prescription drug product

(3) The term “prescription drug product” means a specific strength or potency of a drug in final dosage form— (A) for which a human drug application has been approved, (B) which may be dispensed only under prescription pursuant to section 353(b) of this title , and (C) which is on the list of products described in section 355(j)(7)(A) of this title (not including the discontinued section of such list) or is on a list created and maintained by the Secretary of products approved under human drug applications under section 262 of title 42 (not including the discontinued section of such list). Such term does not include whole blood or a blood component for transfusion, does not include a bovine blood product for topical application licensed before September 1, 1992 , an allergenic extract product, or an in vitro diagnostic biologic product licensed under section 262 of title 42 . Such term does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion.


21 USC § 379g(3)

Scoping language

For purposes of this subpart
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