FDA ends semaglutide shortage listing and sets compounding deadlines
People who get compounded semaglutide injectables face a possible switch to brand-name products by late April or late May 2025, depending on which type of pharmacy made their supply.
The FDA removed semaglutide from its drug shortage list on February 21, 2025, ending a listing that had been in place since 2022, according to an analysis by the law firm Frier Levitt [1]. The decision starts countdown clocks for compounding pharmacies that make their own versions of the drug.
The FDA is allowing a 60-calendar-day grace period, until April 22, 2025, for 503A pharmacies, and a 90-calendar-day grace period, until May 22, 2025, for 503B outsourcing facilities to stop compounding, distributing and dispensing semaglutide products that are "essentially a copy" of the now commercially available products [1]. The grace period is all-inclusive: it covers not only compounding but also distributing and dispensing those products, and it applies to anticipatory compounding as well as compounded product that 503B facilities already obtained [1].
In a declaratory order announcing the end of the shortage, the FDA said it considered data submitted by brand manufacturer Novo Nordisk and also information from other sources, including telehealth companies, pharmacy compounders, associations representing compounders and outsourcing facilities, and individuals [1]. The agency wrote: "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" [1].
The letter carrying the decision was dated February 21, 2025 and came from Jacqueline A. Corrigan-Curry at the FDA's Center for Drug Evaluation and Research to Robert Fischer, Novo Nordisk's director of regulatory affairs [1].
The semaglutide action is separate from the continuing fight over tirzepatide. In that dispute, the Outsourcing Facilities Association sued the FDA in the Northern District of Texas (No. 4:24-cv-00953, filed October 7, 2024), and the tirzepatide grace period now depends on the district court's decision on a preliminary injunction motion in that case [1]. Whether a similar legal challenge is filed over the semaglutide determination has not been disclosed; the analysis notes that other industry stakeholders may seek to challenge the FDA's semaglutide decisions, and that compounders will have to make difficult decisions about their GLP-1 operations [1].
The FDA's wording has also raised questions, because the agency does not have direct authority over pharmacy dispensing, which is generally left to state boards of pharmacy [1]. Neither the semaglutide nor the tirzepatide action prohibits all compounding of these GLP-1 drugs by 503A pharmacies; instead, it creates limits, and FDA guidance spells out what counts as "essentially a copy" [1].
Why it matters for patients
People who receive compounded semaglutide injections may lose access to that supply when the grace periods end, depending on whether their pharmacy is a 503A or 503B operation [1]. The FDA itself expects that "some number of patients currently receiving those products can be expected to seek Novo Nordisk's approved products when compounding is curtailed" [1].
The FDA has said it will keep monitoring supply and demand, and pharmacies that have trouble obtaining brand products from wholesalers are asked to keep reporting those shortages to the agency [1]. Because dispensing is generally regulated by state boards of pharmacy rather than the FDA, the practical effect may vary by state, and the analysis describes the compliance picture as evolving [1].
What happens next
Two dates are set: April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities [1]. The separate tirzepatide grace period is waiting on the district court's ruling on a preliminary injunction motion in the Outsourcing Facilities Association case [1]. No court date or filing has been reported for any semaglutide challenge.
Sources
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