Daily eCFR

Subpart B—Administrative Procedures

Administrative Procedures

ContainsSections 330.10–330.15

CorpusDaily eCFR

Displayed edition2026-08-27

Last updated2026-08-27

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.