Compounding Regulated by the FDA?

Why should the FDA regulate atraditional practice that pharmacistshave successfullyperformed since the profession cameinto existence?

We are driven to ask this question byproposed legislation covering the practiceof compounding. As drafted by SensEdward Kennedy (D, Mass), Pat Roberts(R, Kan), and Richard Burr (R, NC), theSafe Drug Compounding Act of 2007would hand over regulation of compoundingto the FDA, effectively strippingstate pharmacy boards of the power toregulate a key aspect of pharmacy operations.If passed, the legislation couldseverely restrict our ability to performthis valuable—indeed, for many patients,essential—role.

Some of the biggest concerns are thatthe legislation would give the FDAauthority to determine when compoundedmedications are needed. It could createnew restrictions on compoundingpractices previously authorized understate regulations and successfully carriedout for years on that basis. The proposedlegislation would include newrequirements for physicians to documentwhen compounding is needed. Itwould restrict their ability to prescribeand administer compounded medicationsfor office use. In addition, byrestricting distribution across state lines,the legislation could pose problems forpatients who live near state borders orneed to travel.

Proponents have justified the needfor federal legislation by pointing toproblems, such as the apparent volumeof drug manufacturing conductedunregulated under the guise of compounding.The number of these documentedabuses is small, when comparedwith the vast number of legitimate,valuable uses of compounding bypharmacists every day. Nevertheless,state and national pharmacy associationshave recognized the concerns andsuccessfully implemented a variety ofactions to tighten controls over compounding.You can find out more at theirrespective Web sites. The FDA's previousattempts to control compoundinghave been rejected by the courts, butthis time, with backing from legislators,a different outcome could result.

I have received copies of letters tosenators, written by pharmacists whospent many years compounding medicationsand providing those essentialmedications to patients without anyreported problems. You could help byexpressing your views. The more legislatorshear from those with genuine experiencewith compounding, the betterthe chance of defeating this ill-advisedproposal.

Mr. Eckel is professor and director ofthe Office of Practice Developmentand Education at the School ofPharmacy, University of NorthCarolina at Chapel Hill.