California Pharmacies USP-797 / USP-800

Renovating Hospital Pharmacies for Compounding Safety Compliance

In 2016, the Board of Pharmacy’s (BOP) adopted new regulations USP-797 and USP-800 for identifying, mixing and storing hazardous drugs – a direct result of a landmark 2012 civil lawsuit that found the western Massachusetts-based New England Compounding Center (NECC) liable after 64 people died and 793 people were hospitalized with infections from fungal meningitis due to NECC’s negligent compounding practices. The new government regulations in 2016 forced compliance updates to pharmacies across the United States, leaving hospitals rushing to allocate costs, designs and construction resources to comply with new and unfamiliar regulations.

Since GDG Healthcare Architects had extensive experience in hospital pharmacy renovations years before the BOP regulation changes in 2016, the firm was in-demand by a number of hospitals across California looking to update facilities for compliance. GDG met with the top leaders in pharmacopeia who were responsible for passing early drafts of the BOP code and had extensive knowledge of upcoming regulation changes that were expected to be enforced. This early warning positioned GDG as one of the leading architectural firms that was able to interpret and decode how these changing regulations would impact hospital operations.

Importantly, GDG was one of the few architectural firms that understood the complex ventilation systems required to meet the new BOP regulations. The GDG team engaged with healthcare facilities early on to support the specific needs at each site, since the new BOP regulations were on a tight time-sensitive deadline for getting plans into HCAI.

GDG found itself simultaneously designing entirely new compliant pharmacies while providing construction support for renovating 16 separate pharmacies at the same time. The bulk of these renovations occurred between 2016 and 2019, prior to the COVID-19 pandemic, at a range of hospitals as far north as San Jose and as south as Temecula.

Pharmacies are not like other areas of a hospital. They are the most sterile environment in the entire hospital – even more than an operating room. The clean room of a hospital pharmacy must pass incredibly stringent standards for bacterial sterility, and importantly a hospital pharmacy cannot shut down operation since patients throughout the facility are relying on medications, pain killers, IV bags and chemo treatments to stay on schedule. The challenge presented to GDG was redesigning and renovating these hospital pharmacies while ensuring the hospital had continuous pharmaceutical operations.

But meeting the minimum code for BOP compliance was not enough for GDG. With extensive knowledge of hospital operations and the need to “future-proof” critical facilities like pharmacies, the GDG team produced designs that greatly exceeded code minimums. For example, GDG plans called for oversized air handlers because it was the only way that filters purifying the air to 99.9999% purity without clogging or reducing airflow. This level of specialized knowledge and experience in healthcare environments gave GDG the edge over newcomers who were eager to capitalize on USP-797 and USP-800 renovations without the expertise to do so at a high quality and safety standard. In the past seven years, GDG has successfully designed & completed pharmacy renovations that meet the previous BOP regulations even the latest rounds of BOP regulations published in 2023, with enforcement deadlines of September 2023.

In all, GDG fully designed or renovated 25 different hospital pharmacies over an eight-year period, transforming a collective total of 44,000 square feet to not just meet new USP-797 and USP-800 regulations – but to exceed potential regulations in the future.

Pharmacies renovated by GDG include:

  • Northridge Hospital Medical Center – x3 pharmacies
  • Verity Health Systems – x 3 pharmacies (Saint Frances, Saint Vincent, Seton Medical Center)
  • Santa Clara County – x3 pharmacies (O’Connor Hospital, Saint Louise Regional Hospital, Valley Health Center)
  • City of Hope – x8 pharmacies (Simi Valley, Mission Hills, Antelope Valley Medical Center, West Covina, South Pasadena, Corona, Hemet & Temecula)
  • Hollywood Presbyterian Medical Center – x2 pharmacies
  • AHMC Healthcare – x5 pharmacies (Garfield Medical Center, San Gabriel Medical Center, Anaheim Medical Center, Monterey Park Hospital, Greater El Monte Community Hospital)
  • Plaza Home Care Pharmacy (Pasadena)

By The Numbers

Location:   Southern California Hospitals
Type of Project Compounding Pharmacy
Project duration 8 Years
Total Square Footage 44,000 (collectively)
Contractor: Tiller Constructors
Engineering: P2S and M.W. Weber
Project Cost +/- $27,950,000

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