The Impact of the FDA's Decision on Semaglutide Shortage and the Future of Compounds
In February 2025, the U.S. Food and Drug Administration (FDA) announced that the shortage of semaglutide injections had been resolved, leading to the removal of these products from the agency’s drug shortage list. This decision was based on data suggesting that manufacturers could now meet the current and projected demand for injectable semaglutide, the active ingredient in popular medications like Ozempic and Wegovy.
During the shortage, many compounding pharmacies and 503B outsourcing facilities stepped in to fill the gap by producing compounded semaglutide injections. However, with the shortage officially declared over, the FDA has set deadlines for these entities to cease compounding semaglutide injections—April 22, 2025, for 503A compounding pharmacies and May 22, 2025, for 503B outsourcing facilities. This decision carries significant implications for the compounding industry, healthcare providers, and patients alike.
Impact on Compounding Pharmacies and 503B Outsourcing Facilities
For compounding pharmacies and 503B outsourcing facilities, the FDA’s decision means they will no longer be permitted to produce injectable semaglutide under the shortage exception. This shift may significantly impact their operations and revenue, particularly for facilities that had invested in equipment and processes to compound semaglutide injections safely and effectively. Furthermore, patients who had been receiving compounded semaglutide injections may now face challenges in transitioning back to commercially available products, particularly if supply fluctuations persist or pricing remains a concern.
Is the Shortage Really Over?
Despite the FDA’s assertion that injectable semaglutide supply has stabilized, some industry groups and healthcare providers remain skeptical. The Outsourcing Facilities Association (OFA), which represents 503B outsourcing facilities, has filed a lawsuit against the FDA, arguing that supply issues still persist and that the removal of semaglutide injections from the shortage list was premature. Some healthcare providers also worry that restricting access to compounded semaglutide injections could leave patients with fewer options, particularly those who may have difficulty obtaining or affording brand-name medications, as there is currently no generic option.
Sublingual Compounded Semaglutide: A Potential Alternative
While the FDA has restricted the compounding of injectable semaglutide, sublingual compounded semaglutide remains a possible alternative for both patients and healthcare providers. Sublingual formulations, which are absorbed through the mucosal lining under the tongue, offer several potential advantages:
- Regulatory Compliance: Since the FDA’s recent decision only applies to compounded injectable semaglutide which is “essentially a copy” of an FDA-approved product when not in shortage, pharmacies may still compound sublingual versions where legally permissible.
- Patient Accessibility: Sublingual formulations may provide an alternative for patients who have difficulty obtaining or affording commercially available injectable semaglutide.
- Ease of Administration: For patients who are uncomfortable with injections, sublingual formulations may offer a non-injectable option under the supervision of a healthcare provider.
- Cost Effectiveness: Commercially available options can cost upwards of $1,000 per month without insurance. Compounded sublingual semaglutide may provide a lower-cost option depending on individual circumstances and insurance coverage.
What Comes Next?
As the landscape for semaglutide access shifts, it is crucial for healthcare providers and patients to stay informed of all available options. While compounded injectable semaglutide is being phased out, sublingual formulations may be considered for patients who need continued access to semaglutide therapy.
Carie Boyd Pharmaceuticals offers patient-specific sublingual semaglutide that is made in compliance with all applicable regulations. With a balance between innovation, affordability, and patient care, Carie Boyd Pharmaceuticals empowers healthcare providers to continue delivering semaglutide therapy to their patients. Learn more about our sublingual semaglutide at Carie Boyd Pharmaceuticals – Semaglutide Compound.
References:
- FDA. “FDA Clarifies Policies as National GLP-1 Supply Begins to Stabilize.” Available at: FDA.gov
- McDermott Will & Emery. “Semaglutide Shortage Resolved.” Available at: McDermott Will & Emery
- Alston & Bird. “FDA Resolves Semaglutide Shortage.” Available at: Alston & Bird
- Cardiovascular Business. “FDA Sued Over Semaglutide Drug Shortage List Removal.” Available at: Cardiovascular Business
- Wired. “The Ozempic Shortage Is Over.” Available at: Wired
