{"abstract":"The Food and Drug Administration (FDA or the Agency) is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.","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/2014/12/18/2014-29522.html","cfr_references":[{"chapter":null,"citation_url":null,"part":201,"title":21},{"chapter":null,"citation_url":null,"part":606,"title":21},{"chapter":null,"citation_url":null,"part":610,"title":21}],"citation":"79 FR 75506","comment_url":null,"comments_close_on":"2015-03-18","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by March 18, 2015. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 20, 2015 (see the \"Paperwork Reduction Act of 1995\" section of this document). See section XI for the proposed effective date of a final rule based on this proposed rule.","disposition_notes":null,"docket_ids":["Docket No. FDA-2007-N-0363"],"dockets":[],"document_number":"2014-29522","effective_on":null,"end_page":75527,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/12/18/2014-29522.xml","html_url":"https://www.federalregister.gov/documents/2014/12/18/2014-29522/electronic-distribution-of-prescribing-information-for-human-prescription-drugs-including-biological","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-29522?publication_date=2014-12-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-12-18/2014-29522/mods.xml","not_received_for_publication":null,"page_length":22,"page_views":{"count":14788,"last_updated":"2026-10-23 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-12-18/pdf/2014-29522.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-29522.pdf?1418746938","publication_date":"2014-12-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/12/18/2014-29522.txt","regulation_id_number_info":{"0910-AG18":{"issue":"201510","html_url":"https://www.federalregister.gov/regulations/0910-AG18/electronic-distribution-of-prescribing-information-for-human-prescription-drugs-including-biological","title":"Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201510&RIN=0910-AG18&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AG18"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 7 Electronic Distribution of Prescribing Information for Human Prescriptions Drugs Including Biological Products","document_id":"FDA-2007-N-0363-0047"},{"title":"Reference 6 Electronic Distribution of Labeling Proposed Rule Final Report","document_id":"FDA-2007-N-0363-0046"},{"title":"Reference 5 Incidence of New Postmarket Boxed Warnings for New\nMolecular Entities","document_id":"FDA-2007-N-0363-0045"},{"title":"Reference 4 Internal Analysis of Safety-Related Labeling Changes Approved by FDA Between 2003 and 2013 Source MedWatch Drug Safety Labeling Changes","document_id":"FDA-2007-N-0363-0044"},{"title":"Reference 3 Ho et al An assessment of pharmacists readiness\nfor paperless labeling a national survey","document_id":"FDA-2007-N-0363-0043"},{"title":"Reference 2 Electronic Drug Lageling No Consensus on the Advantages and Disadvantages of Its Exclusive Use","document_id":"FDA-2007-N-0363-0042"},{"title":"Reference 1 Final Report Analysis of the Feasibility of Safety Labeling Changes Implementation Timeline","document_id":"FDA-2007-N-0363-0041"},{"title":"Publish December 18, 2014","document_id":"FDA-2007-N-0363-0039"},{"title":"Publish December 18, 2014","document_id":"FDA-2007-N-0363-0038"},{"title":"Publish December 18, 2014","document_id":"FDA-2007-N-0363-0037"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG18/electronic-distribution-of-prescribing-information-for-human-prescription-drugs-including-biological","title":"Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2007-N-0363","supporting_documents_count":14,"docket_id":"FDA-2007-N-0363","regulation_id_number":"0910-AG18","title":"Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing","checked_regulationsdotgov_at":"2015-03-19T05:00:22Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":75506,"subtype":null,"title":"Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products","toc_doc":"Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products","toc_subject":null,"topics":["Biologics","Blood","Drugs","Labeling","Laboratories","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":79}