Overview
Join FDLI in exploring recent regulatory developments in drug compounding. Last year, the DC District Court ruled in favor of drug compounders in Wellness Pharmacy, Inc. et al. v. Azar et al., finding that FDA’s memorandum of understanding limiting interstate distribution of compounded drugs was developed improperly and failed to assess the potential economic impact of the limitation on pharmacies. Most recently, FDA released long-awaited draft guidance on “Animal Drug Compounding from Bulk Drug Substances”. This webinar will address these updates and other important topics within drug compounding, including outsourcing facility compliance, limitations on FDA’s bulk list for compounding drug substances, and recent concerns about the safety and effectiveness of a commonly used compounded hormone therapy for women.
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Speakers
Scott Brunner , CEO, Alliance for Pharmacy Compounding
Karla L. Palmer, Director, Hyman, Phelps & McNamara, P.C.
Ann Randall, Senior Counsel, Blue Rabbit Veterinary
Moderated by Rachael G. Pontikes, Partner, Reed Smith LLP
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SCOTT BRUNNER is CEO of the Alliance for Pharmacy Compounding. APC is the voice for pharmacy compounding, representing compounding pharmacists and technicians in both 503A and 503B settings, as well as prescribers, educators, researchers, and suppliers. APC works to elevate the essential role of pharmacy compounding in the American healthcare system and drug supply chain. Brunner was formerly the senior vice president communications and external relations for the National Community Pharmacists Association and CEO of the Georgia Pharmacy Association. In his 33-year career in association management, he has also led statewide trade associations in Mississippi and Virginia. He earned his BBA at the University of Montevallo and MPS from Auburn University Montgomery. He earned the prestigious Certified Association Executive designation in 1997.
KARLA L. PALMER is a director at Hyman, Phelps & McNamara, PC. With 25 years’ experience as a litigator, Palmer’s focus at Hyman Phelps is on DEA and FDA enforcement and litigation matters. Palmer advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of issues including DEA and FDA regulations and guidance, government inspections (including Form 483s) and investigations, warning letters, consent decrees, and administrative and federal proceedings. She has also handled administrative proceedings at DEA involving, but not limited to, registrant revocation actions, including the appeal of those matters in federal courts. In addition, she has written about and addressed industry audiences across the country on all aspects of the passage and implementation of the 2013 Drug Quality and Security Act including both compounding and supply chain issues, its guidance documents, and implementing regulations. She is well-versed in compounding laws, regulations and guidance, and regularly counsels clients on these topics. Over the course of her career, Palmer has also been involved in all aspects of general commercial litigation matters. She has served as trial counsel in federal, state, and administrative courts in the District of Columbia, Florida, Illinois, Maryland, New York, Nevada, Pennsylvania, Kansas, Virginia, and before the Court of Federal Claims, the US Tax Court, and Federal Energy Regulatory Commission (FERC). She also has significant arbitration and mediation experience. Before joining Hyman, Phelps & McNamara in 2010, Palmer was a partner at a large international law firm where she was head of the Washington, DC trial department and co-partner-in-charge of its national recruiting program. Following law school, Ms. Palmer clerked for the Honorable Claude M. Hilton, former Chief Judge of the US District Court for the Eastern District of Virginia, Alexandria Division. She has served as both lead and local counsel in the Eastern District of Virginia. While in law school, Palmer was an associate editor of The University of Richmond Law Review, a member of the McNeill Law Honor Society, and a legal writing teaching assistant. Palmer is an immediate past member of the Board of Directors of the Law School Alumni Association at the University of Richmond, and is a former board member of Chattering Children, a nonprofit that provides speech and language education, therapy, and services to hearing impaired children throughout the Washington, DC area.
ANN RANDALL is an experienced regulatory lawyer who has over 20 years legal experience in highly regulated industries: animal health, environmental and financial services. She was former regulatory counsel with Covetrus, Inc. which included technology, compounding, pharmacy and wholesale distribution lines of business. Ann has experience working with various regulatory agencies and accreditation boards including, but not limited to state Boards of Pharmacy and Veterinary Medicine boards and FDA.



























































































