### Question
What is the definition of innovator multiple source drug?


### Answer
The definition of **innovator multiple source drug** is as follows in *42 U.S.C. § 1396r*:

> a multiple source drug that is marketed under a new drug application approved by the Food and Drug Administration, unless the Secretary determines that a narrow exception applies (as described in section 447.502 of title 42, Code of Federal Regulations (or any successor regulation))

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

