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Faster Access to Experimental Drugs: New Definition for Medical Use of Controlled Substances.

This bill amends the Controlled Substances Act to define 'currently accepted medical use with severe restrictions.' This definition applies to experimental drugs designated as 'breakthrough therapies' or authorized for 'expanded access' for patients with serious or life-threatening diseases. The change allows these substances to be moved more quickly from the highly restricted Schedule I to Schedule II, potentially accelerating patient access to promising, yet unapproved, treatments.
Key points
Easier access to experimental drugs: Active ingredients in drugs designated as 'breakthrough therapy' or authorized for 'expanded access' can be moved faster from Schedule I (most restrictive) to Schedule II of controlled substances.
New Definition: Introduction of the term 'currently accepted medical use with severe restrictions' into the Controlled Substances Act.
Expedited Procedures: Authorities (Attorney General) must act quickly (within 90 days) to reclassify a substance upon receiving notification from the Secretary of Health and Human Services regarding the drug's status.
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Additional Information
Print number: 118_S_689
Sponsor: Sen. Booker, Cory A. [D-NJ]
Process start date: 2023-03-07
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Summarized by: gemini-flash-latest
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

A bill to amend the Controlled Substances Act to define currently accepted medical use with severe restrictions, and for other purposes.

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_S_689.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2023-03-07.

What are the main provisions?

Key points include:

  • Easier access to experimental drugs: Active ingredients in drugs designated as 'breakthrough therapy' or authorized for 'expanded access' can be moved faster from Schedule I (most restrictive) to Schedule II of controlled substances.
  • New Definition: Introduction of the term 'currently accepted medical use with severe restrictions' into the Controlled Substances Act.
  • Expedited Procedures: Authorities (Attorney General) must act quickly (within 90 days) to reclassify a substance upon receiving notification from the Secretary of Health and Human Services regarding the drug's status.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Booker, Cory A. [D-NJ].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-27.

CATEGORIES

Health Courts and Law