The US Food and Drug Administration (FDA) has released draft guidance to assist sponsors with incorporating dose banding information in drug labeling for ready-to-use containers in new drug applications (NDAs), biologics license applications (BLA) or supplements to those applications.
Dose banding refers to dosing a drug product based on weight or body surface area (BSA), and labeling can include a range of different strengths.
This approach reduces “significant drug waste” from discarded single-dose vials and eliminates the need to calculate and extract partial doses from vials, said FDA.
For example, when the calculated dose for the patient is 1250 mg, a drug product may only be available in 1000 (mg) single-dose vials (100 mg/mL). In this case, “administering this exact dose would necessitate use of two vials, with the residual 750 mg in the second vial being discarded. The use of a pre-mixed, ready-to-use infusion bag that delivers 1250 mg of the drug simplifies the preparation and administration steps.”
Members of Congress have expressed concern on the amount of waste generated from discarded drugs. Draft legislation introduced in the 115th Congress and the 116th Congress focused on discarded drug from single-dose vials…