Complying with all the current compounding regulations can seem like a steep hill to climb for health facilities professionals. Trying to understand all of the standards that must be met, facility and budget obstacles that pose challenges to implementing the measures needed to be in full compliance, and uncertainty over what lies ahead make navigating all of the regulations very challenging.
While it may seem daunting, health facility managers can achieve compliance with USP 797, USP 800 and Board of Pharmacy (BOP) regulations with the appropriate investment in planning, time and funding. Getting started now, understanding where a facility stands relative to the current and anticipated regulations, and engaging stakeholders in the process will ensure a facility’s full USP 797, USP 800 and BOP compliance.
Regardless of the obstacles, the revisions will impose a clearly defined time frame by which hospitals must achieve compliance with USP 797, intensifying the pressure to take immediate action and secure the financial resources needed to implement the necessary changes quickly.
Any leeway hospitals believed they had under USP 797 disappears with the new revisions. A compounding facility generally consists of separate, designated operational clean areas, including an ante area, a buffer area and a primary engineering control (PEC), or a segregated compounding area containing a PEC where CSPs are prepared.
All health facilities that prepare sterile compounds are affected by the revisions to USP 797 and if hazardous drugs are being compounded, USP 800 as well. Given the extent of the revisions and the cost implications to hospitals, it is likely that the USP will open a second round of comments. Should that occur, the enforceable date of the new regulations may be no earlier than spring 2018.
This timing represents an opportunity to take action. The following measures can help to make a health facility consistent with USP 797 and USP 800:
- Start planning now. December 2019 is just over a year away, it takes a long time to make sure all the engineering and environmental monitoring are compliant. Many upgrades require a significant investment in planning, new construction or retrofitting of existing spaces, and financial resources.
- Conduct a gap analysis of the facility design elements. Cost has been one of the key barriers to compliance with USP 797 and USP 800. Understanding where the hospital falls short and the work needed to meet the new regulations will drive the budget discussions that need to start now.
- Get in touch with our team of experts. Getting help from the industry professionals and getting them involved early to your project can save you time and money on the long run. By getting the job done right you can rest assured that your facility will remain compliant if properly maintained for many years and revisions to come.
Call 800.418.9289 and request a site visit from our pharmacy project specialists. There is just enough time left for you to start your USP compliance process.