Dose banding: FDA aims to reduce drug waste in new labeling guidance

Regulatory NewsRegulatory News | 20 July 2022 |  By 

The US Food and Drug Administration (FDA) has released draft guidance to assist sponsors with incorporating dose banding information in drug labeling for ready-to-use containers in new drug applications (NDAs), biologics license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.
Applicants who want to include dose banding information in labeling “need to support this information with adequate evidence of safety and substantial evidence of effectiveness.”
Applications should also justify the acceptability of the differences between the proposed dose in the ready-to-use containers and the exact weight or BSA based dose from the approved drug product.
FDA said that model-informed drug development (MIDD) approaches can also be used to compare the dose based on weight or BSA and using strengths available in ready-to-use containers.
The dosage and administration sections should also include information on how to select the best ready-to-use contains to achieve the recommended dose. For example, “If the ready-to-use containers are supplied as infusion bags in a range of strengths, with each bag containing a different total amount of the drug at a specified concentration, this section should explain how to select the correct infusion bag(s).”
The labeling should also address situations when the dose based on weight or BSA falls outside the dose range of the ready-to-use containers. “If the calculated dose for a specific weight or BSA is lower than the lowest dose available in the ready-to-use infusion bags, this section should (1) clarify that use of the bags is not recommended for patients of this weight or BSA because the calculated dose cannot be achieved and (2) recommend that use of another drug product containing the same active ingredient be considered,” FDA said.
The guidance includes a fictitious labeling example incorporating dose banding information in the dosage administration and clinical pharmacology sections.
 Draft guidance


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