Part 330 — Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
Subpart A — General Provisions
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.