FDA clarifies compounding policies as GLP-1 supply stabilizes

December 20, 2024

FDA issued updated guidance for compounders following the stabilization of the national supply of GLP-1 receptor agonists, particularly tirzepatide (a dual GIP/GLP-1 RA). The shortage of tirzepatide, a key medication for diabetes and weight management, has been resolved after two years of limited availability. FDA's new policy allows temporary compounding of tirzepatide by state-licensed pharmacies and outsourcing facilities until early 2025. After this period, strict legal restrictions will apply to prevent the compounding of FDA-approved drug copies. Despite the resolution of the tirzepatide shortage, other GLP-1 products, including dulaglutide, semaglutide, and liraglutide, continue to face supply issues.

Current shortage status of other GLP-1 products (as of December 19, 2024):

FDA continues to actively monitor drug availability and is currently working to determine whether the demand or projected demand for each drug in shortage exceeds the available supply.

• Dulaglutide injection: In shortage. Manufacturer has reported all presentations are available.
• Semaglutide injection: In shortage. Manufacturer has reported all presentations are available.
• Liraglutide injection: In shortage. Manufacturer has reported two presentations are available, and three have limited availability.

When a status is noted as “available,” that reflects the most current information from the manufacturer but is not an FDA determination that the shortage has been resolved.

Source:

FDA. (2024, December 19). FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize