### Question
Can you define what single source drug means?


### Answer
**Single source drug** is defined as the following in *42 U.S.C. § 1396r*:

> a covered outpatient drug, including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under paragraph (4), 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 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**

