Pew Comments on FDA Draft Guidance Documents on Compounded Copies of Approved Drugs

The Pew Charitable Trusts offered comments on draft guidance documents issued by the Food and Drug Administration in July 2016 regarding compounded drugs that are essentially copies of commercially available or approved drugs. The proposed guidance would preserve the FDA’s approval process, which is critical to protecting patient safety, while allowing important exceptions under limited, specific circumstances, including when a patient has a clinical need for a customized formulation and when FDA-approved drugs are in shortage.