AHA urges FDA to clarify draft memorandum on compounded drugs

The AHA today urged the Food and Drug Administration to clarify certain provisions in its draft memorandum of understanding with states for interstate distribution of compounded drugs, which pharmacies seeking exemption from certain FDA requirements must satisfy. Specifically, AHA urged the agency to clarify how it defines “distribution” and how it will determine whether “inordinate” amounts of compounded drug products have been distributed interstate. “Doing so will help to ensure the continued safety and availability of compounded medications prepared in-house by hospital and health care system pharmacies for the treatment of patients,” wrote Linda Fishman, AHA senior vice president of public policy analysis and development. Among other comments, AHA said a pharmacy within a health care system “should not be considered to have ‘distributed’ compounded drugs interstate if the pharmacy is merely moving drugs between facilities that are part of the same health care system, even if the movement occurs between facilities located across state lines.”