### Question
How is the term manufacturer defined?


### Answer
The term **manufacturer** is defined in *21 CFR § 1300.01* as the following:

> a person who manufactures a drug or other substance, whether under a registration as a manufacturer or under authority of registration as a researcher or chemical analyst.

#### Citation:
  - *21 CFR § 1300.01*
  - Heading: **Title 21-Food and Drugs > PART 1300—DEFINITIONS**

