Senior Microbiology Consultant Stephen Langille was recently elected to the United States Pharmacopeia’s Compounding Expert Committee for the 2020-2025 cycle. (USP). The role of this Expert Committee is to develop new and revise existing general chapters related to physical analysis (e.g., particles, powders, rheology). USP Expert Committees are responsible for developing and revising USP standards that comprise its compendia: the USP and the NF, USP Compounding Compendium, Herbal Medicines Compendium, Dietary Supplements Compendium, and Food Chemicals Codex. They are each focused on a different area of standards for medicines (including chemical medicines, biologic medicines, excipients, and compounded preparations), dietary supplements, and food ingredients. Expert Committees publish proposed standards for public comment, then review public comments related to the draft standards. The standards are adjusted based on the Expert Committee consideration of the public comments, and then are adopted by those USP expert volunteers by a majority vote.
Stephen Langille, Ph.D., is a senior microbiology consultant at ValSource, Inc. He specializes in microbiological and particulate matter contamination control. He holds a B.S. degree in biology from the University of Massachusetts and a Ph.D. in microbiology from the University of Maryland. He spent 19 years with the FDA as a microbiology reviewer, branch chief, and director of the Division of Microbiology Assessment in the Center for Drug Evaluation and Research.