrate
• § 582.5201 — Calcium glycerophosphate
• § 582.5210 — Calcium oxide
• § 582.5212 — Calcium pantothenate
• § 582.5217 — Calcium phosphate
• § 582.5223 — Calcium pyrophosphate
• § 582.5230 — Calcium sulfate
• § 582.5245 — Carotene
• § 582.5250 — Choline bitartrate
• § 582.5252 — Choline chloride
• § 582.5260 — Copper gluconate
• § 582.5271 — Cysteine
• § 582.5273 — Cystine
• § 582.5301 — Ferric phosphate
• § 582.5304 — Ferric pyrophosphate
• § 582.5306 — Ferric sodium pyrophosphate
• § 582.5308 — Ferrous gluconate
• § 582.5311 — Ferrous lactate
• § 582.5315 — Ferrous sulfate
• § 582.5361 — Histidine
• § 582.5370 — Inositol
• § 582.5375 — Iron reduced
• § 582.5381 — Isoleucine
• § 582.5406 — Leucine
• § 582.5411 — Lysine
• § 582.5431 — Magnesium oxide
• § 582.5434 — Magnesium phosphate
• § 582.5443 — Magnesium sulfate
• § 582.5446 — Manganese chloride
• § 582.5449 — Manganese citrate
• § 582.5452 — Manganese gluconate
• § 582.5455 — Manganese glycerophosphate
• § 582.5458 — Manganese hypophosphite
• § 582.5461 — Manganese sulfate
• § 582.5464 — Manganous oxide
• § 582.5470 — Mannitol
• § 582.5475 — Methionine
• § 582.5477 — Methionine hydroxy analog and its calcium salts
• § 582.5530 — Niacin
• § 582.5535 — Niacinamide
• § 582.5580 — D-Pantothenyl alcohol
• § 582.5590 — Phenylalanine
• § 582.5622 — Potassium chloride
• § 582.5628 — Potassium glycerophosphate
• § 582.5634 — Potassium iodide
• § 582.5650 — Proline
• § 582.5676 — Pyridoxine hydrochloride
• § 582.5695 — Riboflavin
• § 582.5697 — Riboflavin-5-phosphate
• § 582.5701 — Serine
• § 582.5772 — Sodium pantothenate
• § 582.5778 — Sodium phosphate
• § 582.5835 — Sorbitol
• § 582.5875 — Thiamine hydrochloride
• § 582.5878 — Thiamine mononitrate
• § 582.5881 — Threonine
• § 582.5890 — Tocopherols
• § 582.5892 — a-Tocopherol acetate
• § 582.5915 — Tryptophane
• § 582.5920 — Tyrosine
• § 582.5925 — Valine
• § 582.5930 — Vitamin A
• § 582.5933 — Vitamin A acetate
• § 582.5936 — Vitamin A palmitate
• § 582.5945 — Vitamin B12
• § 582.5950 — Vitamin D2
• § 582.5953 — Vitamin D3
• § 582.5985 — Zinc chloride
• § 582.5988 — Zinc gluconate
• § 582.5991 — Zinc oxide
• § 582.5994 — Zinc stearate
• § 582.5997 — Zinc sulfate
• § 582.6033 — Citric acid
• § 582.6085 — Sodium acid phosphate
• § 582.6099 — Tartaric acid
• § 582.6185 — Calcium acetate
• § 582.6193 — Calcium chloride
• § 582.6195 — Calcium citrate
• § 582.6197 — Calcium diacetate
• § 582.6199 — Calcium gluconate
• § 582.6203 — Calcium hexametaphosphate
• § 582.6215 — Monobasic calcium phosphate
• § 582.6219 — Calcium phytate
• § 582.6285 — Dipotassium phosphate
• § 582.6290 — Disodium phosphate
• § 582.6386 — Isopropyl citrate
• § 582.6511 — Monoisopropyl citrate
• § 582.6625 — Potassium citrate
• § 582.6751 — Sodium citrate
• § 582.6754 — Sodium diacetate
• § 582.6757 — Sodium gluconate
• § 582.6760 — Sodium hexametaphosphate
• § 582.6769 — Sodium metaphosphate
• § 582.6778 — Sodium phosphate
• § 582.6787 — Sodium pyrophosphate
• § 582.6789 — Tetra sodium pyrophosphate
• § 582.6801 — Sodium tartrate
• § 582.6804 — Sodium potassium tartrate
• § 582.6807 — Sodium thiosulfate
• § 582.6810 — Sodium tripolyphosphate
• § 582.6851 — Stearyl citrate
• § 582.7115 — Agar-agar
• § 582.7133 — Ammonium alginate
• § 582.7187 — Calcium alginate
• § 582.7255 — Chondrus extract
• § 582.7330 — Gum arabic
• § 582.7333 — Gum ghatti
• § 582.7339 — Guar gum
• § 582.7343 — Locust bean gum
• § 582.7349 — Sterculia gum
• § 582.7351 — Gum tragacanth
• § 582.7610 — Potassium alginate
• § 582.7724 — Sodium alginate

PART 584

• § 584.200 — Ethyl alcohol containing ethyl acetate
• § 584.700 — Hydrophobic silicas
• § 584.725 — 25-Hydroxyvitamin D3

PART 589

• § 589.1 — Substances prohibited from use in animal food or feed
• § 589.1000 — Gentian violet
• § 589.1001 — Propylene glycol in or on cat food
• § 589.2000 — Animal proteins prohibited in ruminant feed
• § 589.2001 — Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy

PART 600

• § 600.2 — Mailing addresses
• § 600.3 — Definitions
• § 600.10 — Personnel
• § 600.11 — Physical establishment, equipment, animals, and care
• § 600.12 — Records
• § 600.13 — Retention samples
• § 600.14 — Reporting of biological product deviations by licensed manufacturers
• § 600.15 — Temperatures during shipment
• § 600.20 — Inspectors
• § 600.21 — Time of inspection
• § 600.22 — [Reserved]
• § 600.80 — Postmarketing reporting of adverse experiences
• § 600.81 — Distribution reports
• § 600.82 — Notification of a permanent discontinuance or an interruption in manufacturing
• § 600.90 — Waivers

PART 601

• § 601.2 — Applications for biologics licenses; procedures for filing
• § 601.3 — Complete response letter to the applicant
• § 601.4 — Issuance and denial of license
• § 601.5 — Revocation of license
• § 601.6 — Suspension of license
• § 601.7 — Procedure for hearings
• § 601.8 — Publication of revocation
• § 601.9 — Licenses; reissuance
• § 601.12 — Changes to an approved application
• § 601.14 — Regulatory submissions in electronic format
• § 601.15 — Foreign establishments and products: samples for each importation
• § 601.20 — Biologics licenses; issuance and conditions
• § 601.21 — Products under development
• § 601.22 — Products in short supply; initial manufacturing at other than licensed location
• § 601.27 — Pediatric studies
• § 601.28 — Annual reports of postmarketing pediatric studies
• § 601.29 — Guidance documents
• § 601.30 — Scope
• § 601.31 — Definition
• § 601.32 — General factors relevant to safety and effectiveness
• § 601.33 — Indications
• § 601.34 — Evaluation of effectiveness
• § 601.35 — Evaluation of safety
• § 601.40 — Scope
• § 601.41 — Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity
• § 601.42 — Approval with restrictions to assure safe use
• § 601.43 — Withdrawal procedures
• § 601.44 — Postmarketing safety reporting
• § 601.45 — Promotional materials
• § 601.46 — Termination of requirements
• § 601.50 — Confidentiality of data and information in an investigational new drug notice for a biological product
• § 601.51 — Confidentiality of data and information in applications for biologics licenses
• § 601.70 — Annual progress reports of postmarketing studies
• § 601.90 — Scope
• § 601.91 — Approval based on evidence of effectiveness from studies in animals
• § 601.92 — Withdrawal procedures
• § 601.93 — Postmarketing safety reporting
• § 601.94 — Promotional materials
• § 601.95 — Termination of requirements

PART 606

• § 606.3 — Definitions
• § 606.20 — Personnel
• § 606.40 — Facilities
• § 606.60 — Equipment
• § 606.65 — Supplies and reagents
• § 606.100 — Standard operating procedures
• § 606.110 — Plateletpheresis, leukapheresis, and plasmapheresis
• § 606.120 — Labeling, general requirements
• § 606.121 — Container label
• § 606.122 — Circular of information
• § 606.140 — Laboratory controls
• § 606.145 — Control of bacterial contamination of platelets
• § 606.151 — Compatibility testing
• § 606.160 — Records
• § 606.165 — Distribution and receipt; procedures and records
• § 606.170 — Adverse reaction file
• § 606.171 — Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services

PART 607

• § 607.1 — Scope
• § 607.3 — Definitions
• § 607.7 — Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products
• § 607.20 — Who must register and submit a blood product list
• § 607.21 — Times for establishment registration and blood product listing
• § 607.22 — How to register establishments and list blood products
• § 607.25 — Information required for establishment registration and blood product listing
• § 607.26 — Amendments to establishment registration
• § 607.30 — Updating blood product listing information
• § 607.31 — Additional blood product listing information
• § 607.35 — Blood product establishment registration number
• § 607.37 — Public disclosure of establishment registration and blood product listing information
• § 607.39 — Misbranding by reference to establishment registration, validation of registration, or to registration number
• § 607.40 — Establishment registration and blood product listing requirements for foreign blood product establishments
• § 607.65 — Exemptions for blood product establishments
• § 607.80 — Applicability of part 607 to licensed devices

PART 610

• § 610.1 — Tests prior to release required for each lot
• § 610.2 — Requests for samples and protocols; official release
• § 610.9 — Equivalent methods and processes
• § 610.10 — Potency
• § 610.11-610.11a — [Reserved]
• § 610.12 — Sterility
• § 610.13 — Purity
• § 610.14 — Identity
• § 610.15 — Constituent materials
• § 610.16 — Total solids in serums
• § 610.17 — Permissible combinations
• § 610.18 — Cultures
• § 610.39 — Definitions
• § 610.40 — Test requirements
• § 610.41 — Donor deferral
• § 610.42 — Restrictions on use for further manufacture of medical devices
• § 610.44 — Use of reference panels by manufacturers of test kits
• § 610.46 — Human immunodeficiency virus (HIV) “lookback” requirements
• § 610.47 — Hepatitis C virus (HCV) “lookback” requirements
• § 610.48 — [Reserved]
• § 610.50 — Date of manufacture for biological products
• § 610.53 — Dating periods for Whole Blood and blood components
• § 610.60 — Container label
• § 610.61 — Package label
• § 610.62 — Proper name; package label; legible type
• § 610.63 — Divided manufacturing responsibility to be shown
• § 610.64 — Name and address of distributor
• § 610.65 — Products for export
• § 610.67 — Bar code label requirements
• § 610.68 — Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile

PART 630

• § 630.1 — Purpose and scope
• § 630.3 — Definitions
• § 630.5 — Medical supervision
• § 630.10 — General donor eligibility requirements
• § 630.15 — Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis
• § 630.20 — Exceptions for certain ineligible donors
• § 630.25 — Exceptions from certain donor eligibility requirements for infrequent plasma donors
• § 630.30 — Donation suitability requirements
• § 630.35 — Requalification of previously deferred donors
• § 630.40 — Requirements for notifying deferred donors

PART 640

• § 640.1 — Whole Blood
• § 640.2 — General requirements
• § 640.4 — Collection of the blood
• § 640.5 — Testing the blood
• § 640.6 — Modifications of Whole Blood
• § 640.10 — Red Blood Cells
• § 640.11 — General requirements
• § 640.12 — Eligibility of donor
• § 640.13 — Collection of the blood
• § 640.14 — Testing the blood
• § 640.15 — Segments for testing
• § 640.16 — Processing
• § 640.17 — Modifications for specific products
• § 640.20 — Platelets
• § 640.21 — Eligibility of donors
• § 640.22 — Collection of source material
• § 640.23 — Testing the blood
• § 640.24 — Processing
• § 640.25 — General requirements
• § 640.30 — Plasma
• § 640.31 — Eligibility of donors
• § 640.32 — Collection of source material
• § 640.33 — Testing the blood
• § 640.34 — Processing
• § 640.50 — Cryoprecipitated AHF
• § 640.51 — Eligibility of donors
• § 640.52 — Collection of source material
• § 640.53 — Testing the blood
• § 640.54 — Processing
• § 640.55 — U.S. Standard preparation
• § 640.56 — Quality control test for potency
• § 640.60 — Source Plasma
• § 640.64 — Collection of blood for Source Plasma
• § 640.65 — Plasmapheresis
• § 640.66 — Immunization of donors
• § 640.67 — Laboratory tests
• § 640.68 — Processing
• § 640.69 — General requirements
• § 640.71 — Manufacturing responsibility
• § 640.72 — Records
• § 640.73 — Reporting of fatal donor reactions
• § 640.74 — Modification of Source Plasma
• § 640.76 — Products stored or shipped at unacceptable temperatures
• § 640.80 — Albumin (Human)
• § 640.81 — Processing
• § 640.82 — Tests on final product
• § 640.83 — General requirements
• § 640.84 — Labeling
• § 640.90 — Plasma Protein Fraction (Human)
• § 640.91 — Processing
• § 640.92 — Tests on final product
• § 640.93 — General requirements
• § 640.94 — Labeling
• § 640.100 — Immune Globulin (Human)
• § 640.101 — General requirements
• § 640.102 — Manufacture of Immune Globulin (Human)
• § 640.103 — The final product
• § 640.104 — Potency
• § 640.120 — Alternative procedures
• § 640.125 — Definitions
• § 640.130 — Medical supervision

PART 660

• § 660.1 — Antibody to Hepatitis B Surface Antigen
• § 660.2 — General requirements
• § 660.3 — Reference panel
• § 660.4 — Potency test
• § 660.5 — Specificity
• § 660.6 — Samples; protocols; official release
• § 660.20 — Blood Grouping Reagent
• § 660.21 — Processing
• § 660.22 — Potency requirements with reference preparations
• § 660.25 — Potency tests without reference preparations
• § 660.26 — Specificity tests and avidity tests
• § 660.28 — Labeling
• § 660.30 — Reagent Red Blood Cells
• § 660.31 — Eligibility of donor
• § 660.32 — Collection of source material
• § 660.33 — Testing of source material
• § 660.34 — Processing
• § 660.35 — Labeling
• § 660.36 — Samples and protocols
• § 660.40 — Hepatitis B Surface Antigen
• § 660.41 — Processing
• § 660.43 — Potency test
• § 660.44 — Specificity
• § 660.45 — Labeling
• § 660.46 — Samples; protocols; official release
• § 660.50 — Anti-Human Globulin
• § 660.51 — Processing
• § 660.52 — Reference preparations
• § 660.53 — Controls for serological procedures
• § 660.54 — Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties
• § 660.55 — Labeling

PART 680

• § 680.1 — Allergenic Products
• § 680.2 — Manufacture of Allergenic Products
• § 680.3 — Tests

PART 700

• § 700.3 — Definitions
• § 700.11 — Cosmetics containing bithionol
• § 700.13 — Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs
• § 700.14 — Use of vinyl chloride as an ingredient, including propellant of cosmetic aerosol products
• § 700.15 — Use of certain halogenated salicylanilides as ingredients in cosmetic products
• § 700.16 — Use of aerosol cosmetic products containing zirconium
• § 700.18 — Use of chloroform as an ingredient in cosmetic products
• § 700.19 — Use of methylene chloride as an ingredient of cosmetic products
• § 700.23 — Chlorofluorocarbon propellants
• § 700.25 — Tamper-resistant packaging requirements for cosmetic products
• § 700.27 — Use of prohibited cattle materials in cosmetic products
• § 700.35 — Cosmetics containing sunscreen ingredients

PART 701

• § 701.1 — Misbranding
• § 701.2 — Form of stating labeling requirements
• § 701.3 — Designation of ingredients
• § 701.9 — Exemptions from labeling requirements
• § 701.10 — Principal display panel
• § 701.11 — Identity labeling
• § 701.12 — Name and place of business of manufacturer, packer, or distributor
• § 701.13 — Declaration of net quantity of contents
• § 701.20 — Detergent substances, other than soap, intended for use in cleansing the body
• § 701.30 — Ingredient names established for cosmetic ingredient labeling

PART 710

• § 710.1 — Who should register
• § 710.2 — Time for registration
• § 710.3 — How and where to register
• § 710.4 — Information requested
• § 710.5 — Amendments to registration
• § 710.6 — Notification of registrant; cosmetic product establishment registration number
• § 710.7 — Inspection of registrations
• § 710.8 — Misbranding by reference to registration or to registration number
• § 710.9 — Exemptions

PART 720

• § 720.1 — Who should file
• § 720.2 — Times for filing
• § 720.3 — How and where to file
• § 720.4 — Information requested about cosmetic products
• § 720.5 — [Reserved]
• § 720.6 — Amendments to statement
• § 720.7 — Notification of person submitting cosmetic product ingredient statement
• § 720.8 — Confidentiality of statements
• § 720.9 — Misbranding by reference to filing or to statement number

PART 740

• § 740.1 — Establishment of warning statements
• § 740.2 — Conspicuousness of warning statements
• § 740.10 — Labeling of cosmetic products for which adequate substantiation of safety has not been obtained
• § 740.11 — Cosmetics in self-pressurized containers
• § 740.12 — Feminine deodorant sprays
• § 740.17 — Foaming detergent bath products
• § 740.18 — Coal tar hair dyes posing a risk of cancer
• § 740.19 — Suntanning preparations

PART 800

• § 800.10 — Contact lens solutions; sterility
• § 800.12 — Contact lens solutions and tablets; tamper-resistant packaging
• § 800.20 — Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration
• § 800.30 — Over-the-counter hearing aid controls
• § 800.55 — Administrative detention
• § 800.75 — Requests for supervisory review of certain decisions made by the Center for Devices and Radiological Health

PART 801

• § 801.1 — Medical devices; name and place of business of manufacturer, packer or distributor
• § 801.3 — Definitions
• § 801.4 — Meaning of intended uses
• § 801.5 — Medical devices; adequate directions for use
• § 801.6 — Medical devices; misleading statements
• § 801.15 — Medical devices; prominence of required label statements; use of symbols in labeling
• § 801.16 — Medical devices; Spanish-language version of certain required statements
• § 801.18 — Format of dates provided on a medical device label
• § 801.20 — Label to bear a unique device identifier
• § 801.30 — General exceptions from the requirement for the label of a device to bear a unique device identifier
• § 801.35 — Voluntary labeling of a device with a unique device identifier
• § 801.40 — Form of a unique device identifier
• § 801.45 — Devices that must be directly marked with a unique device identifier
• § 801.50 — Labeling requirements for stand-alone software
• § 801.55 — Request for an exception from or alternative to a unique device identifier requirement
• § 801.57 — Discontinuation of legacy FDA identification numbers assigned to devices
• § 801.60 — Principal display panel
• § 801.61 — Statement of identity
• § 801.62 — Declaration of net quantity of contents
• § 801.63 — Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances
• § 801.109 — Prescription devices
• § 801.110 — Retail exemption for prescription devices
• § 801.116 — Medical devices having commonly known directions
• § 801.119 — In vitro diagnostic products
• § 801.122 — Medical devices for processing, repacking, or manufacturing
• § 801.125 — Medical devices for use in teaching, law enforcement, research, and analysis
• § 801.127 — Medical devices; expiration of exemptions
• § 801.128 — Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile
• § 801.150 — Medical devices; processing, labeling, or repacking
• § 801.405 — Labeling of articles intended for lay use in the repairing and/or refitting of dentures
• § 801.410 — Use of impact-resistant lenses in eyeglasses and sunglasses
• § 801.415 — Maximum acceptable level of ozone
• § 801.417 — Chlorofluorocarbon propellants
• § 801.422 — Prescription hearing aid labeling
• § 801.430 — User labeling for menstrual tampons
• § 801.433 — Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances
• § 801.435 — User labeling for latex condoms
• § 801.437 — User labeling for devices that contain natural rubber

PART 803

• § 803.1 — What does this part cover?
• § 803.3 — How does FDA define the terms used in this part?
• § 803.9 — What information from the reports do we disclose to the public?
• § 803.10 — Generally, what are the reporting requirements that apply to me?
• § 803.11 — What form should I use to submit reports of individual adverse events and where do I obtain these forms?
• § 803.12 — How do I submit initial and supplemental or followup reports?
• § 803.13 — Do I need to submit reports in English?
• § 803.15 — How will I know if you require more information about my medical device report?
• § 803.16 — When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
• § 803.17 — What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
• § 803.18 — What are the requirements for establishing and maintaining MDR files or records that apply to me?
• § 803.19 — Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
• § 803.20 — How do I complete and submit an individual adverse event report?
• § 803.21 — Where can I find the reporting codes for adverse events that I use with medical device reports?
• § 803.22 — What are the circumstances in which I am not required to file a report?
• § 803.23 — Where can I find information on how to prepare and submit an MDR in electronic format?
• § 803.30 — If I am a user facility, what reporting requirements apply to me?
• § 803.32 — If I am a user facility, what information must I submit in my individual adverse event reports?
• § 803.33 — If I am a user facility, what must I include when I submit an annual report?
• § 803.40 — If I am an importer, what reporting requirements apply to me?
• § 803.42 — If I am an importer, what information must I submit in my individual adverse event reports?
• § 803.50 — If I am a manufacturer, what reporting requirements apply to me?
• § 803.52 — If I am a manufacturer, what information must I submit in my individual adverse event reports?
• § 803.53 — If I am a manufacturer, in which circumstances must I submit a 5-day report?
• § 803.56 — If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
• § 803.58 — Foreign manufacturers

PART 806

• § 806.1 — Scope
• § 806.2 — Definitions
• § 806.10 — Reports of corrections and removals
• § 806.20 — Records of corrections and removals not required to be reported
• § 806.30 — FDA access to records
• § 806.40 — Public availability of reports

PART 807

• § 807.3 — Definitions
• § 807.20 — Who must register and submit a device list?
• § 807.21 — How to register establishments and list devices
• § 807.22 — Times for establishment registration and device listing
• § 807.25 — Information required for device establishment registration and device listing
• § 807.26 — Additional listing information
• § 807.28 — Updating device listing information
• § 807.34 — Summary of requirements for owners or operators granted a waiver from submitting required information electronically
• § 807.35 — Notification of registrant
• § 807.37 — Public availability of establishment registration and device listing information
• § 807.39 — Misbranding by reference to establishment registration or to registration number
• § 807.40 — Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States
• § 807.41 — Identification of importers and persons who import or offer for import
• § 807.65 — Exemptions for device establishments
• § 807.81 — When a premarket notification submission is required
• § 807.85 — Exemption from premarket notification
• § 807.87 — Information required in a premarket notification submission
• § 807.90 — Format of a premarket notification submission
• § 807.92 — Content and format of a 510(k) summary
• § 807.93 — Content and format of a 510(k) statement
• § 807.94 — Format of a class III certification
• § 807.95 — Confidentiality of information
• § 807.97 — Misbranding by reference to premarket notification
• § 807.100 — FDA action on a premarket notification

PART 808

• § 808.1 — Scope
• § 808.3 — Definitions
• § 808.5 — Advisory opinions
• § 808.20 — Application
• § 808.25 — Procedures for processing an application
• § 808.35 — Revocation of an exemption
• § 808.53 — [Reserved]
• § 808.55 — California
• § 808.57-808.101 — 808.57-808.101 [Reserved]

PART 809

• § 809.3 — Definitions
• § 809.4 — Confidentiality of submitted information
• § 809.10 — Labeling for in vitro diagnostic products
• § 809.11 — Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile
• § 809.20 — General requirements for manufacturers and producers of in vitro diagnostic products
• § 809.30 — Restrictions on the sale, distribution and use of analyte specific reagents
• § 809.40 — Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing

PART 810

• § 810.1 — Scope
• § 810.2 — Definitions
• § 810.3 — Computation of time
• § 810.4 — Service of orders
• § 810.10 — Cease distribution and notification order
• § 810.11 — Regulatory hearing
• § 810.12 — Written request for review of cease distribution and notification order
• § 810.13 — Mandatory recall order
• § 810.14 — Cease distribution and notification or mandatory recall strategy
• § 810.15 — Communications concerning a cease distribution and notification or mandatory recall order
• § 810.16 — Cease distribution and notification or mandatory recall order status reports
• § 810.17 — Termination of a cease distribution and notification or mandatory recall order
• § 810.18 — Public notice

PART 812

• § 812.1 — Scope
• § 812.2 — Applicability
• § 812.3 — Definitions
• § 812.5 — Labeling of investigational devices
• § 812.7 — Prohibition of promotion and other practices
• § 812.10 — Waivers
• § 812.18 — Import and export requirements
• § 812.19 — Address for IDE correspondence
• § 812.20 — Application
• § 812.25 — Investigational plan
• § 812.27 — Report of prior investigations
• § 812.28 — Acceptance of data from clinical investigations conducted outside the United States
• § 812.30 — FDA action on applications
• § 812.35 — Supplemental applications
• § 812.36 — Treatment use of an investigational device
• § 812.38 — Confidentiality of data and information
• § 812.40 — General responsibilities of sponsors
• § 812.42 — FDA and IRB approval
• § 812.43 — Selecting investigators and monitors
• § 812.45 — Informing investigators
• § 812.46 — Monitoring investigations
• § 812.47 — Emergency research under § 50.24 of this chapter
• § 812.60 — IRB composition, duties, and functions
• § 812.62 — IRB approval
• § 812.64 — IRB's continuing review
• § 812.65 — [Reserved]
• § 812.66 — Significant risk device determinations
• § 812.100 — General responsibilities of investigators
• § 812.110 — Specific responsibilities of investigators
• § 812.119 — Disqualification of a clinical investigator
• § 812.140 — Records
• § 812.145 — Inspections
• § 812.150 — Reports

PART 814

• § 814.1 — Scope
• § 814.2 — Purpose
• § 814.3 — Definitions
• § 814.9 — Confidentiality of data and information in a premarket approval application (PMA) file
• § 814.15 — Research conducted outside the United States
• § 814.17 — Service of orders
• § 814.19 — Product development protocol (PDP)
• § 814.20 — Application
• § 814.37 — PMA amendments and resubmitted PMAs
• § 814.39 — PMA supplements
• § 814.40 — Time frames for reviewing a PMA
• § 814.42 — Filing a PMA
• § 814.44 — Procedures for review of a PMA
• § 814.45 — Denial of approval of a PMA
• § 814.46 — Withdrawal of approval of a PMA
• § 814.47 — Temporary suspension of approval of a PMA
• § 814.80 — General
• § 814.82 — Postapproval requirements
• § 814.84 — Reports
• § 814.100 — Purpose and scope
• § 814.102 — Designation of HUD status
• § 814.104 — Original applications
• § 814.106 — HDE amendments and resubmitted HDE's
• § 814.108 — Supplemental applications
• § 814.110 — New indications for use
• § 814.112 — Filing an HDE
• § 814.114 — Timeframes for reviewing an HDE
• § 814.116 — Procedures for review of an HDE
• § 814.118 — Denial of approval or withdrawal of approval of an HDE
• § 814.120 — Temporary suspension of approval of an HDE
• § 814.122 — Confidentiality of data and information
• § 814.124 — Institutional Review Board requirements
• § 814.126 — Postapproval requirements and reports

PART 820

• § 820.1 — Scope
• § 820.3 — Definitions
• § 820.5 — [Reserved]
• § 820.7 — Incorporation by reference
• § 820.10 — Requirements for a quality management system
• § 820.20-820.30 — 820.20-820.30 [Reserved]
• § 820.35 — Control of records
• § 820.40 — [Reserved]
• § 820.45 — Device labeling and packaging controls

PART 821

• § 821.1 — Scope
• § 821.2 — Exemptions and variances
• § 821.3 — Definitions
• § 821.4 — Imported devices
• § 821.20 — Devices subject to tracking
• § 821.25 — Device tracking system and content requirements: manufacturer requirements
• § 821.30 — Tracking obligations of persons other than device manufacturers: distributor requirements
• § 821.50 — Availability
• § 821.55 — Confidentiality
• § 821.60 — Retention of records

PART 822

• § 822.1 — What does this part cover?
• § 822.2 — What is the purpose of this part?
• § 822.3 — How do you define the terms used in this part?
• § 822.4 — Does this part apply to me?
• § 822.5 — How will I know if I must conduct postmarket surveillance?
• § 822.6 — When will you notify me that I am required to conduct postmarket surveillance?
• § 822.7 — What should I do if I do not agree that postmarket surveillance is appropriate?
• § 822.8 — When, where, and how must I submit my postmarket surveillance plan?
• § 822.9 — What must I include in my submission?
• § 822.10 — What must I include in my surveillance plan?
• § 822.11 — What should I consider when designing my plan to conduct postmarket surveillance?
• § 822.12 — Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?
• § 822.13 — [Reserved]
• § 822.14 — May I reference information previously submitted instead of submitting it again?
• § 822.15 — How long must I conduct postmarket surveillance of my device?
• § 822.16 — What will you consider in the review of my submission?
• § 822.17 — How long will your review of my submission take?
• § 822.18 — How will I be notified of your decision?
• § 822.19 — What kinds of decisions may you make?
• § 822.20 — What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct surveillance in accordance with my approved plan?
• § 822.21 — What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?
• § 822.22 — What recourse do I have if I do not agree with your decision?
• § 822.23 — Is the information in my submission considered confidential?
• § 822.24 — What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
• § 822.25 — What are my responsibilities after my postmarket surveillance plan has been approved?
• § 822.26 — If my company changes ownership, what must I do?
• § 822.27 — If I go out of business, what must I do?
• § 822.28 — If I stop marketing the device subject to postmarket surveillance, what must I do?
• § 822.29 — May I request a waiver of a specific requirement of this part?
• § 822.30 — May I request exemption from the requirement to conduct postmarket surveillance?
• § 822.31 — What records am I required to keep?
• § 822.32 — What records are the investigators in my surveillance plan required to keep?
• § 822.33 — How long must we keep the records?
• § 822.34 — What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
• § 822.35 — Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
• § 822.36 — Can you inspect and copy the records related to my postmarket surveillance plan?
• § 822.37 — Under what circumstances would you inspect records identifying subjects?
• § 822.38 — What reports must I submit to you?

PART 830

• § 830.3 — Definitions
• § 830.10 — Incorporation by reference
• § 830.20 — Requirements for a unique device identifier
• § 830.40 — Use and discontinuation of a device identifier
• § 830.50 — Changes that require use of a new device identifier
• § 830.60 — Relabeling of a device that is required to bear a unique device identifier
• § 830.100 — FDA accreditation of an issuing agency
• § 830.110 — Application for accreditation as an issuing agency
• § 830.120 — Responsibilities of an FDA-accredited issuing agency
• § 830.130 — Suspension or revocation of the accreditation of an issuing agency
• § 830.200 — When FDA will act as an issuing agency
• § 830.210 — Eligibility for use of FDA as an issuing agency
• § 830.220 — Termination of FDA service as an issuing agency
• § 830.300 — Devices subject to device identification data submission requirements
• § 830.310 — Information required for unique device identification
• § 830.320 — Submission of unique device identification information
• § 830.330 — Times for submission of unique device identification information
• § 830.340 — Voluntary submission of ancillary device identification information
• § 830.350 — Correction of information submitted to the Global Unique Device Identification Database
• § 830.360 — Records to be maintained by the labeler

PART 860

• § 860.1 — Scope
• § 860.3 — Definitions
• § 860.5 — Confidentiality and use of data and information submitted in connection with classification and reclassification
• § 860.7 — Determination of safety and effectiveness
• § 860.10 — Implants and life-supporting or life-sustaining devices
• § 860.15 — Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act
• § 860.84 — Classification procedures for “preamendments devices.”
• § 860.90 — Consultation with panels
• § 860.120 — General
• § 860.123 — Reclassification petition: Content and form
• § 860.125 — Consultation with panels
• § 860.130 — General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act
• § 860.132 — Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act
• § 860.133 — Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act
• § 860.134 — Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act
• § 860.136 — Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act
• § 860.200 — Purpose and applicability
• § 860.210 — De Novo request format
• § 860.220 — De Novo request content
• § 860.230 — Accepting a De Novo request
• § 860.240 — Procedures for review of a De Novo request
• § 860.250 — Withdrawal of a De Novo request
• § 860.260 — Granting or declining a De Novo request

PART 861

• § 861.1 — Purpose and scope
• § 861.5 — Statement of policy
• § 861.7 — Contents of standards
• § 861.20 — Summary of standards development process
• § 861.24 — Existing standard as a proposed standard
• § 861.30 — Development of standards
• § 861.34 — Amendment or revocation of a standard
• § 861.36 — Effective dates
• § 861.38 — Standards advisory committees

PART 862

• § 862.1 — Scope
• § 862.2 — Regulation of calibrators
• § 862.3 — Effective dates of requirement for premarket approval
• § 862.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 862.1020 — Acid phosphatase (total or prostatic) test system
• § 862.1025 — Adrenocorticotropic hormone (ACTH) test system
• § 862.1030 — Alanine amino transferase (ALT/SGPT) test system
• § 862.1035 — Albumin test system
• § 862.1040 — Aldolase test system
• § 862.1045 — Aldosterone test system
• § 862.1050 — Alkaline phosphatase or isoenzymes test system
• § 862.1055 — Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry
• § 862.1060 — Delta-aminolevulinic acid test system
• § 862.1065 — Ammonia test system
• § 862.1070 — Amylase test system
• § 862.1075 — Androstenedione test system
• § 862.1080 — Androsterone test system
• § 862.1085 — Angiotensin I and renin test system
• § 862.1090 — Angiotensin converting enzyme (A.C.E.) test system
• § 862.1092 — Anti-mullerian hormone test system
• § 862.1093 — Menopause test system
• § 862.1095 — Ascorbic acid test system
• § 862.1100 — Aspartate amino transferase (AST/SGOT) test system
• § 862.1110 — Bilirubin (total or direct) test system
• § 862.1113 — Bilirubin (total and unbound) in the neonate test system
• § 862.1115 — Urinary bilirubin and its conjugates (nonquantitative) test system
• § 862.1117 — B-type natriuretic peptide test system
• § 862.1118 — Biotinidase test system
• § 862.1120 — Blood gases (PCO2, PO2) and blood pH test system
• § 862.1130 — Blood volume test system
• § 862.1135 — C-peptides of proinsulin test system
• § 862.1140 — Calcitonin test system
• § 862.1145 — Calcium test system
• § 862.1150 — Calibrator
• § 862.1155 — Human chorionic gonadotropin (HCG) test system
• § 862.1160 — Bicarbonate/carbon dioxide test system
• § 862.1163 — Cardiac allograft gene expression profiling test system
• § 862.1164 — Setmelanotide eligibility gene variant detection system
• § 862.1165 — Catecholamines (total) test system
• § 862.1170 — Chloride test system
• § 862.1175 — Cholesterol (total) test system
• § 862.1177 — Cholylglycine test system
• § 862.1180 — Chymotrypsin test system
• § 862.1185 — Compound S (11-deoxycortisol) test system
• § 862.1187 — Conjugated sulfolithocholic acid (SLCG) test system
• § 862.1190 — Copper test system
• § 862.1195 — Corticoids test system
• § 862.1200 — Corticosterone test system
• § 862.1205 — Cortisol (hydrocortisone and hydroxycorticosterone) test system
• § 862.1210 — Creatine test system
• § 862.1215 — Creatine phosphokinase/creatine kinase or isoenzymes test system
• § 862.1220 — Acute kidney injury test system
• § 862.1225 — Creatinine test system
• § 862.1230 — Cyclic AMP test system
• § 862.1235 — Cyclosporine test system
• § 862.1240 — Cystine test system
• § 862.1245 — Dehydroepiandrosterone (free and sulfate) test system
• § 862.1250 — Desoxycorticosterone test system
• § 862.1255 — 2,3-Diphosphoglyceric acid test system
• § 862.1260 — Estradiol test system
• § 862.1265 — Estriol test system
• § 862.1270 — Estrogens (total, in pregnancy) test system
• § 862.1275 — Estrogens (total, nonpregnancy) test system
• § 862.1280 — Estrone test system
• § 862.1285 — Etiocholanolone test system
• § 862.1290 — Fatty acids test system
• § 862.1295 — Folic acid test system
• § 862.1300 — Follicle-stimulating hormone test system
• § 862.1305 — Formiminoglutamic acid (FIGLU) test system
• § 862.1310 — Galactose test system
• § 862.1315 — Galactose-1-phosphate uridyl transferase test system
• § 862.1320 — Gastric acidity test system
• § 862.1325 — Gastrin test system
• § 862.1330 — Globulin test system
• § 862.1335 — Glucagon test system
• § 862.1340 — Urinary glucose (nonquantitative) test system
• § 862.1345 — Glucose test system
• § 862.1350 — Continuous glucose monitor secondary alarm system
• § 862.1355 — Integrated continuous glucose monitoring system
• § 862.1356 — Interoperable automated glycemic controller
• § 862.1358 — Insulin therapy adjustment device
• § 862.1360 — Gamma-glutamyl transpeptidase and isoenzymes test system
• § 862.1365 — Glutathione test system
• § 862.1370 — Human growth hormone test system
• § 862.1373 — Hemoglobin A1c test system
• § 862.1375 — Histidine test system
• § 862.1377 — Urinary homocystine (nonquantitative) test system
• § 862.1380 — Hydroxybutyric dehydrogenase test system
• § 862.1385 — 17-Hydroxycorticosteroids (17-ketogenic steroids) test system
• § 862.1390 — 5-Hydroxyindole acetic acid/serotonin test system
• § 862.1395 — 17-Hydroxyprogesterone test system
• § 862.1400 — Hydroxyproline test system
• § 862.1405 — Immunoreactive insulin test system
• § 862.1410 — Iron (non-heme) test system
• § 862.1415 — Iron-binding capacity test system
• § 862.1420 — Isocitric dehydrogenase test system
• § 862.1430 — 17-Ketosteroids test system
• § 862.1435 — Ketones (nonquantitative) test system
• § 862.1440 — Lactate dehydrogenase test system
• § 862.1445 — Lactate dehydrogenase isoenzymes test system
• § 862.1450 — Lactic acid test system
• § 862.1455 — Lecithin/sphingomyelin ratio in amniotic fluid test system
• § 862.1460 — Leucine aminopeptidase test system
• § 862.1465 — Lipase test system
• § 862.1470 — Lipid (total) test system
• § 862.1475 — Lipoprotein test system
• § 862.1485 — Luteinizing hormone test system
• § 862.1488 — Lysosomal storage disorder newborn screening test system
• § 862.1490 — Lysozyme (muramidase) test system
• § 862.1493 — Breast milk macronutrients test system
• § 862.1495 — Magnesium test system
• § 862.1500 — Malic dehydrogenase test system
• § 862.1505 — Mucopolysaccharides (nonquantitative) test system
• § 862.1506 — Muscular dystrophy newborn screening test
• § 862.1509 — Methylmalonic acid (nonquantitative) test system
• § 862.1510 — Nitrite (nonquantitative) test system
• § 862.1515 — Nitrogen (amino-nitrogen) test system
• § 862.1520 — 5′-Nucleotidase test system
• § 862.1530 — Plasma oncometry test system
• § 862.1535 — Ornithine carbamyl transferase test system
• § 862.1540 — Osmolality test system
• § 862.1542 — Oxalate test system
• § 862.1545 — Parathyroid hormone test system
• § 862.1550 — Urinary pH (nonquantitative) test system
• § 862.1555 — Phenylalanine test system
• § 862.1560 — Urinary phenylketones (nonquantitative) test system
• § 862.1565 — 6-Phosphogluconate dehydrogenase test system
• § 862.1570 — Phosphohexose isomerase test system
• § 862.1575 — Phospholipid test system
• § 862.1580 — Phosphorus (inorganic) test system
• § 862.1585 — Human placental lactogen test system
• § 862.1590 — Porphobilinogen test system
• § 862.1595 — Porphyrins test system
• § 862.1600 — Potassium test system
• § 862.1605 — Pregnanediol test system
• § 862.1610 — Pregnanetriol test system
• § 862.1615 — Pregnenolone test system
• § 862.1620 — Progesterone test system
• § 862.1622 — Prognostic test for assessment of liver related disease progression
• § 862.1625 — Prolactin (lactogen) test system
• § 862.1630 — Protein (fractionation) test system
• § 862.1635 — Total protein test system
• § 862.1640 — Protein-bound iodine test system
• § 862.1645 — Urinary protein or albumin (nonquantitative) test system
• § 862.1650 — Pyruvate kinase test system
• § 862.1655 — Pyruvic acid test system
• § 862.1660 — Quality control material (assayed and unassayed)
• § 862.1665 — Sodium test system
• § 862.1670 — Sorbitol dehydrogenase test system
• § 862.1675 — Blood specimen collection device
• § 862.1676 — Blood collection device for cell-free nucleic acids
• § 862.1678 — Tacrolimus test system
• § 862.1680 — Testosterone test system
• § 862.1685 — Thyroxine-binding globulin test system
• § 862.1690 — Thyroid stimulating hormone test system
• § 862.1695 — Free thyroxine test system
• § 862.1700 — Total thyroxine test system
• § 862.1705 — Triglyceride test system
• § 862.1710 — Total triiodothyronine test system
• § 862.1715 — Triiodothyronine uptake test system
• § 862.1720 — Triose phosphate isomerase test system
• § 862.1725 — Trypsin test system
• § 862.1730 — Free tyrosine test system
• § 862.1770 — Urea nitrogen test system
• § 862.1775 — Uric acid test system
• § 862.1780 — Urinary calculi (stones) test system
• § 862.1785 — Urinary urobilinogen (nonquantitative) test system
• § 862.1790 — Uroporphyrin test system
• § 862.1795 — Vanilmandelic acid test system
• § 862.1805 — Vitamin A test system
• § 862.1810 — Vitamin B12 test system
• § 862.1815 — Vitamin E test system
• § 862.1820 — Xylose test system
• § 862.1825 — Vitamin D test system
• § 862.1840 — Total 25-hydroxyvitamin D mass spectrometry test system
• § 862.2050 — General purpose laboratory equipment labeled or promoted for a specific medical use
• § 862.2100 — Calculator/data processing module for clinical use
• § 862.2120 — Continuous glucose monitor data management system
• § 862.2140 — Centrifugal chemistry analyzer for clinical use
• § 862.2150 — Continuous flow sequential multiple chemistry analyzer for clinical use
• § 862.2160 — Discrete photometric chemistry analyzer for clinical use
• § 862.2170 — Micro chemistry analyzer for clinical use
• § 862.2230 — Chromatographic separation material for clinical use
• § 862.2250 — Gas liquid chromatography system for clinical use
• § 862.2260 — High pressure liquid chromatography system for clinical use
• § 862.2265 — High throughput genomic sequence analyzer for clinical use
• § 862.2270 — Thin-layer chromatography system for clinical use
• § 862.2300 — Colorimeter, photometer, or spectrophotometer for clinical use
• § 862.2310 — Clinical sample concentrator
• § 862.2320 — Beta or gamma counter for clinical use
• § 862.2400 — Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use
• § 862.2485 — Electrophoresis apparatus for clinical use
• § 862.2500 — Enzyme analyzer for clinical use
• § 862.2540 — Flame emission photometer for clinical use
• § 862.2560 — Fluorometer for clinical use
• § 862.2570 — Instrumentation for clinical multiplex test systems
• § 862.2680 — Microtitrator for clinical use
• § 862.2700 — Nephelometer for clinical use
• § 862.2720 — Plasma oncometer for clinical use
• § 862.2730 — Osmometer for clinical use
• § 862.2750 — Pipetting and diluting system for clinical use
• § 862.2800 — Refractometer for clinical use
• § 862.2850 — Atomic absorption spectrophotometer for clinical use
• § 862.2860 — Mass spectrometer for clinical use
• § 862.2900 — Automated urinalysis system
• § 862.2920 — Plasma viscometer for clinical use
• § 862.3030 — Acetaminophen test system
• § 862.3035 — Amikacin test system
• § 862.3040 — Alcohol test system
• § 862.3050 — Breath-alcohol test system
• § 862.3080 — Breath nitric oxide test system
• § 862.3100 — Amphetamine test system
• § 862.3110 — Antimony test system
• § 862.3120 — Arsenic test system
• § 862.3150 — Barbiturate test system
• § 862.3170 — Benzodiazepine test system
• § 862.3200 — Clinical toxicology calibrator
• § 862.3220 — Carbon monoxide test system
• § 862.3240 — Cholinesterase test system
• § 862.3245 — Clozapine test system
• § 862.3250 — Cocaine and cocaine metabolite test system
• § 862.3270 — Codeine test system
• § 862.3280 — Clinical toxicology control material
• § 862.3300 — Digitoxin test system
• § 862.3320 — Digoxin test system
• § 862.3350 — Diphenylhydantoin test system
• § 862.3360 — Drug metabolizing enzyme genotyping system
• § 862.3364 — Pharmacogenetic assessment system
• § 862.3380 — Ethosuximide test system
• § 862.3450 — Gentamicin test system
• § 862.3460 — Plazomicin test system
• § 862.3520 — Kanamycin test system
• § 862.3550 — Lead test system
• § 862.3555 — Lidocaine test system
• § 862.3560 — Lithium test system
• § 862.3580 — Lysergic acid diethylamide (LSD) test system
• § 862.3590 — Meprobamate test system
• § 862.3600 — Mercury test system
• § 862.3610 — Methamphetamine test system
• § 862.3620 — Methadone test system
• § 862.3630 — Methaqualone test system
• § 862.3640 — Morphine test system
• § 862.3645 — Neuroleptic drugs radioreceptor assay test system
• § 862.3650 — Opiate test system
• § 862.3652 — Organophosphate test system
• § 862.3660 — Phenobarbital test system
• § 862.3670 — Phenothiazine test system
• § 862.3680 — Primidone test system
• § 862.3700 — Propoxyphene test system
• § 862.3750 — Quinine test system
• § 862.3800 — Reagents for molecular diagnostic instrument test systems
• § 862.3830 — Salicylate test system
• § 862.3840 — Sirolimus test system
• § 862.3850 — Sulfonamide test system
• § 862.3870 — Cannabinoid test system
• § 862.3880 — Theophylline test system
• § 862.3900 — Tobramycin test system
• § 862.3910 — Tricyclic antidepressant drugs test system
• § 862.3950 — Vancomycin test system
• § 862.3970 — Voriconazole test system

PART 864

• § 864.1 — Scope
• § 864.3 — Effective dates of requirement for premarket approval
• § 864.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 864.1850 — Dye and chemical solution stains
• § 864.1860 — Immunohistochemistry reagents and kits
• § 864.1865 — Cervical intraepithelial neoplasia (CIN) test system
• § 864.1866 — Lynch syndrome test systems
• § 864.1870 — Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization
• § 864.1880 — Fluorescence in situ hybridization (FISH)-based detection of chromosomal abnormalities from patients with hematologic malignancies
• § 864.2220 — Synthetic cell and tissue culture media and components
• § 864.2240 — Cell and tissue culture supplies and equipment
• § 864.2260 — Chromosome culture kit
• § 864.2280 — Cultured animal and human cells
• § 864.2360 — Mycoplasma detection media and components
• § 864.2800 — Animal and human sera
• § 864.2875 — Balanced salt solutions or formulations
• § 864.3010 — Tissue processing equipment
• § 864.3250 — Specimen transport and storage container
• § 864.3260 — OTC test sample collection systems for drugs of abuse testing
• § 864.3300 — Cytocentrifuge
• § 864.3400 — Device for sealing microsections
• § 864.3600 — Microscopes and accessories
• § 864.3700 — Whole slide imaging system
• § 864.3750 — Software algorithm device to assist users in digital pathology
• § 864.3800 — Automated slide stainer
• § 864.3875 — Automated tissue processor
• § 864.4010 — General purpose reagent
• § 864.4020 — Analyte specific reagents
• § 864.4400 — Enzyme preparations
• § 864.5200 — Automated cell counter
• § 864.5220 — Automated differential cell counter
• § 864.5240 — Automated blood cell diluting apparatus
• § 864.5260 — Automated cell-locating device
• § 864.5300 — Red cell indices device
• § 864.5350 — Microsedimentation centrifuge
• § 864.5400 — Coagulation instrument
• § 864.5425 — Multipurpose system for in vitro coagulation studies
• § 864.5430 — Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients
• § 864.5600 — Automated hematocrit instrument
• § 864.5620 — Automated hemoglobin system
• § 864.5680 — Automated heparin analyzer
• § 864.5700 — Automated platelet aggregation system
• § 864.5800 — Automated sedimentation rate device
• § 864.5850 — Automated slide spinner
• § 864.5950 — Blood volume measuring device
• § 864.6100 — Bleeding time device
• § 864.6150 — Capillary blood collection tube
• § 864.6160 — Manual blood cell counting device
• § 864.6400 — Hematocrit measuring device
• § 864.6550 — Occult blood test
• § 864.6600 — Osmotic fragility test
• § 864.6650 — Platelet adhesion test
• § 864.6675 — Platelet aggregometer
• § 864.6700 — Erythrocyte sedimentation rate test
• § 864.7010 — Flow cytometric test system for hematopoietic neoplasms
• § 864.7040 — Adenosine triphosphate release assay
• § 864.7060 — Antithrombin III assay
• § 864.7100 — Red blood cell enzyme assay
• § 864.7140 — Activated whole blood clotting time tests
• § 864.7250 — Erythropoietin assay
• § 864.7275 — Euglobulin lysis time tests
• § 864.7280 — Factor V Leiden DNA mutation detection systems
• § 864.7290 — Factor deficiency test
• § 864.7295 — Heparin and direct oral factor Xa inhibitor drug test system
• § 864.7300 — Fibrin monomer paracoagulation test
• § 864.7320 — Fibrinogen/fibrin degradation products assay
• § 864.7340 — Fibrinogen determination system
• § 864.7360 — Erythrocytic glucose-6-phosphate dehydrogenase assay
• § 864.7375 — Glutathione reductase assay
• § 864.7400 — Hemoglobin A2 assay
• § 864.7415 — Abnormal hemoglobin assay
• § 864.7425 — Carboxyhemoglobin assay
• § 864.7440 — Electrophoretic hemoglobin analysis system
• § 864.7455 — Fetal hemoglobin assay
• § 864.7470 — Glycosylated hemoglobin assay
• § 864.7490 — Sulfhemoglobin assay
• § 864.7500 — Whole blood hemoglobin assays
• § 864.7525 — Heparin assay
• § 864.7660 — Leukocyte alkaline phosphatase test
• § 864.7675 — Leukocyte peroxidase test
• § 864.7695 — Platelet factor 4 radioimmunoassay
• § 864.7720 — Prothrombin consumption test
• § 864.7735 — Prothrombin-proconvertin test and thrombotest
• § 864.7750 — Prothrombin time test
• § 864.7825 — Sickle cell test
• § 864.7875 — Thrombin time test
• § 864.7900 — Thromboplastin generation test
• § 864.7925 — Partial thromboplastin time tests
• § 864.8100 — Bothrops atrox reagent
• § 864.8150 — Calibrator for cell indices
• § 864.8165 — Calibrator for hemoglobin or hematocrit measurement
• § 864.8175 — Calibrator for platelet counting
• § 864.8185 — Calibrator for red cell and white cell counting
• § 864.8200 — Blood cell diluent
• § 864.8500 — Lymphocyte separation medium
• § 864.8540 — Red cell lysing reagent
• § 864.8625 — Hematology quality control mixture
• § 864.8950 — Russell viper venom reagent
• § 864.9050 — Blood bank supplies
• § 864.9100 — Empty container for the collection and processing of blood and blood components
• § 864.9115 — Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions
• § 864.9125 — Vacuum-assisted blood collection system
• § 864.9145 — Processing system for frozen blood
• § 864.9160 — Blood group substances of nonhuman origin for in vitro diagnostic use
• § 864.9165 — Blood establishment computer software and accessories
• § 864.9175 — Automated blood grouping and antibody test system
• § 864.9185 — Blood grouping view box
• § 864.9195 — Blood mixing devices and blood weighing devices
• § 864.9205 — Blood and plasma warming device
• § 864.9225 — Cell-freezing apparatus and reagents for in vitro diagnostic use
• § 864.9245 — Automated blood cell separator
• § 864.9275 — Blood bank centrifuge for in vitro diagnostic use
• § 864.9285 — Automated cell-washing centrifuge for immuno-hematology
• § 864.9300 — Automated Coombs test systems
• § 864.9320 — Copper sulfate solution for specific gravity determinations
• § 864.9400 — Stabilized enzyme solution
• § 864.9550 — Lectins and protectins
• § 864.9575 — Environmental chamber for storage of platelet concentrate
• § 864.9600 — Potentiating media for in vitro diagnostic use
• § 864.9650 — Quality control kit for blood banking reagents
• § 864.9700 — Blood storage refrigerator and blood storage freezer
• § 864.9750 — Heat-sealing device
• § 864.9875 — Transfer set
• § 864.9900 — Cord blood processing system and storage container

PART 866

• § 866.1 — Scope
• § 866.3 — Effective dates of requirement for premarket approval
• § 866.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 866.1620 — Antimicrobial susceptibility test disc
• § 866.1640 — Antimicrobial susceptibility test powder
• § 866.1645 — Fully automated short-term incubation cycle antimicrobial susceptibility system
• § 866.1650 — A cellular analysis system for multiplexed antimicrobial susceptibility testing
• § 866.1655 — System for detection of microorganisms and antimicrobial resistance using reporter expression
• § 866.1700 — Culture medium for antimicrobial susceptibility tests
• § 866.2050 — Staphylococcal typing bacteriophage
• § 866.2120 — Anaerobic chamber
• § 866.2160 — Coagulase plasma
• § 866.2170 — Automated colony counter
• § 866.2180 — Manual colony counter
• § 866.2190 — Automated image assessment system for microbial colonies on solid culture media
• § 866.2300 — Multipurpose culture medium
• § 866.2320 — Differential culture medium
• § 866.2330 — Enriched culture medium
• § 866.2350 — Microbiological assay culture medium
• § 866.2360 — Selective culture medium
• § 866.2390 — Transport culture medium
• § 866.2410 — Culture medium for pathogenic Neisseria spp
• § 866.2420 — Oxidase screening test for gonorrhea
• § 866.2440 — Automated medium dispensing and stacking device
• § 866.2450 — Supplement for culture media
• § 866.2480 — Quality control kit for culture media
• § 866.2500 — Microtiter diluting and dispensing device
• § 866.2540 — Microbiological incubator
• § 866.2560 — Microbial growth monitor
• § 866.2580 — Gas-generating device
• § 866.2600 — Wood's fluorescent lamp
• § 866.2660 — Microorganism differentiation and identification device
• § 866.2680 — Streptococcus spp. nucleic acid-based assay
• § 866.2850 — Automated zone reader
• § 866.2900 — Microbiological specimen collection and transport device
• § 866.2950 — Microbial nucleic acid storage and stabilization device
• § 866.2952 — Device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples
• § 866.3010 — Acinetobacter calcoaceticus serological reagents
• § 866.3020 — Adenovirus serological reagents
• § 866.3035 — Arizona spp. serological reagents
• § 866.3040 — Aspergillus spp. serological reagents
• § 866.3045 — In vitro diagnostic device for Bacillus spp. detection
• § 866.3050 — Beta-glucan serological assays
• § 866.3060 — Blastomyces dermatitidis serological reagents
• § 866.3065 — Bordetella spp. serological reagents
• § 866.3085 — Brucella spp. serological reagents
• § 866.3110 — Campylobacter fetus serological reagents
• § 866.3120 — Chlamydia serological reagents
• § 866.3125 — Citrobacter spp. serological reagents
• § 866.3130 — Clostridium difficile toxin gene amplification assay
• § 866.3135 — Coccidioides immitis serological reagents
• § 866.3140 — Corynebacterium spp. serological reagents
• § 866.3145 — Coxsackievirus serological reagents
• § 866.3165 — Cryptococcus neoformans serological reagents
• § 866.3169 — Hepatitis C virus antibody tests
• § 866.3170 — Nucleic acid-based hepatitis C virus ribonucleic acid tests
• § 866.3172 — Qualitative hepatitis B virus antigen assays
• § 866.3173 — Hepatitis B virus antibody assays
• § 866.3174 — Hepatitis B virus nucleic acid-based assays
• § 866.3175 — Cytomegalovirus serological reagents
• § 866.3180 — Quantitative cytomegalovirus nucleic acid tests for transplant patient management
• § 866.3181 — Cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection
• § 866.3183 — Quantitative viral nucleic acid test for transplant patient management
• § 866.3200 — Echinococcus spp. serological reagents
• § 866.3205 — Echovirus serological reagents
• § 866.3210 — Endotoxin assay
• § 866.3215 — Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis
• § 866.3220 — Entamoeba histolytica serological reagents
• § 866.3225 — Enterovirus nucleic acid assay
• § 866.3230 — Device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections
• § 866.3231 — Device to detect bacterial protease activity in chronic wound fluid
• § 866.3235 — Epstein-Barr virus serological reagents
• § 866.3236 — Device to detect or measure nucleic acid from viruses associated with head and neck cancers
• § 866.3240 — Equine encephalomyelitis virus serological reagents
• § 866.3250 — Erysipelothrix rhusiopathiae serological reagents
• § 866.3255 — Escherichia coli serological reagents
• § 866.3270 — Flavobacterium spp. serological reagents
• § 866.3280 — Francisella tularensis serological reagents
• § 866.3290 — Gonococcal antibody test (GAT)
• § 866.3300 — Haemophilus spp. serological reagents
• § 866.3305 — Herpes simplex virus serological assays
• § 866.3307 — Herpes simplex virus nucleic acid-based assay for central nervous system infections
• § 866.3309 — Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel
• § 866.3310 — Hepatitis A virus (HAV) serological assays
• § 866.3320 — Histoplasma capsulatum serological reagents
• § 866.3328 — Influenza virus antigen detection test system
• § 866.3330 — Influenza virus serological reagents
• § 866.3332 — Reagents for detection of specific novel influenza A viruses
• § 866.3336 — John Cunningham Virus serological reagents
• § 866.3340 — Klebsiella spp. serological reagents
• § 866.3350 — Leptospira spp. serological reagents
• § 866.3355 — Listeria spp. serological reagents
• § 866.3360 — Lymphocytic choriomeningitis virus serological reagents
• § 866.3361 — Mass spectrometer system for clinical use for the identification of microorganisms
• § 866.3365 — Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures
• § 866.3367 — Device to detect and identify microbial nucleic acids by FISH in clinical specimens
• § 866.3370 — Mycobacterium tuberculosis immunofluorescent reagents
• § 866.3372 — Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens
• § 866.3373 — Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens
• § 866.3375 — Mycoplasma spp. serological reagents
• § 866.3376 — Device to detect and identify fungal nucleic acids directly in respiratory specimens
• § 866.3378 — Clinical mass spectrometry microorganism identification and differentiation system
• § 866.3380 — Mumps virus serological reagents
• § 866.3390 — Neisseria spp. direct serological test reagents
• § 866.3393 — Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s)
• § 866.3395 — Norovirus serological reagents
• § 866.3400 — Parainfluenza virus serological reagents
• § 866.3402 — Plasmodium species antigen detection assays
• § 866.3405 — Poliovirus serological reagents
• § 866.3410 — Proteus spp. (Weil-Felix) serological reagents
• § 866.3415 — Pseudomonas spp. serological reagents
• § 866.3460 — Rabiesvirus immunofluorescent reagents
• § 866.3470 — Reovirus serological reagents
• § 866.3480 — Respiratory syncytial virus serological reagents
• § 866.3490 — Rhinovirus serological reagents
• § 866.3500 — Rickettsia serological reagents
• § 866.3510 — Rubella virus serological reagents
• § 866.3520 — Rubeola (measles) virus serological reagents
• § 866.3550 — Salmonella spp. serological reagents
• § 866.3600 — Schistosoma spp. serological reagents
• § 866.3630 — Serratia spp. serological reagents
• § 866.3660 — Shigella spp. serological reagents
• § 866.3680 — Sporothrix schenckii serological reagents
• § 866.3700 — Staphylococcus aureus serological reagents
• § 866.3720 — Streptococcus spp. exoenzyme reagents
• § 866.3740 — Streptococcus spp. serological reagents
• § 866.3780 — Toxoplasma gondii serological reagents
• § 866.3820 — Treponema pallidum nontreponemal test reagents
• § 866.3830 — Treponema pallidum treponemal test reagents
• § 866.3850 — Trichinella spiralis serological reagents
• § 866.3860 — Trichomonas vaginalis nucleic acid assay
• § 866.3870 — Trypanosoma spp. serological reagents
• § 866.3900 — Varicella-zoster virus serological reagents
• § 866.3920 — Assayed quality control material for clinical microbiology assays
• § 866.3930 — Vibrio cholerae serological reagents
• § 866.3935 — Zika virus serological reagents
• § 866.3940 — West Nile virus serological reagents
• § 866.3945 — Dengue virus serological reagents
• § 866.3946 — Dengue virus nucleic acid amplification test reagents
• § 866.3950 — In vitro human immunodeficiency virus (HIV) drug resistance genotype assay
• § 866.3955 — Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology
• § 866.3956 — Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test
• § 866.3957 — Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test
• § 866.3958 — Human immunodeficiency virus (HIV) viral load monitoring test
• § 866.3960 — Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens
• § 866.3966 — Device to detect and identify selected microbial agents that cause acute febrile illness
• § 866.3970 — Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid
• § 866.3975 — Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis
• § 866.3980 — Respiratory viral panel multiplex nucleic acid assay
• § 866.3981 — Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test
• § 866.3985 — Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens
• § 866.3988 — Device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection
• § 866.3990 — Gastrointestinal microorganism multiplex nucleic acid-based assay
• § 866.4001 — A multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens
• § 866.4070 — RNA Preanalytical Systems
• § 866.4100 — Complement reagent
• § 866.4500 — Immunoelectrophoresis equipment
• § 866.4520 — Immunofluorometer equipment
• § 866.4540 — Immunonephelometer equipment
• § 866.4600 — Ouchterlony agar plate
• § 866.4700 — Automated fluorescence in situ hybridization (FISH) enumeration systems
• § 866.4750 — Automated indirect immunofluorescence microscope and software-assisted system
• § 866.4800 — Radial immunodiffusion plate
• § 866.4830 — Rocket immunoelectrophoresis equipment
• § 866.4900 — Support gel
• § 866.5040 — Albumin immunological test system
• § 866.5060 — Prealbumin immunological test system
• § 866.5065 — Human allotypic marker immunological test system
• § 866.5080 — Alpha-1-antichymotrypsin immunological test system
• § 866.5090 — Antimitochondrial antibody immunological test system
• § 866.5100 — Antinuclear antibody immunological test system
• § 866.5110 — Antiparietal antibody immunological test system
• § 866.5120 — Antismooth muscle antibody immunological test system
• § 866.5130 — Alpha-1-antitrypsin immunological test system
• § 866.5150 — Bence-Jones proteins immunological test system
• § 866.5160 — Beta-globulin immunological test system
• § 866.5170 — Breast milk immunological test system
• § 866.5180 — Fecal calprotectin immunological test system
• § 866.5200 — Carbonic anhydrase B and C immunological test system
• § 866.5210 — Ceruloplasmin immunological test system
• § 866.5220 — Cohn fraction II immunological test system
• § 866.5230 — Colostrum immunological test system
• § 866.5240 — Complement components immunological test system
• § 866.5250 — Complement C1 inhibitor (inactivator) immunological test system
• § 866.5260 — Complement C3b inactivator immunological test system
• § 866.5270 — C-reactive protein immunological test system
• § 866.5320 — Properdin factor B immunological test system
• § 866.5330 — Factor XIII, A, S, immunological test system
• § 866.5340 — Ferritin immunological test system
• § 866.5350 — Fibrinopeptide A immunological test system
• § 866.5360 — Cohn fraction IV immunological test system
• § 866.5370 — Cohn fraction V immunological test system
• § 866.5380 — Free secretory component immunological test system
• § 866.5400 — Alpha-globulin immunological test system
• § 866.5420 — Alpha-1-glycoproteins immunological test system
• § 866.5425 — Alpha-2-glycoproteins immunological test system
• § 866.5430 — Beta-2-glycoprotein I immunological test system
• § 866.5440 — Beta-2-glycoprotein III immunological test system
• § 866.5460 — Haptoglobin immunological test system
• § 866.5470 — Hemoglobin immunological test system
• § 866.5490 — Hemopexin immunological test system
• § 866.5500 — Hypersensitivity pneumonitis immunological test system
• § 866.5510 — Immunoglobulins A, G, M, D, and E immunological test system
• § 866.5520 — Immunoglobulin G (Fab fragment specific) immunological test system
• § 866.5530 — Immunoglobulin G (Fc fragment specific) immunological test system
• § 866.5540 — Immunoglobulin G (Fd fragment specific) immunological test system
• § 866.5550 — Immunoglobulin (light chain specific) immunological test system
• § 866.5560 — Lactic dehydrogenase immunological test system
• § 866.5570 — Lactoferrin immunological test system
• § 866.5580 — Alpha-1-lipoprotein immunological test system
• § 866.5590 — Lipoprotein X immunological test system
• § 866.5600 — Low-density lipoprotein immunological test system
• § 866.5620 — Alpha-2-macroglobulin immunological test system
• § 866.5630 — Beta-2-microglobulin immunological test system
• § 866.5640 — Infectious mononucleosis immunological test system
• § 866.5660 — Multiple autoantibodies immunological test system
• § 866.5665 — Aquaporin-4 autoantibody immunological test system
• § 866.5670 — Zinc transporter 8 autoantibody immunological test system
• § 866.5680 — Myoglobin immunological test system
• § 866.5700 — Whole human plasma or serum immunological test system
• § 866.5715 — Plasminogen immunological test system
• § 866.5735 — Prothrombin immunological test system
• § 866.5750 — Radioallergosorbent (RAST) immunological test system
• § 866.5760 — Tryptase test system
• § 866.5765 — Retinol-binding protein immunological test system
• § 866.5775 — Rheumatoid factor immunological test system
• § 866.5780 — Anti-phospholipase A2 receptor immunological test system
• § 866.5785 — Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems
• § 866.5800 — Seminal fluid (sperm) immunological test system
• § 866.5820 — Systemic lupus erythematosus immunological test system
• § 866.5830 — Brain trauma assessment test
• § 866.5840 — Alzheimer's disease pathology assessment test
• § 866.5860 — Total spinal fluid immunological test system
• § 866.5870 — Thyroid autoantibody immunological test system
• § 866.5880 — Transferrin immunological test system
• § 866.5890 — Inter-alpha trypsin inhibitor immunological test system
• § 866.5900 — Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system
• § 866.5910 — Quality control material for cystic fibrosis nucleic acid assays
• § 866.5920 — Postnatal chromosomal copy number variation detection system
• § 866.5930 — Newborn screening test for severe combined immunodeficiency disorder (SCID)
• § 866.5940 — Autosomal recessive carrier screening gene mutation detection system
• § 866.5950 — Genetic health risk assessment system
• § 866.5960 — Human leukocyte antigen typing companion diagnostic test
• § 866.5970 — Inherited nucleotide repeat disorder DNA test
• § 866.6000 — Whole exome sequencing constituent device
• § 866.6010 — Tumor-associated antigen immunological test system
• § 866.6020 — Immunomagnetic circulating cancer cell selection and enumeration system
• § 866.6030 — AFP-L3% immunological test system
• § 866.6040 — Gene expression profiling test system for breast cancer prognosis
• § 866.6050 — Ovarian adnexal mass assessment score test system
• § 866.6060 — BCR-ABL quantitation test
• § 866.6070 — Mutation detection test for myeloproliferative neoplasms
• § 866.6080 — Next generation sequencing based tumor profiling test
• § 866.6090 — Cancer predisposition risk assessment system
• § 866.6100 — DNA-based test to measure minimal residual disease in hematological malignancies
• § 866.6110 — Circulating tumor cell enrichment device

PART 868

• § 868.1 — Scope
• § 868.3 — Effective dates of requirement for premarket approval
• § 868.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 868.1030 — Manual algesimeter
• § 868.1040 — Powered algesimeter
• § 868.1075 — Argon gas analyzer
• § 868.1100 — Arterial blood sampling kit
• § 868.1120 — Indwelling blood oxyhemoglobin concentration analyzer
• § 868.1150 — Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer
• § 868.1170 — Indwelling blood hydrogen ion concentration (pH) analyzer
• § 868.1200 — Indwelling blood oxygen partial pressure (PO2) analyzer
• § 868.1400 — Carbon dioxide gas analyzer
• § 868.1430 — Carbon monoxide gas analyzer
• § 868.1500 — Enflurane gas analyzer
• § 868.1505 — Ventilatory electrical impedance tomograph
• § 868.1575 — Gas collection vessel
• § 868.1620 — Halothane gas analyzer
• § 868.1640 — Helium gas analyzer
• § 868.1670 — Neon gas analyzer
• § 868.1690 — Nitrogen gas analyzer
• § 868.1700 — Nitrous oxide gas analyzer
• § 868.1720 — Oxygen gas analyzer
• § 868.1730 — Oxygen uptake computer
• § 868.1750 — Pressure plethysmograph
• § 868.1760 — Volume plethysmograph
• § 868.1780 — Inspiratory airway pressure meter
• § 868.1800 — Rhinoanemometer
• § 868.1840 — Diagnostic spirometer
• § 868.1850 — Monitoring spirometer
• § 868.1860 — Peak-flow meter for spirometry
• § 868.1870 — Gas volume calibrator
• § 868.1880 — Pulmonary-function data calculator
• § 868.1890 — Predictive pulmonary-function value calculator
• § 868.1900 — Diagnostic pulmonary-function interpretation calculator
• § 868.1910 — Esophageal stethoscope
• § 868.1920 — Esophageal stethoscope with electrical conductors
• § 868.1930 — Stethoscope head
• § 868.1965 — Switching valve (ploss)
• § 868.1975 — Water vapor analyzer
• § 868.2025 — Ultrasonic air embolism monitor
• § 868.2300 — Bourdon gauge flowmeter
• § 868.2320 — Uncompensated thorpe tube flowmeter
• § 868.2340 — Compensated thorpe tube flowmeter
• § 868.2350 — Gas calibration flowmeter
• § 868.2375 — Breathing frequency monitor
• § 868.2376 — Device for sleep apnea testing based on mandibular movement
• § 868.2377 — Apnea monitor
• § 868.2380 — Nitric oxide analyzer
• § 868.2385 — Nitrogen dioxide analyzer
• § 868.2450 — Lung water monitor
• § 868.2480 — Cutaneous carbon dioxide (PcCO2) monitor
• § 868.2500 — Cutaneous oxygen (PcO2) monitor
• § 868.2550 — Pneumotachometer
• § 868.2600 — Airway pressure monitor
• § 868.2610 — Gas pressure gauge
• § 868.2620 — Gas pressure calibrator
• § 868.2700 — Pressure regulator
• § 868.2775 — Electrical peripheral nerve stimulator
• § 868.2875 — Differential pressure transducer
• § 868.2885 — Gas flow transducer
• § 868.2900 — Gas pressure transducer
• § 868.5090 — Emergency airway needle
• § 868.5095 — Retrograde intubation device
• § 868.5100 — Nasopharyngeal airway
• § 868.5105 — External negative pressure airway aid
• § 868.5110 — Oropharyngeal airway
• § 868.5115 — Device to relieve acute upper airway obstruction
• § 868.5120 — Anesthesia conduction catheter
• § 868.5130 — Anesthesia conduction filter
• § 868.5140 — Anesthesia conduction kit
• § 868.5150 — Anesthesia conduction needle
• § 868.5160 — Gas machine for anesthesia or analgesia
• § 868.5165 — Nitric oxide administration apparatus
• § 868.5170 — Laryngotracheal topical anesthesia applicator
• § 868.5180 — Rocking bed
• § 868.5220 — Blow bottle
• § 868.5240 — Anesthesia breathing circuit
• § 868.5250 — Breathing circuit circulator
• § 868.5260 — Breathing circuit bacterial filter
• § 868.5270 — Breathing system heater
• § 868.5273 — Positive airway pressure delivery system
• § 868.5280 — Breathing tube support
• § 868.5300 — Carbon dioxide absorbent
• § 868.5310 — Carbon dioxide absorber
• § 868.5320 — Reservoir bag
• § 868.5330 — Breathing gas mixer
• § 868.5340 — Nasal oxygen cannula
• § 868.5350 — Nasal oxygen catheter
• § 868.5365 — Posture chair for cardiac or pulmonary treatment
• § 868.5375 — Heat and moisture condenser (artificial nose)
• § 868.5400 — Electroanesthesia apparatus
• § 868.5420 — Ether hook
• § 868.5430 — Gas-scavenging apparatus
• § 868.5440 — Portable oxygen generator
• § 868.5450 — Respiratory gas humidifier
• § 868.5454 — High flow humidified oxygen delivery device
• § 868.5460 — Therapeutic humidifier for home use
• § 868.5470 — Hyperbaric chamber
• § 868.5480 — Isocapnic ventilation device
• § 868.5530 — Flexible laryngoscope
• § 868.5540 — Rigid laryngoscope
• § 868.5550 — Anesthetic gas mask
• § 868.5560 — Gas mask head strap
• § 868.5570 — Nonrebreathing mask
• § 868.5580 — Oxygen mask
• § 868.5590 — Scavenging mask
• § 868.5600 — Venturi mask
• § 868.5620 — Breathing mouthpiece
• § 868.5630 — Nebulizer
• § 868.5640 — Medicinal nonventilatory nebulizer (atomizer)
• § 868.5650 — Esophageal obturator
• § 868.5655 — Portable liquid oxygen unit
• § 868.5665 — Powered percussor
• § 868.5675 — Rebreathing device
• § 868.5690 — Incentive spirometer
• § 868.5700 — Nonpowered oxygen tent
• § 868.5710 — Electrically powered oxygen tent
• § 868.5720 — Bronchial tube
• § 868.5730 — Tracheal tube
• § 868.5740 — Tracheal/bronchial differential ventilation tube
• § 868.5750 — Inflatable tracheal tube cuff
• § 868.5760 — Cuff spreader
• § 868.5770 — Tracheal tube fixation device
• § 868.5780 — Tube introduction forceps
• § 868.5790 — Tracheal tube stylet
• § 868.5795 — Tracheal tube cleaning brush
• § 868.5800 — Tracheostomy tube and tube cuff
• § 868.5810 — Airway connector
• § 868.5820 — Dental protector
• § 868.5830 — Autotransfusion apparatus
• § 868.5860 — Pressure tubing and accessories
• § 868.5870 — Nonrebreathing valve
• § 868.5880 — Anesthetic vaporizer
• § 868.5895 — Continuous ventilator
• § 868.5905 — Noncontinuous ventilator (IPPB)
• § 868.5915 — Manual emergency ventilator
• § 868.5925 — Powered emergency ventilator
• § 868.5935 — External negative pressure ventilator
• § 868.5955 — Intermittent mandatory ventilation attachment
• § 868.5965 — Positive end expiratory pressure breathing attachment
• § 868.5975 — Ventilator tubing
• § 868.5995 — Tee drain (water trap)
• § 868.6100 — Anesthetic cabinet, table, or tray
• § 868.6175 — Cardiopulmonary emergency cart
• § 868.6225 — Nose clip
• § 868.6250 — Portable air compressor
• § 868.6400 — Calibration gas
• § 868.6700 — Anesthesia stool
• § 868.6810 — Tracheobronchial suction catheter
• § 868.6820 — Patient position support
• § 868.6885 — Medical gas yoke assembly

PART 870

• § 870.1 — Scope
• § 870.3 — Effective dates of requirement for premarket approval
• § 870.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 870.1025 — Arrhythmia detector and alarm (including ST-segment measurement and alarm)
• § 870.1100 — Blood pressure alarm
• § 870.1110 — Blood pressure computer
• § 870.1120 — Blood pressure cuff
• § 870.1130 — Noninvasive blood pressure measurement system
• § 870.1140 — Venous blood pressure manometer
• § 870.1200 — Diagnostic intravascular catheter
• § 870.1210 — Continuous flush catheter
• § 870.1220 — Electrode recording catheter or electrode recording probe
• § 870.1230 — Fiberoptic oximeter catheter
• § 870.1240 — Flow-directed catheter
• § 870.1250 — Percutaneous catheter
• § 870.1251 — Temporary catheter for embolic protection during transcatheter intracardiac procedures
• § 870.1252 — Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access
• § 870.1255 — Balloon aortic valvuloplasty catheter
• § 870.1270 — Intracavitary phonocatheter system
• § 870.1280 — Steerable catheter
• § 870.1290 — Steerable catheter control system
• § 870.1300 — Catheter cannula
• § 870.1310 — Vessel dilator for percutaneous catheterization
• § 870.1330 — Catheter guide wire
• § 870.1340 — Catheter introducer
• § 870.1342 — Reverse central venous recanalization system
• § 870.1345 — Intravascular bleed monitor
• § 870.1350 — Catheter balloon repair kit
• § 870.1360 — Trace microsphere
• § 870.1370 — Catheter tip occluder
• § 870.1380 — Catheter stylet
• § 870.1390 — Trocar
• § 870.1405 — Interventional cardiovascular implant simulation software device
• § 870.1415 — Coronary vascular physiologic simulation software device
• § 870.1420 — Coronary artery disease risk indicator using acoustic heart signals
• § 870.1425 — Programmable diagnostic computer
• § 870.1435 — Single-function, preprogrammed diagnostic computer
• § 870.1450 — Densitometer
• § 870.1650 — Angiographic injector and syringe
• § 870.1660 — Indicator injector
• § 870.1670 — Syringe actuator for an injector
• § 870.1750 — External programmable pacemaker pulse generator
• § 870.1800 — Withdrawal-infusion pump
• § 870.1875 — Stethoscope
• § 870.1915 — Thermodilution probe
• § 870.2050 — Biopotential amplifier and signal conditioner
• § 870.2060 — Transducer signal amplifier and conditioner
• § 870.2100 — Cardiovascular blood flowmeter
• § 870.2120 — Extravascular blood flow probe
• § 870.2200 — Adjunctive cardiovascular status indicator
• § 870.2210 — Adjunctive predictive cardiovascular indicator
• § 870.2220 — Adjunctive hemodynamic indicator with decision point
• § 870.2300 — Cardiac monitor (including cardiotachometer and rate alarm)
• § 870.2310 — Apex cardiograph (vibrocardiograph)
• § 870.2320 — Ballistocardiograph
• § 870.2330 — Echocardiograph
• § 870.2340 — Electrocardiograph
• § 870.2345 — Electrocardiograph software for over-the-counter use
• § 870.2350 — Electrocardiograph lead switching adaptor
• § 870.2360 — Electrocardiograph electrode
• § 870.2370 — Electrocardiograph surface electrode tester
• § 870.2390 — Phonocardiograph
• § 870.2400 — Vectorcardiograph
• § 870.2450 — Medical cathode-ray tube display
• § 870.2600 — Signal isolation system
• § 870.2620 — Line isolation monitor
• § 870.2640 — Portable leakage current alarm
• § 870.2675 — Oscillometer
• § 870.2700 — Oximeter
• § 870.2710 — Ear oximeter
• § 870.2750 — Impedance phlebograph
• § 870.2770 — Impedance plethysmograph
• § 870.2780 — Hydraulic, pneumatic, or photoelectric plethysmographs
• § 870.2785 — Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate
• § 870.2786 — Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate
• § 870.2790 — Photoplethysmograph analysis software for over-the-counter use
• § 870.2800 — Medical magnetic tape recorder
• § 870.2810 — Paper chart recorder
• § 870.2840 — Apex cardiographic transducer
• § 870.2850 — Extravascular blood pressure transducer
• § 870.2855 — Implantable Intra-aneurysm Pressure Measurement System
• § 870.2860 — Heart sound transducer
• § 870.2870 — Catheter tip pressure transducer
• § 870.2880 — Ultrasonic transducer
• § 870.2890 — Vessel occlusion transducer
• § 870.2900 — Patient transducer and electrode cable (including connector)
• § 870.2910 — Radiofrequency physiological signal transmitter and receiver
• § 870.2920 — Telephone electrocardiograph transmitter and receiver
• § 870.3250 — Vascular clip
• § 870.3260 — Vena cava clip
• § 870.3300 — Vascular embolization device
• § 870.3375 — Cardiovascular intravascular filter
• § 870.3450 — Vascular graft prosthesis
• § 870.3460 — Endovascular Suturing System
• § 870.3470 — Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene
• § 870.3535 — Intra-aortic balloon and control system
• § 870.3545 — Ventricular bypass (assist) device
• § 870.3600 — External pacemaker pulse generator
• § 870.3605 — Pacing system analyzer
• § 870.3610 — Implantable pacemaker pulse generator
• § 870.3620 — Pacemaker lead adaptor
• § 870.3630 — Pacemaker generator function analyzer
• § 870.3640 — Indirect pacemaker generator function analyzer
• § 870.3650 — Pacemaker polymeric mesh bag
• § 870.3670 — Pacemaker charger
• § 870.3680 — Cardiovascular permanent or temporary pacemaker electrode
• § 870.3690 — Pacemaker test magnet
• § 870.3700 — Pacemaker programmers
• § 870.3710 — Pacemaker repair or replacement material
• § 870.3720 — Pacemaker electrode function tester
• § 870.3730 — Pacemaker service tools
• § 870.3800 — Annuloplasty ring
• § 870.3850 — Carotid sinus nerve stimulator
• § 870.3925 — Replacement heart valve
• § 870.3935 — Prosthetic heart valve holder
• § 870.3945 — Prosthetic heart valve sizer
• § 870.4075 — Endomyocardial biopsy device
• § 870.4100 — Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure
• § 870.4150 — Extracorporeal system for carbon dioxide removal
• § 870.4200 — Cardiopulmonary bypass accessory equipment
• § 870.4205 — Cardiopulmonary bypass bubble detector
• § 870.4210 — Cardiopulmonary bypass vascular catheter, cannula, or tubing
• § 870.4220 — Cardiopulmonary bypass heart-lung machine console
• § 870.4230 — Cardiopulmonary bypass defoamer
• § 870.4240 — Cardiopulmonary bypass heat exchanger
• § 870.4250 — Cardiopulmonary bypass temperature controller
• § 870.4260 — Cardiopulmonary bypass arterial line blood filter
• § 870.4270 — Cardiopulmonary bypass cardiotomy suction line blood filter
• § 870.4280 — Cardiopulmonary prebypass filter
• § 870.4290 — Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting
• § 870.4300 — Cardiopulmonary bypass gas control unit
• § 870.4310 — Cardiopulmonary bypass coronary pressure gauge
• § 870.4320 — Cardiopulmonary bypass pulsatile flow generator
• § 870.4330 — Cardiopulmonary bypass on-line blood gas monitor
• § 870.4340 — Cardiopulmonary bypass level sensing monitor and/or control
• § 870.4350 — Cardiopulmonary bypass oxygenator
• § 870.4360 — Nonroller-type blood pump
• § 870.4370 — Roller-type cardiopulmonary bypass blood pump
• § 870.4380 — Cardiopulmonary bypass pump speed control
• § 870.4390 — Cardiopulmonary bypass pump tubing
• § 870.4400 — Cardiopulmonary bypass blood reservoir
• § 870.4410 — Cardiopulmonary bypass in-line blood gas sensor
• § 870.4420 — Cardiopulmonary bypass cardiotomy return sucker
• § 870.4430 — Cardiopulmonary bypass intracardiac suction control
• § 870.4450 — Vascular clamp
• § 870.4475 — Surgical vessel dilator
• § 870.4500 — Cardiovascular surgical instruments
• § 870.4510 — Apical closure device
• § 870.4875 — Intraluminal artery stripper
• § 870.4885 — External vein stripper
• § 870.5050 — Patient care suction apparatus
• § 870.5100 — Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
• § 870.5125 — Laser-powered inferior vena cava filter retrieval catheter
• § 870.5150 — Embolectomy catheter
• § 870.5175 — Septostomy catheter
• § 870.5200 — External cardiac compressor
• § 870.5210 — Cardiopulmonary resuscitation (CPR) aid
• § 870.5225 — External counter-pulsating device
• § 870.5300 — DC-defibrillator (including paddles)
• § 870.5310 — Automated external defibrillator system
• § 870.5325 — Defibrillator tester
• § 870.5550 — External transcutaneous cardiac pacemaker (noninvasive)
• § 870.5600 — Adjunctive open loop fluid therapy recommender
• § 870.5700 — Steerable cardiac ablation catheter remote control system
• § 870.5800 — Compressible limb sleeve
• § 870.5900 — Thermal regulating system
• § 870.5910 — Esophageal thermal regulation device
• § 870.5925 — Automatic rotating tourniquet

PART 872

• § 872.1 — Scope
• § 872.3 — Effective dates of requirement for premarket approval
• § 872.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 872.1500 — Gingival fluid measurer
• § 872.1720 — Pulp tester
• § 872.1730 — Electrode gel for pulp testers
• § 872.1740 — Caries detection device
• § 872.1745 — Laser fluorescence caries detection device
• § 872.1800 — Extraoral source x-ray system
• § 872.1810 — Intraoral source x-ray system
• § 872.1820 — Dental x-ray exposure alignment device
• § 872.1830 — Cephalometer
• § 872.1840 — Dental x-ray position indicating device
• § 872.1850 — Lead-lined position indicator
• § 872.1870 — Sulfide detection device
• § 872.1905 — Dental x-ray film holder
• § 872.2050 — Dental sonography device
• § 872.2060 — Jaw tracking device
• § 872.3060 — Noble metal alloy
• § 872.3070 — Dental amalgam, mercury, and amalgam alloy
• § 872.3080 — Mercury and alloy dispenser
• § 872.3100 — Dental amalgamator
• § 872.3110 — Dental amalgam capsule
• § 872.3130 — Preformed anchor
• § 872.3140 — Resin applicator
• § 872.3150 — Articulator
• § 872.3165 — Precision attachment
• § 872.3200 — Resin tooth bonding agent
• § 872.3220 — Facebow
• § 872.3240 — Dental bur
• § 872.3250 — Calcium hydroxide cavity liner
• § 872.3260 — Cavity varnish
• § 872.3275 — Dental cement
• § 872.3285 — Preformed clasp
• § 872.3300 — Hydrophilic resin coating for dentures
• § 872.3310 — Coating material for resin fillings
• § 872.3330 — Preformed crown
• § 872.3350 — Gold or stainless steel cusp
• § 872.3360 — Preformed cusp
• § 872.3400 — Karaya and sodium borate with or without acacia denture adhesive
• § 872.3410 — Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive
• § 872.3420 — Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive
• § 872.3450 — Ethylene oxide homopolymer and/or karaya denture adhesive
• § 872.3480 — Polyacrylamide polymer (modified cationic) denture adhesive
• § 872.3490 — Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive
• § 872.3500 — Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive
• § 872.3520 — OTC denture cleanser
• § 872.3530 — Mechanical denture cleaner
• § 872.3540 — OTC denture cushion or pad
• § 872.3560 — OTC denture reliner
• § 872.3570 — OTC denture repair kit
• § 872.3580 — Preformed gold denture tooth
• § 872.3590 — Preformed plastic denture tooth
• § 872.3600 — Partially fabricated denture kit
• § 872.3630 — Endosseous dental implant abutment
• § 872.3640 — Endosseous dental implant
• § 872.3645 — Subperiosteal implant material
• § 872.3660 — Impression material
• § 872.3661 — Optical Impression Systems for CAD/CAM
• § 872.3670 — Resin impression tray material
• § 872.3680 — Polytetrafluoroethylene (PTFE) vitreous carbon materials
• § 872.3690 — Tooth shade resin material
• § 872.3710 — Base metal alloy
• § 872.3730 — Pantograph
• § 872.3740 — Retentive and splinting pin
• § 872.3750 — Bracket adhesive resin and tooth conditioner
• § 872.3760 — Denture relining, repairing, or rebasing resin
• § 872.3765 — Pit and fissure sealant and conditioner
• § 872.3770 — Temporary crown and bridge resin
• § 872.3810 — Root canal post
• § 872.3820 — Root canal filling resin
• § 872.3830 — Endodontic paper point
• § 872.3840 — Endodontic silver point
• § 872.3850 — Gutta percha
• § 872.3890 — Endodontic stabilizing splint
• § 872.3900 — Posterior artificial tooth with a metal insert
• § 872.3910 — Backing and facing for an artificial tooth
• § 872.3920 — Porcelain tooth
• § 872.3930 — Bone grafting material
• § 872.3940 — Total temporomandibular joint prosthesis
• § 872.3950 — Glenoid fossa prosthesis
• § 872.3960 — Mandibular condyle prosthesis
• § 872.3970 — Interarticular disc prosthesis (interpositional implant)
• § 872.3980 — Endosseous dental implant accessories
• § 872.4120 — Bone cutting instrument and accessories
• § 872.4130 — Intraoral dental drill
• § 872.4200 — Dental handpiece and accessories
• § 872.4465 — Gas-powered jet injector
• § 872.4475 — Spring-powered jet injector
• § 872.4535 — Dental diamond instrument
• § 872.4565 — Dental hand instrument
• § 872.4600 — Intraoral ligature and wire lock
• § 872.4620 — Fiber optic dental light
• § 872.4630 — Dental operating light
• § 872.4730 — Dental injecting needle
• § 872.4760 — Bone plate
• § 872.4770 — Temporary mandibular condyle reconstruction plate
• § 872.4840 — Rotary scaler
• § 872.4850 — Ultrasonic scaler
• § 872.4880 — Intraosseous fixation screw or wire
• § 872.4920 — Dental electrosurgical unit and accessories
• § 872.5410 — Orthodontic appliance and accessories
• § 872.5470 — Orthodontic plastic bracket
• § 872.5500 — Extraoral orthodontic headgear
• § 872.5525 — Preformed tooth positioner
• § 872.5550 — Teething ring
• § 872.5560 — Electrical salivary stimulatory system
• § 872.5570 — Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea
• § 872.5571 — Auto titration device for oral appliances
• § 872.5575 — Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea
• § 872.5580 — Oral rinse to reduce the adhesion of dental plaque
• § 872.6010 — Abrasive device and accessories
• § 872.6030 — Oral cavity abrasive polishing agent
• § 872.6050 — Saliva absorber
• § 872.6070 — Ultraviolet activator for polymerization
• § 872.6080 — Airbrush
• § 872.6100 — Anesthetic warmer
• § 872.6140 — Articulation paper
• § 872.6200 — Base plate shellac
• § 872.6250 — Dental chair and accessories
• § 872.6290 — Prophylaxis cup
• § 872.6300 — Rubber dam and accessories
• § 872.6350 — Ultraviolet detector
• § 872.6390 — Dental floss
• § 872.6475 — Heat source for bleaching teeth
• § 872.6510 — Oral irrigation unit
• § 872.6570 — Impression tube
• § 872.6640 — Dental operative unit and accessories
• § 872.6650 — Massaging pick or tip for oral hygiene
• § 872.6660 — Porcelain powder for clinical use
• § 872.6670 — Silicate protector
• § 872.6710 — Boiling water sterilizer
• § 872.6730 — Endodontic dry heat sterilizer
• § 872.6770 — Cartridge syringe
• § 872.6855 — Manual toothbrush
• § 872.6865 — Powered toothbrush
• § 872.6866 — Radiofrequency toothbrush
• § 872.6870 — Disposable fluoride tray
• § 872.6880 — Preformed impression tray
• § 872.6890 — Intraoral dental wax

PART 874

• § 874.1 — Scope
• § 874.3 — Effective dates of requirement for premarket approval
• § 874.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 874.1050 — Audiometer
• § 874.1060 — Acoustic chamber for audiometric testing
• § 874.1070 — Short increment sensitivity index (SISI) adapter
• § 874.1080 — Audiometer calibration set
• § 874.1090 — Auditory impedance tester
• § 874.1100 — Earphone cushion for audiometric testing
• § 874.1120 — Electronic noise generator for audiometric testing
• § 874.1325 — Electroglottograph
• § 874.1500 — Gustometer
• § 874.1600 — Olfactory test device
• § 874.1800 — Air or water caloric stimulator
• § 874.1820 — Surgical nerve stimulator/locator
• § 874.1925 — Toynbee diagnostic tube
• § 874.3300 — Air-conduction hearing aid
• § 874.3302 — Bone-conduction hearing aid
• § 874.3305 — Wireless air-conduction hearing aid
• § 874.3310 — Hearing aid calibrator and analysis system
• § 874.3315 — Tympanic membrane contact hearing aid
• § 874.3320 — Group hearing aid or group auditory trainer
• § 874.3325 — Self-fitting air-conduction hearing aid
• § 874.3330 — Master hearing aid
• § 874.3340 — Active implantable bone conduction hearing system
• § 874.3375 — Battery-powered artificial larynx
• § 874.3400 — Tinnitus masker
• § 874.3430 — Middle ear mold
• § 874.3450 — Partial ossicular replacement prosthesis
• § 874.3495 — Total ossicular replacement prosthesis
• § 874.3540 — Prosthesis modification instrument for ossicular replacement surgery
• § 874.3620 — Ear, nose, and throat synthetic polymer material
• § 874.3695 — Mandibular implant facial prosthesis
• § 874.3730 — Laryngeal prosthesis (Taub design)
• § 874.3760 — Sacculotomy tack (Cody tack)
• § 874.3820 — Endolymphatic shunt
• § 874.3850 — Endolymphatic shunt tube with valve
• § 874.3880 — Tympanostomy tube
• § 874.3900 — Nasal dilator
• § 874.3930 — Tympanostomy tube with semipermeable membrane
• § 874.3950 — Transcutaneous air conduction hearing aid system
• § 874.4100 — Epistaxis balloon
• § 874.4140 — Ear, nose, and throat bur
• § 874.4175 — Nasopharyngeal catheter
• § 874.4180 — Eustachian tube balloon dilation system
• § 874.4250 — Ear, nose, and throat electric or pneumatic surgical drill
• § 874.4350 — Ear, nose, and throat fiberoptic light source and carrier
• § 874.4420 — Ear, nose, and throat manual surgical instrument
• § 874.4450 — Powered insertion system for a cochlear implant electrode array
• § 874.4490 — Argon laser for otology, rhinology, and laryngology
• § 874.4500 — Ear, nose, and throat microsurgical carbon dioxide laser
• § 874.4680 — Bronchoscope (flexible or rigid) and accessories
• § 874.4710 — Esophagoscope (flexible or rigid) and accessories
• § 874.4720 — Mediastinoscope and accessories
• § 874.4750 — Laryngostroboscope
• § 874.4760 — Nasopharyngoscope (flexible or rigid) and accessories
• § 874.4770 — Otoscope
• § 874.4780 — Intranasal splint
• § 874.4800 — Bone particle collector
• § 874.5220 — Ear, nose, and throat drug administration device
• § 874.5300 — Ear, nose, and throat examination and treatment unit
• § 874.5350 — Suction antichoke device
• § 874.5370 — Tongs antichoke device
• § 874.5550 — Powered nasal irrigator
• § 874.5800 — External nasal splint
• § 874.5840 — Antistammering device
• § 874.5900 — External upper esophageal sphincter compression device
• § 874.6000 — Transcutaneous electrical nerve stimulator for the relief of congestion

PART 876

• § 876.1 — Scope
• § 876.3 — Effective dates of requirement for premarket approval
• § 876.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 876.1050 — Endoscopic transhepatic venous access needle
• § 876.1075 — Gastroenterology-urology biopsy instrument
• § 876.1080 — Gastroenterology-urology accessories to a biopsy instrument
• § 876.1300 — Ingestible telemetric gastrointestinal capsule imaging system
• § 876.1310 — Magnetically maneuvered capsule endoscopy system
• § 876.1330 — Colon capsule endoscopy system
• § 876.1400 — Stomach pH electrode
• § 876.1450 — Esophageal tissue characterization system
• § 876.1500 — Endoscope and accessories
• § 876.1510 — Anchored esophageal sheath
• § 876.1520 — Gastrointestinal lesion software detection system
• § 876.1620 — Urodynamics measurement system
• § 876.1725 — Gastrointestinal motility monitoring system
• § 876.1735 — Electrogastrography system
• § 876.1800 — Urine flow or volume measuring system
• § 876.2040 — Enuresis alarm
• § 876.2050 — Prostate lesion documentation system
• § 876.2100 — Pressure ulcer management tool
• § 876.3350 — Penile inflatable implant
• § 876.3500 — Penile implant surgical accessories
• § 876.3630 — Penile rigidity implant
• § 876.3750 — Testicular prosthesis
• § 876.4020 — Fiberoptic light ureteral catheter
• § 876.4270 — Colostomy rod
• § 876.4300 — Endoscopic electrosurgical unit and accessories
• § 876.4310 — Endoscopic electrosurgical clip cutting system
• § 876.4330 — Endoscopic pancreatic debridement device
• § 876.4340 — High intensity ultrasound system for prostate tissue ablation
• § 876.4350 — Fluid jet system for prostate tissue removal
• § 876.4370 — Gastroenterology-urology evacuator
• § 876.4400 — Hemorrhoidal ligator
• § 876.4480 — Electrohydraulic lithotriptor
• § 876.4500 — Mechanical lithotriptor
• § 876.4530 — Gastroenterology-urology fiberoptic retractor
• § 876.4560 — Ribdam
• § 876.4590 — Interlocking urethral sound
• § 876.4620 — Ureteral stent
• § 876.4630 — Ureteral stent accessories
• § 876.4650 — Water jet renal stone dislodger system
• § 876.4680 — Ureteral stone dislodger
• § 876.4730 — Manual gastroenterology-urology surgical instrument and accessories
• § 876.4770 — Urethrotome
• § 876.4890 — Urological table and accessories
• § 876.5010 — Biliary catheter and accessories
• § 876.5011 — Metallic biliary stent system for benign strictures
• § 876.5012 — Biliary stent, drain, and dilator accessories
• § 876.5015 — Pancreatic drainage stent and delivery system
• § 876.5020 — External penile rigidity devices
• § 876.5025 — Vibrator for climax control of premature ejaculation
• § 876.5026 — Non-implanted electrical stimulation device for management of premature ejaculation
• § 876.5030 — Continent ileostomy catheter
• § 876.5090 — Suprapubic urological catheter and accessories
• § 876.5100 — Suprapubic catheter accessories
• § 876.5130 — Urological catheter and accessories
• § 876.5140 — Urethral insert with pump for bladder drainage
• § 876.5160 — Urological clamp
• § 876.5210 — Enema kit
• § 876.5220 — Colonic irrigation system
• § 876.5250 — Urine collector and accessories
• § 876.5270 — Implanted electrical urinary continence device
• § 876.5280 — Implanted mechanical/hydraulic urinary continence device
• § 876.5290 — Implanted mechanical/hydraulic urinary continence device surgical accessories
• § 876.5310 — Nonimplanted, peripheral electrical continence device
• § 876.5320 — Nonimplanted electrical continence device
• § 876.5330 — Transcutaneous electrical continence device
• § 876.5340 — Nonimplanted nerve stimulator for functional abdominal pain relief
• § 876.5360 — Laparoscopic gastrointestinal sizing tool
• § 876.5365 — Esophageal dilator
• § 876.5450 — Rectal dilator
• § 876.5470 — Ureteral dilator
• § 876.5510 — Temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia
• § 876.5520 — Urethral dilator
• § 876.5530 — Implantable transprostatic tissue retractor system
• § 876.5540 — Blood access device and accessories
• § 876.5550 — Prostatic artery embolization device
• § 876.5600 — Sorbent regenerated dialysate delivery system for hemodialysis
• § 876.5630 — Peritoneal dialysis system and accessories
• § 876.5665 — Water purification system for hemodialysis
• § 876.5820 — Hemodialysis system and accessories
• § 876.5830 — Hemodialyzer with disposable insert (Kiil type)
• § 876.5860 — High permeability hemodialysis system
• § 876.5861 — Pediatric continuous renal replacement therapy system
• § 876.5862 — Hemodialyzer with expanded solute removal profile
• § 876.5870 — Sorbent hemoperfusion system
• § 876.5880 — Isolated kidney perfusion and transport system and accessories
• § 876.5885 — Tissue culture media for human ex vivo tissue and cell culture processing applications
• § 876.5895 — Ostomy irrigator
• § 876.5900 — Ostomy pouch and accessories
• § 876.5920 — Protective garment for incontinence
• § 876.5930 — Rectal control system
• § 876.5955 — Peritoneo-venous shunt
• § 876.5960 — Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions
• § 876.5970 — Hernia support
• § 876.5980 — Gastrointestinal tube and accessories
• § 876.5981 — Oral removable palatal space occupying device for weight management and/or weight loss
• § 876.5982 — Ingested, transient, space occupying device for weight management and/or weight loss
• § 876.5985 — Enzyme packed cartridge
• § 876.5990 — Extracorporeal shock wave lithotripter

PART 878

• § 878.1 — Scope
• § 878.3 — Effective dates of requirement for premarket approval
• § 878.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 878.1800 — Speculum and accessories
• § 878.1820 — Software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer
• § 878.3250 — External facial fracture fixation appliance
• § 878.3300 — Surgical mesh
• § 878.3500 — Polytetrafluoroethylene with carbon fibers composite implant material
• § 878.3510 — Carbon dioxide gas controlled tissue expander
• § 878.3530 — Silicone inflatable breast prosthesis
• § 878.3540 — Silicone gel-filled breast prosthesis
• § 878.3550 — Chin prosthesis
• § 878.3590 — Ear prosthesis
• § 878.3610 — Esophageal prosthesis
• § 878.3680 — Nose prosthesis
• § 878.3720 — Tracheal prosthesis
• § 878.3750 — External prosthesis adhesive
• § 878.3800 — External aesthetic restoration prosthesis
• § 878.3900 — Inflatable extremity splint
• § 878.3910 — Noninflatable extremity splint
• § 878.3925 — Plastic surgery kit and accessories
• § 878.4010 — Tissue adhesive
• § 878.4011 — Tissue adhesive with adjunct wound closure device for topical approximation of skin
• § 878.4014 — Nonresorbable gauze/sponge for external use
• § 878.4015 — Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive
• § 878.4018 — Hydrophilic wound dressing
• § 878.4020 — Occlusive wound dressing
• § 878.4022 — Hydrogel wound dressing and burn dressing
• § 878.4025 — Silicone sheeting
• § 878.4040 — Surgical apparel
• § 878.4100 — Organ bag
• § 878.4160 — Surgical camera and accessories
• § 878.4165 — Wound autofluorescence imaging device
• § 878.4200 — Introduction/drainage catheter and accessories
• § 878.4300 — Implantable clip
• § 878.4320 — Removable skin clip
• § 878.4340 — Contact cooling system for aesthetic use
• § 878.4350 — Cryosurgical unit and accessories
• § 878.4360 — Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia
• § 878.4370 — Surgical drape and drape accessories
• § 878.4371 — Irrigating wound retractor device
• § 878.4380 — Drape adhesive
• § 878.4400 — Electrosurgical cutting and coagulation device and accessories
• § 878.4410 — Low energy ultrasound wound cleaner
• § 878.4420 — Electrosurgical device for over-the-counter aesthetic use
• § 878.4430 — Microneedling device for aesthetic use
• § 878.4440 — Eye pad
• § 878.4450 — Nonabsorbable gauze for internal use
• § 878.4452 — Nonabsorbable expandable hemostatic sponge for temporary internal use
• § 878.4454 — Non-absorbable, hemostatic gauze for temporary internal use
• § 878.4456 — Hemostatic device for intraluminal gastrointestinal use
• § 878.4460 — Non-powdered surgeon's glove
• § 878.4470 — Surgeon's gloving cream
• § 878.4490 — Absorbable hemostatic agent and dressing
• § 878.4493 — Absorbable poly(glycolide/l-lactide) surgical suture
• § 878.4494 — Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology
• § 878.4495 — Stainless steel suture
• § 878.4520 — Polytetrafluoroethylene injectable
• § 878.4550 — Autofluorescence detection device for general surgery and dermatological use
• § 878.4580 — Surgical lamp
• § 878.4590 — Focused ultrasound stimulator system for aesthetic use
• § 878.4630 — Ultraviolet lamp for dermatologic disorders
• § 878.4635 — Sunlamp products and ultraviolet lamps intended for use in sunlamp products
• § 878.4660 — Skin marker
• § 878.4670 — Internal tissue marker
• § 878.4680 — Nonpowered, single patient, portable suction apparatus
• § 878.4683 — Non-Powered suction apparatus device intended for negative pressure wound therapy
• § 878.4685 — Extracorporeal shock wave device for treatment of chronic wounds
• § 878.4700 — Surgical microscope and accessories
• § 878.4730 — Surgical skin degreaser or adhesive tape solvent
• § 878.4740 — Surgical stapler
• § 878.4750 — Implantable staple
• § 878.4755 — Absorbable lung biopsy plug
• § 878.4760 — Removable skin staple
• § 878.4780 — Powered suction pump
• § 878.4783 — Negative pressure wound therapy device for reduction of wound complications
• § 878.4790 — Powered surgical instrument for improvement in the appearance of cellulite
• § 878.4800 — Manual surgical instrument for general use
• § 878.4805 — Manual percutaneous surgical set assembled in the abdomen
• § 878.4810 — Laser surgical instrument for use in general and plastic surgery and in dermatology
• § 878.4815 — Magnetic surgical instrument system
• § 878.4820 — Surgical instrument motors and accessories/attachments
• § 878.4825 — General laparoscopic power morcellation containment system
• § 878.4830 — Absorbable surgical gut suture
• § 878.4840 — Absorbable polydioxanone surgical suture
• § 878.4850 — Blood lancets
• § 878.4860 — Light based energy source device for topical application
• § 878.4880 — Phototherapy device for reducing the appearance of acute post-surgical incisions
• § 878.4930 — Suture retention device
• § 878.4950 — Manual operating table and accessories and manual operating chair and accessories
• § 878.4960 — Operating tables and accessories and operating chairs and accessories
• § 878.4961 — Mountable electromechanical surgical system for transluminal approaches
• § 878.5000 — Nonabsorbable poly(ethylene terephthalate) surgical suture
• § 878.5010 — Nonabsorbable polypropylene surgical suture
• § 878.5020 — Nonabsorbable polyamide surgical suture
• § 878.5030 — Natural nonabsorbable silk surgical suture
• § 878.5035 — Nonabsorbable expanded polytetrafluoroethylene surgical suture
• § 878.5040 — Suction lipoplasty system
• § 878.5050 — Surgical smoke precipitator
• § 878.5070 — Air-handling apparatus for a surgical operating room
• § 878.5080 — Air-handling apparatus accessory
• § 878.5350 — Needle-type epilator
• § 878.5360 — Tweezer-type epilator
• § 878.5400 — Low level laser system for aesthetic use
• § 878.5650 — Topical oxygen chamber for extremities
• § 878.5900 — Nonpneumatic tourniquet
• § 878.5910 — Pneumatic tourniquet

PART 880

• § 880.1 — Scope
• § 880.3 — Effective dates of requirement for premarket approval
• § 880.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 880.2200 — Liquid crystal forehead temperature strip
• § 880.2400 — Bed-patient monitor
• § 880.2420 — Electronic monitor for gravity flow infusion systems
• § 880.2460 — Electrically powered spinal fluid pressure monitor
• § 880.2500 — Spinal fluid manometer
• § 880.2700 — Stand-on patient scale
• § 880.2720 — Patient scale
• § 880.2740 — Surgical sponge scale
• § 880.2750 — Image processing device for estimation of external blood loss
• § 880.2800 — Sterilization process indicator
• § 880.2900 — Clinical color change thermometer
• § 880.2910 — Clinical electronic thermometer
• § 880.2920 — Clinical mercury thermometer
• § 880.2930 — Apgar timer
• § 880.5025 — I.V. container
• § 880.5045 — Medical recirculating air cleaner
• § 880.5075 — Elastic bandage
• § 880.5090 — Liquid bandage
• § 880.5100 — AC-powered adjustable hospital bed
• § 880.5110 — Hydraulic adjustable hospital bed
• § 880.5120 — Manual adjustable hospital bed
• § 880.5130 — Infant radiant warmer
• § 880.5140 — Pediatric medical crib
• § 880.5145 — Medical bassinet
• § 880.5150 — Nonpowered flotation therapy mattress
• § 880.5160 — Therapeutic medical binder
• § 880.5180 — Burn sheet
• § 880.5200 — Intravascular catheter
• § 880.5210 — Intravascular catheter securement device
• § 880.5220 — Intravenous catheter force-activated separation device
• § 880.5240 — Medical adhesive tape and adhesive bandage
• § 880.5270 — Neonatal eye pad
• § 880.5300 — Medical absorbent fiber
• § 880.5400 — Neonatal incubator
• § 880.5410 — Neonatal transport incubator
• § 880.5420 — Pressure infusor for an I.V. bag
• § 880.5430 — Nonelectrically powered fluid injector
• § 880.5440 — Intravascular administration set
• § 880.5445 — Intravascular administration set, automated air removal system
• § 880.5450 — Patient care reverse isolation chamber
• § 880.5475 — Jet lavage
• § 880.5500 — AC-powered patient lift
• § 880.5510 — Non-AC-powered patient lift
• § 880.5550 — Alternating pressure air flotation mattress
• § 880.5560 — Temperature regulated water mattress
• § 880.5570 — Hypodermic single lumen needle
• § 880.5580 — Acupuncture needle
• § 880.5630 — Nipple shield
• § 880.5640 — Lamb feeding nipple
• § 880.5680 — Pediatric position holder
• § 880.5700 — Neonatal phototherapy unit
• § 880.5725 — Infusion pump
• § 880.5730 — Alternate controller enabled infusion pump
• § 880.5740 — Suction snakebite kit
• § 880.5760 — Chemical cold pack snakebite kit
• § 880.5780 — Medical support stocking
• § 880.5820 — Therapeutic scrotal support
• § 880.5860 — Piston syringe
• § 880.5950 — Umbilical occlusion device
• § 880.5960 — Lice removal kit
• § 880.5965 — Subcutaneous, implanted, intravascular infusion port and catheter
• § 880.5970 — Percutaneous, implanted, long-term intravascular catheter
• § 880.6025 — Absorbent tipped applicator
• § 880.6050 — Ice bag
• § 880.6060 — Medical disposable bedding
• § 880.6070 — Bed board
• § 880.6080 — Cardiopulmonary resuscitation board
• § 880.6085 — Hot/cold water bottle
• § 880.6100 — Ethylene oxide gas aerator cabinet
• § 880.6140 — Medical chair and table
• § 880.6150 — Ultrasonic cleaner for medical instruments
• § 880.6175 — [Reserved]
• § 880.6185 — Cast cover
• § 880.6190 — Mattress cover for medical purposes
• § 880.6200 — Ring cutter
• § 880.6210 — Sharps needle destruction device
• § 880.6230 — Tongue depressor
• § 880.6250 — Non-powdered patient examination glove
• § 880.6260 — Filtering facepiece respirator for use by the general public in public health medical emergencies
• § 880.6265 — Examination gown
• § 880.6280 — Medical insole
• § 880.6300 — Implantable radiofrequency transponder system for patient identification and health information
• § 880.6305 — Ingestible event marker
• § 880.6310 — Medical device data system
• § 880.6315 — Remote Medication Management System
• § 880.6320 — AC-powered medical examination light
• § 880.6350 — Battery-powered medical examination light
• § 880.6375 — Patient lubricant
• § 880.6430 — Liquid medication dispenser
• § 880.6450 — Skin pressure protectors
• § 880.6500 — Medical ultraviolet air purifier
• § 880.6600 — Ultraviolet (UV) radiation chamber disinfection device
• § 880.6710 — Medical ultraviolet water purifier
• § 880.6730 — Body waste receptacle
• § 880.6740 — Vacuum-powered body fluid suction apparatus
• § 880.6760 — Protective restraint
• § 880.6775 — Powered patient transfer device
• § 880.6785 — Manual patient transfer device
• § 880.6800 — Washers for body waste receptacles
• § 880.6820 — Medical disposable scissors
• § 880.6850 — Sterilization wrap
• § 880.6860 — Ethylene oxide gas sterilizer
• § 880.6870 — Dry-heat sterilizer
• § 880.6880 — Steam sterilizer
• § 880.6885 — Liquid chemical sterilants/high level disinfectants
• § 880.6887 — Spore test strip
• § 880.6890 — General purpose disinfectants
• § 880.6900 — Hand-carried stretcher
• § 880.6910 — Wheeled stretcher
• § 880.6920 — Syringe needle introducer
• § 880.6960 — Irrigating syringe
• § 880.6970 — Liquid crystal vein locator
• § 880.6980 — Vein stabilizer
• § 880.6990 — Infusion stand
• § 880.6991 — Medical washer
• § 880.6992 — Medical washer-disinfector

PART 882

• § 882.1 — Scope
• § 882.3 — Effective dates of requirement for premarket approval
• § 882.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 882.1020 — Rigidity analyzer
• § 882.1030 — Ataxiagraph
• § 882.1200 — Two-point discriminator
• § 882.1240 — Echoencephalograph
• § 882.1275 — Electroconductive media
• § 882.1310 — Cortical electrode
• § 882.1320 — Cutaneous electrode
• § 882.1330 — Depth electrode
• § 882.1340 — Nasopharyngeal electrode
• § 882.1350 — Needle electrode
• § 882.1400 — Electroencephalograph
• § 882.1410 — Electroencephalograph electrode/lead tester
• § 882.1420 — Electroencephalogram (EEG) signal spectrum analyzer
• § 882.1430 — Electroencephalograph test signal generator
• § 882.1440 — Neuropsychiatric interpretive electroencephalograph assessment aid
• § 882.1450 — Brain injury adjunctive interpretive electroencephalograph assessment aid
• § 882.1455 — Traumatic brain injury eye movement assessment aid
• § 882.1460 — Nystagmograph
• § 882.1470 — Computerized cognitive assessment aid
• § 882.1471 — Computerized cognitive assessment aid for concussion
• § 882.1480 — Neurological endoscope
• § 882.1491 — Pediatric Autism Spectrum Disorder diagnosis aid
• § 882.1500 — Esthesiometer
• § 882.1525 — Tuning fork
• § 882.1540 — Galvanic skin response measurement device
• § 882.1550 — Nerve conduction velocity measurement device
• § 882.1560 — Skin potential measurement device
• § 882.1561 — Evoked photon image capture device
• § 882.1565 — Brain temperature measurement system
• § 882.1570 — Powered direct-contact temperature measurement device
• § 882.1580 — Non-electroencephalogram (EEG) physiological signal based seizure monitoring system
• § 882.1610 — Alpha monitor
• § 882.1620 — Intracranial pressure monitoring device
• § 882.1630 — Cranial motion measurement device
• § 882.1700 — Percussor
• § 882.1750 — Pinwheel
• § 882.1790 — Ocular plethysmograph
• § 882.1825 — Rheoencephalograph
• § 882.1835 — Physiological signal amplifier
• § 882.1845 — Physiological signal conditioner
• § 882.1855 — Electroencephalogram (EEG) telemetry system
• § 882.1870 — Evoked response electrical stimulator
• § 882.1880 — Evoked response mechanical stimulator
• § 882.1890 — Evoked response photic stimulator
• § 882.1900 — Evoked response auditory stimulator
• § 882.1925 — Ultrasonic scanner calibration test block
• § 882.1935 — Near Infrared (NIR) Brain Hematoma Detector
• § 882.1950 — Tremor transducer
• § 882.4030 — Skull plate anvil
• § 882.4060 — Ventricular cannula
• § 882.4100 — Ventricular catheter
• § 882.4125 — Neurosurgical chair
• § 882.4150 — Scalp clip
• § 882.4175 — Aneurysm clip applier
• § 882.4190 — Clip forming/cutting instrument
• § 882.4200 — Clip removal instrument
• § 882.4215 — Clip rack
• § 882.4250 — Cryogenic surgical device
• § 882.4275 — Dowel cutting instrument
• § 882.4300 — Manual cranial drills, burrs, trephines, and their accessories
• § 882.4305 — Powered compound cranial drills, burrs, trephines, and their accessories
• § 882.4310 — Powered simple cranial drills, burrs, trephines, and their accessories
• § 882.4325 — Cranial drill handpiece (brace)
• § 882.4360 — Electric cranial drill motor
• § 882.4370 — Pneumatic cranial drill motor
• § 882.4400 — Radiofrequency lesion generator
• § 882.4440 — Neurosurgical headrests
• § 882.4460 — Neurosurgical head holder (skull clamp)
• § 882.4500 — Cranioplasty material forming instrument
• § 882.4525 — Microsurgical instrument
• § 882.4535 — Nonpowered neurosurgical instrument
• § 882.4545 — Shunt system implantation instrument
• § 882.4560 — Stereotaxic instrument
• § 882.4565 — Field generator positioning device
• § 882.4600 — Leukotome
• § 882.4650 — Neurosurgical suture needle
• § 882.4700 — Neurosurgical paddie
• § 882.4725 — Radiofrequency lesion probe
• § 882.4750 — Skull punch
• § 882.4800 — Self-retaining retractor for neurosurgery
• § 882.4840 — Manual rongeur
• § 882.4845 — Powered rongeur
• § 882.4900 — Skullplate screwdriver
• § 882.4950 — Diagnostic neurosurgical microscope filter
• § 882.5030 — Methyl methacrylate for aneurysmorrhaphy
• § 882.5050 — Biofeedback device
• § 882.5060 — Conditioning tool for eating disorders
• § 882.5070 — Bite block
• § 882.5150 — Intravascular occluding catheter
• § 882.5175 — Carotid artery clamp
• § 882.5200 — Aneurysm clip
• § 882.5225 — Implanted malleable clip
• § 882.5235 — Aversive conditioning device
• § 882.5250 — Burr hole cover
• § 882.5275 — Nerve cuff
• § 882.5300 — Methyl methacrylate for cranioplasty
• § 882.5320 — Preformed alterable cranioplasty plate
• § 882.5330 — Preformed nonalterable cranioplasty plate
• § 882.5360 — Cranioplasty plate fastener
• § 882.5500 — Lesion temperature monitor
• § 882.5550 — Central nervous system fluid shunt and components
• § 882.5560 — Cerebrospinal fluid shunt system
• § 882.5600 — Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
• § 882.5700 — Thermal system for insomnia
• § 882.5705 — Digital therapy device to reduce sleep disturbance for psychiatric conditions
• § 882.5800 — Cranial electrotherapy stimulator
• § 882.5801 — Computerized behavioral therapy device for psychiatric disorders
• § 882.5802 — Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions
• § 882.5803 — Digital therapy device for Attention Deficit Hyperactivity Disorder
• § 882.5805 — Repetitive transcranial magnetic stimulation system
• § 882.5808 — Transcranial magnetic stimulator for headache
• § 882.5810 — External functional neuromuscular stimulator
• § 882.5820 — Implanted cerebellar stimulator
• § 882.5830 — Implanted diaphragmatic/phrenic nerve stimulator
• § 882.5840 — Implanted intracerebral/subcortical stimulator for pain relief
• § 882.5850 — Implanted spinal cord stimulator for bladder evacuation
• § 882.5855 — Brain stimulation programming planning software
• § 882.5860 — Implanted neuromuscular stimulator
• § 882.5870 — Implanted peripheral nerve stimulator for pain relief
• § 882.5880 — Implanted spinal cord stimulator for pain relief
• § 882.5889 — Electrical tongue nerve stimulator to treat motor deficits
• § 882.5890 — Transcutaneous electrical nerve stimulator for pain relief
• § 882.5891 — Transcutaneous electrical nerve stimulator to treat headache
• § 882.5892 — External vagal nerve stimulator for headache
• § 882.5893 — Thermal vestibular stimulator for headache
• § 882.5894 — Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites
• § 882.5895 — Vibratory counter-stimulation device
• § 882.5896 — Percutaneous nerve stimulator for substance use disorders
• § 882.5897 — External upper limb tremor stimulator
• § 882.5898 — Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder
• § 882.5899 — Trunk and limb electrical stimulator to treat headache
• § 882.5900 — Preformed craniosynostosis strip
• § 882.5910 — Dura substitute
• § 882.5940 — Electroconvulsive therapy device
• § 882.5950 — Neurovascular embolization device
• § 882.5955 — Temporary coil embolization assist device
• § 882.5960 — Skull tongs for traction
• § 882.5970 — Cranial orthosis

PART 884

• § 884.1 — Scope
• § 884.3 — Effective dates of requirement for premarket approval
• § 884.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 884.1040 — Viscometer for cervical mucus
• § 884.1050 — Endocervical aspirator
• § 884.1060 — Endometrial aspirator
• § 884.1100 — Endometrial brush
• § 884.1175 — Endometrial suction curette and accessories
• § 884.1185 — Endometrial washer
• § 884.1300 — Uterotubal carbon dioxide insufflator and accessories
• § 884.1425 — Perineometer
• § 884.1550 — Amniotic fluid sampler (amniocentesis tray)
• § 884.1560 — Fetal blood sampler
• § 884.1600 — Transabdominal amnioscope (fetoscope) and accessories
• § 884.1630 — Colposcope
• § 884.1640 — Culdoscope and accessories
• § 884.1660 — Transcervical endoscope (amnioscope) and accessories
• § 884.1690 — Hysteroscope and accessories
• § 884.1700 — Hysteroscopic insufflator
• § 884.1710 — Closed loop hysteroscopic insufflator with cutter-coagulator
• § 884.1720 — Gynecologic laparoscope and accessories
• § 884.1730 — Laparoscopic insufflator
• § 884.2050 — Obstetric data analyzer
• § 884.2225 — Obstetric-gynecologic ultrasonic imager
• § 884.2600 — Fetal cardiac monitor
• § 884.2620 — Fetal electroencephalographic monitor
• § 884.2640 — Fetal phonocardiographic monitor and accessories
• § 884.2660 — Fetal ultrasonic monitor and accessories
• § 884.2675 — Fetal scalp circular (spiral) electrode and applicator
• § 884.2685 — Fetal scalp clip electrode and applicator
• § 884.2700 — Intrauterine pressure monitor and accessories
• § 884.2720 — External uterine contraction monitor and accessories
• § 884.2730 — Home uterine activity monitor
• § 884.2740 — Perinatal monitoring system and accessories
• § 884.2800 — Computerized Labor Monitoring System
• § 884.2900 — Fetal stethoscope
• § 884.2960 — Obstetric ultrasonic transducer and accessories
• § 884.2980 — Telethermographic system
• § 884.2982 — Liquid crystal thermographic system
• § 884.2990 — Breast lesion documentation system
• § 884.3200 — Cervical drain
• § 884.3575 — Vaginal pessary
• § 884.3650 — Fallopian tube prosthesis
• § 884.3900 — Vaginal stent
• § 884.4050 — Gynecologic laparoscopic power morcellation containment system
• § 884.4100 — Endoscopic electrocautery and accessories
• § 884.4120 — Gynecologic electrocautery and accessories
• § 884.4150 — Bipolar endoscopic coagulator-cutter and accessories
• § 884.4160 — Unipolar endoscopic coagulator-cutter and accessories
• § 884.4250 — Expandable cervical dilator
• § 884.4260 — Hygroscopic Laminaria cervical dilator
• § 884.4270 — Vibratory cervical dilators
• § 884.4340 — Fetal vacuum extractor
• § 884.4350 — Fetal head elevator
• § 884.4400 — Obstetric forceps
• § 884.4500 — Obstetric fetal destructive instrument
• § 884.4520 — Obstetric-gynecologic general manual instrument
• § 884.4530 — Obstetric-gynecologic specialized manual instrument
• § 884.4550 — Gynecologic surgical laser
• § 884.4900 — Obstetric table and accessories
• § 884.4910 — Specialized surgical instrumentation for use with urogynecologic surgical mesh
• § 884.5050 — Metreurynter-balloon abortion system
• § 884.5070 — Vacuum abortion system
• § 884.5100 — Obstetric anesthesia set
• § 884.5150 — Nonpowered breast pump
• § 884.5160 — Powered breast pump
• § 884.5200 — Hemorrhoid prevention pressure wedge
• § 884.5210 — Pressure wedge for the reduction of cesarean delivery
• § 884.5225 — Abdominal decompression chamber
• § 884.5250 — Cervical cap
• § 884.5300 — Condom
• § 884.5305 — External condom for anal intercourse or vaginal intercourse
• § 884.5310 — Condom with spermicidal lubricant
• § 884.5320 — Glans sheath
• § 884.5330 — Multiple-use female condom
• § 884.5340 — Single-use internal condom
• § 884.5350 — Contraceptive diaphragm and accessories
• § 884.5360 — Contraceptive intrauterine device (IUD) and introducer
• § 884.5370 — Software application for contraception
• § 884.5380 — Contraceptive tubal occlusion device (TOD) and introducer
• § 884.5390 — Perineal heater
• § 884.5400 — Menstrual cup
• § 884.5425 — Scented or scented deodorized menstrual pad
• § 884.5435 — Unscented menstrual pad
• § 884.5460 — Scented or scented deodorized menstrual tampon
• § 884.5470 — Unscented menstrual tampon
• § 884.5900 — Therapeutic vaginal douche apparatus
• § 884.5920 — Vaginal insufflator
• § 884.5940 — Powered vaginal muscle stimulator for therapeutic use
• § 884.5960 — Genital vibrator for therapeutic use
• § 884.5970 — Clitoral engorgement device
• § 884.5980 — Surgical mesh for transvaginal pelvic organ prolapse repair
• § 884.6100 — Assisted reproduction needles
• § 884.6110 — Assisted reproduction catheters
• § 884.6120 — Assisted reproduction accessories
• § 884.6130 — Assisted reproduction microtools
• § 884.6140 — Assisted reproduction micropipette fabrication instruments
• § 884.6150 — Assisted reproduction micromanipulators and microinjectors
• § 884.6160 — Assisted reproduction labware
• § 884.6165 — Intravaginal culture system
• § 884.6170 — Assisted reproduction water and water purification systems
• § 884.6180 — Reproductive media and supplements
• § 884.6190 — Assisted reproductive microscopes and microscope accessories
• § 884.6195 — Assisted Reproduction Embryo Image Assessment System
• § 884.6200 — Assisted reproduction laser system

PART 886

• § 886.1 — Scope
• § 886.3 — Effective dates of requirement for premarket approval
• § 886.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 886.1040 — Ocular esthesiometer
• § 886.1050 — Adaptometer (biophotometer)
• § 886.1070 — Anomaloscope
• § 886.1090 — Haidinger brush
• § 886.1100 — Retinal diagnostic software device
• § 886.1120 — Ophthalmic camera
• § 886.1140 — Ophthalmic chair
• § 886.1150 — Visual acuity chart
• § 886.1160 — Color vision plate illuminator
• § 886.1170 — Color vision tester
• § 886.1190 — Distometer
• § 886.1200 — Optokinetic drum
• § 886.1220 — Corneal electrode
• § 886.1250 — Euthyscope
• § 886.1270 — Exophthalmometer
• § 886.1290 — Fixation device
• § 886.1300 — Afterimage flasher
• § 886.1320 — Fornixscope
• § 886.1330 — Amsler grid
• § 886.1340 — Haploscope
• § 886.1342 — Strabismus detection device
• § 886.1350 — Keratoscope
• § 886.1360 — Visual field laser instrument
• § 886.1375 — Bagolini lens
• § 886.1380 — Diagnostic condensing lens
• § 886.1385 — Polymethylmethacrylate (PMMA) diagnostic contact lens
• § 886.1390 — Flexible diagnostic Fresnel lens
• § 886.1395 — Diagnostic Hruby fundus lens
• § 886.1400 — Maddox lens
• § 886.1405 — Ophthalmic trial lens set
• § 886.1410 — Ophthalmic trial lens clip
• § 886.1415 — Ophthalmic trial lens frame
• § 886.1420 — Ophthalmic lens gauge
• § 886.1425 — Lens measuring instrument
• § 886.1430 — Ophthalmic contact lens radius measuring device
• § 886.1435 — Maxwell spot
• § 886.1450 — Corneal radius measuring device
• § 886.1460 — Stereopsis measuring instrument
• § 886.1500 — Headband mirror
• § 886.1510 — Eye movement monitor
• § 886.1570 — Ophthalmoscope
• § 886.1605 — Perimeter
• § 886.1630 — AC-powered photostimulator
• § 886.1640 — Ophthalmic preamplifier
• § 886.1650 — Ophthalmic bar prism
• § 886.1655 — Ophthalmic Fresnel prism
• § 886.1660 — Gonioscopic prism
• § 886.1665 — Ophthalmic rotary prism
• § 886.1670 — Ophthalmic isotope uptake probe
• § 886.1680 — Ophthalmic projector
• § 886.1690 — Pupillograph
• § 886.1700 — Pupillometer
• § 886.1750 — Skiascopic rack
• § 886.1760 — Ophthalmic refractometer
• § 886.1770 — Manual refractor
• § 886.1780 — Retinoscope
• § 886.1790 — Nearpoint ruler
• § 886.1800 — Schirmer strip
• § 886.1810 — Tangent screen (campimeter)
• § 886.1840 — Simulatan (including crossed cylinder)
• § 886.1850 — AC-powered slitlamp biomicroscope
• § 886.1860 — Ophthalmic instrument stand
• § 886.1870 — Stereoscope
• § 886.1880 — Fusion and stereoscopic target
• § 886.1905 — Nystagmus tape
• § 886.1910 — Spectacle dissociation test system
• § 886.1925 — Diurnal pattern recorder system
• § 886.1930 — Tonometer and accessories
• § 886.1940 — Tonometer sterilizer
• § 886.1945 — Transilluminator
• § 886.3100 — Ophthalmic tantalum clip
• § 886.3130 — Ophthalmic conformer
• § 886.3200 — Artificial eye
• § 886.3300 — Absorbable implant (scleral buckling method)
• § 886.3320 — Eye sphere implant
• § 886.3340 — Extraocular orbital implant
• § 886.3400 — Keratoprosthesis
• § 886.3600 — Intraocular lens
• § 886.3800 — Scleral shell
• § 886.3920 — Aqueous shunt
• § 886.4070 — Powered corneal burr
• § 886.4100 — Radiofrequency electrosurgical cautery apparatus
• § 886.4115 — Thermal cautery unit
• § 886.4150 — Vitreous aspiration and cutting instrument
• § 886.4155 — Scleral plug
• § 886.4170 — Cryophthalmic unit
• § 886.4230 — Ophthalmic knife test drum
• § 886.4250 — Ophthalmic electrolysis unit
• § 886.4270 — Intraocular gas
• § 886.4275 — Intraocular fluid
• § 886.4280 — Intraocular pressure measuring device
• § 886.4300 — Intraocular lens guide
• § 886.4320 — Corneal storage medium with preservatives including antifungals
• § 886.4335 — Operating headlamp
• § 886.4350 — Manual ophthalmic surgical instrument
• § 886.4355 — Corneal inlay inserter handle
• § 886.4360 — Ocular surgery irrigation device
• § 886.4370 — Keratome
• § 886.4390 — Ophthalmic laser
• § 886.4392 — Nd:YAG laser for posterior capsulotomy and peripheral iridotomy
• § 886.4400 — Electronic metal locator
• § 886.4440 — AC-powered magnet
• § 886.4445 — Permanent magnet
• § 886.4570 — Ophthalmic surgical marker
• § 886.4610 — Ocular pressure applicator
• § 886.4670 — Phacofragmentation system
• § 886.4690 — Ophthalmic photocoagulator
• § 886.4750 — Ophthalmic eye shield
• § 886.4770 — Ophthalmic operating spectacles (loupes)
• § 886.4790 — Ophthalmic sponge
• § 886.4855 — Ophthalmic instrument table
• § 886.5100 — Ophthalmic beta radiation source
• § 886.5120 — Low-power binocular loupe
• § 886.5200 — Eyelid thermal pulsation system
• § 886.5201 — Intense pulsed light device for managing dry eye
• § 886.5300 — Tear electrostimulation device
• § 886.5305 — Electromechanical tear stimulator
• § 886.5310 — Intranasal electrostimulation device for dry eye symptoms
• § 886.5350 — Ultrasound cyclodestructive device
• § 886.5420 — Contact lens inserter/remover
• § 886.5500 — Digital therapy device for amblyopia
• § 886.5540 — Low-vision magnifier
• § 886.5600 — Ptosis crutch
• § 886.5700 — Eyelid weight
• § 886.5800 — Ophthalmic bar reader. P>(a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device is placed directly onto reading material to magnify print
• § 886.5810 — Ophthalmic prism reader
• § 886.5820 — Closed-circuit television reading system
• § 886.5838 — Nasolacrimal compression device
• § 886.5840 — Magnifying spectacles
• § 886.5842 — Spectacle frame
• § 886.5844 — Prescription spectacle lens
• § 886.5850 — Sunglasses (nonprescription)
• § 886.5870 — Low-vision telescope
• § 886.5900 — Electronic vision aid
• § 886.5905 — Oral electronic vision aid
• § 886.5910 — Image intensification vision aid
• § 886.5915 — Optical vision aid
• § 886.5916 — Rigid gas permeable contact lens
• § 886.5918 — Rigid gas permeable contact lens care products
• § 886.5919 — Hydrophilic re-coating solution
• § 886.5925 — Soft (hydrophilic) contact lens
• § 886.5928 — Soft (hydrophilic) contact lens care products
• § 886.5933 — [Reserved]

PART 888

• § 888.1 — Scope
• § 888.3 — Effective dates of requirement for premarket approval
• § 888.5 — Resurfacing technique
• § 888.6 — Degree of constraint
• § 888.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 888.1100 — Arthroscope
• § 888.1240 — AC-powered dynamometer
• § 888.1250 — Nonpowered dynamometer
• § 888.1500 — Goniometer
• § 888.1520 — Nonpowered goniometer
• § 888.1600 — Bone indentation device
• § 888.3000 — Bone cap
• § 888.3010 — Bone fixation cerclage
• § 888.3015 — Bone heterograft
• § 888.3020 — Intramedullary fixation rod
• § 888.3023 — In vivo cured intramedullary fixation rod
• § 888.3025 — Passive tendon prosthesis
• § 888.3027 — Polymethylmethacrylate (PMMA) bone cement
• § 888.3030 — Single/multiple component metallic bone fixation appliances and accessories
• § 888.3040 — Smooth or threaded metallic bone fixation fastener
• § 888.3043 — Screw sleeve bone fixation device
• § 888.3044 — Resorbable implant for anterior cruciate ligament (ACL) repair
• § 888.3045 — Resorbable calcium salt bone void filler device
• § 888.3050 — Spinal interlaminal fixation orthosis
• § 888.3060 — Spinal intervertebral body fixation orthosis
• § 888.3070 — Thoracolumbosacral pedicle screw system
• § 888.3075 — Posterior cervical screw system
• § 888.3080 — Intervertebral body fusion device
• § 888.3083 — Spinal spheres for use in intervertebral fusion procedures
• § 888.3085 — Intervertebral body graft containment device
• § 888.3090 — Intraoperative orthopedic strain sensor
• § 888.3100 — Ankle joint metal/composite semi-constrained cemented prosthesis
• § 888.3110 — Ankle joint metal/polymer semi-constrained cemented prosthesis
• § 888.3120 — Ankle joint metal/polymer non-constrained cemented prosthesis
• § 888.3150 — Elbow joint metal/polymer constrained cemented prosthesis
• § 888.3160 — Elbow joint metal/polymer semi-constrained cemented prosthesis
• § 888.3170 — Elbow joint radial (hemi-elbow) polymer prosthesis
• § 888.3180 — Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis
• § 888.3200 — Finger joint metal/metal constrained uncemented prosthesis
• § 888.3210 — Finger joint metal/metal constrained cemented prosthesis
• § 888.3220 — Finger joint metal/polymer constrained cemented prosthesis
• § 888.3230 — Finger joint polymer constrained prosthesis
• § 888.3300 — Hip joint metal constrained cemented or uncemented prosthesis
• § 888.3310 — Hip joint metal/polymer constrained cemented or uncemented prosthesis
• § 888.3320 — Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis
• § 888.3330 — Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis
• § 888.3340 — Hip joint metal/composite semi-constrained cemented prosthesis
• § 888.3350 — Hip joint metal/polymer semi-constrained cemented prosthesis
• § 888.3353 — Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
• § 888.3358 — Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
• § 888.3360 — Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
• § 888.3370 — Hip joint (hemi-hip) acetabular metal cemented prosthesis
• § 888.3380 — Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis
• § 888.3390 — Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
• § 888.3400 — Hip joint femoral (hemi-hip) metallic resurfacing prosthesis
• § 888.3410 — Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis
• § 888.3480 — Knee joint femorotibial metallic constrained cemented prosthesis
• § 888.3490 — Knee joint femorotibial metal/composite non-constrained cemented prosthesis
• § 888.3500 — Knee joint femorotibial metal/composite semi-constrained cemented prosthesis
• § 888.3510 — Knee joint femorotibial metal/polymer constrained cemented prosthesis
• § 888.3520 — Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
• § 888.3530 — Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis
• § 888.3535 — Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis
• § 888.3540 — Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis
• § 888.3550 — Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis
• § 888.3560 — Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
• § 888.3565 — Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
• § 888.3570 — Knee joint femoral (hemi-knee) metallic uncemented prosthesis
• § 888.3580 — Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis
• § 888.3590 — Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis
• § 888.3600 — Implantable post-surgical kinematic measurement knee device
• § 888.3630 — Resorbable shoulder spacer
• § 888.3640 — Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis
• § 888.3650 — Shoulder joint metal/polymer non-constrained cemented prosthesis
• § 888.3660 — Shoulder joint metal/polymer semi-constrained cemented prosthesis
• § 888.3670 — Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis
• § 888.3680 — Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis
• § 888.3690 — Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis
• § 888.3720 — Toe joint polymer constrained prosthesis
• § 888.3730 — Toe joint phalangeal (hemi-toe) polymer prosthesis
• § 888.3750 — Wrist joint carpal lunate polymer prosthesis
• § 888.3760 — Wrist joint carpal scaphoid polymer prosthesis
• § 888.3770 — Wrist joint carpal trapezium polymer prosthesis
• § 888.3780 — Wrist joint polymer constrained prosthesis
• § 888.3790 — Wrist joint metal constrained cemented prosthesis
• § 888.3800 — Wrist joint metal/polymer semi-constrained cemented prosthesis
• § 888.3810 — Wrist joint ulnar (hemi-wrist) polymer prosthesis
• § 888.4150 — Calipers for clinical use
• § 888.4200 — Cement dispenser
• § 888.4210 — Cement mixer for clinical use
• § 888.4220 — Cement monomer vapor evacuator
• § 888.4230 — Cement ventilation tube
• § 888.4300 — Depth gauge for clinical use
• § 888.4505 — Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation
• § 888.4510 — Manual surgical instrument for appropriate patient selection for orthopedic implant
• § 888.4515 — Orthopedic manual surgical instrumentation for use with total disc replacement devices
• § 888.4520 — Orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices
• § 888.4540 — Orthopedic manual surgical instrument
• § 888.4580 — Sonic surgical instrument and accessories/attachments
• § 888.4600 — Protractor for clinical use
• § 888.4800 — Template for clinical use
• § 888.5850 — Nonpowered orthopedic traction apparatus and accessories
• § 888.5890 — Noninvasive traction component
• § 888.5940 — Cast component
• § 888.5960 — Cast removal instrument
• § 888.5980 — Manual cast application and removal instrument

PART 890

• § 890.1 — Scope
• § 890.3 — Effective dates of requirement for premarket approval
• § 890.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 890.1175 — Electrode cable
• § 890.1225 — Chronaximeter
• § 890.1375 — Diagnostic electromyograph
• § 890.1385 — Diagnostic electromyograph needle electrode
• § 890.1450 — Powered reflex hammer
• § 890.1575 — Force-measuring platform
• § 890.1600 — Intermittent pressure measurement system
• § 890.1615 — Miniature pressure transducer
• § 890.1850 — Diagnostic muscle stimulator
• § 890.1925 — Isokinetic testing and evaluation system
• § 890.3025 — Prosthetic and orthotic accessory
• § 890.3050 — External compression device for internal jugular vein compression
• § 890.3075 — Cane
• § 890.3100 — Mechanical chair
• § 890.3110 — Electric positioning chair
• § 890.3150 — Crutch
• § 890.3175 — Flotation cushion
• § 890.3410 — External limb orthotic component
• § 890.3420 — External limb prosthetic component
• § 890.3450 — Upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components
• § 890.3475 — Limb orthosis
• § 890.3480 — Powered lower extremity exoskeleton
• § 890.3490 — Truncal orthosis
• § 890.3500 — External assembled lower limb prosthesis
• § 890.3520 — Plinth
• § 890.3610 — Rigid pneumatic structure orthosis
• § 890.3640 — Arm sling
• § 890.3665 — Congenital hip dislocation abduction splint
• § 890.3675 — Denis Brown splint
• § 890.3690 — Powered wheeled stretcher
• § 890.3700 — Nonpowered communication system
• § 890.3710 — Powered communication system
• § 890.3725 — Powered environmental control system
• § 890.3750 — Mechanical table
• § 890.3760 — Powered table
• § 890.3790 — Cane, crutch, and walker tips and pads
• § 890.3800 — Motorized three-wheeled vehicle
• § 890.3825 — Mechanical walker
• § 890.3850 — Mechanical wheelchair
• § 890.3860 — Powered wheelchair
• § 890.3880 — Special grade wheelchair
• § 890.3890 — Stair-climbing wheelchair
• § 890.3900 — Standup wheelchair
• § 890.3910 — Wheelchair accessory
• § 890.3920 — Wheelchair component
• § 890.3930 — Wheelchair elevator
• § 890.3940 — Wheelchair platform scale
• § 890.5050 — Daily activity assist device
• § 890.5100 — Immersion hydrobath
• § 890.5110 — Paraffin bath
• § 890.5125 — Nonpowered sitz bath
• § 890.5150 — Powered patient transport
• § 890.5160 — Air-fluidized bed
• § 890.5170 — Powered flotation therapy bed
• § 890.5180 — Manual patient rotation bed
• § 890.5225 — Powered patient rotation bed
• § 890.5250 — Moist steam cabinet
• § 890.5275 — Microwave diathermy
• § 890.5290 — Shortwave diathermy
• § 890.5300 — Ultrasonic diathermy
• § 890.5350 — Exercise component
• § 890.5360 — Measuring exercise equipment
• § 890.5370 — Nonmeasuring exercise equipment
• § 890.5380 — Powered exercise equipment
• § 890.5410 — Powered finger exerciser
• § 890.5420 — Electroencephalography (EEG)-driven upper extremity powered exerciser
• § 890.5500 — Infrared lamp
• § 890.5525 — Iontophoresis device
• § 890.5575 — Powered external limb overload warning device
• § 890.5650 — Powered inflatable tube massager
• § 890.5660 — Therapeutic massager
• § 890.5670 — Internal therapeutic massager
• § 890.5700 — Cold pack
• § 890.5710 — Hot or cold disposable pack
• § 890.5720 — Water circulating hot or cold pack
• § 890.5730 — Moist heat pack
• § 890.5740 — Powered heating pad
• § 890.5760 — Nonpowered lower extremity pressure wrap
• § 890.5765 — Pressure-applying device
• § 890.5800 — Virtual reality behavioral therapy device for pain relief
• § 890.5850 — Powered muscle stimulator
• § 890.5860 — Ultrasound and muscle stimulator
• § 890.5870 — xxx
• § 890.5880 — Multi-function physical therapy table
• § 890.5900 — Power traction equipment
• § 890.5925 — Traction accessory
• § 890.5940 — Chilling unit
• § 890.5950 — Powered heating unit
• § 890.5975 — Therapeutic vibrator

PART 892

• § 892.1 — Scope
• § 892.3 — Effective dates of requirement for premarket approval
• § 892.9 — Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
• § 892.1000 — Magnetic resonance diagnostic device
• § 892.1001 — Liver iron concentration imaging companion diagnostic for deferasirox
• § 892.1100 — Scintillation (gamma) camera
• § 892.1110 — Positron camera
• § 892.1130 — Nuclear whole body counter
• § 892.1170 — Bone densitometer
• § 892.1180 — Bone sonometer
• § 892.1200 — Emission computed tomography system
• § 892.1220 — Fluorescent scanner
• § 892.1300 — Nuclear rectilinear scanner
• § 892.1310 — Nuclear tomography system
• § 892.1320 — Nuclear uptake probe
• § 892.1330 — Nuclear whole body scanner
• § 892.1350 — Nuclear scanning bed
• § 892.1360 — Radionuclide dose calibrator
• § 892.1370 — Nuclear anthropomorphic phantom
• § 892.1380 — Nuclear flood source phantom
• § 892.1390 — Radionuclide rebreathing system
• § 892.1400 — Nuclear sealed calibration source
• § 892.1410 — Nuclear electrocardiograph synchronizer
• § 892.1420 — Radionuclide test pattern phantom
• § 892.1540 — Nonfetal ultrasonic monitor
• § 892.1550 — Ultrasonic pulsed doppler imaging system
• § 892.1560 — Ultrasonic pulsed echo imaging system
• § 892.1570 — Diagnostic ultrasonic transducer
• § 892.1600 — Angiographic x-ray system
• § 892.1610 — Diagnostic x-ray beam-limiting device
• § 892.1620 — Cine or spot fluorographic x-ray camera
• § 892.1630 — Electrostatic x-ray imaging system
• § 892.1640 — Radiographic film marking system
• § 892.1650 — Image-intensified fluoroscopic x-ray system
• § 892.1660 — Non-image-intensified fluoroscopic x-ray system
• § 892.1670 — Spot-film device
• § 892.1680 — Stationary x-ray system
• § 892.1700 — Diagnostic x-ray high voltage generator
• § 892.1710 — Mammographic x-ray system
• § 892.1715 — Full-field digital mammography system
• § 892.1720 — Mobile x-ray system
• § 892.1730 — Photofluorographic x-ray system
• § 892.1740 — Tomographic x-ray system
• § 892.1750 — Computed tomography x-ray system
• § 892.1760 — Diagnostic x-ray tube housing assembly
• § 892.1770 — Diagnostic x-ray tube mount
• § 892.1820 — Pneumoencephalographic chair
• § 892.1830 — Radiologic patient cradle
• § 892.1840 — Radiographic film
• § 892.1850 — Radiographic film cassette
• § 892.1860 — Radiographic film/cassette changer
• § 892.1870 — Radiographic film/cassette changer programmer
• § 892.1880 — Wall-mounted radiographic cassette holder
• § 892.1890 — Radiographic film illuminator
• § 892.1900 — Automatic radiographic film processor
• § 892.1910 — Radiographic grid
• § 892.1920 — Radiographic head holder
• § 892.1940 — Radiologic quality assurance instrument
• § 892.1950 — Radiographic anthropomorphic phantom
• § 892.1960 — Radiographic intensifying screen
• § 892.1970 — Radiographic ECG/respirator synchronizer
• § 892.1980 — Radiologic table
• § 892.1990 — Transilluminator for breast evaluation
• § 892.2010 — Medical image storage device
• § 892.2020 — Medical image communications device
• § 892.2030 — Medical image digitizer
• § 892.2040 — Medical image hardcopy device
• § 892.2050 — Medical image management and processing system
• § 892.2060 — Radiological computer-assisted diagnostic software for lesions suspicious of cancer
• § 892.2070 — Medical image analyzer
• § 892.2080 — Radiological computer aided triage and notification software
• § 892.2090 — Radiological computer-assisted detection and diagnosis software
• § 892.2100 — 892.2100 Radiological acquisition and/or optimization guidance system.
• § 892.5050 — Medical charged-particle radiation therapy system
• § 892.5300 — Medical neutron radiation therapy system
• § 892.5650 — Manual radionuclide applicator system
• § 892.5700 — Remote controlled radionuclide applicator system
• § 892.5710 — Radiation therapy beam-shaping block
• § 892.5720 — Rectal balloon for prostate immobilization
• § 892.5725 — Absorbable perirectal spacer
• § 892.5730 — Radionuclide brachytherapy source
• § 892.5740 — Radionuclide teletherapy source
• § 892.5750 — Radionuclide radiation therapy system
• § 892.5770 — Powered radiation therapy patient support assembly
• § 892.5780 — Light beam patient position indicator
• § 892.5785 — Radiation therapy marking device
• § 892.5840 — Radiation therapy simulation system
• § 892.5900 — X-ray radiation therapy system
• § 892.5930 — Therapeutic x-ray tube housing assembly
• § 892.6500 — Personnel protective shield
• § 892.6510 — Cream for x-ray attenuation

PART 895

• § 895.1 — Scope
• § 895.20 — General
• § 895.21 — Procedures for banning a device
• § 895.22 — Submission of data and information by the manufacturer, distributor, or importer
• § 895.25 — Labeling
• § 895.30 — Special effective date
• § 895.101 — Prosthetic hair fibers
• § 895.102 — Powdered surgeon's glove
• § 895.103 — Powdered patient examination glove
• § 895.104 — Absorbable powder for lubricating a surgeon's glove
• § 895.105 — Electrical stimulation devices for self-injurious or aggressive behavior

PART 898

• § 898.11 — Applicability
• § 898.12 — Performance standard
• § 898.13 — Compliance dates
• § 898.14 — Exemptions and variances

PART 900

• § 900.1 — Scope
• § 900.2 — Definitions
• § 900.3 — Application for approval as an accreditation body
• § 900.4 — Standards for accreditation bodies
• § 900.5 — Evaluation
• § 900.6 — Withdrawal of approval
• § 900.7 — Hearings
• § 900.8-900.9 — 900.8-900.9 [Reserved]
• § 900.10 — Applicability
• § 900.11 — Requirements for certification
• § 900.12 — Quality standards
• § 900.13 — Revocation of accreditation and revocation of accreditation body approval
• § 900.14 — Suspension or revocation of certificates
• § 900.15 — Appeals of adverse accreditation or reaccreditation decisions that preclude certification or recertification
• § 900.16 — Appeals of denials of certification
• § 900.17 — [Reserved]
• § 900.18 — Alternative requirements for § 900.12 quality standards
• § 900.20 — Scope
• § 900.21 — Application for approval as a certification agency
• § 900.22 — Standards for certification agencies
• § 900.23 — Evaluation
• § 900.24 — Withdrawal of approval
• § 900.25 — Hearings and appeals

PART 1000

• § 1000.1 — General
• § 1000.3 — Definitions
• § 1000.15 — Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968

PART 1002

• § 1002.1 — Applicability
• § 1002.2 — [Reserved]
• § 1002.3 — Notification to user of performance and technical data
• § 1002.4 — Confidentiality of information
• § 1002.7 — Submission of data and reports
• § 1002.10 — Product reports
• § 1002.11 — Supplemental reports
• § 1002.12 — Abbreviated reports
• § 1002.13 — Annual reports
• § 1002.20 — Reporting of accidental radiation occurrences
• § 1002.30 — Records to be maintained by manufacturers
• § 1002.31 — Preservation and inspection of records
• § 1002.40 — Records to be obtained by dealers and distributors
• § 1002.41 — Disposition of records obtained by dealers and distributors
• § 1002.42 — Confidentiality of records furnished by dealers and distributors
• § 1002.50 — Special exemptions
• § 1002.51 — Exemptions for manufacturers of products intended for the U.S. Government

PART 1003

• § 1003.1 — Applicability
• § 1003.2 — Defect in an electronic product
• § 1003.5 — Effect of regulations on other laws
• § 1003.10 — Discovery of defect or failure of compliance by manufacturer; notice requirements
• § 1003.11 — Determination by Secretary that product fails to comply or has a defect
• § 1003.20 — Notification by the manufacturer to the Secretary
• § 1003.21 — Notification by the manufacturer to affected persons
• § 1003.22 — Copies of communications sent to purchasers, dealers or distributors
• § 1003.30 — Application for exemption from notification requirements
• § 1003.31 — Granting the exemption

PART 1004

• § 1004.1 — Manufacturer's obligation to repair, replace, or refund cost of electronic products
• § 1004.2 — Plans for the repair of electronic products
• § 1004.3 — Plans for the replacement of electronic products
• § 1004.4 — Plans for refunding the cost of electronic products
• § 1004.6 — Approval of plans

PART 1005

• § 1005.1 — Applicability
• § 1005.2 — Definitions
• § 1005.3 — Importation of noncomplying goods prohibited
• § 1005.10 — Notice of sampling
• § 1005.11 — Payment for samples
• § 1005.20 — Hearing
• § 1005.21 — Application for permission to bring product into compliance
• § 1005.22 — Granting permission to bring product into compliance
• § 1005.23 — Bonds
• § 1005.24 — Costs of bringing product into compliance
• § 1005.25 — Service of process on manufacturers

PART 1010

• § 1010.1 — Scope
• § 1010.2 — Certification
• § 1010.3 — Identification
• § 1010.4 — Variances
• § 1010.5 — Exemptions for products intended for United States Government use
• § 1010.13 — Special test procedures
• § 1010.20 — Electronic products intended for export

PART 1020

• § 1020.10 — Television receivers
• § 1020.20 — Cold-cathode gas discharge tubes
• § 1020.30 — Diagnostic x-ray systems and their major components
• § 1020.31 — Radiographic equipment
• § 1020.32 — Fluoroscopic equipment
• § 1020.33 — Computed tomography (CT) equipment
• § 1020.40 — Cabinet x-ray systems

PART 1030

• § 1030.10 — Microwave ovens

PART 1040

• § 1040.10 — Laser products
• § 1040.11 — Specific purpose laser products
• § 1040.20 — Sunlamp products and ultraviolet lamps intended for use in sunlamp products
• § 1040.30 — High-intensity mercury vapor discharge lamps

PART 1100

• § 1100.1 — Scope
• § 1100.2 — Requirements
• § 1100.3 — Definitions
• § 1100.5 — Exclusion from tobacco regulation
• § 1100.200 — Purpose and scope
• § 1100.202 — Definitions
• § 1100.204 — Recordkeeping requirements

PART 1105

• § 1105.10 — Refusal to accept a premarket submission

PART 1107

• § 1107.1 — Exemptions
• § 1107.3 — Recordkeeping
• § 1107.10 — Scope
• § 1107.12 — Definitions
• § 1107.16 — Submission of a substantial equivalence report
• § 1107.18 — Required content and format of an SE Report
• § 1107.19 — Comparison information
• § 1107.20 — Amendments
• § 1107.22 — Withdrawal by applicant
• § 1107.24 — Change in ownership of an SE Report
• § 1107.40 — Communications between FDA and applicants
• § 1107.42 — Review cycles
• § 1107.44 — FDA action on an SE Report
• § 1107.46 — Issuance of an order finding a new tobacco product substantially equivalent
• § 1107.48 — Issuance of an order denying marketing authorization
• § 1107.50 — Rescission of order
• § 1107.58 — Record retention
• § 1107.60 — Confidentiality
• § 1107.62 — Electronic submission

PART 1114

• § 1114.1 — Scope
• § 1114.3 — Definitions
• § 1114.5 — Application submission
• § 1114.7 — Required content and format
• § 1114.9 — Amendments
• § 1114.11 — Withdrawal by applicant
• § 1114.13 — Change in ownership of an application
• § 1114.15 — Supplemental applications
• § 1114.17 — Resubmissions
• § 1114.25 — Communication between FDA and applicants
• § 1114.27 — Review procedure
• § 1114.29 — FDA action on an application
• § 1114.31 — Issuance of a marketing granted order
• § 1114.33 — Issuance of a marketing denial order
• § 1114.35 — Withdrawal of a marketing granted order
• § 1114.37 — Temporary suspension of a marketing granted order
• § 1114.39 — Postmarket changes
• § 1114.41 — Reporting requirements
• § 1114.45 — Record retention
• § 1114.47 — Confidentiality
• § 1114.49 — Electronic submission

PART 1140

• § 1140.1 — Scope
• § 1140.2 — Purpose
• § 1140.3 — Definitions
• § 1140.10 — General responsibilities of manufacturers, distributors, and retailers
• § 1140.12 — Additional responsibilities of manufacturers
• § 1140.14 — Additional responsibilities of retailers
• § 1140.16 — Conditions of manufacture, sale, and distribution
• § 1140.30 — Scope of permissible forms of labeling and advertising
• § 1140.32 — Format and content requirements for labeling and advertising
• § 1140.34 — Sale and distribution of nontobacco items and services, gifts, and sponsorship of events

PART 1141

• § 1141.1 — Scope
• § 1141.3 — Definitions
• § 1141.5 — Incorporation by reference
• § 1141.10 — Required warnings
• § 1141.12 — Misbranding of cigarettes

PART 1143

• § 1143.1 — Definitions
• § 1143.3 — Required warning statement regarding addictiveness of nicotine
• § 1143.5 — Required warning statements for cigars
• § 1143.7 — Language requirements for required warning statements
• § 1143.9 — Irremovable or permanent required warning statements
• § 1143.11 — Does not apply to foreign distribution
• § 1143.13 — Effective date

PART 1150

• § 1150.1 — Scope
• § 1150.3 — Definitions
• § 1150.5 — Required information
• § 1150.7 — Yearly class allocation
• § 1150.9 — Domestic manufacturer or importer assessment
• § 1150.11 — Notification of assessments
• § 1150.13 — Payment of assessments
• § 1150.15 — Disputes
• § 1150.17 — Penalties

PART 1210

• § 1210.1 — Authority
• § 1210.2 — Scope of act
• § 1210.3 — Definitions
• § 1210.10 — Availability for examination and inspection
• § 1210.11 — Sanitary inspection of dairy farms
• § 1210.12 — Physical examination of cows
• § 1210.13 — Tuberculin test
• § 1210.14 — Sanitary inspection of plants
• § 1210.15 — Pasteurization; equipment and methods
• § 1210.16 — Method of bacterial count
• § 1210.17 — Authority to sample and inspect
• § 1210.18 — Scoring
• § 1210.20 — Application for permit
• § 1210.21 — Permit number
• § 1210.22 — Form of tag
• § 1210.23 — Permits granted on certificates
• § 1210.24 — Temporary permits
• § 1210.25 — Permits for pasteurized milk or cream
• § 1210.26 — Permits for raw milk or cream
• § 1210.27 — Permits waiving clauses 2 and 5, section 2 of the Federal Import Milk Act
• § 1210.28 — Permits waiving clause 4, section 2 of the Federal Import Milk Act
• § 1210.30 — Hearing procedure for permit denial, suspension, and revocation
• § 1210.31 — Hearing before prosecution

PART 1230

• § 1230.2 — Scope of the act
• § 1230.3 — Definitions
• § 1230.10 — Placement
• § 1230.11 — Required wording
• § 1230.12 — Manufacturer; distributor
• § 1230.13 — Labeling of “poison”
• § 1230.14 — Directions for treatment
• § 1230.15 — Responsibility for labeling directions for treatment
• § 1230.16 — Exemption from labeling directions for treatment
• § 1230.20 — General guaranty
• § 1230.21 — Specific guaranty
• § 1230.30 — Collection of samples
• § 1230.31 — Where samples may be collected
• § 1230.32 — Analyzing of samples
• § 1230.33 — Investigations
• § 1230.34 — Analysis
• § 1230.35 — Hearings
• § 1230.36 — Hearings; when not provided for
• § 1230.37 — Publication
• § 1230.40 — Required label information
• § 1230.41 — Delivery of containers
• § 1230.42 — Invoices
• § 1230.43 — Enforcement
• § 1230.44 — Samples
• § 1230.45 — No violation; release
• § 1230.46 — Violation
• § 1230.47 — Rejected containers
• § 1230.48 — Relabeling of containers
• § 1230.49 — Penalties

PART 1240

• § 1240.3 — General definitions
• § 1240.10 — Effective bactericidal treatment
• § 1240.20 — Issuance and posting of certificates following inspections
• § 1240.30 — Measures in the event of inadequate local control
• § 1240.45 — Report of disease
• § 1240.60 — Molluscan shellfish
• § 1240.61 — Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption
• § 1240.62 — Turtles intrastate and interstate requirements
• § 1240.65 — Psittacine birds
• § 1240.75 — Garbage
• § 1240.80 — General requirements for water for drinking and culinary purposes
• § 1240.83 — Approval of watering points
• § 1240.86 — Protection of pier water system
• § 1240.90 — Approval of treatment aboard conveyances
• § 1240.95 — Sanitation of water boats

PART 1250

• § 1250.3 — Definitions
• § 1250.20 — Applicability
• § 1250.21 — Inspection
• § 1250.22 — General requirements
• § 1250.25 — Source identification and inspection of food and drink
• § 1250.26 — Special food requirements
• § 1250.27 — Storage of perishables
• § 1250.28 — Source and handling of ice
• § 1250.30 — Construction, maintenance and use of places where food is prepared, served, or stored
• § 1250.32 — Food-handling operations
• § 1250.33 — Utensils and equipment
• § 1250.34 — Refrigeration equipment
• § 1250.35 — Health of persons handling food
• § 1250.38 — Toilet and lavatory facilities for use of food-handling employees
• § 1250.39 — Garbage equipment and disposition
• § 1250.40 — Applicability
• § 1250.41 — Submittal of construction plans
• § 1250.42 — Water systems; constant temperature bottles
• § 1250.43 — Ice
• § 1250.44 — Drinking utensils and toilet articles
• § 1250.45 — Food handling facilities on railroad conveyances
• § 1250.49 — Cleanliness of conveyances
• § 1250.50 — Toilet and lavatory facilities
• § 1250.51 — Railroad conveyances; discharge of wastes
• § 1250.52 — Discharge of wastes on highway conveyances
• § 1250.53 — Discharge of wastes on air conveyances
• § 1250.60 — Applicability
• § 1250.61 — Inspection and approval
• § 1250.62 — Submittal of construction plans
• § 1250.63 — General requirements
• § 1250.65 — Drainage
• § 1250.67 — Watering equipment
• § 1250.70 — Employee conveniences
• § 1250.75 — Disposal of human wastes
• § 1250.79 — Garbage disposal
• § 1250.80 — Applicability
• § 1250.81 — Inspection
• § 1250.82 — Potable water systems
• § 1250.83 — Storage of water prior to treatment
• § 1250.84 — Water in galleys and medical care spaces
• § 1250.85 — Drinking fountains and coolers; ice; constant temperature bottles
• § 1250.86 — Water for making ice
• § 1250.87 — Wash water
• § 1250.89 — Swimming pools
• § 1250.90 — Toilets and lavatories
• § 1250.93 — Discharge of wastes
• § 1250.95 — Insect control
• § 1250.96 — Rodent control

PART 1271

• § 1271.1 — What are the purpose and scope of this part?
• § 1271.3 — How does FDA define important terms in this part?
• § 1271.10 — Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?
• § 1271.15 — Are there any exceptions from the requirements of this part?
• § 1271.20 — If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?
• § 1271.21 — When do I register, submit an HCT/P list, and submit updates?
• § 1271.22 — How do I register and submit an HCT/P list?
• § 1271.23 — How is a waiver from the electronic format requirements requested?
• § 1271.25 — What information is required for establishment registration and HCT/P listing?
• § 1271.26 — When must I amend my establishment registration?
• § 1271.27 — Will FDA assign me a registration number?
• § 1271.37 — Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?
• § 1271.45 — What requirements does this subpart contain?
• § 1271.47 — What procedures must I establish and maintain?
• § 1271.50 — How do I determine whether a donor is eligible?
• § 1271.55 — What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
• § 1271.60 — What quarantine and other requirements apply before the donor-eligibility determination is complete?
• § 1271.65 — How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
• § 1271.75 — How do I screen a donor?
• § 1271.80 — What are the general requirements for donor testing?
• § 1271.85 — What donor testing is required for different types of cells and tissues?
• § 1271.90 — Are there other exceptions and what labeling requirements apply?
• § 1271.145 — Prevention of the introduction, transmission, or spread of communicable diseases
• § 1271.150 — Current good tissue practice requirements
• § 1271.155 — Exemptions and alternatives
• § 1271.160 — Establishment and maintenance of a quality program
• § 1271.170 — Personnel
• § 1271.180 — Procedures
• § 1271.190 — Facilities
• § 1271.195 — Environmental control and monitoring
• § 1271.200 — Equipment
• § 1271.210 — Supplies and reagents
• § 1271.215 — Recovery
• § 1271.220 — Processing and process controls
• § 1271.225 — Process changes
• § 1271.230 — Process validation
• § 1271.250 — Labeling controls
• § 1271.260 — Storage
• § 1271.265 — Receipt, predistribution shipment, and distribution of an HCT/P
• § 1271.270 — Records
• § 1271.290 — Tracking
• § 1271.320 — Complaint file
• § 1271.330 — Applicability
• § 1271.350 — Reporting
• § 1271.370 — Labeling
• § 1271.390 — Applicability
• § 1271.400 — Inspections
• § 1271.420 — HCT/Ps offered for import
• § 1271.440 — Orders of retention, recall, destruction, and cessation of manufacturing

PART 1300

• § 1300.01 — Definitions relating to controlled substances
• § 1300.02 — Definitions relating to listed chemicals
• § 1300.03 — Definitions relating to electronic orders for controlled substances and electronic prescriptions for controlled substances
• § 1300.04 — Definitions relating to the dispensing of controlled substances by means of the Internet
• § 1300.05 — Definitions relating to the disposal of controlled substances
• § 1300.06 — Definitions relating to emergency medical services agencies

PART 1301

• § 1301.01 — Scope of this part 1301
• § 1301.02 — Definitions. Link
• § 1301.03 — Information; special instructions
• § 1301.11 — Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy
• § 1301.12 — Separate registrations for separate locations
• § 1301.13 — Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities
• § 1301.14 — Filing of application; acceptance for filing; defective applications
• § 1301.15 — Additional information
• § 1301.16 — Amendments to and withdrawal of applications
• § 1301.17 — Special procedures for certain applications
• § 1301.18 — Research protocols
• § 1301.19 — Special requirements for online pharmacies
• § 1301.20 — Registration for emergency medical services agencies
• § 1301.21 — Exemption from fees
• § 1301.22 — Exemption of agents and employees; affiliated practitioners
• § 1301.23 — Exemption of certain military and other personnel
• § 1301.24 — Exemption of law enforcement officials
• § 1301.25 — Registration regarding ocean vessels, aircraft, and other entities
• § 1301.26 — Exemptions from import or export requirements for personal medical use
• § 1301.27 — Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities
• § 1301.28 — Exemption from separate registration for practitioners dispensing or prescribing Schedule III, IV, or V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment
• § 1301.29 — [Reserved]
• § 1301.31 — Administrative review generally
• § 1301.32 — Action on applications for research in Schedule I substances
• § 1301.33 — Application for bulk manufacture of Schedule I and II substances
• § 1301.34 — Application for importation of Schedule I and II substances
• § 1301.35 — Certificate of registration; denial of registration
• § 1301.36 — Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order
• § 1301.37 — Order to show cause
• § 1301.41 — Hearings generally
• § 1301.42 — Purpose of hearing
• § 1301.43 — Request for hearing or appearance; waiver; default
• § 1301.44 — Burden of proof
• § 1301.45 — Time and place of hearing
• § 1301.46 — Final order
• § 1301.51 — Modification in registration
• § 1301.52 — Termination of registration; transfer of registration; distribution upon discontinuance of business
• § 1301.71 — Security requirements generally
• § 1301.72 — Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs; storage areas
• § 1301.73 — Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas
• § 1301.74 — Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs
• § 1301.75 — Physical security controls for practitioners
• § 1301.76 — Other security controls for practitioners
• § 1301.77 — Security controls for freight forwarding facilities
• § 1301.78-1301.79 — [Reserved]
• § 1301.80 — Security controls for emergency medical services agencies
• § 1301.90 — Employee screening procedures
• § 1301.91 — Employee responsibility to report drug diversion
• § 1301.92 — Illicit activities by employees
• § 1301.93 — Sources of information for employee checks

PART 1302

• § 1302.01 — Scope of part 1302
• § 1302.02 — Definitions
• § 1302.03 — Symbol required; exceptions
• § 1302.04 — Location and size of symbol on label and labeling
• § 1302.05 — Effective dates of labeling requirements
• § 1302.06 — Sealing of controlled substances
• § 1302.07 — Labeling and packaging requirements for imported and exported substances
• § 1302.08 — False labeling of anabolic steroids

PART 1303

• § 1303.01 — Scope of part 1303
• § 1303.02 — Definitions
• § 1303.03 — Types of quotas
• § 1303.04 — Subcategories of manufacturing and procurement quotas
• § 1303.05 — Estimation of Diversion
• § 1303.11 — Aggregate production quotas
• § 1303.12 — [Reserved]
• § 1303.13 — Adjustments of aggregate production quotas
• § 1303.15 — Procurement quotas
• § 1303.16 — Inventory allowance for procurement quotas
• § 1303.17 — Abandonment of procurement quota
• § 1303.21 — Individual manufacturing quotas
• § 1303.22 — Procedure for applying for individual manufacturing quotas
• § 1303.23 — Procedure for fixing individual manufacturing quotas
• § 1303.24 — Inventory allowance for individual manufacturing quotas
• § 1303.25 — Increase in individual manufacturing quotas
• § 1303.26 — Reduction in individual manufacturing quotas
• § 1303.27 — Abandonment of quota for Individual Manufacturing Quota
• § 1303.31 — Hearings generally
• § 1303.32 — Purpose of hearing
• § 1303.33 — Waiver or modification of rules
• § 1303.34 — Request for hearing or appearance; waiver
• § 1303.35 — Burden of proof
• § 1303.36 — Time and place of hearing
• § 1303.37 — Final order

PART 1304

• § 1304.01 — Scope of part 1304
• § 1304.02 — Definitions
• § 1304.03 — Persons required to keep records and file reports
• § 1304.04 — Maintenance of records and inventories
• § 1304.05 — Records of authorized central fill pharmacies and retail pharmacies
• § 1304.06 — Records and reports for electronic prescriptions
• § 1304.11 — Inventory requirements
• § 1304.21 — General requirements for continuing records
• § 1304.22 — Records for manufacturers, distributors, dispensers, researchers, importers, exporters, registrants that reverse distribute, and collectors
• § 1304.23 — Records for chemical analysts
• § 1304.24 — Records for maintenance treatment programs, mobile narcotic treatment programs, and detoxification treatment programs
• § 1304.25 — Records for treatment programs that compound narcotics for treatment programs and other locations
• § 1304.26 — Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid
• § 1304.27 — Additional recordkeeping requirements applicable to emergency medical services agencies
• § 1304.31 — Reports from manufacturers importing narcotic raw material
• § 1304.32 — Reports of manufacturers importing coca leaves
• § 1304.33 — Reports to Automation of Reports and Consolidated Orders System (ARCOS)
• § 1304.40 — Notification by online pharmacies
• § 1304.45 — Internet Web site disclosure requirements
• § 1304.50 — Disclosure requirements for Web sites of nonpharmacy practitioners that dispense controlled substances by means of the Internet
• § 1304.55 — Reports by online pharmacies

PART 1305

• § 1305.01 — Scope of part 1305
• § 1305.02 — Definitions
• § 1305.03 — Distributions requiring a Form 222 or a digitally signed electronic order
• § 1305.04 — Persons entitled to order Schedule I and II controlled substances
• § 1305.05 — Power of attorney
• § 1305.06 — Persons entitled to fill orders for Schedule I and II controlled substances
• § 1305.07 — Special procedure for filling certain orders
• § 1305.11 — Procedure for obtaining DEA Forms 222
• § 1305.12 — Procedure for executing DEA Forms 222
• § 1305.13 — Procedure for filling DEA Forms 222
• § 1305.14 — Procedure for endorsing DEA Forms 222
• § 1305.15 — Unaccepted and defective DEA Forms 222
• § 1305.16 — Lost and stolen DEA Forms 222
• § 1305.17 — Preservation of DEA Forms 222
• § 1305.18 — Return of unused DEA Forms 222
• § 1305.19 — Cancellation and voiding of DEA Forms 222
• § 1305.20 — [Reserved]
• § 1305.21 — Requirements for electronic orders
• § 1305.22 — Procedure for filling electronic orders
• § 1305.23 — Endorsing electronic orders
• § 1305.24 — Central processing of orders
• § 1305.25 — Unaccepted and defective electronic orders
• § 1305.26 — Lost electronic orders
• § 1305.27 — Preservation of electronic orders
• § 1305.28 — Canceling and voiding electronic orders
• § 1305.29 — Reporting to DEA

PART 1306

• § 1306.01 — Scope of part 1306
• § 1306.02 — Definitions
• § 1306.03 — Persons entitled to issue prescriptions
• § 1306.04 — Purpose of issue of prescription
• § 1306.05 — Manner of issuance of prescriptions
• § 1306.06 — Persons entitled to fill prescriptions
• § 1306.07 — Administering or dispensing of narcotic drugs
• § 1306.08 — Electronic prescriptions
• § 1306.09 — Prescription requirements for online pharmacies
• § 1306.11 — Requirement of prescription
• § 1306.12 — Refilling prescriptions; issuance of multiple prescriptions
• § 1306.13 — Partial filling of prescriptions
• § 1306.14 — Labeling of substances and filling of prescriptions
• § 1306.15 — Provision of prescription information between retail pharmacies and central fill pharmacies for prescriptions of Schedule II controlled substances
• § 1306.21 — Requirement of prescription
• § 1306.22 — Refilling of prescriptions
• § 1306.23 — Partial filling of prescriptions
• § 1306.24 — Labeling of substances and filling of prescriptions
• § 1306.25 — Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes
• § 1306.26 — Dispensing without prescription
• § 1306.27 — Provision of prescription information between retail pharmacies and central fill pharmacies for initial and refill prescriptions of Schedule III, IV, or V controlled substances
• § 1306.28-1306.49 — [Reserved]
• § 1306.51 — 1306.51 Telemedicine prescribing of schedule III-V medications for the treatment of Opioid Use Disorder.
• § 1306.52 — Other circumstances where Department of Veterans Affairs practitioners may prescribe controlled substances via the practice of telemedicine

PART 1307

• § 1307.01 — Definitions
• § 1307.02 — Application of State law and other Federal law
• § 1307.03 — Exceptions to regulations
• § 1307.11 — Distribution by dispenser to another practitioner
• § 1307.13 — Incidental manufacture of controlled substances
• § 1307.14 — Delivery of controlled substances to designated locations of emergency medical services agencies
• § 1307.15 — Delivery of controlled substances in emergency situations
• § 1307.22 — Delivery of surrendered and forfeited controlled substances
• § 1307.31 — Native American Church
• § 1307.41 — Temporary extension of certain COVID-19 telemedicine flexibilities for prescription of controlled medications

PART 1308

• § 1308.01 — Scope of this part
• § 1308.02 — Definitions
• § 1308.03 — Administration Controlled Substances Code Number
• § 1308.11 — Schedule I
• § 1308.12 — Schedule II
• § 1308.13 — Schedule III
• § 1308.14 — Schedule IV
• § 1308.15 — Schedule V
• § 1308.21 — Application for exclusion of a nonnarcotic substance
• § 1308.22 — Excluded substances
• § 1308.23 — Exemption of certain chemical preparations; application
• § 1308.24 — Exempt chemical preparations
• § 1308.25 — Exclusion of a veterinary anabolic steroid implant product; application
• § 1308.26 — Excluded veterinary anabolic steroid implant products
• § 1308.31 — Application for exemption of a nonnarcotic prescription product
• § 1308.32 — Exempted prescription products
• § 1308.33 — Exemption of certain anabolic steroid products; application
• § 1308.34 — Exempt anabolic steroid products
• § 1308.35 — Exemption of certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols
• § 1308.41 — Hearings generally
• § 1308.42 — Purpose of hearing
• § 1308.43 — Initiation of proceedings for rulemaking
• § 1308.44 — Request for hearing or appearance; waiver
• § 1308.45 — Final order
• § 1308.46 — Control required under international treaty
• § 1308.47 — Control of immediate precursors
• § 1308.49 — Temporary scheduling
• § 1308.50 — Temporary and permanent scheduling of recently emerged anabolic steroids

PART 1309

• § 1309.01 — Scope of part 1309
• § 1309.02 — Definitions
• § 1309.03 — Information; special instructions
• § 1309.11 — Fee Amounts
• § 1309.12 — Time and method of payment; refund
• § 1309.21 — Persons required to register
• § 1309.22 — Separate registration for independent activities
• § 1309.23 — Separate registration for separate locations
• § 1309.24 — Waiver of registration requirement for certain activities
• § 1309.25 — Temporary exemption from registration for chemical registration applicants
• § 1309.26 — Exemption of law enforcement officials
• § 1309.31 — Time for application for registration; expiration date
• § 1309.32 — Application forms; contents; signature
• § 1309.33 — Filing of application; joint filings
• § 1309.34 — Acceptance for filing; defective applications
• § 1309.35 — Additional information
• § 1309.36 — Amendments to and withdrawals of applications
• § 1309.41 — Administrative review generally
• § 1309.42 — Certificate of registration; denial of registration
• § 1309.43 — Suspension or revocation of registration
• § 1309.44 — Suspension of registration pending final order
• § 1309.45 — Extension of registration pending final order
• § 1309.46 — Order to show cause
• § 1309.51 — Hearings generally
• § 1309.52 — Purpose of hearing
• § 1309.53 — Request for hearing or appearance; waiver; default
• § 1309.54 — Burden of proof
• § 1309.55 — Time and place of hearing
• § 1309.61 — Modification in registration
• § 1309.62 — Termination of registration
• § 1309.63 — Transfer of registration
• § 1309.71 — General security requirements
• § 1309.72 — Felony conviction; employer responsibilities
• § 1309.73 — Employee responsibility to report diversion

PART 1310

• § 1310.01 — Definitions
• § 1310.02 — Substances covered
• § 1310.03 — Persons required to keep records and file reports
• § 1310.04 — Maintenance of records
• § 1310.05 — Reports
• § 1310.06 — Content of records and reports
• § 1310.07 — Proof of identity
• § 1310.08 — Excluded transactions
• § 1310.09 — Temporary exemption from registration
• § 1310.10 — Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act
• § 1310.11 — Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act
• § 1310.12 — Exempt chemical mixtures
• § 1310.13 — Exemption of chemical mixtures; application
• § 1310.14 — Removal of exemption from definition of regulated transaction
• § 1310.16 — Exemptions for certain scheduled listed chemical products
• § 1310.21 — Sale by Federal departments or agencies of chemicals which could be used to manufacture controlled substances

PART 1311

• § 1311.01 — Scope
• § 1311.02 — Definitions
• § 1311.05 — Standards for technologies for electronic transmission of orders
• § 1311.08 — Incorporation by reference
• § 1311.10 — Eligibility to obtain a CSOS digital certificate
• § 1311.15 — Limitations on CSOS digital certificates
• § 1311.20 — Coordinators for CSOS digital certificate holders
• § 1311.25 — Requirements for obtaining a CSOS digital certificate
• § 1311.30 — Requirements for storing and using a private key for digitally signing orders
• § 1311.35 — Number of CSOS digital certificates needed
• § 1311.40 — Renewal of CSOS digital certificates
• § 1311.45 — Requirements for registrants that allow powers of attorney to obtain CSOS digital certificates under their DEA registration
• § 1311.50 — Requirements for recipients of digitally signed orders
• § 1311.55 — Requirements for systems used to process digitally signed orders
• § 1311.60 — Recordkeeping
• § 1311.100 — General
• § 1311.102 — Practitioner responsibilities
• § 1311.105 — Requirements for obtaining an authentication credential—Individual practitioners
• § 1311.110 — Requirements for obtaining an authentication credential—Individual practitioners eligible to use an electronic prescription application of an institutional practitioner
• § 1311.115 — Additional requirements for two-factor authentication
• § 1311.116 — Additional requirements for biometrics
• § 1311.120 — Electronic prescription application requirements
• § 1311.125 — Requirements for establishing logical access control—Individual practitioner
• § 1311.130 — Requirements for establishing logical access control—Institutional practitioner
• § 1311.135 — Requirements for creating a controlled substance prescription
• § 1311.140 — Requirements for signing a controlled substance prescription
• § 1311.145 — Digitally signing the prescription with the individual practitioner's private key
• § 1311.150 — Additional requirements for internal application audits
• § 1311.170 — Transmission requirements
• § 1311.200 — Pharmacy responsibilities
• § 1311.205 — Pharmacy application requirements
• § 1311.210 — Archiving the initial record
• § 1311.215 — Internal audit trail
• § 1311.300 — Application provider requirements—Third-party audits or certifications
• § 1311.302 — Additional application provider requirements
• § 1311.305 — Recordkeeping

PART 1312

• § 1312.01 — Scope of part 1312
• § 1312.02 — Definitions
• § 1312.03 — Forms applicable to this part
• § 1312.11 — Requirement of authorization to import
• § 1312.12 — Application for import permit; return information
• § 1312.13 — Issuance of import permit
• § 1312.14 — Distribution of import permits
• § 1312.15 — Shipments in greater or less amount than authorized
• § 1312.16 — Amendment, cancellation, expiration of import permit
• § 1312.17 — Special report from importers
• § 1312.18 — Import declaration
• § 1312.19 — Distribution of import declaration
• § 1312.21 — Requirement of authorization to export
• § 1312.22 — Application for export or reexport permit; return information
• § 1312.23 — Issuance of export permit
• § 1312.24 — Distribution of export permit
• § 1312.25 — Amendment, cancellation, expiration of export permit
• § 1312.26 — Records required of exporter
• § 1312.27 — Export/reexport declaration
• § 1312.28 — Distribution of export declaration
• § 1312.29 — Domestic release prohibited
• § 1312.30 — Schedule III, IV, and V non-narcotic controlled substances requiring an import and export permit
• § 1312.31 — Schedule I: Application for prior written approval
• § 1312.32 — Schedules II, III, IV: Advance notice
• § 1312.41 — Hearings generally
• § 1312.42 — Purpose of hearing
• § 1312.43 — Waiver or modification of rules
• § 1312.44 — Request for hearing or appearance; waiver
• § 1312.45 — Burden of proof
• § 1312.46 — Time and place of hearing
• § 1312.47 — Final order

PART 1313

• § 1313.01 — Scope
• § 1313.02 — Definitions
• § 1313.03 — Forms applicable to this part
• § 1313.05 — Requirements for an established business relationship
• § 1313.08 — Requirements for establishing a record as an importer
• § 1313.12 — Notification prior to import
• § 1313.13 — Requirements of import declaration
• § 1313.14 — Disposition of import declaration
• § 1313.15 — Qualification of regular importers
• § 1313.16 — Updated notice for change in circumstances
• § 1313.17 — Return declaration for imports
• § 1313.21 — Notification prior to export
• § 1313.22 — Export declaration
• § 1313.23 — Disposition of export declaration
• § 1313.24 — Waiver of 15-day advance notice for chemical exporters
• § 1313.25 — Foreign import restrictions
• § 1313.26 — Updated notice for change in circumstances
• § 1313.27 — Return declaration for exports
• § 1313.31 — Advance notice of importation for transshipment or transfer
• § 1313.32 — Notification of international transactions
• § 1313.33 — Contents of an international transaction declaration
• § 1313.34 — Disposition of the international transaction declaration
• § 1313.35 — Return declaration or amendment to Form 486 for international transactions
• § 1313.41 — Suspension of shipments
• § 1313.42 — Prohibition of shipments from certain foreign sources
• § 1313.51 — Hearings generally
• § 1313.52 — Purpose of hearing
• § 1313.53 — Waiver of modification of rules
• § 1313.54 — Request for hearing
• § 1313.55 — Burden of proof
• § 1313.56 — Time and place of hearing
• § 1313.57 — Final order

PART 1314

• § 1314.01 — Scope
• § 1314.02 — Applicability
• § 1314.03 — Definitions
• § 1314.05 — Requirements regarding packaging of nonliquid forms
• § 1314.10 — Effect on State laws
• § 1314.15 — Loss reporting
• § 1314.20 — Restrictions on sales quantity
• § 1314.25 — Requirements for retail transactions
• § 1314.30 — Recordkeeping for retail transactions
• § 1314.35 — Training of sales personnel
• § 1314.40 — Self-certification
• § 1314.42 — Self-certification fee; time and method of fee payment
• § 1314.45 — Privacy protections
• § 1314.50 — Employment measures
• § 1314.100 — Sales limits for mail-order sales
• § 1314.101 — Training of sales personnel
• § 1314.102 — Self-certification
• § 1314.103 — Self-certification fee; time and method of fee payment
• § 1314.105 — Verification of identity for mail-order sales
• § 1314.110 — Reports for mail-order sales
• § 1314.115 — Distributions not subject to reporting requirements
• § 1314.150 — Order To show cause
• § 1314.155 — Suspension pending final order

PART 1315

• § 1315.01 — Scope
• § 1315.02 — Definitions
• § 1315.03 — Personal use exemption
• § 1315.05 — Applicability
• § 1315.06 — Assessment of Annual Needs; Types of quotas
• § 1315.07 — Subcategories of manufacturing and procurement quota
• § 1315.11 — Assessment of annual needs
• § 1315.13 — Adjustments of the assessment of annual needs
• § 1315.21 — Individual manufacturing quotas
• § 1315.22 — Procedure for applying for individual manufacturing quotas
• § 1315.23 — Procedure for fixing individual manufacturing quotas
• § 1315.24 — Inventory allowance for individual manufacturing quotas
• § 1315.25 — Increase in individual manufacturing quotas
• § 1315.26 — Reduction in individual manufacturing quotas
• § 1315.27 — Abandonment of quota
• § 1315.30 — Procurement and import quotas
• § 1315.31 — Inventory allowance for procurement quotas
• § 1315.32 — Obtaining a procurement quota
• § 1315.33 — Power of attorney
• § 1315.34 — Obtaining an import quota
• § 1315.36 — Amending an import quota
• § 1315.37 — Abandonment of procurement quota
• § 1315.50 — Hearings generally
• § 1315.52 — Purpose of hearing
• § 1315.54 — Waiver or modification of rules
• § 1315.56 — Request for hearing or appearance; waiver
• § 1315.58 — Burden of proof
• § 1315.60 — Time and place of hearing
• § 1315.62 — Final order

PART 1316

• § 1316.01 — Scope of subpart A
• § 1316.02 — Definitions
• § 1316.03 — Authority to make inspections
• § 1316.04 — Exclusion from inspection
• § 1316.05 — Entry
• § 1316.06 — Notice of inspection
• § 1316.07 — Requirement for administrative inspection warrant; exceptions
• § 1316.08 — Consent to inspection
• § 1316.09 — Application for administrative inspection warrant
• § 1316.10 — Administrative probable cause
• § 1316.11 — Execution of warrants
• § 1316.12 — Refusal to allow inspection with an administrative warrant
• § 1316.13 — Frequency of administrative inspections
• § 1316.21 — Definitions
• § 1316.22 — Exemption
• § 1316.23 — Confidentiality of identity of research subjects
• § 1316.24 — Exemption from prosecution for researchers
• § 1316.31 — Authority for enforcement proceeding
• § 1316.32 — Notice of proceeding; time and place
• § 1316.33 — Conduct of proceeding
• § 1316.34 — Records of proceeding
• § 1316.41 — Scope of subpart D
• § 1316.42 — Definitions
• § 1316.43 — Information; special instructions
• § 1316.44 — Waiver or modification of rules
• § 1316.45 — Filings; address; hours
• § 1316.46 — Inspection of record
• § 1316.47 — Request for hearing; answer
• § 1316.48 — Notice of appearance
• § 1316.49 — Waiver of hearing
• § 1316.50 — Appearance; representation; authorization
• § 1316.51 — Conduct of hearing and parties; ex parte communications
• § 1316.52 — Presiding officer
• § 1316.53 — Time and place of hearing
• § 1316.54 — Prehearing conference
• § 1316.55 — Prehearing ruling
• § 1316.56 — Burden of proof
• § 1316.57 — Submission of documentary evidence and affidavits and identification of witnesses subsequent to prehearing conference
• § 1316.58 — Summary of testimony; affidavits
• § 1316.59 — Submission and receipt of evidence
• § 1316.60 — Objections; offer of proof
• § 1316.61 — Exceptions to rulings
• § 1316.62 — Interlocutory appeals from rulings of the presiding officer
• § 1316.63 — Official transcript; index; corrections
• § 1316.64 — Proposed findings of fact and conclusions of law
• § 1316.65 — Report and record
• § 1316.66 — Exceptions
• § 1316.67 — Final order
• § 1316.68 — Copies of petitions for judicial review

PART 1317

• § 1317.01 — Scope
• § 1317.05 — Registrant disposal
• § 1317.10 — Registrant return or recall
• § 1317.15 — Reverse distributor registration requirements and authorized activities
• § 1317.30 — Authorization to collect from non-registrants
• § 1317.35 — Collection by law enforcement
• § 1317.40 — Registrants authorized to collect and authorized collection activities
• § 1317.55 — Reverse distributor and distributor acquisition of controlled substances from collectors or law enforcement
• § 1317.60 — Inner liner requirements
• § 1317.65 — Take-back events
• § 1317.70 — Mail-back programs
• § 1317.75 — Collection receptacles
• § 1317.80 — Collection receptacles at long-term care facilities
• § 1317.85 — Ultimate user delivery for the purpose of recall or investigational use of drugs
• § 1317.90 — Methods of destruction
• § 1317.95 — Destruction procedures

PART 1318

• § 1318.01 — Scope of this part
• § 1318.02 — Definitions
• § 1318.03 — Implementation of statutory requirements
• § 1318.04 — Specific control measures applicable to the bulk manufacture of marihuana
• § 1318.05 — Application of the public interest factors
• § 1318.06 — Factors affecting prices for the purchase and sale by the Administration of cannabis
• § 1318.07 — Non-liability of Drug Enforcement Administration

PART 1321

• § 1321.01 — DEA mailing addresses

PART 1401

• § 1401.1 — Purpose
• § 1401.2 — The Office of National Drug Control Policy—organization and functions
• § 1401.3 — Definitions
• § 1401.4 — Access to information
• § 1401.5 — Records requiring consultation
• § 1401.6 — How to request records—form and content
• § 1401.7 — Responses—form and content
• § 1401.8 — Expedited process
• § 1401.9 — Extension of time
• § 1401.10 — Appeal procedures
• § 1401.11 — Fees to be charged—general
• § 1401.12 — Fees to be charged—miscellaneous provisions
• § 1401.13 — Fees to be charged—categories of requesters
• § 1401.14 — Restrictions on charging fees
• § 1401.15 — Waiver or reduction of fees
• § 1401.16 — Aggregation of requests
• § 1401.17 — Markings on released documents
• § 1401.18 — Confidential commercial information
• § 1401.19 — Definitions
• § 1401.20 — Purpose and scope
• § 1401.21 — How do I make a Privacy Act request?
• § 1401.22 — How will ONDCP respond to my Privacy Act request?
• § 1401.23 — What can I do if I am dissatisfied with ONDCP's response to my Privacy Act request?
• § 1401.24 — What does it cost to get records under the Privacy Act?

PART 1402

• § 1402.1 — Purpose
• § 1402.2 — Responsibility
• § 1402.3 — Information in the custody of ONDCP
• § 1402.4 — Information classified by another agency
• § 1402.5 — Appeal procedure
• § 1402.6 — Fees
• § 1402.7 — Suggestions and complaints