After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

An online pharmacy that tests medications before dispensing them advocated for regulations requiring independent testing and verification of the chemical content of pharmaceuticals; it also alleged that the US FDA’s testing method for evaluating the carcinogenic risk of metformin needs refinement.