{"abstract":"The Food and Drug Administration (FDA) is amending its regulations governing the content and format of labeling for human prescription drug products (including biological products that are regulated as drugs). The final rule revises current regulations to require that the labeling of new and recently approved products include highlights of prescribing information and a table of contents. The final rule also reorders certain sections, requires minor content changes, and sets minimum graphical requirements. These revisions will make it easier for health care practitioners to access, read, and use information in prescription drug labeling. The revisions will enhance the safe and effective use of prescription drug products and reduce the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information. For both new and recently approved products and older products, the final rule requires that all FDA-approved patient labeling be reprinted with or accompany the labeling. The final rule also revises current regulations for prescription drug labeling of older products by clarifying certain requirements. These changes will make the labeling for older products more informative for health care practitioners.","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/2006/01/24/06-545.html","cfr_references":[{"chapter":null,"citation_url":null,"part":201,"title":21},{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":601,"title":21}],"citation":"71 FR 3922","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective June 30, 2006. See section III of this document for the implementation dates of this final rule.","disposition_notes":null,"docket_ids":["Docket No. 2000N-1269"],"dockets":[],"document_number":"06-545","effective_on":"2006-06-30","end_page":3997,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2006/01/24/06-545.xml","html_url":"https://www.federalregister.gov/documents/2006/01/24/06-545/requirements-on-content-and-format-of-labeling-for-human-prescription-drug-and-biological-products","images":{"ER24JA06.002":{"large":"https://img.federalregister.gov/ER24JA06.002/ER24JA06.002_large.png","medium":"https://img.federalregister.gov/ER24JA06.002/ER24JA06.002_medium.png","original_size":"https://img.federalregister.gov/ER24JA06.002/ER24JA06.002_original_size.png"},"ER24JA06.003":{"large":"https://img.federalregister.gov/ER24JA06.003/ER24JA06.003_large.png","medium":"https://img.federalregister.gov/ER24JA06.003/ER24JA06.003_medium.png","original_size":"https://img.federalregister.gov/ER24JA06.003/ER24JA06.003_original_size.png"},"ER24JA06.000":{"large":"https://img.federalregister.gov/ER24JA06.000/ER24JA06.000_large.png","medium":"https://img.federalregister.gov/ER24JA06.000/ER24JA06.000_medium.png","original_size":"https://img.federalregister.gov/ER24JA06.000/ER24JA06.000_original_size.png"},"ER24JA06.001":{"large":"https://img.federalregister.gov/ER24JA06.001/ER24JA06.001_large.png","medium":"https://img.federalregister.gov/ER24JA06.001/ER24JA06.001_medium.png","original_size":"https://img.federalregister.gov/ER24JA06.001/ER24JA06.001_original_size.png"}},"images_metadata":{"ER24JA06.002":{"large":{"identifier":"ER24JA06.002","content_type":"image/png","size":37748,"width":823,"sha":"cf3ec9e0eefd032bb79def95c124e86e","url":"https://img.federalregister.gov/ER24JA06.002/ER24JA06.002_large.png","height":414},"medium":{"identifier":"ER24JA06.002","content_type":"image/png","size":23247,"width":562,"sha":"1d828f67f9a7d107b54d588f6ae3c960","url":"https://img.federalregister.gov/ER24JA06.002/ER24JA06.002_medium.png","height":283},"original_size":{"identifier":"ER24JA06.002","content_type":"image/png","size":75541,"width":4241,"sha":"9768fc4513b0355335a52b16ea6cc47e","url":"https://img.federalregister.gov/ER24JA06.002/ER24JA06.002_original_size.png","height":2133}},"ER24JA06.003":{"large":{"identifier":"ER24JA06.003","content_type":"image/png","size":49723,"width":822,"sha":"c9e8f151fded17bd4fc9914feb0d71f2","url":"https://img.federalregister.gov/ER24JA06.003/ER24JA06.003_large.png","height":551},"medium":{"identifier":"ER24JA06.003","content_type":"image/png","size":28247,"width":543,"sha":"27c40d841afcf8be8e876344cbc88034","url":"https://img.federalregister.gov/ER24JA06.003/ER24JA06.003_medium.png","height":364},"original_size":{"identifier":"ER24JA06.003","content_type":"image/png","size":91207,"width":4107,"sha":"1d49e8f7a2f628bb1e0fdd777050ef8d","url":"https://img.federalregister.gov/ER24JA06.003/ER24JA06.003_original_size.png","height":2753}},"ER24JA06.000":{"large":{"identifier":"ER24JA06.000","content_type":"image/png","size":99741,"width":823,"sha":"950e65838ac974929637c9e3436de140","url":"https://img.federalregister.gov/ER24JA06.000/ER24JA06.000_large.png","height":943},"medium":{"identifier":"ER24JA06.000","content_type":"image/png","size":51494,"width":574,"sha":"672b8481e9fa79498c7da2f3713cb5e7","url":"https://img.federalregister.gov/ER24JA06.000/ER24JA06.000_medium.png","height":657},"original_size":{"identifier":"ER24JA06.000","content_type":"image/png","size":283548,"width":4401,"sha":"f9c88095551369782ede2d846fa8d5e9","url":"https://img.federalregister.gov/ER24JA06.000/ER24JA06.000_original_size.png","height":5041}},"ER24JA06.001":{"large":{"identifier":"ER24JA06.001","content_type":"image/png","size":46913,"width":823,"sha":"9d654f4ce41a852710071cd0f28519e5","url":"https://img.federalregister.gov/ER24JA06.001/ER24JA06.001_large.png","height":554},"medium":{"identifier":"ER24JA06.001","content_type":"image/png","size":27226,"width":530,"sha":"7bca93c7c0b59a4629106ed220c06bea","url":"https://img.federalregister.gov/ER24JA06.001/ER24JA06.001_medium.png","height":357},"original_size":{"identifier":"ER24JA06.001","content_type":"image/png","size":87837,"width":3997,"sha":"2754588eb9e4b576b4218c8ef6488900","url":"https://img.federalregister.gov/ER24JA06.001/ER24JA06.001_original_size.png","height":2692}}},"json_url":"https://www.federalregister.gov/api/v1/documents/06-545?publication_date=2006-01-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2006-01-24/06-545/mods.xml","not_received_for_publication":null,"page_length":76,"page_views":{"count":20370,"last_updated":"2026-05-09 10:15:13 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2006-01-24/pdf/06-545.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2006-01-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2006/01/24/06-545.txt","regulation_id_number_info":{"0910-AA94":{"issue":"200410","html_url":"https://www.federalregister.gov/regulations/0910-AA94/requirements-on-content-and-format-of-labeling-for-human-prescription-drugs-and-biological-products","title":"Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200410&RIN=0910-AA94&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AA94"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T17:57:52Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":3922,"subtype":null,"title":"Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products","toc_doc":"Prescription drug products; labeling requirements","toc_subject":"Human drugs and biological products:","topics":["Administrative practice and procedure","Biologics","Confidential business information","Drugs","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":71}