{"abstract":"The Food and Drug Administration (FDA) is amending certain of its regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals as the culmination of the first phase of an incremental approach to modifying the CGMP regulations for these products. This rule revises CGMP requirements primarily concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters. We are amending the regulations to modernize or clarify some of the requirements as well as to harmonize them with other FDA regulations and international CGMP standards.","action":"Final rule.","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/2008/09/08/E8-20709.html","cfr_references":[{"chapter":null,"citation_url":null,"part":210,"title":21},{"chapter":null,"citation_url":null,"part":211,"title":21}],"citation":"73 FR 51919","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective December 8, 2008.","disposition_notes":null,"docket_ids":["Docket No. FDA-2007-N-0379"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2025-07-28T15:55:55.179-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2007-N-0379-0007","allow_late_comments":false,"id":"FDA-2007-N-0379-0007","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2007-N-0379","title":"Amendment to the CGMP Regulations for Finished Pharmaceuticals"}],"document_number":"E8-20709","effective_on":"2008-12-08","end_page":51933,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2008/09/08/E8-20709.xml","html_url":"https://www.federalregister.gov/documents/2008/09/08/E8-20709/amendments-to-the-current-good-manufacturing-practice-regulations-for-finished-pharmaceuticals","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E8-20709?publication_date=2008-09-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2008-09-08/E8-20709/mods.xml","not_received_for_publication":null,"page_length":15,"page_views":{"count":6338,"last_updated":"2026-09-22 04:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2008-09-08/pdf/E8-20709.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2008-09-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2008/09/08/E8-20709.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-2007-N-0379","supporting_documents_count":0,"docket_id":"FDA-2007-N-0379","document_id":"FDA-2007-N-0379-0007","regulation_id_number":null,"title":"Amendment to the CGMP Regulations for Finished Pharmaceuticals","checked_regulationsdotgov_at":"2025-07-29T21:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51919,"subtype":null,"title":"Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals","toc_doc":"Amendments to Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals","toc_subject":null,"topics":["Drugs","Labeling","Laboratories","Packaging and containers","Prescription drugs","Reporting and recordkeeping requirements","Warehouses"],"type":"Rule","volume":73}