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