{"abstract":"The Food and Drug Administration (FDA) is proposing a regulation to implement administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). Once the applicable regulation is finalized, FDA's administrative detention authority with respect to drugs will allow FDA to better protect the integrity of the drug supply chain. Specifically, FDA will be able to administratively detain drugs encountered during an inspection that an officer or employee conducting an inspection has reason to believe are adulterated or misbranded. This authority is intended to protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate.","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/2013/07/15/2013-16843.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1,"title":21},{"chapter":null,"citation_url":null,"part":16,"title":21}],"citation":"78 FR 42382","comment_url":null,"comments_close_on":"2013-09-13","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by September 13, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0365"],"dockets":[],"document_number":"2013-16843","effective_on":null,"end_page":42386,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/07/15/2013-16843.xml","html_url":"https://www.federalregister.gov/documents/2013/07/15/2013-16843/administrative-detention-of-drugs-intended-for-human-or-animal-use","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-16843?publication_date=2013-07-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-07-15/2013-16843/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":1308,"last_updated":"2026-07-26 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-07-15/pdf/2013-16843.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-16843.pdf?1373633356","publication_date":"2013-07-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/07/15/2013-16843.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0365","supporting_documents_count":0,"docket_id":"FDA-2013-N-0365","regulation_id_number":null,"title":"Establishment of a Public Docket for Administrative Detention under Section 709 of the Food and Drug Administration Safety and Innovation Act - CLOSED","checked_regulationsdotgov_at":"2013-09-21T05:00:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":42382,"subtype":null,"title":"Administrative Detention of Drugs Intended for Human or Animal Use","toc_doc":"Administrative Detention of Drugs Intended for Human or Animal Use","toc_subject":null,"topics":["Administrative practice and procedure","Cosmetics","Drugs","Exports","Food labeling","Imports","Labeling","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":78}