### Question
What does single source drug mean?


### Answer
**Single source drug** has the following meaning in *42 U.S.C. § 1396r*:

> a covered outpatient drug which is produced or distributed under an original new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributers [11](#1396r-8_11_target) operating under the new drug application

#### Citation:
  - *42 U.S.C. § 1396r*
  - Heading: **CHAPTER 7-SOCIAL SECURITY > SUBCHAPTER XIX-GRANTS TO STATES FOR MEDICAL ASSISTANCE PROGRAMS**

