The U.S. Pharmacopeia is implementing a comprehensive program to support the public health response to the COVID-19 pandemic. Our immediate work is focused on facilitating the supply of quality medicines from across the global supply chain – especially for those medicines that treat symptoms associated with the virus – by working closely with regulators, manufacturers and other stakeholders around the world. We also are engaging in middle and long-term activities to assess vulnerabilities in the global supply chain for medicines, advocate for greater transparency and more diversity in the sources of medicines and their ingredients, and ultimately help build a more resilient supply chain.
Our current activities include:
- Ensuring the availability of USP public quality standards – 6,800 documentary and reference standards build trust and confidence in the safety of medicines throughout the global supply chain
- Documentary standards or monographs establish the quality expectations for a medicine including for its identity, strength, purity, and performance, along with the tests to validate that a medicine and its ingredients meet these criteria
- Material reference standards are used in conjunction with monographs and general chapters to verify that a medicine and its ingredients can pass tests to ensure adherence to quality requirements
- Supporting drug and vaccine development for COVID-19 – expand access to standards to manufacturers and regulators to help alleviate potential drug shortages, with a focus on the antibiotics and fever-reducing medicines that treat symptoms and infections related to COVID-19. Work with developers and manufacturers of vaccines and drugs to facilitate development and production of COVID-19 medicines
- Developing insights on acute supply chain vulnerabilities – support greater transparency in the supply chain by sharing USP’s exclusive data, such as global distribution of material reference standards and online user data of documentary standards
- Advocating for investment and policy reform to advance a more resilient supply chain – engage with policy makers, regulators and other stakeholders to increase awareness of supply chain vulnerabilities and highlight potential solutions
- Building the capabilities needed to optimize standards – expand training and education programs to strengthen regulator, manufacturer ability to utilize public quality standards to accelerate methods to support vaccines and drugs in response to COVID-19
- Support expansion of advanced pharmaceutical manufacturing technologies (e.g. continuous manufacturing) – develop standards and other solutions that help make possible higher quality production at potentially lower costs, and can increase geographic diversity and options for manufacturing
- Strengthening health systems in low- and middle-income countries – expand the supply of safe, quality medicines through the Promoting the Quality of Medicines Plus program (PQM+), funded by USAID and implemented by USP. We will regularly update and share our work to support the public health response to the COVID-19 pandemic.
- Addressing shortages associated with the COVID-19 pandemic – the USP Compounding Expert Committee developed recommendations to help conserve garbing and PPE and for compounding alcohol-based hand sanitizers
- Keeping stakeholders updated on USP Reference Standards