Readers might recall Ronak Kadakia’s excellent article “Are You Ready for USP 800?” in the June/July 2019 issue of Today’s Veterinary Business. 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. My firm has been busy working with veterinary clients to bring their hospitals into compliance.
What USP <800> is and why it’s important were described well in the article, but I’ll summarize here. 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 is a scientific organization known formally as United States Pharmacopeia. It’s not a government or enforcement entity. USP develops guidelines and standards that may be adopted and enforced by regulators.
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 also can contact your state’s veterinary association to learn about USP <800> enforcement.
Here are a few key starting points:
- 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.”
- 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.
USP guidelines take a layered approach to protecting employees. They include:
- Define risks of using and manipulating different materials.
- Conduct staff training on proper transporting, handling and cleaning procedures.
- Provide personal protection equipment (PPE).
- Use a primary containment device and secondary containment of possible airborne contaminants.
- Ensure that environmental controls are in place to prevent the migration of hazardous materials.
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. Let’s look at the differences.
Minor Handling and Non-Sterile Compounding
Practices that administer non-sterile compounds or do the compounding in-house should have a room separate from other clinical spaces. Within the room is a filtered and vented hood, also known as the Containment Primary Engineering Control (C-PEC). Not all hoods are equal. In this situation, you need a Containment Ventilated Enclosure (CVE), a Class 1 Biological Safety Cabinet (BSC) or a Class 2 BSC. The cabinet should be externally vented and filtered. The air movement within the cabinet varies by cabinet type, but all 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 room housing a C-PEC is called the Containment Secondary Engineering Control (C-SEC), or buffer room. It is externally vented and must be completely enclosed, not an alcove or a corner in a larger space. Total airflow is 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 easilyaccessible.
- 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. (See sidebar.) A separate anteroom 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 usually has three rooms. With the anteroom serving both hood rooms, all three need to 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.
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.
WHAT ABOUT <795> AND <797>?
United States Pharmacopeia (USP) on June 1, 2019, published revisions to two general chapters: <795> (Pharmaceutical Compounding—Non-Sterile Preparations) and <797> (Pharmaceutical Compounding—Sterile Preparations). Afterward, certain provisions, including their applicability to veterinary practices, were appealed. In September, USP postponed the start dates of the revised <795> and <797> chapters until the appeals process is completed. They are pending as of this writing.
Of the three standards discussed here, only <800> went into effect Dec. 1. Because <800> is referenced in the proposed updated language of <795> and <797>, <800> is informational only until the appeals are settled and does not have compendial applicability. Effectively, <800> is recommended for now rather than required. Should the appeals be denied, all three standards will become official. Practitioners are advised to contact their state boards to determine how or if the standards are being applied.