C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 208—MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS › Subpart A—General Provisions

21 C.F.R. § 208.3

Definitions

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

For the purposes of this part, the following definitions shall apply:

(a) Authorized dispenser means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice.

(b) Dispense to patients means the act of delivering a prescription drug product to a patient or an agent of the patient either:

(1) By a licensed practitioner or an agent of a licensed practitioner, either directly or indirectly, for self-administration by the patient, or the patient's agent, or outside the licensed practitioner's direct supervision; or

(2) By an authorized dispenser or an agent of an authorized dispenser under a lawful prescription of a licensed practitioner.

(c) Distribute means the act of delivering, other than by dispensing, a drug product to any person.

(d) Distributor means a person who distributes a drug product.

(e) Drug product means a finished dosage form, e.g., tablet, capsule, or solution, that contains an active drug ingredient, generally, but not necessarily, in association with inactive ingredients. For purposes of this part, drug product also means biological product within the meaning of section 351(a) of the Public Health Service Act.

(f) Licensed practitioner means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to prescribe drug products in the course of professional practice.

(g) Manufacturer means for a drug product that is not also a biological product, both the manufacturer as described in § 201.1 and the applicant as described in § 314.3(b) of this chapter, and for a drug product that is also a biological product, the manufacturer as described in § 600.3(t) of this chapter.

(h) Medication Guide means FDA-approved patient labeling conforming to the specifications set forth in this part and other applicable regulations.

(i) Packer means a person who packages a drug product.

(j) Patient means any individual with respect to whom a drug product is intended to be, or has been, used.

(k) Serious risk or serious adverse effect means an adverse drug experience, or the risk of such an experience, as that term is defined in §§ 310.305, 312.32, 314.80, and 600.80 of this chapter.

Notes of Decisions
Cited in 5 cases (2 in the last 5 years), 2012–2022 · leading case: Frazier v. Mylan Inc., 911 F. Supp. 2d 1285 (N.D. Ga. 2012).
Sort: Relevance Newest Treatment
Frazier v. Mylan Inc., 911 F. Supp. 2d 1285 (N.D. Ga. 2012). “See 21 C.F.R. §§ 208.3 (h), 208.24(b). Plaintiff asserts that Dilantin met the requirements for issuing a medication guide and had Pfizer “instituted” a medication guide “advising the decedent of the risks” associated with Dilantin, the decedent “would likely still be alive.”
Abortion Statutory Interpretation –Whether Section 20-208 of the Health-Gen. Article Prohibits Nurse Practitioners, Certified Nurse Midwives, & Physician Assistants from Providing Medication Abortions – Whether the Same Statute Prohibits Physician Assistants from Performing Surgical Abortions (Md. Att'y Gen. 2020). “” 21 C.F.R. § 208.3 (b). That definition is somewhat different than the definition of “dispense” under Maryland law, which is “the procedure which results in the receipt of a prescription or nonprescription drug or device by a patient or the patient’s agency and which entails…”
Abortion Statutory Interpretation –Whether Section 20-208 of the Health-Gen. Article Prohibits Nurse Practitioners, Certified Nurse Midwives, & Physician Assistants from Providing Medication Abortions – Whether the Same Statute Prohibits Physician Assistants from Performing Surgical Abortions (Md. Att'y Gen. 2020). “” 21 C.F.R. § 208.3 (b). That definition is somewhat different than the definition of “dispense” under Maryland law, which is “the procedure which results in the receipt of a prescription or nonprescription drug or device by a patient or the patient’s agency and which entails…”
Amiodarone Cases (Cal. Ct. App. 2022). “( 21 C.F.R. § 208.3 (h).) Patient labeling is required when the FDA determines that such labeling is necessary to patients’ safe and effective use of drug products because it could help prevent serious adverse side effects from the drug, or because the drug has serious risks…”
Roncal v. Aurobindo Pharma USA, Inc. (D.N.J. 2022). “Medication Guides are “FDA-approved patient labeling,” 21 C.F.R. § 208.3 (h), that must be written “in nontechnical, understandable language,” describe “the particular serious and significant public health concern that has created the need for the Medication Guide,” 21 C.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.