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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 27, 2025
All Titles
Title 21
Chapter I
Part 330
Subpart B - Subpart B—Administrative Procedures
§ 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.
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