Subpart A - General Provisions

§ 310.3 - Definitions and interpretations.

§ 310.4 - Biologics; products subject to license control.

§ 310.6 - 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.

Subpart B - Specific Administrative Rulings and Decisions

§ 310.100 - New drug status opinions; statement of policy.

§ 310.101 - FD&C Red No. 4; procedure for discontinuing use in new drugs for ingestion; statement of policy.

§ 310.103 - New drug substances intended for hypersensitivity testing.

Subpart C - New Drugs Exempted From Prescription-Dispensing Requirements

§ 310.200 - Prescription-exemption procedure.

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

Subpart D - Records and Reports

§ 310.303 - Continuation of long-term studies, records, and reports on certain drugs for which new drug applications have been approved.

§ 310.304 - Drugs that are subjects of approved new drug applications and that require special studies, records, and reports.

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

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

Subpart E - Requirements for Specific New Drugs or Devices

§ 310.500 - Digoxin products for oral use; conditions for marketing.

§ 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.

§ 310.504 - Amphetamines (amphetamine, dextroamphetamine, and their salts and levamfetamine and its salts) for human use.

§ 310.506 - Use of vinyl chloride as an ingredient, including propellant, of aerosol drug products.

§ 310.507 - Aerosol drug products for human use containing 1,1,1-trichloroethane.

§ 310.508 - Use of certain halogenated salicylanilides as an inactive ingredient in drug products.

§ 310.509 - Parenteral drug products in plastic containers.

§ 310.510 - Use of aerosol drug products containing zirconium.

§ 310.513 - Chloroform, use as an ingredient (active or inactive) in drug products.

§ 310.515 - Patient package inserts for estrogens.

§ 310.516 - Progestational drug products; labeling directed to the patient.

§ 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.

§ 310.525 - Sweet spirits of nitre drug products.

§ 310.526 - Camphorated oil drug products.

§ 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.