|IACP/PCCA Statement on the Pew Charitable Study Compounding Reports|
We applaud the PEW Charitable Trust for undertaking such a comprehensive review of the regulatory landscape. We support the recommendations for the United States Pharmacopeial Convention (USP) to set standards for compounding practices and strongly recommend all state Boards of pharmacy adopt all USP standards pertinent to compounding. We point to PEW’s sister publication on this subject, the “Best Practices for State Oversight of Drug Compounding,” as a guide for state Boards on this subject.
We also agree with the study's theme that state boards should have primary oversight of compounding practices including those in the pharmacy, physician and hospital setting.
We are continuing to review the PEW study. However, on initial review, we have identified a primary point of concern which we believe warrants additional clarification and study: the claim that all office-use compounding by 503As is prohibited by the Drug Quality & Security Act (DQSA). The study recommends States act to align State laws with this assertion. We would point to the six Congressional Statements on the Record supporting office-use when DQSA was passed, along with the reiteration of this support with the approved 2016 Congressional appropriations language and FDA's own language within their 2017 Appropriations Justification which was just released. The FDA has recognized the Appropriations language and actually states, in some instances, office-use is needed.
We appreciate the effort put into this comprehensive study. We welcome the opportunity to further participate in any and all regulatory discussions, both at the state and federal levels. As leaders in this industry, our goal is to create an environment for compounding pharmacists to provide innovative solutions to both patients and prescribers and welcome PEW’s input in strengthening the compounding industry.
February 26, 2016
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