FDA clarifies compounder policies amid stabilizing GLP-1 supply

As the national supply of glucagon-like peptide-1 (GLP-1) receptor agonists begins to stabilize, the U.S. Food and Drug Administration (FDA) has issued updated guidance, re-evaluating its statements from October 2024 and clarifying its policies for compounders. In an announcement on December 19, 2024, the administration declared that the shortage of tirzepatide injection—a key GLP-1 medication used for diabetes and weight management—has been resolved, concluding a two-year period of limited availability.

New policy framework

To avoid abrupt disruptions in patient treatment, the FDA has outlined temporary enforcement discretion for compounders:

• State-licensed pharmacies, under section 503A of the Federal Food, Drug and Cosmetic (FD&C) Act, may compound and dispense tirzepatide for 60 calendar days from the announcement, until February 18, 2025.
• Outsourcing facilities, under section 503B of the FD&C Act, may continue compounding and dispensing tirzepatide for 90 calendar days from the announcement, until March 19, 2025.

After these dates, compounders will need to comply with strict legal restrictions against compounding drugs that are essentially copies of FDA-approved medications.

The agency emphasized that it retains the authority to address concerns regarding quality or safety, writing, “FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.”

Broader GLP-1 supply

Although tirzepatide’s shortage is resolved, other GLP-1 products remain in limited supply. As of December 19, 2024:

• Dulaglutide injections are in shortage, although manufacturers report all presentations are available.
• Semaglutide injections are in shortage, with full availability reported by manufacturers.
• Liraglutide injections are in shortage, with two presentations fully available and three experiencing limited availability.

The FDA cautioned that manufacturer reports of availability may not be accurate reflections of the true supply stability, as localized distribution issues persist.

Key decisions in 2024

The FDA’s latest decision marks a culmination of months of regulatory deliberation. On October 2, 2024, the administration declared the tirzepatide shortage resolved, citing assurances from manufacturers regarding production capacity. However, subsequent litigation led to a temporary reevaluation of that determination by October 22. In an FDA letter on October 17, they confirmed that tirzepatide’s removal from the shortage list would not preclude temporary compounding allowances during the review period, an approach intended to mitigate treatment gaps amidst the administration’s assessment.

Clinicians should be aware of the evolving regulatory landscape and work closely alongside pharmacists to ensure uninterrupted patient care. In addition, the FDA encourages prescribers to consult its Drug Shortages Database for real-time updates on availability.