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May 22, 2020

FDA Releases Proposed MOU with States Addressing Compounded Drug Distribution

On May 13, the FDA released a proposed final MOU with states that addresses the regulation of human drug compounding.  The goal of the MOU is to “reduc[e] the risks associated with compounded drugs, while ensuring appropriate patient access.”  One such provision included in the MOU requires states to “identify pharmacy compounders that distribute inordinate amounts (greater than 50 percent) of compounded drug products interstate, as well as to report certain information to the FDA about those compounders.”  States signatories will also be required to “investigate complaints about drugs compounded at a pharmacy within their state and distributed outside of the state and advise the FDA when they receive reports of serious adverse drug experiences or serious product quality issues, like drug contamination.”  These provisions would not apply to drugs compounded for veterinary use, nor would they apply to 503B outsourcing facilities.  States now have one year to review and sign the MOU, and pass any legislation required to implement its provisions.