Experience and Credentials

Andrew Warther, PharmD, is a licensed pharmacist with extensive experience in pharmacy operations, quality systems, and regulatory compliance across regulated pharmacy environments, including both compounding and non-compounding practice settings. His professional background includes operational leadership, inspection readiness, and expert witness engagements.

Professional Background

Andrew has served in senior operational and leadership roles with responsibility for day-to-day pharmacy operations, quality systems, regulatory compliance, organizational effectiveness, and facility oversight. His experience includes working directly with pharmacy leadership teams, quality personnel, and operational staff to assess risk, remediate deficiencies, and improve execution in highly regulated environments.

His background combines hands-on operational leadership with a strong understanding of regulatory expectations, inspection readiness, and standard-of-care considerations within pharmacy practice. Engagements are grounded in practical execution, professional judgment, and alignment with applicable regulatory requirements.

  • Areas of expertise reflect hands-on operational leadership, regulatory experience, and professional judgment within pharmacy practice.

    • Pharmacy operations and workflow design

    • Compounding and non-compounding pharmacy practice

    • Quality systems and regulatory compliance

    • Controlled substance regulation and compliance, including DEA and state board of pharmacy requirements

    • Inspection readiness and remediation support

    • SOP development, review, and governance

    • Organizational effectiveness and leadership alignment

    • Interim and advisory leadership support

  • Representative experience includes leadership, advisory, and expert witness engagements across regulated pharmacy environments.

    • Served in senior operational and leadership roles with responsibility for pharmacy operations, quality systems, regulatory compliance, and facility oversight in regulated pharmacy environments.

    • Led and supported inspection readiness activities involving state boards of pharmacy, the DEA, and other regulatory authorities, including gap assessments, corrective action planning, and remediation efforts.

    • Provided operational and compliance leadership for pharmacy organizations subject to controlled substance regulations, including DEA requirements and state board of pharmacy oversight.

    • Evaluated and remediated quality systems, SOPs, workflows, and governance structures to address regulatory risk and improve operational execution.

    • Supported organizations during periods of transition, stabilization, or remediation through interim leadership and advisory engagements.

    • Provided expert witness services involving pharmacy operations, regulatory compliance, and standard-of-care considerations, including record review, regulatory analysis, and written opinions.

  • Doctor of Pharmacy (PharmD)

    • Licensed Pharmacist in multiple U.S. states, with experience supporting pharmacy operations and regulatory compliance across diverse state and federal regulatory environments, including controlled substance requirements.

    Six Sigma Education

    • Formal training in process improvement and operational efficiency methodologies applied within regulated environments.