Hacker News new | ask | show | jobs
by bananaportfolio 1196 days ago
The FDA allows generics to be sold within much looser tolerances than the brand product (variances allowed of +/- 20% of active ingredient per dose.) If you've ever noticed a "brand medically necessary" checkbox on a prescription a doctor has given you, that's what it is there for.
1 comments

There's no way that the variance allowed is +/- 20%. That's insane.

Does that also imply that a 30mg Adderall could come out as either a 24mg or a 36mg? In reality that is likely easier for the manufacturer to detect than the individual weights of the active ingredients in a random mixture, but still.

They measure maximum blood concentration and other parameters. Not just how much of the primary ingredient. But the variance allowed for those parameters is 80% to 125%.
I see, that makes much more sense