### Question
How is the "prescription drug establishment" defined?


### Answer
The term **prescription drug establishment** is defined in *21 U.S.C. § 379g* as follows -

> a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form

#### Citation:
  - *21 U.S.C. § 379g*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 2-fees relating to drugs**

