Subpart B—Administrative Procedures
Sections
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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.