Bill > HR6434

This bill establishes a special registration process under the Controlled Substances Act for physicians who want to directly administer Schedule I eligible investigational drugs to eligible patients under the Federal Right to Try law. The bill requires physicians to submit a detailed application to the Attorney General, which must include evidence of their controlled substances registration, documentation from the drug's manufacturer verifying it is an eligible investigational drug, an agreement from the manufacturer to supply the drug, proof of compliance with state laws, evidence of the physician's relevant training or experience, and details about where the drug will be stored and administered. The Attorney General must respond to the application within 45 days, either registering the physician or issuing an order to show cause for denial. Physicians can apply electronically and are limited to possessing only the amount of drug specified in their application or a subsequent supplemental notification. The bill allows a single registration for multiple treatment sites within the same city or county under one institution's 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 matters such as drug delivery, storage, record-keeping, and preventing drug diversion.

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https://www.congress.gov/bill/119th-congress/house-bill/6434/all-info