REMS DOCUMENT 
TECHNICAL CONFORMANCE GUIDE 
 
Technical Specifications Document 
 
 
 
 
 
 
 
This document is incorporated by reference into the following Guidance Document: 
 
Format and Content of a REMS Document 
 
 
 
For questions regarding this technical specifications document, contact CDER at 
OSE.PMKTREGS@fda.hhs.gov or CBER at the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
3128, Silver Spring, MD 20993-0002, 1-800-835-4709 or 240-402-8010, ocod@fda.hhs.gov.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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)  
 
January 2023 
 
   
 
 
 
 
REMS DOCUMENT 
TECHNICAL CONFORMANCE GUIDE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
January 2023 
 
 
  Contains Nonbinding Recommendations 
 
 
Revision History 
Date  Version  Summary of Revisions 
January 2023  1.0  Initial Version 
     
     
     
     
     
     
 
   
 
  Contains Nonbinding Recommendations 
 
Table of Contents 
 
1.   INTRODUCTION........................................................................................................... 40  
1.1.   Background .................................................................................................................................. 40  
1.2.   Purpose ......................................................................................................................................... 41  
1.3.   Document Revision Control ........................................................................................................ 41  
1.4.   Relationship to Other Documents ..............................................................................................41  
1.5.   Document Organization  .............................................................................................................. 42  
2.   GENERAL INSTRUCTIONS FOR DRAFTING A REMS DOCUMENT .............. 42  
3.   GENERAL INSTRUCTIONS FOR DRAFTING A BIFURCATED REMS 
DOCUMENT................................................................................................................... 42  
4.   RELATED REFERENCES .......................................................................................... 43  
5.  APPENDICES ................................................................................................................. 43  
 
 
 
  Contains Nonbinding Recommendations 
 
REMS DOCUMENT 
TECHNICAL CONFORMANCE GUIDE1  
 
This document represents the current thinking of the Food and Drug Administration (FDA or Agency). 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 staff responsible for implementing this guidance at OSE.PMKTREGS@fda.hhs.gov  
or CBER at the Office of Communication, Outreach and Development, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 
20993-0002, 1-800-835-4709 or 240-402-8010, ocod@fda.hhs.gov.   
 
 
1.   INTRODUCTION 
1.1.   Background 
This Risk Evaluation and Mitigation Strategy (REMS) Document Technical Conformance Guide (Guide) 
provides updated, detailed instructions on the format of a REMS Document, along with standardized 
language that describes common REMS requirements2  for applicants to use whenever possible, to help 
ensure consistency and facilitate efficient review of the REMS Document. This Guide supports submission 
of a REMS Document in Structured Product Labeling (SPL) format. In addition, this Guide provides an 
outline to assist applicants in drafting a Bifurcated3 REMS Document. 
 
This Guide supplements the guidance for industry Format and Content of a REMS Document (Month 
YEAR). 
 
A REMS Document establishes the goals and requirements of the REMS as they relate to the required 
REMS elements. 
 
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. 
 
1 This  guidance has been  prepared by the Division of Risk  Management in the Center for Drug Evaluation and Research in  
cooperation with Center for Biologics Evaluation and Research at the Food and Drug Administration. You may submit comments on  
this guidance at any time. Submit comments to Docket No. FDA-2018-D-1216  (available at 
https://www.regulations.gov/docket?D=FDA-2018-D-1216) (see the instructions  for submitting comments in the docket). [Note: The 
docket number in this footnote is intended for general comments related to technical specifications.  It is not for comments specific to 
documents or issues that are  the subject of other dockets, or for comments specific to electronic submission guidances.] 
2 Section 505-1  of the Federal Food, Drug, and Cosmetic Act (21  U.S.C. 355-1) 
3 A Bifurcated REMS Document is used when the approval of a shared system REMS may coincide with tentative approval  of an  
ANDA or section 505(b)(2) application. For more information, refer to  the revised draft guidance for industry  Development of a 
Shared System REMS  (June  2018).  When final, this guidance will represent FDAs current thinking on this topic.  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. 
 
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  Contains Nonbinding Recommendations 
 
 
1.2.  Purpose 
This Guide provides technical recommendations to applicants for the purposes of drafting a REMS 
Document. 
 
This Guide is intended to complement and promote interactions between applicants and the FDA. However, 
it is not intended to replace the need for applicants to communicate directly with review staff regarding 
implementation approaches or issues relating to their REMS. The use of these templates is expected to 
improve efficiency of the review process for REMS.  
 
1.3.  Document Revision Control 
In the Federal Register of October 12, 2017 (82 FR 47529), FDA issued notice announcing the availability 
of the revised draft guidance for industry Format and Content of a REMS Document, which included a 
template for the REMS Document as an appendix for public comment on its contents. The REMS 
Document template is now part of this Guide. Future revisions will be posted directly on FDAs REMS 
website (https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/roles-different-
participants-rems), and the revision history page of this document will contain information to indicate which 
sections of the Guide have been revised. 
 
1.4.  Relationship to Other Documents 
 
This Guide should be considered a companion document to the following:  
   Guidance for industry Format and Content of a REMS Document (January 2023) 
   Guidance for industry Development of a Shared System REMS (June 2018)  
   Guidance for industry Providing Regulatory Submissions in Electronic Format  Content of the 
Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling Format 
(December 2020)  
   Guidance for industry Risk Evaluation and Mitigation Strategies: Modifications and Revisions (June 
2020) 
   Draft Guidance for industry Use of a Drug Master File (DMF) for Shared System REMS 
Submissions (November 2017)4  
   Technical Conformance Guide for Shared System REMS Drug Master File Submissions (the SSR 
DMF Technical Conformance Guide) 
   Technical Specifications Document, Structured Product Labeling (SPL) Implementation Guide with 
Validation Procedures (May 2018) 
   REMS SPL Sample (accessible at https://www.fda.gov/industry/fda-data-standards-advisory-
board/structured-product-labeling-resources) 
   Related REMS SPL Terminology web pages: 
o   Document Type including Content of Labeling Type (available at 
https://www.fda.gov/industry/structured-product-labeling-resources/document-type-
including-content-labeling-type) 
o   REMS Approval (accessible at https://www.fda.gov/industry/structured-product-labeling-
available
resources/rems-approval) 
 
4 When final, this guidance will represent FDAs current thinking on this topic. 
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  Contains Nonbinding Recommendations 
 
o   REMS Protocol (accessible at https://www.fda.gov/industry/structured-product-labeling-
resources/rems-protocol)    
o   REMS Requirements (accessible at  https://www.fda.gov/industry/structured-product-
available
labeling-resources/rems-requirements) 
o   REMS Stakeholder (accessible at https://www.fda.gov/industry/structured-product-labeling-
resources/rems-stakeholder) 
 
1.5.  Document Organization 
 
This Guide contains instructions that are specific to the REMS Document as well as instructions that are 
specific to a Bifurcated REMS Document. 
 
Section 2: General instructions for drafting a REMS Document  
 
Section 3: General instructions for drafting a Bifurcated REMS Document  
 
Appendices: Detailed template and outline for drafting a REMS Document and Bifurcated REMS  
Document 
 
2.   GENERAL INSTRUCTIONS FOR DRAFTING A REMS DOCUMENT  
 
The REMS Document template includes six sections: (I) Administrative Information, (II) REMS Goals, (III) 
REMS Requirements, (IV) REMS Assessment Timetable, (V) REMS Materials, and (VI) Statutory Elements. 
Depending on the REMS requirements, an approved REMS Document will include the appropriate sections and 
text, as applicable, and can include up to six sections. 
 
The margins of the document should be set at narrow providing a half inch margin at the top, bottom, and 
sides. The header should be Verdana font size 14, bold. The body text style should be Verdana font size 10.  
 
3.   GENERAL INSTRUCTIONS FOR DRAFTING A BIFURCATED REMS 
DOCUMENT 
 
A Bifurcated REMS Document is used when the approval of a shared system REMS may coincide with 
tentative approval of an ANDA or section 505(b)(2) application. Tentative approval for an ANDA or section 
505(b)(2) application is a notification to an applicant that an application meets the requirements for approval, 
but cannot be approved because of unexpired patents or exclusivity.5  In such cases, it would not be appropriate 
for the shared system REMS to be operational yet, because the product proposed in the ANDA or section 
505(b)(2) application could not yet be on the market.6  For more information, refer to the guidance for 
industry Development of a Shared System REMS (June 2018).  
  
A Bifurcated REMS is a single REMS Document consisting of two parts:   
 
 
5 Section 505(j)(5)(B)(iv)(II)(dd)(AA) of the Federal Food,  Drug, and Cosmetic Act (21 U.S.C.  355(j)(5)(B)(iv)(II)(dd)(AA));  21  CFR  
314.3(b) and 314.107. 
6 Bifurcated REMS  for a biosimilar product and reference product will be  handled  on an individual case basis. 
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  Contains Nonbinding Recommendations 
 
Part A: The currently approved REMS for the applicable listed drug, which remains in effect until the first 
ANDA that references the reference listed drug or section 505(b)(2) application that relies upon 
the listed drug receives full approval, and 
  
Part B: The Shared System REMS, which is implemented upon full approval of the first ANDA that 
references the reference listed drug or section 505(b)(2) application that relies upon the listed 
drug.    
 
The Bifurcated REMS Document Outline provides the framework for the format, structure, and main headings  
that should be included in a Bifurcated REMS Document. The outline should be used in conjunction with the 
REMS Document Template which provides more detailed information about the specific requirements and 
templated text.  
 
4.   RELATED REFERENCES 
 
1.   Guidance for industry Formant and Content of a REMS Document (Month Year) 
 
2.   Guidance for industry Development of a Shared System REMS (June 2018) 
 
3.   Guidance for industry Providing Regulatory Submissions in Electronic Format  Content of the Risk 
Evaluation and Mitigation Strategies Document Using Structured Product Labeling Format (December 
2020) 
 
4.   Guidance for industry Risk Evaluation and Mitigation Strategies: Modifications and Revisions (June 2020) 
 
5.   Draft guidance for industry Use of a Drug Master File for Shared System REMS Submissions (November 
2017) 
 
6.   Technical Conformance Guide for Shared System REMS Drug Master File Submissions (the SSR DMF 
Technical Conformance Guide) (November 2017) 
 
7.   Technical Specifications Document, Structured Product Labeling (SPL) Implementation Guide with 
Validation Procedures (May 2018) 
 
8.   REMS SPL Sample (accessible at https://www.fda.gov/industry/fda-data-standards-advisory-
board/structured-product-labeling-resources)) 
 
9.   REMS SPL Resources (accessible at  https://www.fda.gov/industry/structured-product-labeling-
available
resources/risk-evaluation-and-mitigation-strategies-rems-spl-resources) 
 
5.  APPENDICES  
 
Appendix A: REMS Document Template  
Appendix B: Bifurcated REMS Document Outline 
 
 
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  Contains Nonbinding Recommendations 
 
Appendix A: REMS Document Template  
 
Risk Evaluation and Mitigation Strategy (REMS) Document 
[PROPRIETARY7 (established/proper name)] or 
[Established/Proper/Class Name] [Shared System] REMS 
The REMS  Document template  has six sections: (I) Administrative Information, (II) REMS  
Goals, (III) REMS Requirements, (IV) REMS Assessment Timetable, (V) REMS Materials, and 
(VI) Statutory Elements. Depending on the REMS requirements, the REMS Document  will  
include sections and text, as applicable.  
 
  
   
Template Key  
  Red Text  = Instructions  
Black Text  = Standardized text  
 
Blue text with hyperlink  = Name of REMS  Material(s)  
  [Bracketed (blue or black) text]  = Information that needs to be entered 
 
Formatting and Style Key  
  Document margins = Narrow (0.5 top, bottom, left, and right) 
Header Style  = Verdana font size 14, bold    
 
Body Text Style = Verdana font size 10   
   
Additional style and formatting instructions, as applicable, are included 
 
in sections  below  
 
I.   Administrative Information 
Retain  the  text that apply  to your  REMS and delete the text that does not apply. 
Risk: [risk REMS is designed to address.  Use  the term consistent  with how the risk is  
described in labeling. If  this  REMS addresses more than one risk, list the risks in the same 
order that they appear in the Goals  section.] 
Application Number(s): NDA/BLA [application number(s)] Use  this only for single-applicant  
REMS. Add (and Authorized Generic) after the corresponding NDA number.   
Application Holder: [applicant name] Use this only for single-applicant REMS.  
Initial [Shared System]  REMS Approval: [MM/YYYY]  
Most Recent REMS Update: [MM/YYYY] Enter the date of the most recent REMS Revision or 
approved Modification.  If there are no updates since the initial approval, delete  the text.  
 
II.   REMS Goal(s) 
This section describes the overall,  safety-related health outcome that the REMS is designed  
to achieve (e.g., mitigate the risk of a particular serious adverse event) and the specific,  
 
7 [PROPRIETARY NAME] includes [list the dosage  forms] and applicable authorized generics.  
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  Contains Nonbinding Recommendations 
 
measurable objectives. In many cases, it is not possible to measure a risk mitigation goal 
directly; therefore, it  is important to include one or more specific, measurable objectives 
that, if achieved, indicate that the REMS is meeting its goal(s).  
 
[Overall REMS goal] 
1.   [REMS objective]  
2.   [Other REMS objectives, as needed] 
 
III.   REMS Requirements 
This section describes the REMS requirements  for the applicant, including requirements that 
the applicant must  undertake directly and requirements that the applicant must ensure that  
REMS participants undertake. REMS participants can include prescribers, dispensers, health 
care settings, patients (or their guardians), and wholesalers/distributors.  
The REMS Requirements section is  divided into two subsections. These subsections are 
labeled  A and B in the template.  
A. REMS Participant Requirements  describes the requirements that REMS Participants 
must undertake. 
B. REMS Applicant Requirements describes  requirements for applicants to develop  
training, communications, systems, and processes to support REMS operations and 
compliance.  
Standardized text for the most commonly used REMS requirements is included in  each 
subsection  in black text. Whenever possible, use the standardized text provided in the 
template. If you modify from the template text, you should provide a  justification for doing 
so to facilitate FDA review.  
Retain the subsections that apply to  your REMS  and delete the subsections that do not 
apply.   
The participants should appear in the order that they interact with the REMS.  Because the 
patient does not initiate involvement in the REMS, the patient section should  not be the first  
participant section.  
If there are different requirements  for different patient populations (e.g., pediatric), repeat 
this subsection for each population, and modify the header accordingly. With-in each 
subsection: 
   Select the REMS requirements that apply to your REMS and delete the REMS 
requirements that do not apply 
   If a particular REMS requirement applies only to a subset of patients (e.g., patients 
who can get pregnant),  use the following format for the requirement:   
For [subset to which the requirement applies]: [Requirement]  
Example:  For patients who can get pregnant: Counsel the patient on  pregnancy  
prevention  
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  Contains Nonbinding Recommendations 
 
   Some REMS requirements have multiple  versions to describe the different ways the 
requirement can be carried out (e.g.,  with or without using a REMS  material).  The 
different versions of the requirement appear in black text, separated by the word  
OR in red  text. Select  the appropriate version from the choices provided and delete 
the version(s) that  does not apply to your REMS.   
------------------------------------------Start Subsection A--------------------------------- 
REMS Participant Requirements  
This subsection describes the requirements that each REMS participant needs to undertake 
and that the applicant must ensure REMS participants comply with.  
The information in this subsection is organized  by REMS participant. There is a separate 
table for each participant that  includes the following  information:  
 
1.   [REMS Participant]  
[Timing Category]    1.   [REMS Requirement] using [REMS  Material]  
2.   [REMS Requirement]   
[Timing Category]   3.   [REMS Requirement]  
 
[REMS Participant]  = who (which participant) needs to complete the REMS Requirement(s)  
[REMS Requirement]  = what the REMS participant is required to do  
[Timing Category] = when the participant must carry out the requirement  
[REMS Material] = with  what REMS  material the participants need to use to carry out a 
requirement. Titles of REMS materials are included as a hyperlink within  
the requirement text.  
Style and Formatting  Instructions for REMS Participant tables: 
   Gray border lines:  
o   Add gray horizontal border lines to the REMS Participant header to begin each  
table 
o   Add a gray horizontal border line to separate each  time category  to ensure  
requirements are aligned with  the appropriate time category 
   Numbering throughout the section:  
o   Restart numbering when beginning a new REMS  Participant Table 
o   Use continuous numbering throughout all the timing categories for each REMS  
Participant Table   
When listing the REMS materials,  do not include the name of the REMS in  the title of the 
material. For example, use Prescriber  Enrollment Form instead of Drug X REMS Prescriber  
Enrollment Form.   
If there are no requirements that a particular REMS participant has to  carry out to comply  
with the REMS, delete the table for that participant.  
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  Contains Nonbinding Recommendations 
 
If there are no requirements that REMS participants have  to carry out to comply  with the 
REMS, delete subsection A. For example, if the  REMS only includes requirements that the 
applicant has to carry out, such as developing and disseminating REMS communications to 
health care providers, delete subsection A. 
[Applicant] must ensure that [List the participants  who have requirements under this REMS in the 
order they appear in this section e.g., health care providers/health  care  
settings/patients/pharmacies/wholesalers-distributors] comply with the following  
requirements: 
1.   Health care providers who prescribe [proprietary/established/proper/class name] must:  
To become certified to  1.   Be able  to [clinical activity to be performed].  
prescribe   Include this requirement if the prescriber has to have  the ability to  
Include this timing category  carry out a particular activity, such as administer a particular 
if there are  requirements  treatment, diagnose  a particular disease, or recognize a particular  
that the health care provider   adverse event.   
must complete to be  able to  2.   Review the drugs  Prescribing  Information.  
prescribe  Note that the  Prescribing Information is not a REMS Material.  
  3.   Review the following: [List the Prescriber Educational Material(s)]. 
Include this requirement if the health care  provider is required to  
review certain educational materials that are provided as part of  the 
REMS.  
4.   Take training provided  by [entity providing the training, e.g., a CE  
provider, live or instructor led training by the REMS]. 
     OR  
Take the [REMS Material] training provided by the [entity  providing 
the training, e.g., live or instructor led training  by the REMS]. 
5.   Successfully complete the [Knowledge Assessment] and submit it to 
the REMS.  
6.   Enroll by completing and submitting the [Enrollment Form] to the 
REMS. 
Before treatment initiation   7.   Counsel the patient on  [topic(s)].  
([at specified interval]  or  Include this requirement if the health care  provider is required to  
[first dose])    counsel the patient. The provider may be required to cover a 
Include this timing category  particular topic, use a particular REMS material (e.g., counseling  
if there are  requirements  tool, Medication Guide), or both.  
that the health care provider   OR  
must complete with a   Counsel the patient using [REMS Material]. 
patient, before the patient   OR  
initiates treatment   Counsel the patient on  [topic(s)] using  [REMS Material]. 
OR  
Counsel the patient on  [topic(s)] using  [REMS Material]. Provide a 
copy of the material to the patient.  
8.   Assess the patients [condition(s) or health status(es)].   
Include this requirement if there is monitoring  and/or a particular  
lab test that must take  place (e.g., pregnancy test that  needs to 
take place before each prescription). Repeat this requirement, as  
needed, to address multiple  health conditions  and/or lab tests.  
OR  
Assess the patients [condition(s) or health status(es)].  Document 
and submit  [the results] to the REMS using [REMS Material(s)]. 
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1.   Health care providers who prescribe [proprietary/established/proper/class name] must:  
OR  
Assess the patients [condition(s) or health status(es)] by [list lab 
test(s) or monitoring].  
OR  
Assess the patients [condition(s) or health status(es)] by [list lab 
test(s) or monitoring].  Document and submit [the results] to the 
REMS using  [REMS Material(s)]. 
9.   Assess the patient for [adverse event].   
Include this requirement if there is monitoring  for an adverse event 
that must take place (e.g., infusion reactions or anaphylaxis). 
Repeat this  requirement, as needed, to address multiple adverse 
events.  
OR  
Assess  the patient for [adverse event].  Document and submit [the  
results] to the REMS using [REMS Material(s)]. 
OR  
Assess the patient for [adverse  event] by [list lab test(s) or  
monitoring]. 
OR  
Assess the patient for [adverse  event] by [list lab test(s) or  
monitoring]. Document and submit [the results] to the REMS using 
[REMS Material(s)]. 
10. Complete the  [Patient Form]. Provide a completed copy of  the form 
to the patient.  
OR  
Complete the  [Patient Form]. Retain a completed copy  in the 
patients record.   
OR  
Complete the  [Patient Form]. Provide a completed copy of  the form 
to the patient and retain a copy in  the patients record.  
Include this requirement if there is a Patient Form that needs to be  
completed (e.g., a Patient-Provider Agreement Form), but that  is 
not required to be  submitted to the REMS (If the patients 
information is required to be submitted to the REMS, use 
requirement #11).   
11. Enroll the patient by completing and submitting the [applicable 
enrollment forms] [List all Enrollment Forms] to the REMS. 
OR  
Enroll the patient by completing and submitting the [applicable 
enrollment forms] [List all Enrollment Forms] to the REMS. Provide 
a completed copy of the form to the patient.  
OR  
Enroll the patient by completing and submitting the [applicable 
enrollment forms] [List all Enrollment Forms] to the REMS. Retain a 
completed copy in the patients record.   
Include this requirement if the Enrollment Form is required to be 
submitted to the REMS (If the patients  information is not required  
to be submitted to the REMS, use requirement #10). List  the 
applicable  Enrollment Forms if there are different Enrollment Forms  
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1.   Health care providers who prescribe [proprietary/established/proper/class name] must:  
for different patient populations (e.g., patients who can get  
pregnant).  
12. Provide the  patient [with the  [REMS Material(s)].  
Include this requirement if there are materials or an additional 
medication  that must be provided to a patient (e.g., Patient 
Brochure). Do not repeat materials that are provided to the patient  
as part of another requirement (e.g., see requirements  #7, #10, 
and #11).  
OR   
Provide the patient with [additional medication prescription]. 
13. Order the prescription using the [Prescription Order Form]. Include 
this requirement only when there is a separate  Prescription Order  
Form that is not part of  another REMS form, such as a Patient 
Enrollment Form, that the prescriber must use.  
14. Prescribe no more than a [# of days] days supply.  
15. Not prescribe refills.  
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During treatment,  before  16. Counsel the patient on  [topic(s)].  
each  Include this requirement if the health care  provider is required to  
[dose/infusion/prescription]   counsel the patient. The provider may be required to cover a 
Include this timing category  particular topic, use a particular  REMS material (e.g., a counseling  
if there are  requirements  tool, a Medication Guide), or both.  
that the health care provider   OR  
must complete with the  Counsel the patient using [REMS Material]. 
patient, before each dose,  OR  
infusion, or prescription   Counsel the patient on  [topic(s)] using  [REMS Material]. 
OR  
Counsel the patient on  [topic(s)] using  [REMS Material]. Provide a 
copy of the material to the patient.  
17. Provide the patient with  [REMS Material]. 
Include this requirement if there are materials or an additional 
medication  that must be provided to a patient (e.g., Patient 
Brochure). Materials that are provided to the patient as part of 
another requirement (e.g., see requirements #7, #10, and #11) do 
not need to be repeated here.  
OR   
Provide the patient with [additional medication prescription]. 
18. Assess the patients [condition(s) or health status(es)].   
Include this requirement if there is monitoring  and/or a particular  
lab test that must take  place (e.g., pregnancy test that  needs to 
take place before each prescription). Repeat this requirement, as  
needed, to address multiple  health conditions  and/or lab tests.  
OR  
Assess the patients [condition(s) or health status(es)].  Document 
and submit  [the results] to the REMS using [REMS Material(s)]. 
OR  
Assess the patients [condition(s) or health status(es)] by [list lab 
test(s) or monitoring].  
OR  
Assess the patients [condition(s) or health status(es)] by [list lab 
test(s) or monitoring].  Document and submit [the results] to the 
REMS using  [REMS Material(s)]. 
19. Assess the patient for [adverse event].   
Include this requirement if there is monitoring  for an adverse event 
that must take place (e.g., infusion reactions or anaphylaxis). 
Repeat this  requirement, as needed, to address multiple adverse 
events.  
OR  
Assess  the patient for [adverse event].  Document and submit [the  
results] to the REMS using [REMS Material(s)]. 
OR  
Assess the patient for [adverse  event] by [list lab test(s) or  
monitoring]. 
OR  
Assess the patient for [adverse  event] by [list lab test(s) or  
monitoring].   Document and submit  [the  results] to the REMS using 
[REMS Material(s)]. 
20. Order the prescription using the [Prescription Order Form]. Include 
this requirement only when there is a separate  Prescription Order  
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1.   Health care providers who prescribe [proprietary/established/proper/class name] must:  
Form that is not part of  another REMS form, such as a Patient 
Enrollment Form, that the prescriber must use.  
21. Prescribe no more than a [# of days] days supply.  
22. Not prescribe refills.  
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During treatment, [at  23. Counsel the patient on  [topic(s)].  
specified interval]   Include this requirement if the health care  provider is required to  
Include this timing category  counsel the patient. The provider may be required to cover a 
if there are  requirements  particular topic, use a particular  REMS material (e.g., a counseling  
that the health care provider   tool, a Medication Guide), or both.  
must complete with the  OR  
patient at specified intervals  Counsel the patient using [REMS Material]. 
(i.e., not linked to the  OR  
time/a visit  that a  Counsel the patient on  [topic(s)] using  [REMS Material]. 
prescription is written)   OR  
Counsel the patient on  [topic(s)] using  [REMS Material]. Provide a 
copy of the material to the patient.  
24. Provide the  patient [with the  [REMS Material] 
Include this requirement if there are materials or an additional 
medication  that must be provided to a patient (e.g., Patient REMS 
Brochure). Materials that are provided to the patient as part of 
another requirement (e.g., see requirements #7, #10, and #11) do 
not need to be repeated here.  
OR   
Provide the patient with [additional medication prescription]. 
25. Assess the patients [condition(s) or health status(es)].   
Include this requirement if there is monitoring  and/or a particular  
lab test that must take  place (e.g., pregnancy test that  needs to 
take place before each prescription). Repeat this requirement, as  
needed, to address multiple  health conditions  and/or lab tests.  
OR  
Assess the patients [condition(s) or health status(es)].  Document 
and submit  [the results] to the REMS using [REMS Material(s)]. 
OR  
Assess the patients [condition(s) or health status(es)] by [list lab 
test(s) or monitoring].  
OR  
Assess the patients [condition(s) or health status(es)] by [list lab 
test(s) or monitoring].   Document and submit [the results] to the 
REMS using  [REMS Material(s)].    
26. Assess the patient for [adverse event].   
Include this requirement if there is monitoring  for an adverse event 
that must take place (e.g., infusion reactions or anaphylaxis). 
Repeat this  requirement, as needed, to address multiple adverse 
events.  
OR  
Assess  the patient for [adverse event].  Document and submit [the  
results] to the REMS using [REMS Material(s)]. 
OR  
Assess the patient for [adverse  event] by [list lab test(s) or  
monitoring]. 
OR  
Assess the patient for [adverse  event] by [list lab test(s) or  
monitoring].   Document and submit  [the  results] to the REMS using 
[REMS Material(s)]. 
 
52 
  Contains Nonbinding Recommendations 
 
1.   Health care providers who prescribe [proprietary/established/proper/class name] must:  
After treatment  27. Assess the patients [condition(s) or health status(es)].   
discontinuation, [at specified  Include this requirement if there is monitoring  and/or a particular  
interval] Include this timing  lab test that must take  place (e.g., pregnancy test that  needs to 
category if there are  take place). Repeat this requirement, as needed, to address 
requirements that the    multiple health conditions and/or lab tests.  
health care provider must  OR  
complete after the patient  Assess the patients [condition(s) or health status(es)].  Document 
has discontinued treatment   and submit  [the results] to the REMS using [REMS Material(s)]. 
OR  
Assess the patients [condition(s) or health status(es)] by [list lab 
test(s) or monitoring].  
OR  
Assess the patients [condition(s) or health status(es)] by [list lab 
test(s) or monitoring].  Document and submit [the results] to the 
REMS using  [REMS Material(s)]  
28. Assess the patient for [adverse event].   
Include this requirement if there is monitoring  for an adverse event 
that must take place (e.g., infusion reactions or anaphylaxis). 
Repeat this  requirement, as needed, to address multiple adverse 
events.  
OR  
Assess  the patient for [adverse event].  Document and submit [the  
results] to the REMS using [REMS Material(s)]. 
OR  
Assess the patient for [adverse  event] by [list lab test(s) or  
monitoring]. 
OR  
Assess the patient for [adverse  event] by [list lab test(s) or  
monitoring].   Document and submit  [the  results] to the REMS using 
[REMS Material(s)]. 
 
To maintain certification to  
29. Review the drugs  Prescribing  Information.  
prescribe, [at specified 
Note that the  Prescribing Information is not appended to  the REMS.  
interval, e.g., every  2 years]   
30. Review the following: [List the Educational Material(s)]. 
Include this timing category 
31. Successfully complete the [Knowledge Assessment] and submit it to 
if there are  requirements 
the REMS.  
that the health care provider  
32. Re-Enroll by completing and submitting the [Re-Enrollment Form] to 
must complete to be  able to 
the REMS.  
continue prescribing  
53 
  Contains Nonbinding Recommendations 
 
1.   Health care providers who prescribe [proprietary/established/proper/class name] must:  
At all times    33. Report [adverse event(s) of interest] to [the Manufacturer/the 
Include this timing category  REMS/MedWatch]. 
if there are  requirements  OR  
that the health care provider   Report [adverse  event(s) of interest] to the REMS using [REMS 
must complete on an  Material]. 
ongoing basis, as part of   34. Report [treatment discontinuation or transfer of care] to [the 
complying  with the REMS    Manufacturer/the REMS].  
OR 
Report [treatment discontinuation or transfer  of care] to the REMS 
using [REMS Material]. 
    Use this  requirement if a patient is no  longer under the      
    prescribers care or has discontinued treatment.  
35. Maintain records of [REMS activity].  
Include this requirement if there are records of certain REMS 
activities (e.g.,  records documenting staffs completion of  REMS  
training) that must be  maintained but are not submitted to the 
REMS. These records may be requested at any  time by the applicant 
or as part of a REMS audit.  
 
2.   Patients who are prescribed [proprietary/established/proper/class name]:  
Before treatment initiation    1.   Review the [List the Patient Material(s)]. 
OR   2.   Complete  [Patient Form] with the prescriber.  
Before treatment initiation,   Include this requirement if the patient form is not submitted to the 
[at specified interval]  REMS. If the form is submitted to the REMS, use requirement #3.  
Include this timing  3.   Enroll in the REMS by completing the [Enrollment Form] with  the  
category if there are  [prescriber/health care provider]. Enrollment  information will be  
requirements that the  provided to  the REMS.   
patient must complete  to  Include this requirement if the form must be submitted to the REMS.  
be able to initiate  Otherwise, use requirement #2.  
treatment   4.   Get [description of lab test].  
OR  
Be monitored for [description of monitoring].  
Include this requirement if the patient is required to have a lab test  
completed or to be monitored.  
5.   Receive counseling from the [prescriber/pharmacy/health care provider] 
on [topic(s)].  
OR  
Receive counseling from the [prescriber/pharmacy/health care provider] 
using [REMS Material]. 
OR  
Receive counseling from the [prescriber/pharmacy/health care provider] 
on [topic(s)] using  [REMS Material]. 
6.   Complete  [Patient Questionnaire].   
Include this requirement if there are questions that patients need to  
answer (e.g., monthly questionnaire to assess a patients  understanding 
of the drugs risks and  safe use conditions).   
54 
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2.   Patients who are prescribed [proprietary/established/proper/class name]:  
During treatment,  before each   7.   Receive counseling from the [prescriber/pharmacy/health care provider] 
[dose/infusion/prescription]   on [topic(s)].  
Include this timing category if there  OR  
are requirements that the patient  Receive counseling from the [prescriber/pharmacy/health care provider] 
must complete before receiving   using [REMS Material]. 
subsequent prescriptions   OR  
Receive counseling from the [prescriber/pharmacy/health care provider] 
on [topic(s)] using  [REMS Material]. 
8.   Get [description of lab test].  
OR  
Be monitored for [description of monitoring].  
Include this requirement if the patient is required to have a lab test  
completed or to be monitored.  
9.   Complete  [Patient Questionnaire].  
Include this requirement if there are questions that patients need to  
answer (e.g., monthly questionnaire to assess a patients  understanding 
of the drugs risks and  safe use conditions).  
During treatment    10.  Adhere to the safe use conditions: [safe use condition(s), e.g., use of  
Include this timing category if there  contraception].  
are requirements that the patient  OR 
must adhere to during  treatment  Adhere  to the safe  use conditions described in  the [Patient Educational 
(i.e., not linked to the time a   Material]. 
prescription is written)   OR 
Adhere to the safe use conditions: [safe use condition(s), e.g., use of  
contraception] described in the [Patient Educational Material]. 
11.  Get [description of lab test].  
OR  
Be monitored for [description of monitoring].  
Include this requirement if the patient is required to have a lab test  
completed or to be monitored.  
During treatment  after   12.  Get [description of lab test].  
administration  OR  
Include this timing category if there  Be monitored for [description of monitoring].  
are requirements that the patient  Include this requirement if the patient is required to have a lab test  
must complete at after  completed or to be monitored  
administration during treatment  
(i.e., not linked to the time a  
prescription is written)  
During treatment, [At specified  13.  Get [description of lab test].  
interval]   OR  
Include this timing category if there  Be monitored for [description of monitoring].  
are requirements that the patient  Include this requirement if the patient is required to have a lab test  
must complete at specified intervals  completed or to be monitored.   
during treatment (i.e.,  not linked to  
the time a prescription is written)  
55 
  Contains Nonbinding Recommendations 
 
2.   Patients who are prescribed [proprietary/established/proper/class name]:  
After treatment discontinuation,    14.  Get [description of lab test].  
[at specified interval]  OR  
Include this timing category if there  Be monitored for [description of monitoring].  
are requirements that the patient  Include this requirement if the patient is required to have a lab test  
must  complete after they  have   completed or to be monitored.  
discontinued treatment  
At all times   15.  Inform [prescriber/healthcare provider] [conditions under which  
Include this timing category if there  prescriber should be contacted]. 
are requirements that the patient  16.  Have [item] with you. 
must complete on an ongoing basis  Include this requirement if the patient is required to have on hand or 
under the REMS    carry with them a specific item or intervention  (e.g., wallet card, 
bracelet, emergency  treatment).  
 
3.   [Health care settings/prescribers/pharmacies]  that dispense [proprietary/established/ 
proper/class name] must:  
If there are different requirements  for different types of pharmacies and/or health  care settings (e.g., inpatient  
pharmacies vs. outpatient pharmacy) repeat this table for each type of pharmacy and/or health care setting.  
To become certified to dispense    1.   Be able  to [clinical activity to be performed].  
Include this timing category if there  Include this requirement if the dispenser has to have  the ability to carry 
are requirements that  the dispenser  out a particular activity, such as administer a particular treatment.  
must complete to be  able to  2.   Have [personnel with specific training/experience and/or specific 
dispense   equipment] on-site.  
  OR 
Have the  following on-site: [personnel  with specific training/experience 
and/or specific equipment]  
Include this requirement if the health care  setting needs to have  
personnel with particular training or  particular medical equipment on-site.  
3.   Designate an authorized representative to carry out the certification  
process and oversee implementation and compliance with  the REMS on  
behalf of the [health care setting/pharmacy].  
Include this requirement if the health care  setting must designate an  
authorized representative to act on the health  care settings behalf.  
4.   Have the authorized representative  review the [List the Educational  
Material(s)]. 
Include this requirement if the authorized representative is  required to 
review certain educational materials that are provided as part of  the 
REMS.  
5.   Have the authorized representative  take training provided  by [entity 
providing the training,  e.g., a continuing  education provider, live or 
instructor led training by the REMS]. 
     OR  
Have the authorized representative  take the [REMS Material] training 
provided by the [entity  providing the training,  e.g., live or instructor led 
training by  the REMS]. 
56 
  Contains Nonbinding Recommendations 
 
3.   [Health care settings/prescribers/pharmacies]  that dispense [proprietary/established/ 
proper/class name] must:  
6.   Have the authorized representative  successfully complete the  [Knowledge 
Assessment] and submit it to the REMS.  
7.   Have the authorized representative  enroll by completing and submitting  
the [Enrollment Form] to the REMS.  
OR 
Have the authorized representative  enroll by completing and submitting  
the applicable enrollment form(s) to the REMS: [List all Enrollment 
Forms]. 
Use this version of the requirement if there are  different  enrollment forms 
for different types of settings (e.g., inpatient vs. outpatient pharmacy,  
chain vs. independent pharmacy).  
8.   Train all relevant staff involved in [activity] on  [training topic(s)].  
OR  
Train all relevant staff involved in [activity] using [REMS Material(s)]. 
OR  
Train all relevant staff involved in [activity] on  [training topic(s)] using 
[REMS Material(s)]. 
9.   Establish processes and procedures to verify [safe use conditions to be  
met].  
Include this requirement if the dispenser  is responsible for setting  up  their  
own system to verify that safe use conditions have been met. If  
requirement #9 is included, also include requirement #13  to verify that 
safe use conditions have been met before dispensing.  
10. Establish processes and procedures to [e.g., notify, provide] [safe use 
conditions to be met].   
Include this requirement if the dispenser is responsible for setting up 
their own system to carry out safe use conditions beyond verification. If 
requirement #10 is included, also include a corresponding  requirement 
to carry out the safe use conditions.  
57 
  Contains Nonbinding Recommendations 
 
3.   [Health care settings/prescribers/pharmacies]  that dispense [proprietary/established/ 
proper/class name] must:  
 Before dispensing    11.  Counsel the patient on  [topic(s)].  
Include this timing category if there  Include this requirement if the health care  provider is required to counsel  
are requirements that  the dispenser  the patient. The provider may be required to cover a particular topic, use 
must complete before dispensing   a particular REMS material (e.g., a  counseling tool, a Medication Guide), 
or both.  
OR  
Counsel the patient using [REMS Material]. 
OR 
Counsel the patient on  [topic(s)] using  [REMS Material]. 
OR  
Counsel the patient on  [topic(s)] using  [REMS Material]. Provide a copy 
of the material to the patient.  
12. Provide the patient with  [REMS Material]. 
Include this requirement if there are materials or an additional medication 
that must be provided to a patient (e.g., Patient REMS Brochure, 
Medication Guide).   
OR   
Provide the patient with [additional medication prescription]. 
13. Verify [safe use conditions to be met] through the processes and 
procedures  established  as a requirement of the REMS.   
OR 
Verify and document  [safe use conditions to be met] through the 
processes and procedures established as a requirement of the REMS.  
Include this requirement if the dispenser must  verify that safe use 
conditions have been met before dispensing and must use systems 
established through requirement #9.  
14. Notify [safe use conditions to be met] through the processes and 
procedures  established  as a requirement of the REMS.  
15. Provide [safe use conditions to be  met] through the processes and  
procedures  established  as a requirement of the REMS.  
16. Obtain authorization to dispense  each prescription by contacting the 
REMS  to verify [safe use condition to be met].   
Include this requirement if the dispenser must  obtain authorization from  
the REMS to dispense the drug.  
17. Dispense no more than  a [# of days] days supply.  
18. Not dispense refills.  
19. Not dispense [dose(s) e.g., first dose] outside [type of facility]. 
58 
  Contains Nonbinding Recommendations 
 
3.   [Health care settings/prescribers/pharmacies]  that dispense [proprietary/established/ 
proper/class name] must:  
After dispensing   20. Assess the patients [condition(s) or health status(es)].   
Include this timing category if there  Include this requirement if there is monitoring  and/or a particular lab test  
are requirements that  the dispenser  that  must  take place (e.g., pregnancy test that needs to take place before  
must complete after dispensing   each prescription). Repeat this requirement, as needed, to address  
multiple health conditions and/or lab tests.  
OR  
Assess the patients [condition(s) or health status(es)].   Document and 
submit [the results]  to the REMS using  [REMS Material(s)]. 
OR  
Assess the patients [condition(s) or health status(es)] by [list lab test(s)  
or monitoring].  
OR  
Assess the patients [condition(s) or health status(es)] by [list lab test(s)  
or monitoring]. Document and submit [the results] to the REMS using 
[REMS Material(s)]. 
21. Assess the patient for [adverse event].   
Include this requirement if there is monitoring  for an adverse event that 
must  take place  (e.g., infusion reactions or anaphylaxis).  Repeat  this 
requirement, as needed, to address multiple adverse events.  
OR  
Assess  the patient for [adverse event].  Document and submit [the  
results] to the REMS using [REMS Material(s)]. 
OR  
Assess the patient for [adverse event] by [list lab test(s) or monitoring].  
OR  
Assess the patient for [adverse event] by [list lab test(s) or monitoring]. 
Document and submit [the results] to the REMS using  [REMS Material(s)]. 
 
59 
  Contains Nonbinding Recommendations 
 
3.   [Health care settings/prescribers/pharmacies]  that dispense [proprietary/established/ 
proper/class name] must:  
Before administering   22. Counsel the patient on  [topic(s)].  
For drugs administered by a health   Include this requirement if the health care  provider is required to counsel  
care provider: Include this timing   the patient. The provider may be required to cover a particular topic, use 
category if there are requirements   a particular REMS material (e.g., a  counseling tool, a Medication Guide), 
that the health care provider must   or both.  
complete before the drug is   OR  
administered   Counsel the patient using [REMS Material]. 
OR 
Counsel the patient on  [topic(s)] using  [REMS Material]. 
OR  
Counsel the patient on  [topic(s)] using  [REMS Material]. Provide a copy of  
the material to the patient.  
23. Provide the patient with  [REMS Material]. 
Include this requirement if there are materials or an additional medication 
that must be provided to a patient (e.g., Patient Brochure, Medication  
Guide).   
OR   
Provide the patient with [additional medication prescription]. 
24. Assess the patients [condition(s) or health status(es)].   
Include this requirement if there is monitoring  and/or a particular lab test  
that  must  take place (e.g., pregnancy test that needs to take place before  
each prescription). Repeat this requirement, as needed, to address  
multiple health conditions and/or lab tests.  
OR  
Assess the patients [condition(s) or health status(es)].   Document and 
submit [the results]  to the REMS using  [REMS Material(s)]. 
OR  
Assess the patients [condition(s) or health status(es)] by [list lab test(s)  
or monitoring].  
OR  
Assess the patients [condition(s) or health status(es)] by [list lab test(s)  
or monitoring]. Document and submit [the results] to the REMS using 
[REMS Material(s)]. 
25. Assess the patient for [adverse event].   
Include this requirement if there is monitoring  for an adverse event that 
must  take place  (e.g., infusion reactions or anaphylaxis).  Repeat  this 
requirement, as needed, to address multiple adverse events.  
OR  
Assess  the patient for [adverse event].  Document and submit [the  
results] to the REMS using [REMS Material(s)]. 
OR  
Assess the patient for [adverse event] by [list lab test(s) or monitoring].  
OR  
Assess the patient for [adverse event] by [list lab test(s) or monitoring]. 
Document and submit [the results] to the REMS using  [REMS Material(s)]. 
 
60 
  Contains Nonbinding Recommendations 
 
3.   [Health care settings/prescribers/pharmacies]  that dispense [proprietary/established/ 
proper/class name] must:  
During and after administering,    26. Assess the patients [condition(s) or health status(es)].   
[at specified interval]  Include this requirement if there is monitoring  and/or a particular lab test  
Include this timing category if there  that  must  take place (e.g., pregnancy test that needs to take place before  
are requirements that  the health   each prescription). Repeat this requirement, as needed, to address  
care provider must complete during  multiple health conditions and/or lab tests.  
and after the drug is administered   OR  
Assess the patients [condition(s) or health status(es)].   Document and 
submit [the results]  to the REMS using  [REMS Material(s)]. 
OR  
Assess the patients [condition(s) or health status(es)] by [list lab test(s)  
or monitoring].  
OR  
Assess the patients [condition(s) or health status(es)] by [list lab test(s)  
or monitoring].   Document and submit [the results] to the REMS using 
[REMS Material(s)]. 
27. Assess the patient for [adverse event].   
Include this requirement if there is monitoring  for an adverse event that 
must  take place  (e.g., infusion reactions or anaphylaxis).  Repeat  this 
requirement, as needed, to address multiple adverse events.  
OR  
Assess  the patient for [adverse event].  Document and submit [the  
results] to the REMS using [REMS Material(s)]. 
OR  
Assess the patient for [adverse event] by [list lab test(s) or monitoring].  
OR  
Assess the patient for [adverse event] by [list lab test(s) or monitoring].  
Document and submit [the results] to the REMS using  [REMS Material(s)]. 
61 
  Contains Nonbinding Recommendations 
 
3.   [Health care settings/prescribers/pharmacies]  that dispense [proprietary/established/ 
proper/class name] must:  
     
After administering, [at specified   28. Assess the patients [condition(s) or health status(es)].   
interval]  Include this requirement if there is monitoring  and/or a particular lab test  
Include this timing category if there  that  must  take place (e.g., pregnancy test that needs to take place before  
are requirements that  the health   each prescription). Repeat this requirement, as needed, to address  
care provider must complete after  multiple health conditions and/or lab tests.  
the drug is  administered   OR  
Assess the patients [condition(s) or health status(es)].   Document and 
submit [the results]  to the REMS using  [REMS Material(s)]. 
OR  
Assess the patients [condition(s) or health status(es)] by [list lab test(s)  
or monitoring].  
OR  
Assess the patients [condition(s) or health status(es)] by [list lab test(s)  
or monitoring].   Document and submit [the results] to the REMS using 
[REMS Material(s)]. 
29. Assess the patient for [adverse event].   
Include this requirement if there is monitoring  for an adverse event that 
must  take place  (e.g., infusion reactions or anaphylaxis).  Repeat  this 
requirement, as needed, to address multiple adverse events.  
OR  
Assess  the patient for [adverse event].  Document and submit [the  
results] to the REMS using [REMS Material(s)]. 
OR  
Assess the patient for [adverse event] by [list lab test(s) or monitoring].  
OR  
Assess the patient for [adverse event] by [list lab test(s) or monitoring].  
Document and submit [the results] to the REMS using  [REMS Material(s)]. 
At discharge  30. Provide the patient with  [REMS Material]. 
Include this timing category  Include this requirement if there are materials or an additional medication 
if there are  requirements  that must be provided to a patient (e.g., Patient REMS Brochure, 
that the health care provider   Medication Guide).   
must complete when the  OR   
patient is discharged   Provide the patient with [additional medication prescription]. 
31. Dispense no more than  a [# of days] days supply.  
 
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  Contains Nonbinding Recommendations 
 
3.   [Health care settings/prescribers/pharmacies]  that dispense [proprietary/established/ 
proper/class name] must:  
To maintain certification to   32. Have the authorized representative  review the [List the Educational  
dispense, [at specified interval,   Material(s)]. 
e.g., every 2 years]   Include this requirement if the authorized representative is  required to 
Include this timing category if there  review certain educational materials that are provided as part of  the 
are requirements that  the dispenser  REMS.  
must complete to be  able to  33. Have the authorized representative  successfully complete the  [Knowledge 
continue dispensing   Assessment] and submit it to the REMS.  
 
34. Have the authorized representative  re-enroll by completing and 
submitting the [Re-Enrollment Form] to the REMS. 
OR 
Have the authorized representative  re-enroll by completing and 
submitting the applicable  form(s) to the REMS: [List all Re-Enrollment 
Forms]. 
Use this version of the requirement if there are  different  enrollment forms 
for different types of settings (e.g., inpatient vs. outpatient pharmacy,  
chain vs. independent pharmacy).  
35. Have  a new authorized representative enroll by  completing  and 
submitting the applicable form [Enrollment Form], if the authorized  
representative changes to the REMS. 
     Include  this requirement if the pharmacy designates a  new authorized  
representative.  
At all times   36. Report [adverse event(s) of interest] to [the Manufacturer/the REMS 
Include this timing category if there  /MedWatch]. 
are requirements that  the dispenser  OR 
must complete on an ongoing basis  Report [adverse  event(s) of interest] to the REMS using [REMS Form]. 
as part of complying with the REMS  37. Return unused  product to [the manufacturer]. 
38. Not distribute, transfer, loan, or sell [proprietary/established/ 
proper/class name].  
OR  
Not distribute, transfer, loan, or sell [proprietary/established/ 
proper/class name], except to certified dispensers.  
39. Maintain records of [activity].  
Include this requirement if there are records of certain REMS activities 
(e.g., records of staffs completion of REMS training, all processes and 
procedures  and compliance with those processes and procedures) that  
must be maintained but are not submitted to the REMS. These records 
may be requested by the applicant or as part of a REMS audit.  
OR  
Maintain and submit records of [activity] to [the REMS/Manufacturer].  
40. Comply with audits carried out by [Entity to conduct audit, e.g., applicant 
or third party acting on behalf of the applicant] to ensure that all 
processes and procedures are in place and are being followed.   
Include this requirement if the REMS participant has to agree to be 
audited.  
 
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  Contains Nonbinding Recommendations 
 
 
4.   Wholesalers-distributors that distribute [proprietary/established/proper/class name] must:  
To be able to distribute   1.   Establish processes and procedures to ensure that the drug is distributed  
Include this timing category if  only to certified [setting(s)].  
there are requirements  that the 2.   Train all relevant staff involved in [activity] on  [topic(s)].  
wholesalers-distributors must    
complete to be  able to  distribute  
At all times    3.   Distribute only to certified [setting(s)].  
Include this timing category if  4.   Maintain records of [activity].   
there are requirements  that the  Include this requirement if there are records of certain REMS activities 
wholesalers-distributors must   (e.g., records of drug distribution, all processes and procedures and  
complete on an ongoing basis as  compliance with those processes and procedures) that must be maintained  
part of complying with the REMS   but are not submitted to the REMS. These records may be requested by 
the applicant or as part of a REMS audit.  
OR 
Maintain and submit records of [activity] to [the REMS/manufacturer].  
Include this requirement if there are records of certain REMS activities 
(e.g., records of drug distribution) that must be maintained and submitted 
to the REMS.  
5.   Comply with audits carried out by [Entity to conduct audit, e.g., applicant 
or third party acting on behalf of the applicant] to ensure that all 
processes and procedures are in place and are being followed.   
Include this requirement if the wholesaler-distributor is required to comply 
with audits of their activities under the  REMS.  
------------------------------------------End Subsection A----------------------------------------- 
------------------------------------------Start Subsection B-------------------------------------- 
REMS Applicant Requirements  
This subsection describes requirements for applicants to develop and  make available REMS training; 
develop and provide packaging and disposal systems; develop and disseminate REMS  communications 
materials; develop systems and processes to support REMS operations; and ensure participants  
compliance  with the REMS. 
 
REMS Training  
The requirements under this header relate to the requirement for the applicant to develop REMS training 
and provide to health care providers. REMS training requirements might also include the requirement for 
the applicant to develop a knowledge assessment for health care providers.  
The REMS training requirements include information about how  the training is being provided (e.g.,  
website, mailing,  in-person) and whether the training is being provided by a third party (such as a  
Continuing  Education (CE) provider). The REMS training section may  also include whether the applicant is  
required to provide funding for training.  
If there are no requirements for the applicant to develop and make available REMS  training, delete the 
requirements under this heading.  
 
[Applicant] must provide training to health care providers who prescribe [proprietary/ 
established/proper/class name].  
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The training includes the following  educational material(s):  [Educational Material(s)]. The training must be  
[describe  how training will be provided, e.g., available on  a website, delivered by the applicant or 
accredited CE  providers].  
[Applicant] must provide training to [health care settings/prescribers/pharmacies] that 
dispense [proprietary/established/proper/class name].  
The training includes the following  educational material(s):  [Educational Material(s)]. The training must be  
[describe how training will be provided,  e.g., available on  a website, delivered by the applicant or 
accredited CE  providers].  
 
REMS Packaging and Disposal  
The requirements under this header relate to the requirement for the applicant to make a drug available 
for dispensing in packaging (e.g., unit dose) or implement a requirement that a disposal system be  
dispensed. 
If there are no packaging and/or disposal requirements for the applicant to implement, delete the 
requirements under this heading.  
 
REMS Communications  
The requirements under this header support the development and dissemination of REMS communication 
materials to health care providers and professional organizations or societies. If  there are no requirements  
for the applicant to disseminate REMS communications, delete the requirements  under this heading.   
 
The table below describes  who should receive the  REMS communication materials,  what materials they  
should receive, as well  as how,  when, and how often they should receive the materials. The table includes 
the following information:  
 
Target Audience: The target audience is the particular group of health care providers that are the 
intended recipients of a REMS communication. For each target audience, include a description of the 
audience.  Include an additional row for each  distinct audience. 
Communication Materials: The communication  materials are intended to  disseminate information 
about the REMS (e.g., REMS Letter for Health  Care Providers and for Professional  Societies, REMS  Fact 
Sheets, Journal information piece, and REMS Slides).   
Dissemination Plan:  The dissemination plan  describes how the communication materials will be  
distributed (e.g.,  via  e-mail), the timing (e.g., start, end, how frequent),  and whether  there is any 
follow-up required. Include additional distribution plans if  a given material is distributed in multiple  
ways.  
 
To inform health care providers about the REMS  and the risks and safe use of 
[proprietary/established/proper/class name], [Applicant] must disseminate REMS  
communication materials according to the table below:  
Target Audience    Communication Materials & Dissemination Plans    
[Target Audience]   [Communication Material(s)]   
     [Dissemination Plan  1]  
   [Dissemination Plan  2]  
Health care  providers   Include Communication Materials that apply to this REMS and delete those 
likely to prescribe  that do not apply. Under each REMS communication, include dissemination 
[proprietary/established/   methods that apply to  this REMS and delete  those that do not apply:  
proper/class name]   REMS Letter(s): [Health care  Provider REMS Letter] [with attachment(s) 
  REMS material(s)], [Professional Society REMS Letter] [with  attachment(s)  
REMS material(s)]  
1.   Mail within  [X] calendar days of the [date [proprietary/established/  
proper/class name] is first commercially distributed/approval of the 
REMS modification] ([mm/dd/yyyy]) and again [X] months  later.    
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Target Audience    Communication Materials & Dissemination Plans    
a.   Send by mail within 30 calendar days of the [date 
[proprietary/established/proper/class  name] is first 
commercially distributed/approval  of the REMS modification] 
([mm/dd/yyyy]) if a health care providers  email address is not  
available or the email is undeliverable.  
b.   Send a second  email within 30 calendar days of the date  the 
first email was sent if the first email is  marked as unopened.   
c.   Send by mail within 30 calendar days of the date the second 
email was sent if the second email is marked as unopened.  
2.   Email within [X] calendar days of  the [date [proprietary/established/ 
proper/class name] is first commercially distributed/approval of the 
REMS modification] ([mm/dd/yyyy]) and again [X] months  later. If a 
health  care providers email address is not available, send by mail.  
a.   For emails that are undeliverable: send by mail within [X]  
calendar days of the [date [proprietary/established/proper/class 
name] is first commercially distributed/approval of the REMS  
modification] ([mm/dd/yyyy]).    
b.   For first  emails marked unopened: send a second email within  
[X] calendar days of the date the first email was sent.  
c.   For second emails marked unopened: send by mail within [X] 
calendar days of the date the second email was sent. 
3.   Make available via a link from the [proprietary/established/proper/ 
class name] REMS Website. 
4.   Disseminate through [field-based sales and medical representatives]  
for [X] months from [the [date [proprietary/established/proper/class  
name] is first commercially distributed/approval of the REMS  
modification] ([mm/dd/yyyy]).  
5.   Disseminate  within [X] calendar days of the [date [proprietary/  
established/proper/class  name] is first commercially  
distributed/approval of  the REMS  modification] [(mm/dd/yyyy)] [and  
again [X] months later] through the following  professional societies 
and request the letter or content be provided to their members:  
a.   [List all professional societies,  e.g., professional society 1; 
Professional society 2; Professional society 3] 
6.   Disseminate at Professional Meetings where [Applicant] has a presence  
for [duration] from [the [date [proprietary/established/proper/class  
name] is first commercially distributed/approval of the REMS  
modification] ([mm/dd/yyyy]).  
[Journal Information Piece]  
1.   Publish every [frequency, e.g., quarterly] for [duration] after the [date 
[proprietary/established/proper/class name] is first commercially 
distributed/approval of the REMS modification] ([mm/dd/yyyy]) in the 
following journals: 
 [Fact Sheet]  
1.   Disseminate and prominently display at Professional Meetings where 
[Applicant] has a presence for [duration] from the [date [proprietary/ 
established/proper/class name] is first commercially distributed/ approval 
of the REMS modification] ([mm/dd/yyyy]). 
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Target Audience    Communication Materials & Dissemination Plans    
2.   Disseminate through [field-based sales and medical representatives]  
during [the  initial and/or follow-up] discussion  with  health  care 
providers for [duration] after [[proprietary/established/proper/class  
name] is first commercially distributed/approval of this REMS 
modification] ([mm/dd/yyyy]). [Field-based sales and medical 
representatives] must verbally review the risk messages contained in 
the REMS Fact Sheet during the visit with  the health care provider.  
[Website]  
1.   Make the REMS website fully operational and all REMS materials  
available through the website [by the date [proprietary/ 
established/proper/class name] is first commercially distributed /within  
[30/60/90] calendar days of REMS modification] ([mm/dd/yyyy]).  
2.   Maintain the REMS  website for [duration] from [the date [proprietary/ 
established/proper/class  name] is first commercially  
distributed/approval of  the REMS  modification] ([mm/dd/yyyy]).  
3.   Include a prominent REMS-specific  link to the [proprietary/established/  
proper/class name] REMS website on all product websites for 
consumers and health care providers.  The [proprietary/established/ 
proper/class name] REMS website must not link  back  to the 
promotional product website(s).  
 
REMS Operations  
The requirements  under this  header support activities that  are described in subsections A,  REMS Training  
Requirements, and/or  the REMS includes a Medication  Guide. Only include these requirements (or the 
relevant subset) if  the REMS Document includes subsection A and/or  REMS Training Requirements. Use 
continuous numbering for the Applicant Requirements included in  the REMS Operations and Compliance 
sections.  
 
To support REMS operations, [Applicant] must:  
1.   Authorize dispensing  for each [patient] based on verifying [safe  use conditions  to be met]. 
OR 
Authorize dispensing  for each [patient] based on verifying [safe  use conditions  to be met], and  
[receiving the [form/acceptable lab results]. The authorization is valid for [describe terms].   
OR 
Authorize dispensing  for each [patient] based on verifying [safe  use conditions  to be met], [and   
[receiving the [form/acceptable lab results] on  the following schedule: [schedule].  
 
If a completed [form/acceptable lab result] is not received [timeframe], the patient is not  
authorized to receive the drug until a completed [form/acceptable lab results] is received.  
OR 
Authorize dispensing  for each [patient] based on verifying [safe  use conditions  to be met], [and   
[receiving the [form/acceptable lab results]  within [schedule].  
 
If a completed [form/acceptable lab result] is not received [timeframe], the patient is not  
authorized to receive the drug until a completed [form/acceptable lab result] is received. Use this 
requirement when the health care setting must obtain authorization to dispense the drug.  
2.   Establish and maintain  a REMS website, [REMS Website]. The REMS website must include [the  
capability to complete [prescriber/pharmacy/health care setting setting] certification or enrollment  
online,] [the capability to enroll and manage patients online], and the option to print the Prescribing  
Information[, Instructions For Use, Medication  Guide], and REMS materials. All product websites for 
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consumers and health care providers must include prominent REMS-specific links to the REMS 
website. The REMS  website must not link back to the promotional product website(s). 
3.   Make the REMS Program website fully operational  and all REMS materials available through [medium 
e.g., website or call center] [within [30/60/90] calendar days of REMS modification (mm/dd/yyyy)]. 
Include implementation dates only  if applicable for a REMS modification.  
4.   Establish and maintain  a REMS [coordinating/call] center at [phone  number].   
5.   Establish and maintain  a validated, secure database of all  REMS participants who are [enrolled 
and/or certified OR trained]  in the [proprietary/established/proper/class name] REMS.  
6.   Ensure [List REMS participants] are able to [REMS activity(ies),  e.g., enrollment,  dispensing  
authorization] by  [method(s) through which activity may be completed]. Use this requirement to 
specify the multiple ways that an applicant must provide for a REMS participant to comply with a  
particular REMS requirement(s); for example, REMS participants must be able to  enroll in the REMS 
by phone, fax, and online. Repeat this requirement as needed (e.g.,  to address multiple REMS 
participants, requirements, or activities).  
7.   Maintain a process to [describe activity (e.g., to notify the REMS participant of a change  in the 
patients status, to validate the pharmacy management system configuration is  complete, to ensure  
health care providers who want to become  certified have  necessary qualifications)].  
8.   Ensure that a Medication Guide is  made available for dispensing with  each  
[proprietary/established/proper/class name] prescription. Use this requirement only if the Medication  
Guide is an  element of  the REMS.  
9.   Provide [List REMS Material(s)], and the Prescribing Information to REMS participants who (1) 
attempt to [prescribe/dispense/distribute] [proprietary/established/proper/class  name] and are not 
yet certified or (2) inquire about  how to become certified.  
10.   Notify  [List REMS  participants] within [specific, reasonable amount of  time]  after they become  
certified in the REMS. Use this requirement if the REMS requires certification to prescribe and/or 
dispense the drug.  
11.   Notify  [list of REMS participants] within  [specific, reasonable amount of time] before their enrollment 
expires and the  need to re-enroll.   
12.   Provide [REMS participants] access to the database of [list of REMS participants].  Repeat this  
requirement as needed. 
13.   Provide public access to a database of [certified health care settings/certified pharmacies].  
14.   Establish and maintain  a registry which includes a reporting and collection system for [all  
patients/specific population] to provide information on [e.g., the incidence of AE or interest, 
outcomes]. 
15.   Ensure that once a report suggestive of [adverse event of  interest] is  received, [Applicant] follows up 
with the health care provider to obtain all required  data  for the registry.   
16.   Report [AE of interest] as soon as possible to the FDA but no later than 15 calendar days from the 
initial receipt of the information by  the applicant. This requirement does not affect the applicants 
other reporting and follow-up requirements under applicable FDA regulations.  
 
REMS Compliance 
The requirements  under this  header support activities that  are described in subsections A. Only include 
these requirements (or the relevant subset) if  the REMS Document includes subsection A. Use continuous  
numbering for the Applicant Requirements included in  the REMS Operations and Compliance sections.  
 
To  ensure REMS participants compliance with  the REMS, [Applicant] must:   
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17.   Ensure [form/acceptable lab result] is received for each patient. If the [form/lab result]  is not 
received [timeframe], [applicant] must contact the [REMS participant] to obtain  the [form/lab 
result]. If the [form/acceptable lab result] is not received [timeframe], the patient is not authorized  
to receive the drug until the [form/acceptable lab result] is received.    
 
18.   Verify [annually] that the authorized representatives name and contact information correspond to  
those of the current designated authorized representative  for the [health care  setting and/or  
pharmacy]. If different, the [health care setting  and/or pharmacy] must be required to re-certify 
with a new authorized representative. 
 
19.   Maintain adequate records to demonstrate that REMS requirements have been met, including, but 
not limited to records of: [proprietary/established/proper/class name] distribution and dispensing; 
certification of [prescribers, pharmacies, and health care settings; enrollment of patients]; and  
audits of REMS participants]. These records must be readily available for FDA inspections.  
20.   Establish and maintain a plan for addressing  noncompliance with REMS  requirements.  
21.   Monitor [List REMS participant(s) to be monitored] on an ongoing basis to ensure the requirements  
of the REMS are being  met. Take  corrective action if non-compliance is identified, including de-
certification.   
22.   Audit [quantity e.g., all, percentage, number] [REMS participant(s) to be audited] no later than 
[number of  days, e.g., 180 days] after [timepoint e.g., they become certified,  commercial 
distribution, they have ordered [proprietary/established/proper/class name] to ensure that  all REMS  
processes and procedures are in  place, functioning, and support the REMS requirements.  
Repeat this  requirement if the audit approach differs among REMS participants. 
23.   Take reasonable steps to improve operations of and compliance with the requirements in  the 
[proprietary/established/proper/class name] REMS based on monitoring and evaluation of the 
[proprietary/established/proper/class name] REMS. Include this requirement for all REMS with  a 
subsection A. 
-----------------------------------------End Subsection B------------------------------------ 
IV.   REMS Assessment Timetable 
This section describes the timetable for the applicant to submit its REMS Assessments.  
[NDA/BLA Holder(s)] must submit  REMS Assessments at [time intervals/frequency, e.g., 18 months, 3  
years, and 7 years from the date  of the initial REMS approval OR 6  months,12 months, and annually 
thereafter from the date of the initial approval of the REMS (MM/DD/YYYY)].  To facilitate inclusion of as 
much information as possible while allowing reasonable time to prepare the submission, the reporting 
interval covered by  each assessment should conclude no earlier than 60 calendar days before the 
submission  date for that assessment. [NDA/BLA Holder(s)] must submit  each  assessment so that it will be 
received by  the FDA  on  or before the due date. 
This section does not apply to ANDAs and should not be included in ANDA-only REMS  Document.  
 
 
V.   REMS Materials 
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This section should include a consolidated list  of all materials mentioned in the REMS Requirements 
Section. The materials  listed in this section are part of the REMS.  
 
When listing the REMS materials,  do not include the name of the REMS in  the title of the material. For 
example, use Prescriber Enrollment Form instead of Drug X REMS Prescriber Enrollment Form.  
Delete headings and items from the list of materials that do not apply  to your REMS. Use continuous  
numbering throughout the section.  
 
The following materials are part of  the [proprietary/established/proper/class name]  REMS: 
 
Enrollment Form(s):  
Prescriber: 
1.   [Prescriber Enrollment Form] 
Patient:   
2.   [Patient Enrollment Form] 
3.   If the REMS includes different enrollment  forms for different patient populations, include  
them as follows:   
[Patient Enrollment Form for [type of patient]]  
Pharmacy:   
4.   [Pharmacy Enrollment Form] 
5.   If the REMS includes specific enrollment forms for different types of pharmacies, include 
them as follows:  
[[Type of pharmacy] Pharmacy Enrollment Form]  
For example:  
[Independent Pharmacy Enrollment Form]  
[Inpatient Pharmacy Enrollment Form]  
Health Care Setting:   
6.   [Health Care  Setting Enrollment  Form] 
7.   [Other setting-specific Enrollment Forms, as needed]  
 
Other Enrollment Form(s): Include the names of other enrollment forms here 
 
Training and Educational Materials  
Prescriber: 
8.   [Prescriber Education]  
9.   [REMS Overview]  
10.   [Knowledge Assessment]  
 
Patient:   
11.   [Patient Guide]  
12.   [Medication Guide]  
 
Pharmacy:  
13.   [Pharmacy Education]  
14.   [REMS Overview]  
15.   [Knowledge Assessment]  
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Patient Care Form(s) 
16.   [Patient Care  Form] Include the names of forms used in patient care (other than enrollment 
forms), such as forms used to support patient monitoring or to document safe use 
conditions  
 
Communication Material(s) 
17.   [Health Care Provider REMS  Letter] 
18.   [REMS Letter] 
19.   [Journal Information Piece] 
20.   [Fact Sheet]  
 
Other Material(s)    
21.   [REMS website]  
22.   [Administrative forms and materials] Include any administrative forms or materials here, as 
well as materials that dont fit into the above categories  
 
VI.   Statutory Elements 
This section describes the elements of  the REMS as defined by  the Food, Drug,  and Cosmetic Act.   
This REMS is approved under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21  
U.S.C. 355-1) and consists of the following elements:  
Delete the elements that do not apply to this REMS.  
1.   Medication Guide 
2.   Packaging and Disposal 
3.   Communication Plan  
4.   Elements to Assure  Safe  Use (ETASU):  
   Health care  providers who prescribe [proprietary/established/proper/class name]  are 
specially certified under 505-1(f)(3)(A)(ETASU A)  
   Pharmacies and health care settings that dispense [proprietary/established/proper/class 
name] are specially certified under 505-1(f)(3)(B)(ETASU B)  
   [proprietary/established/proper/class  name] is dispensed to patients only in certain health  
care settings under 505-1(f)(3)(C)(ETASU C)  
   [proprietary/established/proper/class  name] is dispensed to patients with evidence or other 
documentation of safe-use conditions under 505-1(f)(3)(D)(ETASU D)  
   Each patient using [proprietary/established/proper/class  name] is subject to certain 
monitoring under 505-1(f)(3)(E)(ETASU E)  
   Each patient using [proprietary/established/proper/class  name] is enrolled in the 
[proprietary/established/proper/class name] REMS program/Registry  under 505-
1(f)(3)(F)(ETASU F)  
5.   Implementation System  Only include if  ETASU  B, C or D are used  
6.   Timetable for Submission of  Assessments  Include if the application is an NDA or BLA  
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Appendix B: Bifurcated REMS Document Outline  
 
Risk Evaluation and Mitigation Strategy (REMS) Document  
This is the template  for a Bifurcated REMS Document. A Bifurcated REMS Document is used when the 
approval of a shared system REMS may coincide  with  tentative approval of an ANDA or section 505(b)(2) 
application.  For more information,  refer to the Guidance for Industry, Development of a Shared System or 
Separate Comparable REMS, available at  https://www.fda.gov/media/113869/download. 
 
A Bifurcated REMS, is a  single REMS consisting of two parts:   
(Part A)   The currently approved REMS for the applicable listed drug, which remains in effect until the 
first ANDA that references the reference listed  drug or section 505(b)(2) application that relies 
upon the listed drug receives full approval, and 
 
(Part B)   The Shared  System REMS, which is implemented upon  full approval of the first ANDA that  
references the reference listed drug or section 505(b)(2) application that relies upon the listed 
drug. 
 
A. [PROPRIETARY NAME]8,9 REMS  
I.   Administrative Information 
Retain  the  text that apply  to your  REMS and delete the text that does not apply. 
Risk: [risk REMS is designed to address]  
Application Number(s): NDA/BLA [application number(s)] Use  this only for single-applicant REMS. Add 
(and Authorized Generic) after the corresponding NDA number.   
Application Holder: [applicant name] Use this only for single-applicant REMS.  
Initial REMS Approval: [MM/YYYY] Initial approval of the REMS for the reference listed drug.  
Most Recent REMS Update: [MM/YYYY] Enter the date of the most recent REMS Revision or approved  
Modification. If there are no updates since the initial approval, delete the text.  
 
II.   REMS Goal(s) 
 
[Add goals  here] 
 
III.   REMS Requirements 
[Applicant] must ensure that [List the participants  who have requirements under this REMS in the 
order they appear in this section e.g.,  health care providers/pharmacies/health  care  
settings/patients/wholesalers-distributors] comply with the following requirements: 
 
8   [PROPRIETARY NAME] includes [list the dosage forms and applicable authorized generics].  
9  The [PROPRIETARY NAME]-specific requirements contained in this document apply until the date of full approval of 
the first [abbreviated new drug application (ANDA)/505(b)(2) application] joining a shared system REMS with 
[PROPRIETARY NAME].  
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1.   Health care Providers who prescribe [PROPRIETARY NAME] must:  
1.    
   
2.   Patients who are prescribed [PROPRIETARY NAME]:  
1.    
   
3.   [Health care settings/prescribers/pharmacies] that dispense [PROPRIETARY NAME] 
must:  
1.    
   
4.   Wholesalers-distributors that distribute [PROPRIETARY NAME] must:  
1.    
   
 
Training:  [Applicant] must make training available to health care providers who prescribe 
[PROPRIETARY NAME]. 
The training includes the following  educational material(s): [Educational Material(s)]. The training must be  
[describe how training will be provided,  e.g., available on  a website, delivered by the applicant or 
accredited CE  providers].  
 
REMS Communications:  To inform health care providers about the REMS Program and the risks  
and safe use of [PROPRIETARY NAME], [Applicant] must disseminate REMS communication 
materials according to the table below:  
Target Audience    Communication Materials & Dissemination Plans    
[Target Audience]   [Communication Material(s)]   
 
   [Dissemination Plan  1]  
   [Dissemination Plan  2]  
     [Insert requirements]  
 
Operations:  To support REMS Program operations, [Applicant] must:  
1.   [Insert requirements]  
 
Compliance:  To ensure REMS participants compliance with the REMS Program, [Applicant] must:  
2.   [Insert requirements]  
 
IV.   REMS Assessment Timetable 
[NDA/BLA Holder(s)] must submit  REMS Assessments at [time intervals/frequency, e.g.,  18 months, 3  
years, and 7 years from the date  of the initial REMS approval OR 6  months, 12  months, and annually 
73 
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thereafter from the date of the initial approval of the REMS (MM/DD/YYYYY)].  To facilitate inclusion of as  
much information as possible while allowing reasonable time to prepare the submission, the reporting 
interval covered by  each assessment should conclude no earlier than 60 calendar days before the 
submission date for that assessment. [NDA/BLA Holder(s)] must submit each assessment so that it will be 
received by  the FDA  on  or before the due date. 
 
V.   REMS Materials  
The following materials are part of  the [PROPRIETARY NAME] REMS: 
Enrollment Forms  
1.   form 
2.   form 
Training and Educational Materials  
3.   material 
4.   material 
Patient Care Form(s) 
5.   form 
6.   form 
Communication Materials  
7.   material 
8.   material 
Other Materials  
9.   material 
10. material 
11. material 
 
VI.   Statutory Elements 
This REMS is approved under section 505-1 of the Federal Food, Drug  and Cosmetic Act (FD&C Act) and 
consists of the following elements: Delete the elements that do not apply to this REMS.  
1.   Medication Guide 
2.   Communication Plan  
3.   Packaging and Disposal 
4.   Elements to Assure Safe Use:  (ETASU)   
   Health care  providers who prescribe [PROPRIETARY NAME] are specially certified  under 505-
1(f)(3)(A).  (ETASU A)  
   Pharmacies and health care settings that dispense [PROPRIETARY NAME] are specially  
certified under 505-1(f)(3)(B). (ETASU B)  
   [PROPRIETARY NAME]  is dispensed to patients only in certain  health  care settings under 
505-1(f)(3)(C). (ETASU C). 
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   [PROPRIETARY NAME] is dispensed to patients with evidence or other documentation of  
safe-use  conditions under 505-1(f)(3)(D). (ETASU D)  
   Each patient using [PROPRIETARY  NAME] is subject to certain monitoring under 505-
1(f)(3)(E).  (ETASU E)  
   Each patient using [PROPRIETARY  NAME] is enrolled in the [PROPRIETARY NAME] REMS  
program/Registry under 505-1(f)(3)(F). (ETASU F)  
5.   Implementation System  Only include if  Elements B,  C or  D are used.  
6.   Timetable for Submission of  Assessments  Include if the application is an NDA or BLA.  
 
 
TTThhheee    rrreeeqqquuuiiirrreeemmmeeennntttsss    ooofff    ttthhheee    ssshhhaaarrreeeddd    sssyyysssttteeemmm    RRREEEMMMSSS    fffooorrr    [[[DDDrrruuuggg    CCClllaaassssss    ooorrr    EEEssstttaaabbbllliiissshhheeeddd///PPPrrrooopppeeerrr    
 
NNNaaammmeee]]]    aaapppppplllyyy    aaasss    ooofff    ttthhheee    dddaaattteee    ooofff    fffuuullllll    aaapppppprrrooovvvaaalll    ooofff    ttthhheee    fffiiirrrsssttt    [AAAbbbbbbrrreeevvviiiaaattteeeddd    NNNeeewww    DDDrrruuuggg    
  ApplicatAAioppnpp ll(iiAccaaNttDiiooAnn)   /(( AA5NN05DD(AAb)))   (jj2oo)ii nnaiipnnpggl   iaac   asshthiaaorrnee]dd j   ossiyynssittneegmm a    wwshiittahhr   e[[PPdRR sOOysPPtRReIImEETT wAARRitYYh    NN[PAARMMOEEP]]R   IETARY 
  NAME] 
 
B.  [Drug Class or Established/Proper Name] Shared System REMS  
 
I.   Administrative Information 
Retain  the  text that apply  to your  REMS and delete the text that does not apply. 
Risk: [risk REMS is designed to address]  
Initial Shared System REMS Approval: [MM/YYYY]  
Most Recent REMS Update: [MM/YYYY] Enter the date of the most recent REMS Revision or approved  
Modification. If there are no updates since the initial approval, delete the text.  
 
II.   REMS Goal(s) 
 
[Add goals  here] 
 
III.   REMS Requirements 
[Drug Class or Established/Proper Name] Applicants must ensure that [List the  participants who 
have requirements under this REMS in the order they appear in this section e.g.,  health care  
providers/pharmacies/health care settings/patients/wholesalers-distributors] comply with 
the following requirements:  
1.   Health care Providers who prescribe [Drug Class or Established/Proper Name] must:  
1.    
   
2.   Patients who are prescribed [Drug Class or Established/Proper Name]:  
1.    
   
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3.   [Health care settings/prescribers/pharmacies] that dispense [Drug Class or 
Established/Proper Name] must: 
1.    
   
4.   Wholesalers-distributors that distribute [Drug Class or Established/Proper Name] must:  
1.    
   
 
Training:  [Drug Class or Established/Proper Name] Applicants must make training available to  
health care providers who prescribe [Drug Class or Established/Proper Name].  
The training includes the following  educational material(s): [Educational Material(s)]. The training must be  
[describe how training will be provided,  e.g., available on  a website, delivered by the applicants or 
accredited CE  providers].  
 
REMS Communications:  To inform health care providers about the REMS Program and the risks  
and safe use of [Drug Class or Established/Proper Name], [Drug Class or Established/Proper 
Name] Applicants must disseminate REMS communication materials according to the table 
below:  
Target Audience    Communication Materials & Dissemination Plans    
[Target Audience]   [Communication Material(s)]   
 
   [Dissemination Plan  1]  
   [Dissemination Plan  2]  
     [insert requirements]  
 
Operations:  To support REMS Program operations, [Drug Class or Established/Proper Name] 
Applicants must:  
1.   [Insert requirements]  
 
Compliance: To ensure REMS participants compliance with the REMS Program, [Drug Class or 
Established/Proper Name] Applicants must:  
2.   [Insert requirements]  
 
IV.   REMS Assessment Timetable 
[Drug  Class or Established/Proper Name] NDA/BLA Applicants(s) must submit REMS Assessments at [time 
intervals/frequency,  e.g., 18 months, 3 years, and 7 years from the date of the initial REMS approval OR  
6 months, 12 months, and annually thereafter from the date of the initial approval of the REMS  
(MM/DD/YYYYY)]. To facilitate inclusion of as much information as possible while allowing reasonable time 
to prepare the submission, the reporting interval covered by each assessment should conclude no earlier 
than 60 calendar days  before the submission date for that assessment. [Drug Class or Established/Proper  
Name] Applicants(s) must  submit  each assessment so that it will be received by the FDA on  or before  the 
due date. 
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V.   REMS Materials  
The following materials are part of  the [Drug Class or Established/Proper Name] REMS: 
Enrollment Forms  
1.   form 
2.   form 
Training and Educational Materials  
3.   material 
4.   material 
Patient Care Form(s) 
5.   form 
6.   form 
Communication Materials  
7.   material 
8.   material 
Other Materials  
9.   material 
10. material 
11. material 
 
VI.   Statutory Elements 
This REMS is approved under section 505-1 of the Federal Food, Drug  and Cosmetic Act (FD&C Act) and 
consists of the following elements: Delete the elements that do not apply to this REMS.  
1.   Medication Guide 
2.   Communication Plan  
3.   Packaging and Disposal 
4.   Elements to Assure Safe Use:  (ETASU)  
   Health care  providers who prescribe [Drug Class or Established/Proper Name] are specially  
certified under 505-1(f)(3)(A). (ETASU A)  
   Pharmacies and health care settings that dispense [Drug Class or Established/Proper Name] 
are specially certified under  505-1(f)(3)(B). (ETASU B)  
   [Drug  Class or Established/Proper Name] is dispensed to  patients only in certain health care 
settings under 505-1(f)(3)(C). (ETASU C)  
   [Drug  Class or Established/Proper Name] is dispensed to patients  with evidence or other 
documentation of safe-use conditions under 505-1(f)(3)(D). (ETASU D)  
   Each patient using [Drug Class or Established/Proper Name] is subject  to certain monitoring 
under 505-1(f)(3)(E).  (ETASU E)  
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   Each patient using [Drug Class or Established/Proper Name] is enrolled in the [Drug Class or 
Established/Proper Name] REMS program/Registry under 505-1(f)(3)(F). (ETASU F)  
5.   Implementation System  Only include if  Elements B,  C or  D are used.  
6.   Timetable for Submission of  Assessments  Include if the application is an NDA or BLA.  
 
 
 
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