; and (II) in the case of a refundable single-dose container or single-use package drug described in subclause (II) of clause (iii), may increase the applicable percentage otherwise applicable under clause (i)(I) as determined appropriate by the Secretary. (iii) Drug described For purposes of clause (ii), a refundable single-dose container or single-use package drug described in this clause is either of the following: (I) A refundable single-dose container or single-use package drug for which preparation instructions required and approved by the Commissioner of the Food and Drug Administration include filtration during the drug preparation process, prior to dilution and administration, and require that any unused portion of such drug after the filtration process be discarded after the completion of such filtration process. (II) Any other refundable single-dose container or single-use package drug that has unique circumstances involving similar loss of product. (4) Frequency Amounts required to be refunded pursuant to paragraph (2) shall be paid in regular intervals (as determined appropriate by the Secretary). (5) Refund deposits Amounts paid as refunds pursuant to paragraph (2) shall be deposited into the Federal Supplementary Medical Insurance Trust Fund established under section 1841. (6) Enforcement (A) Audits (i) Manufacturer audits Each manufacturer of a refundable single-dose container or single-use package drug that is required to provide a refund under this subsection shall be subject to periodic audit with respect to such drug and such refunds by the Secretary. (ii) Provider audits The Secretary shall conduct periodic audits of claims submitted under this part with respect to refundable single-dose container or single-use package drugs in accordance with the authority under section 1833(e) to ensure compliance with the requirements applicable under this subsection. (B) Civil money penalty (i) In general The Secretary shall impose a civil money penalty on a manufacturer of a refundable single-dose