3.0.0 752 2020-02-10T17:00:11Z 2020-02-10T17:00:11Z Senate S S 2013-04-17 113 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2013-04-17T19:35:02Z Cody Miller Initiative for Safer Prescriptions Act 113 1608 HR 2013-04-19 Referred to the Subcommittee on Health. Identical bill CRS 2013-04-17 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2013-04-17 Introduced in Senate IntroReferral 10000 9 Library of Congress G000555 Sen. Gillibrand, Kirsten E. [D-NY] Kirsten Gillibrand D NY E. N Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Health information and medical records Prescription drugs Health 00 2013-04-17 Introduced in Senate 2013-07-01T19:28:08Z 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.

]]> Cody Miller Initiative for Safer Prescriptions Act Short Titles as Introduced Cody Miller Initiative for Safer Prescriptions Act Display Title Cody Miller Initiative for Safer Prescriptions Act Official Title as Introduced A bill to require the Secretary of Health and Human Services to promulgate regulations regarding the authorship, content, format and dissemination of Patient Medication Information to ensure patients receive consistent and high-quality information about their prescription medications and are aware of the potential risks and benefits of prescription medications. Introduced in Senate 2013-04-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113s752is/xml/BILLS-113s752is.xml 2013-04-17 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.