GLP-1 Drugs: FDA “Re-Confirms” Decision Removing Tirzepatide from the Drug Shortage List

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October 2, 2024, decision on tirzepatide.

FDA’s Declaratory Order: FDA’s 12-page order describes the process that FDA undertook to come to this conclusion and explains that FDA obtained information both from the manufacturer (Eli Lilly) as well as relevant information from “from patients, health care providers, and others, including compounders, along with data from other sources that we independently identified.” FDA acknowledges several times in the order that:

[E]ven when a shortage is considered resolved, patients and prescribers may still see intermittent localized supply disruptions as products move through the supply chain from the manufacturer and distributors to local pharmacies.

Current Status of Compounding of Tirzepatide: With respect to the current status of compounding of tirzepatide, FDA noted that it wished to “avoid unnecessary disruption to patient treatment, and outlined the current enforcement policy moving forward”:

[T]he agency does not intend to take action against compounders for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) arising from conditions that depend on tirzepatide injection products’ inclusion on FDA’s drug shortage list:  

• For a state-licensed pharmacy under section 503A of the FD&C Act compounding, distributing or dispensing tirzepatide injections within 60 calendar days from today’s announcement, until February 18, 2025.

• For outsourcing facilities under section 503B compounding, distributing or dispensing tirzepatide injections within 90 calendar days from today’s announcement, until March 19, 2025. 

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.  

In addition to the Declaratory Order, FDA also published an update to its website entitled “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize.” This update also included FDA’s enforcement policy described above, as well as referencing that while dulaglutide and semaglutide remain “in shortage” that the manufacturers have reported all presentations are available. For liraglutide, it is also in shortage, but the manufacturer has reported two presentations are available while three have limited availability. Finally, FDA notes that “[w]hen a status is noted as ‘available,’ that reflects the most current information from the manufacturer but is not an FDA determination that the shortage has been resolved.”

In the ongoing case with the Outsourcing Facilities Association (OFA), the parties filed a second joint status report stating FDA’s determination that the shortage is resolved but recognizing that Plaintiff’s as result may seek a motion for preliminary injunction. FDA stated that:

If [OFA] file[s] a motion for preliminary injunction within two weeks of today’s decision, [FDA] will continue to exercise such enforcement discretion through the Court’s resolution of that motion.

The parties also agreed to file another joint status report on January 2, 2025, and to confer regarding a possible preliminary injunction briefing schedule. To our knowledge, OFA has not publicly stated whether they intend to seek a preliminary injunction, but our expectation is that they will in near future. See our prior blog “GLP-1 Drugs: FDA Sued Over Removing Tirzepatide from the Drug Shortage List” for additional information.

Key Takeaways. FDA’s determination to “re-confirm” the resolution of the tirzepatide drug is not surprising, the only surprise is the timing here. Compounding of tirzepatide will continue until at least 90 days from December 19^th for 503B Pharmacies (also known as 503B Outsourcing Facilities, which are compounding pharmacies that can produce large batches of medications without patient-specific prescriptions). Whether it will extend beyond that timeframe will depend on the outcome of the OFA litigation. 

Want To Learn More? See our prior blogs.

• FDA Targets GLP-1 Providers with Warning Letters
• pharmaGLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Shortage List
• GLP-1 Drugs: Brand Companies Push FDA to Limit Compounding

Foley will continue to monitor these developments. Foley is here to help you address the short and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group and Health Care & Life Sciences Sector with any questions.