FDA Proposals for Compounded Drugs Draw Broad Support

The U.S. Food and Drug Administration (FDA) issued three draft guidance documents in April on implementation of the Drug Quality and Security Act (DQSA), a 2013 law governing the production of compounded drugs—medications made by pharmacies instead of drug manufacturers.

On July 18, The Pew Charitable Trusts—along with the American Public Health Association, the Biotechnology Industry Organization, the Generic Pharmaceutical Association, the Pharmaceutical Research and Manufacturers of America, and the Trust for America’s Health—sent comments to FDA expressing support for the draft guidance documents, which describe prescription requirements, set forth how those requirements would apply to hospital and health systems compounding, and propose policies for when traditional pharmacies or conventional manufacturers may share their premises with outsourcing facilities. FDA’s guidance is an important step toward ensuring patient safety by fully implementing the mandate from Congress in the DQSA.

Pew also submitted its own comments indicating support for strong policies at both the state and federal levels to protect patients by ensuring that compounded medications are produced under appropriate quality standards. Since the federal compounding law was enacted, Pew—in addition to tracking adverse events attributable to compounded medication and presenting research and other materials to explain the distinction between the quality standards that apply in different compounding settings—also commissioned an assessment of state oversight of pharmacy compounding and worked with state regulators to develop best practices for improving oversight.