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Lowering the High Cost of USP 800 Compliance

Online First

Chicago, IL—Maintaining a clean room compliant with US Pharmacopeial Convention Chapter 800 (USP 800) can come with a significant price tag, but noncompliance can drive up costs to oncology practices and institutions. However, certain measures can contribute to the successful construction, renovation, and maintenance of hazardous drug sterile compounding spaces in an oncology setting, according to Ryan A. Forrey, PharmD, MS, FASHP, Director of Pharmacy, Emory University Hospital Midtown, Atlanta, GA. Dr Forrey provided practical tips related to USP 800 compliance in clinical practice at the 2016 Annual Hematology/Oncology Pharmacy Association (HOPA) Oncology Pharmacy Practice Management Program.

The USP 800 standard applies to the handling of hazardous drugs during their receipt, storage, compounding, dispensing, administration, and disposal, and affects all healthcare workers who perform these activities. The standard emphasizes that there is no “acceptable” level of exposure to hazardous drugs, but any exposure should be limited through the use of engineering controls and personal protective equipment.

“USP 800 is about your work practices every single day, and as long as you have humans executing these practices, you’re going to have flaws, and you’re going to be noncompliant in some way,” Dr Forrey said.

The Costs of Sterile Compounding

When dealing with nonsterile compounding, USP 800 allows for external venting (preferred) or redundant high-efficiency particulate air (HEPA) filtration of containment primary engineering controls. In sterile compounding, containment primary engineering controls must provide International Standards Organization (ISO) class 5 or better air quality, and can be located in an ISO class 7 buffer room with an ISO class 7 anteroom, or in a containment segregated compounding area (C-SCA).

“This is important, because you don’t have to have a classified space to be able to do hazardous drug sterile compounding. And the cost of the heating, ventilation, and air conditioning system is one of the pieces that really drives up the cost of your entire project, and can also take up space you may not have in the building facilities,” Dr Forrey said.

However, the consequence of using a C-SCA is that the beyond-use date of any compounded sterile preparation is limited to a maximum of 12 hours.

“This is one of the things you might want to think about as you’re deciding on a renovation plan. If your facility is dependent on advanced compounding more than 12 hours in advance, then a C-SCA won’t work in your environment,” he added.

A containment secondary engineering control is a negative pressure room that must be externally ventilated and physically separated from other preparation areas, but is not required to be ventilated through HEPA filtration. The USP 800 rule initially required it, but an erratum was published on May 27, 2016, to correct it.

“It’s great if you do have HEPA filtration on the exhaust coming from your compounding room, but it can add a lot of cost to your project,” Dr Forrey said.

Planning and Executing Renovations

Dr Forrey emphasized the importance of developing a program of requirements in advance of any facility planning. The program of requirements determines services to be provided, identifies future needs, and allows standardized planning for adequate space.

“The important thing is not to consider your current space sufficient. Don’t limit yourself, because then you may not get to the right compliant design in the end,” he said.

Construction costs and furniture, fixture, and equipment costs per square foot decrease with increasing size, but he recommends 50 to 100 sq ft of clean room for every primary engineering control, no less than 100 sq ft of clean room per anteroom, and 80 to 120 sq ft of “office space” per primary engineering control (an area distinct from a clean room space).

According to Dr Forrey, some ways to cut costs while still maintaining compliance with USP 800 standards include removing HEPA filtration from containment secondary engineering control exhaust systems, changing stainless steel exhaust ducts to galvanized sheet metal, changing heating, ventilation, and air conditioning in C-SCA, removal of superfluous pass-through chambers to hazardous drug compounding, and purchase of an uninterruptable power supply.

Visiting the site often to oversee construction is crucial, as is ordering equipment early and understanding whether “inside” or “white glove” delivery is needed, because special moving services for heavy equipment can significantly increase costs.

“You also want to ask for construction documents and drawings and look at them very closely. Then if the wrong lights are used, you won’t be the one paying for them to be replaced,” Dr Forrey advised. He recommends planning for approximately 6 months of fine-tuning and system failures until everything works as expected. “Work closely with the contractors. Trust, but verify. And always walk through as much as you can,” he concluded.

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