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# Draft ‘Dose Banding’ Guidance Out
- URL: https://www.fdaweb.com/draft-dose-banding-guidance-out/
- Published: 2022-07-20T12:00:00.000Z
- Updated: 2026-09-14T17:52:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152324

FDA has published a draft guidance, *Human Prescription Drug and Biological Products—Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers—“Dose Banding”,* with recommendations to assist applicants in incorporating information into proposed human prescription drug labeling under specified conditions. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-prescription-drug-and-biological-products-labeling-dosing-based-weight-or-body-surface-area?ref=fdaweb.com) applies to situations when:

- dosing for the drug product is based on weight or body surface area;
- the drug product is available in a range of strengths in ready-to-use containers; and
- the entire drug content of the ready-to-use container(s) is intended to be administered to a patient.

FDA says the practice described in those situations is known as “drug banding.”

The guidance contains Introduction, Background and Scope, Data to Support Dose Banding, Recommendations for Labeling, and an Example appendix.