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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 450.200 Drugs - General Provisions and Administrative Procedures for Recognition as Safe and Effective

 

BACKGROUND AND POLICY:
 

An OTC drug listed in subchapter 21 CFR 330 is generally recognized as safe and effective and is not misbranded if it meets each of the conditions of 21 CFR 330.1 and each of the conditions contained in specific final monographs. Following the establishment of a final monograph, any related OTC drug that fails to meet the requirements of the monograph and 21 CFR 330.1 will be recognized as misbranded (Section 502 FD&C Act) or as a new drug requiring an approved NDA before it can be marketed (Section 505 FD&C Act). Prior to the final publication of a proposed monograph, it would not be in the agency's interest to pursue regulatory action unless failure to do so poses a potential health hazard to the consumer.
 

REGULATORY ACTION GUIDANCE:
 

*The "OTC Drug Monograph Implementation - General Program" (7361.003) includes a discussion of the intent of the monograph program as well as descriptions of the various advisory drug review panels and status of final monographs. This CP indicates that the primary responsibility for determining the compliance of OTC drug products lies with the *Center for Drug Evaluation and Research, Division of Drug Labeling Compliance, OTC Compliance Branch, HFD-312*.
 

Samples of OTC drugs, subject to a final monograph should not be submitted for regulatory action consideration under sections 502 or 505 of the FD&C Act without specific instructions from *CDER* to do so.
 

Samples of OTC drugs, not subject to a final monograph should not be submitted for regulatory action consideration on the basis of suspected labeling deficiencies unless there is a reasonable basis to conclude that the deficiency constitutes a potential hazard to health. Examples: 1) documented consumer injuries; 2) drugs requiring the prescription legend marketed as OTC; and 3) unwarranted claims for the treatment of serious disease conditions which could preclude obtaining proper medical attention.
 

This *guide* does not preclude the submission of regulatory action recommendations based upon adulteration charges.
 

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 5/22/87, 3/95