{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.\" The guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for unit-dose repackaged solid oral dosage form drug products and appropriate expiration dates under those circumstances. This guidance finalizes the revised draft guidance for industry issued in August 2017.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and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/2020/07/30/2020-16526.html","cfr_references":[],"citation":"85 FR 45889","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on July 30, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-D-0829"],"dockets":[],"document_number":"2020-16526","effective_on":null,"end_page":45890,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/07/30/2020-16526.xml","html_url":"https://www.federalregister.gov/documents/2020/07/30/2020-16526/expiration-dating-of-unit-dose-repackaged-solid-oral-dosage-form-drug-products-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-16526?publication_date=2020-07-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-07-30/2020-16526/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1259,"last_updated":"2026-08-26 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-07-30/pdf/2020-16526.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-16526.pdf?1596026732","publication_date":"2020-07-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/07/30/2020-16526.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-2017-D-0829","supporting_documents_count":0,"docket_id":"FDA-2017-D-0829","document_id":"FDA-2017-D-0829-0005","regulation_id_number":null,"title":"Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products","checked_regulationsdotgov_at":"2020-08-02T03:30:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45889,"subtype":null,"title":"Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Guidance for Industry; Availability","toc_doc":"Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}