Title 21, Part 310 — New Drugs

Definitions and interpretations.

Biologics; products subject to license control.

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.

New drug status opinions; statement of policy.

New drug substances intended for hypersensitivity testing.

Prescription-exemption procedure.

Exemption for certain drugs limited by new-drug applications to prescription sale.

Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.

Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.

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.