; or (bb) if applicable, the appropriate price determination made by the Bureau; and (II) direct the manufacturer to set the wholesale acquisition cost at a level that does not exceed the interim appropriate price. (ii) Applicable drugs A prescription drug described in this clause is a prescription drug— (I) that— (aa) as of the date of the enactment of this Act, has in effect an application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) ) or section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ); and (bb) is not a listed drug or a reference product for more than 2 prescription drugs or biological products approved and currently marketed under section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) or under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) )