USP and Public Policy

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USP White Paper: Building Geographic Diversity in the Medicines Supply Chain (2023)
Promoting geographic diversification of the manufacturing base for U.S. drug products can help reduce supply chain vulnerabilities. Published December 2023. Learn More
USP Global Public Policy Position: Recognizing Challenges and Opportunities to Support Adoption of Advanced Manufacturing Technologies for Medical Products (2024)
USP Public Policy Position on advanced manufacturing technologies (AMTs) for medical products. Published in 2024. Learn More
USP Statement for the Record: Submitted to the Senate Finance Committee for the Hearing: “Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective” (2023)
United States Pharmacopeia (USP) Statement for the Record Submitted to the Senate Finance Committee for the Hearing: “Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a… Learn More
USP White Paper: Unvalidated methods for medicine quality testing lead to misleading results (2023)
Recently, media reports have highlighted the results of drug quality testing from some contract laboratories that are analyzing the quality attributes of human drug products using testing methods… Learn More
USP White Paper: Advancing Regulatory and Pharmacopeial Convergence, Harmonization, and Global Cooperation to Improve Medicines Supply Chain Resiliency (2023)
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
Reauthorize PAHPA Congress Letter 2023
101 signatures, including USP, wrote to express the collective strong desire to see the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorized before the end of the calendar year in the same… Learn More
USP Global Public Policy Position: Identifying and addressing vulnerabilities in the upstream medicines supply chain to build resilience and reduce drug shortages (2024)
Identifying and addressing vulnerabilities in the upstream pharmaceutical supply chain are essential to mitigating and preventing drug shortages and to ensuring patients have access to the critical… Learn More
USP White Paper: Addressing Barriers to the Development of Complex Generics: Understanding Challenges and Opportunities (2023)
Addressing Barriers to the Development of Complex Generics: Understanding Challenges and Opportunities Learn More
USP Comment Letter: Submitted to Congress on Medicine Supply Chain (2023)
USP Comment Letter to Senators Sanders and Cassidy and Representatives McMorris-Rodgers and Pallone ( ranking members of the Senate HELP Committee and House Energy and Commerce Committee) regarding… Learn More
USP Comment Letter: Submitted to Congress on Request for Information Regarding the Food and Drug Administration Regulation of Cannabidiol (Cannabis) Products (2023)
Submitted August 18, 2023 to Senators Sanders and Cassidy and Representatives McMorris-Rodgers and Pallone regarding the Request for Information Regarding the Food and Drug Administration Regulation… Learn More

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