Subpart B. 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.