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Improved Medicine Access: New Rules for Active Ingredients

This act changes how key drug components are defined, potentially affecting the approval process for new medications. The goal is to ensure citizens have access to safe and effective medicines by standardizing terminology in food and drug regulations.
Key points
The act changes the definition of a drug's "active ingredient" to "active moiety" in federal regulations.
This change aims to facilitate and accelerate the market introduction of new, safe, and effective medicines.
Standardizing terminology can help avoid misunderstandings and streamline drug regulatory processes.
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Expired
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Additional Information
Print number: 117_HR_1857
Sponsor: Rep. Schrader, Kurt [D-OR-5]
Process start date: 2021-03-11
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Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

Protecting Access to Safe and Effective Medicines Act of 2021

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_HR_1857.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2021-03-11.

What are the main provisions?

Key points include:

  • The act changes the definition of a drug's "active ingredient" to "active moiety" in federal regulations.
  • This change aims to facilitate and accelerate the market introduction of new, safe, and effective medicines.
  • Standardizing terminology can help avoid misunderstandings and streamline drug regulatory processes.
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 Rep. Schrader, Kurt [D-OR-5].

What is the latest detailed status?

The latest detailed status is: Referred to the Subcommittee on Health.

Is this summary verified?

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

CATEGORIES

Health