{"abstract":"The Food and Drug Administration (FDA) is amending its regulations on tamper-resistant packaging to require that all over-the- counter (OTC) human drug products marketed in two-piece, hard gelatin capsules be sealed using a tamper-evident technology; to change the term ``tamper-resistant'' in the labeling of all OTC drug products to ``tamper-evident;'' and to specify that the required OTC drug product labeling statement must refer to all packaging features used to comply with the tamper-evident packaging requirements, including those on the secondary package, the immediate container or closure, and any capsule sealing technologies used. FDA is taking this action as a result of its continuing review of the potential public health threat posed by product tampering and to improve consumer protection by addressing specific vulnerabilities in the OTC drug market.","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/1998/11/04/98-29388.html","cfr_references":[{"chapter":null,"citation_url":null,"part":211,"title":21}],"citation":"63 FR 59463","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective December 4, 1998.","disposition_notes":null,"docket_ids":["Docket No. 92N-0314"],"dockets":[],"document_number":"98-29388","effective_on":"1998-12-04","end_page":59471,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1998/11/04/98-29388/tamper-evident-packaging-requirements-for-over-the-counter-human-drug-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/98-29388?publication_date=1998-11-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1998-11-04/98-29388/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":664,"last_updated":"2026-09-21 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1998-11-04/pdf/98-29388.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1998-11-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1998/11/04/98-29388.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T12:16:33Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59463,"subtype":null,"title":"Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":63}