When you work with a US compounding pharmacy... Where does their product actually come from?

[Morbius]

I assume that if you use a GLP-1 telehealth clinic that sends an Rx to a compounding pharmacy, the pharmacy is not squirting Ozempic pens into a sterile vial and shipping it to you.

So... Where do those peptides come from?

Are they using the same Chinese suppliers as gray market enthusiasts? Or is there some legit USA manufacturing which supplies the handful of compounding pharmacies who supply all the clinics?

Semaglutide is patented, which would seem to be problematic for domestic manufacturing... Or importing... Though I suppose the patent may cover the final product as seen in Ozempic etc, and not the raw amino acid sequence. (I guess I should look it up and read it.)

I'm just curious how this business works. Can anyone enlighten me? I'm not trying to start a clinic, haha.

 

[Vicki]

I'd like to know too because what I've been told is that compound is not even FDA approved anyway. So why wouldn't they source from china and just test it?

 

[Bjd4162]

I've read posts from sellers who have indicated they buy directly from them as well, just like us. Optima is one who has indicated they buy from her.

 

[keangkong]

I'd like to know too because what I've been told is that compound is not even FDA approved anyway. So why wouldn't they source from china and just test it?

Because they can only legally buy from FDA approved facilities.

 

[hexagonal]

Because they can only legally buy from FDA approved facilities.

For both 503a and 503b?

I've had someone who worked at a 503a tell me they were buying from China as well.

 

[Heywood Jablowme]

This is something that occurred to me the other day, so thanks for bringing it up!

I'd also like to drop a little nugget of information that I came across for the first time the other day: WuXi AppTec Co., a Chinese company, supplies "much" of the main ingredient to Eli Lilly for Zepbound and Mounjaro:

• https://www.bloomberg.com/news/arti...rugs-threatened-by-us-effort-to-contain-china
• https://glp1forum.com/threads/are-any-of-these-vendors-repping-manufacturers.2146/post-33822

My guess is that some manufacturers enjoy doing a little extra business on the side. Nudge nudge, wink wink...

 

[Morbius]

Oh that's pretty interesting.

 

[keangkong]

I assume that if you use a GLP-1 telehealth clinic that sends an Rx to a compounding pharmacy, the pharmacy is not squirting Ozempic pens into a sterile vial and shipping it to you.

So... Where do those peptides come from?

Are they using the same Chinese suppliers as gray market enthusiasts? Or is there some legit USA manufacturing which supplies the handful of compounding pharmacies who supply all the clinics?

Semaglutide is patented, which would seem to be problematic for domestic manufacturing... Or importing... Though I suppose the patent may cover the final product as seen in Ozempic etc, and not the raw amino acid sequence. (I guess I should look it up and read it.)

I'm just curious how this business works. Can anyone enlighten me? I'm not trying to start a clinic, haha.

There are also legitimate Chinese manufacturers who supply the compounding pharmacies who follow the law.

This is something that occurred to me the other day, so thanks for bringing it up!

I'd also like to drop a little nugget of information that I came across for the first time the other day: WuXi AppTec Co., a Chinese company, supplies "much" of the main ingredient to Eli Lilly for Zepbound and Mounjaro:

• https://www.bloomberg.com/news/arti...rugs-threatened-by-us-effort-to-contain-china
• https://glp1forum.com/threads/are-any-of-these-vendors-repping-manufacturers.2146/post-33822

My guess is that some manufacturers enjoy doing a little extra business on the side. Nudge nudge, wink wink...

Unlikely. They make too much money being FDA approved to risk losing that source of revenue.

 

[keangkong]

I assume that if you use a GLP-1 telehealth clinic that sends an Rx to a compounding pharmacy, the pharmacy is not squirting Ozempic pens into a sterile vial and shipping it to you.

So... Where do those peptides come from?

Are they using the same Chinese suppliers as gray market enthusiasts? Or is there some legit USA manufacturing which supplies the handful of compounding pharmacies who supply all the clinics?

Semaglutide is patented, which would seem to be problematic for domestic manufacturing... Or importing... Though I suppose the patent may cover the final product as seen in Ozempic etc, and not the raw amino acid sequence. (I guess I should look it up and read it.)

I'm just curious how this business works. Can anyone enlighten me? I'm not trying to start a clinic, haha.

At least if the compounding pharmacies are following the law, they only use facilities that are registered with the FDA and subject to FDA inspections. Food Drug & Cosmetic Act §§ 503A (21 U.S.C. § 353a), subd. (b)(1)(A)(ii) [503a pharmacies], 503B (21 U.S.C. §353b), subd. (A)(2)(C) [503B pharmacies], 510 (21 U.S.C. § 360) [registration and inspection requirements].

 

[Vicki]

Because they can only legally buy from FDA approved facilities.

China has fda approved manufacturers too.

Edit. Sorry saw you mentioned the same

 

[rkl123]

It’s worth mentioning that a select few US compounders do you offer reta… which guarantees they are getting it from the same gray market as us. No FDA API sell it yet.

 

[Bjd4162]

For both 503a and 503b?

I've had someone who worked at a 503a tell me they were buying from China as well.

Yes because they are.

 

[RestingGhostFace]

This is something that occurred to me the other day, so thanks for bringing it up!

I'd also like to drop a little nugget of information that I came across for the first time the other day: WuXi AppTec Co., a Chinese company, supplies "much" of the main ingredient to Eli Lilly for Zepbound and Mounjaro:

• https://www.bloomberg.com/news/arti...rugs-threatened-by-us-effort-to-contain-china
• https://glp1forum.com/threads/are-any-of-these-vendors-repping-manufacturers.2146/post-33822

My guess is that some manufacturers enjoy doing a little extra business on the side. Nudge nudge, wink wink...

Thank you I’ve been looking for this

 

[YoYoFat]

Because they can only legally buy from FDA approved facilities.

Not “approved,” but “registered.” There’s a regulatory difference.

 

[YoYoFat]

Here’s the list of FDA registered API manufacturers of Tirz:

National Drug Code Directory

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that products that emit radiation.

dps.fda.gov