Do any US compounding pharmacies produce their own GLP-1s?

Jilla

Jilla

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Compounding isn't something I have much knowledge of — it isn't a thing here in the U.K. — but I've come across conflicting posts on forums. Some claim every compounding pharmacy sources its products from China, from the same suppliers we use. Is that accurate? And in your view, what are the biggest differences between compounding pharmacies and grey market buyers?
 
I've heard that US compounding pharmacies are required to source their ingredients (API/powder) from a "green flag vendor list," and that this list is issued by the FDA. My impression is that few people actually know which vendors appear on it. Years back, Dave from On The Pen (YouTube) filed a public records request for it and got no answer at all.
 
Jilla said:

Compounding isn't something I have much knowledge of — it isn't a thing here in the U.K. — but I've come across conflicting posts on forums. Some claim every compounding pharmacy sources its products from China, from the same suppliers we use. Is that accurate? And in your view, what are the biggest differences between compounding pharmacies and grey market buyers?
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A few, such as Hims, are distributing genuine NN/EL pharma product. The majority — and every one offering Reta, Cagri or Elora — source from China. Plenty of those are 503As that really just purchase grey finished peptides in vials and reconstitute them (they skip the B12 workaround entirely), and if you're lucky they test them at all. A handful of 503As and 503Bs likely strike arrangements with Chinese API makers, do full testing, and finish (rather than lyophilize) the product in-house. Naturally, those are the ones hit hardest by enforcement. They're probably the larger players, like Brello/Mochi and similar.

What compounders ought to be delivering is a thoroughly tested, sterile, reproducible setting with a solid cold chain for the vials they ship out. Bigger operations are more apt to face audits and testing requirements; smaller ones, though, will vanish before anyone gets the chance to sue.
 
I assumed this thread would be discussing this article.

Per an FDA notice, Apothecary Pharma LLC began a voluntary recall of tirzepatide injections — the active ingredient in Zepbound and Mounjaro — on Sept. 24, citing "lack of assurance of sterility." The agency's notice can be found here. On Oct. 10, the federal agency reclassified the recall as "Class II," which indicates that using the medication may lead to "temporary or medically reversible adverse health consequences." Serious harm, however, is unlikely.
 
Seasonal1 said:

I assumed this thread would be discussing this article.

Per an FDA notice, Apothecary Pharma LLC began a voluntary recall of tirzepatide injections — the active ingredient in Zepbound and Mounjaro — on Sept. 24, citing "lack of assurance of sterility." The agency's notice can be found here. On Oct. 10, the federal agency reclassified the recall as "Class II," which indicates that using the medication may lead to "temporary or medically reversible adverse health consequences." Serious harm, however, is unlikely.
Click to expand...
I had just come across that same piece on USA Today.
 
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