The FDA’s Ruling on Compounded GLP-1s
Implications for Pharmacists and Patients
3/14/2025
Latest Update: District court denied the plaintiffs’ preliminary injunction motion for tirzepatide products
On March 5th, the U.S. District Court ruled in favor of the FDA and denied a preliminary injunction that would prevent the FDA from removing tirzepatide products from the FDA’s drug shortage list. This decision means that the FDA will continue with its plans to phase out compounded tirzepatide products, creating challenges for both compounding pharmacies and patients. Following the court’s decision:
- 503A compounding pharmacies should stop compounding tirzepatide immediately, as the “period of enforcement discretion” has passed.
- 503B outsourcing facilities should stop compounding tirzepatide by March 19, 2025.
Similarly, the future of semaglutide compounding is also uncertain. The FDA ruled in February that the shortage of semaglutide products had been resolved; however, a preliminary injunction motion was filed with the district court by the Outsourcing Facilities Association (OFA) to stop the drug’s removal from the shortage list. According to the FDA:
- 503A compounding pharmacies can compound semaglutide until April 22, or until the date of the district court’s decision on the preliminary injunction motion, whichever is later.
- 503B outsourcing facilities can compounding semaglutide until May 22, or until the date of the district court’s decision on the preliminary injunction motion, whichever is later.
Despite the recent rulings, the Outsourcing Facilities Association recently posted on their LinkedIn page that they have filed a Notice of Appeal (NOA) to appeal the court’s decision. Stay tuned for additional court rulings and FDA decisions that can impact the ability to compound GLP-1 products.
Perspectives
Compounding Pharmacies
According to the lawsuit filed by OFA, compounding pharmacies believe they should be allowed to continue producing compounded GLP-1 products because 1) there is still a shortage of the drugs and 2) the FDA ruling dodged federal rulemaking requirements when making the decision to remove the products from the shortage list. The OFA lawsuit for semaglutide alleges that the FDA made its decision based on data provided by primary manufacturer Novo Nordisk, without considering evidence from healthcare providers and patients. According to the lawsuit, many providers and patients are struggling to obtain the branded product, despite aggressive advertising campaigns from the manufacturers.
Pharmaceutical Manufacturers
Pharmaceutical manufacturers believe that they have the right to protect their investment in developing the drugs and expanding their manufacturing capabilities. As of the end of 2024, Eli Lilly stated that they are able to meet the current demand for tirzepatide and that they have developed reserves of the drug. In fact, Lilly filed a motion to join the FDA as a defendant in the OFA lawsuit to take a more active role in the legal process. Novo Nordisk and Lilly have put substantial legal effort into the case against compounding - including arguing to the FDA that semaglutide is too complex to compound, asking for the drug to be added to the Demonstrable Difficulties for Compounding (DDC) list.
Impact on Patients
The loss of compounded GLP-1 options creates challenges for patients, both in terms of access to the medications and affording the treatment.
- Access to medication - Without compounded products, industry representatives expect patients to struggle to access branded GLP-1 products, especially the properly sized first dose required to start treatment. Medical experts recommend that patients immediately contact their provider to obtain a new prescription for a branded GLP-1 product; proactive outreach may help limit disruption in treatment.
- Cost of Treatment - When patients switch to branded GLP-1 treatments, they should expect a much higher price tag. Branded GLP-1 products can cost between $1,000 - $2,000 per month, depending on the product and source. In comparison, compounded GLP-1s are often less than $200 per month. One of the key challenges with branded products is that they usually aren’t covered by insurance or Medicare.
Next Steps for Pharmacists
What should compounders do now? Despite the uncertainty associated with the recent ruling, there are steps pharmacists can take to position themselves for success in the new environment.
Advice from DiversifyRx’s “Emergency Tirzepatide Webinar”
The B&B team recently attended a webinar hosted by pharmacy consultant Dr. Lisa Faast of DiversifyRx. During the session, she provided advice on how to approach the FDA’s recent ruling on Tirzepatide.
Near term actions:
- Stop compounding with APIs of either tirzepatide or semaglutide. This will put your legal pharmacy at risk with boards of pharmacy, the FDA, and Lilly/Novo legal teams.
- Dr. Faast recommended that pharmacies quarantine any GLP-1 supply that’s left over, ensuring that the drugs are properly stored. If OFA wins its appeal, there could be a chance to dispense the drugs that have already been purchased by the pharmacy.
- Pharmacies should communicate with patients and prescribers, making sure they understand how to continue their treatment plan.
- Follow the FDA website for further updates and guidance.
Longer term actions:
- Dr. Faast also provided several other therapeutics that can be considered alternatives for weight loss patients, including tesofensine, sermorelin, or liraglutide. Shifting your pharmacy’s formulary to include other weight loss products could help offset the loss of compounded GLP-1s.
Next generation of weight loss therapies:
- Other industry experts believe that semaglutide and tirzepatide are only the tip of the iceberg - there is a robust pipeline of next-generation weight loss therapies that will reach the market over the next few years.
- Anecdotally, one investment banker B&B spoke with believes that these next generation drugs will have substantial demand and may also end up on the shortage list.
- As a 503A compounder, you should closely watch FDA announcements (for both product approvals and shortage list decisions) and be prepared to opportunistically add the next generation products to your formulary.
Diversify your product mix with B&B:
- B&B is currently looking for 503A compounding pharmacies to partner with as a platform in our portfolio. We have strong relationships with provider groups in a variety of specialities, which can provide non-GLP-1 script volume.
- If you’ve thought about exiting your business after the GLP-1 craze, let’s talk! There might be opportunities to collaborate on a mutually exciting transition plan. See what your pharmacy might be worth here.
Contact
Email: partnerships@brockhurstgroup.com
Website: brockhurstandbuchanan.com
References
- https://www.wsgr.com/en/insights/fda-can-keep-tirzepatide-off-the-drug-shortage-list-judge-says.html
- https://www.fda.gov/drugs/drug-safety-and-availability
- https://www.businesswire.com/news/home/20241008699576/en/Outsourcing-Facilities-Association-Sues-FDA-Over-Sudden-Removal-of-Tirzepatide-from-Drug-Shortage-List
- https://www.linkedin.com/posts/ofa-compounding_90544ac4fabbddb94b4d2ba867566bfd1278d4pdf-activity-7300300104870113280-7JPH?utm_source=share&utm_medium=member_desktop&rcm=ACoAACPpXV0BaXWC_34NgHuzMkffr8KDTWvp1ts
- https://www.503bs.org/_files/ugd/90544a_c4fabbddb94b4d2ba867566bfd1278d4.pdf
- https://www.biospace.com/policy/compounders-sue-fda-for-declaring-ozempic-wegovy-shortage-over
- https://iclg.com/news/22322-fda-sued-over-weight-loss-drug-designation
- https://www.martilawgroup.com/post/eli-lilly-joins-fda-as-defendant-in-lawsuit-over-tirzepatide-shortage
- https://www.linkedin.com/pulse/perspective-eli-lillys-intervention-ofas-lawsuit-fda-brunner-cae-mvt8f/
- https://natlawreview.com/article/compounded-glp-1-drugs-texas-judge-denies-pi-motion-and-request-stay-fdas
- https://abcnews.go.com/GMA/Wellness/compound-versions-weight-loss-drugs-longer-fda-rules/story?id=119665010
- https://apnews.com/article/wegovy-ozempic-mounjaro-shortage-insurance-64014bc2887a518b33c597b2bf936e37
- https://www.self.com/story/compounded-glp-1s-semaglutide-tirzepatide-availability?utm_source=chatgpt.com
- https://www.wolterskluwer.com/en/expert-insights/glp-1-medications-and-weight-loss-help-patients-navigate-beyond-trends