21 CFR Subpart E - Subpart E—Requirements for Specific New Drugs or Devices

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  1. § 310.501 Patient package inserts for oral contraceptives.
  2. § 310.502 Certain drugs accorded new drug status through rulemaking procedures.
  3. § 310.503 Requirements regarding certain radioactive drugs.
  4. § 310.509 Parenteral drug products in plastic containers.
  5. § 310.515 Patient package inserts for estrogens.
  6. § 310.517 Labeling for oral hypoglycemic drugs of the sulfonylurea class.
  7. § 310.518 Drug products containing iron or iron salts.
  8. § 310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives.
  9. § 310.527 Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.
  10. § 310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
  11. § 310.529 Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
  12. § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
  13. § 310.531 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
  14. § 310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
  15. § 310.533 Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.
  16. § 310.534 Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
  17. § 310.536 Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.
  18. § 310.537 Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.
  19. § 310.538 Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
  20. § 310.540 Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
  21. § 310.541 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.
  22. § 310.542 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
  23. § 310.543 Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
  24. § 310.544 Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
  25. § 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
  26. § 310.546 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.
  27. § 310.547 Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
  28. § 310.548 Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.