{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled \"Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.\" This guidance provides updated recommendations on testing and other activities that will help pharmaceutical manufacturers, repackers, other suppliers, and compounders prevent the use of high-risk drug components, including glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, and sorbitol solution, that are contaminated with diethylene glycol (DEG) and ethylene glycol (EG). These and other appropriate measures under current good manufacturing practice (CGMP) are vital to prevent incidents of consumer poisoning.","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/2023/05/10/2023-09973.html","cfr_references":[],"citation":"88 FR 30139","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 10, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-1573"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-05-10","updated_at":"2023-05-10T09:56:25.502-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-1573-0002","allow_late_comments":null,"id":"FDA-2023-D-1573-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-1573","title":"Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol; Guidance for Industry; Availability"}],"document_number":"2023-09973","effective_on":null,"end_page":30141,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/05/10/2023-09973.xml","html_url":"https://www.federalregister.gov/documents/2023/05/10/2023-09973/testing-of-glycerin-propylene-glycol-maltitol-solution-hydrogenated-starch-hydrolysate-sorbitol","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-09973?publication_date=2023-05-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-05-10/2023-09973/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1174,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-05-10/pdf/2023-09973.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-09973.pdf?1683636329","publication_date":"2023-05-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/05/10/2023-09973.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-2023-D-1573","supporting_documents_count":0,"docket_id":"FDA-2023-D-1573","document_id":"FDA-2023-D-1573-0002","regulation_id_number":null,"title":"Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol; Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-05-11T13:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":30139,"subtype":null,"title":"Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol; Guidance for Industry; Availability","toc_doc":"Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}