To clarify that the Federal Right to Try law applies to schedule I substances for which a phase I clinical trial has been completed and to provide access for eligible patients to such substances pursuant to the Federal Right to Try law.
Right to Try Clarification Act
This bill specifies that investigational drugs that are provided via the Right to Try pathway are exempt from restrictions that would otherwise apply under the Controlled Substances Act (e.g., restrictions on the use or possession of schedule I controlled substances).
The Right to Try pathway allows drug manufacturers to provide certain investigational drugs for which a Phase I clinical trial has been completed, but that have not yet received approval from the Food and Drug Administration, directly to individuals who have imminently life-threatening diseases or conditions and who have exhausted other treatment options and are unable to participate in clinical trials.
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