IACP's Statement Regarding Draft Federal Legislation

U.S. Senate HELP Committee Releases Draft Compounding Bill 

IACP just today received a copy of the draft bill and we are still reviewing it. We applaud the steps the Committee and the U.S. Senate are taking to ensure that compounded medications are as safe as they can be. IACP believes that the safety of patients must always be the first consideration of any pharmacy-oriented public policy. 

From our preliminary review of that draft, we see that there are some aspects of the draft that will need further discussion and refinement, and we intend to work with the Committee on these. The draft does not contain any provisions that speak directly to standards aimed at raising the quality of compounded medications.   Additionally, IACP is concerned that some provisions may reduce patient and physician access to customized medications, the very services that compounding pharmacists provide.

IACP reiterates its position that state boards of pharmacy are responsible for the licensing and oversight of compounding pharmacies and the FDA is responsible for overseeing and regulating pharmaceutical manufacturers. We think the term “compounding manufacturer” and several of the definitions of that new category create more confusion and further blur the jurisdictional authority of regulators. IACP will recommend improvements in the draft language to make the proposed categories more clear.

Most importantly, IACP is gravely concerned that compounding pharmacies located in hospitals and health systems have been exempted from many of the proposed changes. Such an exemption denies patients and their families the assurance, regardless of where they receive their medications, of the quality and safety that they deserve. 

We look forward to continuing to work with the House and Senate on refining this legislation.