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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 330 - Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded |
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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. |