The announcement, made by the FDA on Dec. 19, said compounding pharmacies must stop manufacturing less expensive, copycat versions of the medications within 60 to 90 days.
The Outsourcing Facilities Association, which has sued the FDA over the decision, criticized the agency’s assessment, claiming it disregards ongoing supply issues and could jeopardize patient access to medications.
In October, the FDA declared that the shortage of Mounjaro and Zepbound had been resolved, but the decision faced pushback from compounding pharmacies.
Eli Lilly has taken a firm stance against the sale of compounded versions of its drugs, citing safety and quality concerns. The company has warned that any marketing or selling of unapproved versions of tirzepatide, the active ingredient in both drugs, must cease immediately.
