Weight Loss Drug Shortage Update: Is It Over in 2025?

Is the weight loss drug shortage over in 2025?

The answer is yes for the two injectable products at the center of the shortage. FDA declared the tirzepatide injection shortage resolved on December 19, 2024, and the semaglutide injection shortage resolved on February 21, 2025 [1][2]. In its current compounding statement, FDA says tirzepatide and semaglutide do not appear on its drug shortage list or on the list of bulk substances outsourcing facilities may use [1].

The dates mark a legal change, not just a supply update. The shortage list was one of the conditions that allowed outsourcing facilities to use bulk semaglutide or tirzepatide in compounding [1]. Once the drugs came off the list, that route closed [1].

What the shortage list actually controls

An outsourcing facility may not compound with a bulk drug substance unless the substance is on FDA's bulk-substances list or the compounded drug is on FDA's shortage list at the time of compounding, distribution and dispensing [1]. FDA's April 1, 2026 reminder states that tirzepatide and semaglutide are on neither list [1].

State-licensed pharmacies have a different path. FDA says a pharmacy may compound for an individual patient based on a prescription, but it may not compound regularly or in inordinate amounts a product that is essentially a copy of a commercially available drug [1]. The exception is a prescriber's documented determination that the compounded product contains a change that produces a significant difference for that patient [1]. FDA also said it does not intend to take action against a compounder that fills four or fewer prescriptions of that copy in a calendar month [1].

What changed in 2025

For semaglutide, FDA said it did not intend to take action against outsourcing facilities for the injection until May 22, 2025, and that the enforcement discretion period for state-licensed pharmacies had ended [1]. The practical effect is that a compounded copy made only because of the shortage no longer has that basis [1]. For tirzepatide, FDA issued its own timeline update for compounders after a district court denied a preliminary injunction motion on March 5, 2025 [1].

The 2026 proposal would tighten bulk compounding further

On April 30, 2026, FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the list of bulk substances that outsourcing facilities may compound with, finding no clinical need [3]. Comments were due June 29, 2026, and FDA said it would consider them before making a final determination [3]. The proposal does not change the 2025 shortage answer; it addresses the separate bulk-substances list [3].

What FDA says about compounded GLP-1 safety

FDA says compounded drugs are not FDA approved and are not reviewed for safety, effectiveness or quality before they are marketed [2]. As of May 31, 2026, FDA had 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide, plus reports of dosing errors [1][2].

FDA's telehealth red flags include a seller that claims a compounded drug is the same as an FDA-approved drug, does not require screening and a prescription by a licensed doctor, has no licensed doctor available for questions after purchase, sends broken or damaged packaging, or has spelling errors on the label [2]. FDA also says retatrutide and cagrilintide cannot be used in compounding under federal law and have not been found safe and effective for any condition [2]. For injectable GLP-1s, FDA recommends discarding a multi-dose vial 28 days after first use, even if medication remains, and not using a product that arrives warm [2].

What are the approved weight-management options now?

The products with FDA approval for weight management are Wegovy (semaglutide injection and tablets), Saxenda and generic liraglutide for weight, Zepbound (tirzepatide), and Foundayo (orforglipron) [4][5][6][7]. Their labels list the approved doses, titration schedules and warnings [4][5][6][7]. Compounded semaglutide or tirzepatide is not one of those approved products [2].