Update on compliance with standards for sterile compounding with emphasis on USP chapters <797> and <800> (Technicians)

• Richard Capps, PharmD, Pharmacy Manager at Oconee Memorial Hospital in Seneca, SC
  • ?Richard Capps has over twenty-five years’ experience in pharmacy management and has been a Pharmacy Manager with the Greenville Health System since 2000. Richard is currently the Pharmacy Manager of Oconee Memorial Hospital, a 160 bed community hospital. Before transferring to Oconee, Richard designed and opened an off-site compounding pharmacy to support seven GHS hospitals. The compounding pharmacy is registered with the FDA and DEA as a manufacturer and employs two RIVA robots for sterile compounding. The compounding pharmacy has an extensive environmental monitoring plan and performs its own end product sterility testing in compliance with USP <71>. The compounding pharmacy also repackages oral medications to support the health system. Before opening the compounding pharmacy, Richard was the Pharmacy Manager of the Greenville Memorial Hospital Pharmacy. In that role, he transitioned the pharmacy from a completely manual distribution system to a fully automated barcode assisted dispensing system. Richard was also responsible for overseeing Omnicell medication cabinets; the Alaris drug library, corporate compliance, and controlled substance diversion monitoring.
  • Richard is a graduate of The Citadel, The Military College of South Carolina. He received his Doctorate of Pharmacy from Mercer University Southern School of Pharmacy in Atlanta and completed an American Society of Health-system Pharmacy accredited Pharmacy Practice Residency at Emory University Hospital. In 2010, Richard graduated from the ASHP Foundation Pharmacy Leadership Academy and the ASHP Foundation Leaders Innovation Masters Series in 2013. Richard is an active member with ASHP’s Section on Pharmacy Informatics and Technology and the Regulatory Committee for the South Carolina Society of Health-system Pharmacy. Richard authored the chapter Primary Engineering Controls in ASHP’s Compounding Sterile Preparations, 4^th ed. 
• Shay Garrison, RPh, MPH, Pharmacist Specialist at Palmetto Health Richland Hospital in Columbia, SC (specializing in sterile compounding, USP <797>, and USP <800>)
  •  Shay received a B.S. in Microbiology from Clemson University in 1978.  He furthered his career with a B.S. degree in pharmacy from the Medical University of South Carolina School of Pharmacy in 1981 followed later in 1992 with a Masters in Public Health Administration from the University of South Carolina.
  • Shay has over 30 years of experience in hospital pharmacy practice, the majority at Palmetto Health Richland Hospital in Columbia, South Carolina as a manager. In Shay’s 25 plus years experience in pharmacy administration he has spent working the majority of his time maintaining direct and in-direct oversight over the oncology and sterile product components.  During this time, he was directly involved with the new construction and/or renovation of several sterile compounding areas in the Palmetto Health facilities and most recently with the establishment of a robotic sterile processing facility.   In the past, Shay has also held adjunct teaching functions for Midlands Technical College Pharmacy Technician Program and currently lectures in sterile compounding as part of the Kennedy Pharmacy Innovation Center of the University of South Carolina.  He also works in an advisory role on the Compounding Committee for the South Carolina Board of Pharmacy. 
• Bill Mixon, RPh, MS, FIACP, FACA, Former Owner/Manager of The Compounding Pharmacy (a Pharmacy Compounding Accreditation Board (PCAB) accredited compounding-only pharmacy) in Hickory, NC
  • Bill Mixon is the former owner of The Compounding Pharmacy in Hickory, North Carolina.  He received his BS degree from the Medical University of South Carolina in 1977, and his MS degree from UNC Chapel Hill in 1983.  He has completed two hospital pharmacy residencies, has been a Certified Diabetes Educator and a Certified Geriatric Pharmacist.
  • Mr. Mixon is a Fellow of the International Academy of Compounding Pharmacists and the American College of Apothecaries.   He has served on the USP Expert Committee for Compounding since 2010.  He also serves as the non-voting industry representative to the FDA Pharmacy Compounding Advisory Committee.  Mr. Mixon is a member of the NC Board of Pharmacy, is a pharmacy surveyor for the Accreditation Commission for Healthcare, and a senior associate with Gates Healthcare Associates.  Memberships include APhA, NABP, ASPL and ACA. He and his wife Jan live in Hickory, NC.?
• Eric Sparks, President of BioTech Balancing
  • Eric is a United States Air Force veteran and certified Metrologist with more than 20 years of experience in the certification, calibration and quality field. He holds a bachelor’s degree in marketing from Thomas Edison State University with a background in electrical engineering technology.  His current certifications include; CETA/CNBT Certified Professional for Testing USP <797> Sterile Compounding Facilities, NSF Accredited for Testing and Certification of Class II Biosafety Cabinet, and NEBB (TAB) Testing, Adjusting and Balancing Technician.
  • Eric has a vast knowledge of every aspect of a sterile environment in relation to certification and air balancing. Throughout his career, he has managed many projects for major pharmaceutical manufacturers and sterile pharmacies. These projects include construction, air balancing, microbial sampling, calibration and certification within cleanrooms. He has also managed several software development projects which handles the throughput of data collected during the cleanroom certification process.

Program Schedule:

• Cancellations received in writing at least 30 days prior to program date via letter or email to CE@cop.sc.edu will receive a full refund minus a $200 cancellation fee.
• USC COP reserves the right to cancel the entire program.  In the event of a conference cancellation, each participant will be notified via phone and/or email at least 14 days prior to the program and a full tuition refund will be made.
• In the event of inclement weather, the decision to cancel a course will be made no later than 9:00 am Eastern time the day before the program.

• Individuals attending the course in place of the registered individual will be honored as long as the request is made in advance of the registration deadline, which is 14 days prior to the event. 

• Refund requests are subject to a $200.00 cancellation fee and must be received 30 days prior to the start of the live component. All registration cancellations must be submitted in writing or by e-mail to the Continuing Education Department at the following address:  University of South Carolina College of Pharmacy Continuing Education, 715 Sumter Street, Room 314C, Columbia, SC  29208, Email: CE@cop.sc.edu
• Registrants may receive 100% of the program registration fees, less the $200.00 cancellation fee up to 30 days prior to start date of the live component. No refunds are offered for cancellations fewer than 30 days prior to the start date of the live component or for no shows.

• Registration will be accepted until 7 days prior to the start of the program or until capacity has been reached.