GLP1 dicission

The FDA’s 12-page order outlines the steps taken to reach this conclusion, noting that the agency gathered information from multiple sources, including the manufacturer, Eli Lilly, as well as input from patients, healthcare providers, compounders, and other independent sources. The FDA acknowledged that, even when a shortage is deemed resolved, patients and prescribers might still experience intermittent, localized supply disruptions as the drug moves through the supply chain. 

Healthcare providers looking to prescribe GLP-1 inhibitors can now order these medications through the Medspa Network. This platform offers an efficient way for medical professionals to access a range of GLP-1 inhibitors, helping to streamline the ordering process and ensure a steady supply of these important treatments for patients. With the ongoing updates in the availability of GLP-1 drugs, Medspa Network offers a reliable option for providers to meet their patients’ needs. 

Regarding compounding, the FDA emphasized its goal to prevent disruption to patient treatment and provided clarity on its enforcement policy moving forward. The agency confirmed that it would not take action against compounders for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to tirzepatide injections being included on the FDA’s drug shortage list: 

• For state-licensed pharmacies under section 503A of the FD&C Act, compounding, distributing, or dispensing tirzepatide injections is permissible for 60 days from December 19, 2024, until February 18, 2025. 

• For outsourcing facilities under section 503B, compounding, distributing, or dispensing tirzepatide injections is permitted for 90 days from December 19, 2024, until March 19, 2025. 

However, the FDA still reserves the right to take action against compounders who violate other regulatory or statutory requirements, such as those related to product quality or safety. 

In addition to the Declaratory Order, the FDA updated its website with a statement titled “FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize.” This update reiterated the enforcement policy and provided an overview of other GLP-1 drug supply statuses: 

• Dulaglutide and semaglutide remain in shortage, but manufacturers have confirmed that all presentations are now available. 

• Liraglutide is also in shortage, though two presentations are available, while three have limited availability. The FDA clarified that when a drug is marked as “available,” it reflects the most current information from the manufacturer and does not equate to a determination that the shortage is officially resolved. 

In the ongoing legal case with the Outsourcing Facilities Association (OFA), the parties filed a second joint status report acknowledging the FDA’s resolution of the tirzepatide shortage. The FDA also stated that if the OFA files a motion for a preliminary injunction within two weeks of the decision, it will continue exercising enforcement discretion until the court resolves the motion. 

Both parties agreed to submit another joint status report by January 2, 2025, and to discuss a potential schedule for preliminary injunction briefing. While OFA has not yet publicly disclosed whether they will seek a preliminary injunction, it is expected that they will do so in the near future. 

The FDA’s decision to reaffirm the resolution of the tirzepatide shortage is not unexpected, though the timing may be. Compounding of tirzepatide will continue until at least 90 days from December 19, 2024, for 503B Outsourcing Facilities. Whether this period will be extended depends on the outcome of ongoing litigation with the OFA.