; (II) creates, monitors, and assures an uncompromised ISO 5 environment, with continuous isolation of its interior from the external environment; (III) demonstrates unidirectional air within the compounding chamber and loading area or areas; (IV) incorporates barcode verification of all drug ingredients, which are comprised solely of finished sterile drug products approved by the Food and Drug Administration; (V) assures drug dose accuracy and control using gravimetric (or comparable) analysis; (VI) provides photographic evidence of all supply containers; (VII) applies labels to compounded sterile preparations within ISO 5 environment; (VIII) maintains detailed compounding, cleaning, and other operational records; and (IX) is developed, manufactured, and serviced as a pharmacy compounding device or system per guidance promulgated by the Food and Drug Administration. .