Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

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Patient Counseling Information
Section of 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
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
December 2014
Labeling

Patient Counseling Information
Section of 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
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: druginfo@fda.hhs.gov
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
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
Phone: 800-835-4709 or 240-402-7800
Email: ocod@fda.hhs.gov
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
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)
December 2014
Labeling

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TABLE OF CONTENTS
I. 	INTRODUCTION............................................................................................................. 1
II. 	BACKGROUND ............................................................................................................... 2
III. 	CONTENT ......................................................................................................................... 3
A. 	Reference to FDA-Approved Patient Labeling ........................................................................... 3
B. 	Counseling Topics .......................................................................................................................... 4
1. Presentation of the Information ....................................................................................................... 4
2. Types of Information to Consider for Inclusion ............................................................................... 5
C. 	Information Not to Include ........................................................................................................... 8
IV. 	FORMAT ........................................................................................................................... 9
A. 	Subheadings .................................................................................................................................... 9
B. 	Cross-Referencing .......................................................................................................................... 9
C. 	Appending FDA-Approved Patient Labeling .............................................................................. 9

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Patient Counseling Information Section of Labeling for Human
Prescription Drug and Biological Products —
Content and Format
Guidance for Industry1
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes
and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate
number listed on the title page of this guidance.
I. 	INTRODUCTION
This guidance is intended to assist applicants in developing the PATIENT COUNSELING
INFORMATION section of labeling required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). 2
The recommendations in this guidance are intended to help ensure that this section of labeling is
clear, useful, informative, and to the extent possible, consistent in content and format.
This guidance is intended to assist applicants with the following:
• 	How to decide what topics to include in the PATIENT COUNSELING INFORMATION
section
• 	How to present information in the PATIENT COUNSELING INFORMATION section
• 	How to organize the PATIENT COUNSELING INFORMATION section
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s 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 guidances means that something is suggested or
recommended, but not required.
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 This guidance applies to drugs, including biological products. For the purposes of this guidance, drug product or
drug will be used to refer to human prescription drug and biological products that are regulated as drugs.

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II. 	BACKGROUND
On January 24, 2006, FDA published a final rule that amended the requirements for the content
and format of labeling for human prescription drug and biological products (commonly referred
to as the physician labeling rule (PLR)).3 This rule created a new required section in labeling
entitled PATIENT COUNSELING INFORMATION (§ 201.57(c)(18)). The PATIENT
COUNSELING INFORMATION section summarizes the information that a health care provider
should convey to a patient (or caregiver when applicable) when a counseling discussion is taking
place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge
instructions at a hospital, or a pharmacist conveying information at a pharmacy). Under
§ 201.57(c)(18), the PATIENT COUNSELING INFORMATION section of labeling must
contain the following:
• Information necessary for patients to use the drug safely and effectively.
• If applicable, reference to FDA-approved patient labeling; the full text of such patient
labeling must be reprinted immediately following the full prescribing information (FPI)
or, alternatively, accompany the prescribing information.
Before FDA published the final rule, labeling regulations required that any information
necessary for patients to use the drug safely and effectively be presented under Information for
Patients, a subsection of the PRECAUTIONS section of old format labeling.4 By requiring a
dedicated section for such information in the PLR format, FDA recognized the importance of
health care providers’ counseling of patients. As labeling in the old format is converted to the
PLR format in accordance with the implementation schedule under 21 CFR 201.56(c), applicants
with labeling that did not include an Information for Patients subsection must develop a
PATIENT COUNSELING INFORMATION section unless the section is clearly inapplicable
and omitted under § 201.56(d)(4) (21 CFR 201.56(d)(4)) (see section III of this guidance).
Because regulatory requirements for the PATIENT COUNSELING INFORMATION section are
broadly worded and many different presentations have been used in labeling approved in PLR
format, this guidance seeks to (1) provide recommendations on how to select information to
include and (2) bring greater consistency to the content and format of the PATIENT
COUNSELING INFORMATION section.
3 See the final rule “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological
Products” (71 FR 3922, January 24, 2006). This rule is commonly referred to as the physician labeling rule (PLR)
because it addresses prescription drug labeling that is used by prescribers and other health care professionals. The
requirements are found at 21 CFR 201.56 and 201.57.
4 Prescription drug products not described under § 201.56(b)(1) are not subject to § 201.57(c)(18), but are subject to
21 CFR 201.80(f)(2) addressing the Information for Patients subsection. The term old format refers to labeling that
meets the requirements at 21 CFR 201.56(e) and 201.80.

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III. 	CONTENT
The PATIENT COUNSELING INFORMATION section is written for use by a health care
provider to identify topics for a counseling discussion with the patient. Therefore, the content
and presentation of information in the PATIENT COUNSELING INFORMATION section
typically will differ from those in FDA-approved patient labeling (e.g., Patient Package Inserts,
Medication Guides, and Instructions for Use). The PATIENT COUNSELING INFORMATION
section should contain the most important information for providers to convey to patients for the
safe and effective use of a drug. Consequently, all topics presented in the PATIENT
COUNSELING INFORMATION section should typically be included in any FDA-approved
patient labeling. Information in the PATIENT COUNSELING INFORMATION section and any
FDA-approved patient labeling, along with the provider-patient conversation, are essential and
complementary components for the safe and effective use of prescription drugs.
The intent of the PATIENT COUNSELING INFORMATION section is to identify topics for
counseling discussions between health care providers and patients after a prescribing decision
has been made. Other sections of the labeling contain the detailed information used by
prescribers to fully assess the risks and benefits of a drug for an individual patient.
The PATIENT COUNSELING INFORMATION section is required in all labeling subject to
§ 201.57, including for drugs used in an inpatient setting or other health care setting, such as a
clinic or a physician’s office. In extremely rare circumstances, the section may be omitted if its
inclusion would be clearly inapplicable (e.g., labeling for standard intravenous fluids) as allowed
under§ 201.56(d)(4).
Requirements and recommendations for the content of the PATIENT COUNSELING
INFORMATION section are presented below in sections III.A through C.
A. 	Reference to FDA-Approved Patient Labeling
Under § 201.57(c)(18), if a product has FDA-approved patient labeling (e.g., Patient Package
Insert, Medication Guide, and Instructions for Use), such labeling must be referenced in the
PATIENT COUNSELING INFORMATION section. The reference to patient labeling informs
health care providers of the existence of approved patient labeling and should direct them to
advise patients to read such labeling.
The reference statement should appear first in the PATIENT COUNSELING INFORMATION
section and identify the type(s) of FDA-approved patient labeling. Recommended language for
the reference statement includes:
• 	Advise the patient to read the FDA-approved patient labeling (Patient Information).5
• 	Advise the patient to read the FDA-approved patient labeling (Instructions for Use).
5 In this reference statement, Patient Information is used instead of Patient Package Insert because Patient
Information more clearly identifies the purpose of and audience for the information and is generally used as the title
of the FDA-approved patient labeling that is appended to the end of the FPI.

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• 	Advise the patient to read the FDA-approved patient labeling (Patient Information and
Instructions for Use).
• 	Advise the patient to read the FDA-approved patient labeling (Medication Guide).
• 	Advise the patient to read the FDA-approved patient labeling (Medication Guide and
Instructions for Use).
If counseling for a particular product is typically directed to a caregiver rather than the patient,
the statements can be modified accordingly.
B. 	Counseling Topics
Information in the PATIENT COUNSELING INFORMATION section typically focuses on
major risks of the drug and, when appropriate, how the patient may mitigate or manage these
risks. This section should also include, when appropriate, other patient-focused information
relevant for providers to convey, such as critical administration instructions or unique storage
and handling instructions. In addition, there may be other information that is important for the
health care provider to convey to the patient, such as a common drug effect that does not pose a
risk to patients but could be important because it may be worrisome or potentially affect
compliance (e.g., cough from the use of angiotensin-converting enzyme inhibitors).
Not every risk discussed in labeling will always be included in the PATIENT COUNSELING
INFORMATION section, and those present in the PATIENT COUNSELING INFORMATION
section will typically be serious or otherwise clinically significant. Only those topics critical for
safe and effective use of the drug and appropriate for a provider-patient discussion should be
included. These would typically include the most important risks about which patients should be
informed and those for which a patient may need to do something actionable (e.g., contact the
prescriber, immediately discontinue the drug, or seek emergency medical care). Topics
presented elsewhere in labeling that provide information relevant only for the prescriber or other
health care provider should typically not appear in the PATIENT COUNSELING
INFORMATION section. Examples include information pertinent to proper patient selection, an
explanation of the interpretation of laboratory results, or issues related to proper drug
administration in an inpatient setting.
1. 	Presentation of the Information
The PATIENT COUNSELING INFORMATION section should summarize each topic to
facilitate discussion between a health care provider and a patient and should include the level of
detail appropriate for a counseling discussion. This focus and level of detail is typically not the
same as the discussion of the related topic or risk described elsewhere in the FPI. The
information in the PATIENT COUNSELING INFORMATION section should not be presented
simply as a list of risks from use of the drug, nor should the information be a repeat of entire
paragraphs from elsewhere in the labeling. Only in very rare instances will an entirely new

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concept be included in the PATIENT COUNSELING INFORMATION section that does not
have a related discussion elsewhere in labeling.
Consistent with the approach used for other sections of labeling (e.g., BOXED WARNING,
WARNINGS AND PRECAUTIONS), information in the PATIENT COUNSELING
INFORMATION section should be ordered by the relative clinical significance of the
information, with the most important topics applicable to the patient appearing first. For this
reason the topics presented may or may not reflect the order in which they first appear overall in
the FPI (i.e., within the PATIENT COUNSELING INFORMATION section, a topic from the
WARNINGS AND PRECAUTIONS section may appear before a topic from the DOSAGE
AND ADMINISTRATION section).
Information in the PATIENT COUNSELING INFORMATION section should typically be
presented using active voice (e.g., “Advise the patient to…”) rather than passive voice (e.g.,
“Patients should be advised to…”) to provide clearer directives to the reader.
2. 	Types of Information to Consider for Inclusion
a. 	Important adverse reactions and other risks
The PATIENT COUNSELING INFORMATION section summarizes important adverse
reactions and other risks to convey to patients. Information should typically include, as
appropriate, the identification of the risk, management recommendations that are pertinent to
patients, self-monitoring information, and information on when to contact a health care provider,
seek emergency help, or discontinue the drug. For example:
Serious Allergic Reactions
Advise the patient to discontinue DRUG-X and seek immediate medical attention
if any signs or symptoms of a hypersensitivity reaction occur [see Warnings and
Precautions (5.X)].
A listing of the most common adverse reactions should not be included in the PATIENT
COUNSELING INFORMATION section. However, an individual common adverse reaction
should be included if it is among the most important adverse reactions applicable to the patient
(e.g., appears in WARNINGS AND PRECAUTIONS) or the risk of its occurrence is important
to convey to a patient (e.g., urine discoloration from use of rifampin).
b. 	Contraindications
Although contraindications are essential for informing prescribing decisions, most are typically
not appropriate for a patient counseling discussion that occurs once a prescribing decision has
been made. Some contraindications, however, may warrant inclusion in the PATIENT
COUNSELING INFORMATION section for conditions that may develop after starting drug
therapy (e.g., development of an acute infection).

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c. 	Drug interactions
Interactions or effects from other drugs or foods should be included in the PATIENT
COUNSELING INFORMATION section if they concern an important risk (e.g., are mentioned
in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS AND PRECAUTIONS
sections). Additionally, an interaction should be included if coadministration could be initiated
by the patient (e.g., an interaction with food or an over-the-counter drug or dietary supplement).
A complete listing of known drug interactions should typically not be included in the PATIENT
COUNSELING INFORMATION section because the decision to coadminister two prescription
drugs generally rests with the provider at the time of prescribing.
In rare cases, a drug may have multiple serious drug interactions (e.g., warfarin or certain
antiretroviral drugs) that would warrant a broadly worded recommendation in the PATIENT
COUNSELING INFORMATION section to inform patients of the overall risk. A cross-
reference would direct the health care provider to the more detailed discussion elsewhere in
labeling.
d. 	Information on use in pediatric patients, pregnancy, and lactation
Consistent with the approach taken for drug interactions, include a discussion of the risks of a
drug in pediatric patients, pregnancy, or during lactation should be included in the PATIENT
COUNSELING INFORMATION section if the information concerns an important risk (e.g., is
mentioned in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS AND
PRECAUTIONS sections). If the drug has no such risk, general advice on the use of drugs in
pediatric patients or during pregnancy or lactation (e.g., “Advise a female patient to inform the
prescriber if she is pregnant or planning to become pregnant”) should not be included in the
PATIENT COUNSELING INFORMATION section (see Section III.C. Information Not to
Include).
Additionally, if there is a pregnancy exposure registry mentioned in the Pregnancy subsection of
the USE IN SPECIFIC POPULATIONS section, the availability of the registry should be
included in the PATIENT COUNSELING INFORMATION section, with a cross-reference to
the Pregnancy subsection where the contact information necessary to enroll may be found.
e. 	Information on preparation and administration
Full details on proper preparation and administration of a drug should typically appear in the
DOSAGE AND ADMINISTRATION section, whereas the PATIENT COUNSELING
INFORMATION section should summarize the most important points relevant to a counseling
conversation. For example:
Importance of Second Application
Inform the patient that the second application of DRUG-X is necessary to kill any
live lice that hatch following the initial treatment [see Dosage and Administration
(2.X)].

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In general, the PATIENT COUNSELING INFORMATION section should not include typical
dosage regimen information (e.g., instructions to take one 30 mg tablet every 12 hours) for drugs
that are self-administered by the patient. However, pertinent advice on how to self-administer
should be briefly summarized if there are specific instructions for administration that need to be
followed so that the drug is used safely and effectively. Specific information may include
instructions to take the drug with a high-fat meal or on an atypical dosing schedule (e.g., tapered
dosing of prednisone). For example:
Administration Instructions
Advise the patient to swallow DRUG-X capsules intact and not to open, chew, or
crush the capsules. Inform the patient that the nonabsorbable DRUG-X capsule
shell may be visible in the stool.
If a product has FDA-approved patient labeling that includes details on self-administration (e.g.,
Instructions for Use), the detailed information should not be repeated verbatim in the PATIENT
COUNSELING INFORMATION section. The reference statement appearing at the beginning
of the PATIENT COUNSELING INFORMATION section directs health care providers to
advise patients to read the FDA-approved patient labeling.
For self-administered injectable drugs, information regarding proper sharps disposal will
typically be included in the FDA-approved Instructions for Use. The PATIENT COUNSELING
INFORMATION section should include a statement directing providers to advise patients to
follow sharps disposal recommendations,6 but should not summarize or repeat the information
found in the Instructions for Use.
f. 	Products with restricted distribution as a component of a Risk Evaluation
and Mitigation Strategies (REMS) program
Reference the to the existence of a REMS program that includes restricted distribution should be
included in the PATIENT COUNSELING INFORMATION section along with a brief
description of only those program elements that directly impact the patient (e.g., a requirement to
enroll in the program or the availability of the drug only from pharmacies participating in the
program). If no elements of restricted distribution directly impact patients, information
regarding the REMS program should not appear in the PATIENT COUNSELING
INFORMATION section.
g. 	Instructions related to storage and handling
In rare cases, there may be important, atypical storage or handling information appropriate for a
provider-patient discussion that should be included in the PATIENT COUNSELING
INFORMATION section. For example:
6 Information about safe disposal of needles and other sharps outside of health care settings is available on the
Internet at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/
Sharps/default.htm.

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Handling Instructions
Advise the patient that females of reproductive potential should not handle broken
or crushed DRUG-X tablets because DRUG-X may cause harm to a male fetus
[see Warnings and Precautions (5.X)].
As with preparation and administration instructions, the same topics may be discussed in the
PATIENT COUNSELING INFORMATION section, the HOW SUPPLIED/STORAGE AND
HANDLING section, and in the FDA-approved patient labeling regarding proper storage and
handling, but the focus of the discussion should reflect the intent of the section of labeling in
which the information resides.
h. 	Additional requirements
Certain products have additional, specific requirements for the PATIENT COUNSELING
INFORMATION section based on the product’s therapeutic or pharmacologic class (e.g., 21
CFR 201.24(d) for systemic antibacterial drug products).
C. 	Information Not to Include
Not all information related to use of a drug should be included in the PATIENT COUNSELING
INFORMATION section. The PATIENT COUNSELING INFORMATION section is intended
to facilitate the provider-patient discussion, but is not intended to serve as a script for the
provider.
Examples of information that should generally not be included in the PATIENT
COUNSELING INFORMATION section include the following:
• 	Indication or use of a drug
• 	General recommendations lacking context that would be considered a standard
component of any provider-patient discussion (e.g., “Discuss the risks and benefits of
DRUG-X”)
• 	General advice that could apply to any drug (e.g., “Instruct the patient to keep
DRUG-X out of reach of children”) unless particularly relevant for an individual
product (e.g., the need to keep opioid-containing patches away from children and
pets)
• 	Information that informs prescribing decisions (e.g., “DRUG-X is contraindicated in
patients with a history of thromboembolic events”)
• 	Routine administration or storage and handling information that would typically be
conveyed to the patient at the time of dispensing (e.g., the need to shake an oral
suspension before use or to store it in the refrigerator at home)

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• 	Definitions or descriptions of medical terminology (e.g., a listing of signs and
symptoms of neuroleptic malignant syndrome, a potential serious adverse reaction
from the use of antipsychotic drugs) that need not be explained to a health care
provider audience
• 	Graphics (e.g., illustrations or pictures related to administration)
IV. 	FORMAT
The PATIENT COUNSELING INFORMATION section is subject to the applicable formatting
requirements under §§ 201.56(d) and 201.57(d). Additional recommendations are presented
below in sections IV.A through C.
A. 	Subheadings
Following the required reference to any FDA-approved patient labeling, information in the
PATIENT COUNSELING INFORMATION section should be presented in a consistent format
that enhances its readability and usefulness. The use of subheadings to organize and differentiate
topics within the PATIENT COUNSELING INFORMATION section is recommended because
they allow the reader to quickly identify the major concepts. Subheading titles should clearly
identify the focus of each discussion (e.g., Acute Hepatic Failure rather than simply Hepatic),
and a consistent formatting of the subheading titles (e.g., underlining or italicizing) is
recommended.
Because the content presented about each topic is generally one or two short statements,
numbered subsections (e.g., 17.1, 17.2) are typically unnecessary and are not recommended.
Moreover, numbered subsections cause unnecessary length and clutter in both the PATIENT
COUNSELING INFORMATION and in Contents (§ 201.57(b)) and may be redundant with
subsection titles elsewhere in the labeling (e.g., the WARNINGS AND PRECAUTIONS
section).
B. 	Cross-Referencing
Because information under the PATIENT COUNSELING INFORMATION section typically
summarizes information presented elsewhere in the labeling, cross-referencing should be used to
direct the reader to the more detailed discussion. If, however, the other section of the labeling
where the related topic is discussed contains no more information than appears in the PATIENT
COUNSELING INFORMATION section, no cross-reference is necessary.
C. 	Appending FDA-Approved Patient Labeling
If FDA-approved patient labeling immediately follows the FPI, the FDA-approved patient
labeling should not be assigned a subsection number and should instead be separated from the
FPI by other formatting techniques (e.g., a horizontal line or page break).