FDA does not intend to take action against compounders for compounding tirzepatide, it said in a letter to the Alliance for Pharmacy Compounding. This is a win for both NCPA and APC, who jointly asked the FDA to allow compounders to keep compounding tirzepatide. NCPA still encourages members to check with their state boards of pharmacy to make sure that they are taking the same approach.
Federal law permits the compounding of copies of FDA-approved drugs when a drug is in shortage. On Oct. 7, 2024, FDA was sued by a compounder and a trade association regarding removal of tirzepatide injection from FDA’s drug shortages list. On Oct. 11, upon FDA’s motion, a court order remanded the decision to the FDA for reevaluation. See Outsourcing Facilities Ass’n v. FDA, No. 4:24‐ cv‐953, ECF Nos. 27, 28 (N.D. Tex.).
In that litigation, FDA stated in its motion that during the reevaluation and until 2 weeks after the FDA makes its decision (and if the plaintiffs file a motion for preliminary injunction, until the court resolves such a motion), FDA does not intend to take action against the plaintiffs in the case for violations of the Federal Food, Drug, and Cosmetic Act arising from conditions that depend on tirzepatide’s inclusion on the FDA drug shortage list.
The FDA letter to APC also stated that neither FDA’s statement nor the court’s order prevents FDA from taking action for violations of any other statutory or regulatory requirements, such as to address findings that the product may be of substandard quality or otherwise unsafe.