Administrative Procedures

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
  7. Administrative Procedures

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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.