Administrative Procedures | Midpage

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Code of Federal Regulations

Subpart B

Administrative Procedures

330.10Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.330.11NDA deviations from applicable monograph.330.12Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).330.13Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.330.14Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.330.15Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.