Title 21

PART 330 Part 330 - Over-the-counter (otc) Human Drugs Which Are Generally Recognized As Safe And Effective And Not Misbranded

PART 330 - OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED Authority:21 U.S.C. 321, 351, 352, 353, 355, 360, 360fff-6, 371. Source:39 FR 11741, Mar. 29, 1974, unless otherwise noted. Editorial Note:Nomenclature changes to part 330 appear at 69 FR 13717, Mar. 24, 2004.

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

21:5.0.1.1.11.1	SUBPART A	Subpart A - General Provisions
21:5.0.1.1.11.1.1.1	SECTION 330.1	330.1 General conditions for general recognition as safe, effective and not misbranded.
21:5.0.1.1.11.1.1.2	SECTION 330.2	330.2 Pregnancy-nursing warning.
21:5.0.1.1.11.1.1.3	SECTION 330.3	330.3 Imprinting of solid oral dosage form drug products.
21:5.0.1.1.11.1.1.4	SECTION 330.5	330.5 Drug categories.
21:5.0.1.1.11.2	SUBPART B	Subpart B - Administrative Procedures
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.