Title 21, Part 330 — Over-the-counter (Otc) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
10 sections
Section 330.1
General conditions for general recognition as safe, effective and not misbranded.
Section 330.2
Pregnancy-nursing warning.
Section 330.3
Imprinting of solid oral dosage form drug products.
Section 330.5
Drug categories.
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.