On February 21, 2025, the FDA officially removed semaglutide from the 506e shortage list, which had been on the list since 2022. To avoid patient care disruptions, FDA is providing a grace period of 60 calendar days (until April 22, 2025) for 503A pharmacies and 90 calendar days (until May 22, 2025) for 503B outsourcing facilities to cease all compounding of “essentially a copy” of the now commercially available products. The grace period is all-inclusive and comprises not only compounding, but also distributing and dispensing of semaglutide products that are “essentially a copy.” This action has implications for anticipatory compounding as well as compounded product previously obtained from 503B outsourcing facilities.
Further, the language of FDA’s pronouncement has created several questions, as the FDA does not have direct authority over the act of pharmacy dispensing, something that is generally relegated to State Boards of Pharmacy. The FDA’s actions are separate and apart from the ongoing fight surrounding tirzepatide, and do not affect the tirzepatide grace period which is now dependent upon the district court’s decision on the preliminary injunction motion in OFA v. FDA lawsuit.[1] Although 503B outsourcing facilities would not be able to compound these drugs after the grace period, neither of these FDA actions prohibit all compounding of these GLP-1s by 503A compounding pharmacies. Rather, it results in certain limitations on the compounding of GLP-1s. FDA’s Guidance details what constitutes “essentially a copy.”
Interestingly, FDA stated in its Declaratory Order announcing the end of the semaglutide shortage that it has not only considered brand manufacturer submitted data, but also considered information from multiple sources other than Novo Nordisk. This allegedly included telehealth companies, pharmacy compounders, associations representing pharmacy compounders and outsourcing facilities, and individuals. FDA has additionally stated that: “We recognize that significant compounding of semaglutide injection products is occurring, and that some number of patients currently receiving those products can be expected to seek Novo Nordisk’s approved products when compounding is curtailed. However, the additional information provided by patients, healthcare providers, and others, including compounders, does not demonstrate that Novo Nordisk will be unable to meet projected demand, especially when weighed against the Novo Nordisk-provided data.”[2] FDA has indicated that it will continue to monitor supply and demand. At the same time, though, pharmacies experiencing shortages in obtaining the brand products from trading partners such as wholesalers should continue to report such shortages to FDA.
Because the FDA’s actions here differ from those at issue in the tirzepatide litigation, it is very possible that other industry-stakeholders may similarly seek to challenge FDA’s determinations regarding semaglutide. In any case, however, both 503A and 503B compounders will have to make difficult and complex decisions regarding their GLP-1 compounding operations.
Frier Levitt is at the forefront of advising compounders regarding the limitations on compounding GLP-1 products, as well as the compliance considerations under complex and nuanced FDA Guidance and evolving state policies. Frier Levitt attorneys recently presented two webinars on GLP-1 compounding and continue to advise clients on these matters. If you are compounding GLP-1s, it is imperative that you evaluate your operations to ensure compliance with FDA requirements, such as “medical necessity” and “not essentially a copy,” and engage competent counsel. Contact Frier Levitt attorneys today.
[1] Outsourcing Facilities Ass’n, et al. v. FDA, et al., No. 4:24-cv-00953 (N. D. Tex., filed Oct. 7, 2024).
[2] Letter from Jacqueline A. Corrigan-Curry, CDER, FDA to Robert Fischer, Director, Regulatory Affairs, Novo Nordisk Inc. Dated February 21, 2025.
