FDA’s Memorandum of Understanding for Compounding Pharmacies: What it Means for Patients

FDA`s Memorandum of Understanding for Compounding Pharmacies: What it Means for Patients

What is the Memorandum of Understanding (MOU) for compounding pharmacies?

The Memorandum of Understanding, or MOU, is formally known as the Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the States and the US FDA. The MOU asserts that states who sign the MOU will need to observe and monitor any 503A compounding pharmacies who distribute more than 50% of their product out of state; states who do not sign the MOU will be able to ship no more than 5% of their product out of state. The MOU was initially drafted in 1997 and was expected to be updated with input from state boards of pharmacy as well as compounding pharmacy associations, with the final MOU published in October of 2020.

What are some specific definitions in the MOU I should know about?

The MOU specifically states that it applies only to 503A pharmacies, not 503B pharmacies. The difference between these two types of compounding pharmacies is critical, as 503A pharmacies compound prescriptions only for specific patients and typically process much fewer prescriptions than do 503B pharmacies, which compound medications generally, not for specific patients. Additionally, 503A pharmacies do not need to register with the FDA. The MOU also specifies that the distribution caps will apply only to human prescriptions, not veterinary prescriptions. Finally, the FDA importantly defines “distribution” of product to include patient-specific prescription dispensing. This is a departure from previous statutes, which typically define distribution as dissemination of product that does not include patient-specific prescriptions.

What kind of compounding pharmacy information will states be expected to report to the FDA as a result of this MOU?

The MOU was created to balance risks to patient safety with availability of compounded medications to patients with a medical need. States will be expected to monitor compounding pharmacies who distribute more than 50% of their product out of state for complaints about adverse events and product quality issues. Any complaints that have been deemed to be genuine and concerning will be reported to the FDA. While this seems to be a well-intended system for elevating patient safety, it is significantly limited by monetary and personnel constraints. States will be primarily responsible to bear the responsibility of completing this monitoring without any federal assistance, creating a considerable burden on states.

What does this mean for me as a patient?

First, the MOU needs to be signed within 365 days of publication, so there will likely not be any immediate effects on patients. In the long-term, however, the results of the MOU will likely be state-specific. If the state in which your compounding pharmacy resides does sign the MOU, little will change regarding the status of your compounded prescriptions. However, if the state in which your compounding pharmacy resides does not sign the MOU, shipment of prescriptions across state lines will be significantly restricted. This will likely mean fewer options for patients, as most compounding pharmacies do not exclusively distribute to the state in which they reside.

  1. Draft Memorandum Of Understanding Addressing Certain Distributions Of Compounded Drug Products Between The State Of [Insert State] And The U.S. Food And Drug Administration. US Food and Drug Administration. October 26, 2020. Access at: https://www.fda.gov/media/91085/download
  2. Compounding Information for States. US Food and Drug Administration. Updated October 30, 2020. Access at: https://www.fda.gov/drugs/human-drug-compounding/compounding-information-states
  3. Kahn J. FDA in Brief: FDA Announces Significant Milestone in Compounding Program to Protect Public Health Through Collaboration with States. US Food and Drug Administration. Updated October 26, 2020. Access at: https://www.fda.gov/news-events/fda-brief/fda-brief-fda-announces-significant-milestone-compounding-program-protect-public-health-through
  4. Pore D, Brunner S. Compounding MOU: FDA has underestimated the administrative burden on states. Alliance for Pharmacy Compounding. Updated September 2020. Access at: https://a4pc.org/APC/Advocacy/Federal-advocacy/2020-05-15-FDA-finally-releases-final-MOU.aspx#:~:text=The%20issue,interstate%20shipment%20of%20compounded%20drugs.
  5. Shank A. What Does The FDA Final Standard MOU Do? Pharmacy Compounding Centers of America. July 16, 2020. Access at: https://www.pccarx.com/Blog/what-does-the-fda-final-standard-mou-do