21 CFR Part 310
PART 310—NEW DRUGS
- PART 310—NEW DRUGS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter D—Drugs for Human Use
- 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.
- § 310.103 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
- § 310.305 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.
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