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

FinalCenter for Drug Evaluation and Research03/01/1995

Description

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.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

1
OTC drug

Nonprescription human drug products marketed without an approved application.

Stakeholders

1
advisory drug review panels

Panels involved in the review of OTC drugs

Regulatory Context

Regulatory Activities

1
NDA

New Drug Application

Document Types

1
final monograph

Specifies conditions under which OTC drugs are generally recognized as safe and effective

Identified Hazards

Hazards

1
potential health hazard

TEP derived from patients with transmissible disorders

View on FDA.gov

Related CFR Sections (1)

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Misbranded drug
31
Unapproved new drug
29
Adulterated drug
16
Unapproved New Drug
8
Unapproved new drugs
8
Misbranded drugs
5
Misbranded drug product
4
Adulterated within the meaning of section 501(d)(2)
4
misbranded under section 502(ee)
3
Misbranded Drug
3

Recent Cases

Related Warning Letters (10)

See Also (8)