federal_register: E9-28247

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
E9-28247 Guidance for Industry on Residual Solvents in Drug Products Marketed in the United States; Availability Notice 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. 2009-11-25 2009 11 https://www.federalregister.gov/documents/2009/11/25/E9-28247/guidance-for-industry-on-residual-solvents-in-drug-products-marketed-in-the-united-states https://www.govinfo.gov/content/pkg/FR-2009-11-25/pdf/E9-28247.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...  

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