Title 21

PART 330 SUBPART B

Subpart B - Administrative Procedures

• 21 U.S.C. 321, 351, 352, 353, 355, 360, 360fff-6, 371.
• 39 FR 11741, Mar. 29, 1974, unless otherwise noted.

21:5.0.1.1.11.2.1.1	SECTION 330.10	330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
21:5.0.1.1.11.2.1.2	SECTION 330.11	330.11 NDA deviations from applicable monograph.
21:5.0.1.1.11.2.1.3	SECTION 330.12	330.12 Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).
21:5.0.1.1.11.2.1.4	SECTION 330.13	330.13 Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.
21:5.0.1.1.11.2.1.5	SECTION 330.14	330.14 Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.
21:5.0.1.1.11.2.1.6	SECTION 330.15	330.15 Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.

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