single source drug or biological
Defined in 1 dictionary — U.S. Code
United States Code
42 U.S.C. § 1395W — in this section
The term “single source drug or biological” means—
(i) a biological; or
(ii) a drug which is not a multiple source drug and which is produced or distributed under a new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application.