{"abstract":"The Food and Drug Administration (FDA) is amending 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 permitting 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 than permitted by current CGMPs.","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/2012/03/20/2012-6502.html","cfr_references":[{"chapter":null,"citation_url":null,"part":211,"title":21}],"citation":"77 FR 16158","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This final rule is effective on March 20, 2013, except for the amendment adding Sec. 211.122(g)(4), which is effective April 19, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-1997-N-0518"],"dockets":[],"document_number":"2012-6502","effective_on":"2013-03-20","end_page":16163,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/03/20/2012-6502.xml","html_url":"https://www.federalregister.gov/documents/2012/03/20/2012-6502/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/2012-6502?publication_date=2012-03-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-03-20/2012-6502/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":7804,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-03-20/pdf/2012-6502.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-06502.pdf?1332161794","publication_date":"2012-03-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/03/20/2012-6502.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-1997-N-0518","supporting_documents_count":0,"docket_id":"FDA-1997-N-0518","regulation_id_number":null,"title":"CGMP in Mfg. Processing, Packing or Holding of Drugs; Revisi","checked_regulationsdotgov_at":"2012-04-27T21:51:30Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16158,"subtype":null,"title":"Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls","toc_doc":"Revision of Certain Labeling Controls","toc_subject":"Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs:","topics":["Drugs","Labeling","Laboratories","Packaging and containers","Prescription drugs","Reporting and recordkeeping requirements","Warehouses"],"type":"Rule","volume":77}