salt forms of semaglutide

I feel like I should memorize this because people don’t know and they repeat the same BS over and over and over. Thanks!

Great question, Jim. Thank you.

Short answer - The big pharmacies I've researched and listed on my site are using pure API sourced from FDA 510 cGMP facilities and have 3rd party testing for sterility and purity built into their process. They are inspected and the API's COA examined regularly by the State Pharmacy Board using FDA protocol. The FDA is called in if anything needs a second look. They are highly regulated, and are not using the salt version.

--

503A compounding pharmacies are required to source their API (Active Pharmaceutical Ingredient) from a 510 FDA bulks supplier. These facilities can be in the US or overseas, just as the branded API can be sourced here or overseas. The facilities are inspected and selected by the FDA using cGMP compliance, which if you read my bio, I used to be in charge of cGMP compliance for a sterile lab. The requirements are incredibly strict, down to tracking even the cleaning chemicals coming into the building. The only form of tirzepatide these facilities are allowed to offer to US pharmacies is the pure tirzepatide peptide. The pharmacy must be able to produce a COA for their API to State Pharmacy Board inspectors, as well as the FDA should they be called in for additional oversight.

The Alliance for Compounding Pharmacy CEO Scott Brunner keeps releasing these amazing statements to answer claims in the media. He just revised it today actually, May 22.  Here are some snippets:

"How are compounders sourcing semaglutide and tirzepatide active pharmaceutical ingredient (API) if Novo and Lilly hold patents on the API? Assertions in news stories that the only legitimate semaglutide API must be obtained directly from the manufacturers are flatly incorrect. For instance, compounders of semaglutide base – the active ingredient in Novo’s Wegovy and Ozempic – are purchasing it from registered wholesalers who are documenting for the pharmacies that the API comes from FDA-registered manufacturers. While Novo surely may exercise control over the supply of the API via its contracts with manufacturers, it has not locked down the supply chain on the API – and so compounding pharmacies still are able to access semaglutide base from FDA-registered facilities."

"In early March 2024, both Novo and Lilly both published open letters again alleging impurities in substances they had acquired that they say purport to be semaglutide or tirzepatide. In those letters, both drugmakers seem to conflate illicit substances obtained without a prescription with legitimate compounded drugs obtained from a state-licensed pharmacy in a way that makes it unclear whether the impure substances in question are compounded medications at all. Unfortunately, many reporters are falling for it. Instead of questioning the drugmakers, they are simply publishing the drugmakers’ claims as if they are fact."

Source

https://a4pc.org/files/APC-Compounded-GLP-1s-Media-Brief-REVISED-March-2024.pdf

That being said, based on word-of-mouth in my industry contacts including someone very high up at of one of the largest pharmacies, there are thousands of small compounding pharmacies out there and regulatory compliance may or may not be 100%. I do not personally know, but I do know that the large pharmacies that I dug into on my trusted list are not using the salt version. They also are performing 3rd party testing as it is built into their process. It is expensive, and if a provider suddenly pops up in the marketplace with very low pricing, that's the first thing I question -- Which pharmacy are they using, does any other provider use them, and are they for-sure performing 3rd party testing for purity and sterility. The large pharmacies I share here are the most highly regulated in the industry with the most oversight. Not to mention, they are large businesses with all eyes on them, as they are essentially the brand's largest competitor since the FDA approved compounded tirzepatide through declaring a national shortage. Cutting corners would be detrimental to their business, so they have all of the motivation to make everything as pure as possible. The smaller pharmacies and Medspas, I can't speak to.