{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Residual Solvents in Drug Products Marketed in the United States.\" On July 1, 2008, the United States Pharmacopeia (USP) published a new test requirement for the control of residual solvents, General Chapter <467> \"Residual Solvents,\" which replaced USP General Chapter <467> \"Organic Volatile Impurities.\" The change affects all compendial drug products marketed in the United States. This guidance reflects FDA's recommendations on how to comply with those USP changes.","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/2009/11/25/E9-28247.html","cfr_references":[],"citation":"74 FR 61692","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-D-0413"],"dockets":[],"document_number":"E9-28247","effective_on":null,"end_page":61693,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/11/25/E9-28247.xml","html_url":"https://www.federalregister.gov/documents/2009/11/25/E9-28247/guidance-for-industry-on-residual-solvents-in-drug-products-marketed-in-the-united-states","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-28247?publication_date=2009-11-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-11-25/E9-28247/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":492,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-11-25/pdf/E9-28247.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-11-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/11/25/E9-28247.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2020-05-17T16:30:27Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":61692,"subtype":null,"title":"Guidance for Industry on Residual Solvents in Drug Products Marketed in the United States; Availability","toc_doc":"Residual Solvents in Drug Products Marketed in the United States","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":74}