Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s (FDA) recent determinations that both semaglutide and tirzepatide shortages are officially resolved.
Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act prohibit physicians, pharmacies, and outsourcing facilities from compounding essential copies of commercially available approved drugs. However, essential copies of approved drugs may be compounded when such drugs are included on the FDA’s drug shortage list.
The FDA will take action against those continuing to compound these medications after the enforcement deadlines. Providers should start transition planning now.
Current Status of GLP-1 Medications
The FDA has officially determined that the shortage of both semaglutide and tirzepatide injection products is now resolved.
- Semaglutide: The FDA determined on February 21, 2025, that the shortage of semaglutide injection products (Ozempic and Wegovy) is resolved.
- Tirzepatide: The shortage of tirzepatide injection products (Mounjaro and Zepbound) was previously determined to be resolved as of December 19, 2024.
Legal Challenges to the FDA’s Decision to End Semaglutide and Tirzepatide Shortage
On February 24, 2025, the Outsourcing Facilities Association, the trade association representing FDA-registered 503B outsourcing facilities, filed a lawsuit (Outsourcing Facilities Association v. FDA, 4:25-cv-00174) challenging the FDA’s decision to remove semaglutide from the drug shortage list.
The plaintiffs argue that the FDA’s decision to remove semaglutide from the federal drug shortage list is “reckless and arbitrary” and filed a motion requesting a preliminary injunction to prevent the FDA from enforcing its decision. A decision on that matter is still pending.
This case is significant because it creates uncertainty around the FDA’s enforcement deadlines for compounded semaglutide.
The association filed a similar lawsuit (Outsourcing Facilities Association v. FDA, 4:24-cv-953) on October 7, 2024, over the removal of tirzepatide from the federal drug shortage list. A request to temporarily prevent the FDA from enforcing its decision was denied. The Outsourcing Facilities Association and the FDA have jointly requested the court to enter a judgement on the merits of this case to speed up the appellate review process.
On March 20, 2025, the court stated that it was reluctant to enter a decision on the merits without allowing the parties to present further evidence in support of their positions and scheduled a hearing on the joint motion for April 24, 2025.
When Must Providers and Pharmacies Comply?
For Semaglutide
- State-licensed pharmacies or physicians (503A): FDA will not take enforcement action until April 22, 2025, or until the date of the district court's decision on the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:25-cv-00174, whichever is later.
- Outsourcing facilities (503B): FDA will not take enforcement action until May 22, 2025, or until the date of the district court's decision on the plaintiffs' preliminary injunction motion in the same case, whichever is later.
For Tirzepatide
- State-licensed pharmacies or physicians (503A): The enforcement discretion period has ended as of March 5, 2025.
- Outsourcing facilities (503B): FDA will begin taking enforcement action on March 19, 2025.
Drugmakers Also Taking Legal Action Against Physicians, Telehealth Companies
It should also be noted that the drugmakers may also take legal action against physicians and businesses marketing or prescribing compounded versions of their drug.
Eli Lilly & Co. CEO Dave Ricks said in an interview, “We’re going after this with our legal tools, we send letters to people and threaten them. We can challenge the physicians who are doing the prescribing.”
The drugmaker sent cease-and-desist letters to telehealth companies, wellness centers, and medical spas last August to stop the promotion of the compounded versions of Zepbound and Mounjaro.
Eli Lilly also filed lawsuits in several states in September 2023 seeking to prevent pharmacies from selling compounded versions of tirzepatide. At least one of those lawsuits was dismissed on the grounds that the claim was an attempt to preempt federal law.
What This Means for Prescribers and Pharmacists
Tirzepatide Prescribing:
If you are a state-licensed pharmacy or physician compounding under 503A or an outsourcing facility under 503B, you can no longer compound tirzepatide as the enforcement discretion period has ended.
While the FDA rules do not directly prohibit physicians or other prescribers from ordering compound tirzepatide, 503A pharmacies and 503B outsourcing facilities will be unable to fill orders for compounded tirzepatide, unless an exception applies.
For example, patient-specific orders for compounded drug products without a particular inactive ingredient for a patient that has an allergy to the inactive ingredient would be permissible because the drug compound would not be considered an essential copy of a commercially available approved drug.
Semaglutide Prescribing:
You may continue to compound, distribute, or dispense semaglutide injection products within the timeframes specified above. This applies to:
- 503A compounders: Until April 22, 2025 (or later, depending on court decision)
- 503B facilities: Until May 22, 2025 (or later, depending on court decision)
Important Caveat:
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.
Status of Other GLP-1 Products:
As of February 21, 2025, the FDA is also monitoring other GLP-1 medications:
- Dulaglutide injection: Still in shortage, though the manufacturer has reported all presentations are available.
- Liraglutide injection: Still in shortage, with the manufacturer reporting two presentations available and three with limited availability.
Please note that when a status is noted as "available," this reflects the most current information from the manufacturer but is not an FDA determination that the shortage has been resolved.
Questions about Compliance with these FDA Enforcement Deadlines?
Weight loss clinics, telehealth companies, physicians, and pharmacies: Consult with the healthcare attorneys at Hendershot Cowart P.C. to ensure compliance with FDA regulations as these enforcement discretion periods end or approach their end dates.
Contact us online or call (713) 783-3110.