FDA is announcing the fiscal year 2024 Report on the State of Pharmaceutical Quality 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.
FDA encourages the pharmaceutical industry and its stakeholders, including the public, to read this year’s report and collaborate with FDA to continuously improve the state of pharmaceutical quality.
