Subpart E—Requirements for Specific New Drugs or Devices

1. CFR
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3. Title 21
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5. Chapter I
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7. Part 310
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9. Subpart E

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 310.501
  § 310.501 Patient package inserts for oral contraceptives.
• 310.502
  § 310.502 Certain drugs accorded new drug status through rulemaking procedures.
• 310.503
  § 310.503 Requirements regarding certain radioactive drugs.
• 310.509
  § 310.509 Parenteral drug products in plastic containers.
• 310.515
  § 310.515 Patient package inserts for estrogens.
• 310.517
  § 310.517 Labeling for oral hypoglycemic drugs of the sulfonylurea class.
• 310.518
  § 310.518 Drug products containing iron or iron salts.
• 310.519
  § 310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives.
• 310.527
  § 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
  § 310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
• 310.529
  § 310.529 Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
• 310.530
  § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
• 310.531
  § 310.531 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
• 310.532
  § 310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
• 310.533
  § 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
  § 310.534 Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
• 310.536
  § 310.536 Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.
• 310.537
  § 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
  § 310.538 Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
• 310.540
  § 310.540 Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
• 310.541
  § 310.541 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.
• 310.542
  § 310.542 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
• 310.543
  § 310.543 Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
• 310.544
  § 310.544 Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
• 310.545
  § 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
• 310.546
  § 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
  § 310.547 Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
• 310.548
  § 310.548 Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.