Issue Date: August 5, 2011
Issued by: Center for Drug Evaluation and Research
Topic(s): Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Status: Final
PET Drugs–Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide
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).
Download the Guidance Document
