21 C.F.R. PART 310--NEW DRUGS
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
PART 310--NEW DRUGS
Subpart A--GENERAL PROVISIONS
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| Definitions and interpretations.
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| Biologics; products subject to license control.
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| 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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Subpart B--SPECIFIC ADMINISTRATIVE RULINGS AND DECISIONS
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| New drug status opinions; statement of policy.
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| New drug substances intended for hypersensitivity testing.
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Subpart C--NEW DRUGS EXEMPTED FROM PRESCRIPTION-DISPENSING REQUIREMENTS
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| Prescription-exemption procedure.
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| Exemption for certain drugs limited by new-drug applications to prescription sale.
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Subpart D--RECORDS AND REPORTS
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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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| Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
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Subpart E--REQUIREMENTS FOR SPECIFIC NEW DRUGS OR DEVICES
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| Patient package inserts for oral contraceptives.
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| Certain drugs accorded new drug status through rulemaking procedures.
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| Requirements regarding certain radioactive drugs.
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| Parenteral drug products in plastic containers.
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| Patient package inserts for estrogens.
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| Labeling for oral hypoglycemic drugs of the sulfonylurea class.
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| Drug products containing iron or iron salts.
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| Drug products marketed as over-the-counter (OTC) daytime sedatives.
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| 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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| Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
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| Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
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| Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
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| Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
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| Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
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| 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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| Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
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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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| 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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| Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
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| Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
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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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| Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
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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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| Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
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| Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
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| 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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| Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
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| 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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