; or (bb) 200 percent of the amount of such overcharge; and . (2) Clarifications Section 340B(d)(1) of the Public Health Service Act ( 42 U.S.C. 256b(d)(1) ) is amended by adding at the end the following new subparagraph: (C) Clarifications For purposes of subparagraph (B)(vi)— (i) an instance of overcharging described in subclause (II) of such subparagraph shall— (I) apply to each unit of a national drug code within an order, whether placed directly with a manufacturer or through a wholesaler, authorized distributor, or agent, and may not be offset by other discounts provided on any other National Drug Code or discounts provided on the same National Drug Code on other transactions, orders or purchases; and (II) include a manufacturer’s failure, such as through a limited distribution network, to offer a covered outpatient drug to a covered entity at the 340B ceiling price to the same extent the manufacturer makes the drug available to non-340B providers, unless such action is taken to narrowly address an actual or imminent shortage and has been approved in advance by the Secretary pursuant to standards issued through an appropriate policy or regulatory issuance; and (ii) in applying subclause (III) of such subparagraph— (I) the term knowingly shall have the meaning given the term should know in section 1003.101 of title 42 of the Code of Federal Regulations (or any successor regulation)