{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Insanitary Conditions at Compounding Facilities.\" Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events in patients, including death. FDA is issuing this draft guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions, and to assist State regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions.","action":"Notice.","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/2016/08/04/2016-18461.html","cfr_references":[],"citation":"81 FR 51449","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 3, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-2268"],"dockets":[],"document_number":"2016-18461","effective_on":null,"end_page":51450,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/08/04/2016-18461.xml","html_url":"https://www.federalregister.gov/documents/2016/08/04/2016-18461/insanitary-conditions-at-compounding-facilities-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-18461?publication_date=2016-08-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-08-04/2016-18461/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1829,"last_updated":"2026-10-23 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-08-04/pdf/2016-18461.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-18461.pdf?1470228344","publication_date":"2016-08-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/08/04/2016-18461.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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","regulation_id_number":null,"title":"Insanitary Conditions at Compounding Facilities","checked_regulationsdotgov_at":"2016-10-04T05:00:48Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51449,"subtype":null,"title":"Insanitary Conditions at Compounding Facilities; Draft Guidance for Industry; Availability","toc_doc":"Insanitary Conditions at Compounding Facilities","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}