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6/5/2002

FDA Issues Guide for Pharmacy Compounding

Cheryl A. Thompson

A new "compliance policy guide" from the Food and Drug Administration (FDA) describes the factors that the agency will consider in deciding whether to take action against a pharmacy that compounds.

The document became available Tuesday, a day after FDA officials held a teleconference call with representatives of several pharmacy organizations, including ASHP.

FDA’s development of the guide was prompted by the April 29 U.S. Supreme Court decision that invalidated the compounding provisions of the FDA Modernization Act of 1997 (FDAMA). The high court’s decision had left the pharmacy profession puzzled about the extent of the federal government’s legal oversight of compounding activities.

Among the activities that would raise FDA’s interest are the compounding of drugs that have been withdrawn or removed from the market for safety reasons and the use of commercial-scale manufacturing or testing equipment in compounding activities. Also of concern to FDA are pharmacies that compound drugs for third parties that then resell the products.

ASHP Professional Affairs Associate Joseph H. Deffenbaugh, M.P.H., who participated in the June 3 conference call, said the agency will develop the Bush administration’s proposal for new legislation on pharmacy compounding.

The compliance policy guide includes an appendix listing the drugs that have been withdrawn or removed from the market for safety reasons. An upcoming issue of the Federal Register will provide instructions and a deadline for providing FDA with comments on the guide.