Is Semaglutide Still in Shortage? FDA Status for 2026

No. Semaglutide injection products (Ozempic and Wegovy) are not on the FDA drug shortage list. The FDA declared the shortage resolved on February 21, 2025, after confirming with the manufacturer that availability and manufacturing capacity can meet present and projected national demand ^[1]. An FDA statement dated April 1, 2026 reiterates that semaglutide does not appear on the drug shortage list or on the 503B bulks list ^[1], and a legal summary dated September 10, 2026 reports that the FDA’s shortage determinations for semaglutide and tirzepatide remain in place after the Fifth Circuit upheld them ^[10].

That does not mean every pharmacy always has every dose in stock. The FDA has warned that patients and prescribers may still see intermittent and limited localized supply disruptions as products move through the supply chain from manufacturers and distributors to local pharmacies ^[1]. A national shortage determination and a temporary stock-out at one drugstore are two different things.

When did the semaglutide shortage start and why?

The FDA added Wegovy to its drug shortage list on March 31, 2022, and added Ozempic on August 23, 2022 ^{[9] [2]}. The cause was increased demand: semaglutide injection products had been in shortage since 2022 because demand in the United States exceeded the existing supply ^{[1] [2]}.

Under federal law, a drug shortage is the period when demand or projected demand for a drug within the United States exceeds the supply of the drug (21 U.S.C. 356c) ^[9]. Throughout the shortage, Novo Nordisk made significant investments to expand its production capacity to meet patient demand ^[9]. The FDA reviewed data on Novo Nordisk’s production and inventory for all strengths of the drug products, projected supply and demand in future months, and wholesaler inventory data before concluding the shortage was resolved ^{[9] [2]}.

Why did removing semaglutide from the shortage list matter for compounded versions?

Federal law restricts compounding. Section 503A covers state-licensed pharmacies and physicians compounding for an individual patient based on a prescription, while section 503B covers outsourcing facilities that compound on a larger scale ^{[2] [3]}. Neither may compound a drug that is essentially a copy of a commercially available drug — with one key exception: the restriction is relaxed while the approved drug appears on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing ^{[2] [3] [9]}. That exception is what allowed compounded semaglutide to be sold widely during the shortage.

When the FDA declared the shortage resolved on February 21, 2025, it gave compounders a transition window before enforcement resumed ^[1]:

Compounder type	Enforcement discretion ended
503A state-licensed pharmacies and physicians	April 22, 2025 (60 days)
503B outsourcing facilities	May 22, 2025 (90 days)

Those deadlines held after the district court denied the compounders’ preliminary injunction motion on April 24, 2025, in Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.) ^[1]. The FDA said the deadlines were set to avoid unnecessary disruption to patient treatment ^{[1] [3]}. In reaching its decision, the FDA considered the manufacturer’s production capabilities and inventory, wholesaler inventory, and information from telehealth companies, pharmacy compounders, associations representing compounders and outsourcing facilities, and individuals ^{[2] [9]}.

What did the courts decide, including the August 2026 appeal?

The Outsourcing Facilities Association sued the FDA under the Administrative Procedure Act, and Novo Nordisk intervened as a defendant. On June 13, 2025, the district court granted summary judgment to the FDA ^[9].

On August 27, 2026, the Fifth Circuit affirmed, in No. 25-10758 for semaglutide and No. 25-10600 for tirzepatide ^{[9] [10]}. The court held that any error by the FDA in not using notice-and-comment procedures was harmless, because affected parties had actual notice and repeated opportunities to submit information to the agency, and that the delisting action was not arbitrary or capricious ^{[9] [10]}.

The court also upheld the FDA’s reliance on manufacturer supply and inventory data over contrary evidence such as screenshots, patient reports, surveys, and news articles offered to show that shortages persisted ^[10]. Both opinions are unpublished under Fifth Circuit Rule 47.5 ^{[9] [10]}. A legal analysis notes that although unpublished, the decisions apply settled precedent, and district courts facing materially similar challenges should reach the same result absent materially different facts ^[10].

Is tirzepatide (Mounjaro, Zepbound) in shortage?

No. Tirzepatide’s path was bumpier but ended in the same place. The FDA declared the tirzepatide shortage resolved on October 2, 2024; the decision was remanded for reevaluation on October 22, 2024 as part of litigation; and the FDA again determined the shortage was resolved on December 19, 2024 ^[1].

Enforcement discretion for tirzepatide ran until February 18, 2025 for 503A compounders or the district court’s preliminary injunction decision on March 5, 2025, whichever was later, and until March 19, 2025 for 503B outsourcing facilities ^{[1] [4]}. On May 7, 2025, the district court upheld the FDA’s tirzepatide decision ^[4]. In that case, the FDA discounted information collected through a Hims & Hers website because the submissions did not reliably establish when a reported access problem occurred, where the user was located, why the individual could not obtain the drug, or whether the same person submitted multiple reports ^[10].

My pharmacy is out of Wegovy or Ozempic — does that mean there’s still a shortage?

Not necessarily. The FDA’s shortage list is a national determination about whether demand exceeds supply across the country ^[9]. When it declared the semaglutide shortage resolved, the FDA said patients and prescribers may still see intermittent and limited localized supply disruptions as products move through the supply chain ^[1].

The FDA also acknowledged in its declaratory order that patients using compounded products could face gaps in treatment and that local shortages could persist, and it extended the enforcement discretion period partly so local pharmacies could assess inventory and adjust ordering patterns based on new patterns of patient demand ^{[2] [3]}. Patients typically start at the lowest strength and step up over time, and the FDA reviewed supply data for all strengths before delisting ^[9]. During the transition from compounded to FDA-approved products, insurance barriers such as prior authorizations were anticipated ^[2].

How do I check the FDA drug shortage list?

The FDA maintains its drug shortage database at accessdata.fda.gov/scripts/drugshortages, and federal law requires the agency to keep the list up to date ^{[1] [9]}. You can search by active ingredient (such as semaglutide injection) or by brand name.

One caution when reading shortage databases: a product being discontinued is not the same as a shortage. Australia’s Therapeutic Goods Administration, for example, lists the Ozempic 0.25/0.5 mg 1.5 mL pen as discontinued, deleted from the market on December 31, 2025 for commercial reasons and replaced by a 3 mL pen, with PBS supply-only listing extended to June 1, 2026 ^[7]. That is a discontinuation of one presentation, not a shortage listing ^[7].

Could semaglutide go back on the shortage list?

It could if demand again exceeded supply under the statutory definition, but nothing in the current record points that way. Supply has continued to grow since delisting: a Wegovy pill was approved on December 22, 2025, Wegovy HD 7.2 mg injection was approved on March 19, 2026, and Novo Nordisk announced a significant reduction in the US list price for Wegovy, Ozempic, and Rybelsus on February 24, 2026 ^[8].

Separately, on April 30, 2026, the FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances ^[5]. Outsourcing facilities may compound from a bulk drug substance only if it appears on the 503B bulks list or the compounded drug is on the shortage list at the time of compounding, distribution, and dispensing ^{[1] [5]}. Comments on the proposal were due by June 29, 2026, and a final determination is pending ^[5].

What compounded semaglutide is still legal, and what are the risks?

Patient-specific compounding remains lawful in narrow circumstances. A 503A pharmacy may still compound semaglutide for an identified individual patient when a prescriber determines and documents that the compounded product contains a change producing a significant difference from the commercially available product — for example, a different dose or a change in inactive ingredients for a patient who cannot tolerate them ^{[1] [2] [10]}.

The FDA has also stated it does not intend to take action against a compounder for compounding an essential copy regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that product during a calendar month ^[1]. Combining semaglutide with another ingredient such as vitamin B12 does not escape the rule: FDA treats such combinations as essential copies when the products are used by the same route of administration and the strengths are within 10% of the commercially available products ^[1].

On safety, as of May 31, 2026, the FDA had received 990 reports of adverse events associated with compounded semaglutide and more than 730 associated with compounded tirzepatide ^[6]. Those numbers are likely underreported, because state-licensed pharmacies that are not outsourcing facilities are not required to submit adverse events to the FDA ^[6]. The FDA also flags salt forms of semaglutide — semaglutide sodium and semaglutide acetate — as different active ingredients from the approved drugs, with no lawful basis known to the agency for their use in compounding, and it maintains a green list import alert (66-80) aimed at GLP-1 active pharmaceutical ingredients with potential quality concerns ^[6]. One telehealth red flag the FDA lists is a company claiming its compounded drug is the same as an FDA-approved drug ^[6].

Sources

1. US Food and Drug Administration. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize.
2. Alston & Bird. FDA Resolves Semaglutide Shortage: Next Steps for Community Pharmacies, Telehealth Companies, and Other Providers. March 12, 2025.
3. Burr & Forman LLP. The FDA Removes Semaglutide from the Drug Shortage List. April 29, 2025.
4. McDermott Will & Emery. Court Backs FDA in Tirzepatide Compounding Case.
5. US Food and Drug Administration. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List.
6. US Food and Drug Administration. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.
7. Therapeutic Goods Administration. Semaglutide - medicine shortage information.
8. Drugs.com. Wegovy FDA Approval History. May 18, 2026.
9. US Court of Appeals for the Fifth Circuit. Outsourcing Facilities Association v. Food and Drug Administration, No. 25-10758. August 27, 2026.
10. Clark Hill. Fifth Circuit Upholds FDA GLP-1 Shortage Decisions, Narrowing Path for Mass-Market Compounding. September 10, 2026.