Bill > S3346

This bill establishes a special registration process under the Controlled Substances Act for physicians who want to administer Schedule I investigational drugs to eligible patients under the Federal Right to Try law. The bill requires physicians to submit a comprehensive application to the Attorney General that includes evidence of their controlled substances registration, documentation from the drug manufacturer verifying the investigational drug's eligibility, an agreement from the manufacturer to supply the drug, proof of compliance with state laws, evidence of relevant training or experience, and details about the drug storage and administration site. The Attorney General must respond to the application within 45 days, either registering the physician or issuing an order to show cause. Physicians can apply electronically and are limited to possessing only the amount of investigational drug specified in their application or in a supplemental notification. The bill also allows physicians to use a single registration for multiple treatment sites within the same city or county under the same institutional control. The Attorney General is required to issue an interim final rule within 240 days and a final rule within two years to implement these provisions, addressing drug delivery, storage, security, record-keeping, and registration processes while ensuring controls against drug diversion.

Justice

https://www.congress.gov/bill/119th-congress/senate-bill/3346/all-info