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Section 310.3
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Biologics; products subject to license control |
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Section 310.4
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Applicability of ``new drug'' or safety or effectiveness findings in drug efficacy study implementation notices and notices of |
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Section 310.6
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New drug status opinions; statement of policy |
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Section 310.100
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New drug substances intended for hypersensitivity testing |
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Section 310.103
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Prescription-exemption procedure |
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Section 310.200
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Exemption for certain drugs limited by new-drug applications to prescription sale |
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Section 310.201
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Continuation of long-term studies, records, and reports on certain drugs for which new drug applications have been approved |
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Section 310.303
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Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug |
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Section 310.305
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Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved |
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Section 310.305
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Patient package inserts for oral contraceptives |
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Section 310.501
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Certain drugs accorded new drug status through rulemaking procedures |
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Section 310.502
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Requirements regarding certain radioactive drugs |
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Section 310.503
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Parenteral drug products in plastic containers |
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Section 310.509
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Patient package inserts for estrogens |
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Section 310.515
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Labeling for oral hypoglycemic drugs of the sulfonylurea class |
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Section 310.517
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Drug products containing iron or iron salts |
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Section 310.518
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Drug products marketed as over-the-counter (OTC) daytime sedatives |
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Section 310.519
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Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair |
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Section 310.527
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Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac |
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Section 310.528
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Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents |
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Section 310.529
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Topically applied hormone-containing drug products for over-the-counter (OTC) human use |
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Section 310.530
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Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils |
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Section 310.531
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Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic |
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Section 310.532
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Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in |
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Section 310.533
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Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents |
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Section 310.534
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Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent |
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Section 310.536
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Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of |
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Section 310.537
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Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief |
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Section 310.538
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Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers |
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Section 310.540
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Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia |
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Section 310.541
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Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia |
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Section 310.542
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Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency |
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Section 310.543
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Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent |
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Section 310.544
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Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses |
|
Section 310.545
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Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal |
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Section 310.546
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Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria |
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Section 310.547
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Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment |
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Section 310.548
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Scope |