Based on a court-ordered re-evaluation of its previous determination that the tirzepatide shortage is over, on December 19, 2024, the Food & Drug Administration (FDA) again determined that the shortage has been resolved. The FDA based this determination on its conclusion that “supply meets or exceeds current demand, and . . . will also meet or exceed projected demand.” The FDA stated it would continue to monitor the situation and did not rule out adding tirzepatide back to the drug shortage list in the future, if warranted. The 503B lawsuit against FDA which resulted in the court-ordered re-evaluation is ongoing and shortages continue to be reported by pharmacies, so the situation may change.
During this re-evaluation period, FDA refrained from taking action against stakeholders – including compounding pharmacies and outsourcing facilities – that had continued to compound ‘essentially a copy’ (as defined in FDA Guidance) the branded tirzepatide. While the FDA is now taking the position that the shortage is effectively over and entities are technically restrained in compounding tirzepatide, in an effort to avoid interruptions to patient care, the FDA has created a “grace period,” to allow compounders time to “wind down” their tirzepatide compounding and dispensing/distribution. The FDA is extending its pause on enforcement for a limited time depending on the type of entity:
- 503A pharmacies have a 60-day period in which FDA does not intend to take enforcement action for compounding ‘essentially a copy’ of tirzepatide brand products. This period expires on February 18, 2025.
- 503B outsourcing facilities have a 90-day period in which FDA does not intend to take enforcement action for compounding ‘essentially a copy’ of tirzepatide brand products. This period expires on March 19, 2025.
The caveat to these periods of no-action is that FDA will still take any action necessary for violations of other statutory or regulatory requirements.
While 503B outsourcing facilities will not be able to compound tirzepatide (as it must either be on the FDA shortage list or on the 503B Bulks List), under a narrow set of circumstances, such as documentation of medical necessity, 503A compounding pharmacies will still be able to compound the drug. However, 503A pharmacies will be prohibited from compounding ‘essentially a copy’ of the commercially available tirzepatide. It is vital that pharmacies and outsourcing facilities impacted by this determination review and – if necessary – adjust their compounding practices to ensure compliance with FDA regulations. Importantly, while the change in status limits compounding pharmacies’ and outsourcing facilities’ ability to compound products that are essentially copies of commercially available, FDA-approved drugs, other options may exist. However, compounders may nevertheless face other compliance considerations and liability from third parties. As such, experienced legal guidance is critical. Regarding other GLP-1 products, FDA continues to list Dulaglutide injection, Semaglutide injection, and Liraglutide injection as in shortage.
How Frier Levitt Can Help
Contact us if you are contemplating or currently compounding GLP-1s, if you need a detailed review of the regulatory aspects of compounding, or a particular scenario. GLP-1 compounding presents a myriad of regulatory compliance issues for clinicians. We develop policies and proceduress, conduct mock compounding inspections, assist with the VPP process, review labeling and advertising, and assist many clients in meeting full regulatory compliance in the GLP-1 503A and 503B compounding space.
