Compounding From BDS: Understanding FDA’s Final Guidance
April 12, 2023 | 1-2 PM CDT
This presentation is an overview of FDA’s Guidance for Industry #256, “Compounding Animal Drugs from Bulk Drug Substances.” The guidance is intended for veterinarians, state-licensed pharmacies, and federal facilities interested in compounding animal drugs from bulk drug substances for use in nonfood-producing animals, as antidotes in food-producing animals, or as sedatives or anesthetics in free-ranging wildlife under limited circumstances when no other medically appropriate treatment options exist.
The complimentary webinar is eligible for Accreditation Council for Pharmacy Education-accredited continuing pharmacy education (CPE) credit. More details regarding the presentation, CPE activity credits, and browser requirements can be found in the CPE Activity Information Guide.
Amber McCoig, DVM, MPH
Senior Veterinary Medical Officer, US FDA Center for Veterinary Medicine
Amber McCoig is a senior veterinary medical officer, science policy, at United States Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM). Dr McCoig has been with FDA for 15 years, beginning in the Center for Food Safety and Applied Nutrition. During the last 15 years, she has worked on veterinary public health policy issues for CVM with a focus on human food safety, drug residues, animal drug compounding, antimicrobial stewardship, and unapproved drugs. Dr McCoig has served in various capacities for CVM, including as the deputy director for CVM’s Division of Compliance.
Before her tenure with the federal government, Dr McCoig worked in clinical veterinary practice. She earned a bachelor of science degree and a doctor of veterinary medicine degree from the University of Missouri and a master’s degree in public health from Johns Hopkins University with a focus on public health policy communication.
Neal Bataller, ME, DVM
Director, Division of Drug Compliance, US FDA Center for Veterinary Medicine
Neal Bataller is a veterinarian with FDA CVM. He is currently the director of the Division of Drug Compliance, which directs enforcement and regulatory strategies involving FDA-regulated entities, such as animal drug and devices companies. Dr Bataller was previously the director of the FDA CVM Office of Surveillance and Compliance (OS&C), which deals with all other aspects of drugs that are marketed and used in animals. He was also previously the director of the OS&C Division of Drug Compliance, which addresses all animal drugs, devices, and food. For a short time, he was at the US Department of Agriculture Animal and Plant Health Inspection Service, where he worked on the transition of bovine spongiform encephalopathy (BSE) surveillance to a long-term program. During his career, Dr Bataller has worked on a variety of issues, including melamine in animal feed, animal drug residues, BSE prevention, monkeypox, animal drug compounding, and antimicrobial resistance.