PocketLaw | CFR 21 | Requirements for Specific New Drugs or Devices

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

Requirements for Specific New Drugs or Devices

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Patient package inserts for oral contraceptives.

Certain drugs accorded new drug status through rulemaking procedures.

Requirements regarding certain radioactive drugs.

Parenteral drug products in plastic containers.

Patient package inserts for estrogens.

Labeling for oral hypoglycemic drugs of the sulfonylurea class.

Drug products containing iron or iron salts.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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