Sunday, June 30, 2002

FDA gives guidance on compounding

Q. What guidance has the FDA given to compounding pharmacies in response to the U.S. Supreme Court decision in Thompson v. Western States Medical Center, which affirmed striking the pharmacy compounding provisions from the Food and Drug Administration Modernization Act (FDAMA)?

A. In response to the Western States case, the FDA has reissued Compliance Policy Guide 460.200, formerly CPG 7132.16, that was originally issued in 1992. According to CPG 460.200, although the FDA recognizes the right of pharmacies to engage in traditional extemporaneous compounding, the FDA retains the right to bring an enforcement action against pharmacies that cross over the line from compounding to manufacturing.

The FDA sets out a number of factors that indicate if a pharmacy has crossed this line. Some of these factors are (i) compounding drugs in anticipation of receiving prescriptions, except in limited quantities; (ii) compounding drugs that were withdrawn or removed from the market for safety reasons; (iii) compounding drugs from bulk active ingredients that are not components of FDA approved drugs; (iv) compounding from drug substances without obtaining written assurance from the supplier that the drug substance is made in an FDA registered facility; (v) using commercial scale manufacturing equipment; (vi) compounding drugs for resale; and (vii) compounding drugs that are otherwise commercially available.

Therefore, even though pharmacies are no longer prohibited from advertising specific compounded drugs, they must be careful to avoid the other activities that will cause the FDA to view them as engaged in manufacturing.

Jeffrey S. Baird, Esq., is chairman of the Health Care Group of Brown & Fortunato P.C., Amarillo, Texas. Reach him at (806) 345-6320 or