FDA Licensed Compounder distributed contaminated GLP, "Black flakes", shut down

[Ghoul]

Filter sterilizing weight loss and other peptides is becoming an increasingly common precaution. Remember, it's not about "I didn't get sick so it's ok", but about the 1 in 5000 chance of injected bacteria leading to sepsis and costing a leg.

It'll also help your peptide last longer.

FDA is warning patients and health care professionals not to use drugs

FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., and distributed to patients by medical offices and clinics.

www.fda.gov

 

[readalot]

Sad state of affairs. Behold the bastion of quality...a 503B outsourcing facility.

Post in thread 'Readalots Enhanced Testing'

Friday at 7:44 AM

love letter FDA sent to about Empower Pharmacy.

https://www.fda.gov/media/182593/download

You can do better than this, right @GenericAsia?

• readalot

• 
• 

 

[Ghoul]

Sad state of affairs. Behold the bastion of quality...a 503B outsourcing facility.

Post in thread 'Readalots Enhanced Testing'

Friday at 7:44 AM

love letter FDA sent to about Empower Pharmacy.

https://www.fda.gov/media/182593/download

You can do better than this, right @GenericAsia?

• readalot

• 
• 

Thankfully most of us here are smart enough to source from anonymous labs in China, where health and safety concerns take precedence over making a quick profit.

 

[readalot]

Thankfully most of here are smart enough to source from anonymous labs in China, where health and safety concerns take precedence over making a quick profit.

I am slowly getting there. Takes me a long time to learn on some things.

 

[Ghoul]

I am slowly getting there. Takes me a long time to learn on some things.

Of course I'm guilty as well, there's really little option if you participate in the peptide game. Testing will help keep at least some pressure on suppliers to do the right thing behind closed doors, but at the end of the day, it's your health, and taking safety into your own hands is the most effective thing you can do...

 

[readalot]

peptide game

You are light years ahead of me. Thanks.

Just starting to formulate a GH plan. Glacial.

 

[Ghoul]

You are light years ahead of me. Thanks.

Just starting to formulate a GH plan. Glacial.

Consider using a vented lateral flow needle for reconstitution. It stops vial vacuum from violently sucking water from the syringe, and completely eliminated the (aggregation inducing) foaming that some peptides are so prone to.

There are a lot types available and pretty inexpensive.

Use it to inject BAC, reconstitute, draw with same needle, remove needle, attach filter, attach needle, inject filtered peptide into sterile vial.

This is standard protocol for reconstituting lypholized peptides/protein drugs in many medical facilities.

https://www.medline.com/product/Lateral-Flow-Vented-Needles/Z05-PF144704

 

[Intrepid]

so what is the requirement to become a 503b compounded pharmacy? (and I'm talking about a 100% legal entity that files returns)

pay the FDA an annual fee and pass a yearly inspection, and the rest is really upfront costs with equipment and space?

 

[Ghoul]

so what is the requirement to become a 503b compounded pharmacy? (and I'm talking about a 100% legal entity that files returns)

pay the FDA an annual fee and pass a yearly inspection, and the rest is really upfront costs with equipment and space?

Pretty much, inspection schedule "risk based" after initial look at the facilities. Must have a dedicated QA department, this one probably staffed by the nearsighted guy moonlighting at Qs oil producing facility..

 

[readalot]

Consider using a vented lateral flow needle for reconstitution. It stops vial vacuum from violently sucking water from the syringe, and completely eliminated the (aggregation inducing) foaming that some peptides are so prone to.

There are a lot types available and pretty inexpensive.

Use it to inject BAC, reconstitute, draw with same needle, remove needle, attach filter, attach needle, inject filtered peptide into sterile vial.

This is standard protocol for reconstituting lypholized peptides/protein drugs in many medical facilities.

View attachment 301427

https://www.medline.com/product/Lateral-Flow-Vented-Needles/Z05-PF144704

Thanks very much for this. I got decent form reconstituting hCG but these look handy. Appreciate you.

 

[Ghoul]

Thanks very much for this. I got decent form reconstituting hCG but these look handy. Appreciate you.

I didn't know these existed until recently.

Keep in mind about 2% of pharma HGH patients develop enough immunogenicity that treatment becomes ineffective. And no doubt many more than that develop enough to reduce effectiveness to a lesser degree. Therefore it probobly pays off to treat your peptide nicely, since degraded proteins play a part in that problem.

 

[readalot]

I didn't know these existed until recently.

Keep in mind about 2% of pharma HGH patients develop enough immunogenicity that treatment becomes ineffective. And no doubt many more than that develop enough to reduce effectiveness to a lesser degree. Therefore it probobly pays off to treat your peptide nicely, since degraded proteins play a part in that problem.

You should see my form. OCD like everything else haha. Thanks!

 

[BP_6]

Anyone remember that one pharmacist at the compounding pharmacy that was heavily diluting a very expensive cancer drug, or plain not adding any of it to the compound to make a lot of extra money?

 

[Ghoul]

Anyone remember that one pharmacist at the compounding pharmacy that was heavily diluting a very expensive cancer drug, or plain not adding any of it to the compound to make a lot of extra money?

There was also that compounding pharmacy that forgot to put the benzyl alcohol into a batch of steroids, and ended up killing a bunch of people and sickening many others. They were sterile, for a while, so tested fine. Thank god the "garage and ink jet printer" made BAC on Amazon is personally checked for proper alcohol content by Jeff Bezos, and while some UGLs have used the wrong raws (or no raws at all) they'd never forget the Benzyl Alcohol.


Don't mind me and my "bubble boy" musings...

"However, as the present outbreak tragically illustrates, meticulous attention to sterility and quality control to ensure the absence of microbial contamination is required for all products that are parenterally (injection) administered to humans. Sadly, we keep relearning this lesson."

Compounding drugs contaminated with fungi: a recipe for disaster - PMC

pmc.ncbi.nlm.nih.gov

 

[BP_6]

There was also that compounding pharmacy that forgot to put the benzyl alcohol into a batch of steroids, and ended up killing a bunch of people and sickening many others. They were sterile, for a while, so tested fine. Thank god the "garage and ink jet printer" made BAC on Amazon is personally checked for proper alcohol content by Jeff Bezos, and while some UGLs have used the wrong raws (or no raws at all) they'd never forget to Benzyl Alcohol.


Don't mind me and my "bubble boy" musings...

"However, as the present outbreak tragically illustrates, meticulous attention to sterility and quality control to ensure the absence of microbial contamination is required for all products that are parenterally (injection) administered to humans. Sadly, we keep relearning this lesson."

Compounding drugs contaminated with fungi: a recipe for disaster - PMC

pmc.ncbi.nlm.nih.gov

While a UGL, but not a compounding pharmacy, the scariest story recently is Janoshik saying he tested some clenbuterol tabs that were supposed to be 40mcg/tab and were actually around 40mg/tab. A single pill would likely be fatal without prompt medical intervention.

 

[Ghoul]

While a UGL, but not a compounding pharmacy, the scariest story recently is Janoshik saying he tested some clenbuterol tabs that were supposed to be 40mcg/tab and were actually around 40mg/tab. A single pill would likely be fatal without prompt medical intervention.

Bit my tongue when I read a post from someone looking for advice on how to measure Telmasartin raws for direct dosing. Because avoiding the expense of 7¢ pharma tablets is worth seeing if you might manage to become the first fatality from that BP med.

 

[BP_6]

Bit my tongue when I read a post from someone looking for advice on how to measure Telmasartin raws for direct dosing. Because avoiding the expense of 7¢ pharma tablets is worth seeing if you might manage to become the first fatality from that BP med.

What I don't get is if you legit have high BP, literally almost any primary care doctor, or even online doctors will write you a scrip for Telmasartin. Plus the generic form is cheap in the US even if you don't have insurance.

Something as serious as your blood pressure I would try to stick with full pharmacy grade whenever possible.

 

[Ghoul]

What I don't get is if you legit have high BP, literally almost any primary care doctor, or even online doctors will write you a scrip for Telmasartin. Plus the generic form is cheap in the US even if you don't have insurance.

Something as serious as your blood pressure I would try to stick with full pharmacy grade whenever possible.

"Legit" BP isn't even required. Telehealth will be happy to write a prescription for these dirt cheap meds, since they're safe and not abusable.

 

[Grey Spartan]

I would try to stick with full pharmacy grade whenever possible.

To bad we can't just go to the Doc and tell them what and how much we want to run and they just prescribe and monitor. Shit, I would even bribe a pharmacist If I could.

 

[BP_6]

To bad we can't just go to the Doc and tell them what and how much we want to run and they just prescribe and monitor. Shit, I would even bribe a pharmacist If I could.

What's sad is when I was first on the boards, about 20 years ago. Pharm grade gear was pretty easy to find for many compounds and it wasn't very expensive. It was most of what I used. Norma Hellas Test amps, 2 cc deca vials, Omnadren, Pakistan test E from Bayer, Turkish sustanon, Thai Pinks, Schering Primo that wasn't $20/amp, hell even a big 50 cc vial of true vet grade 50mg/ml EQ from Fort Dodge labs etc etc I could go on.

While some of these can still be found, from a lot less suppliers and the prices are much higher. Plus the fakes got very good even to the point of having the legit compound, just charging pharm grade prices for UGL quality.