GLP-1 No Longer on FDA’s Drug Shortage List

During the recent surge in demand for glucagon-like peptide-1 (GLP-1) receptor agonists, such as those found in semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), these medications quickly became scarce. In response, compounding pharmacies stepped in to help meet patient needs by formulating alternative versions, something that was rampant in the past few years. But now, things have changed.

Compounding pharmacies help meet patient needs by formulating alternative versions in the face of drug shortages but are no longer allowed to compound them. | Image Credit: Edugrafo - stock.adobe.com

“The FDA has declared the shortages of these drugs resolved and removed them from its official shortage list, so compounding pharmacies are no longer permitted to produce these copies without risking regulatory action,” said David Braverman, PharmD, RPh, an assistant professor in the Department of Pharmaceutical and Biomedical Sciences at Touro College of Pharmacy in New York, New York.

That means that traditional compounding pharmacies may no longer compound GLP-1 drugs unless they meet specific criteria, such as documented significant differences needed for a particular patient (eg, allergy to an excipient or need for a different dosage form). In addition, 503B outsourcing facilities must stop compounding essentially copies of FDA-approved drugs.

The 503A pharmacies had until April 22, 2025, and the 503B outsourcing facilities had until May 22, 2025, to stop compounding semaglutide. For tirzepatide, these dates were February 19, 2025, for 503A pharmacies and March 19, 2025, for 503B outsourcing facilities.

What does this mean for patients? Those relying on compounded versions may now face significantly higher out-of-pocket costs, as brand-name GLP-1 medications can exceed $1000 per month compared with the $100-to-$300 range typically charged by compounding pharmacies. Beyond cost, factors such as convenience and privacy may also be impacted.

Making a Transition

Transitioning from a compounded to an FDA-approved GLP-1 medication should be done under the guidance of a health care professional, Alyssa Billingsley, PharmD, director of pharmacy content at GoodRx, said, noting that such an individual can help the patient navigate any changes to the formulation, concentration, dosage, or delivery method.

“One challenge patients may face during this transition is the cost difference,” she said. “Compounded GLP-1s are often less expensive than FDA-approved versions. Insurance coverage can vary, especially if someone is using a GLP-1 medication off label or for weight loss alone. As a result, patients may face higher out-of-pocket costs when switching, which can impact access and adherence to treatment.”

To help manage these costs, Billingsley recommends exploring manufacturer co-pay cards, patient assistance programs, direct pharmacy options, or platforms like GoodRx.

It is also good to check pharmacy availability in advance, as certain doses of FDA-approved products may still be limited in some areas. Early planning can help ensure a smoother transition.

Brian Laird, PharmD, pharmacy operation manager at OSF HealthCare in Urbana, Illinois, noted that once patients can obtain the correct medication, transitioning to an FDA-approved version should not be difficult, as the same dose would have the same instructions for use.

The Road Ahead

The role of compounded GLP-1 therapy will wane as the FDA-approved GLP-1 drugs become widely available again, Thomas So, PharmD, senior manager of the consumer drug information group at First Databank. Based in South San Francisco, California, said.

“There will be only limited cases where a patient would have a need that cannot be met with the commercially available products,” he said. “The manufacturers will also push the FDA to tighten the enforcement and restrictions on the GLP-1 drugs. Litigation may serve as a potential pathway for compounding facilities, but it is likely to result in significant regulatory and legal challenges. While the compounded versions of GLP-1 medications have been more affordable, the manufacturers are expanding savings programs to help address this issue.”

To read these stories and more, download the PDF of the Drug Topics July/August issue here.

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