FDA winds down GLP-1 compounding policies

FDA’s temporary compounding measures

GLP-1 receptor agonists -- including blockbuster brands like Ozempic and Wegovy (semaglutide) and Mounjaro and Zepbound (tirzepatide) -- have gained widespread recognition for their effectiveness in treating type 2 diabetes and obesity. But over the past two years, demand surged so quickly that manufacturers Novo Nordisk and Eli Lilly struggled to keep up, leading to significant and prolonged drug shortages.

In response, the FDA invoked provisions under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, allowing temporary compounding of the affected drugs despite restrictions on duplicating commercially available products.

Section 503A covers traditional state-licensed pharmacies that compound drugs for individual patients by prescription. Section 503B applies to registered outsourcing facilities that can compound in bulk without patient-specific prescriptions.

These provisions enabled pharmacies, physicians, and outsourcing facilities to help address the shortage.

End of compounding enforcement discretion

With semaglutide and tirzepatide supplies now considered stabilized, the FDA is rolling back its compounding flexibility by establishing firm deadlines for ending enforcement discretion.

Tirzepatide (Mounjaro, Zepbound)

• Section 503A (state-licensed pharmacies and physicians). Enforcement discretion ended on February 18, 2025.
• Section 503B (outsourcing facilities). Enforcement discretion ended on March 19, 2025.

Semaglutide (Ozempic, Wegovy)

• Section 503A (state-licensed pharmacies and physicians). Enforcement discretion remains in place until April 22, 2025, or until the district court rules on the plaintiffs’ forthcoming motion for a preliminary injunction in Outsourcing Facilities Association (OFA) v. FDA, 4:25-cv-00174 (N.D. Tex.), whichever is later.
• Section 503B (outsourcing facilities). Enforcement discretion will apply through May 22, 2025, or until the court issues a decision on the same motion in the OFA v. FDA case, whichever comes later.

The FDA has emphasized that these policies are specific to the drugs' shortage status and that the agency retains full authority to intervene if compounded products are found to be unsafe, substandard or misbranded.

Ongoing legal dispute

A key factor influencing the timeline for semaglutide is the outcome of a lawsuit filed by the Outsourcing Facilities Association (OFA), which challenges the FDA’s compounding restrictions. The OFA contends that the FDA’s current framework imposes unreasonable limitations on compounding facilities and fails to adequately support patient access in times of drug shortages.

In early March 2025, a U.S. district court denied the OFA’s motion for a preliminary injunction related to tirzepatide, effectively allowing the FDA to proceed with the enforcement of its policies. However, a decision on semaglutide is still pending, and the outcome may influence whether the FDA can enforce the same deadlines for that compound.

Industry implications

For manufacturers of FDA-approved GLP-1 receptor agonists, the resolution of national shortages provides a path to reassert control over their product lines. The expiration of the FDA’s enforcement discretion limits the availability of compounded alternatives, allowing branded manufacturers to regain exclusivity and secure their market position. This shift also enables companies to reinforce their product integrity, particularly considering concerns about the quality and labeling of some compounded GLP-1 products.

In addition to competitive advantages, manufacturers must continue investing in scalable production capacity and streamlined distribution networks to meet ongoing demand. Although the FDA has determined that national supply has stabilized, regional variability in access may persist. Companies that are proactive in identifying and addressing these issues will be best positioned to support providers and patients.

Compounding pharmacies and outsourcing facilities now face the need to unwind operations involving compounded GLP-1 receptor agonists. These organizations must take steps to ensure that all compounding activities cease by the FDA deadlines.

Internal compliance reviews, inventory audits and legal consultations should be initiated well in advance to prevent inadvertent violations. Given the potential legal complexity stemming from the ongoing OFA litigation, compounders should also prepare for the possibility of ongoing guidance or judicial interventions that could alter enforcement timelines or requirements.

For healthcare providers, the policy shift creates a need to ensure continuity of care for patients who were receiving compounded versions of semaglutide or tirzepatide. Providers must verify the availability of FDA-approved formulations through pharmacy partners and wholesale distributors and work closely with patients to facilitate timely transitions.

Although the national shortage is considered resolved, temporary or localized access challenges may still occur, so ongoing monitoring and adaptability will remain important.

Public health concerns

The FDA continues to highlight the distinction between FDA-approved and compounded products, especially in terms of safety and efficacy. While compounding serves a critical role during shortages, the agency warns against the ongoing use of compounded alternatives once commercial supply is restored. In particular, it has raised concerns about illegal or unregulated sales of GLP-1 products online, some of which may be adulterated or contain unverified ingredients.

To mitigate these risks, suspicious products should be reported to the FDA’s MedWatch or Bad Ad Program.

Other GLP-1 products facing limited availability

Although the supply of semaglutide and tirzepatide has improved, other GLP-1 receptor agonists remain in short supply. For instance, Eli Lilly recently announced that limited availability of its type 2 diabetes treatment dulaglutide, marketed as Trulicity, will persist through June 30, 2025.

Liraglutide, sold under the brand names Victoza and Saxenda, also remains in short supply due to ongoing manufacturing delays, with two of its five formulations still facing limited availability.

Novo Nordisk has placed both the 2-count and 3-count packages of Victoza 6 mg/mL, 3 mL pens on backorder, projecting a restock by mid-April 2025. In the meantime, Teva Pharmaceuticals introduced an authorized generic version of liraglutide in late June 2024, which could help ease supply constraints.

Next steps

As this regulatory transition unfolds, pharmaceutical stakeholders must align with the FDA’s updated policies. They can also monitor guidance updates through the FDA’s Drug Shortage and Compounding Policy webpages. Manufacturers and supply chain partners should also anticipate demand fluctuations and continue expanding access to FDA-approved medications.

Finally, effective communication with healthcare providers and patients will be key to ensuring a smooth return to standard prescribing and dispensing practices.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.