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 
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Silver Spring, MD 20993  
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Email: druginfo@fda.hhs.gov  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
and/or 
 
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 Food and Drug Administration 
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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 
 
  Contains Nonbinding Recommendations 
 
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 
i 
  Contains Nonbinding Recommendations 
 
Patient Counseling Information Section of Labeling for Human 
Prescription Drug and Biological Products   
Content and Format 
 
1
Guidance for Industry  
 
 
This guidance represents the Food and Drug Administrations (FDAs) 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 
 
FDAs guidance documents, including this guidance, 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 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.   
  1  Contains Nonbinding Recommendations 
 
 
 
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. 
  2  Contains Nonbinding Recommendations 
 
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 physicians 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.   
  3  Contains Nonbinding Recommendations 
 
 
  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 
  4  Contains Nonbinding Recommendations 
 
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).   
 
  5  Contains Nonbinding Recommendations 
 
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)]. 
 
  6  Contains Nonbinding Recommendations 
 
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.  
  7  Contains Nonbinding Recommendations 
 
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 products 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) 
 
  8  Contains Nonbinding Recommendations 
 
  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). 
 
 
  9