Affirmation of Compliance Codes (A of C Codes) indicate:

• A. Affirmation that a product identified meets FDA requirements
• B. A certification of environmental compliance
• C. A certification of manufacturing facility
• D. A certification of import legality

Answer: (A)

Affirmation of Compliance codes signal that the product identified meets FDA requirements. This means the item has been evaluated to ensure it complies with regulatory standards for drugs, including labeling, safety, and manufacturing controls set by the FDA. It’s specifically about the product’s regulatory status with the FDA, not about environmental compliance, the manufacturing facility’s certifications, or import legality. So a product carrying this code indicates it aligns with FDA rules, giving pharmacists confidence in its regulatory validity.