Summary

Creates a new special federal registration that lets DEA-registered physicians directly give certain Schedule I investigational drugs to eligible patients under the federal right-to-try pathway. It sets application rules, required documentation (including manufacturer supply agreements and state authority proof), timelines for agency action, and deadlines for interim and final rules to govern security, recordkeeping, and other diversion controls.

• Creates a new DEA special registration enabling physicians to administer Schedule I investigational drugs under the federal right-to-try pathway.
• Requires applicants to hold existing DEA registration for Schedules II–V and submit manufacturer supply agreements, state authority evidence, site details, and diversion-prevention plans.
• Mandates electronic applications and a 45-day agency decision or written show-cause response.
• Allows supplemental quantity notifications to be deemed approved after 30 days if no denial; one registration can cover multiple related sites within the same city/county and institution.
• Requires an interim final rule within 240 days and a final rule within two years after the interim rule to set operational requirements.
• Delegates rulemaking on delivery, storage/security, recordkeeping, renewal/suspension/revocation, and other diversion controls.
• Focuses on regulatory procedures and safeguards rather than allocating new appropriations.
• Targets investigational Schedule I drugs eligible under the FDCA right-to-try pathway; does not change drug scheduling or clinical trial requirements directly.