{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). A nonprescription drug product with an ACNU is a drug product that could be marketed without a prescription if an applicant implements an additional condition to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a practitioner licensed by law to administer such drug. The final rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products and increase consumer access to appropriate, safe, and effective drug products, which could improve public health.","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/2024/12/26/2024-30261.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"201","title":21},{"chapter":null,"citation_url":null,"part":"314","title":21}],"citation":"89 FR 105288","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective January 27, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0862"],"dockets":[{"supporting_documents":[{"title":"TAB C-NSURE-ProposedRule-Final","document_id":"FDA-2021-N-0862-0234"},{"title":"TAB A-2017-723-NSURE-PRIA","document_id":"FDA-2021-N-0862-0229"},{"title":"Reference 19 - 83 FR 40973_Docket FDA-2017-N-6730_08-17-2018","document_id":"FDA-2021-N-0862-0227"},{"title":"Reference 18 - 73 FR 63491_Docket FDA-2008-N-0549_10-24-2008","document_id":"FDA-2021-N-0862-0226"},{"title":"Reference 17 - 87 FR 68702_Docket FDA-2022-N-2673_11-16-2022","document_id":"FDA-2021-N-0862-0225"},{"title":"Reference 15 - 83 FR 13394_Docket FDA-2008-N-0549_04-02-2018","document_id":"FDA-2021-N-0862-0223"},{"title":"Reference 12 - FDA Prescription to Over-the-Counter (OTC) Switch List web page","document_id":"FDA-2021-N-0862-0221"},{"title":"Reference 11 - MOU Between the FTC and FDA Concerning the Exchange of Information (FDA-225-71-8003)_April 1971","document_id":"FDA-2021-N-0862-0220"},{"title":"Reference 10 - FDA Combination Products web page","document_id":"FDA-2021-N-0862-0219"},{"title":"Reference 9 - FDA eCTD Resources web page","document_id":"FDA-2021-N-0862-0218"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-12-26","updated_at":"2024-12-26T10:56:13.601-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0862-0207","allow_late_comments":false,"id":"FDA-2021-N-0862-0207","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":44,"id":"FDA-2021-N-0862","title":"Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed Rule"}],"document_number":"2024-30261","effective_on":"2025-01-27","end_page":105331,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/12/26/2024-30261.xml","html_url":"https://www.federalregister.gov/documents/2024/12/26/2024-30261/nonprescription-drug-product-with-an-additional-condition-for-nonprescription-use","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-30261?publication_date=2024-12-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-12-26/2024-30261/mods.xml","not_received_for_publication":null,"page_length":44,"page_views":{"count":6431,"last_updated":"2026-05-29 12:15:10 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-26/pdf/2024-30261.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-30261.pdf?1734961513","publication_date":"2024-12-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/12/26/2024-30261.txt","regulation_id_number_info":{"0910-AH62":{"issue":"202410","html_url":"https://www.federalregister.gov/regulations/0910-AH62/nonprescription-drug-product-with-an-additional-condition-for-nonprescription-use","title":"Nonprescription Drug Product With an Additional Condition for Nonprescription Use","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202410&RIN=0910-AH62&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH62"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"TAB C-NSURE-ProposedRule-Final","document_id":"FDA-2021-N-0862-0234"},{"title":"TAB A-2017-723-NSURE-PRIA","document_id":"FDA-2021-N-0862-0229"},{"title":"Reference 19 - 83 FR 40973_Docket FDA-2017-N-6730_08-17-2018","document_id":"FDA-2021-N-0862-0227"},{"title":"Reference 18 - 73 FR 63491_Docket FDA-2008-N-0549_10-24-2008","document_id":"FDA-2021-N-0862-0226"},{"title":"Reference 17 - 87 FR 68702_Docket FDA-2022-N-2673_11-16-2022","document_id":"FDA-2021-N-0862-0225"},{"title":"Reference 15 - 83 FR 13394_Docket FDA-2008-N-0549_04-02-2018","document_id":"FDA-2021-N-0862-0223"},{"title":"Reference 12 - FDA Prescription to Over-the-Counter (OTC) Switch List web page","document_id":"FDA-2021-N-0862-0221"},{"title":"Reference 11 - MOU Between the FTC and FDA Concerning the Exchange of Information (FDA-225-71-8003)_April 1971","document_id":"FDA-2021-N-0862-0220"},{"title":"Reference 10 - FDA Combination Products web page","document_id":"FDA-2021-N-0862-0219"},{"title":"Reference 9 - FDA eCTD Resources web page","document_id":"FDA-2021-N-0862-0218"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AH62/nonprescription-drug-product-with-an-additional-condition-for-nonprescription-use","title":"Nonprescription Drug Product With an Additional Condition for Nonprescription Use"},"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-N-0862","supporting_documents_count":44,"docket_id":"FDA-2021-N-0862","document_id":"FDA-2021-N-0862-0207","regulation_id_number":"0910-AH62","title":"Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed Rule","checked_regulationsdotgov_at":"2024-12-27T15:00:08Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":105288,"subtype":null,"title":"Nonprescription Drug Product With an Additional Condition for Nonprescription Use","toc_doc":"Nonprescription Drug Product With an Additional Condition for Nonprescription Use","toc_subject":null,"topics":["Administrative practice and procedure","Confidential business information","Drugs","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":89}