specified dates (in the case of determinations during a plan year, on a quarterly basis), and for any associated formulary changes to be implemented promptly thereafter (in accordance with timeframes specified by the Secretary). Such uniform requirements shall also specify circumstances under which a part D generic drug or part D biosimilar biological product shall be deemed for purposes of subclauses (I) and (II) of clause (i) to have a lower wholesale acquisition cost than its part D reference drug or part D reference biological product (so as to require its inclusion on formularies), including where no wholesale acquisition cost is published for such part D reference drug or part D reference biological product or the part D reference drug or part D reference biological product is not available for purchase by the PDP sponsor (or its network pharmacies) from its manufacturer at the published wholesale acquisition cost. (iii) Prohibition on certain limits on access The PDP sponsor offering the prescription drug plan may not impose limits on access to a part D generic drug required to be included on the formulary under clause (i)(I) or a part D biosimilar biological product required to be included on the formulary under clause (i)(II), including through prior authorization, utilization management, or step therapy, that are more restrictive than any such limits imposed on access to the part D reference drug of such part D generic drug or part D reference biological product of such part D biosimilar biological product, respectively, or that otherwise have the effect of giving preferred status to such part D reference drug or part D reference biological product over such part D generic drug or part D biosimilar biological product, respectively. (iv) Definitions In this subparagraph and subparagraph (K): (I) Part D biosimilar biological product The term part D biosimilar biological product means a covered part D drug that is a biosimilar biological product (as defined in section 1847A(c)(6)(H)). (II) Part D generic