Compounding Legal, Regulatory & Quality Practice Update: What Pharmacies Need to Know Now

Monday, October 12, 2015, 4:00 p.m. - 5:30 p.m.
Gaylord National Resort and Convention Center
Continuing Education Credits: 0.15 (1.5 Contact Hours)
ACPE #: 207-000-15-122-L03-P and ACPE #: 207-000-15-122-L03-T

With implementation of the compounding provisions contained within the 2013 Drug Quality and Security Act (DQSA) well underway, there is a lot of fast moving information you need to be aware of. This education session will focus on what you need to know related to FDA’s inspection activities and how to respond, the Memorandum of Understanding addressing interstate shipment of compounds, and the differing positive and negative lists that are being created by FDA and the Pharmacy Compounding Advisory Committee (PCAC). The session will also cover the current status of office-use compounding as well as provide helpful tips on how to maintain a quality compounding practice in light of all the ongoing changes in the marketplace. FDA’s implementation of the DQSA compounding law will be discussed from a legal standpoint.

Pharmacist and Pharmacy Technician Learning Objectives:

  1. Discuss the current position of the FDA on compounding and the ramifications for your compounding practice.
  2. Explain how the memorandum of understanding addressing interstate shipment of compounds is being enforced and potential practice effects for compounding pharmacies.
  3. Discuss the rights of the pharmacy related to FDA’s inspection activities.

Speakers: Rachael G. Pontikes, Partner, Duane Morris LLP, Chicago, Illinois; Ronna B. Hauser, PharmD, Vice President of Pharmacy Affairs, NCPA, Alexandria, Virginia; A.J. Day, PharmD, RPh, Director, Pharmacy Consulting, PCCA, Houston, Texas

Activity Type: Application-based
Audience: Pharmacists and Pharmacy Technicians