{"abstract":"The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the \"Pregnancy,\" \"Labor and delivery,\" and \"Nursing mothers\" subsections of the \"Use in Specific Populations\" section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the \"Labor and delivery\" subsection because information about labor and delivery is included in the \"Pregnancy\" subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.","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/2014/12/04/2014-28241.html","cfr_references":[{"chapter":null,"citation_url":null,"part":201,"title":21}],"citation":"79 FR 72064","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective June 30, 2015. See section IV of this document for the implementation dates of this final rule.","disposition_notes":null,"docket_ids":["Docket No. FDA-2006-N-0515 (formerly Docket No. 2006N-0467)"],"dockets":[],"document_number":"2014-28241","effective_on":"2015-06-30","end_page":72103,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/12/04/2014-28241.xml","html_url":"https://www.federalregister.gov/documents/2014/12/04/2014-28241/content-and-format-of-labeling-for-human-prescription-drug-and-biological-products-requirements-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-28241?publication_date=2014-12-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-12-04/2014-28241/mods.xml","not_received_for_publication":null,"page_length":40,"page_views":{"count":79763,"last_updated":"2026-09-29 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-12-04/pdf/2014-28241.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-28241.pdf?1417614805","publication_date":"2014-12-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/12/04/2014-28241.txt","regulation_id_number_info":{"0910-AF11":{"issue":"201410","html_url":"https://www.federalregister.gov/regulations/0910-AF11/content-and-format-of-labeling-for-human-prescription-drugs-and-biologics-requirements-for-pregnancy","title":"Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201410&RIN=0910-AF11&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AF11"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 4 Evaluation of How Best to Communicate with Healthcare Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women A Mental Models Research Report Final Report re Ref2 Final Regulatory Impact Analysis for Dock","document_id":"FDA-2006-N-0515-0091"},{"title":"Reference 3 Final Report Evaluation of How Best to Communicate to Healthcare Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women re Ref2 Final Regulatory Impact Analysis for Docket No. FDA-2006-N-0515 (formerly D","document_id":"FDA-2006-N-0515-0090"},{"title":"Reference 2 O'Reilly, Pharma scales back drug samples to physician offices re Ref2 Final Regulatory Impact Analysis for Docket No. FDA-2006-N-0515 (formerly Docket No. 2006N-0467)","document_id":"FDA-2006-N-0515-0089"},{"title":"Reference 1 U.S. Bureau of Labor Statistics Occupational Employment Statistics May 2011 National Industry-Specific Occupational Employment and Wage Estimates NAICS 325400 - Pharmaceutical and Medicine Manufacturingre Ref2 Final Regulatory Impact Analysis ","document_id":"FDA-2006-N-0515-0088"},{"title":"Reference 18 U.S. Food and Drug Administration, \"Draft Guidance for industry Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling,\" re Content and Format of Labeling for Human Prescription Drug and Biological Products;","document_id":"FDA-2006-N-0515-0087"},{"title":"Reference 17 - Sachs, H. C. and Committee on Drugs. \"The Transfer of Drugs and Therapeutics Into Human Breast Milk: An Update on Selected Topics.\" re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Preg","document_id":"FDA-2006-N-0515-0086"},{"title":"Reference 16 - American Academy of Pediatrics Policy Statement. \"Breastfeeding and the Use of Human Milk.\" re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling","document_id":"FDA-2006-N-0515-0085"},{"title":"Reference 15 - Anderson, G. D., \"Pregnancy-Induced Changes in Pharmacokinetics.\" re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling","document_id":"FDA-2006-N-0515-0084"},{"title":"Reference 14 - Tracy, T. S., et al. \"Temporal Changes in Drug Metabolism (CYP1A2, CYP2D6 and CYP3A Activity) During Pregnancy.\" re Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation","document_id":"FDA-2006-N-0515-0083"},{"title":"Reference 13 - FDA, \"Guidance for industry, M3 (R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing\nAuthorization for Pharmaceuticals and the International Conference on Harmonisation S5 (R2) Guideline: Detection of Toxic","document_id":"FDA-2006-N-0515-0082"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2006-N-0515","supporting_documents_count":24,"docket_id":"FDA-2006-N-0515","regulation_id_number":null,"title":"Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling","checked_regulationsdotgov_at":"2015-01-12T19:20:26Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":72064,"subtype":null,"title":"Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling","toc_doc":"Pregnancy and Lactation Labeling Requirements","toc_subject":"Content and Format of Labeling for Human Prescription Drug and Biological Products:","topics":["Drugs","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":79}