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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADM...
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PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHI...
PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
§ 330.1 - General conditions for general recognition as safe, effective and not misbranded.
§ 330.2 - Pregnancy-nursing warning.
§ 330.3 - Imprinting of solid oral dosage form drug products.
§ 330.5 - Drug categories.
§ 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
§ 330.11 - NDA deviations from applicable monograph.
§ 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).
§ 330.13 - Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.
§ 330.14 - Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.
§ 330.15 - Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.