U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. For Industry
  3. FDA Data Standards Advisory Board
  4. Structured Product Labeling Resources
  5. REMS Requirements
  1. Structured Product Labeling Resources

REMS Requirements

NCI Thesaurus OID: 2.16.840.1.113883.3.26.1.1

NCI concept code for REMS Requirements: C128494

 

SPL Acceptable Term Code
Adhere to REMS Patient Safe Use Conditions C128526
Assess Patient Condition, Health Status, or Adverse Event C128507
Be Able To Perform a Clinical Activity C128496
Complete a Patient Form with the Healthcare Provider C128522
Complete Knowledge Assessment C128500
Complete Patient Form C128508
Complete Patient Questionnaire C128525
Cooperate with REMS Audits C128521
Counsel Patient C128505
Designate a Healthcare Setting Representative C128495
Dispense Limited Days' Supply C128513
Dispense Limited Quantity C135014
Distribute Only to Certified Healthcare Provider or Setting C192157
Do Not Dispense Outside of Specified Facility C192155
Do Not Dispense Refills C128511
Do Not Distribute, Transfer, Loan, or Sell Product C128518
Do Not Prescribe Refills C128510
Enroll in the REMS C128504
Enroll Patient in the REMS C128509
Establish Processes and Procedures to Notify C192148
Establish Processes and Procedures to Provide C192150
Establish Processes and Procedures to Verify REMS Safe Use Conditions C128503
Get Lab Test or Monitoring C128523
Have Necessary Healthcare Personnel or Equipment C128497
Inform Prescriber C128527
Maintain Records C128519
Notify of Safe Use Conditions C195151
Obtain REMS Dispensing Authorization C128516
Participate in Training Session C128502
Patient Must have a Specified Item or Intervention C192156
Prescribe Limited Days' Supply C128512
Prescribe Limited Quantity C135015
Provide Patient with Materials C128506
Provide Safe Use Conditions C192154
Receive Counseling C128524
Report Adverse Events C128520
Report Treatment Discontinuation or Transfer of Care C192147
Return Unused Product C128517
Review Prescribing Information C128498
Review Training or Educational Materials C128499
Train Staff C128501
Use REMS Prescription Ordering Form C128514
Verify Safe Use Conditions C128515

 

Back to Top