{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product--Compliance Policies.\" This guidance explains that FDA intends to extend the delay in enforcement described in the guidance entitled \"Wholesale Distributor Verification Requirement for Saleable Returned Drug Product--Compliance Policy,\" published in the Federal Register on September 24, 2019 (the 2019 Compliance Policy), which relates to Drug Supply Chain Security Act (DSCSA) provisions requiring wholesale distributors to verify the product identifier prior to further distributing returned product beginning on November 27, 2019. In addition, this guidance announces FDA's intended enforcement policy with respect to DSCSA provisions requiring dispensers to verify the product identifier for suspect or illegitimate product in the dispenser's possession or control beginning on November 27, 2020.","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/2020/10/23/2020-23524.html","cfr_references":[],"citation":"85 FR 67550","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on October 23, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-4212"],"dockets":[],"document_number":"2020-23524","effective_on":null,"end_page":67552,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/10/23/2020-23524.xml","html_url":"https://www.federalregister.gov/documents/2020/10/23/2020-23524/wholesale-distributor-verification-requirement-for-saleable-returned-drug-product-and-dispenser","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-23524?publication_date=2020-10-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-10-23/2020-23524/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1237,"last_updated":"2026-10-25 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-10-23/pdf/2020-23524.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-23524.pdf?1603370738","publication_date":"2020-10-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/10/23/2020-23524.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-2019-D-4212","supporting_documents_count":0,"docket_id":"FDA-2019-D-4212","document_id":"FDA-2019-D-4212-0006","regulation_id_number":null,"title":"Wholesale Distributor Verification Requirement for Saleable Returned Drug Product-Compliance Policy; Guidance for Industry; Availability","checked_regulationsdotgov_at":"2020-10-26T03:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":67550,"subtype":null,"title":"Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product-Compliance Policies; Guidance for Industry; Availability","toc_doc":"Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product; Compliance Policies","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}