As compounding regulations become more complex, it is crucial to have a resource for your CSP-related questions. Whether you are looking to supplement in-house talent, begin a special project, or undertake new construction, the expertise of a compounding consultant can be invaluable to your success. Following is a list of pharmacy consultants who specialize in compounding.
LDT Health Solutions, Inc, is a medication safety and quality management consulting firm that provides expertise in all areas of pharmacy practice, including the centralization of health system compounding, USP <795>, <797>, and <800> compliance, regulatory affairs, and 503B facility management. With over 40 years’ experience developing policy and procedure manuals, LDT now offers traditional static manuals or Web (network-based) references that can be accessed by all employees. In addition, LDT has expertise in automated compounding devices (ACDs), compounding technologies, robotics, and computer conductivity to maximize this technology within the organization, regardless of geography, service model, or bar coding requirements.
With the advent of the Drug Quality and Security Act (DQSA), managing contracted pharmacy services is more complex. LDT brings experience from assisting multistate compounding facilities with facility design, program development, and formulary management under these federal regulations. LDT can guide the selection or development process of an organization contemplating a shift in its medication delivery model. Since LDT maintains one of the country’s largest databases of FDA regulatory activity surrounding compounding, LDT can assist organizations in the formulation of strategic plans, regulatory filings, and government response documents.
Microbiology Research Associates, Inc
Fran McAteer, MBA
33 Nagog Park, Acton, MA 01720
Microbiology Research Associates, Inc (MRA), an FDA-registered consulting and testing laboratory specializing in USP <797>, <800>, and cGMP sterilization validation, provides expertise in sterile compounding, cleanroom engineering, environmental monitoring, cleaning, disinfecting, and contamination control. With experience implementing USP <797> quality programs for 503A pharmacies, including IV, oncology, OR, allergy, and nuclear pharmacies, MRA also has technical expertise in GMP processing, 503B compounding, rapid sterility methods, BUD extension, cleaning verification, airflow pattern testing, anticipatory compounding, BOP inspections, and FDA remediation reporting.
MRA offers full-service consulting programs for USP <797> and <800> compliance, including cleanroom design and engineering; ISO 14644 certification; environmental monitoring program implementation; full pharmaceutical microbiology laboratory service for USP <71> sterility tests, USP <85> bacterial endotoxin tests, and species IDs; administering pharmacy staff media proficiency programs; quality SOPs; automated compounding device validation; equipment calibration; 503B compliance assessment reports for high-risk CSPs; robotic fill automation validation; stability testing; depyrogenation; cleaning validations; and staff educational seminars. MRA is FDA-registered and ISO 9001-approved.
Bio-Med QC helps sterile compounding pharmacists meet the increasing pressures of accreditation, as well as state and federal regulation. A former Director of the Public Health Laboratories of the Indiana State Board of Health, Doug has more than 30 years of experience in the manufacturing of sterile diagnostics, pharmaceutical sterility control, and cGMP procedural design. Doug is uniquely trained to detect and eliminate the root cause of microbial contamination in compounding suites; he explains how to remediate and improve processes so the problem is eradicated.
Willis Triplett, PharmD
20 Waterford Ct
Zionsville, IN 46077
With a commitment to helping pharmacy sterile compounding organizations understand USP <797> and <800> and to implement continuous quality improvement solutions, Comply797 collaborates with a variety of industry-leading vendors to help pharmacy meet increasing compliance pressures. Services include cleanroom planning and design, personnel training and assessment, SOP development, environmental monitoring and facility certification strategies, gap analyses, and mock surveys/inspection readiness. Send Willis an e-mail to request his free newsletter on FDA actions against 503A and 503B pharmacies.
Eric Bauer, RPh
The CAPS Consulting team comprises pharmacists, quality systems managers, chemists, regulatory compliance specialists, microbiologists, and facilities engineers with expertise in sterile compounding. Whether preparing for expansion, remodel, or a future inspection, CAPS Consulting can help pharmacies prepare with CAPS’ ReadyCheck compliance program for USP <797> and USP <800>. CAPS has been compounding for more than 25 years, including 503A and 503B compounding at 24 compounding facilities across the United States.
Kennedy Pharmacy Innovation Center
Nancy L. Roberts, PharmD, MS
University of South Carolina College of Pharmacy
715 Sumter St, Coker Life Sciences
Bldg Rm 416
Columbia, SC 29208
The Kennedy Pharmacy Innovation Center (KPIC) at the University of South Carolina College of Pharmacy, Columbia, provides sterile product training programs for pharmacists and pharmacy technicians that are designed to meet current and emerging educational needs. KPIC programs are based on current regulatory guidelines specified by USP <797> and <800> standards. The center strives to provide affordable access to continuing education programs related to sterile compounding. Upon satisfactory completion of a program participants receive a certificate of completion, as well as ACPE CE credits. Certificate of completion courses include a home-study component that is completed by the participant prior to attending a workshop. Live 1- or 2-day workshops explore practical applications of the current USP standards. The workshops emphasize hands-on practice at an individual level in a state-of-the-art sterile compounding training facility, as well as core competencies based on current USP standards.
Controlled Environment Consulting
2527 King’s Mill Rd
Hellertown, PA 18055
James Wagner served on the USP Sterile Compounding Committee for the 2005-2010 appointment cycle and has presented at many USP forums on sterile compounding. He is currently a member of the USP Compounding with Hazardous Drugs Expert Panel and has been elected to serve on the 2015-2020 USP Compounding Expert Committee. Controlled Environment Consulting provides consultation to the compounding industry, including performing facility gap analyses and sterile compounding facility design consultations, and has worked with over 100 pharmacy and facility leaders to pick the best solutions and integration strategies for their sterile compounding applications.
Eric Kastango, MBA, RPh, FASHP
Kate Douglass, MS, RN, CRNI
CriticalPoint Center for Training and Research
11B Commerce Way
Totowa, NJ 07512
CriticalPoint strives to increase patient safety through a variety of educational offerings focusing on USP <797> and <800>. In partnership with industry experts, CriticalPoint provides training on industry standards, resulting in improved competency and patient safety. Its offerings include eLearning, live training, and standard operating procedures (SOPs), while its Web-based training focuses on standards and best practice.
Hands-on live training classes are offered in sterile compounding, hazardous drug handling, and 503B at the CriticalPoint Center for Training and Research, located in Totowa, NJ. These classes incorporate didactic eLearning, lecture, and labs to provide training on the standards of USP <797> and <800>. In addition, certification programs for 503A and 503B are now offered.
To help with SOPs, CriticalPoint partnered with Clinical IQ to capture its expertise through the development of a set of template policies, procedures, and accompanying documentation forms.
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