{"abstract":"The Consumer Product Safety Commission (Commission or CPSC) is amending the child-resistant packaging requirements of CPSC's regulation to exempt baloxavir marboxil tablets, currently marketed as XOFLUZA<SUP>TM</SUP>, in packages containing not more than 80 mg of the drug, from the special packaging requirements. XOFLUZA is used to treat the flu, and the drug is taken in one dose within 48 hours of experiencing flu symptoms. The final rule exempts this prescription drug product on the basis that child-resistant packaging is not needed to protect young children from serious injury or illness because the product is not acutely toxic and lacks adverse human experience associated with ingestion.","action":"Final rule.","agencies":[{"raw_name":"CONSUMER PRODUCT SAFETY COMMISSION","name":"Consumer Product Safety Commission","id":84,"url":"https://www.federalregister.gov/agencies/consumer-product-safety-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/84","parent_id":null,"slug":"consumer-product-safety-commission"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2024/04/19/2024-07651.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"1700","title":16}],"citation":"89 FR 28604","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The rule is effective May 20, 2024.","disposition_notes":null,"docket_ids":["Docket No. CPSC-2021-0027"],"dockets":[{"supporting_documents":[{"title":"Phone Log (Schlick-Wilson 3-4-24)","document_id":"CPSC-2021-0027-0003"}],"agency_name":"CPSC","documents":[{"comment_count":0,"comment_start_date":"2024-04-19","updated_at":"2024-09-03T16:54:30.980-04:00","comment_url":"https://www.regulations.gov/commenton/CPSC-2021-0027-0004","allow_late_comments":false,"id":"CPSC-2021-0027-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"CPSC-2021-0027","title":"Petition to Exempt Baloxavir Marboxil (XOFLUZA™) in 40 mg and 80 mg Tablet Doses from Special Packaging Requirements of the PPPA"}],"document_number":"2024-07651","effective_on":"2024-05-20","end_page":28606,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/04/19/2024-07651.xml","html_url":"https://www.federalregister.gov/documents/2024/04/19/2024-07651/poison-prevention-packaging-requirements-exemption-of-baloxavir-marboxil-tablets-in-packages","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-07651?publication_date=2024-04-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-04-19/2024-07651/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":202,"last_updated":"2026-08-23 18:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-19/pdf/2024-07651.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-07651.pdf?1713444331","publication_date":"2024-04-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/04/19/2024-07651.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Phone Log (Schlick-Wilson 3-4-24)","document_id":"CPSC-2021-0027-0003"}],"comments_count":0,"agency_id":"CPSC","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=CPSC-2021-0027","supporting_documents_count":1,"docket_id":"CPSC-2021-0027","document_id":"CPSC-2021-0027-0004","regulation_id_number":null,"title":"Petition to Exempt Baloxavir Marboxil (XOFLUZA™) in 40 mg and 80 mg Tablet Doses from Special Packaging Requirements of the PPPA","checked_regulationsdotgov_at":"2024-04-20T15:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28604,"subtype":null,"title":"Poison Prevention Packaging Requirements; Exemption of Baloxavir Marboxil Tablets in Packages Containing Not More Than 80 mg of the Drug","toc_doc":"Exemption of Baloxavir Marboxil Tablets in Packages Containing Not More than 80 mg of the Drug","toc_subject":"Poison Prevention Packaging Requirements:\n","topics":["Consumer protection","Drugs","Infants and children","Packaging and containers","Poison prevention"],"type":"Rule","volume":89}