Andrew M. Warther, PharmD Expert Witness
Curriculum Vitae

Pharmacy Standard of Care Expert

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Specialties & Experience of this Expert Witness

General Specialties:

Pharmacist

Keywords/Search Terms:

Pharmacy standard of care, Compounding, USP 795, Dispensing errors, Controlled substances DEA, Diversion prevention, Pharmacy negligence, Medical errors, Pharmacist in charge PIC, Board of Pharmacy matters, Pharmacy policies and procedures, Pharmacy operations, Quality assurance, USP 797, USP 800, Sterile, Non-Sterile, Veterinary

Education:

PharmD, South Carolina College of Pharmacy; Bachelor of Science in Retail, University of South Carolina

Years in Practice:

20

Number of Times Deposed/Testified in Last 4 Yrs:

0

Additional Information

I am a PharmD and experienced pharmacy operations and compliance leader with extensive expertise in pharmacy regulatory requirements, pharmacy standard of care, medication-use systems, and quality programs. I provide expert witness services in matters involving pharmacy and pharmacist negligence/standard of care, medication errors, dispensing and verification processes, controlled substance compliance and diversion prevention, policies/procedures (SOPs), documentation and record-keeping, and Board of Pharmacy-related issues. My professional background includes senior leadership roles overseeing day-to-day pharmacy operations, staffing models, workflow design, training programs, and continuous improvement initiatives. I have led and supported internal audits, corrective and preventive actions (CAPA), root cause analysis, and the development/implementation of quality systems to reduce error risk and improve compliance. I am comfortable reviewing and opining on pharmacy practices, corporate policies, and whether actions were consistent with applicable standards, regulations, and reasonable pharmacy practice and standard of care. I also have hands-on and leadership experience with compounding operations, including both sterile and non-sterile workflows and compliance alignment to USP <795>, USP <797>, and USP <800> where applicable. My expertise includes environmental and personnel practices, documentation/logbooks, beyond-use dating practices, and operational controls intended to ensure safe preparation and dispensing. I am available for case screening, record review, written reports/affidavits, deposition, and trial testimony. I work with counsel on clear, practical opinions supported by the evidentiary record, applicable standard of care, and accepted pharmacy practice. Areas of focus include: pharmacy standard of care; medication error and dispensing error cases; controlled substances/DEA compliance; diversion prevention; pharmacist-in-charge (PIC) responsibilities; Board of Pharmacy matters; policies and procedures; quality assurance/quality management systems; compounding pharmacy compliance (USP <795>/<797>/<800>); and veterinary pharmacy. I received my Doctorate of Pharmacy from the South Carolina College of Pharmacy in 2011 and have been actively practicing since that time. I am currently licensed in a dozen states.