Title 21

PART 310 Part 310 - New Drugs

PART 310 - NEW DRUGS Authority:21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-l; 42 U.S.C. 216, 241, 242(a), 262.

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-l; 42 U.S.C. 216, 241, 242(a), 262.

21:5.0.1.1.2.1	SUBPART A	Subpart A - General Provisions
21:5.0.1.1.2.1.1.1	SECTION 310.3	310.3 Definitions and interpretations.
21:5.0.1.1.2.1.1.2	SECTION 310.4	310.4 Biologics; products subject to license control.
21:5.0.1.1.2.1.1.3	SECTION 310.6	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.
21:5.0.1.1.2.2	SUBPART B	Subpart B - Specific Administrative Rulings and Decisions
21:5.0.1.1.2.2.1.1	SECTION 310.100	310.100 New drug status opinions; statement of policy.
21:5.0.1.1.2.2.1.2	SECTION 310.103	310.103 New drug substances intended for hypersensitivity testing.
21:5.0.1.1.2.3	SUBPART C	Subpart C - New Drugs Exempted From Prescription-Dispensing Requirements
21:5.0.1.1.2.3.1.1	SECTION 310.200	310.200 Prescription-exemption procedure.
21:5.0.1.1.2.3.1.2	SECTION 310.201	310.201 Exemption for certain drugs limited by new-drug applications to prescription sale.
21:5.0.1.1.2.4	SUBPART D	Subpart D - Records and Reports
21:5.0.1.1.2.4.1.1	SECTION 310.305	310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
21:5.0.1.1.2.4.1.2	SECTION 310.306	310.306 Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.
21:5.0.1.1.2.5	SUBPART E	Subpart E - Requirements for Specific New Drugs or Devices
21:5.0.1.1.2.5.1.1	SECTION 310.501	310.501 Patient package inserts for oral contraceptives.
21:5.0.1.1.2.5.1.2	SECTION 310.502	310.502 Certain drugs accorded new drug status through rulemaking procedures.
21:5.0.1.1.2.5.1.3	SECTION 310.503	310.503 Requirements regarding certain radioactive drugs.
21:5.0.1.1.2.5.1.4	SECTION 310.509	310.509 Parenteral drug products in plastic containers.
21:5.0.1.1.2.5.1.5	SECTION 310.515	310.515 Patient package inserts for estrogens.
21:5.0.1.1.2.5.1.6	SECTION 310.517	310.517 Labeling for oral hypoglycemic drugs of the sulfonylurea class.
21:5.0.1.1.2.5.1.7	SECTION 310.518	310.518 Drug products containing iron or iron salts.
21:5.0.1.1.2.5.1.8	SECTION 310.519	310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives.
21:5.0.1.1.2.5.1.9	SECTION 310.527	310.527 Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.
21:5.0.1.1.2.5.1.10	SECTION 310.528	310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
21:5.0.1.1.2.5.1.11	SECTION 310.529	310.529 Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
21:5.0.1.1.2.5.1.12	SECTION 310.530	310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
21:5.0.1.1.2.5.1.13	SECTION 310.531	310.531 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
21:5.0.1.1.2.5.1.14	SECTION 310.532	310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
21:5.0.1.1.2.5.1.15	SECTION 310.533	310.533 Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.
21:5.0.1.1.2.5.1.16	SECTION 310.534	310.534 Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
21:5.0.1.1.2.5.1.17	SECTION 310.536	310.536 Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.
21:5.0.1.1.2.5.1.18	SECTION 310.537	310.537 Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.
21:5.0.1.1.2.5.1.19	SECTION 310.538	310.538 Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
21:5.0.1.1.2.5.1.20	SECTION 310.540	310.540 Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
21:5.0.1.1.2.5.1.21	SECTION 310.541	310.541 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.
21:5.0.1.1.2.5.1.22	SECTION 310.542	310.542 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
21:5.0.1.1.2.5.1.23	SECTION 310.543	310.543 Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
21:5.0.1.1.2.5.1.24	SECTION 310.544	310.544 Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
21:5.0.1.1.2.5.1.25	SECTION 310.545	310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
21:5.0.1.1.2.5.1.26	SECTION 310.546	310.546 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.
21:5.0.1.1.2.5.1.27	SECTION 310.547	310.547 Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
21:5.0.1.1.2.5.1.28	SECTION 310.548	310.548 Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.