The Food and Drug Administration has reaffirmed its decision that the shortage of tirzepatide, the active ingredient in the popular diabetes and weight loss drugs Mounjaro and Zepbound, is over.
The ruling means most compounding pharmacies must stop producing their versions of the drugs within 90 days. Compounding pharmacies create medications from base ingredients, with licensed pharmacists preparing them as prescribed by doctors.
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During FDA-declared shortages, these pharmacies are legally allowed to produce compounded versions of brand-name drugs.
The compounded alternatives gained significant popularity as patients sought more affordable options to the brand-name products.
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The decision marks a victory for drugmaker Eli Lilly, which challenged the FDA’s 2022 decision to officially declare a shortage of tirzepatide.
The FDA says it considers a number of factors before determining that a drug shortage is resolved, including a company's ability to meet current and historical demand, the amount in a manufacturer’s stock, affected market share, among other things.
