{"abstract":"The Food and Drug Administration (FDA) is proposing to amend certain requirements of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These amendments would clarify certain manufacturing, quality control, and documentation requirements and would ensure that the regulations more accurately encompass CGMP. In addition, the agency is updating the requirements for process and methods validation to incorporate guidance previously issued to industry and to reflect current practice. These proposed amendments are intended to enhance the integrity of the drug manufacturing process and the safety of drug products.","action":"Proposed 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/1996/05/03/96-11094.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"210","title":21},{"chapter":null,"citation_url":null,"part":"211","title":21}],"citation":"61 FR 20104","comment_url":null,"comments_close_on":"1996-08-01","correction_of":null,"corrections":[],"dates":"Submit written comments on the proposed rule by August 1, 1996. Submit written comments on the information collection requirements by June 3, 1996. FDA proposes that any final rule that may issue based upon this proposal become effective 90 days after its date of publication in the Federal Register.","disposition_notes":null,"docket_ids":["Docket No. 95N-0362"],"dockets":[],"document_number":"96-11094","effective_on":null,"end_page":20115,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1996/05/03/96-11094/current-good-manufacturing-practice-proposed-amendment-of-certain-requirements-for-finished","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/96-11094?publication_date=1996-05-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1996-05-03/96-11094/mods.xml","not_received_for_publication":null,"page_length":12,"page_views":{"count":270,"last_updated":"2026-10-23 12:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-05-03/pdf/96-11094.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1996-05-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1996/05/03/96-11094.txt","regulation_id_number_info":{"0910-AA45":{"issue":"200110","html_url":"https://www.federalregister.gov/regulations/0910-AA45/current-good-manufacturing-practice-amendment-of-certain-requirements-for-finished-pharmaceuticals","title":"Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200110&RIN=0910-AA45&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AA45"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T03:41:36Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":20104,"subtype":null,"title":"Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals","toc_doc":null,"toc_subject":null,"topics":[],"type":"Proposed Rule","volume":61}