FDA-state compounding MOU now available for signing
A standard memorandum of understanding between the US Food and Drug Administration (FDA) and the states regarding interstate distribution of compounded drugs is available for signing.State boards of pharmacy or other state agencies have 365 days to sign the document. After that time, FDA intends to begin enforcing a provision of the Federal Food, Drug and Cosmetic Act (FD&C Act) that prohibits states that have not signed the MOU from distributing more than 5% of a compounded drug outside the state.
States entering into the agreement with FDA agree to notify the agency of quality problems or the occurrence of serious adverse events associated with compounded drugs that are distributed outside of the state.
"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,” said FDA Commissioner Stephen Hahn, MD, in a press release. “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.”
The release of the MOU in May 2020 marked a long-awaited refinement of how FDA defines “inordinate amounts” of compounded drugs put into interstate commerce. The MOU, said FDA in announcing its availability, “will serve as an important information-sharing mechanism about compounders, primarily pharmacies, that distribute compounded drugs interstate.” (RELATED: FDA addresses interstate distribution of compounded drugs in new MOU, Regulatory Focus 18 May 2020)
“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,” said Hahn. "This is expected to facilitate early collaboration on issues that have the potential to affect patients in multiple states"
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