Expert Witness in Pharmacy Design and Construction
Bernstein & Associates, Architects, through its principal William N. Bernstein, AIA, has provided expert witness services in matters involving the design and construction of pharmacies and related properties. Attorneys litigating cases that involve construction defects, hospital central pharmacy layout problems, IV admixture and sterile compounding room failures, hazardous drug compounding deficiencies, retail pharmacy and ambulatory pharmacy design issues, controlled substance storage and DEA-related design defects, automation and robotics integration problems, refrigerated and frozen storage failures, HVAC and pressurization problems, accessibility violations, fire safety and egress issues, water infiltration and building envelope failures, phased-construction disputes, and other claims related to the design and construction of pharmacies require an expert witness architect who understands both the applicable building codes and standards and the practical realities of how those requirements are applied in the design, construction, and renovation of real pharmacies.
About Pharmacy Design and Construction
Pharmacy design and construction encompasses a range of facility types, including hospital central pharmacies, hospital satellite pharmacies, IV admixture rooms and sterile compounding suites, hazardous drug compounding suites, ambulatory infusion center pharmacies, retail pharmacies, mail-order and central-fill pharmacies, specialty pharmacies, 503A pharmacy compounding facilities, 503B outsourcing facilities, nuclear pharmacies, and the support spaces that serve them, including dispensing areas, pharmacist work areas, compounding rooms with primary and secondary engineering controls, anterooms, gowning areas, controlled substance storage, refrigerated and frozen storage, automation and robotics areas, and consultation areas.
The design and construction of pharmacies is governed by a complex framework of technical standards, including the applicable building code (for example, in New York City, the New York City Building Code), the International Building Code, ICC A117.1, NFPA 101 Life Safety Code, NFPA 99 Health Care Facilities Code (where applicable), ASHRAE 170, USP General Chapter <795> for non-sterile compounding, USP General Chapter <797> for sterile compounding, USP General Chapter <800> for handling hazardous drugs, ISO 14644 cleanroom classification standards, FDA cGMP requirements for 503B outsourcing facilities, DEA controlled substance storage requirements (21 CFR 1301.72), the FGI Guidelines for Design and Construction of Hospitals (Pharmacy chapter), state board of pharmacy regulations, ADA requirements, and state and local department of health requirements.
Disputes commonly arise over construction defects affecting building envelopes, interior finishes, and pharmacy spaces; central pharmacy layout and workflow problems; IV admixture and sterile compounding room failures to achieve required ISO classifications; hazardous drug compounding deficiencies under USP <800>; retail pharmacy layout and ADA compliance; controlled substance storage failures including non-compliant safes, alarms, vaults, and access controls; automation and robotics integration problems; refrigerated and frozen storage system failures; HVAC and pressurization problems; non-compliant accessibility features; inadequate fire-rated assemblies and egress; and disputes arising from phased-construction projects. Responsibility for compliance with the applicable standards is shared, in different ways, among the operator, the landlord, the design professional, the contractor, subcontractors, specialty vendors, and the party responsible for ongoing maintenance, and litigation in this area frequently turns on the allocation of responsibility for design decisions, construction means and methods, and post-occupancy maintenance.
Expert Witness Services Related to Pharmacy Design and Construction
Expert witness services in pharmacy design and construction matters typically include a careful review of the project documents (drawings, specifications, submittals, RFIs, change orders, permits, certificates of occupancy, ICRA plans, department of health filings and approvals, lease agreements, commissioning reports, and as-built conditions) (along with cleanroom certification reports, environmental monitoring records, and HVAC validation documentation), a site survey to measure and document the conditions at issue, comparison of those conditions against the applicable building codes, life safety codes, pharmacy facility guidelines, USP standards, accessibility standards, and industry standards of care, review of construction administration records and maintenance histories, and the preparation of clear, well-supported opinions regarding the cause of the defect or failure, the responsibility of the various parties, and the standard of care applicable to the design, construction, and maintenance of pharmacies.
An effective pharmacy design and construction expert witness must be able to explain technical requirements — central pharmacy layout and workflow, sterile compounding room design under USP <797>, hazardous drug compounding design under USP <800>, primary and secondary engineering control integration, cleanroom classification under ISO 14644, controlled substance storage, automation integration, fire-rated assembly construction, egress geometry, accessibility clearances, and building envelope detailing — in plain language to judges, juries, arbitrators, and mediators, and must have the credentials, written record, and courtroom-ready communication skills to render credible opinions.
Mr. Bernstein is a Yale-trained, NCARB-certified, LEED-accredited, registered architect. He has expertise in architectural design, engineering design, and construction as the founder/owner of an architectural firm, Bernstein & Associates, Architects, (1990-present) and as the founder/owner of a construction project management firm, Empire Projects, Inc. (2003-Present). He has been the expert witness (as of May 2026) on (40) cases involving design and construction (2006-present) across the United States and Internationally.
Mr. Bernstein’s pharmacy design experience includes pharmacy projects including hospital central pharmacies, USP <797> and USP <800> compliant compounding pharmacies, and pharmacy design commissions in New York, Connecticut, and Las Vegas. Mr. Bernstein has authored published work on pharmacy design and compounding facility design. This depth of hands-on architectural design experience — from program development and code analysis through construction administration and commissioning — provides the technical foundation needed to render credible expert opinions on pharmacy design and construction disputes.
Contact
Please contact Bernstein & Associates, for expert witness services related to the design and construction of pharmacies.