{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products.\" This guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research's (CDER's) current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). In particular, the guidance recommends that the pharmaceutical industry avoid the use of these two specific phthalates as excipients in CDER-regulated drug and biologic products, including prescription and nonprescription products.","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/2012/12/06/2012-29461.html","cfr_references":[],"citation":"77 FR 72869","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-2012-D-1135"],"dockets":[],"document_number":"2012-29461","effective_on":null,"end_page":72870,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/12/06/2012-29461.xml","html_url":"https://www.federalregister.gov/documents/2012/12/06/2012-29461/guidance-for-industry-on-limiting-the-use-of-certain-phthalates-as-excipients-in-center-for-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-29461?publication_date=2012-12-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-12-06/2012-29461/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1352,"last_updated":"2026-08-26 04:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-12-06/pdf/2012-29461.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-29461.pdf?1354742624","publication_date":"2012-12-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/12/06/2012-29461.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-2012-D-1135","supporting_documents_count":0,"docket_id":"FDA-2012-D-1135","regulation_id_number":null,"title":"Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products; Availability","checked_regulationsdotgov_at":"2012-12-26T06:00:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":72869,"subtype":null,"title":"Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products; Availability","toc_doc":"Limiting Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products","toc_subject":"Guidances for Industry; Availability:","topics":[],"type":"Notice","volume":77}