Amy Summers, PharmD, BCSCP is a consultant for Restore Health Consulting, specializing in business, operations, quality assurance, and regulatory compliance matters for the compounding pharmacy and pharmaceutical manufacturing industries. She earned her PharmD degree from the University of California San Francisco and was among the first pharmacists in the nation to earn a Board Certified Sterile Compounding Pharmacist (BCSCP) credential. Dr. Summers has spent her entire career as a pharmacist in various settings centered around non-sterile and sterile compounding as well as pharmaceutical manufacturing. She has formerly served as Director of Operations and Pharmacist in Charge at a handful of organizations engaged in compounding and also as Managing Director of a FDA-registered 503B outsourcing facility. With extensive experience in USP 797, USP 795, USP 800, PCAB accreditation, state Board of
Pharmacy and FDA compliance and inspections, cGMP, and 21 CFR 211, Dr. Summers also serves as an expert witness for all matters related to pharmacy compounding, and provides evidence review, reports and testimony.
