FDA works with pharmacy, states on compounding

By now, we’re all aware of the terrible tragedy and 39 deaths that resulted when unfortunate and unsuspecting patients were injected with products inappropriately manufactured by a pharmacy in Massachusetts that called itself a compounding pharmacy.

Yesterday FDA held a closed intergovernmental meeting on a Framework for Pharmacy Compounding: State and Federal Roles for representatives from all 50 states as well as FDA staff—more than 100 people in all.

The last 2 hours of the meeting were public. In opening remarks, FDA Commissioner Margaret A. Hamburg, MD, noted that the agency had spoken with more than 50 different organizations, including pharmacy groups, leading up to the meeting. “Today was the states’ turn,” Hamburg said, to discuss four questions that get to the heart of federal and state roles. What FDA heard underscores the need for new legislation, she added.

During the public discussion of the questions, state representatives zeroed in on the need for clear definitions of pharmacy compounding versus manufacturing, and better communication among states and between FDA and states. Cody Wiberg, PharmD, MS, Executive Director of the Minnesota Board of Pharmacy, said at the meeting that most states have the authority and resources to handle traditional compounding, but fewer states may have the resources to handle nontraditional compounding in facilities like the New England Compounding Center (NECC). “I think the consensus in our group was in the latter case, with NECC, there is a role for the FDA to be involved,” Wiberg said.

Hamburg responded minutes later that the issue about defining the terms—compounder, manufacturer—and how that then aligns with regulatory actions is “just so, so fundamental.” She suggested a working group to address the issue.

Another takeaway from the meeting was the National Association of Boards of Pharmacy’s work with the Iowa Board of Pharmacy to start investigating out-of-state pharmacies, leading in turn to the creation of a database for all boards of pharmacy that will track the licenses and disciplinary measures taken against pharmacies nationwide. 

FDA’s meeting with states followed a separate meeting with FDA that I attended on December 14 with about a dozen other national pharmacy organizations and stakeholders. We discussed the agency’s interest, among other things, in a clear distinction between manufacturing and compounding that could allow state and federal regulators to better protect the public.

Representing APhA, I shared the perspective that pharmacy is committed to doing everything possible to enhance patient safety while maintaining access to our compounding services. We promoted greater recognition of Pharmacy Compounding Accreditation Board standards and offered some suggestions on ways to help differentiate compounding from manufacturing.

FDA is not on a mission to stop compounding, as may have been the perception in prior years. Rather, they are looking for ways to better define manufacturing, which they see as their responsibility to regulate and to enforce maintenance of good practices. We appreciated FDA’s recognition of the value of compounding and did not observe any interest on their part in hindering that practice. Their goal is to better regulate manufacturing in order to protect the public.

This discussion is just beginning, but based on FDA’s posture on the 14th, we’ll be at the table throughout the debate.

More to follow on this. Meanwhile, you are encouraged to comment on the agency’s four questions—outlined in the November 28 Federal Register notice for the FDA meeting with states—due January 18, 2013. And remember, APhA continues to post compounding updates and resources on pharmacist.com at Just the Facts: Compounding