Regulatory Advisory: USP Chapters <797> and <800> New and Revised Compounding Standards

The United States Pharmacopeia (USP) in June 2019 released several new and revised pharmacy compounding standards. Specifically, USP published the final revised version of general chapter <797> (Pharmaceutical Compounding of Sterile Preparations) to accompany the previous released general chapter <800> (Hazardous Drugs Handling in Healthcare Settings). Due to pending appeals, the effective date of USP <797> remains postponed until further notice and USP <800> remains “informational” until <797> is finalized. While federal regulatory agencies and accrediting organizations likely will not begin enforcement of both chapters until after the appeals process is complete, several state boards of pharmacy already have begun enforcement of <800>, which may affect your hospital or health system’s timeline for compliance.

AHA Take

While these standards provide an important reminder of the potential hazards of the chemical compounds used in medications, implementation of these standards will be complicated, and likely costly and time-consuming. In addition, while the effective date of USP <797> remains delayed and USP <800> remains informational until further notice, the AHA anticipates required compliance once final. We recommend organizations take immediate steps to assess their specific organizational readiness for compliance and develop a plan to make all necessary changes. Protecting health care personnel from harm resulting from occupational exposure to environmental hazards is a top priority for hospitals and health systems, and implementation of these standards will play a critical role in keeping providers and the patients they treat safe.

Key Takeaways

• Significant investment and cross-organization coordination will be necessary to comply with these standards.
• Consult your state board of pharmacy to determine if compliance with USP <800> is required in your state.
•  If you have not done so already, begin assessing what changes your organization will need to make to comply with the new standards.
• USP <800>, while only informational for the time being, provides important standards around employee and environmental safety that all hospitals and health systems should consider.
• We anticipate required compliance with USP <800> at some point in the near future.

What You Can Do

• Share this advisory with your leaders in human resources, nursing, operations, risk management, pharmacy and information technology.
• Organize your internal team with responsibility for different components of implementation. (see checklist)
• Have staff develop an implementation plan and identify opportunities for early progress to demonstrate efforts to move toward full compliance. Use the resources included below as a starting point for your organization’s work, as appropriate.

View details under key resources.