{"abstract":"The Food and Drug Administration (FDA) is proposing to require that all systemic antibacterial drug products (i.e., antibiotics and their synthetic counterparts) intended for human use contain additional labeling information about the emergence of drug-resistant bacterial strains. The proposal reflects a growing concern in FDA and the medical community that overprescription and inappropriate use of systemic antibacterials has contributed to a dramatic increase in recent years in the prevalence of drug-resistant bacterial infections. The proposal is intended to encourage physicians to prescribe systemic antibacterials more judiciously and only when clinically necessary. The proposal is also intended to encourage physicians to counsel their patients about the proper use of such drugs and the importance of taking them exactly as directed.","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/2000/09/19/00-24007.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"201","title":21}],"citation":"65 FR 56511","comment_url":null,"comments_close_on":"2000-12-04","correction_of":null,"corrections":[],"dates":"Submit written comments by December 4, 2000. See section III of this document for the proposed effective date of a final rule based on this document.","disposition_notes":null,"docket_ids":["Docket No. 00N-1463"],"dockets":[],"document_number":"00-24007","effective_on":null,"end_page":56518,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2000/09/19/00-24007.xml","html_url":"https://www.federalregister.gov/documents/2000/09/19/00-24007/labeling-requirements-for-systemic-antibacterial-drug-products-intended-for-human-use","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/00-24007?publication_date=2000-09-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2000-09-19/00-24007/mods.xml","not_received_for_publication":null,"page_length":8,"page_views":{"count":201,"last_updated":"2026-09-20 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2000-09-19/pdf/00-24007.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2000-09-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2000/09/19/00-24007.txt","regulation_id_number_info":{"0910-AB78":{"issue":"200210","html_url":"https://www.federalregister.gov/regulations/0910-AB78/antibiotic-resistance-labeling","title":"Antibiotic Resistance Labeling","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200210&RIN=0910-AB78&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AB78"],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":56511,"subtype":null,"title":"Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use","toc_doc":"Systemic antibacterial products; labeling requirements","toc_subject":"Human drugs:","topics":["Drugs","Labeling","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":65}