Compounding Sources

What is a 503a/b Pharmacy?

A 503A/B pharmacy is a licensed compounding pharmacy that prepares personalized medications for patients based on a prescription. 503A pharmacies serve individual patients, while 503B pharmacies can manufacture larger batches for hospitals and healthcare providers. These pharmacies have been able to compound tirzepatide because it was previously considered a “drug shortage,” allowing them to produce and distribute it for patient use. However, as of December 19, 2024, the FDA officially ruled that the tirzepatide API is no longer in shortage. As a result, compounding of tirzepatide by these pharmacies will end in Feb & March 2025, when it will be available only through prescription via Mounjaro/Zepbound, or sourced through the gray market.

Who are their API sources?

503a/b compliant pharmacies must source their API tirzepatide from FDA registered manufacturers or resellers. source The manufacturing of raw powder tirzepatide happens entirely in China with the U.S approved labelers being wholesale resellers (and a single labeler in India which we have not seen in the U.S. as of Dec 2024).

Red Rock Pharmacy – a 503a compounding pharmacy based in Utah – provided the following manufacturer COAs upon request. They at least source from Genohope and Avlantis who are on the FDA registered labelers list for tirzepatide.

Who are the FDA-Registered Labelers?

The chart below highlights the distribution of labeler names by country, broken down by their FDA market categories. It underscores how China is the primary source for bulk tirzepatide API, especially as only 7 of these Labelers sell quantities of tirzepatide in amounts 1kg+. It’s likely the others are resellers of the manufactured tirzepatide raw powder.

Cumulative Growth of Registered Labelers

Over time, the cumulative count of registered labelers for tirzepatide has steadily increased since Jan 2023, with China leading the way. As illustrated in the graph, labelers in the U.S. remain limited, reflecting their role as intermediaries rather than primary producers. Only Corden Pharma, who is licensed by Eli Lily, is known to actually manufacture tirzepatide API in the US.

What form of tirzepatide are they using?

Red Rock Pharmacy provided the following answer that shows they compound directly from the tirzepatide base form as raw powder. Red Rock does not source or use lyophilized tirzepatide. We speculate the other major compounding shops are doing the same – Hallandale and Empower.

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