Title 21

PART 310 SUBPART E

Subpart E - Requirements for Specific New Drugs or Devices

• 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.

21:5.0.1.1.2.5.1.1	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.

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