{"abstract":"The Food and Drug Administration (FDA) is proposing to amend the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also proposing to permit the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques.","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/1997/07/29/97-19817.html","cfr_references":[{"chapter":null,"citation_url":null,"part":211,"title":21}],"citation":"62 FR 40489","comment_url":null,"comments_close_on":"1997-10-27","correction_of":null,"corrections":[],"dates":"Comments by October 27, 1997. FDA proposes that any final rule that may issue based on this proposal become effective 6 months after its date of publication in the Federal Register.","disposition_notes":null,"docket_ids":["Docket No. 97N-0300"],"dockets":[],"document_number":"97-19817","effective_on":null,"end_page":40492,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1997/07/29/97-19817/current-good-manufacturing-practice-in-manufacturing-processing-packing-or-holding-of-drugs-revision","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/97-19817?publication_date=1997-07-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1997-07-29/97-19817/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":78,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1997-07-29/pdf/97-19817.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1997-07-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1997/07/29/97-19817.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":40489,"subtype":null,"title":"Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls","toc_doc":null,"toc_subject":null,"topics":[],"type":"Proposed Rule","volume":62}