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.

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

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