Compounding Regulated by the FDA?

Author: Fred M. Eckel, RPh, MS, Pharmacy TimesEditor-in-Chief

Why should the FDA regulate a traditional practice that pharmacists have successfully performed since the profession came into existence?

We are driven to ask this question by proposed legislation covering the practice of compounding. As drafted by Sens Edward Kennedy (D, Mass), Pat Roberts (R, Kan), and Richard Burr (R, NC), the Safe Drug Compounding Act of 2007 would hand over regulation of compounding to the FDA, effectively stripping state pharmacy boards of the power to regulate a key aspect of pharmacy operations. If passed, the legislation could severely restrict our ability to perform this valuable—indeed, for many patients, essential—role.

Some of the biggest concerns are that the legislation would give the FDA authority to determine when compounded medications are needed. It could create new restrictions on compounding practices previously authorized under state regulations and successfully carried out for years on that basis. The proposed legislation would include new requirements for physicians to document when compounding is needed. It would restrict their ability to prescribe and administer compounded medications for office use. In addition, by restricting distribution across state lines, the legislation could pose problems for patients who live near state borders or need to travel.

Proponents have justified the need for federal legislation by pointing to problems, such as the apparent volume of drug manufacturing conducted unregulated under the guise of compounding. The number of these documented abuses is small, when compared with the vast number of legitimate, valuable uses of compounding by pharmacists every day. Nevertheless, state and national pharmacy associations have recognized the concerns and successfully implemented a variety of actions to tighten controls over compounding. You can find out more at their respective Web sites. The FDA's previous attempts to control compounding have been rejected by the courts, but this time, with backing from legislators, a different outcome could result.

I have received copies of letters to senators, written by pharmacists who spent many years compounding medications and providing those essential medications to patients without any reported problems. You could help by expressing your views. The more legislators hear from those with genuine experience with compounding, the better the chance of defeating this ill-advised proposal.

Mr. Eckel is professor and director of the Office of Practice Development and Education at the School of Pharmacy, University of North Carolina at Chapel Hill.