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Subchapter D—Drugs for Human Use

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Subchapter D—Drugs for Human Use SUBCHAPTER DÐDRUGS FOR HUMAN USE PART 300ÐGENERAL priate National Academy of Sciences- National Research Council panel re- Subpart AÐ[Reserved] port, or if substantial evidence of effec- tiveness has not otherwise been pre- Subpart BÐCombination Drugs sented for it, then formulation, label- ing, or dosage changes may be proposed Sec. 300.50 Fixed-combination prescription drugs and any resulting formulation may for humans. meet the appropriate criteria listed in paragraph (a) of this section. Subpart CÐSubstances Generally (c) A fixed-combination prescription Prohibited From Drugs drug for humans that has been deter- mined to be effective for labeled indica- 300.100 Chlorofluorocarbon propellants. tions by the Food and Drug Adminis- tration, based on evaluation of the Subpart AÐ[Reserved] NAS±NRC report on the combination, is considered to be in compliance with Subpart BÐCombination Drugs the requirements of this section. [40 FR 13496, Mar. 27, 1975] AUTHORITY: Secs. 301, 501, 502, 505, 507, 512, 601, 701 of the Federal Food, Drug, and Cos- metic Act (21 U.S.C. 331, 351, 352, 355, 357, Subpart CÐSubstances Generally 360b, 361, 371). 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 humans is as follows: [43 FR 11317, Mar. 17, 1978] (a) Two or more drugs may be com- bined in a single dosage form when PART 310ÐNEW DRUGS each component makes a contribution to the claimed effects and the dosage of Subpart AÐGeneral 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 BÐSpecific 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 or antibiotic monograph Subpart CÐNew Drugs Exempted From has not been recognized as effective by Prescription-Dispensing Requirements the Commissioner of Food and Drugs based on his evaluation of the appro- 310.200 Prescription-exemption procedure. 6 VerDate 29<MAY>97 12:37 Jun 06, 1997 Jkt 174063 PO 00000 Frm 00001 Fmt 8010 Sfmt 8010 21V5.TXT pfrm13 Food and Drug Administration, HHS Pt. 310 310.201 Exemption for certain drugs limited 310.530 Topically applied hormone-contain- by new drug applications to prescription ing drug products for over-the-counter sale. (OTC) human use. 310.531 Drug products containing active in- Subpart DÐRecords and Reports gredients offered over-the-counter (OTC) for the treatment of boils. 310.303 Continuation of long-term studies, 310.532 Drug products containing active in- records, and reports on certain drugs for gredients offered over-the-counter (OTC) which new drug applications have been to relieve the symptoms of benign pros- approved. tatic hypertrophy. 310.305 Records and reports concerning ad- 310.533 Drug products containing active in- verse drug experiences on marketed pre- gredients offered over-the-counter (OTC) scription drugs for human use without for human use as an anticholinergic in approved new drug applications. cough-cold drug products. Subpart EÐRequirements for Specific New 310.534 Drug products containing active in- gredients offered over-the-counter (OTC) Drugs or Devices for human use as oral wound healing 310.500 Digoxin products for oral use; condi- agents. tions for marketing. 310.536 Drug products containing active in- 310.501 Patient package inserts for oral con- gredients offered over-the-counter (OTC) traceptives. for use as a nailbiting or thumbsucking 310.502 Certain drugs accorded new drug sta- deterrent. tus through rulemaking procedures. 310.537 Drug products containing active in- 310.503 Requirements regarding certain ra- gredients offered over±the±counter (OTC) dioactive drugs. for oral administration for the treatment 310.504 Amphetamines (amphetamine, of fever blisters and cold sores. dextroamphetamine, and their salts and 310.538 Drug products containing active in- levamfetamine and its salts) for human gredients offered over-the-counter (OTC) use. for use for ingrown toenail relief. 310.506 Use of vinyl chloride as an ingredi- 310.540 Drug products containing active in- ent, including propellant, of aerosol drug gredients offered over-the-counter (OTC) products. for use as stomach acidifiers. 310.507 Aerosol drug products for human use 310.541 Over-the-counter (OTC) drug prod- containing 1,1,-1-trichloroethane. ucts containing active ingredients of- 310.508 Use of certain halogenated fered for use in the treatment of salicylanilides as an inactive ingredient hypophosphatemia. in drug products. 310.542 Over-the-counter (OTC) drug prod- 310.509 Parenteral drug products in plastic ucts containing active ingredients of- containers. fered for use in the treatment of 310.510 Use of aerosol drug products con- hyperphosphatemia. taining zirconium. 310.543 Drug products containing active in- 310.513 Chloroform, use as an ingredient (ac- gredients offered over-the-counter (OTC) tive or inactive) in drug products. for human use in exocrine pancreatic in- 310.515 Patient package inserts for sufficiency. estrogens. 310.544 Drug products containing active in- 310.516 Progestational drug products; label- gredients offered over-the-counter (OTC) ing directed to the patient. for use as a smoking deterrent. 310.517 Labeling for oral hypoglycemic 310.545 Drug products containing certain ac- drugs of the sulfonylurea class. tive ingredients offered over-the-counter 310.518 Drug products containing iron or (OTC) for certain uses. iron salts. 310.546 Drug products containing active in- 310.519 Drug products marketed as over-the- gredients offered over-the-counter (OTC) counter (OTC) daytime sedatives. for the treatment and/or prevention of 310.525 Sweet spirits of nitre drug products. nocturnal leg muscle cramps. 310.526 Camphorated oil drug products. 310.527 Drug products containing active in- AUTHORITY: Secs. 201, 301, 501, 502, 503, 505, gredients offered over-the-counter (OTC) 506, 507, 512±516, 520, 601(a), 701, 704, 705, 721 of for external use as hair growers or for the Federal Food, Drug, and Cosmetic Act hair loss prevention. (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 310.528 Drug products containing active in- 360b-360f, 360j, 361(a), 371, 374, 375, 379e); secs. gredients offered over-the-counter (OTC) 215, 301, 302(a), 351, 354±360F of the Public for use as an aphrodisiac. Health Service Act (42 U.S.C. 216, 241, 242(a), 310.529 Drug products containing active in- 262, 263b-263n). gredients offered over-the-counter (OTC) for oral use as insect repellents. 7 VerDate 29<MAY>97 12:37 Jun 06, 1997 Jkt 174063 PO 00000 Frm 00002 Fmt 8010 Sfmt 8010 21V5.TXT pfrm13 § 310.3 21 CFR Ch. I (4±1±97 Edition) Subpart AÐGeneral Provisions or other method or duration of admin- istration or application, or different § 310.3 Definitions and interpretations. condition, is not a new drug. As used in this part: (i) [Reserved] (a) The term act means the Federal (j) The term sponsor means the per- Food, Drug, and Cosmetic Act, as son or agency who assumes responsibil- amended (secs. 201±902, 52 Stat. 1040 et ity for an investigation of a new drug, seq., as amended; 21 U.S.C. 321±392). including responsibility for compliance (b) Department means the Department with applicable provisions of the act of Health and Human Services. and regulations. The ``sponsor'' may be (c) Secretary means the Secretary of an individual, partnership, corporation, Health and Human Services. or Government agency and may be a (d) Commissioner means the Commis- manufacturer, scientific institution, or sioner of Food and Drugs. an investigator regularly and lawfully (e) The term person includes individ- engaged in the investigation of new uals, partnerships, corporations, and drugs. associations. (k) The phrase related drug(s) includes (f) The definitions and interpreta- other brands, potencies, dosage forms, tions of terms contained in section 201 salts, and esters of the same drug moi- of the act shall be applicable to such ety, including articles prepared or terms when used in the regulations in manufactured by other manufacturers: this part. and any other drug containing a com- (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
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