### Question
What is the definition of single source drug?


### Answer
The definition of **single source drug** is as follows 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 distributors 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**

