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S. 752 · 113th Congress

Cody Miller Initiative for Safer Prescriptions Act

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Never voted on. It didn't reach a floor vote before the 113th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

No cosponsors.

Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to promulgate regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (PMI) for prescription drugs.

What it does: CRS summary · Introduced in Senate · Apr 17, 2013

Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to promulgate regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (PMI) for prescription drugs.

Requires such regulations to require the PMI for such a drug: (1) to be scientifically accurate and to be based on the approved professional labeling and authoritative, peer-reviewed literature; and (2) to include plain language that is not promotional in tone or content. Requires that such language include: (1) the established name of the drug; (2) drug uses and clinical benefits; (3) general directions for proper use; (4) contraindications, common side effects, and the most serious risks of the drug; (5) measures patients may take to reduce the side effects and risks; (6) when a patient should contact his or her health care professional; (7) instructions not to share medications; (8) any key storage requirements; (9) recommendations relating to proper disposal of any unused portion of the drug; and (10) known clinically important interactions with other drugs and substances.

Requires such regulations to: (1) include standards related to performing timely updates of drug information, ensuring that common information is applied consistently and simultaneously across similar drug products and for drugs within classes of medications, and developing a process to assess the quality and effectiveness of PMI in promoting patient understanding and safe and effective use; and (2) provide for the development of a publicly accessible electronic repository for all PMI.

Requires the Secretary to publish on the Food and Drug Administration (FDA) website a link to the Daily Med website.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Cody Miller Initiative for Safer Prescriptions Act

Latest action (Apr 17, 2013): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Policy area: Health · Origin: Senate · Introduced: Apr 17, 2013

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.