The FDA has maintained its previous statement that the tirzepatide injection shortage is resolved, and that the agency does not intend to take action against:
1. 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 (N.D. Tex.), whichever is longer; and
2. Outsourcing facilities compounding, distributing or dispensing tirzepatide injections until March 19, 2025, or until the date of the district court's decision on the plaintiffs' preliminary injunction motion in OFA v. FDA (N.D. Tex.), whichever is longer.
The FDA said it may still take action regarding violations of 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 FDA's decision to state the tirzepatide injection shortage is now resolved, given that many of our members are still seeing a lack of availability of these injections. However, we support FDA's decision for its 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 apprised of developments, including any developments in ongoing litigation.
