{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.\" The draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, this draft guidance covers the statutory verification system requirements that include quarantine and investigation of a product determined to be suspect and quarantine and disposition of a product determined to be illegitimate. The draft guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser after a suspect product investigation because it is determined that the product is not an illegitimate product.","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/2018/10/25/2018-23306.html","cfr_references":[],"citation":"83 FR 53880","comment_url":null,"comments_close_on":"2018-12-24","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by December 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-3462"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2018-10-25","updated_at":"2023-03-01T03:00:10.599-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-3462-0001","allow_late_comments":null,"id":"FDA-2018-D-3462-0001","comment_end_date":"2018-12-25","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-3462","title":"Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Availability  "}],"document_number":"2018-23306","effective_on":null,"end_page":53882,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/10/25/2018-23306.xml","html_url":"https://www.federalregister.gov/documents/2018/10/25/2018-23306/verification-systems-under-the-drug-supply-chain-security-act-for-certain-prescription-drugs-draft","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-23306?publication_date=2018-10-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-10-25/2018-23306/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":921,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-10-25/pdf/2018-23306.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-23306.pdf?1540385125","publication_date":"2018-10-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/10/25/2018-23306.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":3,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-3462","supporting_documents_count":0,"docket_id":"FDA-2018-D-3462","document_id":"FDA-2018-D-3462-0001","regulation_id_number":null,"title":"Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Availability  ","checked_regulationsdotgov_at":"2023-03-01T08:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":53880,"subtype":null,"title":"Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Availability","toc_doc":"Verification Systems under Drug Supply Chain Security Act for Certain Prescription Drugs","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}