{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled \"Potential Medication Error Risks with Investigational Drug Container Labels.\" This public meeting is being convened and supported by a partnership between the Reagan-Udall Foundation and FDA. The purpose of the public meeting is to solicit input from stakeholders (e.g., sponsors, clinical sites, entities that supply or otherwise label investigational drugs) on the risk of medication errors potentially related to the content and format of information on investigational drug container labels, the prevalence and nature of such errors, and to gather information on practices that minimize the potential for medication errors.","action":"Notice of public meeting; request for comments.","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/2021/03/16/2021-05370.html","cfr_references":[],"citation":"86 FR 14457","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The public meeting will be held virtually and broadcast via webcast on May 18, 2021, from 1 p.m. to 4 p.m. (Eastern Time), and May 19, 2021, from 10 a.m. to 1 p.m. (Eastern Time). Submit either electronic or written comments on this public meeting by June 18, 2021. See the SUPPLEMENTARY INFORMATION section for registration date and information.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0127"],"dockets":[],"document_number":"2021-05370","effective_on":null,"end_page":14459,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/03/16/2021-05370.xml","html_url":"https://www.federalregister.gov/documents/2021/03/16/2021-05370/potential-medication-error-risks-with-investigational-drug-container-labels-public-meeting-request","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-05370?publication_date=2021-03-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-03-16/2021-05370/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3722,"last_updated":"2026-04-24 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-03-16/pdf/2021-05370.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-05370.pdf?1615812323","publication_date":"2021-03-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/03/16/2021-05370.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 13 - ISMP Remdesivir Investigational Drug Labeling Confusion 2020 re: Potential Medication Error Risks With Investigational Drug Container Labels; Public Meeting; Request for Comments","document_id":"FDA-2021-N-0127-0009"},{"title":"Reference 12 (copyrighted) - Medication Safety in Clinical Trials Role of the Pharmacist in Optimizing Practice Collaboration and Education To Reduce Errors 2017 re: Potential Medication Error Risks With Investigational Drug Container Labels; Public Meeting; Request for Comments","document_id":"FDA-2021-N-0127-0008"},{"title":"Reference 11 (copyrighted) - Reducing the Potential for Mistakes With Investigational Drugs 2011 re: Potential Medication Error Risks With \nInvestigational Drug Container Labels; Public Meeting; Request for Comments","document_id":"FDA-2021-N-0127-0007"},{"title":"Reference 10 (copyrighted) - Safety Risks With Investigational Drugs Pharmacy Practices and Perceptions in the Veterans Affairs Health System 2015 re: Potential Medication Error Risks With Investigational Drug Container Labels; Public Meeting; Request for Comments","document_id":"FDA-2021-N-0127-0006"},{"title":"Reference 7 (copyrighted) - ASHP Guidelines for the Management of Investigational Drug Products 2018 re: Potential Medication Error Risks With \nInvestigational Drug Container Labels; Public Meeting; Request for Comments","document_id":"FDA-2021-N-0127-0005"},{"title":"Reference 6 (copyrighted) - SIMulation of Medication Error Induced by Clinical Trial Drug Labeling The SIMME-CT Study 2016 re: Potential Medication Error Risks With Investigational Drug Container Labels; Public Meeting; Request for Comments","document_id":"FDA-2021-N-0127-0004"},{"title":"Reference 5 (copyrighted) - Investigational Drug Labeling Variability 2019 re: Potential Medication Error Risks With Investigational Drug Container Labels; Public Meeting; Request for Comments","document_id":"FDA-2021-N-0127-0003"},{"title":"Reference 2 The Near-Term Viability and Benefits of eLabels for Patients Clinical Sites and Sponsors 2018 re: Potential Medication Error Risks With \nInvestigational Drug Container Labels; Public Meeting; Request for Comments","document_id":"FDA-2021-N-0127-0002"}],"comments_count":6,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-N-0127","supporting_documents_count":8,"docket_id":"FDA-2021-N-0127","document_id":"FDA-2021-N-0127-0001","regulation_id_number":null,"title":"Potential Medication Error Risks With Investigational Drug Container Labels; Public Meeting; Request for Comments","checked_regulationsdotgov_at":"2021-06-19T04:02:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14457,"subtype":null,"title":"Potential Medication Error Risks With Investigational Drug Container Labels; Public Meeting; Request for Comments","toc_doc":"Potential Medication Error Risks With Investigational Drug Container Labels","toc_subject":"Meetings:\n","topics":[],"type":"Notice","volume":86}