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Title 21 - Title 21

Part 330 - OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

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DRUGS FOR HUMAN USE - OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

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10 sections

§330.1 - General conditions for general recognition as safe, effective and not misbranded.

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§330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.

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§330.11 - NDA deviations from applicable monograph.

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§330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

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§330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.

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§330.14 - Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.

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§330.15 - Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.

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§330.2 - Pregnancy-nursing warning.

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§330.3 - Imprinting of solid oral dosage form drug products.

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§330.5 - Drug categories.

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