Tirzepatide may not be removed from the FDA drug shortage list after all.

October 13, 2024

This week the pharmacy compounding, weight loss and anti-aging communities have been abuzz from the October 2, 2024 announcement from the FDA and Eli Lilly that they are removing both of the brand name tirzepatide blockbuster drugs, Mounjaro® and Zepbound® from the FDA drug shortage list. This may have implications for those both compounding this medication and those being prescribed the compounded version of tirzepatide.

On Monday the 7th of October 2024, the Outsourcing Facilities Association, which represents some 503B facilities, filed a lawsuit against the FDA opposing this decision. Eli Lilly has supposedly sent hundreds of cease and desist letters to telehealth companies and sterile compounding pharmacies. On Friday the 10th of October a Texas Federal court granted an unopposed motion filed by the FDA to stay the lawsuit filed over the removal of Mounjaro® and Zepbound® from the FDA drug shortage list. This will allowm the FDA time to reconsider the decision and allow sterile compounding pharmacies to begin compounding the drug again. Many compounding pharmacies, both 503A and 503B facilities believe that this does not restrict their ability to compound this drug, but rather it just limits their ability to make what the FDA refers to as an “essential copy” going forward to fill the gap created by the drug shortage.

The FDA has been in the news nearly constantly in the last year over all the controversy surrounding their decisions to place certain peptides on category 2 for 503A compounding pharmacies. Peptides such as BPC-157, Ibutamoren Mesylate (MK677), Ipamorelin, CJC 1295, MOTs-C and Thymosin Beta-4 (TB500) along with many more have been placed in category 2, disallowing compounders from making these peptides.

One thing is certain, the FDA has substantial influence over a patients access to medications, especially if a person relies on a compounded medicine, and those who work with functional medicine, weight loss and anti-aging practitioners.

For more info check out the links below

https://endpts.com/eli-lilly-obesity-drug-may-go-back-on-shortage-fda-says-in-win-for-compounded-glp-1s

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-reconsider-decision-barring-compounded-versions-lilly-weight-loss-drug-2024-10-11

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FDA has removed certain bulk drug substances that were placed on the category two list and has announced it will consult the Pharmacy Compounding Advisory Committee (PCAC) for potential future inclusion of some of these peptides.

FDA has removed certain bulk drug substances that were placed on the category two list and has announced it will consult the Pharmacy Compounding Advisory Committee (PCAC) for potential future inclusion of some of these peptides.

The FDA stirred enormous controversy when, without much notice, they placed some of the most popular peptides on their category 2 list, which disallows the compounding with these bulk substances also known as (APIs) Active Pharmaceutical Ingredients. Many of the...