{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations.\" This draft guidance is intended to clarify the key factors in calculating the aluminum content to ensure that the total aluminum exposure in parenteral nutrition (PN) does not exceed an acceptable threshold. It also provides FDA's recommendations regarding the aluminum concentration limits for small volume parenterals (SVPs) packaged as single doses or SVPs packaged in pharmacy bulk packages (PBPs). Additionally, this draft guidance is intended to assist sponsors and applicants in determining the appropriate placement of information on aluminum toxicity in SVP and large volume parenteral (LVP) Prescribing Information and container and carton labeling. This draft guidance revises and replaces the draft guidance for industry of the same name published on December 7, 2022.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2025/07/03/2025-12403.html","cfr_references":[],"citation":"90 FR 29554","comment_url":null,"comments_close_on":"2025-09-02","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by September 2, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-2301"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-07-03","updated_at":"2025-07-03T09:58:36.086-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-2301-0004","allow_late_comments":false,"id":"FDA-2022-D-2301-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-2301","title":"Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition:  Aluminum Content and Labeling Recommendations; Draft Guidance for Industry; Availability"}],"document_number":"2025-12403","effective_on":null,"end_page":29555,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/07/03/2025-12403.xml","html_url":"https://www.federalregister.gov/documents/2025/07/03/2025-12403/small-volume-parenteral-drug-products-and-pharmacy-bulk-packages-for-parenteral-nutrition-aluminum","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-12403?publication_date=2025-07-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-07-03/2025-12403/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":461,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-03/pdf/2025-12403.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-12403.pdf?1751460308","publication_date":"2025-07-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/07/03/2025-12403.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-2022-D-2301","supporting_documents_count":0,"docket_id":"FDA-2022-D-2301","document_id":"FDA-2022-D-2301-0004","regulation_id_number":null,"title":"Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition:  Aluminum Content and Labeling Recommendations; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2025-07-04T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":29554,"subtype":null,"title":"Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations; Draft Guidance for Industry; Availability","toc_doc":"Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}