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.
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