Overview
On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the drug. The end of the shortage has important implications for industry stakeholders, as discussed in our previous On the Subject entitled “Weight Loss Drug Shortages Will End Soon.” Compounding pharmacies, outsourcing facilities, and providers should be aware of the impact of this change on their respective operations.
In Depth
This change in shortage status comes on the heels of FDA’s determination to remove tirzepatide from its drug shortage list in October 2024. In that case, industry stakeholders quickly filed a lawsuit against FDA challenging its determination. FDA reaffirmed its determination in a declaratory order on December 19, 2024, and stated that it would exercise enforcement discretion for 503A compounding pharmacies until February 18, 2025, and for 503B outsourcing facilities until March 19, 2025. On February 11, 2025, FDA clarified that this enforcement discretion would continue until the later of such previous date or until the date of the district court’s decision on the plaintiff’s preliminary injunction motion in Outsourcing Facilities Association v. FDA (N.D. Tex.).
In its declaratory order on semaglutide, FDA clarified that it will exercise enforcement discretion for 503A compounding pharmacies until April 22, 2025, and 503B outsourcing facilities until May 22, 2025. On February 24, 2025, the Outsourcing Facilities Association filed a separate lawsuit against FDA, challenging the agency’s determination of the shortage resolution of semaglutide. FDA has yet to comment on whether its enforcement discretion will be extended as a result of this filing.
Accordingly, as of April 22, 2025, 503A compounding pharmacies will generally no longer be able to rely on the FDA shortage list exception for compounding “essentially copies” of semaglutide products. To regularly compound semaglutide products (i.e., to fulfill five or more such products per calendar month), compounding pharmacies must ensure that compounded semaglutide products do not contain the same, similar, or easily substitutable dosage strength, or that such products are not used by the same route of administration as the commercially available product. Otherwise, there must be some other change that a prescriber determines produces a significant difference for the individual patient, documented on the prescription. FDA’s guidance “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” indicates that changes fitting that criterion (although such changes are not necessarily applicable to GLP-1 drugs) may include the removal of inactive ingredients because of a patient allergy or a change from tablet to liquid form because of patient inability to swallow tablets.
Similarly, for 503B compounding, as of May 22, 2025, outsourcing facilities will no longer be able to rely on the shortage exception for compounding of “essentially copies” of semaglutide products. For 503B outsourcing facilities, the compounded product is “essentially a copy” if it is identical or nearly identical to a commercially available product by virtue of having the same active ingredient, route of administration, dosage form, dosage strength, and excipients. FDA does not consider a compounded product to be “essentially a copy” if a prescriber determination of clinical difference for an individual patient is noted on the prescription or order (which may be a patient-specific prescription or a non-patient-specific order) for the compounded drug.
Other GLP-1 medication active pharmaceutical ingredients, such as liraglutide, remain in shortage and are listed as either “available” or “limited availability” in the drug shortage database. As anticipated, the national shortage of certain GLP-1 medications appears to be coming to an end.
We will continue to monitor the shortage status of GLP-1 medications and the impact on the industry.
