{"abstract":"The Food and Drug Administration (FDA or Agency) is proposing a regulation to implement its authority to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act), by providing to the owner or consignee notice and an opportunity to appear and introduce testimony to the Agency prior to the destruction. The proposed regulation is authorized by amendments made to the FD&C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Once finalized, this proposed regulation will allow FDA to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain.","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/2014/05/06/2014-10304.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1,"title":21}],"citation":"79 FR 25758","comment_url":null,"comments_close_on":"2014-07-07","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by July 7, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-0504"],"dockets":[],"document_number":"2014-10304","effective_on":null,"end_page":25763,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/05/06/2014-10304.xml","html_url":"https://www.federalregister.gov/documents/2014/05/06/2014-10304/administrative-destruction-of-certain-drugs-refused-admission-to-the-united-states","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-10304?publication_date=2014-05-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-05-06/2014-10304/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":2434,"last_updated":"2026-04-17 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-05-06/pdf/2014-10304.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-10304.pdf?1399294505","publication_date":"2014-05-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/05/06/2014-10304.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Comment from RxRights re Comment from the Honorable Keith Ellison","document_id":"FDA-2014-N-0504-0023"},{"title":"Appendix A2 - Harel, et al, JAMA Internal Medicine Administrative Destruction of Certain Drugs Refused Admission to the United States, Accessibility","document_id":"FDA-2014-N-0504-0015"},{"title":"Appendix A2 - Harel, et al, JAMA Internal Medicine Administrative Destruction of Certain Drugs Refused Admission to the United States","document_id":"FDA-2014-N-0504-0014"},{"title":"Appendix A1 - Time Period to Request an Informal Hearing on Refusal Administrative Destruction of Certain Drugs Refused Admission to the United States","document_id":"FDA-2014-N-0504-0013"},{"title":"List of References Administrative Destruction of Certain Drugs Refused Admission to the United States","document_id":"FDA-2014-N-0504-0012"},{"title":"Reference 1 - Government Accountability Office. \"Internet Pharmacies: Federal Agencies and States Face Challenges Combating Rogue Sites, Particularly Those Abroad\" Administrative Destruction of Certain Drugs Refused Admission to the United States","document_id":"FDA-2014-N-0504-0011"},{"title":"Reference 2 - U.S. Food and Drug Administration. \"Remarks as Delivered of Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, Partnership for Safe Medicines Interchange,\"Administrative Destruction of Certain Drugs Refused Admission to the United St","document_id":"FDA-2014-N-0504-0010"},{"title":"Reference 3 -  Institute of Medicine. \"Countering the Problem of Falsified and Substandard Drugs.\" Administrative Destruction of Certain Drugs Refused Admission to the United States\"","document_id":"FDA-2014-N-0504-0009"},{"title":"Reference 4 - U.S. Food and Drug Administration. \"Health Care Provider Alert: Another Counterfeit Cancer Medicine Found in the United States,\"  Administrative Destruction of Certain Drugs Refused Admission to the United States","document_id":"FDA-2014-N-0504-0008"},{"title":"Reference 5 - Department of Justice, United States Attorney's Office for the Eastern District of Missouri. \"English Citizen Sentenced for Distributing Adulterated and Counterfeit Cancer Drugs.\" Administrative Destruction of Certain Drugs Refused Admission","document_id":"FDA-2014-N-0504-0007"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-0504","supporting_documents_count":15,"docket_id":"FDA-2014-N-0504","regulation_id_number":null,"title":"Administrative Destruction of Certain Drugs Refused Admission to the United States","checked_regulationsdotgov_at":"2014-07-09T05:00:38Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":25758,"subtype":null,"title":"Administrative Destruction of Certain Drugs Refused Admission to the United States","toc_doc":"Administrative Destruction of Certain Drugs Refused Admission to the United States","toc_subject":null,"topics":["Cosmetics","Drugs","Exports","Food labeling","Imports","Labeling","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":79}