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FEDERAL · 21 CFR

Part 310 — New Drugs

37 sections · Title 21: Food and Drugs

§ 310.3Definitions and interpretations.
§ 310.4Biologics; products subject to license control.
§ 310.6Applicability 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.
§ 310.100New drug status opinions; statement of policy.
§ 310.103New drug substances intended for hypersensitivity testing.
§ 310.200Prescription-exemption procedure.
§ 310.201Exemption for certain drugs limited by new-drug applications to prescription sale.
§ 310.305Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
§ 310.306Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.
§ 310.501Patient package inserts for oral contraceptives.
§ 310.502Certain drugs accorded new drug status through rulemaking procedures.
§ 310.503Requirements regarding certain radioactive drugs.
§ 310.509Parenteral drug products in plastic containers.
§ 310.515Patient package inserts for estrogens.
§ 310.517Labeling for oral hypoglycemic drugs of the sulfonylurea class.
§ 310.518Drug products containing iron or iron salts.
§ 310.519Drug products marketed as over-the-counter (OTC) daytime sedatives.
§ 310.527Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.
§ 310.528Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
§ 310.529Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
§ 310.530Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
§ 310.531Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
§ 310.532Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
§ 310.533Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.
§ 310.534Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
§ 310.536Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.
§ 310.537Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.
§ 310.538Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
§ 310.540Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
§ 310.541Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.
§ 310.542Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
§ 310.543Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
§ 310.544Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
§ 310.545Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
§ 310.546Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.
§ 310.547Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
§ 310.548Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.