Part 330 — Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360fff-6, 371.
Source: 39 FR 11741, Mar. 29, 1974, unless otherwise noted.
Editorial Note: Nomenclature changes to part 330 appear at 69 FR 13717, Mar. 24, 2004.
Sections
- § 330.1 General conditions for general recognition as safe, effective and not misbranded.
- § 330.2 Pregnancy-nursing warning.
- § 330.3 Imprinting of solid oral dosage form drug products.
- § 330.5 Drug categories.
- § 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.