On February 21, 2025, the U.S. Food and Drug Administration (FDA) announced that the shortage of semaglutide—an active ingredient in the popular medications Ozempic and Wegovy—has been resolved. This decision has significant implications for compounding pharmacies and patients relying on more affordable, compounded versions of these drugs.
FDA's Decision and Its Implications
The FDA's determination that semaglutide is no longer in shortage means that compounding pharmacies are expected to cease production of compounded semaglutide. Specifically, state-licensed pharmacies must stop compounding by April 22, 2025, and outsourcing facilities by May 22, 2025. These deadlines were established to allow for a transition period and to minimize disruption to patient care.
Legal Challenge from Compounding Pharmacies
In response to the FDA's announcement, the Outsourcing Facilities Association (OFA), representing compounding pharmacies, filed a lawsuit challenging the decision. The OFA argues that compounded versions of semaglutide are essential for patients who cannot afford the branded medications, which can cost over $1,000 per month. The lawsuit contends that the FDA's decision to end the shortage designation is arbitrary and could harm patients who rely on these more affordable alternatives.
Enforcement Discretion Period
While the legal proceedings are ongoing, the FDA has exercised enforcement discretion, allowing compounding pharmacies to continue producing semaglutide until the later of the established deadlines or the date of the district court's decision on the preliminary injunction motion in the OFA v. FDA case.
Patient Impact and Safety Concerns
The end of compounded semaglutide availability raises concerns about patient access and safety. Many patients have turned to compounded versions due to the high cost of branded drugs. However, compounded medications are not FDA-approved and may pose safety risks, including inconsistent dosing and potential contamination. The FDA has previously issued warnings about the dangers of using unapproved compounded semaglutide products.
As the situation develops, patients are advised to consult with their healthcare providers to discuss treatment options and ensure safe and effective care.
Source: Health.com
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