### Question
How does the law define applicable manufacturer?


### Answer
Under *42 U.S.C. § 1320a*, **applicable manufacturer** is defined as:

> a manufacturer of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States

#### Citation:
  - *42 U.S.C. § 1320a*
  - Heading: **CHAPTER 7-SOCIAL SECURITY > SUBCHAPTER XI-GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE SIMPLIFICATION > Part A-General Provisions**

