In October, Food & Drug Administration (FDA) removed the GLP-1 Tirzepatide from the 506e shortage list. The Outsourcing Facilities Association, which represents 503B Outsourcing Facilities, immediately filed a lawsuit challenging FDA’s decision (Case 4:24-cv-00953-P). Pursuant to an October 11, 2024 Court Order (ECF No. 28), the challenged decision was remanded to the FDA and the litigation was stayed pending FDA’s review which was expected on November 21, 2024 and a further Court Order. Instead of rendering a decision, a Joint Status Report was released indicating that FDA has not yet finished assessing market conditions and the evidence to determine whether Tirzepatide should remain off the shortage list or be placed back on it.
FDA has indicated that while it’s determination is pending, it will not take enforcement action for either 503A pharmacies or 503B outsourcing facilities for compounding of ‘essentially a copy’ of the brand Tirzepatide. While this delay in FDA’s decision benefits 503A compounders and 503B facilities who may continue to compound, it also benefits the manufacturer by granting it more time to ramp up production so that FDA can be in a position to determine the initial removal was warranted.
It is also worth noting that according to the joint status report, “survey data from this month shows increasing numbers of patients unable to obtain branded GLP-1 agonist products, including specifically branded Tirzepatide products. Pharmacy distributors continue to list branded Tirzepatide products as out-of-stock or available in only limited quantities. Meanwhile, production of compounded Tirzepatide products by members of Plaintiff Outsourcing Facilities Association has remained steady or grown, reflecting still more market demand and medical need that is unable to be met by branded Tirzepatide products.”
The next Joint Status Report is due December 19, 2024 or within seven days of FDA’s decision so stay tuned.
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Contact us if you are contemplating or currently compounding GLPs, if you need a detailed review of the regulatory aspects of compounding, or a particular scenario. GLP-1 compounding presents a myriad of regulatory compliance issues for clinicians. We develop P&Ps, conduct mock compounding inspections, review labeling and advertising and assist many clients in meeting full regulatory compliance in the GLP-1 503A and 503B compounding space.
Related Article:
For a deeper dive into the case, check out our October article, “FDA’s Removal of Tirzepatide from the Drug Shortage List Sparks Legal Action and Concerns for Compounding Pharmacies,” which provides a detailed overview of the developments over the past few months.
