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