refundable single-dose container or single-use package drug
(8) Definition of refundable single-dose container or single-use package drug (A) In general Except as provided in subparagraph (B), in this subsection, the term “refundable single-dose container or single-use package drug” means a single source drug or biological (as defined in subsection (c)(6)(D)) or a biosimilar biological product (as defined in subsection (c)(6)(H)) for which payment is made under this part and that is furnished from a single-dose container or single-use package. (B) Exclusions The term “refundable single-dose container or single-use package drug” does not include— (i) a drug or biological that is either a radiopharmaceutical or an imaging agent; (ii) a drug or biological approved by the Food and Drug Administration for which dosage and administration instructions included in the labeling require 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; or (iii) a drug or biological approved by the Food and Drug Administration on or after November 15, 2021 , and with respect to which payment has been made under this part for fewer than 18 months.