From Fiercepharma:
... a compounding pharmacy has stepped up with its own alternative to the med--at about $1 per pill, a tiny fraction of the cost of Turing Pharmaceuticals' brand, which runs $750 per tablet after a widely publicized 5000%-plus price increase.
Imprimis will have its work cut out for it to market the compounded meds, however. After the meningitis outbreak linked to the New England Compounding Center, new regulations tightened up on distribution of compounded drugs, which aren't specifically approved by the FDA. Compounded meds can only be dispensed on specific prescriptions for specific patients, rather than distributed in bulk as FDA-approved products are.
The company's pyrimethamine-plus-leucovorin combination can be ordered directly, an Imprimis spokesman said, with a physicians' prescription. Imprimis Cares is designed to streamline that process.
There's the hook - without FDA approval you are still on the back foot.
As we know, the corporatist EU loves licensing stuff, "in the interests of consumer safety and to ensure high uniform high standards" no doubt, because it is so expensive getting approval it shuts the little guys out of the market.