USP and Public Policy

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USP White Paper: Advancing Regulatory and Pharmacopeial Convergence, Harmonization, and Global Cooperation to Improve Medicines Supply Chain Resiliency

The U.S. Pharmacopeia (USP) recognizes that global coordination, harmonization, and convergence efforts among governments and other stakeholders can facilitate and streamline responses and solutions… Learn More

USP Comments to FDA on the FDA Food Safety Modernization Act -Focus on Inspections and Compliance (2011)

USP comments to FDA on “FDA Food Safety Modernization Act: Focus on Inspections and Compliance” Docket No. FDA-2011-N-0366. Comments were submitted in 2011. Learn More

USP Comments to FDA on Food Chemicals Codex (2011)

USP comments to FDA on “Periodic Review of Existing Regulations: Retrospective Review Under E.O. 13563.” Docket No. FDA–2011–N–0259. Comments were submitted in 2019. Learn More

USP Comment to FDA on Food Safety Modernization Act-Title III (2011)

USP comments to FDA on "FDA Food Safety Modernization Act: Title III--A New Paradigm for Importers. Docket Nos. FDA-2011-N-0134, FDA-2011-N-0143, FDA-2011-B-0144, FDA-2011-N-0145, and FDA-2011-N… Learn More

USP comments to FDA on the Novel Excipient Review Program (2020)

USP Comments to FDA on Docket No. FDA-2019-N-5464 for Novel Excipient Review Program Proposal; Comments were submitted in 2020. Learn More

USP comments to FDA on the Inactive Ingredient Database (IID) and Maximum Daily Exposure (MDE) Information (2022)

USP comments to FDA on Docket No. FDA-2022-N-0236 for “Prioritizing the Addition of Maximum Daily Exposure Information and Removing Dosage Form Information from the Inactive Ingredient Database.… Learn More

USP Oral comments to FDA on Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc (2020)

USP Oral Comments to FDA on Docket No. FDA-2020-N-0025; Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc Learn More

USP Comments to FDA on Inactive Ingredient Database (Excipients) (2015)

USP Comments to FDA on draft guidance for Inactive Ingredient Database. Comments were submitted in 2015. Learn More

USP submitted comments to FDA on Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc (2020)

USP submitted comments to FDA on Docket No. FDA-2020-N-0025; "Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc" Comments were submitted in 2020. Learn More

USP comments for FDA on Draft Guidance for Inactive Ingredient Database (IID) (2019)

USP Comments to FDA on Docket No. FDA-2019-D-2397; Using the Inactive Ingredient Database; Draft Guidance for Industry. Comments were submitted in 2019. Learn More

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