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Amy Summers

Project Lead, 503A & 503B Compounding

Amy Summers, PharmD, BCSCP is an independent consultant, specializing in business, operations, quality assurance, and regulatory compliance matters for the pharmaceutical compounding industry. 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. She has formerly served as Director of Operations and Pharmacist in Charge at organizations engaged in compounding and also as Managing Director of a FDA-registered 503B outsourcing facility. With extensive experience in USP standards, accreditation, cGMP, and regulatory compliance, Dr. Summers has also served as an expert witness for matters related to compounding.


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