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On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage List since 2022 because demand for the drug exceeded the available supply. Initially developed and utilized for treatment of Type 2 diabetes, semaglutide and other GLP-1 medications can also result in substantial weight loss, which has made them popular for on- and off-label use through medications marketed under brand names like Ozempic and Wegovy.

Semaglutide’s presence on the Drug Shortage List allowed physicians, medspas, telehealth companies, pharmacies, and outsourcing facilities greater latitude to make compounded versions of the medication available to their patients to meet the increased demand at a much lower cost than the popular brand name versions. Health care providers who have offered compounded versions of semaglutide for weight loss and weight management will now be severely limited in how they are permitted to compound these medications for their patients.

The FDA will refrain from acting against compounders for violations of the federal Food, Drug & Cosmetic Act (“FD&C Act”) arising from conditions that depend upon semaglutide’s inclusion on the Drug Shortage List in order to avoid unnecessary disruptions to patient treatment, but only until the following dates:

  • For state-licensed pharmacies or physicians compounding under Section 503A of the FD&C Act: compounding, distributing, or dispensing semaglutide injection products that are “essentially a copy” of an FDA-approved product: until April 22, 2025.
  • For outsourcing facilities under Section 503B of the FD&C Act: compounding, distributing, or dispensing semaglutide injection products that are “essentially a copy” of an FDA-approved product: until May 22, 2025.

The FDA may still take enforcement actions during this time regarding other statutory or regulatory violations, such as those relating to product quality or safety.

This action by the FDA creates a sea change in how health care providers who prescribe or compound semaglutide injection products will be permitted to prescribe and compound these medications going forward. No longer will medical practices and medspas be able to financially benefit from prescribing, compounding, and dispensing compounded semaglutide products that are “essentially copies” of their brand name counterparts. Patients will also have to pay for the cost of brand name semaglutide products if they continue treatment.

For similar reasons, this change will also have a substantial impact on pharmacies, outsourcing facilities, and telehealth companies specializing in compounded semaglutide injection products.

If your health care practice, medspa, or business engages in prescribing or compounding semaglutide injection products, consulting with experienced health care attorneys well in advance of the quickly approaching deadlines can help avoid significant compliance risks.

If you have any questions regarding how this change will affect your business, please contact Jonathan B. Schall (jschall@foxrothschild.com) and Edward J. Cyran (ecyran@foxrothschild.com).