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