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- 21 CFR 226.80 · Packaging and labeling.
- 21 CFR 226.102 · Master-formula and batch-production records.
- 21 CFR 226.110 · Distribution records.
- 21 CFR 226.115 · Complaint files.
- 21 CFR 230.1 · Scope of this part.
- 21 CFR 230.2 · Purpose.
- 21 CFR 230.3 · Definitions.
- 21 CFR 230.50 · General requirements for all submission types.
- 21 CFR 230.65 · Withdrawal by the applicant of a certification request before it is deemed granted.
- 21 CFR 230.70 · Supplements and other changes to a granted certification.
- 21 CFR 230.72 · Change in ownership of a granted certification.
- 21 CFR 230.80 · Annual report.
- 21 CFR 230.100 · FDA review of submissions.
- 21 CFR 230.105 · When a submission is deemed granted.
- 21 CFR 230.150 · Withdrawal or revocation of approval of an application.
- 21 CFR 230.205 · Field alert reports.
- 21 CFR 230.210 · General reporting requirements for designated medical gas adverse events.
- 21 CFR 230.220 · Human designated medical gas ICSR requirements.
- 21 CFR 230.230 · Animal designated medical gas adverse event reporting requirements.
- 21 CFR 250.11 · Thyroid-containing drug preparations intended for treatment of obesity in humans.
- 21 CFR 250.12 · Stramonium preparations labeled with directions for use in self-medication regarded as misbranded.
- 21 CFR 250.100 · Amyl nitrite inhalant as a prescription drug for human use.
- 21 CFR 250.101 · Amphetamine and methamphetamine inhalers regarded as prescription drugs.
- 21 CFR 250.102 · Drug preparations intended for human use containing certain “coronary vasodilators”.
- 21 CFR 250.103-250.104 · §§ 250.103-250.104 [Reserved]
- 21 CFR 250.105 · Gelsemium-containing preparations regarded as prescription drugs.
- 21 CFR 250.106-250.107 · §§ 250.106-250.107 [Reserved]
- 21 CFR 250.108 · Potassium permanganate preparations as prescription drugs.
- 21 CFR 250.201 · Preparations for the treatment of pernicious anemia.
- 21 CFR 250.250 · Hexachlorophene, as a component of drug and cosmetic products.
- 21 CFR 251.1 · Scope of the part.
- 21 CFR 251.2 · Definitions.
- 21 CFR 251.3 · SIP proposal submission requirements.
- 21 CFR 251.4 · Review and authorization of importation program proposals.
- 21 CFR 251.5 · Pre-Import Request.
- 21 CFR 251.6 · Termination of authorized importation programs.
- 21 CFR 251.7 · Suspension and revocation of authorized importation programs.
- 21 CFR 251.8 · Modification or extension of authorized importation programs.
- 21 CFR 251.9 · Registration of Foreign Sellers.
- 21 CFR 251.10 · Reviewing and updating registration information for Foreign Sellers.
- 21 CFR 251.11 · Official contact and U.S. agent for Foreign Sellers.
- 21 CFR 251.12 · Importer responsibilities.
- 21 CFR 251.13 · Labeling of eligible prescription drugs.
- 21 CFR 251.14 · Supply chain security requirements for eligible prescription drugs.
- 21 CFR 251.15 · Qualifying laboratory requirements.
- 21 CFR 251.16 · Laboratory testing requirements.
- 21 CFR 251.17 · Importation requirements.
- 21 CFR 251.18 · Post-importation requirements.
- 21 CFR 251.19 · Reports to FDA.
- 21 CFR 251.20 · Severability.
- 21 CFR 251.21 · Consequences for violations.
- 21 CFR 290.1 · Controlled substances.
- 21 CFR 290.2 · Exemption from prescription requirements.
- 21 CFR 290.5 · Drugs; statement of required warning.
- 21 CFR 290.6 · Spanish-language version of required warning.
- 21 CFR 290.10 · Definition of emergency situation.
- 21 CFR 299.3 · Definitions and interpretations.
- 21 CFR 299.4 · Established names for drugs.
- 21 CFR 299.5 · Drugs; compendial name.
- 21 CFR 300.50 · Fixed-combination prescription drugs for humans.
- 21 CFR 300.100 · Chlorofluorocarbon propellants.
- 21 CFR 300.200 · Annual summary requirements under the Right to Try Act.
- 21 CFR 310.3 · Definitions and interpretations.
- 21 CFR 310.4 · Biologics; products subject to license control.
- 21 CFR 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.
- 21 CFR 310.100 · New drug status opinions; statement of policy.
- 21 CFR 310.103 · New drug substances intended for hypersensitivity testing.
- 21 CFR 310.200 · Prescription-exemption procedure.
- 21 CFR 310.201 · Exemption for certain drugs limited by new-drug applications to prescription sale.
- 21 CFR 310.305 · Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
- 21 CFR 310.306 · Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.
- 21 CFR 310.501 · Patient package inserts for oral contraceptives.
- 21 CFR 310.502 · Certain drugs accorded new drug status through rulemaking procedures.
- 21 CFR 310.503 · Requirements regarding certain radioactive drugs.
- 21 CFR 310.509 · Parenteral drug products in plastic containers.
- 21 CFR 310.515 · Patient package inserts for estrogens.
- 21 CFR 310.517 · Labeling for oral hypoglycemic drugs of the sulfonylurea class.
- 21 CFR 310.518 · Drug products containing iron or iron salts.
- 21 CFR 310.519 · Drug products marketed as over-the-counter (OTC) daytime sedatives.
- 21 CFR 310.527 · Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.
- 21 CFR 310.528 · Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
- 21 CFR 310.529 · Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
- 21 CFR 310.530 · Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
- 21 CFR 310.531 · Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
- 21 CFR 310.532 · Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
- 21 CFR 310.533 · Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.
- 21 CFR 310.534 · Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
- 21 CFR 310.536 · Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.
- 21 CFR 310.537 · Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.
- 21 CFR 310.538 · Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
- 21 CFR 310.540 · Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
- 21 CFR 310.541 · Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.
- 21 CFR 310.542 · Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
- 21 CFR 310.543 · Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
- 21 CFR 310.544 · Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
- 21 CFR 310.545 · Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
- 21 CFR 310.546 · Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.
- 21 CFR 310.547 · Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
- 21 CFR 310.548 · Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.
- 21 CFR 312.1 · Scope.