{"abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that certain solid, oral dosage forms of immediate-release (IR) opioid analgesics commonly prescribed for treatment of acute pain be made available in fixed- quantity unit-of-use blister packaging for outpatient dispensing. This could reduce the amount of unused opioid analgesics, thereby reducing opportunities for misuse, abuse, inappropriate access, and overdose, and possibly reducing the development of new opioid addiction.","action":"Notice; establishment of a public docket; request for comments.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2019/05/31/2019-11283.html","cfr_references":[],"citation":"84 FR 25283","comment_url":null,"comments_close_on":"2019-07-30","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by July 30, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-1845"],"dockets":[{"supporting_documents":[{"title":"Fixed-Quantity Blister Packaging of Opioid Analgesics:  Rationale to Support Specific Packaging Sizes - Slides","document_id":"FDA-2019-N-1845-0137"}],"agency_name":"FDA","documents":[{"comment_count":135,"comment_start_date":"2019-05-31","updated_at":"2023-02-28T21:06:20.152-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-N-1845-0001","allow_late_comments":null,"id":"FDA-2019-N-1845-0001","comment_end_date":"2019-07-31","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2019-N-1845","title":"Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments"}],"document_number":"2019-11283","effective_on":null,"end_page":25289,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/05/31/2019-11283.xml","html_url":"https://www.federalregister.gov/documents/2019/05/31/2019-11283/fixed-quantity-unit-of-use-blister-packaging-for-certain-immediate-release-opioid-analgesics-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-11283?publication_date=2019-05-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-05-31/2019-11283/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":4827,"last_updated":"2026-08-25 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-05-31/pdf/2019-11283.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-11283.pdf?1559220318","publication_date":"2019-05-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/05/31/2019-11283.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Fixed-Quantity Blister Packaging of Opioid Analgesics:  Rationale to Support Specific Packaging Sizes - Slides","document_id":"FDA-2019-N-1845-0137"}],"comments_count":135,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-N-1845","supporting_documents_count":1,"docket_id":"FDA-2019-N-1845","document_id":"FDA-2019-N-1845-0001","regulation_id_number":null,"title":"Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments","checked_regulationsdotgov_at":"2023-03-01T02:06:19Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":25283,"subtype":null,"title":"Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments","toc_doc":"Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain","toc_subject":"Establishment of a Public Docket:","topics":[],"type":"Notice","volume":84}