{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.","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/2022/06/28/2022-13309.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"201","title":21},{"chapter":null,"citation_url":null,"part":"314","title":21}],"citation":"87 FR 38313","comment_url":null,"comments_close_on":"2022-10-26","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed rule must be submitted by October 26, 2022. Submit comments (including recommendations) on information collection issues under the Paperwork Reduction Act of 1995 by July 28, 2022.","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":183,"comment_start_date":"2022-06-28","updated_at":"2024-08-22T21:56:13.595-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0862-0001","allow_late_comments":null,"id":"FDA-2021-N-0862-0001","comment_end_date":"2022-11-26","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":"2022-13309","effective_on":null,"end_page":38331,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/06/28/2022-13309.xml","html_url":"https://www.federalregister.gov/documents/2022/06/28/2022-13309/nonprescription-drug-product-with-an-additional-condition-for-nonprescription-use","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-13309?publication_date=2022-06-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-06-28/2022-13309/mods.xml","not_received_for_publication":null,"page_length":19,"page_views":{"count":15303,"last_updated":"2026-08-23 22:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-06-28/pdf/2022-13309.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-13309.pdf?1656333911","publication_date":"2022-06-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/06/28/2022-13309.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":183,"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-0862-0001","regulation_id_number":"0910-AH62","title":"Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed Rule","checked_regulationsdotgov_at":"2024-08-24T01:00:08Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":38313,"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":"Proposed Rule","volume":87}