Prevention is Key: Steps to Prepare for and Respond to a FDA Inspection or Enforcement Action

Saturday, October 15, 2016
3 - 4:30 p.m.
Ernest N. Morial Convention Center
ACPE UAN: 0207-0000-16-111-L04-P and 0207-0000-16-111-L04-T
1.5 contact hours (0.15 CEUs)

Over the decades, there has been an uneasy truce between pharmacies and the FDA. Pharmacies are regulated by their state boards, and the FDA steps in when it concludes the pharmacy has crossed the line into the manufacturing arena. However, the FDA is becoming increasingly aggressive in attempting to assert jurisdiction over pharmacies. There are several reasons for this with the main reason being the FDA's concern that state pharmacy boards are not adequately overseeing compounding pharmacies. In addition, the New England Compounding Center tragedy has cast a spotlight on compounding pharmacies. This program will discuss the legal basis upon which the FDA can assert jurisdiction over pharmacies, the legal arguments against such an assertion of jurisdiction, existing and potential legislation that gives broader authority to the FDA, the steps a pharmacy can take to prepare for a FDA inspection, and the steps a pharmacy can take to reduce the risk of a FDA inspection or enforcement action. This program will also discuss the steps the FDA follows in conducting an inspection or enforcement action. Lastly, this program will lay out steps a pharmacy can take to respond to an FDA inspection/enforcement action.

Pharmacist and Pharmacy Technician Learning Objectives:

  1. Discuss the legal arguments for and against FDA jurisdiction over pharmacies.

  2. Create a preparation protocol for an FDA inspection or enforcement action.

  3. Outline steps your pharmacy can take in responding to an FDA inspection or enforcement action.

Speaker: Jeff Baird, Esq., Chairman, Health Care Group, Brown & Fortunato, PC, Amarillo, Texas


Activity Type: Application-based

Audience: Pharmacists and Pharmacy Technicians