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Title 21 - Title 21
Part 310 - NEW DRUGS
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Details about Part 310
Description
DRUGS FOR HUMAN USE - NEW DRUGS
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38 sections
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§310.100 - New drug status opinions; statement of policy.
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§310.103 - New drug substances intended for hypersensitivity testing.
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§310.200 - Prescription-exemption procedure.
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§310.201 - Exemption for certain drugs limited by new-drug applications to prescription sale.
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§310.3 - Definitions and interpretations.
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§310.303 - Continuation of long-term studies, records, and reports on certain drugs for which new drug applications have been approved.
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§310.305 - Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
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§310.306 - Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.
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§310.4 - Biologics; products subject to license control.
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§310.501 - Patient package inserts for oral contraceptives.
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§310.502 - Certain drugs accorded new drug status through rulemaking procedures.
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§310.503 - Requirements regarding certain radioactive drugs.
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§310.509 - Parenteral drug products in plastic containers.
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§310.515 - Patient package inserts for estrogens.
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§310.517 - Labeling for oral hypoglycemic drugs of the sulfonylurea class.
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§310.518 - Drug products containing iron or iron salts.
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§310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.
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§310.527 - Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.
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§310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
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§310.529 - Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
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§310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
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§310.531 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
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§310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
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§310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.
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§310.534 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
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§310.536 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.
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§310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.
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§310.538 - Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
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§310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
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§310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.
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§310.542 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
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§310.543 - Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
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§310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
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§310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
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§310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.
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§310.547 - Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
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§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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§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.
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