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U.S. Department of Health and Human Services Office of Disease Prevention and Health Promotion

Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding”; Draft Guidance for Industry

About this resource:

Non-Systematic Review

Source: Food and Drug Administration

Last Reviewed: 2022

Workgroups: Medical Product Safety Workgroup

“Dose banding” uses pre-defined ranges (“bands”) of a patient’s weight or body surface area to calculate the appropriate dose of a medicine. Some medicines, like infusions for chemotherapy treatment, are manufactured in ready-to-use containers that are available in different strengths. In this draft guidance, the U.S. Food and Drug Administration (FDA) offers recommendations for drug manufacturers wanting to include information about dose banding on medicine labels. This guidance applies to:

  • New drug applications submitted under the Federal Food, Drug, and Cosmetic Act 
  • Biologics license applications submitted under the Public Health Service Act 
  • Supplements to an approved application
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Objectives related to this resource (1)

Reduce emergency department visits for medication overdoses in children under 5 years — MPS‑01
Little or no detectable change

Suggested Citation

1.

Food and Drug Administration. (2022). Human Prescription Drug and Biological Products — Labeling for Dosing Based  on Weight or Body Surface Area for  Ready-to-Use Containers — “Dose  Banding”; Draft Guidance for Industry. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-prescription-drug-and-biological-products-labeling-dosing-based-weight-or-body-surface-area.