USP Honors Volunteers on the Cutting Edge of Ensuring the Quality and Supply of Medicines and Foods 

USP Expert Volunteers and Government Liaisons direct our work to improve global public health through public standards and related programs that help to ensure the quality of medicines and foods. A volunteer selection committee issues annual recognition to volunteers whose contributions exemplify our mission. 

Honoring leadership and collaboration: The USP Jacob Bigelow Award 

The USP Jacob Bigelow Award—named for the leading botanist and Harvard Medical School Medical Professor who co-founded USP and was an important figure in the development of the first American pharmacopeia in 1820—acknowledges outstanding contributions by an individual volunteer. It is presented in recognition of exceptional dedication and important contributions to the achievement of USP standards-setting and highlights an individual’s impact on or improvement of USP’s standards-setting processes. 

James De Muth, Ph.D., received the 2019 Jacob Bigelow Award in recognition of his contributions to the Statistics Expert Committee and General Chapters–Dosage Forms Expert Committee.  

Dr. De Muth guided Expert Committee members to ensure each member contributed their best effort and fostered an environment that encouraged collaboration and diverse perspectives. With Dr. De Muth as Chair, the General Chapters–Dosage Forms Expert Committee developed and revised several major general chapters and organized several workshops. Under his leadership, the EC was very productive and efficient through the revisions process. Dr. De Muth exemplifies what it means to be an Expert Committee Chair. 

Karen McCullough, M.S., received the 2020 Jacob Bigelow Award in recognition of her contributions to the General Chapters–Microbiology Expert Committee.  

Karen proposed, outlined, and co-authored a new general information chapter, <1085>, to fill a gap in industry education and understanding relevant practices, which is critical to patient safety. She collaborated with FDA experts to revisit a removed legacy FDA guidance document, the Limulus Amoebocyte Lysate (LAL) guideline, and incorporated this valuable information into the new <1085>.  She also proposed, outlined, and co-authored a second new general information chapter, <1085.1>, to begin a typical USP process of recognition and evaluation of new methodology for bacterial endotoxin testing. She successfully led Bacterial Endotoxins subcommittee discussions in weekly meetings for two years consistently and was able to keep the subcommittee members involved and aware of critical information being developed in industry regarding the new methods. She exemplifies what it means to be a USP Volunteer: by being a leader, facilitator, good listener, and an organized coach of fellow expert volunteers. Her passion for patient safety, industry standard-setting, and volunteering represents the best of USP Expert Volunteers. 

Improving global health in the face of challenge: The USP Award for Outstanding Contribution to the Standards 

The USP Award for Outstanding Contribution to the Standards recognizes the remarkable contributions of our volunteer bodies that work to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. Candidacy for this award is open to all volunteer bodies operating anywhere in the world that are affiliated with USP.  

This award honors the contributions of the Nitrosamines Joint Subcommittee and the Healthcare Safety and Quality Expert Committee, which exemplify the spirit of voluntarism that defines USP’s commitment to address public health challenges. USP will send certificates to all members and Government Liaisons of these volunteer bodies. 

Record-setting standards development by the Nitrosamines Joint Subcommittee  

The Nitrosamines Joint Subcommittee, responsible for developing the General Chapter  <1469> Nitrosamine Impurities in record time, received the FY 2019 USP Award for Outstanding Contribution to the Standards.  

In response to public health concerns regarding harmful levels of nitrosamine impurity, N-nitrosodimethylamine (NDMA), in February 2020 USP convened the Nitrosamine Impurities Joint Subcommittee with the charge to develop a roadmap for USP to create public standards and assist in other activities regarding Nitrosamine topics. The joint subcommittee successfully completed a very significant deliverable—the development of Chapter <1469> Nitrosamine Impurities—in the shortest time span ever recorded for development and having official status for a new general chapter public standard. The standard developed by the team is a very high-impact public health standard. All members of this Joint Subcommittee collaborated on efforts and used high levels of creativity to make possible the completion of the chapter and addressing challenges in a developing area. This award recognizes the effort, commitment, and dedication of the members to USP's public standards with a sense of urgency when a public health crisis is concerned.  

Nitrosamines Joint Subcommittee Members 

Rising to meet pandemic challenges: Healthcare Safety and Quality Expert Committee  

The Healthcare Safety and Quality Expert Committee (HSQ EC), responsible for addressing current public health needs, including the handling of COVID-19 vaccines and opioids, received the FY 2020 USP Award for Outstanding Contribution to the Standards.  

During the very first year of the 2020–2025 cycle, the HSQ EC’s list of accomplishments is lengthy and includes developing and publishing the USP COVID-19 Vaccine Handling Toolkit and the USP International COVID-19 Vaccine Handling Guide. The HSQ EC worked quickly and efficiently to develop the USP COVID-19 Vaccine Handling Toolkit during the pandemic and provided critical information gaps and strategies for improved COVID-19 vaccine rollout. The useful information in the toolkit provided answers to many questions in one place, helping to minimize waste, maximize shots in arms, and increase confidence in consistent procedures across vaccination sites. Some sites reported operational efficiencies resulting in 50% more immunizations delivered in a day. This award recognizes the agility, commitment, and productivity of the members and their work with the COVID-19 Vaccine Handling Toolkit and its positive impact both on the pandemic and on the perception of USP. 

The HSQ EC also provided feedback on the USP Medicine Supply Map, an innovative insights platform to support early detection and prevention of drug shortages; successfully published a revision to General Chapter <17> Prescription Container Labeling, which includes a framework for opioid warning label development to mitigate misuse of opioids; and successfully published the USP Drug Classification 2021, USP’s independent classification system developed in response to stakeholder input. 

Healthcare Safety and Quality Expert Committee Members 

Please join us in congratulating the selected volunteer bodies who have exemplified the spirit of voluntarism that defines USP’s commitment to address public health challenges. 

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