By: Jim Hoover
The Food and Drug Administration (“FDA”) has removed semaglutide from its drug shortage list after the agency determined the current supply of the drug can meet present and future demand. On February 21, 2025, the FDA updated its drug shortage list and labeled the shortage of all doses of injectable semaglutide (Ozempic/Wegovy) as being resolved. The FDA’s announcement will affect community pharmacies, telehealth companies, and other providers managing patient care. These stakeholders should assess their current practices and effectively transition during the brief window in which the FDA will employ enforcement discretion. 503A compounding pharmacies may continue to compound semaglutide injection products until April 22, 2025. 503B outsourcing facilities may continue to compound semaglutide injection products until May 22, 2025. The FDA stated the deadlines were set “to avoid unnecessary disruption to patient treatment.”
As a primer, 503A compounding pharmacies compound drug products pursuant to a patient-specific prescription, while 503B outsourcing facilities generally compound drug products on a larger scale without a patient-specific prescription. Among other differences from FDA-approved drug products, compounded drug products have not undergone FDA premarket review for safety, effectiveness, or quality. Further, neither 503A compounding pharmacies nor 503B outsourcing facilities may compound a product that is “essentially a copy” of a commercially available drug. “Essentially a copy” is generally defined as identical or nearly identical to an FDA approved drug. One exception to the “essentially a copy” restriction that allows compounders to compound an essential copy of an FDA approved drug is when the FDA approved drug appears on the drug shortage list at the time of compounding, distribution, and dispensing. Thus, the placement of a drug on the drug shortage list allowed compounding pharmacies to compound semaglutide because the FDA did not consider the drug to be “commercially available” in the U.S.
Importantly, the April 22, 2025 and May 22, 2025 cut-off dates are for those compounded products that are “essentially a copy” of an FDA-approved product. The FDA’s declaratory order does not restrict compounding pharmacies or outsourcing facilities from compounding semaglutide injection products that are not essentially a copy semaglutide to meet individual patient needs. Examples of individual needs typically relate to requiring a different dose or a change in inactive ingredients due to adverse side effects such allergic reactions.
As a result of the FDA’s action, community pharmacies, telehealth companies, and other providers with a patient population relying on compounded semaglutide injection products will need to develop a transition plan. In its declaratory order, the FDA acknowledged that patients using these compounded products may face gaps in treatment and local shortages could persist. The FDA’s reasoning for extending the enforcement discretion period was in part to enable local pharmacies the opportunity to assess inventory and adjust ordering patterns based on new patterns of patient demand. However, the window of “opportunity” the FDA describes will not remain open long. As a result, stakeholders prescribing, receiving, or dispensing compounded semaglutide injection products need to take immediate action to plan and adapt accordingly.
The removal of semaglutide from the drug shortage list also comes as public officials raise concerns about counterfeit and illegal forms of diabetes and obesity medications entering the U.S. On Feb. 19, 2025 the National Association of Attorneys General sent a letter to acting FDA commissioner Sara Brenner, MD, MPH, asking the agency to take steps to stop “bad actors” from profiting off the sale of counterfeit incretin-based drugs. The letter cited reports of counterfeit GLP-1s entering the U.S. from foreign countries, with active ingredients of the drugs being sold illegally to consumers and compounding pharmacies that may be participating illegally in the market. The letter was signed by attorneys general from 38 states and U.S. territories.
The removal of semaglutide from the FDA’s drug shortage list represents a significant shift in the regulatory landscape for compounded GLP-1 medications and will impact the availability of compounded versions of these drugs. Health care providers should ensure they remain compliant with FDA regulations and appropriately guide their patients through this change. Additionally, clinics and pharmacies must be prepared for increased scrutiny surrounding compounded semaglutide and should counsel patients accordingly.
Jim Hoover is a health care trial and compliance Partner at Burr & Forman LLP practicing exclusively in the firm’s health care group. Jim may be reached by telephone at (205) 458-5111 or by E-mail at jhoover@burr.com.
