Healthcare facilities have until December 1, 2019 to comply with the new USP <800> federally enforceable rules and regulations.
The primary objective of USP <800> is to promote patient safety, staff safety and environmental protection from hazardous drugs.
Three action steps to consider in preparing for USP <800>
- Complete an assessment of risk
- Upgrade existing facility to meet standards
- Educate and train personnel
The first step is to have your pharmacist and technicians perform an assessment of risk of their facility. Review this thorough checklist for USP <800> in healthcare facilities.
After the assessment of risk has been completed, it’s a good idea to hire a third party organization who specializes in pharmacy LEAN design and understands the required changes, such as developing evidence-based standard operating procedures that are compliant with USP <800>. But, it’s also important to meet the specific needs of their organization, workflows, HVAC improvements for proper air exchanges, adjustments to the facility’s footprint to comply with storage guidelines, temporary construction phasing if renovating in place, and cost of construction. Once capital improvements are made and new procedures are rolled out, personnel training and education is a key component of the compliance process; not a one‐time event, but a continuing cycle of training, assessment, and improvement that keeps patients, staff, and our environment safe.
Knowing that USP <800> will become official on December 1, 2019, most facilities want to take USP <800> into account so that any newly built or renovated facility does not become obsolete in terms of conformance to standards after December 1, 2019. However, to cover all bases, it is recommended that any facility contemplating this decision contact its State Board of Pharmacy to verify its position on this matter.
EAPC has implemented USP 795, 797, and 800 across the United States. Contact EAPC’s Healthcare Practice Director, Stanley Schimke to discuss upgrading your facility to comply with these federal requirements.