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Part 330
FEDERAL · 21 CFR
Part 330 — Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
10 sections · Title 21: Food and Drugs
§ 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.