Today, the FDA has officially removed Semaglutide from the master shortage list, officially ending the nationwide shortage declaration, and putting mass-compounders on the clock to cease their manufacturing and sales of Semaglutide copies.
According to the FDA’s guidelines, state-licensed pharmacies and physicians compounding under section 503A of the Federal Food, Drug, and Cosmetic Act are permitted to continue compounding, distributing, or dispensing semaglutide injection products that are essentially copies of FDA-approved products for 60 calendar days from the announcement date, until April 22, 2025. Outsourcing facilities operating under section 503B are granted a 90-day period, until May 22, 2025 (READ FDA STATEMENT HERE). During these respective timeframes, the FDA does not intend to take action against these entities for specific violations related to the compounding of semaglutide injection products. However, the FDA may still enforce actions concerning other violations, such as issues related to product quality or safety.
On The Pen has been following along with the Tirzepatide shortage resolution extremely closely, and based upon what we have observed there, here is what we can safely assume will happen next for patients relying on compounded Semaglutide:
This decision will likely not go uncontested. Litigation could shift the above mentioned timelines.
Telehealth companies and prescribers, in coordination will revert their straight Semaglutide offerings to non-commercially available doses (for patients requiring unconventional titration), and custom formulations (for patients requiring additives to help manage side effects).
The question for both the future of compounded GLP-1 (both Semaglutide and Tirzepatide), remains:
“What will pharmacies do in the face of increased FDA scrutiny, and litigation threats from Lilly and Novo?” The answer to this question is any persons guess, but therein lies the answer to everyone’s burning question, “How long until compounds aren’t available anymore?”
For now, it is a great time for patients to take another look at the potential of getting approved for the branded versions of GLP-1. For those uncovered on Semaglutide, looking at Lilly’s offering (now available through our partners at Ro or your pcp), of the discounted 5mg vials of Zepbound (which is comparable in weight loss to Weogvy 2.4mg in clinical trials). For those looking to stay on Semaglutide or for higher doses of Zepbound, take advantage of Ro’s insurance checker tool which
will give you a good idea of what you might be covered for.
Just last week On The Pen published a useful article on how to fight your insurance for coverage in the face of a denial. You can find that article here.
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