No. Compounding a generic is straight up illegal, except in the temporary case of a shortage.
There's a weird loophole in that which the FDA is desperately trying to close due to the public anger over how grandfathered drugs prior to the FD&C 1938 were ungrandfathered in this century (colchicine and quinine being the notorious ones). I wouldn't do a still grandfathered drug now because they are actively being targeted by FDA for USP compliance.Can someone set up and manufacture a generic drug without filing an ANDA with the FDA? Is it possible to just use the formulation data that is already out there?
GDUFA helped a lot with that, too. OGD was hiring people like gangbusters from 2012 up until recently (finally slowed down a bit in early 2015).Also, the PQ office is not as slothful as they used to be about ANDA. Since Ted Sherwood took over that oversight (and he's quite the gung-ho bureaucrat), they've been much better about action dates in case you end up wanting to go that route.
If you want to write a PharmD paper on it, it's a great one if you're going to spend an FDA rotation. It's a highly public (to PhRMA and BIO) issue about the fairness and timeliness of review.
Tomato / tomato. Sure, it doesn't meet the textbook/legal definition of a generic drug, and that's essentially how compounding pharmacies get away with it. It's hard to argue that there is any substantial difference between "bioidentical" testosterone pellets and Testopel (molecule for molecule it's the same thing), or that a levothyroxine 90 mcg tablet is not comparable to synthroid 88mcg... Those types of "slightly different formulation or dosage" changes was all I was referring to, sorry for any misunderstanding.Yes. And a "slightly different formulation or dosage" is not one.