Prescription Drug Establishment Law and Legal Definition

Pursuant to 21 USCS § 379g (5), [Title 21. Food And Drugs; Chapter 9. Federal Food, Drug, And Cosmetic Act; General Authority; Fees; Fees Relating To Drugs] 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.”