Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March 10th, the FDA issued guidance clarifying that 503A and 503B drug compounders must soon cease compounding semaglutide injection products[i] or risk enforcement action.[ii] This has a significant impact on compounding pharmacies as, under the Federal Food, Drug, and Cosmetic Act (the “FD&C”), drug compounders are permitted to compound their own copies of a patented drug if the FDA determines it is in shortage. Due to high demand for the drugs, Wegovy was added to the FDA’s drug shortage list in March 2022, and Ozempic in August 2022.[iii] Wegovy and Ozempic are the only FDA-approved semaglutide injection products.[iv]
Legal Challenges and Practical Impacts of the FDA’s Declaratory Order
After the February Declaratory Order was issued, the Outsourcing Facilities Association (the “OFA”) promptly filed a lawsuit against the FDA over its decision and a motion for a preliminary injunction to prevent the FDA from removing semaglutide from the drug shortage list.[v] U.S. District Court Judge Mark Pittman, who is hearing the case in a federal court in Texas, accepted Novo Nordisk’s renewed motion to intervene in the case to support its claim that the company can meet the high demand for its products.[vi]
In light of the OFA’s lawsuit, the FDA issued clarifying guidance on when compounders must cease compounding semaglutide. For compounders that have relied on the drug shortage to compound semaglutide, the FDA indicated that it will delay any enforcement action until the following dates, in order to avoid unnecessary disruption to patient treatment:
- For state-licensed pharmacists or physicians compounding under Section 503A of the FD&C: April 22, 2025, or until the District Court issues a decision on the OFA’s preliminary injunction motion, whichever is later; and
- For outsourcing facilities compounding under Section 503B of the FD&C: May 22, 2025, or until the District Court issues a decision on the OFA’s preliminary injunction motion, whichever is later.
The FDA noted that this delay in enforcement will allow patients a reasonable amount of time to transfer their prescriptions to different pharmacies to obtain the FDA-approved drug as well as to allow local pharmacies to adjust their stocking and ordering patterns to account for shifts in patient demand.
Bases for the FDA’s Decision
The FDA is required to “maintain an up-to-date list of drugs that are determined by [the FDA] to be in shortage in the United States”[vii] with a “shortage” being “a period of time when the demand or projected demand for the drug within the United Sates exceeds the supply of the drug.”[viii] To reach its decision, the FDA noted its consideration of information from numerous stakeholders, including individuals, telehealth companies, pharmacy compounders, associations representing pharmacy compounders, outsourcing facilities, and Novo Nordisk, the manufacturer of Wegovy and Ozempic. Novo Nordisk provided the FDA with information related to its production and inventory of the drugs, including quantities supplied and demanded, projected supply and demand in future months, and wholesaler inventory data. The FDA concluded that Novo Nordisk successfully demonstrated that its supply currently meets or exceeds the demand for its semaglutide injection products, and Novo Nordisk has developed sufficient reserves such that supply will meet or exceed projected future demands. The decision memorandum “Resolution of Semaglutide Injection Product Shortage and Supply Status”, dated February 21, 2025, sets forth the FDA’s full legal analysis upon which the February Declaratory Order is based.[ix]
The FDA acknowledged that it has received reports that some patients and pharmacists are not able to obtain the semaglutide injection products through the normal supply chain. However, the FDA reasoned these instances of inaccessibility are likely caused “by the practical dynamics of the part of the supply chain between Novo Nordisk and [its] customers, including wholesale distributors and pharmacies” rather than by a national shortage of supply.[x]
What’s Next for Compounders of Semaglutide?
While the OFA’s lawsuit and request for a preliminary injunction has yet to be decided, recent similar lawsuits inform the probable outcome. Specifically, the OFA previously filed a lawsuit against the FDA in October regarding the removal of tirzepatide from the shortage list. The OFA’s October suit delayed enforcement for a few months while the FDA reconsidered its decision, but on March 5th, the court upheld the FDA’s determination that the tirzepatide shortage had ended.[xi] While it is possible that the OFA’s suit challenging the February Declaratory Order could end differently, it is likely to have a similar outcome as the OFA’s challenge of tirzepatide’s removal from the shortage list. That is, enforcement may be delayed slightly, but the FDA will likely affirm its declaration that the semaglutide shortage is over.
It is expected that some compounding pharmacies, despite the February Declaratory Order, may continue to compound modified versions, such as in alternative doses or by adding additional ingredients, taking the position that it is different than the patented versions of semaglutide. However, this is a complex area of law currently being litigated with respect to tirzepatide. In addition, drug manufacturers have been actively issuing cease and desist letters and filing lawsuits against compounding pharmacies that produce tirzepatide. It is reasonable compounders of semaglutide will be met with similar action if they continue to compound modified versions of semaglutide after April 22nd or May 22nd, as applicable. As such, any compounding of drugs not on the shortage list, including semaglutide injection products, should be approached with caution given the current legal and regulatory landscape.
FOOTNOTES
[i] Rybelsus (semaglutide) tablets are FDA-approved for oral use and were not in shortage. The FDA’s February Declaratory order specifically addresses the compounding of semaglutide injection products that are “essentially a copy of a commercially available drug product” on the basis of the drug shortage exception.
[ii] U.S. Food and Drug Administration, Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy) (Feb. 21, 2025) [hereinafter “February Declaratory Order”].
[iii] February Declaratory Order, page 1.
[iv] February Declaratory Order, page 4.
[v] Outsourcing Facilities Ass’n v. United States Food & Drug Admin., 4:25-cv-174 (N.D. Tex. Feb. 24, 2025).
[vi] Kevin Dunleavy, In FDA obesity drug battle with compounders, Texas court allows Novo Nordisk to weigh in, Fierce Pharma (Mar. 6, 2025, 8:45 AM).e
[vii] February Declaratory Order, page 3 (citing Federal Food, Drug, and Cosmetic Act § 506E(a)).
[viii] February Declaratory Order, page 3 (citing Federal Food, Drug, and Cosmetic Act § 506C(h)(2); 21 C.F.R. 314.81(b)(3)(iii)(f)).
[ix] February Declaratory Order, page 1.
[x] February Declaratory Order, page 2.
[xi] Outsourcing Facilities Ass’n v. United States Food & Drug Admin., 4:24-cv-0953-P (N.D. Tex. Mar. 5, 2025).