C128503Level 4
Establish Processes and Procedures to Verify REMS Safe Use Conditions
**Semantic type:** Activity
**Definition:** In the context of REMS, the healthcare provider or setting must establish a system to verify that safe use conditions required by the REMS are in place. For purposes of this definition, "safe use condition" refers to any activity that must be completed before the drug is dispensed (e.g., enrollment or completion of a lab test).
**Synonyms:** - Establish Processes and Procedures to Verify Risk Evaluation and Mitigation Strategies Safe Use Conditions
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