{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.\" The draft guidance focuses on safety aspects of the container label and carton labeling design for prescription drug and biological products. The draft guidance provides sponsors of new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs), and prescription drugs marketed without an approved NDA or ANDA with a set of principles and recommendations for ensuring that critical elements of product container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product to minimize medication errors.","action":"Notice.","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/2013/04/24/2013-09640.html","cfr_references":[],"citation":"78 FR 24211","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 24, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0401"],"dockets":[],"document_number":"2013-09640","effective_on":null,"end_page":24211,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/04/24/2013-09640.xml","html_url":"https://www.federalregister.gov/documents/2013/04/24/2013-09640/draft-guidance-for-industry-on-safety-considerations-for-container-labels-and-carton-labeling-design","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-09640?publication_date=2013-04-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-04-24/2013-09640/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":1877,"last_updated":"2026-06-23 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-04-24/pdf/2013-09640.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-09640.pdf?1366721392","publication_date":"2013-04-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/04/24/2013-09640.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors","document_id":"FDA-2013-D-0401-0031"},{"title":"Safety Considerations for Container\nLabels and Carton Labeling Design To\nMinimize Medication Errors; Guidance\nfor Industry; Availability","document_id":"FDA-2013-D-0401-0030"},{"title":"Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors","document_id":"FDA-2013-D-0401-0002"},{"title":"Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors","document_id":"FDA-2013-D-0401-0001"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0401","supporting_documents_count":4,"docket_id":"FDA-2013-D-0401","regulation_id_number":null,"title":"Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors; Availability","checked_regulationsdotgov_at":"2013-05-26T05:01:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24211,"subtype":null,"title":"Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability","toc_doc":"Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors","toc_subject":"Draft Guidances for Industry; Availability:","topics":[],"type":"Notice","volume":78}