A	FDA	C54452	FDA Structured Product Labeling Terminology	C192147	Report Treatment Discontinuation or Transfer of Care			Report Treatment Discontinuation or Transfer of Care	The healthcare provider or setting must report adverse events of interest to the Manufacturer, MedWatch, and/or a REMS Program.
A	FDA	C54452	FDA Structured Product Labeling Terminology	C192148	Establish Processes and Procedures to Notify			Establish Processes and Procedures to Notify	In the context of REMS, the healthcare provider or setting must establish a system to notify a REMS participant about safe use concerns or safe use conditions required by the REMS. For purposes of this definition, "safe use condition" refers to any activity that must be completed before the drug is dispensed (e.g., communicate information about the patient's disposition, adverse events, reminders about safe use conditions).
A	FDA	C54452	FDA Structured Product Labeling Terminology	C192150	Establish Processes and Procedures to Provide			Establish Processes and Procedures to Provide	In the context of REMS, the healthcare provider or setting must establish a system to provide safe use conditions required by the REMS. For purposes of this definition, "safe use condition" refers to any activity that must be completed (e.g., provide REMS educational material or a prescription).
A	FDA	C54452	FDA Structured Product Labeling Terminology	C192151	Notify of Safe Use Conditions			Notify of Safe Use Conditions	The healthcare provider or setting must notify a REMS participant about safe use concerns or safe use conditions required by the REMS. For purposes of this definition, "safe use conditions" refers to any activity that must be completed before the drug is dispensed (e.g., communicate information about the patient's disposition, adverse events, reminders about safe use conditions).
A	FDA	C54452	FDA Structured Product Labeling Terminology	C192154	Provide Safe Use Conditions			Provide Safe Use Conditions	The healthcare provider or setting must provide the required safe use conditions. For purposes of this definition, "safe use conditions" refers to any activity that must be completed (e.g., provide REMS educational material or a prescription).
A	FDA	C54452	FDA Structured Product Labeling Terminology	C192155	Do Not Dispense Outside of Specified Facility			Do Not Dispense Outside of Specified Facility	The dispenser must not dispense the drug outside of the specified facility.
A	FDA	C54452	FDA Structured Product Labeling Terminology	C192156	Patient Must have a Specified Item or Intervention			Patient Must have a Specified Item or Intervention	The patient must have the specified item or intervention (e.g., educational material or medication).
A	FDA	C54452	FDA Structured Product Labeling Terminology	C192157	Distribute Only to Certified Healthcare Provider or Setting			Distribute Only to Certified Healthcare Provider or Setting	The REMS participant must only distribute the product to a certified healthcare provider or setting.
A	FDA	C54452	FDA Structured Product Labeling Terminology	C25166	Patient Discharge			Patient Discharge	The release of a patient from a course of care.