URGENT CALL TO ACTION:
FDA MEMORANDUM OF UNDERSTANDING
WITH STATES
The FDA has indicated it will finalize an MOU with states before the end of year. IACP and its partners have offered a "middle way" proposal that we believe accommodates FDA's need for data on the interstate shipment of compounded medications while preserving state board of pharmacy oversight of patient-specific dispensing and assuring patient access to essential compounded medications.
The time is now for Members of Congress to press FDA to assure that the final MOU addresses our concerns, as well as those raised by the National Association of Board of Pharmacy, if it wants states to actually sign the final MOU.
Please contact your Members of Congress NOW to urge that they reach out to the FDA immediately this issue. It's fundamental to your ability to practice pharmacy and to serve your patients!
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Thanks for your speedy reply to this important call to action.
BACKGROUND:
Section 503A of the Food, Drug and Cosmetic Act (FDCA) requires FDA to develop a Memorandum of Understanding (MOU) between FDA and the states that establishes a system whereby state boards of pharmacy will track and report to FDA on interstate distributions of inordinate quantities of compounded medications. The intent behind this section of the FDCA was for FDA to have a handle on which pharmacies were shipping large amounts of their compounded medications across state lines. The statute also says that pharmacies in states that do not sign the MOU will be capped at distributing no more than 5% of their compounded medications across state lines. The current draft MOU that the FDA has developed, which they intend to finalize this calendar year, is flawed because FDA has defined the key term of "distribution" to mean anything that leaves your pharmacy, including compounded medications you ship interstate pursuant to a patient-specific prescription. This will mean that if finalized in its current form, pharmacies in large sections of the country will be capped at shipping no more than 5% of their compounded medications interstate. This will greatly limit the ability of patients to obtain their compounded medications from the pharmacy of their choosing. IACP, along with APHA and NCPA, have offered a "middle-way" proposal that would give FDA the data they need without an arbitrary cap on interstate dispensing. Unfortunately, we have not received a response from FDA to-date. We need you to contact your U.S. Representatives and Senators in Washington, DC NOW and urge them to contact FDA and tell them to keep working with IACP and other stakeholders on a final MOU that all the states will sign and that protects the ability of patients to get their compounded medications from the pharmacy of their choosing, no matter which state it's located in.
