USP Standards Setting – How Pharmacy Can Engage

CEO, VetPharm Consulting

Gigi Davidson is the chief executive officer of VetPharm Consulting and former pharmacy director at the North Carolina State University College of Veterinary Medicine. Davidson is a veterinary pharmacy leader with more than 40 years of experience. Her work has focused on the safety, stability, and efficacy of compounded therapies in non-human species, and is currently leading efforts to establish veterinary pharmacy as a recognized pharmacy specialty. Davidson has served as president of the Society of Veterinary Hospital Pharmacists and the American College of Veterinary Pharmacists (ACVP) and represents ACVP on the American Pharmacists Association House of Delegates, advocating for recognition of animals as patients. She chaired the USP Compounding Expert Committee from 2010 to 2020, and in 2015, became the first female and first veterinary recipient of USP’s Beal Award. In 2025, she received the University of North Carolina (UNC) Distinguished Alumna Award for her contributions to the pharmacy profession. Davidson graduated from the UNC and is a diplomate of the International College of Veterinary Pharmacy.

Emeritus Research Services, University of Wisconsin-Madison

Dr Elder is semi-retired from the University of Wisconsin-Madison (UW-Madison) School of Pharmacy following a career that included pharmaceutical industry and academia. Dr Elder is a part-time instructor for industry-focused continuing education in the UW-Madison School of Pharmacy and for the Master of Science in Biotechnology program in the UW-Madison School of Medicine and Public Health. Dr Elder has been a member of the USP Compounding Expert Committee since 2010 and currently serves as the vice chair.

Pharmacy Program Manager – Sterile Compounding, Lexington VA Health Care System

Dr Hawkins is the Compounding and Hazardous Drug Pharmacy Program manager at the Lexington VA Health Care System, where she oversees compounding operations, regulatory compliance, and quality assurance across acute care, residential, and outpatient specialty clinics ranging from ophthalmology to chemotherapy to urology. She played a key role in implementing remote infusion sites, expanding veterans’ access to specialty infusions throughout Kentucky. She has served on the Board of Pharmacy Specialties’ Sterile Compounding Specialty Council since 2021 and is currently serving on USP’s Compounding Expert Committee. A double board-certified pharmacist, published author, and national speaker, she has a passion for emergency management with deployment history to aid in disaster relief. Dr Hawkins holds several leadership certifications and enjoys mentoring the next generation of compounding pharmacists. Dr Hawkins received her doctor of pharmacy degree from Ohio Northern University.

Owner and Consultant, Compounding Consultants, LLC

Brenda Jensen, owner of Compounding Consultants, LLC, has helped hundreds of compounding facilities improve compounding quality and safety by assisting with compliance and training. Jensen is involved with numerous pharmacy-related organizations and has held multiple leadership positions within these organizations. She began volunteering with USP in 2013 and currently chairs the Compounding Expert Committee. Jensen received her bachelor’s and master’s degrees from the University of Sioux Falls.

Senior Scientist, United States Pharmacopeia

Nicole Mercogliano, is a senior scientist for the Compounding Expert Committee within USP’s Healthcare Quality and Safety Center of Excellence. She collaborates with expert volunteers and stakeholders to support the development and revision of compounding documentary standards. Mercogliano is a board-certified sterile compounding pharmacist with over 12 years of experience in community and hospital pharmacy, drug safety and pharmacovigilance, and pharmaceutical manufacturing. Prior to joining USP, she held a leadership role at Suburban Hospital – Johns Hopkins Medicine, where she led regulatory readiness, medication safety initiatives, and sterile and nonsterile compounding operations. Mercogliano holds a bachelor of science degree in industrial pharmacy from the University of the Philippines and a master of science in regulatory science from the University of Maryland, Baltimore, and is currently completing her doctor of pharmacy program at Massachusetts College of Pharmacy and Health Sciences (MCPHS).

System Sterile Compounding Services Specialist, Prisma Health

George R. Smith, is currently serving as the system sterile compounding services specialist at Prisma Health, where he oversees 25 sterile compounding areas, including 2 centralized compounding suites and 6 ambulatory oncology infusion facilities.  With more than 20 years of experience in sterile compounding, Dr Smith has held many leadership roles spanning home infusion, sterile compounding automation, and health-system pharmacy. He is double board-certified in pharmacotherapy and sterile compounding through the Board of Pharmacy Specialties. Prior to rejoining Prisma Health in in 2023, he served as the director and pharmacist consultant of a robotic sterile compounding automation device where he developed expertise in cleanroom design, USP <797> Category 3 compounding operations, process validation, product development and Good Manufacturing Practices in the 503B outsourcing facility space. He was appointed to the USP Compounding Expert Committee and serves as a clinical instructor in sterile compounding for the Kennedy Pharmacy Innovation Center at the University of South Carolina College of Pharmacy. Dr Smith is an American Journal of Health-System Pharmacy (AJHP) peer reviewer and field-tester for American Society of Health-System Pharmacists’ (ASHP) Compounded Sterile Preparation Studies for Recertification.