Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16).

Description

The enforcement policy expressed in this document concern the marketing of OTC drug products containing combinations of ingredients.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

2

OTC Drug

over-the-counter drugs used in combination with VFD drugs

Combination Product

Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.

Stakeholders

1

OTC Advisory Review Panel

Body that classifies ingredients into Category I, II, or III

Regulatory Context

Regulatory Activities

1

NDA

New Drug Application

Document Types

2

Advance Notice of Proposed Rulemaking

Published notice containing panel recommendations for ingredients

Final Monograph

Regulatory document establishing conditions for OTC drug marketing

Technical Details

Substances

1

Active Ingredient

Extent of absorption or other exposure to an active ingredient; Component whose exposure must not be materially affected by dosage change

Identified Hazards

Hazards

1

Potential hazard to health

Basis for regulatory action against products marketed before May 11, 1972

Related CFR Sections (1)

21CFR330.1§ 330.1 General conditions for general recognition as safe, effective and not misbranded.
An over-the-counter (OTC) drug listed in this subchapter is generally recognized as safe and effective and is not misbranded if it meets each of the conditions contained in this part and each of the conditions contained in any applicable monograph. Any product which fails to conform to each of the cRead full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Unapproved new drug

8

Adulterated drug

4

Misbranded drug

4

Misbranded drug product

3

Adulterated drug product due to substitution of methanol for ethanol

1

Adulterated drug product due to methanol substitution

1

Marketing of unapproved new drugs

1

Adulterated within the meaning of section 501(d)(2)

1

Misbranded under section 502

1

Adulterated drug product due to substitution of methanol

1