{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Labeling for Human Prescription Drug and Biological Products--Implementing the PLR Content and Format Requirements.\" This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear; useful; informative; and to the extent possible, consistent in content and format. It will assist applicants in developing labeling for new products, revising existing labeling, and implementing the requirements on content and format of labeling for human prescription drug and biological products (71 FR 3922), which appeared in the Federal Register of January 24, 2006. The rule is commonly referred to as the \"Physician Labeling Rule\" (PLR) because it addresses prescription drug labeling that is used by prescribers and other health care practitioners.","action":"Notice.","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/2013/02/25/2013-04195.html","cfr_references":[],"citation":"78 FR 12760","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2005-D-0153","formerly 2005D-0011"],"dockets":[],"document_number":"2013-04195","effective_on":null,"end_page":12761,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/02/25/2013-04195.xml","html_url":"https://www.federalregister.gov/documents/2013/02/25/2013-04195/guidance-for-industry-on-labeling-for-human-prescription-drug-and-biological-products-implementing","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-04195?publication_date=2013-02-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-02-25/2013-04195/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1902,"last_updated":"2026-10-23 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-02-25/pdf/2013-04195.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-04195.pdf?1361553000","publication_date":"2013-02-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/02/25/2013-04195.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Guidance: Labeling for Human Prescription Drug and Biological Products -- Implementing the New Conte","document_id":"FDA-2005-D-0153-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2005-D-0153","supporting_documents_count":1,"docket_id":"FDA-2005-D-0153","regulation_id_number":null,"title":"Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products","checked_regulationsdotgov_at":"2013-03-17T06:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":12760,"subtype":null,"title":"Guidance for Industry on Labeling for Human Prescription Drug and Biological Products-Implementing the Physician Labeling Rule Content and Format Requirements; Availability","toc_doc":"Implementing the Physician Labeling Rule Content and Format Requirements","toc_subject":"Guidance for Industry on Labeling for Human Prescription Drug and Biological Products; Availability:","topics":[],"type":"Notice","volume":78}