American College of Clinical Pharmacy
      Search      Cart
         
ACCP Report

Member-Driven Advocacy: ACCP Represented in FDA Compounding Listening Session for Pharmacy Groups

McBane

On May 14, 2024, a former member of the ACCP Board of Regents, Sarah McBane, Pharm.D., FCCP, BCPS, attended the FDA Compounding Listening Session for pharmacy groups. ACCP was represented among several other pharmacy groups such as the American Pharmacists Association and the Alliance for Pharmacy Compounding. The session opened with presentations from FDA staff outlining FDA guidance around compounding, specifically sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. After the presentations, the session was opened up for questions and comments from the attendees. Most comments centered on a desire for more clarity on FDA guidance and requests for additional flexibility regarding drug shortages and approved bulk ingredients. Because this was a listening session, FDA staff acknowledged comments but declined to provide any specific response outside the previously prepared materials. Click here to learn more about the FDA’s Compounding Quality Center of Excellence.