Prions in hcg

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Gene Devine

Super Moderator
This concern came up some time ago on another forum I moderated; it's not a threat in legally compounded HCG here in the USA.
 

nuclear

Member
This concern came up some time ago on another forum I moderated; it's not a threat in legally compounded HCG here in the USA.

I spoke with a manufacturer and they told me that they source the urine via a sourcing company that does their best to screen the patients. They also assured purification processes are followed as per their NDA. They can offer no guarantees that the product is prion free. I imagine the risk is low. At least, I hope so.
 
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We've been dispensing hCG for years and have never been asked this question or come across any papers or data about prions in hCG. Every prescription medication in the US has to be sourced from FDA Registered sources. That means that unless the FDA has visited a facility and approved it using its cGMP (current Good Manufacturing Practices) standards then it is not allowed to manufacture or distribute active ingredients that will ultimately be used in the US market.

HCG, being an FDA approved and monographed drug, has to meet certain standards to be accepted for use in the US. That means that the manufacturer of the hCG has to run tests on the chemical to verify it meets a high standard of quality in order for that chemical to be introduced into the US. For hCG these tests, which are shown on its Certificate of Analysis, include verification of solubility, endotoxin levels, potency, water content, transmissivity, estrogenic activity, HBV DNA, HCV RNA, and HIV RNA. Unless the chemical passes all of these specifications then it cannot be used in drug products destined for the US. Nowhere on hCG's monograph does it ask for testing of prions.

Nuclear is correct in that in order to be granted NDA (New Drug Application) through the FDA the manufacturing facility has to be FDA Registered and meet the standards required for that drug's monograph. Not only do the chemical's sources have to been of the highest grade, but the manufacturing process has to be as well. Currently, under USP (United States Pharmacopoeia) and EP (European Pharmacopoeia) standards testing for prions is not a requirement for hCG.
 

tomas

New Member
Sorry to bring up this old topic but I was doing a bit of research on Prions and came upon the thread.
Prion transmission in blood and urine: what are the implications for recombinant and urinary-derived gonadotrophins?
DEFINE_ME

Total cases of iatrogenic CJD world-wide



n

[TH="bgcolor: #F2F5F9, align: left"]Mode[/TH]
[TH="bgcolor: #F2F5F9, align: left"]Cases (

)[/TH]
[TH="bgcolor: #F2F5F9, align: left"]Mean incubation period (years)[/TH]
[TH="bgcolor: #F2F5F9, align: left"]Clinical[/TH]

Neurosurgery

4

1.6

Visual/cerebellar/dementia

Depth electrodes

2

1.5

Dementia

Corneal transplant

3

15.5a

Dementia

Dura mater

136

6b

Visual/cerebellar/dementia

Human growth hormone

162

12b

Cerebellar

Human gonadotrophin

5

13

Cerebellar



Acquired prion disease: iatrogenic CJD, variant CJD, kuru

In the case of HGH
Since 1985, urea-treated cadaveric hGH or recombinant hGH produced in Escherichia coli has been used in place of native pituitary-derived hGH. With urea-treated or recombinant hGH, no cases of iCJD have been identified. iCJD cases begin with a cerebellar syndrome without signs of dementia.
 
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