CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 330 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

Subpart A - General Provisions
   § 330.1 - General conditions for general recognition as safe, effective and not misbranded.
   § 330.2 - Pregnancy-nursing warning.
   § 330.3 - Imprinting of solid oral dosage form drug products.
   § 330.5 - Drug categories.

Subpart B - Administrative Procedures
   § 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.
   § 330.15 - Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.

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