FDA in Brief: FDA Announces Significant Milestone in Compounding Program to Protect Public Health Through Collaboration with States
October 26, 2020
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Jeremy Kahn
301-796-8671
The following quote is attributed to FDA Commissioner Stephen M. Hahn, M.D.:
"We are pleased to have reached this important milestone and continue our collaborative efforts with states and other stakeholders to protect patients from the potential risks associated with poor quality compounded drugs, while ensuring appropriate access to compounded drugs for patients that have a medical need for them. The availability of our standard memorandum of understanding (MOU) for signature by the states will help enhance communication and maximize our federal and state resources for oversight of compounded drugs produced by traditional compounding pharmacies.
These partnerships between states that enter into the MOU and the FDA will further our combined efforts to protect the public health by, among other things, state regulators’ commitment to investigate complaints about adverse drug experiences and product quality issues involving drugs compounded at pharmacies within their state and distributed outside their state. State regulators will also have an efficient information sharing channel to advise the FDA when they receive reports of serious adverse drug experiences or serious product quality issues related to compounded drugs, such as contamination. This is expected to facilitate early collaboration on issues that have the potential to affect patients in multiple states.
As states prepare to sign the MOU, we’ll continue to work closely with them and other stakeholders to promote further improvement in the oversight of compounded drugs."
Additional Information
Today, the U.S. Food and Drug Administration is announcing the availability for signature of the standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products between state boards of pharmacy or other state agencies and FDA. As outlined in the agency’s May FDA Voices, once signed by states, the MOU will serve as an important information-sharing mechanism about compounders, primarily pharmacies, that distribute compounded drugs interstate.
Additionally, as part of the MOU, the agency has worked to refine the definition of “inordinate amount,” a threshold for certain information identification and sharing which does not place a limit on the distribution of compounded human drug products interstate by a pharmacy located in a state that has entered into the MOU. The Federal Food, Drug, and Cosmetic Act (FD&C Act) sets a five percent limit on compounded drugs distributed outside the state by a pharmacist, pharmacy or physician located in a state that has not entered into the MOU.
To provide ample time for state review, the agency has increased the amount of time for signature, from 180 days to 365 days, before it intends to enforce the five percent limit in section 503A of the FD&C Act in states that have not signed the final MOU. This extension should correspond to a full legislative cycle for most states and allows more time for states to modify their laws and regulations, if necessary.
Related Information
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.