{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act.\" This guidance clarifies the enhanced drug distribution security requirements listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act). In addition, this guidance outlines and makes recommendations on the system attributes necessary to enable secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary. This guidance finalizes the draft guidance of the same title issued on June 4, 2021.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health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/2023/08/31/2023-18831.html","cfr_references":[],"citation":"88 FR 60217","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on August 31, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-D-2024"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-08-31","updated_at":"2023-08-31T10:56:26.450-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-2024-0035","allow_late_comments":null,"id":"FDA-2020-D-2024-0035","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-D-2024","title":"Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act"}],"document_number":"2023-18831","effective_on":null,"end_page":60218,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/08/31/2023-18831.xml","html_url":"https://www.federalregister.gov/documents/2023/08/31/2023-18831/enhanced-drug-distribution-security-at-the-package-level-under-the-drug-supply-chain-security-act","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-18831?publication_date=2023-08-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-08-31/2023-18831/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1314,"last_updated":"2026-04-04 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-08-31/pdf/2023-18831.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-18831.pdf?1693399531","publication_date":"2023-08-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/08/31/2023-18831.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-2020-D-2024","supporting_documents_count":0,"docket_id":"FDA-2020-D-2024","document_id":"FDA-2020-D-2024-0035","regulation_id_number":null,"title":"Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act","checked_regulationsdotgov_at":"2023-09-01T14:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60217,"subtype":null,"title":"Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Guidance for Industry; Availability","toc_doc":"Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}