3 ms·

I think this is compounding pharmacies selling legit semaglutide (or tirzepatide?), but doing the packaging (dilution in water) themselves. No? I don't think

by loeg 9mo ago

I think this is compounding pharmacies selling legit semaglutide (or tirzepatide?), but doing the packaging (dilution in water) themselves. No? I don't think Hims is selling RCs. They're violating Novo's (or Lilly's) patents. It is wild to me that compounding pharmacies continued to sell these in violation of patents even after the expiration of the FDA supply shortfall status last year -- but I suppose there's so much money in it they don't want to give it up. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize https://www.fda.gov/drugs/drug-safety-and-availability/fda-c...

cthalupa 9mo ago
Compounding pharmacies are getting the raw API from China. Some of them are getting it from FDA registered facilities in China. Some are not. It should be more or less the same thing as the legit stuff, but it is made with a different process, with different excipients, etc. For those going the more legit route, FDA registered still does not mean FDA inspected or that the FDA has signed off on them as being a reputable manufacturer. There has also been cases of compounding pharmacies offering reta and other unapproved peptides, resulting in the FDA sending lots of angry letters to state pharmacy certification boards.
- loeg 9mo ago
  > There has also been cases of compounding pharmacies offering reta and other unapproved peptides Can you elaborate more on this? I hadn't heard about it.
  - cthalupa 9mo ago
    https://lengealaw.com/fda-warns-companies-over-compounded-retatrutide-what-healthcare-providers-should-know/ https://lengealaw.com/fda-warns-companies-over-compounded-re...
    - loeg 9mo ago
      Huh. It's hard to tell how legit any of these "compounding pharmacies" are, but some example letters: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medclub-dr-jenn-09092025 https://www.fda.gov/inspections-compliance-enforcement-and-c... https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/asn-labs-09092025 https://www.fda.gov/inspections-compliance-enforcement-and-c... (German biz): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glp-1-solution-09092025 https://www.fda.gov/inspections-compliance-enforcement-and-c...
phil21 9mo ago
There is no way for a compounder to acquire “legit” semaglutide or Tirzepatide as novo and Lilly are the sole manufacturers of it using the FDA approved process. Every other source is acquiring the APIs from China and effectively buying from the same sources that the random sites selling a vial of lypholized “research chemical” powder are getting it from. The huge compounding companies might skip the lypholization step and mix it directly due to cost savings at scale, but it’s effectively the same sources you could buy direct from China from if you spent a bit of time researching.
- deleted 9mo ago
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by loeg 9mo ago

cthalupa 9mo ago

Compounding pharmacies are getting the raw API from China. Some of them are getting it from FDA registered facilities in China. Some are not. It should be more or less the same thing as the legit stuff, but it is made with a different process, with different excipients, etc. For those going the more legit route, FDA registered still does not mean FDA inspected or that the FDA has signed off on them as being a reputable manufacturer. There has also been cases of compounding pharmacies offering reta and other unapproved peptides, resulting in the FDA sending lots of angry letters to state pharmacy certification boards.

loeg 9mo ago
> There has also been cases of compounding pharmacies offering reta and other unapproved peptides Can you elaborate more on this? I hadn't heard about it.
- cthalupa 9mo ago
  https://lengealaw.com/fda-warns-companies-over-compounded-retatrutide-what-healthcare-providers-should-know/ https://lengealaw.com/fda-warns-companies-over-compounded-re...
  - loeg 9mo ago
    Huh. It's hard to tell how legit any of these "compounding pharmacies" are, but some example letters: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medclub-dr-jenn-09092025 https://www.fda.gov/inspections-compliance-enforcement-and-c... https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/asn-labs-09092025 https://www.fda.gov/inspections-compliance-enforcement-and-c... (German biz): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glp-1-solution-09092025 https://www.fda.gov/inspections-compliance-enforcement-and-c...

phil21 9mo ago

There is no way for a compounder to acquire “legit” semaglutide or Tirzepatide as novo and Lilly are the sole manufacturers of it using the FDA approved process. Every other source is acquiring the APIs from China and effectively buying from the same sources that the random sites selling a vial of lypholized “research chemical” powder are getting it from. The huge compounding companies might skip the lypholization step and mix it directly due to cost savings at scale, but it’s effectively the same sources you could buy direct from China from if you spent a bit of time researching.

deleted 9mo ago
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