A Risk Evaluation and Mitigation Strategy is an FDA-mandated safety program required for certain drugs whose benefits justify their availability but whose risks require additional measures beyond standard prescribing information. REMS can include medication guides, communication plans for healthcare providers, or restricted distribution systems (Elements to Assure Safe Use, or ETASU).

REMS programs are relevant to the peptide space primarily through the GLP-1 receptor agonist class and some specialty biologics. While current GLP-1 agonists do not require REMS, the rapid expansion of off-label and compounded use has prompted discussion about whether additional risk mitigation is warranted. Understanding REMS helps contextualize the regulatory spectrum between freely available research chemicals and tightly controlled prescription drugs.