{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Inspection of Injectable Products for Visible Particulates.\" Visible particulates in injectable products can jeopardize patient safety. This draft guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination. The draft guidance also clarifies that meeting an applicable U.S. Pharmacopeia (USP) compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (CGMP) requirements for the manufacture of injectable products.","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/2021/12/17/2021-27351.html","cfr_references":[],"citation":"86 FR 71648","comment_url":null,"comments_close_on":"2022-02-15","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by February 15, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2021-D-0241"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2021-12-17","updated_at":"2023-02-28T12:34:48.539-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-D-0241-0001","allow_late_comments":null,"id":"FDA-2021-D-0241-0001","comment_end_date":"2022-02-16","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2021-D-0241","title":"Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry; Availability"}],"document_number":"2021-27351","effective_on":null,"end_page":71650,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/12/17/2021-27351.xml","html_url":"https://www.federalregister.gov/documents/2021/12/17/2021-27351/inspection-of-injectable-products-for-visible-particulates-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-27351?publication_date=2021-12-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-12-17/2021-27351/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3292,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-12-17/pdf/2021-27351.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-27351.pdf?1639662333","publication_date":"2021-12-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/12/17/2021-27351.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-2021-D-0241","supporting_documents_count":0,"docket_id":"FDA-2021-D-0241","document_id":"FDA-2021-D-0241-0001","regulation_id_number":null,"title":"Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-02-28T17:34:47Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":71648,"subtype":null,"title":"Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry; Availability","toc_doc":"Inspection of Injectable Products for Visible Particulates","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":86}