FDA Updates Guidelines on Compounding Tirzepatide Injections as GLP-1 Shortage Ends

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The FDA has updated its guidance on the compounding of tirzepatide injections following the resolution of the drug’s national shortage. According to the regulatory body, the shortage, which had been attributed to an increased demand since 2022, has been declared resolved after the FDA confirmed that the manufacturer’s capacity can meet current and projected demand. However, it does not intend to act against compounders for violations of the FD&C Act arising from conditions that depend on the inclusion of tirzepatide injection products on the FDA’s drug shortage list, aiming to avoid unnecessary disruption to patient treatment.

Under the new guidelines, state-licensed pharmacies must seize compounding, distributing or dispensing of tirzepatide injections within 60 calendar days from the date of the announcement until February 18, 2025, under section 503A of the FD&C Act. Under section 503B, outsourcing facilities must do the same from 90 calendar days of the announcement until March 19, 2025.

Currently, the agency is monitoring drug availability and is working to determine whether the demand or projected demand for each drug in shortage exceeds the available supply. Current shortages include:

• Dulaglutide injection: Manufacturer has reported all presentations are available.
• Semaglutide injection: Manufacturer has reported all presentations are available.
• Liraglutide injection: Manufacturer has reported two presentations are available, and three have limited availability.¹

In October 2024, several compounders filed lawsuits against the FDA amid initial plans to stop the manufacturing of copies.² The Outsourcing Facilities Association, which represents bulk compounders, claimed that the FDA’s decision was arbitrary, capricious, and contrary to law, further arguing that the shortage of GLP-1 drugs from Lilly wasn’t over.³ As a result, the FDA paused enforcement while it reevaluated its decision and analyzed data from Lilly, compounders, and other organizations involved.²

Last month, Pharmaceutical Executive interviewed several industry experts to discuss the risks associated with obtaining compounded medications.⁴

“We're probably seeing about 10% of the [GLP-1] market going into various compounding forms,” said Peter Ax, founder, CEO, UpScriptHealth, in an interview with Pharmaceutical Executive.⁴ “You're looking at what is perhaps as much as a billion-dollar marketplace in compounded drugs right now…If you want to talk about the risks associated with that of purchasing drugs on a compounded basis, you really have to think about risks in two levels. One is, there's the risk of the physician interaction and how robust it is and how meaningful it is and how safe it is. And then the second one is, how safe are these compounded drugs? These are not the branded drugs being manufactured in FDA facilities. They're being manufactured in compounding pharmacies, which are licensed and are inspected, but there's certainly more of a risk when you purchase a drug that is compounded than it is manufactured in an FDA approved facility.”

Many patients have sought out knockoffs to GLP-1 receptors as a result of the medications costing around $1,000 a month without insurance. Back in January, it was reported that several compounding pharmacies were offering fake products ranging from $100 to $200 a month.⁵

“Counterfeit and illicit substances are a scourge in our healthcare system, and with the growth of GLP-1s, this phenomenon that we're seeing more and more counterfeit activity is taking place,” said Scott Brunner, CEO, Alliance for Pharmacy Compounding, in an interview with Pharmaceutical Executive. “We are seeing, not only sellers of substances that purport to be GLP-1 drugs. We're seeing entities that purport to be pharmacies that are not. There was a study a few months ago that had indicated that as many as 40% of online pharmacies were fake, which means not registered with not licensed by the State Board of Pharmacy or any of that. And those websites, they pop up. Somebody takes them down, and they'll pop up in another iteration. Many of them are selling what purport to be prescription drugs without a prescription, and it's just remarkably dangerous.”⁴

Moving forward, the FDA advised stakeholders to monitor its Drug Shortages Database for further updates.¹

References

1. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. FDA. December 19, 2024. Accessed December 19, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

2. Lilly’s US Weight-Loss Drug Shortage Ends, Curtailing Copycats. Bloomberg. December 19, 2024. Accessed December 19, 2024. https://www.bloomberg.com/news/articles/2024-12-19/lilly-weight-loss-drug-shortage-in-us-has-ended-fda-says?leadSource=uverify%20wall&embedded-checkout=true

3. Lilly Weight-Loss Drug Copycat Makers Sue FDA Over Shortage End. Bloomberg. October 7, 2024. Accessed December 19, 2024. https://www.bloomberg.com/news/articles/2024-10-07/lilly-weight-loss-drug-copycat-makers-sue-fda-over-shortage-end?embedded-checkout=true

4. Experts Weigh-In on Compounded GLP-1/Semaglutide Solution. PharmExec. November 6, 2024. Accessed December 19, 2024. https://www.pharmexec.com/view/experts-compounded-glp-1-semaglutide-solution

5. Report: Three US Residents Suffering from Hypoglycemia Used Suspected Counterfeit Ozempic. PharmExec. January 26, 2024. Accessed December 19, 2024. https://www.pharmexec.com/view/report-three-us-residents-suffering-from-hypoglycemia-used-suspected-counterfeit-ozempic