21 CFR Part 330, Subpart B - Administrative Procedures
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- § 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.