USP Pharmacy 797/800 Standard Compliance: How Should Hospitals Revise Facilities in Face of Shifting Regulations?
For organizations operating hospital-based pharmacies, compliance with newly revised standards that go into effect Dec. 1 this year related to managing hazardous drugs (HDs) and non-hazardous drugs can pose challenges. The updated USP 797 and new USP 800 standards may require both design and process changes.
USP 797 provides standards for compounding of sterile preparations while USP 800 provides standards for the safe handling of HDs to minimize exposure risks. USP 797 promotes the protection of the sterility of the drug, while USP 800 is focused on the safety of personnel who come in contact with the HDs. Together, USP 797 and 800 establish an environment for compounding drugs that reduces contamination risk and aims to increase safety for healthcare personnel, patients and the environment.
USP 797 has been in effect for over a decade, while USP 800 has only been in publication for a few years. Recent revisions to these documents reflect some notable opportunities and risks:
- One notable revision allows compounding of low-risk drugs with reduced Beyond Use Date (BUD), in unclassified rooms called Segregated Compounding Areas (SCA) for non-hazardous drugs and Containment Segregated Compounding Areas (C-SCA) for hazardous drugs. These rooms must be used in combination with an appropriate ISO Class 5 Primary Engineering Control such as Laminar Air Flow Workbench, A1 Biosafety Cabinet or Compounding Aseptic Isolator. These rooms do not require ISO Class 7 Buffer Rooms with adjacent ISO Class 1 anterooms, and can be an appropriate option for some pharmacies.
- In addition to the USP federal guidelines, states like Massachusetts have published additional regulations in draft form. 247 CMR chapter 17 was recently amended in its draft form and currently mimics the requirements of USP 797, notably the use of SCAs. 247 CMR chapter 19 aligns with USP 800 but it has yet to be amended to incorporate the use of C-SCAs similar to the chapter 17 revision. This leaves Massachusetts facilities managers with a conundrum: build ISO 7 clean rooms with ISO 8 ante rooms for HD compounding to meet the federal deadline conforming to the state draft requirements, at the risk that they may not be a requirement once the draft 247 CMR chapter 19 regulation, if amended similar to chapter 17, is finalized and promulgated. To proceed with corrective actions, facility managers need to consider many factors such as the risk level of the drugs being compounded, the ability to operate with reduced Beyond Use Date, and existing infrastructure and facility conditions.
An assessment of existing conditions can develop into a gap analysis to identify compliance issues and document the plan for corrective work. Once compliance is met, facilities may require ongoing revisions to maintain compliance. Other considerations include:
- If the plan includes construction of ISO class 7 and 8 rooms, the facility will benefit from an evaluation of using prefab panels vs. custom stick built panels
- Future revisions to the regulations may prohibit use of refrigerators in CSA and S-CSAs, similar to the USP prohibition of refrigerators in anterooms
- Potential revisions may also prohibit use of scrub sinks in ISO 8 ante rooms and non-classified rooms
For hospitals with pharmacies on site, it’s wise to begin shaping a response strategy and design solutions now to prepare for the future. As evidenced by the changes to USP 797 and 800, managing HDs is complex and evolving. A long-term strategic perspective on floorplans, ventilation designs and equipment configurations requires a careful evaluation of your pharmacies’ specific protocols and functions. Early involvement of space planners and end-users, working in collaboration with your design team, can help to ensure that your facilities are adapting and complying with these important standards.