{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Elemental Impurities in Drug Products.\" This draft guidance provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with implementation of International Council for Harmonisation (ICH) guidance for industry \"Q3D Elemental Impurities.\" This draft guidance will also assist manufacturers of compendial drug products in responding to the issuance of the United States Pharmacopeia (USP) requirement for the control of elemental impurities.","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/2016/07/01/2016-15704.html","cfr_references":[],"citation":"81 FR 43211","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 30, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-1692"],"dockets":[],"document_number":"2016-15704","effective_on":null,"end_page":43212,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/07/01/2016-15704.xml","html_url":"https://www.federalregister.gov/documents/2016/07/01/2016-15704/elemental-impurities-in-drug-products-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-15704?publication_date=2016-07-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-07-01/2016-15704/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":801,"last_updated":"2026-04-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-07-01/pdf/2016-15704.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-15704.pdf?1467291052","publication_date":"2016-07-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/07/01/2016-15704.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-1692","supporting_documents_count":0,"docket_id":"FDA-2016-D-1692","regulation_id_number":null,"title":"Elemental Impurities in Drug Products","checked_regulationsdotgov_at":"2016-08-31T05:00:49Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":43211,"subtype":null,"title":"Elemental Impurities in Drug Products; Draft Guidance for Industry; Availability","toc_doc":"Elemental Impurities in Drug Products","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}