On Monday, the Food and Drug Administration stated that enforcement discretion for 503A state-licensed pharmacies to compound tirzepatide has ended. As we noted in our previous letter with APC, we expressed concerns that patients who have been receiving compounded tirzepatide may not immediately be able to transition to the FDA-approved product due to a variety of practical “speedbumps,” including getting a new prescription from their provider, navigating insurance coverage (including possible delays due to insurance prior authorizations), and a very real and continuing shortage of the products. We also expressed concerns about a resulting disruption of treatment, potentially leaving many patients without timely access to their medication.
Previously, the FDA maintained that it did not intend to take action against pharmacies compounding, distributing, or dispensing tirzepatide injections until Feb. 18, 2025, or until the date of the district court's decision on the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association (OFA) v. FDA in the Northern District of Texas, whichever is longer. On March 5, the district court denied the preliminary injunction motion, so the FDA’s recent statement to end enforcement discretion for 503As compounding tirzepatide is consistent with the agency’s past statement.
For 503B outsourcing facilities, the FDA does not intend to take action against compounders for violations of the Federal Food, Drug, and Cosmetic Act arising from conditions that depend on the inclusion of tirzepatide injection products on the FDA’s drug shortage list until March 19, 2025, also consistent with the FDA’s past statement.
Enforcement discretion for 503A state-licensed pharmacies to compound semaglutide remains in force until April 22, 2025, while 503B outsourcing facilities have until May 22, 2025, both consistent with FDA’s previous statement.
The FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.
NCPA is disappointed with the FDA's decision to end enforcement discretion for compounding pharmacies that compound tirzepatide injections and opposes the FDA’s assessment that the shortage is now resolved, given that many of our members are still seeing a lack of availability of these injections. However, we supported the FDA's decision for its now-lapsed transition period for compounding pharmacies, which NCPA and the Alliance for Pharmacy Compounding asked for in a letter to the FDA in October. NCPA will keep its members appraised of developments, including any developments in ongoing litigation.
