SUBPART B—Administrative Procedures (§330.10 to §330.14)
- 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.