USP Chapter <797> Consultants

April 2018 - Vol.15 No. 4 - Page #14
Category: Accreditation Survey Consulting

As compounding enforcement becomes more stringent, it is crucial to have a resource for your CSP-related questions. Whether you are looking to supplement in-house talent, prepare for an inspection, 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.

CAPS Consulting
Eric Bauer, RPh
Senior Consultant

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 26 years, including 503A and 503B compounding at 24 compounding facilities across the United States.

Controlled Environment Consulting
James T. Wagner
3477 Corporate Parkway, Suite 100
Center Valley, PA 18034

Jim Wagner, President of Controlled Environment Consulting (CEC), is 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. In addition, Jim has presented at many USP forums on sterile compounding.

CEC provides consultation services to the compounding industry in the areas of, but not limited to, sterile compounding facility design, facility gap analysis, construction document review, and certification oversight. CEC has assisted over 500 pharmacy and facility leaders in selecting the best solutions and integration strategies for their sterile compounding applications, and its experts have served on many standard development committees for contamination control issues, including NSF International for Class II BSC: NSF/ANSI STD 49, CETA and Application Guides for numerous Contamination Control Applications: CAG-001, 002, 003, 007, and 008.

LDT Health Solutions, Inc (LDT)
Lou Dior
io, RPh, FAPhA
David Thomas, RPh, MBA
36 Cedar Pl, Wayne, NJ 07470

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 has expertise in assisting multi-state 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, it can assist organizations in the formulation of strategic plans, regulatory filings, and government response documents.

Veracorp LLC
Frank Settineri
28 Polk St, Sparta, NJ 07871

With over 35 years of experience in compounding, pharmaceutical manufacturing, and business, Frank Settineri founded Veracorp LLC in 2006. Veracorp specializes in GMP compliance, deviations and investigations, root cause analysis, rectification of sterile and non-sterile microbiological data deviations, particulate matter, and outsourcing of suppliers, contract laboratories, and manufacturing sites. Offering expertise in writing responses to 483s and warning letters that result in both interim controls and sustained cGMP compliance, Veracorp’s client base includes compounding pharmacies, virtual start-ups, API manufacturers, solid and liquid oral dosage manufacturers, sterile facilities, medical device operations, and microbiology laboratories. In addition, teams of multidisciplinary experts can be assembled to help clients reorganize quality systems.

Microbiology Research Associates, Inc
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.

Willis Triplett, PharmD
20 Waterford Ct, Zionsville, IN 46077

With a commitment to helping sterile compounding organizations understand USP <797> and <800> and implement continuous quality improvement solutions, Comply797 collaborates with a variety of industry-leading vendors, consulting groups, and oncology organizations to help providers 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 email to request his free newsletter on FDA actions against 503A and 503B pharmacies.

CriticalPoint, LLC
Eric Ka
stango, MBA, RPh, FASHP
Peter Cantor
Kate Douglass, MS, RN, CRNI

CriticalPoint Center for Training and Research

11B Commerce Way

Totowa, NJ 07512


CriticalPoint focuses on increasing patient safety through a variety of educational compounding offerings concentrating on USP <797>, <800>, and <795>. Partnering with industry experts, CriticalPoint provides the most current and engaging training on industry standards resulting in improved competency and patient safety. Its offerings include eLearning, live training, peer network, Web-based apps, and standard operating procedures (SOPs). 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. CriticalPoint’s Web-based training focuses on standards and best practice.

Hands-on live training classes are offered in sterile compounding, hazardous drug handling, and environmental monitoring 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 are offered.


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