3.0.0 3075 2023-01-11T13:32:38Z 2023-01-11T13:32:38Z Senate S 2016-06-16 114 ssfi00 Finance Committee Senate Standing Referred to 2016-06-16T21:30:17Z Addiction Prevention and Responsible Opioid Practices Act 114 5655 HR 2016-07-20 Referred to the Subcommittee on Health. Identical bill CRS 2016-06-16 ssfi00 Finance Committee Senate Read twice and referred to the Committee on Finance. (text of measure as introduced: CR S4301-4303) IntroReferral 2016-06-16 Introduced in Senate IntroReferral 10000 9 Library of Congress D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. N Health Administrative law and regulatory procedures Advisory bodies Alternative treatments Child health Congressional oversight Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Drug trafficking and controlled substances Drug, alcohol, tobacco use Food and Drug Administration (FDA) Government information and archives Government studies and investigations Health personnel Health programs administration and funding Health promotion and preventive care Law enforcement administration and funding Licensing and registrations Manufacturing Medical education Medicare Military medicine Sales and excise taxes Solid waste and recycling Veterans' medical care Health 00 2016-06-16 Introduced in Senate 2017-04-11T20:39:29Z Addiction Prevention and Responsible Opioid Practices Act

This bill addresses prescription opioid misuse.

The Food and Drug Administration (FDA) must: (1) seek recommendations concerning opioid drugs from an FDA advisory committee relating to the approval of a new drug that is an opioid, and the labeling of opioid drugs for pediatric prescriptions; (2) develop recommendations for education programs for prescribers of opioids; and (3) issue guidance for labeling that deters opioid abuse.

The bill amends the Federal Food, Drug, and Cosmetic Act by requiring manufacturers of opioid drugs to ensure that certain information about the risk factors associated with opioid drugs are included on the drug labels.

The bill amends the Controlled Substances Act by: (1) addressing annual narcotic manufacturing quotas with respect to fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone; and (2) directing the Department of Justice (DOJ) to require medical practitioners to complete a training program on prescribing opioids for chronic pain before they are certified to prescribe controlled substances in schedule II, III, or IV.

The bill establishes requirements for prescription drug monitoring systems to prevent over-prescribing controlled substances.

The Department of Health and Human Services must: (1) submit a plan of action for addressing outliers in opioid prescribing practices and ensuring an adequate response to protect the public health, and (2) study the expansion of Medicare coverage for alternatives to opioid treatments.

The bill amends the Internal Revenue Code to impose an excise tax on manufacturers or producers of opioid pain relievers. A portion of the amount generated from the tax must be used for substance abuse treatment programs.

DOJ must establish a take-back program for the safe and environmentally responsible disposal of controlled substances.

]]> Addiction Prevention and Responsible Opioid Practices Act Display Title Addiction Prevention and Responsible Opioid Practices Act Official Title as Introduced A bill to establish programs related to prevention of prescription opioid misuse, and for other purposes. Introduced in Senate IS Short Titles as Introduced Addiction Prevention and Responsible Opioid Practices Act Introduced in Senate 2016-06-16T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s3075is/xml/BILLS-114s3075is.xml 2016-06-16 Read twice and referred to the Committee on Finance. (text of measure as introduced: CR S4301-4303) 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.