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by nerdsniper 261 days ago
Well, for one ... it's illegal to import drugs that aren't FDA approved. You can import a few months personal supply of a prescribed drug that is FDA-approved but doesn't just mean that the active-ingredient is FDA-approved. It has to be the same exact product, manufactured in the same FDA-approved facility with the same packaging/labeling/etc to be considered "FDA-approved". The most expensive FDA-approved drugs are sold at US prices globally, so there's no geographic arbitration. Then other non-FDA approved brands are sold at lower prices - importing these is a smuggling offense, though enforcement was pretty low (but now with CBP's upcoming budget increases, who knows if this will continue to be practical or ultra-risky).

More practically - HMG is a very difficult drug to assay for purity. It's too complex to interpret with qNMR, HPLC testing is also very hard to interpret. The testing that exists evidently either has a very high margin of error or involves lots of rats and dissections.

Even testing for hCG, while it can be done reliably with HPLC, results between different labs are not comparable because the primary assay is also to test bioactivity on rodents, so they're not normalized to the same standard.

The lack of any independent testing for HMG means that some of the more accessible international manufacturers don't actually test their own product. Combined with its high price, that all makes it a very common target for counterfeit.

Yes, the American pharmaceutical system absolutely has quality-control issues. 80% of our generic pharmaceuticals come from overseas production. The pentagon wanted to independently test the drugs it was purchasing for the VA, so it worked with a company named Valisure who determined that about 10% of the drugs had issues with contamination or a lack of the active ingredient[0]. The FDA responded by shutting down Valisure's third-party testing.

But even with the problems we have here in the USA, HMG is the one drug I would particularly not trust from gray-market supply chains. It's conjecture, but I wouldn't be surprised if the doctor said that because other patients had tried it and had poor results.

0: https://archive.ph/ubLmg

1 comments

Not only the drug has to be approved but the production process and laboratory.

There is a lot of bureaucracy and audits. It is but as if a European laboratory is allowed to sell a generic drug without at huge costs for certifications ( and viceversa)

I am not saying that buying your medicines to questionable online web is a good idea. Just that other countries have their own controls depending on their policies

Yes. There are a lot of good non-FDA drugs that have been available for online purchase by US citizens. It's illegal to get them shipped to you, but enforcement has historically been nearly non-existent and given that 75 million Americans are under-insured ... it probably has been the rational option for many. India, China, and Turkey are perfectly capable of making high quality pharmaceuticals when the business owner actually cares about quality.

Also, compounding pharmacies in the USA sometimes get their raw active ingredients from even the shadiest suppliers in China and India. It's not always perfectly legal, things aren't always QA/QC'd at any point in the process the way they should be, but it happens. So again, "buying American" isn't exactly a golden ticket.

European HMG from reputable pharmacies is probably great quality - but it's still rather expensive compared to Chinese HMG and there's really no way to trust anyone selling it online, you'd basically have to fly to Europe yourself. And taking it back on the airplane would still be illegal, and you'd be rather more likely to be caught by customs than a mailed package.