Part 310 — New Drugs
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
Subpart C — New Drugs Exempted From Prescription-Dispensing Requirements
Subpart D — 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
- § 310.501— Patient package inserts for oral contraceptives.
- § 310.502— Certain drugs accorded new drug status through rulemaking procedures.
- § 310.503— Requirements regarding certain radioactive drugs.
- § 310.509— Parenteral drug products in plastic containers.
- § 310.515— Patient package inserts for estrogens.
- § 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.
- § 310.527— 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.