### Question
What does prescription drug establishment mean?


### Answer
**Prescription drug establishment** has the following meaning in *21 U.S.C. § 379g*:

> a foreign or domestic place of business which is—


(A) at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more prescription drug products are manufactured in final dosage form, and


(B) under the management of a person that is listed as the applicant in a human drug application for a prescription drug product with respect to at least one such product

#### Citation:
  - *21 U.S.C. § 379g*
  - Heading: **CHAPTER 8-NARCOTIC FARMS > SUBCHAPTER VII-GENERAL AUTHORITY > Part C-Fees > subpart 2-fees relating to drugs**

