Related Experiment Video
Updated: Oct 16, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Costs associated with United States pharmacopeia compliant infusion clinics
Carolyn Kusoski1, Jennifer Booth1, Stephanie Salch1
124600The Arthur G. James Cancer Hospital and Richard Solove Research Institute, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Purpose:
As costs continue to rise in oncology, a strategy that has been implemented to limit these costs is use of alternative sites of care. However, there are differences in regulatory standards between common sites of care such as freestanding infusion clinics and hospital outpatient departments. The costs associated with United States Pharmacopeia compliance were evaluated in order to better understand the cost of universally compliant hospital outpatient departments.
Methods:
Annual operational costs associated with United States Pharmacopeia compliance were estimated for a 30-chair infusion clinic with United States Pharmacopeia <797> and <800> pharmacy cleanrooms for non-hazardous and hazardous drugs, respectively. Annual United States Pharmacopeia compliance costs included: competency assessments, personal protective equipment, closed system transfer devices, labels, cleaning supplies, and environmental monitoring. One-time costs included initial cleanroom construction and renovations. Published information and benchmarks provided baseline assumptions for patient volume, staffing, and unit costs. If no published data was available, prices were estimated based on a similarly sized clinic.
Results:
Recurring annual costs for a 30-chair fully compliant infusion clinic were calculated to be $785,207. One-time costs associated with initial construction and renovations were estimated to be $1,365,207-$1,535,207 and $965,207-$1,005,207, respectively.
Conclusions:
Costs associated with increased operational oversight and regulatory standards are a major contributing factor to the facility fee of hospital outpatient departments. Ultimately, all sites of care share in the goal to provide optimal patient care while considering all aspects of patient care, including cost. Therefore, a move towards consistent regulatory standards across all settings would aid in preventing discrepancies in care.
Related Concept Videos
Two-Compartment Open Model: IV Infusion
The model illustrates the decrease in plasma drug concentration from the central compartment with a specific equation. It shows that under steady-state conditions, the drug's input rate...
Dosage Regimens: Designs and Approaches
Clinically Relevant Drug Product Specifications: Methods of Establishment
One-Compartment Model: IV Infusion
The one-compartment model for IV infusion uses mathematical equations to describe the rate of change in drug quantity in the body. At steady-state or infusion equilibrium, the drug input...
Drug Accumulation During Multiple Dosing: Intermittent IV Infusions
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

