{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs.\" This guidance identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards. This guidance finalizes the revised draft guidance of the same title, \"DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs,\" issued in July 2022, as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).","action":"Notice of availability.","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/2023/09/06/2023-19182.html","cfr_references":[],"citation":"88 FR 60951","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on September 6, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-1981"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-09-06","updated_at":"2023-09-06T13:56:42.520-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-D-1981-0035","allow_late_comments":null,"id":"FDA-2014-D-1981-0035","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2014-D-1981","title":"DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs:  How to Exchange Product Tracing Information; Availability"}],"document_number":"2023-19182","effective_on":null,"end_page":60953,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/09/06/2023-19182.xml","html_url":"https://www.federalregister.gov/documents/2023/09/06/2023-19182/drug-supply-chain-security-act-standards-for-the-interoperable-exchange-of-information-for-tracing","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-19182?publication_date=2023-09-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-09-06/2023-19182/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1217,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-09-06/pdf/2023-19182.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-19182.pdf?1693917995","publication_date":"2023-09-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/09/06/2023-19182.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-D-1981","supporting_documents_count":0,"docket_id":"FDA-2014-D-1981","document_id":"FDA-2014-D-1981-0035","regulation_id_number":null,"title":"DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs:  How to Exchange Product Tracing Information; Availability","checked_regulationsdotgov_at":"2023-09-07T18:00:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60951,"subtype":null,"title":"Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Guidance for Industry; Availability","toc_doc":"Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}