21 CFR Part 330
PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
- PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter D—Drugs for Human Use
- Subpart A—General Provisions
- § 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.
- 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.
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