FDA crackdown on HCG

[GFA]

The reason why its harder to find.

http://abcnews.go.com/Health/Wellnes...5#.T04a-HLOxho

I get mine thru CVS but almost all brands are out of stock even at CVS.

[kelkel]

Interesting, thanks. Picked mine up yesterday at Rite Aid, no problem.

[JD250]

WOW, did you catch this in the second paragraph, finally some recognition that it has a place in TRT..........

"Human chorionic gonadotrpin (HCG ), otherwise known as a fertility hormone, is produced in women's placentas and is also found in pregnant women's urine. The hormone is FDA-approved only as a prescription injection drug to treat some cases of infertility and for select male hormone imbalances."

[sirupate]

So, it seems the FDA is after the makers of the diet supplement, which is primarily the drops. How does that translate into problems getting the injectible med.? Maybe just caution on the part of the suppliers...maybe this problem will go away after a bit. I'd sure like to be able to get what I need when I run out in about a year.

[sirupate]

JD250....my packaging insert states that hCG is appropriate for use in hypogonadal males. Nice to see some media recognition though.

[GFA]

They are cracking down on shops that sell without prescriptions. Several indian sites abruptly stopped selling it. I'm guessing they reached out to the manufacturers and threatened to pull their license/fine them if they kept selling to shady sites.

[APIs]

They are cracking down on shops that sell without prescriptions. Several indian sites abruptly stopped selling it. I'm guessing they reached out to the manufacturers and threatened to pull their license/fine them if they kept selling to shady sites.

To sell HCG legally, the actual product must be approved & the manufacturing facility inspected by FDA. It's not likely that the Indian sources are approved in such a manner. HCG is just not that big of a product to warrant this work IMO. I might look for this data when time permits as it might be interesting to see what firms are actually approved for sale in the U.S...

[GFA]

To sell HCG legally, the actual product must be approved & the manufacturing facility inspected by FDA. It's not likely that the Indian sources are approved in such a manner. HCG is just not that big of a product to warrant this work IMO. I might look for this data when time permits as it might be interesting to see what firms are actually approved for sale in the U.S...

Many generics are made in India and imported/sold by Walmart.

http://www.huffingtonpost.com/al-nor..._b_108466.html

[flatscat]

apparently the women over there have overactive bladders - that is where 90 percent of the raw materials come from too lol

[bass]

this could be a good thing!

[GFA]

apparently the women over there have overactive bladders - that is where 90 percent of the raw materials come from too lol

India has a giant population so no shortage of pregnant women. They probably have shops where pregnant women can come in and pee for $.

[APIs]

Many generics are made in India and imported/sold by Walmart.

http://www.huffingtonpost.com/al-nor..._b_108466.html

Yes, but this doesnt mean the HCG you're getting from India is FDA approved though...

[JD250]

I'm lost, first of all the FDA has zero control over anything in India, what they want to control is anything that is being sold without a script that needs one and then being shipped to the states......i've never been asked for a script when I ordered HCG and it gets shipped to my door, that's the problem......not how it's manufactured....again, take a look at your meds and you'll find a great deal of them come from the same places in India. I wouldn't worry about injectable HCG fro India I would however worry about ANYTHING diet related regardless of where it came from. BTW, being approved by the FDA only means that a pharma company will be able to bend you over legally.

[flatscat]

You are right and wrong JD. The wrong part is the FDA does have total control over what is sold legally in the U.S. The manufacturing standards are the same whether it is made here or overseas. And yes - they do inspect plants overseas. If a company want to sell here they have to go through the same process regardless of country of origin.

[GFA]

The FDA does have control over which companies can sell drugs in the USA. Many Indian companies are making generics that are sold in the US. A simple phone call to any one of those manufactures saying "stop selling to shady sites or ban your products in the USA" would have a big impact.

This is all speculation of course but just pointing out how the FDA can affect companies outside the USA.

I dont personally purchase from India but from CVS direct with a prescription. I was considering purchasing it from overseas due to cost. My insurance company doesnt cover HCG for hypogonadism. A vial overseas can be purchased for a fraction of what they charge you here.

If insurance companies got out of the business of covering (or denying) prescription drugs, I would imagine the price of all drugs would come down significantly.

I tried getting HCG from Walmart but they dont sell injectables in my area.

[HRTstudent]

This explains it!

[ecdysone]

The FDA does have control over which companies can sell drugs in the USA. Many Indian companies are making generics that are sold in the US. A simple phone call to any one of those manufactures saying "stop selling to shady sites or ban your products in the USA" would have a big impact.

That's not really how it works. What the FDA does is send letters to the distributors to stop selling it.

There's no issue with Indian manufactured HCG .

The FDA requires all foreign manufacturers to be registered and theoretically inspected. However, in reality, it inspects nearly none of them. If there was an issue of drug safety, then the FDA would simply pull that manufacturer's permit for that drug and customs would seize all shipments in route.

The guys under the gun are the distributors and probably rightly so.

[flatscat]

Are you talking about the illegal distributors?

The FDA obviously is only involved (as far as registered/certifying manufacturing process) with the manufacturer's products that are imported legally and for legitimate Rx's.

[GFA]

That's not really how it works. What the FDA does is send letters to the distributors to stop selling it.

There's no issue with Indian manufactured HCG .

The FDA requires all foreign manufacturers to be registered and theoretically inspected. However, in reality, it inspects nearly none of them. If there was an issue of drug safety, then the FDA would simply pull that manufacturer's permit for that drug and customs would seize all shipments in route.

The guys under the gun are the distributors and probably rightly so.

Right I never implied there was a problem with Indian made HCG, just that its not available because of the FDA crack down.

I think my testosterone is actually manufactured in India too, Watsons t-cyp. Ill check the label when I get home.

Doesnt impact me directly but the hcg dieters are going nuts lol.

[APIs]

You are right and wrong JD. The wrong part is the FDA does have total control over what is sold legally in the U.S. The manufacturing standards are the same whether it is made here or overseas. And yes - they do inspect plants overseas. If a company want to sell here they have to go through the same process regardless of country of origin.

Exactly. I've been in the drug industry over 20 years now. For any Rx pharmaceutical product the FDA must approve its chemical composition, toxicity levels, the manufacturing route, raw material sources & the extensive scientific data that verifies the intended action of the drug by way of clinical trials just to name a few. The actual manufacturing site must also be inspected by FDA to verify the sites cGMP Compliance (Current Good Manufacturing Practices). While Generics (copies of off-patent drugs) are somewhat simpler in the approval process, all Rx drugs must pass the above criteria in order to be sold legally in the U.S. Getting a drug and the production facility approved is no easy task & for good reason. I've been to audits of some foreign facilities that claim to be cGMP and the sites end up being a total disaster. Many times they're making drugs with no traceable data, limited Quality Control & sometimes under unsanitary conditions. Would you want your medicines produced under such conditions? From my experience, I can say there is a certain risk we take in using any over-seas pharmaceutical that is not FDA approved. I'll be the first to admit that the FDA is in bed with U.S. Pharma on many fronts, but it's a necessary evil IMO.

[ecdysone]

Are you talking about the illegal distributors?

The FDA obviously is only involved (as far as registered/certifying manufacturing process) with the manufacturer's products that are imported legally and for legitimate Rx's.

Yes and no. Your right that FDA is only involved with those foreign manufacturers that are approved by them. All distributors are under FDA authority whether they be "illegal or legal." [distinction between "manufactures" vs. "distributors"]

[APIs]

That's not really how it works. What the FDA does is send letters to the distributors to stop selling it.

There's no issue with Indian manufactured HCG .

The FDA requires all foreign manufacturers to be registered and theoretically inspected. However, in reality, it inspects nearly none of them. If there was an issue of drug safety, then the FDA would simply pull that manufacturer's permit for that drug and customs would seize all shipments in route.

The guys under the gun are the distributors and probably rightly so.

The above might apply to certain OTC (over-the-counter) drugs & ingredients, but not Rx (prescription) products such as HCG. Any Rx product & it's manufacturing site must be inspected & approved before it can be legally marketed in the U.S. If the product is not, it will be rejected by FDA upon entry to the U.S. All importers of Chemical & Drug products entering the country must present official documentation to the FDA upon arrival at the air or sea port. FDA has Import Offices located at every point of entry for commercial cargo in the U.S. If the product(s) are not listed in the FDA's database as acceptable/approved sources, the product(s) are denied entry and must be destroyed or sent back to the country of origin. Of course, there are ways around this & people do utilize them. That's how unapproved drugs get in...

[flatscat]

Yes and no. Your right that FDA is only involved with those foreign manufacturers that are approved by them. All distributors are under FDA authority whether they be "illegal or legal." [distinction between "manufactures" vs. "distributors"]

Well they may pursue legal action against illegal distributors but that is it, and only if they can catch them.

Which is what I think you are trying to say, but since i am involved in the legal distribution side of things you confused me a little.

[ecdysone]

I think we are all saying about the same thing here, and APIs, we actually are in agreement (might add I used to work for the FDA years ago).

My only real point was that Indian HCG is fine and not at the issue here. If there is any problem with getting it, might be the distributor you use is either worried about getting one of those well-known FDA letters, or already received one.

[kelkel]

^^^^Ah, a Fed! Call your old contacts. Get Nebido approved here pronto!

[ecdysone]

^^^^Ah, a Fed! Call your old contacts. Get Nebido approved here pronto!

Cant, hated the place and all the bureaucracy.

But just the same, I think the Supreme Court has already ruled against "cruel and unusual punishment," i.e. 4 cc in the ass

[Herman Munster]

http://www.fda.gov/ICECI/Enfor***ent.../ucm282052.htm

I don't know how true it is; I have read on multiple sites that the companies who recently pulled HCG did so based on the FDA pressure and the timing of their decision to pull the product was based on their current supply. They stopped manufacturing and once their stock was depleted they stopped distributing

What now? Pour some drinks, get em drunk, fill the bladder and get it from the source? would i take that orally or inject it?

[JD250]

Now we have to find an UGL for HCG ? Or pay out the ass at my clinic. Dont those dirty sonsabitches have something better to do?

[GFA]

http://www.fda.gov/ICECI/Enfor***ent.../ucm282052.htm

I don't know how true it is; I have read on multiple sites that the companies who recently pulled HCG did so based on the FDA pressure and the timing of their decision to pull the product was based on their current supply. They stopped manufacturing and once their stock was depleted they stopped distributing

What now? Pour some drinks, get em drunk, fill the bladder and get it from the source? would i take that orally or inject it?

The only HCG CVS carries is Novarel, $170 a vial. Pregnyl is not longer available ($80 a vial) and they dont have a date when it will be available again. I was seriously considering purchasing some from online sources but all of a sudden like 10 sites I was looking at all dropped it from their inventory in the same week.

Something is amiss!

A few sites did say they should have it in stock again in a month or 2. Who knows.