AMCP, Pharmacy Stakeholders Discuss Compounding Issues at FDA Meeting

The Academy joined other pharmacy stakeholders last month in an invitation-only meeting on pharmacy compounding issues. The Dec. 14 meeting was convened by the Food and Drug Administration (FDA) in the wake of the deadly fungal meningitis outbreak linked the New England Compounding Center’s (NECC) production of tainted drugs.

The pharmacy groups were generally in agreement that the recent actions of NECC constitute illegal manufacturing and not pharmacy compounding. While the participants indicated that distinctions are necessary to delineate traditional compounding from larger-scale activities, no specific recommendations were offered.

The pharmacy groups focused on the need to ensure that pharmacies that compound conform to the standards in USP Chapters 795, non-sterile preparations and 797, sterile preparations. State boards must be given resources and training to understand issues associated with compounding practices. Accreditation of compounding pharmacies should be highly encouraged but not required.

The FDA noted that eliminating the ability to conduct larger-scale compounding activities would disrupt hospitals and cause unnecessary financial implications.

The FDA further indicated that the traditional distinctions between compounding and manufacturing may not be suited for the needs of modern medicine, particularly as personalized medicine will require more customized preparations.

To meet these needs, FDA has offered recommendations for a two-tiered approach giving FDA oversight for large scale compounding and allowing the states to maintain oversight of traditional pharmacy compounding. Some members of Congress and various pharmacy groups reject this approach and prefer oversight be maintained by state boards with a default to FDA only if states fail in their responsibilities. 

This meeting was one of many ongoing meetings between FDA and health care professionals, consumer groups, state boards, hospitals, and other entities affected by compounding.

Other pharmacy stakeholders at the meeting included: American Association of Colleges of Pharmacy; American Pharmacists Association; American Society of Health-System Pharmacists; International Academy of Compounding Pharmacy; Institute of Safe Medication Practices; National Association of Chain Drug Stores; National Community Pharmacists Association; Pharmacy Compounding Accreditation Board; Society of Veterinary Hospital Pharmacists; and, Express Scripts, Inc. Participants from FDA included representatives from the Administrator's office and key pharmacists and others with pharmacy expertise from various sections of the Agency.