In a significant legal win for the pharmacy compounding industry, the FDA this week conceded that it must conduct formal notice-and-comment rulemaking to implement its memorandum of understanding with states regarding interstate shipments of compounded medications. The agency concession is related to a lawsuit, Wellness Pharmacy v. Azar, brought in federal court against the agency in 2020 by seven compounding pharmacies. NCPA submitted an amicus filing in the case. In a status report filed Tuesday with the U.S. District Court for D.C., the FDA said it would suspend implementation of the MOU and engage in a formal rulemaking process. The agency indicated in its filing that the process may take "several years" to complete.
NCPA
