{"abstract":"The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.","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/2004/04/08/04-7532.html","cfr_references":[{"chapter":null,"citation_url":null,"part":206,"title":21},{"chapter":null,"citation_url":null,"part":250,"title":21},{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":600,"title":21},{"chapter":null,"citation_url":null,"part":601,"title":21}],"citation":"69 FR 18728","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective June 22, 2004.","disposition_notes":null,"docket_ids":["Docket No. 1999N-0193"],"dockets":[],"document_number":"04-7532","effective_on":"2004-06-22","end_page":18767,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2004/04/08/04-7532.xml","html_url":"https://www.federalregister.gov/documents/2004/04/08/04-7532/supplements-and-other-changes-to-an-approved-application","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/04-7532?publication_date=2004-04-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2004-04-08/04-7532/mods.xml","not_received_for_publication":null,"page_length":40,"page_views":{"count":5677,"last_updated":"2026-07-28 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2004-04-08/pdf/04-7532.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2004-04-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2004/04/08/04-7532.txt","regulation_id_number_info":{"0910-AB61":{"issue":"200310","html_url":"https://www.federalregister.gov/regulations/0910-AB61/supplements-and-other-changes-to-an-approved-application","title":"Supplements and Other Changes to an Approved Application","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200310&RIN=0910-AB61&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AB61"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T11:17:02Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":18728,"subtype":null,"title":"Supplements and Other Changes to an Approved Application","toc_doc":"Supplements and other changes to approved application","toc_subject":"Human drugs and biological products:","topics":["Administrative practice and procedure","Biologics","Confidential business information","Drugs","Reporting and recordkeeping requirements"],"type":"Rule","volume":69}