Subpart B—Administrative Procedures

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 330
8. ›
9. Subpart B

Sections

• 330.10
  § 330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
• 330.11
  § 330.11 NDA deviations from applicable monograph.
• 330.12
  § 330.12 Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).
• 330.13
  § 330.13 Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.
• 330.14
  § 330.14 Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.
• 330.15
  § 330.15 Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.