federal_register: E8-18127

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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
E8-18127 Draft Guidance for Industry on Residual Solvents in Drug Products Marketed in the United States; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Control of Residual Solvents in Drug Products Marketed in the United States."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 This draft guidance reflects FDA's recommendations on how to comply with those USP changes. 2008-08-07 2008 8 https://www.federalregister.gov/documents/2008/08/07/E8-18127/draft-guidance-for-industry-on-residual-solvents-in-drug-products-marketed-in-the-united-states https://www.govinfo.gov/content/pkg/FR-2008-08-07/pdf/E8-18127.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Control of Residual Solvents in Drug Products Marketed in the United States." On July 1, 2008, the United States Pharmacopeia (USP)...  

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