Specialty Council on Compounded Sterile Preparations Pharmacy

2023 Members

Barbara A. Knightly, PharmD, RPh {Chair}
CSP_KnightlyKnightly brings over 25 years of pharmacy regulatory leadership, including sterile compounding, long-term care consulting, and home infusion experience. She completed her BS in Pharmacy from Philadelphia College of Pharmacy and Sciences and received her Doctorate of Pharmacy from the University of Kansas. Prior to joining InfuCare RX overseeing Pharmacy Quality and Regulatory Operations, her experiences included Pentec Health, Walgreens (Option Care) Home Infusion and Christiana Care Infusion Services as well as the Director of Pharmacy for Cardiac Solutions, a national company specializing in disease management programs for CHF, CAD, COPD and DM and having a centralized pharmacy. She was also the recipient of SmartCEO’s Executive Management Award in 2015.

Kathleen J. Kane, PharmD, BCSCP, DPLA {Vice Chair}
 Over the past thirteen years, Dr. Kane focused her career on compounding pharmacy. While working in community, institutional, and industry settings she developed extensive expertise on the evolving compounding regulation standards. Prior to beginning pharmacy school, Dr. Kane was laboratory manager for an independent community compounding pharmacy. Dr. Kane graduated from Chicago State University-College of Pharmacy with a PharmD degree in 2014. During her time there she focused her studies on improving the focus on compounding within the curriculum. She led the creation of compounding training videos and establishing CSU-COP as a competitor in the regional and national SPCC- Student Pharmacist Compounding Competition. After graduation, Dr. Kane expanded her knowledge by working on Phase 1 and Phase 2 clinical trials with a local drug manufacturer. Currently at University of Chicago, she is working on designing and constructing cleanroom spaces that meet the new cGMP and USP standards.

Nicholas D. Baker, MPH, PharmD, BCPS, BCSCP
Nicholas D. Baker, MPH, PharmD, BCPS, BCSCP is a Regional Director for Pharmacy Operations in northern California for Kaiser Permanente. He earned his Master of Public Health from San Jose State and his Doctor of Pharmacy degree from the University of the Pacific. His post graduate managed care residency training was completed at Kaiser Permanente in the central valley of California. He oversees pharmacy operations including budgeting, workflow design and implementation, policy development, regional training programs, complex supply chain logistics, business continuity planning, technology implementation, and resource planning for the ambulatory care infusion pharmacies in the region.

Mike Carroll, BSPharm, RPh, BCSCP
Carroll is the Senior Director of Pharmacy for Option Care Health, the nation’s largest independent provider for home infusion therapy. He has national responsibility for the companies 94 clean rooms as well as all sterile compounding related practices. Carroll has over 20 years in pharmacy leadership in both the home infusion and health system fields. He specializes and clean room and facility design as well as compliance with compounding and regulatory standards. Mike is a graduate of the University of Rhode Island where he received a Bachelor of Science degree. He sits on the Vermont Board of Pharmacy where he served as Vice Chair for 2021.

Jessica Hawkins, PharmD, BCSCP, BCPS
JHawkinsHawkins is the Sterile Compounding Pharmacy Program Manager at the Lexington VA Health Care System in Lexington, KY.  She coordinates and oversees compounding activities for the medical facility’s main hospital and long-term care center, as well as a variety of outpatient specialty clinics including urology, ophthalmology, infusion, dermatology, and chemotherapy.  She earned her PharmD from Ohio Northern University and completed a Pharmacy Practice residency at Baptist Health Lexington.

Sarrah Hein, PharmD, BCPPS
 I am currently a pharmacy manager at Akron Children’s Hospital- Mahoning Valley Campus. I also act as the clinical specialist for our level 3 Neonatal Intensive Care Unit. I graduated from Ohio Northern University, received my PGY1 residency from Shands at the University of Florida, and my PGY2 from John Hopkins All Children’s Hospital. I am working toward my Masters in Business Administration. I live in Northeast Ohio with my husband and two teenage children. I look forward to working on the committee .

Jon M. Hicks, PharmD, BCSCP
Dr. Hicks is a Director and Pharmacist in Charge at STAQ Pharma, an FDA registered Outsourcing Facility, where he is responsible for all compounding and manufacturing processes. Hicks specializes in cleanroom and facility design, automation and technology, and regulatory compliance. He received his Doctor of Pharmacy from the University of Toledo and spent 11 years in hospital and health-system pharmacy leadership before transitioning to industry. He enjoys the challenges of working in a highly regulated industry and believes the profession can both learn from and elevate pharmacy compounding towards cGMP.

Kenneth “Chip” Lazenby, PharmD, BCPS, BCSCP
Lazenby serves as Manager, Pharmacy Operations at the Queen’s Medical Center in Honolulu, Hawaii. He oversees sterile compounding and chemotherapy operations and manages the related personnel for the state’s largest hospital and only Level 1 Trauma Center. Previously he served as QMC’s Coordinator of Sterile Compounding and Hazardous Drug Operations and has been involved in multiple sterile compounding facility redesign projects. He earned his PharmD from West Virginia University.

David Melton, PharmD, BCSCP
Melton is an Adjunct Clinical Professor at the University of Michigan College of Pharmacy. He also works as a pharmacy specialist on the Compounding Compliance Team serving as a facilities management lead for over 20 sterile and non-sterile locations. He received his Doctorate of Pharmacy and Bachelors in Pharmaceutical Sciences from the University of Toledo.

Binh Nguyen, PharmD, MSRegSci, BCSCP 
BNguyenDr. Nguyen is a Senior Director at Lachman Consultants providing consulting services in FDA Compliance and CGMP audits for Bio and Pharmaceutical Industries. He has served on the Board of Pharmacy Sterile Compounding Specialty since 2021. He is also a per diem clinical pharmacist at Fountain Valley Hospital since 2002. He has 20+ years of FDA bio/pharmaceutical inspection, compliance, and assessment experience (Level III Certified Pharmaceutical Inspectorate, Level II Drug Auditor, drug branch chief, director regulatory review officer, pharmaceutical educator) in biotech, sterile injectable, sterile compounding, positron emission tomography, and other dosage forms. He completed his Doctorate in pharmacy, a Master in regulatory science, Board Certified in Sterile Compounding Pharmacy, and Certified in Health Profession Education.