Sec. 450.200 Drugs - General Provisions and Administrative Procedures for Recognition
as Safe and Effective (CPG 7132b.15)
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