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Regulations last checked for updates: Nov 22, 2024
Title 21 - Food and Drugs last revised: Nov 19, 2024
All Titles
Title 21
Chapter I
Part 310
Subpart E - Subpart E—Requirements for Specific New Drugs or Devices
§ 310.501 - Patient package inserts for oral contraceptives.
§ 310.502 - Certain drugs accorded new drug status through rulemaking procedures.
§ 310.503 - Requirements regarding certain radioactive drugs.
§ 310.509 - Parenteral drug products in plastic containers.
§ 310.515 - Patient package inserts for estrogens.
§ 310.517 - Labeling for oral hypoglycemic drugs of the sulfonylurea class.
§ 310.518 - Drug products containing iron or iron salts.
§ 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.
§ 310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.
§ 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
§ 310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
§ 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
§ 310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
§ 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
§ 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.
§ 310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
§ 310.536 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.
§ 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.
§ 310.538 - Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
§ 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
§ 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.
§ 310.542 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
§ 310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
§ 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
§ 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
§ 310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.
§ 310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
§ 310.548 - Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.
authority:
21 U.S.C. 321
,
331
,
351
,
352
,
353
,
355
,
360b
,
360j
,
360hh
,
361
,
371
,
374
,
375
,
379e
,
379k
;
42 U.S.C. 216
,
241
,
242
,
262
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