WASHINGTON, D.C. – Global law firm Reed Smith today announced that a team of its Life Science Health Industry attorneys representing a coalition of U.S. compounding pharmacies recently won summary judgment against the U.S. Food and Drug Administration in federal court in Washington, D.C. District Court Judge Christopher Cooper ruled that an October 2020 FDA memorandum of understanding (MOU) affecting pharmacy compounding was a legislative rule with significant impacts on compounding pharmacies.
Example of a lab technician mixing a pharmaceutical compound.

According to Judge Cooper, the FDA’s MOU established an “arbitrary” 50 percent limit on the quantity of drugs that compounding pharmacies are allowed to be shipped interstate before being subject to federal reporting rules. After noting that the memorandum has significant binding legal consequences for pharmacies and that it represents a substantive change in the current federal oversight of interstate compounding, Judge Cooper remanded the new rule back to the FDA.

The Reed Smith team earning the plaintiffs’ win in Wellness Pharmacy Inc. et al. v. Becerra et al. was led by Rachael G. Pontikes and James Segroves, and included Emily L. Hussey, Kelly J. Kearney, David T. Hartmann, and David Bender.

The court deferred ruling on whether the FDA’s issuance of the MOU violated certain other procedural requirements as well as the agency’s statutory authority. Though this is likely not the end of the fight, this preliminary win is a significant victory for the compounding industry.