FDA Issues Order Noting Resolution of Tirzepatide Shortage: Update for Compounding PharmaciesDecember 20, 2024

On December 19^th, the FDA issued a FDA declaratory order noting the resolution of the shortage for tirzepatide injection products, including Mounjaro and Zepbound. The tirzepatide shortage, which began in December 2022, was driven by overwhelming demand for these breakthrough medications used in managing type 2 diabetes and obesity.  The FDA’s most recent decision, effective December 19, 2024, affirms the resolution of the shortage while recognizing potential localized disruptions due to supply chain dynamics. This development signals the end of the special regulatory conditions that allowed compounded tirzepatide products to play a critical role during the shortage.

For background, in October of 2024, the FDA had initially removed tirzepatide from the shortage list. Immediately following this action, Outsourcing Facilities Association (“OFA”) and North American Custom Laboratories, LLC, doing business as FarmaKeio Custom Compounding, sued the FDA, claiming the decision was a “reckless and arbitrary decision – lacking any semblance of lawful process.”

As a result, the FDA backed off its decision, saying it would revisit the ruling. With this order, the FDA is doubling down on its ruling that tirzepatide is once again off of the shortage list. 

What This Means for Compounding Pharmacies

This decision has direct implications for compounding pharmacies that have been producing compounded versions of tirzepatide under Sections 503A or 503B of the FD&C Act during the shortage. With the shortage now resolved according to the FDA, these pharmacies are expected to cease compounding tirzepatide, as federal law generally prohibits compounding copies of commercially available drugs unless they are in shortage. 

The FDA has outlined a transitional enforcement discretion period to facilitate a shift away from compounded tirzepatide products. After these grace periods, compounding pharmacies must cease compounding tirzepatide unless authorized under different legal or regulatory conditions.

60-Day Enforcement Discretion Window for 503A Compounders: For state-licensed entities compounding under Section 503A, the FDA will not take enforcement action until February 18, 2025.

90-Day Enforcement Discretion Window for 503B Outsourcing Facilities:  For outsourcing facilities compounding under Section 503B, the enforcement discretion period extends until March 19, 2025.

It will be key to plan for the end of the enforcement discretion period and to (1) stop compounding tirzepatide from bulk substances after the specified dates and (2) avoid producing compounded products that are essentially copies of Mounjaro or Zepbound.

To ensure compliance, it is important to maintain clear records of your actions during the transition period consistent with FDA guidance, to be prepared for potential FDA inquiries or audits.

Regarding other GLP-1 receptor agonists, such as semaglutide (marketed as Ozempic and Wegovy), the FDA’s December 19^th order does not directly address these products. The shortage status of each drug is assessed individually. As of the latest updates, semaglutide remains on the FDA’s drug shortage list, allowing for continued compounding under specific conditions. 

The evolving implications of cases such as OFA v. FDA and updates from the FDA highlight the need for continued vigilance and proactive planning. Compounding pharmacies should stay informed about the shortage status of each GLP-1 receptor agonist to ensure compliance with FDA regulations, and engage a regulatory attorney who is experienced in working with the FDA for guidance specific to their situation. Stay tuned for further updates on the OFA case and associated FDA actions which may arise in advance of the end of the enforcement discretion period.