{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled \"Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates.\" This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities. This guidance is being published for immediate implementation due to the expected market exit of the predominant source of certain starter parenteral nutrition drug products for neonates in the United States.","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/2026/09/09/2026-18368.html","cfr_references":[],"citation":"91 FR 57358","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on September 9, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-D-9571"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-09-09","updated_at":"2026-09-09T09:57:54.734-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-D-9571-0001","allow_late_comments":false,"id":"FDA-2026-D-9571-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-D-9571","title":"Temporary Policies for Compounding Certain Starter Parenteral Nutrition Products for Neonates; Guidance for Industry; Availability"}],"document_number":"2026-18368","effective_on":null,"end_page":57359,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/09/09/2026-18368.xml","html_url":"https://www.federalregister.gov/documents/2026/09/09/2026-18368/temporary-policies-for-compounding-certain-starter-parenteral-nutrition-drug-products-for-neonates","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-18368?publication_date=2026-09-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-09-09/2026-18368/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":393,"last_updated":"2026-10-24 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18368.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18368.pdf?1788552907","publication_date":"2026-09-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/09/09/2026-18368.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-2026-D-9571","supporting_documents_count":0,"docket_id":"FDA-2026-D-9571","document_id":"FDA-2026-D-9571-0001","regulation_id_number":null,"title":"Temporary Policies for Compounding Certain Starter Parenteral Nutrition Products for Neonates; Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-09-10T17:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":57358,"subtype":null,"title":"Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability","toc_doc":"Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}