U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide
  1. Search for FDA Guidance Documents


PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide August 2011

Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

This guidance is intended to help small businesses understand and comply with FDA’s organ-specific labeling regulation for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The regulation requires IAAA manufacturers to label their products with specific warnings and related information to alert consumers about potential liver injury and stomach bleeding associated with IAAA drug products. Manufacturers must be in compliance with the final rule beginning on April 29, 2010. The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Fairness Act (Public Law 104-121).

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.