FDA Resolves Semaglutide Shortage: What This Means for GLP-1 Compounding Pharmacies and Telehealth Weight Loss Companies
On February 21, 2025, the FDA officially determined that the shortage of semaglutide injection products has been resolved. Semaglutide is a glucagon-like peptide 1 (GLP-1) medication whose shortage has been in effect since 2022. Originally developed to treat type 2 diabetes, semaglutide and other similar GLP-1 medications have found demand in the market as weight loss medications when used together with diet and exercise to help individuals with at least one weight-related medical condition.
The FDA’s shortage resolution marks a pivotal moment for patients, compounding pharmacies, and telehealth companies that offer access to compounded semaglutide and other GLP-1 medications, as the FDA resolution means that semaglutide will no longer be compoundable under shortage-era flexibilities. Those impacted must navigate critical regulatory changes now in play for compounded semaglutide.
What Does This Change in Status Mean?
When a drug is listed on the FDA’s Drug Shortage List, it is considered not commercially available, which lifts the normal restrictions on compounding and opens the door for qualified compounding pharmacists or outsourcing facilities to prepare medications to meet patient needs. When the FDA determines the drug shortage is resolved, the normal restrictions on compounding will apply once again.
The Return of Compounding Restrictions for Semaglutide
Under the Federal Food, Drug, and Cosmetic (FD&C) Act, certain restrictions are placed on compounding drugs that are essentially copies of commercially available medications. Specifically, the law only allows for limited compounding of these drugs by state-licensed pharmacies or physicians when not done “regularly or in inordinate amounts.” In contrast, outsourcing facilities are restricted from compounding drugs that are essentially copies of commercially available medications in any amount. These restrictions ensure that compounded drugs do not replace commercially available products that have undergone rigorous FDA approval.
However, when a drug is on the FDA’s Drug Shortage List, the typical compounding limitations do not apply, which opens the door to compounded versions of popular drugs. When semaglutide was placed on the Drug Shortage List in 2022, state-licensed pharmacies, physicians, and qualified outsourcing facilities could legally produce it without facing typical compounding restrictions imposed by the FDA. With the shortage now resolved, the original limitations will once again govern the compounding of semaglutide products.
What Are the Key Dates to Know?
For compounding pharmacies or physicians that have been compounding semaglutide products during the shortage, the FDA has set clear deadlines for ceasing general semaglutide compounding practices:
State-licensed pharmacies or physicians compounding semaglutide under Section 503A of the FD&C Act must stop compounding, distributing, or dispensing semaglutide injections that are essentially copies of an FDA-approved product by April 22, 2025.
Outsourcing facilities compounding semaglutide under Section 503B of the FD&C Act have until May 22, 2025 to comply with these regulations.
After these dates, the FDA will begin enforcing the normal regulatory restrictions on compounded drugs, and manufacturing or distributing compounded semaglutide injections will be considered a violation of the FD&C Act.
What About Other GLP-1 Products?
While semaglutide is no longer eligible for general compounding, other GLP-1 drugs, such as dulaglutide and liraglutide, remain on the FDA’s Drug Shortage List. This means qualified pharmacies can still compound these products until these drugs are removed from the FDA’s drug shortage list.
How Should Pharmacies and Telehealth Companies Respond?
As the clock ticks down on compliance deadlines, it is critical that compounding pharmacies and telehealth companies that prescribe GLP-1 medications review their practices, including pharmacy relationships, drug fulfillment, and patient-facing materials, to ensure they are prepared to adhere to the FDA’s regulations for semaglutide and other compounded drugs. Semaglutide may still be in high demand, but telehealth practices and pharmacies must adjust their operations to comply with the FD&C Act and avoid enforcement action.
If your telehealth practice or pharmacy has been involved in compounding semaglutide or other GLP-1 drugs and you’re unsure how these changes will impact your operations, Nixon Law Group is here to help. We offer expert legal guidance to ensure that your practice and pharmacy remain compliant with FDA regulations and are ready for any future changes.