December 20, 2024

FDA doubles down: Tirzepatide is off shortage

The FDA released a ruling on Thursday declaring that tirzepatide is, in fact, no longer in shortage — a decision it said was based on Eli Lilly’s “detailed information and data regarding its production and inventory of these drug products at various points in time.”

So it’s official: There is apparently — per Lilly and now the FDA — plenty of Mounjaro and Zepbound to go around. “The information provided in Lilly’s submissions demonstrate that the company is currently meeting or exceeding demand for Mounjaro and Zepbound.”

This doesn’t mean you must immediately stop compounding tirzepatide. The FDA did throw compounders a bone: a 60-day “off-ramp” for 503A compounders (i.e., until Feb. 18, 2025); 90 days for 503Bs (i.e., until Mar. 19, 2025).

All that said, we don’t think the tirzepatide situation is over. Read CEO Scott Brunner’s statement on the FDA decision. Perhaps it can be summed up thusly: “Today’s statement from the agency certainly informs that litigation, but it’s not a decision by a court.”