A Frier Levitt attorney is featured in an Informa TechTarget – Pharma Life Sciences article titled, “Understanding Tirzepatide Compounding Restrictions.” The piece details how the FDA removed tirzepatide from its drug shortage list on December 19, 2024, leading to tighter restrictions and legal risks for compounding pharmacies. Under FDA rules, 503A pharmacies must stop compounding tirzepatide copies by February 18, 2025, while 503B outsourcing facilities have until March 19, 2025.
Our attorney shares her legal insights in the article, warning that compliance is not as straightforward as it may seem. She explains, “After February 18, 503A pharmacies may still compound tirzepatide, but they may not compound ‘essentially a copy.’ Section 503A prohibits compounders from producing drugs that are essentially identical to FDA-approved products unless there is a documented medical necessity.”
She helps illustrate the legal risks and regulatory crackdowns as well, stating, “There is no grace period for pharmacies that fail to meet U.S. Pharmacopeia (UPS) quality standards or use improperly sourced tirzepatide APIs labeled ‘for research use only’…The FDA will take immediate action against such violations.”
Additionally, it is critical to note that brand manufacturers like Eli Lilly have taken legal action against compounding pharmacies, issuing cease-and-desist letters, suing clinics and spas distributing unauthorized tirzepatide, and petitioning the FDA to ban GLP-1 compounding entirely.
Our attorney emphasizes that there is a lot at stake here. “Some of the manufacturer’s legal arguments challenge the very nature of pharmaceutical compounding itself. It’s a pivotal time for independent pharmacies, but those who stay vigilant and compliant will continue to play a vital role in patient care” she adds.