Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

TEXT PDF330.1 General conditions for general recognition as safe, effective and not misbranded.
TEXT PDF330.2 Pregnancy-nursing warning.
TEXT PDF330.3 Imprinting of solid oral dosage form drug products.
TEXT PDF330.5 Drug categories.
TEXT PDF330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
TEXT PDF330.11 NDA deviations from applicable monograph.
TEXT PDF330.12 Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).
TEXT PDF330.13 Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.
TEXT PDF330.14 Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.

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