Final Dosage Form Law and Legal Definition

Pursuant to 21 USCS § 379g (4), [Title 21. Food And Drugs; Chapter 9. Federal Food, Drug, And Cosmetic Act; General Authority; Fees; Fees Relating To Drugs] the term final dosage form means, “with respect to a prescription drug product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as capsules, tablets, or lyophilized products before reconstitution).”