Site Feedback

Website Feedback

This contact form is only for website help or website suggestions. If you have questions or comments regarding a published document please contact the publishing agency. Comments or questions about document content can not be answered by OFR staff. Please do not provide confidential information or personal data.

Title 21

Displaying title 21, up to date as of 7/09/2026. Title 21 was last amended 7/09/2026.
view historical versions
  1. Title 21 —Food and Drugs
  2. Chapter I —Food and Drug Administration, Department of Health and Human Services
  3. Subchapter D —Drugs for Human Use
  4. Part 310 —New Drugs
  5. Subpart E   View Full Text
  • Details
  • Print
  • Search
  • Subscribe
  • Timeline
  • Go to Date
  • Published Edition
  • Developer Tools
eCFR Content

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.

Learn more about the eCFR, its status, and the editorial process.

Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter DDrugs for Human Use300 – 499
Part 310New Drugs310.3 – 310.548
Subpart ERequirements for Specific New Drugs or Devices310.501 – 310.548
§ 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.
eCFR Content