The GLP-1 shortages and what they meant for compounding

On March 31, 2022, FDA added a semaglutide injection to its national drug shortage list. The product was a weekly pen approved in June 2021 for long-term weight management, and supply could not keep up with demand, according to a declaratory order FDA issued in February 2025¹. A second semaglutide pen, approved in 2017 for type 2 diabetes, joined the list on Aug. 23, 2022. Tirzepatide injection followed on Dec. 15, 2022, FDA said in a separate order².

Those listings did more than mark a scarcity. Under federal compounding law, a drug's presence on FDA's shortage list changes what pharmacies are allowed to make. For more than two years, state-licensed pharmacies and FDA-registered outsourcing facilities produced their own versions of both molecules for patients who could not find the approved products.

Both shortages are now over, and the legal room they opened has closed. For the general framework, see our explainer on 503A and 503B compounding.

How a shortage listing opens the door to compounding

Compounded drugs are not FDA-approved, and FDA does not check their safety, effectiveness or quality before they are sold, the agency says⁸. To keep compounding from turning into an unapproved parallel drug industry, the law limits how closely a compounded product may copy an approved one.

Section 503A covers state-licensed pharmacies and physicians. It bars them from compounding "regularly or in inordinate amounts" any drug that is essentially a copy of a commercially available product, FDA's summary of the statute⁶ explains. FDA does not consider products on its shortage list to be commercially available, as the agency put it in an October 2024 guidance⁵. While semaglutide and tirzepatide were listed, that copy restriction did not apply to them.

Section 503B covers outsourcing facilities, which can make larger batches without patient-specific prescriptions and must follow manufacturing-grade quality rules. They may compound from bulk active ingredient only if the substance is on FDA's list of bulk drug substances with a clinical need, or if the finished drug "is on FDA's drug shortage list at the time of compounding, distribution and dispensing," according to FDA's running statement on GLP-1 compounding⁴. Neither molecule appears on that bulks list, so for outsourcing facilities the shortage list was the only route.

The dates, as FDA published them

Each molecule went through the same steps: a listing, a finding that the shortage was resolved, and a wind-down period for compounders. FDA gave 503A pharmacies 60 calendar days and 503B facilities 90, "to avoid unnecessary disruption to patient treatment," the agency said⁴. Litigation pushed both 503A end dates back, by two days for semaglutide and about two weeks for tirzepatide.

Sources: FDA declaratory orders of Dec. 19, 2024² and Feb. 21, 2025¹, and FDA's GLP-1 compounding statement. During each wind-down, FDA said it did not intend to act on violations "arising from conditions that depend on" the drug's inclusion on the shortage list. It kept the right to act on anything else, including products "of substandard quality or otherwise unsafe."

Why tirzepatide came off the list twice

FDA first declared the tirzepatide shortage over on Oct. 2, 2024. It said it had "confirmed with the drug's manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand," and warned that patients might still see "intermittent localized supply disruptions" at pharmacies.

A trade group representing outsourcing facilities sued FDA in federal court in Texas. On Oct. 22, 2024, FDA said that "as part of litigation," the decision had been sent back to the agency for reevaluation. Compounders kept working during the review.

On Dec. 19, 2024, FDA reached the same conclusion again and published its reasoning in a declaratory order, along with a memorandum from its Drug Shortage Staff³ describing the supply and demand evidence, with confidential company data withheld. The semaglutide decision in February 2025 used the same format. The trade group brought a second suit over semaglutide; the court denied a preliminary injunction in that case on April 24, 2025, after denying one in the tirzepatide case on March 5.

Shortage determinations are national. FDA asks whether total supply meets total demand, so a resolved shortage can coexist with empty shelves at individual pharmacies. Our explainer on how FDA tracks drug shortages covers that test, and why drug shortages happen covers demand-driven cases like this one.

FDA's safety concerns about compounded versions

FDA's concerns over the period went beyond the legal questions. The agency reported receiving adverse event reports⁷ that may be related to dosing errors with compounded injectable semaglutide, in which patients measured the wrong amount or clinicians miscalculated doses. Some reports involved compounded semaglutide or tirzepatide prescribed at doses beyond the approved labeling.

FDA also said some compounders were selling salt forms, semaglutide sodium and semaglutide acetate. It called these "different active ingredients than are used in the approved drugs" and said it was "not aware of any lawful basis for their use in compounding."

As of May 31, 2026, FDA said it had received 990 adverse event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. FDA attaches two caveats to those counts. A report does not prove the drug caused the event, and 503A pharmacies are not required to report adverse events to FDA, so compounded-product events are likely underreported.

At the border, FDA created a "green list" import alert, number 66-80, to stop GLP-1 active pharmaceutical ingredients with potential quality concerns. It does not apply to ingredient makers that appear to comply with FDA's manufacturing standards, FDA said⁷.

Where the rules stood in 2026

FDA's latest entry in its GLP-1 statement, dated April 1, 2026, said that "tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list." It then spelled out how FDA reads the "essentially a copy" test for 503A pharmacies. A compounded product counts as a copy if it has the same active ingredient in the same, similar or easily substitutable strength and can be given by the same route, unless a prescriber documents a significant difference for an identified patient.

FDA gave a specific example. A compounded injection combining semaglutide with vitamin B12 (cyanocobalamin), each within 10 percent of the strengths in approved products, may be treated as a copy. FDA also said it does not intend to act against a 503A compounder for making copies if it fills four or fewer prescriptions of that product in a calendar month, according to the April 2026 update⁴.

Anyone holding a compounded GLP-1 product who is unsure where it came from, or whether it is still lawfully made, can ask the dispensing pharmacist or their prescriber; our script for talking to your pharmacist may help frame the question.

GxRadar's copy of FDA's shortage database, drawn from openFDA⁹ on Oct. 30, 2026, shows no current shortage listing for semaglutide or tirzepatide injection. Liraglutide injection, an older GLP-1 drug, is still listed as a current shortage, one of several endocrine and metabolic listings. It was first posted on July 18, 2023, and its listing was last updated on Oct. 14, 2026, with most presentations reported available. The full list is on our shortage tracker, and our analysis of how long shortages last measures the current entries.