Overview
The Memorandum of Understanding establishes an agreement between states that sign on to the MOU and the FDA regarding the interstate distribution of compounded drugs by compounding pharmacies, known as 503A compounders. The MOU, released earlier this year, addresses the limit on prescription orders that can be distributed out-of-state by states that do not sign onto the MOU. The law limits distribution to 5% of the total prescription orders dispensed or distributed. The MOU also defines the statutory term of “inordinate amounts” as it relates to the proportion of compounded drugs that may be distributed interstate for compounders in states who have signed onto the MOU. Another area addressed is reporting requirements and investigations of complaints conducted by states. This panel will address questions and concerns related to the above, including FDA’s implementation of the 5% limit, the pharmacy perspective on this limit, and the importance of the limit and the MOU in general from the health care policy perspective.
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Speakers
Michael Blaire, Vice President – Government and Regulatory Affairs, Wedgewood Pharmacy and Member, Arizona State Board of Pharmacy
Frances (Gail) Bormel, Associate Director for Compounding (Acting), CDER, FDA
Bill Cover, Associate Executive Director, State Pharmacy Affairs, National Association of Boards of Pharmacy
Mark Hendrickson, Senior Director, Leavitt Partners, LLC
GG Levine, Digital Health Manager, National Association of Boards of Pharmacy
Moderated by Julie Dohm, Of Counsel, Covington & Burling LLP
GAIL BORMEL is the acting Associate Director for the Compounding Program in CDER’s Office of Compliance, where she leads the inspectional, policy, and outreach efforts related to human drug compounding. These efforts include the development of the Compounding Quality Center of Excellence, designed to bolster the outsourcing facility sector and to promote quality of compounded drugs. Ms. Bormel joined CDER’s Office of Compliance in 2003 as a Regulatory Counsel, where she worked in the areas of Manufacturing and Product Quality and the Unapproved Drugs and Labeling Compliance. Prior to joining the Agency, Ms. Bormel served as Associate Legal Counsel for Legislative and Regulatory Affairs at the United States Pharmacopeia, an associate with Hyman, Phelps & McNamara, P.C., and Assistant Director, Drug Control Program for the Division of Food and Drugs at the Massachusetts Department of Public Health. Ms. Bormel earned her Pharmacy Degree from the University of Maryland School of Pharmacy and her Juris Doctor degree from the George Washington University, National Law Center. 
MARK HENDRICKSON is a Senior Director at Leavitt Partners, LLC. He has 20 years’ experience working in various roles in Washington advocacy and policy. Currently he works at Leavitt Partners, a healthcare consulting firm based in Washington, DC. Mark specializes in health care policy and advocacy related to the Food and Drug Administration, Congress and regulatory intelligence gathering. At Leavitt Partners he serves as an advisor to the Compounding Quality Coalition, a diverse group of stakeholders from the public health, manufacturing, outsourcing facility, and pharmacy communities, whose goals align with the goals of the FDA to protect patients by ensuring that patients who have a clinical need for a compounded drug have access to the highest-quality product.
JULIE DOHM is of counsel at Covington & Burling LLP where she focuses on regulatory matters for pharmaceutical and biotechnology clients. She has handled matters involving a wide-range of important regulatory topics such as preemption, drug promotion, drug shortage, import-export, exclusivity, and generic drug approvals. Prior to joining the firm, Dr. Dohm served as the lead on compounding for the US Food and Drug Administration (FDA). Between 2016 and 2019, she was responsible for the overall leadership of the agency’s compounding initiative, including inspections and enforcement, policy development, and stakeholder collaboration. Dr. Dohm started at FDA in 2010 as a civil litigator in its Office of Chief Counsel. She represented the FDA with the Department of Justice in affirmative, defensive, and third-party litigations at the trial and appellate levels, including at the U.S. Supreme Court. She also served as a drugs counselor, advising FDA’s Center for Drug Evaluation and Research on legal issues relating to generic drugs and biosimilars. Before pursuing law, Dr. Dohm was a postdoctoral scientist at Northwestern University and a graduate student at Johns Hopkins University where she focused on structural and biophysical characterization of small molecule drugs, nucleic acids, and proteins. She has published multiple peer-reviewed scientific articles and holds two patents.
BILL COVER is the Associate Executive Director of State Pharmacy Affairs for the National Association of Boards of Pharmacy (NABP). In this role he leads the member relations team which serves as the primary point of contact for the association’s state executive directors, monitors and assists in policy development relative to state legislative and regulatory trends and provides support to the boards of pharmacy as they seek to develop regulations that protect the public health. The NABP accreditation and inspection programs are also under his lead. Bill served a three-year term on the NABP Executive Committee. In addition, he served three terms as an Indiana Board of Pharmacy member and was Senior Manager of Pharmacy Affairs for the Walgreen Company prior to coming to NABP in January of 2016. He is also a licensed pharmacist and graduate of the Purdue University College of Pharmacy.
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