### Question
How is the "manufacturer of a covered drug, device, biological, or medical supply" defined?


### Answer
The term **manufacturer of a covered drug, device, biological, or medical supply** is defined in *42 U.S.C. § 1320a* as follows -

> any entity which is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply (or any entity under common ownership with such entity which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply)

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

