RD338 - Report on Actions Workgroup on Compounding Drugs Pursuant to Chapter 147 (2014)


Executive Summary:
This report summarizes the actions taken by a workgroup convened by the Board of Pharmacy pursuant to the enactment clause of Chapter 147 (HB1035) of the 2014 Acts of the Assembly. The charge to the workgroup was to explore and clarify issues related to the compounding of drugs for human and animal use. The 12-member workgroup included representation from the Boards of Pharmacy, Medicine, and Veterinary Medicine, the Virginia Pharmacists Association, the Virginia Society of Health System Pharmacists, the Virginia Veterinary Medicine Association, the Virginia Society of Eye Physicians and Surgeons, a practicing hospital pharmacist who participated at the request of the Board chairman, and a member of the 2010-2015 United States Pharmacopeia (USP) Compounding Expert Committee. Jody H. Allen, PharmD, Board of Pharmacy member presided over the workgroup. The workgroup met for approximately nine hours over two meetings held on July 31, 2014 and August 26, 2014.

Board staff solicited feedback for agenda topics from the workgroup members prior to the first meeting and received several suggestions. During the first meeting, the workgroup had in-depth discussions on the agenda topics which were divided into the following subtopics: compounding performed in pharmacies; compounding performed in physician offices; compounding performed in outsourcing facilities; and miscellaneous topics. During the discussions, state and federal law, board regulations, board guidance, and current and proposed USP chapters were taken into consideration.