Requirements for Specific New Drugs or Devices

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. New Drugs
  7. Requirements for Specific New Drugs or Devices

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Section
310.501

Patient package inserts for oral contraceptives.

Section
310.502

Certain drugs accorded new drug status through rulemaking procedures.

Section
310.503

Requirements regarding certain radioactive drugs.

Section
310.509

Parenteral drug products in plastic containers.

Section
310.515

Patient package inserts for estrogens.

Section
310.517

Labeling for oral hypoglycemic drugs of the sulfonylurea class.

Section
310.518

Drug products containing iron or iron salts.

Section
310.519

Drug products marketed as over-the-counter (OTC) daytime sedatives.

Section
310.527

Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.

Section
310.528

Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.

Section
310.529

Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.

Section
310.530

Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

Section
310.531

Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.

Section
310.532

Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.

Section
310.533

Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.

Section
310.534

Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.

Section
310.536

Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.

Section
310.537

Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.

Section
310.538

Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.

Section
310.540

Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.

Section
310.541

Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.

Section
310.542

Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.

Section
310.543

Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.

Section
310.544

Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.

Section
310.545

Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

Section
310.546

Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.

Section
310.547

Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.

Section
310.548

Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.