Right to Try: Special Registration for Schedule I Investigational Drugs
This Act establishes a special registration process for physicians to administer Schedule I investigational drugs to eligible patients under the federal Right to Try law. This change aims to remove regulatory barriers, allowing patients with life-threatening conditions faster access to experimental treatments that are currently classified as controlled substances. The process requires physicians to meet strict documentation, storage, and security requirements to ensure patient safety and prevent drug diversion.
Key points
Creates a special registration under the Controlled Substances Act (CSA) specifically for physicians administering Schedule I investigational drugs under the 'Right to Try' law.
Physicians must provide evidence of compliance with the Right to Try law, manufacturer agreement for drug supply, and proof of relevant training and secure storage facilities.
The Attorney General must approve or deny the application within 45 days, streamlining the process for accessing these experimental treatments.
Limits the amount of the investigational drug a physician can possess to the quantity specified in the application, with a process for requesting supplemental amounts.
Introduced
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