Human Prescription Drug and 
Biological Products  Labeling 
for Dosing Based on Weight or 
Body Surface Area for Ready-
to-Use Containers  Dose 
Banding 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
October 2023 
Labeling 
 
54099102fnl09-26-23.docx    
Human Prescription Drug and 
Biological Products  Labeling for 
Dosing Based on Weight or Body 
Surface Area for Ready-to-Use 
Containers  Dose Banding 
Guidance for Industry 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
and/or 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances     
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
 October 2023 
Labeling 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND AND SCOPE ....................................................................................... 2 
III.  DATA TO SUPPORT DOSE BANDING ....................................................................... 3 
IV.  RECOMMENDATIONS FOR LABELING .................................................................. 4 
APPENDIX:  DOSE BANDING LABELING EXAMPLE ....................................................... 6 
  Contains Nonbinding Recommendations 
 
Human Prescription Drug and Biological Products  Labeling for 
Dosing Based on Weight or Body Surface Area for Ready-to-Use 
Containers  Dose Banding  
Guidance for Industry1 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page.   
 
 
 
 
I.  INTRODUCTION  
 
This guidance provides recommendations to assist applicants in incorporating information into 
proposed human prescription drug labeling for injectable drug products2 when: 
 
  Dosing for the drug product is based on weight or body surface area (BSA), 
  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. 
 
For the purposes of this guidance, this practice is referred to as dose banding. 
 
This guidance applies to proposed labeling in a new drug application (NDA) submitted under 
section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act);3 a biologics license 
 
1 This guidance has been prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research 
(CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug 
Administration. 
 
2 For the purposes of this guidance, the term drug product or drug products refers, unless otherwise specified, to 
products approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), therapeutic 
biological products licensed under section 351(a) of the Public Health Service Act (PHS Act), and combination 
products that have a drug or biological product primary mode of action and for which CDER has primary 
jurisdiction (see 21 CFR part 3). 
 
3 There are legal and regulatory considerations that apply to 505(b)(2) applications that rely on information (for 
example, FDAs finding of safety and/or effectiveness for a listed drug and/or published literature) that the applicant 
does not own or for which it does not have a right of reference or use to support approval of dose banding 
information.  Applicants of 505(b)(2) applications proposing to rely on such information to support approval of dose 
banding information should discuss their development programs with the appropriate review division in CDERs 
Office of New Drugs.  For additional information on 505(b)(2) applications, see the draft guidance for industry 
 
  1  Contains Nonbinding Recommendations 
 
application (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act);4 
or a supplement to one of these approved applications.     
 
This guidance does not apply to abbreviated new drug applications (ANDAs), which are 
generally required to have the same labeling as the reference listed drug (RLD).5  This guidance 
also does not apply to BLAs submitted under section 351(k) of the PHS Act; the labeling of 
biosimilar and interchangeable products generally incorporates relevant data and information 
from the FDA-approved labeling of the reference product, with certain modifications.6   
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidance means that something is suggested or recommended, but 
not required. 
 
 
II.  BACKGROUND AND SCOPE 
 
Having multiple different strengths of a drug product available in ready-to-use containers from 
which the entire drug content of the container(s) is administered to the patient may simplify the 
preparation and administration of a drug compared to preparing and administering an exact 
weight- or BSA-based dose to the patient.7  The availability of a drug product in a range of 
different strengths in ready-to-use containers (for example, pre-mixed infusion bags) that could 
be administered in their entirety also may reduce significant drug waste from single-dose vials 
used for exact weight- or BSA-based dosing and would eliminate the need to calculate and 
extract partial doses from vials.  For example, consider a drug product that is available in 1,000 
milligram (mg) single-dose vials (100 mg/milliliter (mL)) when the calculated dose for the 
patient is 1,250 mg.  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 1,250 mg of the drug simplifies the preparation and administration 
steps.  Administering the entire drug content of a ready-to-use container, however, may result in 
 
Applications Covered by Section 505(b)(2) (December 1999).  When final, this guidance will represent FDAs 
current thinking on this topic.  We update guidances periodically.  To make sure you have the most recent version of 
a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents.   
 
4 A BLA submitted under section 351(a) of the PHS Act is a stand-alone application and must contain all required 
data and information necessary to demonstrate the safety, purity, and potency of the proposed biological product for 
each of its proposed conditions of use.   
 
5 The FD&C Act and FDAs regulations permit labeling differences because of differences approved under a 
suitability petition or because the generic drug and the RLD are produced or distributed by different manufacturers.  
See sections 505(j)(2)(A)(v) and (j)(4)(G) of the FD&C Act and 21 CFR 314.94(a)(8)(iv).   
 
6 See, for example, the draft guidance for industry Labeling for Biosimilar and Interchangeable Biosimilar Products 
(September 2023); when final, this guidance will represent FDAs current thinking on this topic.  
 
7 Weight refers to either actual or ideal body weight, whichever is appropriate for the drug product. 
  2  Contains Nonbinding Recommendations 
 
a patient receiving a dose that is very close to but not exactly the same as the dose calculated 
based on weight or BSA.  The labeling must provide clear instructions for health care 
practitioners on preparation and administration of the drug product,8 which should include 
information on how to determine which strength(s) of the ready-to-use containers the patient 
should receive based on the patients weight or BSA.  In some instances, dosing with ready-to-
use containers may entail administration of a single ready-to-use container (for example, one 
infusion bag).  In other situations, a patient may need two (or more) ready-to-use containers (for 
example, using two infusion bags of different strengths to provide the calculated total dose to be 
administered) to receive the recommended dose.     
 
The recommendations and examples in this guidance apply when an applicant (1) proposes to 
develop ready-to-use containers with a range of different strengths and (2) seeks to incorporate 
dose banding information into the Prescribing Information based on dosing information of a 
previously approved drug product that is based on weight or BSA and is available in single-dose 
vials.   
 
 
III.  DATA TO SUPPORT DOSE BANDING 
 
Applicants who seek to include dose banding information in labeling need to provide adequate 
data to support the safety and efficacy of the proposed ranges.9  This may include, for example, 
data or information on dosing based on weight or BSA that the applicant owns or to which it has 
a right of reference or by relying on published literature to support approval of a 505(b)(2) 
application.   
 
In general, the application (including a supplemental application) should include data that 
explain and justify the acceptability of the differences between the proposed to-be-administered 
dose in the ready-to-use containers (i.e., dose banding) and the exact weight- or BSA-based dose 
from the approved drug product in single-dose vials.  The evidence used to identify acceptable 
systemic exposure bounds (i.e., acceptable range or differences for dose banding) to support dose 
banding may depend on the nature of the dose- or exposure-response of the drug, therapeutic 
index, and pharmacokinetic characteristics of the drug product.  The evidence should support the 
conclusion that the largest potential differences between the administered dose based upon dose-
banding and the dose based upon weight or BSA from the approved drug product would not 
compromise safety or effectiveness of the drug.  Model-informed drug development approaches 
can be used to assist in determining dosing using strengths available in ready-to-use containers 
(i.e., dose banding).10  FDA encourages applicants to discuss their proposals to describe dose 
banding information in the labeling, including any clinical and/or scientific data to justify the 
 
8 21 CFR 201.57(c)(3)(iv). 
 
9 21 CFR 201.56(a)(3). 
 
10 For further information regarding model-informed drug development approaches, see the guidances for industry 
Population Pharmacokinetics (February 2022) and Exposure-Response Relationships  Study Design, Data 
Analysis, and Regulatory Applications (May 2003).   
 
  3  Contains Nonbinding Recommendations 
 
proposed dosing and administration recommendations, with the appropriate FDA review division 
during drug development.11 
 
IV.  RECOMMENDATIONS FOR LABELING 
 
When included in labeling, dose banding information should be presented in the DOSAGE AND 
ADMINISTRATION section along with the previously approved recommended dose based on 
weight or BSA.12  When applicable, the clinical and/or scientific information supporting the use 
of dose banding may be included in the CLINICAL PHARMACOLOGY section. 
 
The following list provides recommendations to incorporate dose banding information for ready-
to-use containers into the DOSAGE AND ADMINISTRATION section and Pharmacokinetics 
subsection of the CLINICAL PHARMACOLOGY section.  However, these recommendations 
should not be considered comprehensive, and statutory and regulatory requirements for the 
content and format of human prescription drug labeling apply.13   
 
  Information on doses using a range of ready-to-use containers in the DOSAGE AND 
ADMINISTRATION section should include information about the maximum 
acceptable differences between the recommended dose of the previously approved 
drug product based on weight or BSA and the dose based on available strengths of the 
ready-to-use containers and, if applicable, a cross-reference to the supporting data in 
the CLINICAL PHARMACOLOGY section.   
 
  The DOSAGE AND ADMINISTRATION section should include information on 
how to select the appropriate ready-to-use container(s) to achieve the recommended 
dose for an individual patient based on weight or BSA.  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) based on the patients 
weight or BSA.  Presenting drug product selection information for the various 
strengths of the ready-to-use containers in a tabular format may be useful to health 
care practitioners.   
 
  It may sometimes be important to include recommendations for situations when 

the dose based on weight or BSA falls outside of the dose range for which the 
ready-to-use containers are supplied.  For example, 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 
 
11 For example, human factors studies may be necessary for the approval of an NDA submitted under section 505(b) 
of the FD&C Act, a BLA submitted under section 351(a) of the PHS Act, or a supplement to one of these approved 
applications.  
 
12 See 21 CFR 201.57(c)(3); see also the draft guidance for industry Dosage and Administration Section of Labeling 
for Human Prescription Drug and Biological Products  Content and Format (January 2023).  When final, this 
guidance will represent FDAs current thinking on this topic. 
 
13 See generally, section 502 of the FD&C Act and 21 CFR part 201. 
  4  Contains Nonbinding Recommendations 
 
recommended for patients for which the calculated dose cannot be achieved and 
(2) recommend that use of another drug product containing the same active 
ingredient be considered.   
 
  When applicable, the Pharmacokinetics subsection of the CLINICAL 
PHARMACOLOGY section should include pharmacokinetic information about the 
maximum difference (for example, as a percentage) between the previously approved 
drug products recommended dose calculated based on weight or BSA compared to 
the proposed products dose administered using the ready-to-use container(s). 
 
A fictitious labeling example is provided in the appendix. 
 
   
  5  Contains Nonbinding Recommendations 
 
APPENDIX:  Dose Banding Labeling Example  
 
This appendix presents a fictitious example of labeling incorporating dose banding information 
for using ready-to-use containers into the relevant portions of the DOSAGE AND 
ADMINISTRATION and CLINICAL PHARMACOLOGY sections.  The fictitious product is 
DRUG-X (drugozide injection), available in ready-to-use infusion bags, with dose banding 
information based on a body surface area (BSA)-based dose of 500 mg/m2 that was 
recommended in the labeling for a previously approved drugozide injection drug product 
available in single-dose vials. 
 
2 DOSAGE AND ADMINISTRATION 
 
2.1 Recommended Dosage and Administration 
 
The recommended dosage of DRUG-X is 500 mg/m2 administered intravenously over 
30 minutes every 4 weeks.  Doses administered using DRUG-X infusion bags may vary 
from the BSA-calculated dose by up to 5% [see Clinical Pharmacology (12.3)].  Select 
the DRUG-X infusion bag(s) based on the patients BSA as described in Table 1. 
 
DRUG-X is not recommended for use in patients with a BSA less than 1.05 m2.  Dosing 
for such patients is not possible with DRUG-X infusion bags because the lowest available 
strength (infusion bag containing 550 mg per 55 mL (10 mg/mL)) exceeds the BSA-
calculated dose by more than 5%.  Consider the use of another drugozide product for such 
patients. 
 
Table 1. DRUG-X Infusion Bag Selection Based on BSA  
DRUG-X Infusion Bag(s) 
BSA Range  Calculated Dose Range 
(10 mg/mL) 
Less than 1.05 m2  Not recommended 
1.05 to 1.15 m2  525 mg to 577 mg  550 mg 
1.16 to 1.25 m2  578 mg to 627 mg  600 mg 
1.26 to 1.35 m2  628 mg to 677 mg  650 mg 
1.36 to 1.45 m2  678 mg to 727 mg  700 mg 
1.46 to 1.55 m2  728 mg to 777 mg   750 mg 
1.56 to 1.65 m2  778 mg to 827 mg  800 mg 
1.66 to 1.75 m2  828 mg to 877 mg  850 mg 
1.76 to 1.85 m2  878 mg to 927 mg  900 mg 
1.86 to 1.95 m2  928 mg to 977 mg  950 mg 
1.96 to 2.05 m2  978 mg to 1,027 mg  1,000 mg 
2.06 to 2.15 m2  1,028 mg to 1,077 mg  1,050 mg 
2.16 to 2.25 m2  1,078 mg to 1,127 mg  Use two 550 mg infusion bags 
(1,100 mg total) 
 
... 
 
  6  Contains Nonbinding Recommendations 
 
12 CLINICAL PHARMACOLOGY 
 
... 
12.3 Pharmacokinetics 
 
There are no clinically significant differences in drugozide pharmacokinetics between the 
BSA-calculated dose and doses that differ up to 5% from the BSA-calculated dose as 
described in Table 1 based on drugozide dose proportionality, variability, and exposure- 
response for safety and efficacy [see Dosage and Administration (2.1)].   
 
  7