prescription drug establishment
Defined in 1 place of the United States Code.
The term “prescription drug establishment” means 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.
For purposes of this paragraph, the term “manufactured” does not include packaging.
Source
- 1994–199721 U.S.C. § 379GFood and Drugs · Definitions · for purposes of this subpart
The term “prescription drug establishment” means 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. For purposes of this paragraph, the term “manufactured” does not include packaging.
Source
- 1997–present21 U.S.C. § 379GFood and Drugs · Definitions · for purposes of this subpart