USP and Public Policy
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Compounding of medicines has a longstanding history and remains an important aspect of pharmacy practice. USP compounding standards serve as an integral part of the legal and regulatory frameworks…
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Antimicrobial resistance (AMR) presents a catastrophic risk to human health and life around the globe. the U.S. Pharmacopeial Convention (USP) engages in global policy dialogue to advance medicines…
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USP supports comprehensive policies and programs to address AMR, including building capabilities among global stakeholders to reduce the proliferation of poor-quality medicines and advocating and…
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Submitted on September 18, 2017 - USP Comment Letter to FDA in conjunction with the July 18, 2017 meeting on “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and…
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USP comments to FDA for Docket no. FDA-2008-D-0381 Draft Guidance for Industry on Voluntary Third-Party Programs for Food and Feeds. Comments were submitted in 2008.
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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.
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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.
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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…
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USP Comments to FDA on Docket No. FDA-2019-N-5464 for Novel Excipient Review Program Proposal; Comments were submitted in 2020.
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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.…
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