USP Consultants

November 2019 - Vol.16 No. 11 - Page #46

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.


Fred Massoomi, PharmD, FASHP
101 E Fifth St, No. 2220
St. Paul, MN 55101

Visante’s consulting experts help facilities optimize care while meeting safety requirements and managing costs. Bearing in mind that safely compounded medications are essential to quality patient care, Visante can assist in preparation for compliance with USP Chapters <795>, <797>, <800>, and <825>, as well as for inspections by CMS, FDA, DEA, and The Joint Commission. External sources can be evaluated, or the team can demonstrate how insourcing can provide increased control and positive ROI.

Additional services include: 503A and 503B process and procedural assessment for outsourcing consideration, strategic assessment of home infusion compounding services, facility design (including redesign, improvements, or new design), improved operational policies and procedures, and analysis of insourcing and outsourcing opportunities.

Visante’s processes are designed to provide the safest medications to patients based on current standards and best practices, and to ease the compliance burden with the goal of exceeding administrative and safety objectives for patients.

Controlled Environment Consulting

James T. Wagner
1249 South Cedar Crest Blvd, Suite 101
Allentown, PA 18103

Jim Wagner, President of Controlled Environment Consulting (CEC), is a member of the USP Compounding Expert Committee. The team at CEC includes facility consultants, engineers, project managers, and certification and commissioning experts who provide consultation and other 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. CEC’s experts have served on many standard development committees for contamination control issues, including NSF International for Class II BSCs, and CETA for development of application guides, some of which are referenced in USP chapters.

With experience in the design and QA process, CEC’s diversified team is prepared to support 503A and 503B compounding facility build-out and/or certification and commissioning needs. Services include cleanroom planning and design, facility certification, commissioning and environmental monitoring, gap analyses, and on-site construction progress inspections.

CriticalPoint, LLC

Eric Kastango, 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 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, New Jersey. 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.

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 25 compounding facilities across the United States.

WB | Clinical
(a division of WorkingBuildings)


Kurt Last
1230 Peachtree Street NE,
300 Promenade
Atlanta, GA 30309

WB | Clinical offers a wide variety of services to pharmacies to assist in compliance with USP <797>, <800>, <823>, <825>, and with FDA 503A and 503B pharmacy programs. Services include review of pharmacy engineering and administrative controls, operations, behaviors and practices of compounding personnel; environmental conditions and monitoring; labeling and storage procedures; standard operating procedures; and a variety of other areas critical for proper compounding of sterile preparations for patient and personnel safety. Action plans compare current facilities and practices with the requirements of USP <797> and <800>, and a gap analysis lists items to be addressed in order to achieve compliance. The team of compounding experts examines existing cleanroom workflows to develop a complete set of pharmacy compounding standard operating procedures to ensure compliance. Services are also available in all phases of establishing and maintaining 503A and 503B programs.

LDT Health Solutions, Inc (LDT)

Lou Diorio, 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, including FDA matters; 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 technology within the organization, regardless of geography, service model, or bar coding requirements. LDT’s new software, Compound Process Guardian, assists compounders in meeting the rigorous operational and documentation requirements for any category of compounding.

With the advent of the Drug Quality and Security Act (DQSA), managing contracted pharmacy services is more complex. LDT brings experience from 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.


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