USP 800 Presents Significant Compliance Challenges for Long-Term Care Providers

The United States Pharmacopeia (USP) Chapter <800> hazardous drug handling rule is likely to have a profound effect on pharmacy and health care facility operations, according to an analysis by JD Supra.

The USP <800> is a set of practice and quality standards for handling hazardous drugs (HDs) developed by the USP as a part of a compendium of standards related to the compounding of drugs.

The USP rules were supposed to become an official part of the compendium on December 1, 2019, however, revisions to other chapters in the compendium of compounding standards are being appealed. The organization has stated that until such time as those appeals are resolved, USP <800> will be “informational and not compendially applicable.”

USP <800> will be enforced at the federal level primarily by the Occupational Safety and Health Administration and at the state level by the various state boards of pharmacy.

The standards within USP <800> address matters such as the identification of HDs, environmental quality and control, staff training, compounding, and spill control.

It will be critical that long-term care providers familiarize themselves with USP <800> since it can be applied in a variety of different health care settings, according to the JD Supra report. As a result, providers will undertake a risk assessment that considers the HDs administered in the facility, the movement of HDs throughout the facility, staff members who may come into contact with HDs, and quantifying the risk for exposure to HDs for each activity undertaken with respect to HDs.

After the risk assessment is complete, an analysis of the effectiveness of existing controls and containment methods, policies, and procedures for preventing or minimizing exposure to HDs in light of the USP <800> requirements should be started to determine if additional measures will need to be taken, according to the report.

Special engineering controls for compounding may be required depending on the nature of the activities being undertaken in a facility.

USP calls for each facility to designate a qualified, trained individual who is responsible for tasks such as: developing and implementing appropriate procedures, overseeing compliance, ensuring the competency of personnel, and ensuring environmental control of storage and compounding areas. This designated person must understand the risks associated with HDs from a safety and compliance standpoint and must oversee testing and sampling at the facility.

The USP <800> calls for an extensive staff training prior to employees independently handling HDs; staff competency must be demonstrated, documented, and reassessed at least every 12 months.

Click here for information on USP <800>.

REFERENCE

USP 800 to present significant compliance challenges for long-term care providers. JDSupra. https://www.jdsupra.com/legalnews/usp-800-to-present-significant-56926/. Published November 21, 2019. Accessed January 10, 2020.