Overview of the 2023 Revisions
The United States Pharmacopeia's 2023 updates to General Chapter <797> (Sterile Compounding) and General Chapter <800> (Hazardous Drugs) represent the most substantial rewrite in over a decade. Both chapters became official on November 1, 2023.
USP 797 Core Changes
- ISO classification tiers: Primary Engineering Controls (PECs) must now achieve ISO 5 or better at rest and in dynamic conditions.
- Beyond-Use Dating (BUD): New, more conservative BUD tables eliminate many legacy allowances based solely on sterility testing.
- Environmental monitoring frequency: Sampling intervals are now tied directly to compounding risk categories.
- Personnel training: Competency assessments must be documented at initial training and at least every 12 months thereafter.
USP 800 Core Changes
- Scope clarification: Any facility receiving, storing, or administering NIOSH Table 1 agents must comply — not just compounding pharmacies.
- Containment Primary Engineering Controls (C-PECs): Exhaust requirements for Biological Safety Cabinets Class II Type B2 are now mandatory for certain hazardous drug preparations.
- Deactivation & Decontamination: Written procedures with documented wipe-down agents and contact times are required.
What This Means for Your Facility
Pharmacies that were certified under the previous (2008) version of USP 797 may find that their current cleanroom configuration, environmental monitoring program, or documentation practices no longer satisfy the new requirements. A gap assessment is the logical first step.
Gap Assessment Checklist
- Review current ISO classification reports against the new at-rest and dynamic requirements.
- Audit Beyond-Use Dating policies for all CSPs.
- Confirm environmental monitoring schedules match the new risk-tier frequencies.
- Verify all personnel training records include competency assessments dated after November 1, 2023.
- For facilities handling NIOSH Table 1 drugs, confirm C-PEC exhaust configurations and deactivation procedures are documented.
How HSS Can Help
Health Systems Sciences provides full USP 797/800 gap assessments, cleanroom re-certification, and ongoing environmental monitoring programs. Our field engineers are trained to the 2023 standards and can guide your facility from gap identification through remediation and final certification.