Sunday, October 16, 2016
7:45 - 9:15 a.m.
Ernest N. Morial Convention Center
Continuing Education Credits: 0.15 (1.5 Contact Hours)
ACPE UAN: 0207-0000-16-117-L04-P and 0207-0000-16-117-L04-T
This session will provide timely updates on FDA activity regarding office use compounding, inspections, the MOU addressing interstate shipment of compounds, and positive and negatives lists being developed in conjunction with the Pharmacy Compounding Advisory Committee. The session will also provide a legal update that will address rights and responsibilities of compounding pharmacies as well as the intersection of federal and state laws. Also addressed will be what changes in processes and physical layout will need to be implemented to be in compliance with USP <800> Hazardous Drugs- Handling in Healthcare Settings, which may be enforceable beginning on July 1, 2018.
Pharmacist and Pharmacy Technician Learning Objectives:
Discuss the current position of the FDA on compounding and the ramifications for your compounding practice.
Explain how office use compounding and the memorandum of understanding are being addressed by the FDA and state boards of pharmacy and potential practice effects for compounding pharmacies.
Identify the legal/regulatory basis for FDA's ability to inspect pharmacies.
Explain how hazardous drugs are defined by USP <800> and require engineering controls and facility design.
Speakers: Rachael G. Pontikes, Partner, Duane Morris LLP, Chicago, Illinois; John Voliva, PharmD, Executive Vice President, IACP, Missouri City, Texas; Ronna B. Hauser, PharmD, Vice President of Pharmacy Affairs, NCPA, Alexandria, Virginia
Activity Type: Application-based
Audience: Pharmacists and Pharmacy Technicians