FDA Issues FY2024 Report on the State of Pharmaceutical Quality

Date

August 18, 2025

Category

US Regulations

Description

FDA has announced the Report on the State of Pharmaceutical Quality | FDA from the Office of Pharmaceutical Quality (OPQ)

The mission of OPQ in FDA’s Center for Drug Evaluation and Research (CDER) is to assure that quality medicines are available for the American public. In this report, OPQ analyzes FDA-registered drug manufacturers and their CDER-regulated drug products, including biologics, to inform stakeholders about the quality of the U.S. drug supply.

In addition to key data about site and product quality, this report presents some specific deeper analyses that find:

• Active pharmaceutical ingredient (API) manufacturers that manufacture exclusively for compounding pharmacies have been involved in a disproportionately high number of FDA regulatory actions (e.g., warning letters, import alerts, and regulatory meetings).
• Recalls from store brand over-the-counter (OTC) products have approximately the same rate of recall as other OTC products.
• Results from testing fifteen products that were repackaged from bulk drug products into unit-dose blister packages suggest that the repackaging operations do not appear to significantly impact product quality.