Discarded Drug Program

Published 08/07/2024

Section 90004 of the Infrastructure Investment and Jobs Act (Pub. L. 117–58, November 15, 2021) requires manufacturers to provide a refund to CMS for certain discarded amounts from a refundable single-dose container or single-use package drug.  The refund amount is the amount of discarded drug that exceeds an applicable percentage, which is required to be at least 10 percent, of total charges for the drug in a given calendar quarter.

Refundable single-dose container or single-use package drugs approved or licensed by FDA on or after November 15, 2021 are excluded from the definition of refundable single-dose container or single-use package, and thus, not subject to a refund, for the first 6 full calendar quarters following the date of first reported sale for any NDCs of such drug (see 87 FR 69719 through 69724).