FDA's New Guidance on Compounding Bulk Drug Substances

<p>Since 2008, Dr. Bailey has been part of OMUMS, where she has served as a regulatory review scientist managing all aspects of the program administering the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. Prior to joining the OMUMS staff, she was a reviewer on the Antimicrobial Drugs Team, Division of Food Animal Drugs in CVM’s Office of New Animal Drug Evaluation.&nbsp;</p><p>Dr. Bailey received her DVM from the Virginia-Maryland College of Veterinary Medicine. She did her undergraduate work at Clemson University and Sweet Briar College.&nbsp;</p>

<p>Amber McCoig, DVM, MPH, is a Senior Veterinary Medical Officer at the U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM). Guided by One Health principles and a science-based regulatory approach that examines the intersection of human and animal health, Dr. McCoig’ s expertise includes human and animal food safety, animal drugs and drug residues, and antimicrobial stewardship. Dr. McCoig advises on policy issues and is the principal coordinator for CVM’s international antimicrobial resistance, judicious use and drug residue efforts, and unapproved animal drug compounding policies. During her fifteen years with FDA, she has served in many roles, including Deputy Director for CVM’s Division of Compliance.<br><br>Before coming to the federal government, Dr. McCoig worked in clinical veterinary practice. She is an adjunct professor for the University of Missouri’s School of Health Professionals. Dr. McCoig earned a Bachelor of Science and Doctor of Veterinary Medicine from the University of Missouri and a Master’s in Public Health from Johns Hopkins University with a focus on Public Health Policy Communication.</p>

<p>Nicolette Petervary, VMD, MS, DACAW is Director of the Division of Policy and Education in the Office of Laboratory Animal Welfare at the National Institutes of Health and was formerly the National Animal Welfare Specialist for Animal Welfare Operations, USDA, APHIS, Animal Care. Prior to her government positions, she was in private small and exotic animal practice and worked as a research associate at the University of California (Davis and San Francisco Campuses). She has engaged in basic research in genomics and behavioral neuroscience as well as in clinical research projects. Dr. Petervary graduated from the University of Pennsylvania School of Veterinary Medicine, holds an MS in comparative biomedical sciences from North Carolina State University, and is a diplomate of the American College of Animal Welfare.</p>