C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 310—NEW DRUGS › Subpart A—General Provisions

21 C.F.R. § 310.3

Definitions and interpretations

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

As used in this part:

(a) The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).

(b) Department means the Department of Health and Human Services.

(c) Secretary means the Secretary of Health and Human Services.

(d) Commissioner means the Commissioner of Food and Drugs.

(e) The term person includes individuals, partnerships, corporations, and associations.

(f) The definitions and interpretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part.

(g) New drug substance means any substance that when used in the manufacture, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substance.

(h) The newness of a drug may arise by reason (among other reasons) of:

(1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component.

(2) The newness for a drug use of a combination of two or more substances, none of which is a new drug.

(3) The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new drug.

(4) The newness of use of such drug in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect another structure or function of the body.

(5) The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug.

(i) [Reserved]

(j) The term sponsor means the person or agency who assumes responsibility for an investigation of a new drug, including responsibility for compliance with applicable provisions of the act and regulations. The “sponsor” may be an individual, partnership, corporation, or Government agency and may be a manufacturer, scientific institution, or an investigator regularly and lawfully engaged in the investigation of new drugs.

(k) The phrase related drug(s) includes other brands, potencies, dosage forms, salts, and esters of the same drug moiety, including articles prepared or manufactured by other manufacturers: and any other drug containing a component so related by chemical structure or known pharmacological properties that, in the opinion of experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, it is prudent to assume or ascertain the liability of similar side effects and contraindications.

(l) Special packaging as defined in section 2(4) of the Poison Prevention Packaging Act of 1970 means packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.

(m) [Reserved]

(n) The term radioactive drug means any substance defined as a drug in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term “radioactive drug” includes a “radioactive biological product” as defined in § 600.3(ee) of this chapter.

[39 FR 11680, Mar. 29, 1974, as amended at 39 FR 20484, June 11, 1974; 40 FR 31307, July 25, 1975; 46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985]
Notes of Decisions
Cited in 27 cases (1 in the last 5 years), 1977–2025 · leading case: Wyeth v. Levine, 555 U.S. 555 (2009).
Sort: Relevance Newest Treatment
Wyeth v. Levine, 555 U.S. 555 (2009). · cites it 2× “§ 321 (p)(1) (defining "new drug"); 21 CFR § 310.3 (h). Nor would this warning have rendered Phenergan misbranded.”
Thompson v. W. States Med. Ctr., 535 U.S. 357 (2002). · cites it 2× “See 21 CFR § 310.3 (h) (2002) (defining “new drug” broadly).”
Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013). · cites it 2× “See 21 C.F.R. § 310.3 (h) (giving examples of when the FDA considers a drug to be new, including cases involving "newness for drug use of any substance which composes such drug, in whole or in part").”
Trejo v. Johnson, 220 Cal. Rptr. 3d 127 (Cal. Ct. App. 5th 2017). · cites it 2× “§ 355 , 21 C.F.R. §§ 310.3 and 314.70, and Bartlett -defendants could not unilaterally change the chemical composition of Motrin from ibuprofen to dexibuprofen in order to satisfy consumer expectations or to increase the benefits or decrease the risks of Motrin.”
Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013). · cites it 2× “See 21 CFR §310.3 (h) (giving examples of when the FDA considers a drug to be new, including cases involving “newness for drug use of any Cite as: 570 U.”
United States v. Baxter Healthcare Corp., & Glaxo Specialties, Inc., a Corp., Intervenor/defendant-Appellant, 901 F.2d 1401 (7th Cir. 1990). · cites it 3× “” 21 C.F.R. § 310.3 (h)(3), (5). The wording of this regulation suggests that the concerns raised by the FDA in this case are not imaginary obstacles, but part of a policy designed to effectuate the FDCA.”
Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359 (Fed. Cir. 2010). · cites it 2× “§ 355 (b)(1), a term which encompasses a new use for an existing drug, see 21 C.F.R. § 310.3 (h)(4). The application requires that the manufacturer specify the drug (or drugs) in question and the proposed method (or methods) of use.”
Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009). “§ 321 (p)(l) and 21 C.F.R. § 310.3 (h)) and, second, Nor would this warning have rendered [the drug] misbranded.”
Professionals & Patients for Customized Care v. Shalala, 56 F.3d 592 (5th Cir. 1995). “If a pharmacy compounds finished drugs from bulk active ingredient materials considered to be unapproved new drug substances, as defined in 21 CFR 310.3(g), such activity must be covered by an FDA-sanctioned investigational new drug appli *594 cation (IND) that is in effect in…”
United States v. Premo Pharm. Labs., Inc., 511 F. Supp. 958 (D.N.J. 1981). · cites it 2× “21 C.F.R. § 310.3 (h)(1) — (5) (1980) (emphasis added).”
United States v. Articles of Drug, Etc. Appeal of the Lannett Co., Inc, 585 F.2d 575 (3rd Cir. 1978). “21 C.F.R. § 310.3 (h)(l)-(5) (1977). A close reading of the FDA’s “new drug” regulation indicates that newness is a function of the novelty of a particular formulation, including a novel composition, combination, dosage, or administration.”
United States v. X-Otag Plus Tablets, 441 F. Supp. 105 (D. Colo. 1977). “21 C.F.R. 310.3(h)(2) and (3). These regulations raise two issues as to combination drugs.”
Show all 27 citing cases →
— 21 C.F.R. § 310.3(g) — 2 cases
Professionals & Patients for Customized Care v. Shalala, 56 F.3d 592 (5th Cir. 1995). “If a pharmacy compounds finished drugs from bulk active ingredient materials considered to be unapproved new drug substances, as defined in 21 CFR 310.3(g), such activity must be covered by an FDA-sanctioned investigational new drug appli *594 cation (IND) that is in effect in…”
In Re Establishment Inspection Of: Wedgewood Vill. Pharmacy, Inc., 270 F. Supp. 2d 525 (D.N.J. 2003).
— 21 C.F.R. § 310.3(h)(1) — 2 cases
Trejo v. Johnson, 220 Cal. Rptr. 3d 127 (Cal. Ct. App. 5th 2017). “§ 355 , 21 C.F.R. §§ 310.3 and 314.70, and Bartlett -defendants could not unilaterally change the chemical composition of Motrin from ibuprofen to dexibuprofen in order to satisfy consumer expectations or to increase the benefits or decrease the risks of Motrin.”
Trejo v. Johnson & Johnson (Cal. Ct. App. 2017).
— 21 C.F.R. § 310.3(h)(2) — 1 case
United States v. X-Otag Plus Tablets, 441 F. Supp. 105 (D. Colo. 1977). “21 C.F.R. 310.3(h)(2) and (3). These regulations raise two issues as to combination drugs.”
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.