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Subchapter D—Drugs for Human Use

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Subchapter D—Drugs for Human Use SUBCHAPTER D—DRUGS FOR HUMAN USE PART 300—GENERAL presented for it, then formulation, la- beling, or dosage changes may be pro- Subpart A [Reserved] posed and any resulting formulation may meet the appropriate criteria list- Subpart B—Combination Drugs ed in paragraph (a) of this section. (c) A fixed-combination prescription Sec. 300.50 Fixed-combination prescription drugs drug for humans that has been deter- for humans. mined to be effective for labeled indica- tions by the Food and Drug Adminis- Subpart C—Substances Generally tration, based on evaluation of the Prohibited From Drugs NAS-NRC report on the combination, is considered to be in compliance with 300.100 Chlorofluorocarbon propellants. the requirements of this section. AUTHORITY: 21 U.S.C. 331, 351, 352, 355, 360b, 361, 371. [40 FR 13496, Mar. 27, 1975, as amended at 64 FR 401, Jan. 5, 1999] Subpart A [Reserved] Subpart C—Substances Generally Subpart B—Combination Drugs Prohibited From Drugs § 300.50 Fixed-combination prescrip- § 300.100 Chlorofluorocarbon propel- tion drugs for humans. lants. The Food and Drug Administration’s The use of chlorofluorocarbons in policy in administering the new-drug, human drugs as propellants in self- antibiotic, and other regulatory provi- pressurized containers is generally pro- sions of the Federal Food, Drug, and hibited except as provided by § 2.125 of Cosmetic Act regarding fixed combina- this chapter. tion dosage form prescription drugs for [43 FR 11317, Mar. 17, 1978] humans is as follows: (a) Two or more drugs may be com- bined in a single dosage form when PART 310—NEW DRUGS each component makes a contribution to the claimed effects and the dosage of Subpart A—General Provisions each component (amount, frequency, Sec. duration) is such that the combination 310.3 Definitions and interpretations. is safe and effective for a significant 310.4 Biologics; products subject to license patient population requiring such con- control. current therapy as defined in the label- 310.6 Applicability of ‘‘new drug’’ or safety ing for the drug. Special cases of this or effectiveness findings in drug efficacy general rule are where a component is study implementation notices and no- added: tices of opportunity for hearing to iden- (1) To enhance the safety or effec- tical, related, and similar drug products. tiveness of the principal active compo- Subpart B—Specific Administrative Rulings nent; and and Decisions (2) To minimize the potential for abuse of the principal active compo- 310.100 New drug status opinions; statement nent. of policy. (b) If a combination drug presently 310.103 New drug substances intended for the subject of an approved new-drug hypersensitivity testing. application has not been recognized as effective by the Commissioner of Food Subpart C—New Drugs Exempted From and Drugs based on his evaluation of Prescription-Dispensing Requirements the appropriate National Academy of 310.200 Prescription-exemption procedure. Sciences-National Research Council 310.201 Exemption for certain drugs limited panel report, or if substantial evidence by new drug applications to prescription of effectiveness has not otherwise been sale. 5 VerDate Mar<15>2010 13:22 May 12, 2011 Jkt 223069 PO 00000 Frm 00015 Fmt 8010 Sfmt 8010 Y:\SGML\223069.XXX 223069 WReier-Aviles on DSKGBLS3C1PROD with CFR § 310.3 21 CFR Ch. I (4–1–11 Edition) Subpart D—Records and Reports 310.538 Drug products containing active in- gredients offered over-the-counter (OTC) 310.303 Continuation of long-term studies, for use for ingrown toenail relief. records, and reports on certain drugs for 310.540 Drug products containing active in- which new drug applications have been gredients offered over-the-counter (OTC) approved. for use as stomach acidifiers. 310.305 Records and reports concerning ad- 310.541 Over-the-counter (OTC) drug prod- verse drug experiences on marketed pre- ucts containing active ingredients of- scription drugs for human use without fered for use in the treatment of hypo- approved new drug applications. phosphatemia. 310.542 Over-the-counter (OTC) drug prod- Subpart E—Requirements for Specific New ucts containing active ingredients of- Drugs or Devices fered for use in the treatment of hyper- phosphatemia. 310.501 Patient package inserts for oral con- 310.543 Drug products containing active in- traceptives. gredients offered over-the-counter (OTC) 310.502 Certain drugs accorded new drug sta- for human use in exocrine pancreatic in- tus through rulemaking procedures. sufficiency. 310.503 Requirements regarding certain ra- 310.544 Drug products containing active in- dioactive drugs. gredients offered over-the-counter (OTC) 310.509 Parenteral drug products in plastic for use as a smoking deterrent. containers. 310.545 Drug products containing certain ac- 310.515 Patient package inserts for estro- tive ingredients offered over-the-counter gens. (OTC) for certain uses. 310.517 Labeling for oral hypoglycemic 310.546 Drug products containing active in- drugs of the sulfonylurea class. gredients offered over-the-counter (OTC) 310.518 Drug products containing iron or for the treatment and/or prevention of iron salts. nocturnal leg muscle cramps. 310.519 Drug products marketed as over-the- counter (OTC) daytime sedatives. 310.547 Drug products containing quinine of- fered over-the-counter (OTC) for the 310.527 Drug products containing active in- treatment and/or prevention of malaria. gredients offered over-the-counter (OTC) for external use as hair growers or for 310.548 Drug products containing colloidal hair loss prevention. silver ingredients or silver salts offered 310.528 Drug products containing active in- over-the-counter (OTC) for the treatment gredients offered over-the-counter (OTC) and/or prevention of disease. for use as an aphrodisiac. AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353, 310.529 Drug products containing active in- 355, 360b–360f, 360j, 361(a), 371, 374, 375, 379e; 42 gredients offered over-the-counter (OTC) U.S.C. 216, 241, 242(a), 262, 263b–263n. for oral use as insect repellents. 310.530 Topically applied hormone-con- taining drug products for over-the- Subpart A—General Provisions counter (OTC) human use. 310.531 Drug products containing active in- § 310.3 Definitions and interpretations. gredients offered over-the-counter (OTC) As used in this part: for the treatment of boils. 310.532 Drug products containing active in- (a) The term act means the Federal gredients offered over-the-counter (OTC) Food, Drug, and Cosmetic Act, as to relieve the symptoms of benign pros- amended (secs. 201–902, 52 Stat. 1040 et tatic hypertrophy. seq., as amended; 21 U.S.C. 321–392). 310.533 Drug products containing active in- (b) Department means the Department gredients offered over-the-counter (OTC) of Health and Human Services. for human use as an anticholinergic in (c) Secretary means the Secretary of cough-cold drug products. 310.534 Drug products containing active in- Health and Human Services. gredients offered over-the-counter (OTC) (d) Commissioner means the Commis- for human use as oral wound healing sioner of Food and Drugs. agents. (e) The term person includes individ- 310.536 Drug products containing active in- uals, partnerships, corporations, and gredients offered over-the-counter (OTC) associations. for use as a nailbiting or thumbsucking (f) The definitions and interpreta- deterrent. 310.537 Drug products containing active in- tions of terms contained in section 201 gredients offered over-the-counter (OTC) of the act shall be applicable to such for oral administration for the treatment terms when used in the regulations in of fever blisters and cold sores. this part. 6 VerDate Mar<15>2010 13:22 May 12, 2011 Jkt 223069 PO 00000 Frm 00016 Fmt 8010 Sfmt 8010 Y:\SGML\223069.XXX 223069 WReier-Aviles on DSKGBLS3C1PROD with CFR Food and Drug Administration, HHS § 310.4 (g) New drug substance means any ponent so related by chemical struc- substance that when used in the manu- ture or known pharmacological prop- facture, processing, or packing of a erties that, in the opinion of experts drug, causes that drug to be a new qualified by scientific training and ex- drug, but does not include intermedi- perience to evaluate the safety and ef- ates used in the synthesis of such sub- fectiveness of drugs, it is prudent to as- stance. sume or ascertain the liability of simi- (h) The newness of a drug may arise lar side effects and contraindications. by reason (among other reasons) of: (l) Special packaging as defined in sec- (1) The newness for drug use of any tion 2(4) of the Poison Prevention substance which composes such drug, Packaging Act of 1970 means packaging in whole or in part, whether it be an that is designed or constructed to be active substance or a menstruum, ex- significantly difficult for children cipient, carrier, coating, or other com- under 5 years of age to open or obtain ponent. a toxic or harmful amount of the sub- (2) The newness for a drug use of a stance contained therein within a rea- combination of two or more sub- sonable time and not difficult for nor- stances, none of which is a new drug. mal adults to use properly, but does (3) The newness for drug use of the not mean packaging which all such proportion of a substance in a combina- children cannot open or obtain a toxic tion, even though such combination or harmful amount within a reasonable containing such substance in other pro- time. portion is not a new drug. (m) [Reserved] (4) The newness of use of such drug in (n) The term radioactive drug means diagnosing, curing, mitigating, treat- any substance defined as a drug in sec- ing, or preventing a disease, or to af- tion 201(g)(1) of the Federal Food, fect a structure or function of the Drug, and Cosmetic Act which exhibits body, even though such drug is not a spontaneous disintegration of unstable new drug when used in another disease nuclei with the emission of nuclear or to affect another structure or func- particles or photons and includes any tion of the body.
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