What will gray vendors do to compete with new highly reduced prices for US GLP drugs?

[miss-sanne]

In this space, in the context of the above discussion weighing the costs incurred by compounding pharmacies continuing to compound GLP1s, and weighing that against the risk associated with using compound vs. grey, I’m talking about 503as, as 503bs are generally no longer able to produce them except in limited contexts.

503bs, while sometimes called compounding pharmacies, are really outsourcing facilities that outsource in bulk for hospitals and clinics. When we were in a shortage, 503bs were able to produce in bulk for individual patients too. But the shortage ended, so 503bs are not lawfully authorized to dispense directly to patients via mail anymore, as telehealth does. The drugs dispensed by 503bs are not FDA approved.

503as are compounding pharmacies for individual patients. They are currently able to make special doses or special cocktails and dispense to patients; they’re currently used by telehealth for that purpose. Like 503bs, those drugs are also not FDA approved.

Another way of thinking about it is that a 503b is a manufacturer of bulk compound product for use in multi patient vials or bags (think like a cancer drug cocktail to be dispensed in big vials or bags to be used with multiple patients at a chemo clinic); a 503a is a pharmacy compounds and dispenses to individual patients in single patient vials. Current dispensers of telehealth GLP-1 meds to John and Jane Doe via mail are 503a; they might also be a 503b, as an entity can hold both authorizations, but they are not lawfully using their 503b authority to dispense directly to patients via mail anymore, they are using their 503a authority.

503as are regulated — licensed, inspected — by the states, not the Feds. A 503a could operate in Utah for example, and be licensed to dispense to patients in California. California regulators will not be inspecting that pharmacy, neither will FDA. Utah might, if they have the will and resources. If that pharmacy is in Florida, it very well might not ever be inspected after it’s first licensed until… bad things happen. Many, many 503as are rarely inspected after licensure. (Largely a resource issue.)

No drug from any compound pharmacy is FDA approved. Just like no grey product is FDA approved. And 503as are not “regularly” inspected the way a 503b is supposed to be, and that 503a inspection is done at the state level.

Sooooooo, where someone claims that the cost of compound GLP-1s is not likely to go down because of all the heavy inspection and regulation compounding pharmacies go through to continue dispensing compound GLP-1s, that’s… just not true.

It was more likely to be true of 503bs when 503bs were still producing in bulk due to the shortage. We’re not living in the 503b shortage universe anymore.


Depends on the type of pharmacy and the state.

thanks for this !

 

[YoYoFat]

This is all to say, prices for compound will go down too… just as they already have over the last year or longer.

 

[Dos-Dox]

I’ll keep buying through these avenues because for me, having to get an Rx through a Dr or telehealth provider is more of a hassle than I want (and just tacks on a few extra fees). I’d rather buy what I want when I want and keep up with my own bloodwork and keep everyone else out of it.

 

[hexagonal]

I don’t call anyone a shill. I was sticking up for the other fellow that also got accused of calling someone a shill, but also didn’t.

I was speaking of a specific vaccine. Every year since that shit happened more people passed from the Flu or an underlying condition. That vaccine was worthless.

Whoever people where during that pandemic is who the really are.

The person you are quoting quite explicitly did call him a shill - he claimed he had a vested interest in us believing in the pharma industry.

I was also speaking of a specific vaccine - the science is consistent that the covid vaccines, including the mrna versions, were safe and efficacious, and this science was replicated even across countries where it would be in their political interests for western countries and western pharma being undermined.

 

[hexagonal]

My daughter works in a compounding pharmacy and they are indeed inspected - at least once a month - by a variety of oversight agencies. Not every agency comes every month but someone is there very regularly.

Meanwhile in my state, places with active complaints and warnings will go 12+ months before they even follow back up to see if things were resolved after the initial warning.

 

[Foggy-Hollow]

Now I'm danish, so we don't have compounding, and I may have misunderstood. But from I understand there is a difference between the compounding pharmacies ? I think, I read about 503a and 503b, and they have a different degree of inspection ?
Now Denmark is a highly regulated country when it comes to medicine, alternative medicine etc.
And still we had a case of some antibiotics being contaminated with bacteria a few years ago.
Stuff happens. But that was a bad one for sure.

Compounding in a strict sense would be a pharmacist mixing thing manually. They are not everywhere, medium sized cities maybe (my current area in the Midwest is ~300,000 and has only one). These Compounding Pharmacies are run by degreed, professional board-qualified pharmacists.

Compounders in peptide world could mean -in my mind- any unregulated spa that decides to sell gray. Likely mixes with B12 to avoid patent problems.