{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Insanitary Conditions at Compounding Facilities.\" Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients. FDA is issuing this guidance to help compounding facilities and State regulatory agencies understand some examples of what FDA considers to be insanitary conditions that could cause a drug to become contaminated or rendered injurious to health. These examples are intended to help compounding facilities take action to prevent the occurrence of these and other insanitary conditions, as well as to implement appropriate corrective actions when such conditions already exist.","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/2020/11/09/2020-24807.html","cfr_references":[],"citation":"85 FR 71348","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on November 9, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-2268"],"dockets":[],"document_number":"2020-24807","effective_on":null,"end_page":71350,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/11/09/2020-24807.xml","html_url":"https://www.federalregister.gov/documents/2020/11/09/2020-24807/insanitary-conditions-at-compounding-facilities-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-24807?publication_date=2020-11-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-11-09/2020-24807/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1200,"last_updated":"2026-09-22 20:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-11-09/pdf/2020-24807.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-24807.pdf?1604670327","publication_date":"2020-11-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/11/09/2020-24807.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-2016-D-2268","supporting_documents_count":0,"docket_id":"FDA-2016-D-2268","document_id":"FDA-2016-D-2268-0701","regulation_id_number":null,"title":"Insanitary Conditions at Compounding Facilities","checked_regulationsdotgov_at":"2020-11-11T04:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":71348,"subtype":null,"title":"Insanitary Conditions at Compounding Facilities; Guidance for Industry; Availability","toc_doc":"Insanitary Conditions at Compounding Facilities","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}