Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format

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41286071fnl.docx
Instructions for Use —
Patient Labeling for Human
Prescription Drug and Biological
Products — Content and Format
Guidance for Industry
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Combination Products (OCP)
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
July 2022
Labeling

Instructions for Use —
Patient Labeling for Human
Prescription Drug and Biological
Products — Content and Format
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., 4 th 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
Office of Combination Products (OCP)
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
July 2022
Labeling

Contains Nonbinding Recommendations
TABLE OF CONTENTS
I. 	INTRODUCTION............................................................................................................. 1
II. 	BACKGROUND ............................................................................................................... 3
III. 	CONTENT ......................................................................................................................... 4
A. 	General Content Recommendations............................................................................................. 4
1. Consistency With the FDA-Approved Prescribing Information ...................................................... 4
2. Language and Readability ............................................................................................................... 4
3. Headings .......................................................................................................................................... 5
B. 	Specific Content Recommendations ............................................................................................. 6
1. Title .................................................................................................................................................. 6
2. Product Title .................................................................................................................................... 6
3. Purpose Statement ........................................................................................................................... 8
4. Visual of Drug Product .................................................................................................................... 8
5. Important Information for Patients .................................................................................................. 9
6. Preparation Instructions ................................................................................................................ 10
7. Administration Instructions ........................................................................................................... 11
8. Storage Instructions ....................................................................................................................... 12
9. Disposal Instructions ..................................................................................................................... 13
10. 	Additional Information .............................................................................................................. 14
IV. 	FORMAT ......................................................................................................................... 14
A. 	Typeface Styling Recommendations........................................................................................... 15
1. Font and Font Size ......................................................................................................................... 15
2. Letter Case ..................................................................................................................................... 15
3. Bold, Italicized, or Underlined Text .............................................................................................. 15
B. 	Page Layout and Design Recommendations.............................................................................. 16
1. Step-by-Step Instructions ............................................................................................................... 16
2. Visuals for Step-by-Step Instructions ............................................................................................. 16
3. Spacing........................................................................................................................................... 17
4. Color .............................................................................................................................................. 17
REFERENCES............................................................................................................................ 18
APPENDIX: INSTRUCTIONS FOR USE — ......................................................................... 19
RECOMMENDED ORDER OF INFORMATION................................................................. 19

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Instructions for Use — Patient Labeling for Human Prescription
Drug and Biological Products — Content and Format
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 for developing the content and format of a patient
Instructions for Use (IFU) document for human prescription drug and biological products, as
well as drug-led or biologic-led combination products2 submitted under a new drug application
(NDA) or a biologics license application (BLA).3,4,5 The IFU is written for patients (or their
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) and the Office of
Combination Products and in consultation with the Center for Devices and Radiological Health at the Food and
Drug Administration.
2 See 21 CFR 3.2(e).
3 In this guidance, the terms drug, drug product, and product refer to human prescription drug and biological
products and drug-led or biologic-led combination products that are regulated by CDER and CBER. However, the
term biological product is used in order to distinguish between human prescription drug products and biological
products (e.g., where there is a difference in regulatory treatment).
4 For information specific to abbreviated new drug application (ANDA) submissions, please refer to the guidance for
industry Acceptability of Draft Labeling to Support ANDA Approval (October 2015). (We update guidances
periodically. For the most recent version of a guidance, check the FDA guidance web page at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents.) An ANDA is required to contain
information to show that the labeling proposed for the generic drug is the same as the labeling for the reference
listed drug (RLD), except for certain permissible differences required because of differences approved under a
suitability petition (see section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR
314.93) or because the generic drug and the RLD are produced or distributed by different manufacturers (see section
505(j)(2)(A)(v) of the FD&C Act)).
5 For information specific to biosimilar and interchangeable biosimilar products licensed under section 351(k) of the
Public Health Service Act, refer to the guidance for industry Labeling for Biosimilar Products (July 2018), and the
draft guidance for industry Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar

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caregivers) who use drug products that have complicated or detailed patient-use instructions.6
The recommendations in this guidance are intended to help ensure that patients receive clear and
concise information that is easily understood for the safe and effective use of such products. The
recommendations in this guidance are also intended to help provide consistency to the content
and format of IFU documents.7
The recommendations in this guidance do not apply to labeling for stand-alone devices or for
device constituent parts of cross-labeled combination products if the device constituent is
marketed under a device authorization8,9 (i.e., devices that are not constituent parts of drug-
device, biologic-device, or biologic-drug-device combination products submitted under BLA or
NDA), labeling for combination products for which the device constituent part provides the
primary mode of action, or labeling intended for use by health care providers.10 The
recommendations in this guidance also do not apply to stand-alone devices regulated under a
BLA, such as devices associated with blood collection and processing procedures.
This guidance is one of several documents FDA is issuing to fulfill the performance goals under
the fifth reauthorization of the prescription drug user fee program, the Prescription Drug User
Development and the BPCI Act (November 2020). When final, this guidance will represent FDA’s current thinking
on this topic.
6 The IFU is considered part of the product user interface. The need for an IFU may be informed by following a
human factors (HF) engineering process, which includes conducting comprehensive use-related risk analyses
(URRA). The inclusion of an IFU document as a part of prescription drug labeling may be implemented as a
mitigation for use-related risks. A comprehensive URRA helps to determine if an IFU is warranted. Additional
data, such as data from HF studies, could be used to inform the development and design of the IFU, including the
content to be included under the headings recommended in this guidance for a product regulated under an NDA or
BLA. Additional discussions of HF considerations in the development of an IFU are outside the scope of this
guidance. For additional information on development of the user interface and HF considerations, see the draft
guidance for industry and FDA staff Human Factors Studies and Related Clinical Study Considerations in
Combination Product Design and Development (February 2016). When final, this guidance will represent FDA’s
current thinking on this topic. If alternatives to the recommendations in this guidance are proposed for an IFU based
on HF studies, applicants should consult with FDA early in the development process.
7 The format recommendations presented in this guidance are written to apply to an IFU document presented in
portrait orientation on letter size paper (8.5 x 11). We recommend that IFU documents presented in other formats
aim to carry over as many format recommendations as practical unless information or data, such as data from HF
studies, would support otherwise.
8 See generally sections 510(k), 513(f), and 515 of the FD&C Act.
9 For information on developing patient labeling for devices, including in vitro diagnostic products, please see 21
CFR parts 801 and 809 and the FDA web page on device labeling at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/default.htm.
10 FDA also approves IFU documents intended specifically for use by health care providers. These documents
include instructions on how to administer a product safely and effectively to patients. However, the
recommendations provided in this guidance apply to IFU documents intended for use by patients and do not apply to
IFU documents intended specifically for use by health care providers.

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Fee Act (PDUFA) VI. In particular, this guidance relates to the PDUFA VI performance goal
regarding guidance on patient-oriented labeling (e.g., IFU documents).
The contents of this document do not have the force and effect of law and are not meant to bind
the public in any way, unless specifically incorporated into a contract. This document is intended
only to provide clarity to the public regarding existing requirements under the law. FDA
guidance documents, including this guidance, 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
The IFU is a form of prescription drug labeling.11 For drugs for which self-administration may
be complicated (such as requiring the patient to perform multiple steps to prepare, administer,
store, and/or dispose the drug), the IFU is intended to give directions that are clear and
understandable for patients, and therefore, promote the safe and effective use of that drug. For a
drug-led or biologic-led combination product that includes a device constituent part, the IFU
provides directions on the use of the device (e.g., regarding device preparation, injection of the
drug or biologic, and product storage of the device or combination product as a whole). Also, an
IFU may be appropriate for a product with one set of dosing instructions for adult patients and
another set for pediatric patients; in this situation, two separate IFU documents may be
appropriate. The IFU is developed by the applicant, reviewed and approved by FDA, and
provided to patients when the product is dispensed.
Applicants must submit true representations of both the content and format of the IFU, including
page layout, graphic design, and color, for FDA’s review and approval.12 In general, before
implementing and distributing changes to an FDA-approved IFU, applicants should refer to 21
CFR 314.70 or 601.12 for the requirements on submitting changes to previously approved
labeling. The Agency encourages applicants to meet with FDA as early as the investigational
new drug application (IND)/pre-IND phase, if appropriate, to discuss the development of any
IFU.
11 Patients may receive one or more forms of FDA-approved written patient prescription drug product information
(i.e., patient labeling) when they receive a prescription drug, including (1) a Medication Guide, (2) a Patient Package
Insert, and/or (3) an IFU. This guidance provides content and format recommendations only for IFU documents.
12 See 21 CFR 314.50(e)(2)(ii).

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III. 	CONTENT
A. 	General Content Recommendations
The IFU guides the patient on how to safely and effectively use a prescription drug product and
commonly includes instructions on preparation, administration, handling, storage, and disposal.
The primary purpose of an IFU is to provide detailed, step-by-step written instructions, including
visuals if appropriate, in a patient-friendly manner, as visuals can complement written
instructions.
1. 	Consistency With the FDA-Approved Prescribing Information
When reviewing the contents of an IFU, FDA looks for accuracy and consistency with the FDA-
approved Prescribing Information (PI) or in the case of a pending NDA or BLA, the to-be-
approved version of the PI. The IFU must not be false or misleading and must be updated when
new information causes the IFU to become inaccurate, false, or misleading.13
FDA recommends that the IFU include pertinent information from the PI that describes how to
use the drug product. FDA also recommends that the IFU include additional details not typically
discussed in the PI where those details are important for the safe and effective use of the drug
product by patients (for example, step-by-step instructions and visuals for how to self-administer
the drug product using a co-packaged syringe).
The following sections of the PI14 will generally contain the pertinent information for the IFU:
• 	DOSAGE AND ADMINISTRATION
• 	HOW SUPPLIED/STORAGE AND HANDLING
• 	PATIENT COUNSELING INFORMATION
Information from other sections of the PI may also be useful to include in the IFU, as
appropriate.
2. 	Language and Readability
FDA suggests writing the IFU in terms that patients, including those with low literacy skills, are
likely to understand. The IFU should be written at or below the national average reading level to
13 See section 502(a) of the FD&C Act (21 U.S.C. 352(a)).
14 The labeling sections noted are pertinent to drug product labeling that must meet the content and format
requirements of the final rule “Requirements on Content and Format of Labeling for Human Prescription Drug and
Biological Products,” (71 FR 3922, January 24, 2006), available at https://www.fda.gov/drugs/laws-acts-and-
rules/prescription-drug-labeling-resources. (See also 21 CFR 201.56 and 201.57.)

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facilitate understanding. FDA recommends that the IFU be written in nontechnical language.
Overly technical language may deter patients from reading and understanding important
information in the IFU. For example, for products with dosage form terminology that may not
be recognizable to patients, consider defining the dosage form terminology in patient-friendly
terms after its first use in the body of the IFU, e.g., “transdermal system (referred to as a “patch”
in this document).”
FDA recommends that the IFU be written in active voice and command language and that
sentences or phrases in the IFU begin with an action verb when possible. For instance, the IFU
should state “Wash your hands” (rather than “You should wash your hands”) and “Shake the vial
until the solution dissolves and is clear” (rather than “You should shake the vial until the solution
dissolves and is clear”).
In general, FDA recommends avoiding abbreviations in the IFU because they may be
misinterpreted, which could result in medication errors that may harm a patient. The Agency
also recommends writing dose designations (amount and volumetric units) clearly, to help avoid
medication errors. For instance, FDA suggests avoiding trailing zeros after a decimal point for
doses expressed in whole numbers (e.g., state 1 mg rather than 1.0 mg).15
3. 	Headings
Standardized headings in patient labeling materials enhance readability and usefulness (Lorch
et al. 2001; Kools et al. 2008; Cowburn and Stockley 2004). Headings and subheadings help
organize and differentiate topics so patients can quickly locate information in the IFU. Thus,
FDA recommends that headings and subheadings clearly identify the focus of each topic in the
IFU. FDA generally recommends organizing information under each heading such that related
topics are consolidated within a single heading, though FDA recognizes that repeating certain
information can be an important tool for comprehension. FDA also generally recommends using
subheadings (under headings) in the IFU, to group related tasks that accomplish a single
objective.
Section III.B of this guidance provides recommended headings to organize content in the IFU.
The appendix lists the recommended order of all headings described in section III.B. Additional
headings and subheadings can also be useful to include in the IFU.
15 See also the List of Error-Prone Abbreviations at the Institute for Safe Medication Practices website
(https://www.ismp.org/recommendations/error-prone-abbreviations-list).

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B. 	Specific Content Recommendations16
FDA recommends that the following information, if applicable, appear in the order listed to
ensure consistency and to help patients become familiar with the type and location of
information in the IFU.
1. 	Title
FDA recommends that the title INSTRUCTIONS FOR USE appear centered prominently at the
top of the first page of the IFU, in bold uppercase letters, as follows:
INSTRUCTIONS FOR USE
2. 	Product Title
FDA recommends that the product title17 in the IFU include the product’s proprietary name,
nonproprietary name,18 dosage form,19 route of administration (ROA),20 and when applicable,
the controlled substance schedule. The Agency also recommends that the product title appear
beginning on the line immediately below the title INSTRUCTIONS FOR USE and that the
product title appear centered in bold letters across one, two, or three lines.
For drug products with a proprietary name, FDA recommends that the information appear in the
following order:
Line 1: Proprietary name in uppercase letters, followed by the pronunciation spelling in
brackets and, if applicable, the controlled substance schedule
16 Text appearing in brackets in the examples provided in this section indicates a placeholder and should be replaced
with the appropriate product-specific information.
17 See the draft guidance for industry Product Title and Initial U.S. Approval in the Highlights of Prescribing
Information for Human Prescription Drug and Biological Products — Content and Format (January 2018). When
final, this guidance will represent FDA’s current thinking on this topic.
18 In this guidance, the nonproprietary name refers to the established name of the drug (if any) or for biological
products, the proper name. (See section 502(e)(3) of the FD&C Act (21 U.S.C. 352(e)(3)); 21 CFR 600.3(k)). For
more information related to biological products, see the guidance for industry Nonproprietary Naming of Biological
Products (January 2017). See also the draft guidance for industry Nonproprietary Naming of Biological Products:
Update Guidance for Industry (March 2019). When final, this guidance will represent FDA’s current thinking on
this topic.
19 Established names for drug products typically include the dosage form. We include the dosage form separately in
the product title in certain instances because proper names for biological products typically do not include a dosage
form.
20 For some drug products (other than biological products), the route of administration is also part of the
nonproprietary name.

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Line 2: Nonproprietary name in lowercase letters21 in parentheses
Line 3: Dosage form in lowercase letters followed by the ROA in lowercase letters if the
nonproprietary name does not include the dosage form or the ROA; or ROA in
lowercase letters if the nonproprietary name contains the dosage form but does
not include the ROA
Example A: For the fictitious drug product MYDRUG (drugoxide injection), for
intramuscular use, in which the nonproprietary name contains the dosage form but does
not include the ROA, FDA recommends that the product title appear as follows:
MYDRUG [mye-drug]
(drugoxide injection)
for intramuscular use
Example B: For the fictitious biological product MYBIOLOGIC (drugimab-hjxf)
injection, for subcutaneous use, FDA recommends that the product title appear as
follows:
MYBIOLOGIC [mye-bye-oh-LAH-jik]
(drugimab-hjxf)
injection, for subcutaneous use
For drug products without a proprietary name, FDA recommends that the product title appear in
the following order:
Line 1: Nonproprietary name in title case letters, followed by the pronunciation spelling
of the chemical portion of the nonproprietary name in brackets and, if applicable,
the controlled substance schedule; or for biological products, generally, the
proper name in title case letters, followed by the pronunciation spelling of the
proper name in brackets and, if applicable, the controlled substance schedule
Line 2: Dosage form in lowercase letters followed by the ROA in lowercase letters if the
nonproprietary name does not include the dosage form or the ROA; or ROA in
lowercase letters if the nonproprietary name contains the dosage form but does
not include the ROA
Example C: For the fictitious drug product Drugoxide Injection, for intramuscular use,
which does not have a proprietary name (the nonproprietary name contains the dosage
form but does not include the ROA), FDA recommends that the product title appear as
follows:
21 FDA recommends that the location of the parentheses associated with the nonproprietary name mirror the location
of the parentheses associated with the nonproprietary name on the carton and container labeling and the product title
in the Highlights of Prescribing Information. See the draft guidance for industry Product Title and Initial U.S.
Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products —
Content and Format (January 2018).

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Drugoxide Injection [drug-OX-ide]
for intramuscular use
Example D: For the fictitious product Drugoxide Transdermal System (the
nonproprietary name contains the dosage form and the ROA), a combination product,
FDA recommends that the product title appear as follows:
Drugoxide Transdermal System [drug-OX-ide]
3. 	Purpose Statement
FDA recommends that the following purpose statement appear below the product title, flush with
the left margin:
This Instructions for Use contains information on how to [insert applicable action verb22]
[insert Drug Name23].
For example:
This Instructions for Use contains information on how to inject MYDRUG.
4. 	Visual of Drug Product
Following the purpose statement, FDA generally recommends that the IFU display a visual of
the drug product and, if the drug is a constituent part of a drug-led, drug-device combination
product, a visual of the device or devices used to administer the drug. Choose the best type of
visual that clearly depicts the drug product, such as a photograph, simple illustration, or line
drawing. If a product consists of multiple parts, FDA recommends visually identifying and
clearly labeling each part of the product, including the device constituent part(s) if applicable. In
some cases, it can also be useful to include further explanation of the purpose or function of the
parts of the product, including the device constituent part(s) if applicable.
Generally, FDA recommends that IFU documents include a visual of a drug product for an oral
dosage form (such as capsules, tablets, oral solution, or oral suspension) only if manipulation is
necessary to prepare and administer a dose (for example, opening and sprinkling the contents of
a capsule). In other instances of drug products with oral dosage forms, patients could likely
comprehend the instructions without a visual of the drug product.
22 Insert the appropriate action verb as determined by the product’s dosage form; for example, “take” (oral products),
“use” (inhalation, ear or eye products), “inject” (injectable products), “apply” (topical or transdermal products), or
“insert” (suppositories).
23 Drug Name is the proprietary name (if any) or the nonproprietary name of the drug product.

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If a drug product is dispensed in or with multiple components or constituent parts (such as
cartridges, blister cards or packs), FDA recommends that the IFU provide information about all
the components or constituent parts and include the following, if applicable:
• 	A list or visual representation of all components or constituent parts, each clearly
identified and labeled
• 	A list of items needed to use the drug product that are not included within the drug
product package
5. 	Important Information for Patients
FDA recommends that important information for patients to know before using the drug product
be described under the following heading:
Important Information You Need to Know Before [Insert Applicable Action Verb24]
[Insert Drug Name]
For example, FDA recommends that the heading for this section of the IFU for the fictitious drug
product MYDRUG appear as follows:
Important Information You Need to Know Before Injecting MYDRUG
FDA recommends that the IFU include this heading when patients should take specific actions to
prepare, administer, store, and/or dispose of the drug product to prevent or reduce potentially
serious outcomes that might occur if the specific action is not followed. FDA recommends that
information under this heading highlight important instructions and information to alert patients
about the appropriate uses, techniques, and routes of administration that, if not followed, could
result in injury or impair efficacy.
If confusion could occur about the route of administration based on the dosage form, such as
capsules for inhalation that may be mistaken for oral capsules, FDA recommends that the first
statement in this section explain how the drug product should be administered. For example:
• 	For oral use only (take by mouth)
• 	For subcutaneous injection only (inject directly under the skin)
• 	For topical use only (apply on top of skin)
24 Insert the appropriate action verb ending in “ing” as determined by the product’s dosage form; for example,
“taking” (oral products), “using” (inhalation, ear or eye products), “injecting” (injectable products), “applying”
(topical or transdermal products), or “inserting” (suppositories).

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Subsequent content that FDA recommends be placed under this heading includes, but is not
limited to, the following:
• 	The timing of a dose relative to a behavior or action specified in labeling; for example:
Take [Insert Drug Name] 1 hour before eating.
- 	Apply [Insert Drug Name] after bathing.
- 	Wait at least 2 hours after applying [Insert Drug Name] before showering or
swimming.
• 	Safety information or other important instructions specifically related to administration.
For example:
- 	Swallow tablet whole. Do not cut, crush, or chew tablet.
- 	Inject [Insert Drug Name] into the thigh. Do not inject [Insert Drug Name] into any
other area of the body.
- 	Check to see if the safety seal is in place. Do not use [Insert Drug Name] if the safety
seal is broken.
- 	[Insert Drug Name] is for one-time use only. Do not reuse [Insert Drug Name].
Throw away (discard) unused portion.
• 	Instructions to prevent or mitigate the risk of secondary exposure to a drug; for example:
- 	To prevent the transfer of [Insert Drug Name] from your body to others, avoid direct
skin contact or cover the areas of your body where [Insert Drug Name] has been
applied.
6. 	Preparation Instructions
FDA recommends that instructions on preparing the product for use be described under the
following heading:
Preparing to [Insert Applicable Action Verb25][Insert Drug Name]
For example, FDA recommends that the heading for this section of the IFU for the fictitious drug
product MYDRUG appear as follows:
25 See footnote 22.

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Preparing to Inject MYDRUG
Content that FDA recommends be placed under the preparation instructions section includes, but
is not limited to, the following:
• 	Information about supplies and materials for administering the dose (for example, a bowl
and spoon for mixing a drug product with food; alcohol wipes to prepare an injection; an
adhesive bandage to cover an injection site)
• 	Information about the time needed to allow a refrigerated product to warm to room
temperature or the maximum amount of time the product may remain unrefrigerated
before use
• 	Instructions to check the drug product for particles or discoloration and to check the
expiration date on the product’s label
• 	Directions for assembling constituent parts or components of the product at the time of
first use, and if applicable, assembly instructions for subsequent uses
• 	Instructions for priming topical or inhaled products for first use or priming for subsequent
use
• 	Directions for products requiring reconstitution and/or dilution
• 	Directions for drawing a drug product into a syringe
• 	Instructions on how to insert a co-packaged bottle adaptor
7. 	Administration Instructions
FDA recommends that instructions for administering the drug product be described under the
following heading:
[Insert Applicable Action Verb26] [Insert Drug Name]
For example, FDA recommends that the heading for the administration instructions section of the
IFU for the fictitious drug product MYDRUG appear as follows:
26 Insert the appropriate action verb ending in “ing” concerning administration as determined by the product’s
dosage form; for example, “taking” (oral products), “using” (inhalation, ear or eye products), “injecting” (injectable
products), “applying” (topical or transdermal products), or “inserting” (suppositories).

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Injecting MYDRUG
FDA recommends that the IFU clearly state the sequence of actions (e.g., information appears as
logically ordered, detailed, step-by-step instructions) so that patients can safely and effectively
take or administer the drug product.
For drug products with more than one method of administration (for example, sprinkle capsule
contents into food or drink; administer by feeding tube for patients who have difficulty
swallowing), FDA recommends using distinct sections to separate the instructions for each
administration method.
Content that FDA recommends be placed under the administration instructions heading includes,
but is not limited to, the following:
• 	Instructions and illustrations specifying which areas of the body are appropriate and
inappropriate for potential injection sites
• 	Instructions for injecting the drug product
• 	Instructions for rotating the site of application or injection, such as describing the manner
of rotation and the importance of keeping track of injection sites to ensure an injection is
not given in the same spot for consecutive doses
• 	Instructions on how to actuate an inhaler to ensure appropriate dosing
• 	Instructions on how to administer a dose with an auto-injector
• 	Instructions on how to apply and remove a transdermal system
8. 	Storage Instructions
FDA recommends that instructions on appropriate storage be described under the following
heading:
Storing [Insert Drug Name]
For example, FDA recommends that the heading for this section for the fictitious drug product
MYDRUG appear as follows:
Storing MYDRUG
Content that FDA recommends be placed under this heading includes, but is not limited to, the
following:

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• 	Instructions on how to prepare the product for storage (for example, disassembly
instructions, washing or cleaning)
• 	A description of storage conditions (for example, refrigerating the drug product or storing
away from light)
• 	A “Keep out of reach of children” statement
9. 	Disposal Instructions
FDA recommends that disposal instructions be described under the following heading:
Disposing of [Insert Drug Name]
For example, FDA recommends that the heading for this section of the IFU for the fictitious drug
product MYDRUG appear as follows:
Disposing of MYDRUG
Generally, FDA recommends including this heading only when there are specific disposal
instructions to prevent the risk of unintended exposure to or harm from products (for example,
certain transdermal systems). Under this heading, FDA recommends that, where appropriate, the
IFU explain how to dispose of the drug product when it is no longer needed, has expired, or is
otherwise unusable.
Content that FDA recommends be placed under this heading includes, but is not limited to, the
following:
• 	For items that present a risk of needle stick injury or infection (for example, auto-
injectors, pens, syringes), this section should include the appropriate safe sharps disposal
language.27
• 	For drug products that require special disposal procedures (for example, outpatient
chemotherapeutic drug products, drug products on FDA’s flush list28), this section should
provide specific information for patients on how to appropriately dispose of these drug
products.
27 Appropriate language to include for safe sharps disposal is available at www.fda.gov/safesharpsdisposal.
28 Information concerning how to safely dispose of unused or expired medicine is available at
https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know.

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10. 	Additional Information
At the bottom of the last page of the IFU, FDA recommends that the following information be
placed in the order listed below:
(1) 	Resources for additional information on the product, if applicable (for example, a
telephone number that patients can call to speak with a customer service
representative, a telephone number for more product information and to report
problems with the product, and/or a telephone number to report adverse reactions
to FDA).
(2) 	For products marketed under an NDA or ANDA, include the name and place of
business of the manufacturer, packer, and/or distributor.29
(3) 	For products marketed under a BLA, include the name, address, and license
number of the manufacturer (and may include the distributor).30
(4) 	On the last line of the IFU, include the following:
a. 	The verbatim statement, written as follows:
This Instructions for Use has been approved by the U.S. Food and Drug
Administration.
b. 	The verbatim statement is followed by the:
(1) month and year of initial FDA approval of the IFU (for example,
Approved: May 2023)
or
(2) month and year of the subsequent revision to the IFU (for example,
Revised: December 2023).
IV. 	FORMAT
The following formatting recommendations are intended to make the IFU easier for patients to
read and to help them use prescription drug products safely and effectively (Buck 1998; Koo et
al. 2003).
29 21 CFR 201.1 and 201.100(e) provide additional information about labeling and about including this information.
30 21 CFR 610, subpart G, provides additional information about labeling and about including this information.

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A. 	Typeface Styling Recommendations
1. 	Font and Font Size
FDA recommends using a sans-serif font for all text in the IFU because sans serif is easier to
read than a serif type font (American Foundation for the Blind 2020). Recommended sans-serif
fonts include, but are not limited to, Verdana and Arial. FDA recommends against the use of any
reverse type (such as white or neutral color type on a darker color background), lightface,
shading, highlighting, condensed type, or narrow fonts. These techniques can make reading
more difficult for patients (Raynor and Dickinson 2009).
Recommendations on font size are intended for easier readability (Buck 1998). Overall, FDA
recommends that the font size be no smaller than 10 points (1 point equals 0.0138 inches) for any
section of the IFU, except that FDA recommends the following sections or terminology appear in
font no smaller than 8 points:
• 	For products marketed under an NDA or ANDA, the name and place of business of
the manufacturer, packer, and/or distributor.
• 	For products marketed under a BLA, the name, address, and license number of the
manufacturer (and, if included, the distributor).
• 	The verbatim statement: This Instructions for Use has been approved by the U.S.
Food and Drug Administration.
• 	The month and year of initial FDA approval or revision of the IFU.
2. 	Letter Case
FDA recommends that the title INSTRUCTIONS FOR USE appear in all uppercase letters.
FDA also recommends that the letter case of the proprietary name or nonproprietary name used
in the body of the IFU (excluding the IFU product title) match its appearance in the PI. All other
headings in the IFU are recommended to appear in title case. FDA suggests avoiding the use of
words or phrases with all uppercase letters in the body of the IFU. The abundant use of
uppercased text is difficult to read (Hoffmann and Worrall 2004) and may detract from the
prominence of terms that should appear in uppercase text in the IFU.
3. 	Bold, Italicized, or Underlined Text
FDA recommends that the following information appear in bold type: INSTRUCTIONS FOR
USE; product title (including drug name(s), pronunciation spelling, dosage form, and route
of administration, and (when applicable) the controlled substance symbol); headings; step
numbers; and figure titles. Bolded headings can help patients find information quickly and
easily (Raynor and Dickinson 2009). However, FDA suggests that bolding, italicizing, and
underlining in the body of the IFU be used sparingly and be limited to important phrases or

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concepts (for example, important information for patients to know before using the drug product,
such as For oral use only).
B. 	Page Layout and Design Recommendations
1. 	Step-by-Step Instructions
FDA recommends that instructions be sequentially numbered, with each step heading appearing
in bold type and noted as Step 1, Step 2, etc. FDA also recommends using continuous
numbering throughout the document. For example, FDA suggests avoiding more than one
instance of Step 1.
The Agency recommends that action-oriented instruction appear before any supporting
information particular to performing a step. The Agency also suggests that supporting
information appear in bulleted text on a separate line immediately following the corresponding
step.
For example:
Step 4. Check the liquid by looking through the viewing window (Figure F).
• 	The liquid should be yellow and should have no lumps or particles.
• 	You may see air bubbles. This is normal.
If a patient needs to skip a specific step or set of steps that are not necessary for each dose, FDA
recommends that the IFU refer the patient to the next appropriate step. If a patient needs to
repeat a step or steps, FDA recommends that, if appropriate, the IFU refer the patient back to the
listed step or steps (for example, “Repeat Steps 10 to 13 a second time, then continue to Step
14”).
For example:
Step 6. Close your eye for one minute and gently press at the corner of that eye nearest
your nose.
Step 7. If you have been instructed by your health care provider to use drops in both
eyes, repeat Steps 3 to 6 in the other eye. If not, continue to Step 8.
2. 	Visuals for Step-by-Step Instructions
Visuals help patients comprehend instructions (Wolf et al. 2010). Visuals can be useful for
action tasks and informational text that help a patient understand and safely prepare, administer,
store, or dispose of the drug product. FDA recommends that visuals be easy to understand; be of
adequate size to allow patients to see the focal point; and demonstrate one concept, single idea,

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or point of information. Photographs can be compelling because they show the most accurate
visual representation of a product. However, in some instances, the use of line drawings and
sketch illustrations may be most helpful to simplify complexities and highlight key components
or avoid distracting details.
FDA recommends that visuals be placed immediately adjacent to the related instructional step.
The Agency also recommends that visuals be labeled alphabetically in bold type (such as Figure
A, Figure B, etc.). Steps with corresponding figures are recommended to reference the
appropriate figure or figures at the end of the step.
For example:
Step 10. Attach the needle to the pen (see Figure G).
Figure G
3. 	Spacing
FDA recommends that the IFU maintain a sufficient balance of text, visuals, and white space.
White space can be used carefully to keep the document from appearing cramped,
overwhelming, or too spread out (for example, at a minimum, FDA recommends adding a single
line before each heading). For ease of reading, FDA suggests using white space or blocks of text
to separate concepts and to indicate change. Additionally, consider increasing the amount of
white space around important text and visuals for emphasis.
4. 	Color
FDA recommends that the IFU be presented in black type on a white background to facilitate
readability. This combination maximizes contrast and legibility and also facilitates uniform
reprinting of the document. Colored text and visuals may be useful as long as all text and visuals
maintain clarity and remain legible when the IFU is printed in black and white or in grayscale.
Visual corresponding to
Step 10

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REFERENCES
American Foundation for the Blind, Guidelines for Prescription Labeling and Consumer
Medication Information for People With Vision Loss, A Collaborative Project of American
Society of Consultant Pharmacists Foundation and American Foundation for the Blind, available
at https://www.afb.org/blindness-and-low-vision/your-rights/rx-label-enable-
campaign/guidelines-prescription-labeling (accessed July 12, 2022).
Buck ML, 1998, Providing Patients With Written Medication Information, Ann Pharmacother,
32 (9):962–969, https://doi.org/10.1345/aph.17455.
Cowburn, G and L Stockley, 2005, Consumer Understanding and Use of Nutrition Labelling: 	A
Systematic Review, Public Health Nutrition, 8(1): 21–28, https://doi.org/10.1079/PHN2004666.
Hoffmann, T and L Worrall, 2004, Designing Effective Written Health Education Materials:
Considerations for Health Professionals, Disabil Rehabil, 26(19):1166–1173,
https://dx.doi.org/10.1080/09638280410001724816.
Koo, MM, I Krass, and P Aslani, 2003, Factors Influencing Consumer Use of Written Drug
Information, Ann Pharmacother, 37(2):259–267, https://doi.org/10.1177/106002800303700218.
Kools, M, RA Ruiter, MWJ van de Wiel, G Kok, 2008, The Effects of Headings in Information
Mapping on Search Speed and Evaluation of a Brief Health Education Text, Journal of
Information Science, 34(6):833–844, https://doi.org/10.1177/0165551508089719.
Lorch Jr, RF, EP Lorch, K Ritchey, L McGovern, D Coleman, 2001, Effects of Headings on
Text Summarization, Contemporary Educational Psychology, 26(2):171–191,
https://doi.org/10.1006/ceps.1999.1037.
Raynor, DK and D Dickinson, 2009, Key Principles to Guide Development of Consumer
Medicine Information—Content Analysis of Information Design Texts, Ann Pharmacother,
43(4):700–706, https://doi.org/10.1345/aph.1L522.
Wolf, MS, TC Davis, PF Bass, LM Curtis, LA Lindquist, JA Webb, MV Bocchini, SC Bailey,
RM Parker, 2010, Improving Prescription Drug Warnings to Promote Patient Comprehension,
Arch Intern Med, 170(1):50–56, doi: 10.1001/archinternmed.2009.454.

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APPENDIX: INSTRUCTIONS FOR USE —
RECOMMENDED ORDER OF INFORMATION
Numbers in parentheses correspond to items 1 through 10 in Section III.B, Specific Content
Recommendations, of the guidance. The main body of this guidance contains detailed
information about each item. This example is for a drug that is not a biological product.
(1) INSTRUCTIONS FOR USE
(2) [Insert Product Title]
(3) This Instructions for Use contains information on how to [insert applicable action verba] [Insert Drug
Nameb]
(4) [Insert visual of drug product]
(5) Important Information You Need to Know Before [Insert Applicable Action Verbc] [Insert Drug
Name]
(6) Preparing to [Insert Applicable Action Verbd [Insert Drug Name]
(7) [Insert Applicable Action Verbe] [Insert Drug Name]
(8) Storing [Insert Drug Name]
(9) Disposing of [Insert Drug Name]
(10) [At the bottom of the last page of the IFU, insert resources for additional information on how to use
the drug product (for example, a telephone number that patients can call to speak with a customer service
representative)]
[Insert name and place of business of manufacturer, packer, and/or distributor of drug product]
This Instructions for Use has been approved by the U.S. Food and Drug Administration. 	Approved: [insert Month Year]
or
Revised: [insert Month Year]
a Insert the appropriate action verb as determined by the product’s dosage form; for example, “take” (oral products),
“use” (inhalation, ear or eye products), “inject” (injectable products), “apply” (topical or transdermal products), or
“insert” (suppositories).
b Drug Name is the proprietary name (if any) or the nonproprietary name of the drug product.
c Insert the appropriate action verb ending in “ing” as determined by the product’s dosage form; for example,
“taking” (oral products), “using” (inhalation, ear or eye products), “injecting” (injectable products), “applying”
(topical or transdermal products), or “inserting” (suppositories).
d See footnote a.
e Insert the appropriate action verb ending in “ing” concerning administration as determined by the product’s dosage
form; for example, “taking” (oral products), “using” (inhalation, ear or eye products), “injecting” (injectable
products), “applying” (topical or transdermal products), or “inserting” (suppositories).