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Regulations last checked for updates: Jun 14, 2025
Title 21 - Food and Drugs last revised: Jun 03, 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.
authority:
21 U.S.C. 321
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351
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352
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353
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355
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360
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360
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371
source:
39 FR 11741, Mar. 29, 1974, unless otherwise noted.
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