Trending

Article by Paul Gladysz, AIA, NCARB, CSI, ICC

USP <800> Compliance

As of Dec. 1, 2019, the USP <800> standard for the safe handling of hazardous drugs applies to veterinary practices and other health care facilities. Knowing what these standards are and how they apply to your hospital is important.

To begin, what is USP <800>?

USP General Chapter <800> is a standard for defining the means and methods of protecting health care workers and patients during the handling and administering of hazardous drugs, many of which are commonly used in chemotherapy.

USP guidelines take a layered approach to protecting employees. They include:

• Defining risks of using and manipulating different materials.


• Conducting staff training on proper transporting, handling and cleaning procedures.


• Providing personal protection equipment (PPE).


• Using a primary containment device and secondary containment of possible airborne contaminants.


• Ensuring that environmental controls are in place to prevent the migration of hazardous materials.

So then, who is USP?

USP is a scientific organization known formally as United States Pharmacopeia. It is not a government or enforcement entity; USP develops guidelines and standards that may be adopted and enforced by regulators. The USP standards use the terms manipulating and compounding, and there are different requirements for each and for non-sterile (per USP <795>) vs. sterile compounding (per USP <797>).

Most veterinary facilities that take on minor or incidental oncology cases are not doing onsite sterile compounding. Specialty referral practices with a substantial oncology caseload might be.

What are the different requirements?

Minor Handling and Non-Sterile Compounding
For those practices that only administer or do non-sterile compounding in-house a separate room from other clinical spaces (including where the drugs are administered) is required.

This room is called the Containment Secondary Engineering Control (C-SEC), or buffer room, and must contain the following:

• A Containment Primary Engineering Control (C-PEC) – a C-PEC is a filtered and vented hood. This hood must be a Containment Ventilated Enclosure (CVE), a Class 1 Biological Safety Cabinet (BSC) or a Class 2 BSC. The cabinet must be externally vented and filtered. The air movement within the cabinet varies by cabinet type, but each of these use airflow to contain hazardous drug dust and vapor. [One caveat is found in the standard USP <800> 5.3.1, which reads: “A C-PEC is not required if the manipulations are limited to handling of final dosage forms (e.g., counting or repackaging of tablets and capsules) that do not produce particles, aerosols or gasses.”]


• The C-SEC must be completely enclosed with external ventilation, not an alcove or a corner in a larger space.


• Total airflow set at 12 air changes an hour.


• The exhaust must be enough so that it has a negative pressure relative to all adjacent spaces, meaning that when the door opens, air rushes in to maintain containment.

In addition to the room are other requirements. Among them:

• A hand-wash sink must be readily available and not interfere with the room’s cleanliness requirements.


• Water sources and drains must be at least one meter from the C-PEC.


• An eye-wash station is required, as are other emergency or safety precautions called for by law or regulation.


• Personal protection equipment should be easily accessible.


• A cabinet and countertop outside of but adjacent to the C-SEC or buffer room should hold gloves, gowns, eye and face protection, and head, hair and shoe covers.


• An appropriate waste container should be set up inside the C-SEC for the disposal of PPE. Personal protection equipment worn during the handling of hazardous drugs is considered contaminated.

On-Site Sterile Compounding
Additional requirements come into play if sterile hazardous drugs under USP <797> are prepared in the facility. These requirements are:

• A separate anteroom which acts as a secondary buffer between the C-SEC (hood room) and adjacent spaces. This room and the C-SEC must meet the requirements of an ISO Class 7 clean room, which refers to an increased level of air filtration that HEPA-type filtering easily achieves.


• A facility that does both sterile and non-sterile compounding typically has three rooms. With the anteroom serving both hood rooms, all three must meet ISO 7 standards.


• A sterile compounding hood room optimally has 30 air changes an hour and is vented to the exterior, and it has a negative pressure relative to the anteroom.


• Just as in the non-sterile setup, a place is needed outside the room to store and dispense personal protection equipment. Again, all gowning needs to happen before the hood room is entered, and all PPE would be disposed of inside the room.


• A hand-wash sink and eye-wash station need to be provided either in the anteroom or hood room.

The final question is, does USP <800> apply to you?

State boards acting as regulators may choose to enforce USP chapters. If you don’t know what your board is doing, call and ask. You can also contact your state’s veterinary association to learn about USP <800> enforcement.

When it comes to bringing your veterinary hospital into compliance with USP <800> it is important to know and remember a few things:

• Architects cannot define your regulatory environment. Each veterinary practice must evaluate the types of medical treatments provided or envisioned. Once those are known, an architect can help incorporate necessary changes to the physical hospital.


• Hazardous drugs are defined in the National Institute for Occupational Safety and Health’s “List of Hazardous Drugs in Healthcare Settings.” [read more here: CDC: Hazardous Drug Exposure in Healthcare].


• Each practitioner is responsible for understanding the materials being used that are subject to USP <800> and how they must be handled.


• USP standards use the terms "manipulating" and "compounding." Different requirements surround each term.

Fully grasping the scope and complexity of new safety standards takes time, so don’t be surprised to encounter conflicting information. Consider working with an experienced designer to ensure that your veterinary facility continues to provide the same excellent level of care.

Paul’s original article was published in Today's Veterinary Business.

View all trending »