{"abstract":"The Food and Drug Administration (FDA or we) is issuing a revised guidance document that extends the compliance policy described in the guidance for industry entitled \"DSCSA Implementation: Product Tracing Requirements for Dispensers--Compliance Policy.\" This revised guidance announces FDA's intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to take action against dispensers who, prior to March 1, 2016, accept ownership of product without receiving transaction information, transaction history, and transaction statements (product tracing information), prior to or at the time of a transaction, or do not capture and maintain the product tracing information, as required by the FD&C Act.","action":"Notice of availability; revised guidance document.","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/2015/11/02/2015-27841.html","cfr_references":[],"citation":"80 FR 67408","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective November 2, 2015. For information about enforcement dates, please see the SUPPLEMENTARY INFORMATION section.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-2270"],"dockets":[],"document_number":"2015-27841","effective_on":"2015-11-02","end_page":67409,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/11/02/2015-27841.xml","html_url":"https://www.federalregister.gov/documents/2015/11/02/2015-27841/the-drug-supply-chain-security-act-implementation-product-tracing-requirements-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-27841?publication_date=2015-11-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-11-02/2015-27841/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2013,"last_updated":"2026-07-26 08:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-11-02/pdf/2015-27841.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-27841.pdf?1446209197","publication_date":"2015-11-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/11/02/2015-27841.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-2270","supporting_documents_count":null,"docket_id":"FDA-2015-D-2270","regulation_id_number":null,"title":"The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers - Compliance Policy","checked_regulationsdotgov_at":"2015-11-22T06:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":67408,"subtype":null,"title":"The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers-Compliance Policy; Updated Guidance for Industry, Availability","toc_doc":"The Drug Supply Chain Security Act Implementation  Product Tracing Requirements for Dispensers  Compliance Policy","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}