Recorded May 18, 2017 | On-Demand Webinar
In the three years since the DQSA’s Compounding Quality Act (CQA) took effect there have been significant legal and regulatory developments in drug compounding. Learn where compounders, FDA, States, Congress, and pharmaceutical companies stand on the many issues affecting this important, yet challenging, practice. Speakers will cover pressing issues such as the still-unsettled office use compounding debate, FDA’s draft guidance on “essentially copies” of approved drugs, the status of FDA’s draft MOU addressing interstate shipments, and the status of FDA’s “Bulks Lists.” An analysis of what is on the horizon for compounders from a regulatory (FDA and state inspections) and legal (actions for non-compliance) perspective will be provided.
J. Andrew Harrison, Vice President, Legal & Compliance, PharMEDium Services, LLC, an AmerisourceBergen Corporation Company
Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts
Moderated by Karla L. Palmer, Director, Hyman, Phelps & McNamara