1. USP <797> (2023 Revision) Compounding Categories & BUD Limits
The 2023 revision of USP Chapter <797> replaced low-, medium-, and high-risk compounding tiers with three precise Beyond-Use-Dating (BUD) categories based on environmental air quality and sterility testing:
| Compounding Category | Cleanroom Environment | Sterility Testing? | BUD (Controlled Room Temp) | BUD (Refrigerated 2–8°C) |
|---|---|---|---|---|
| Category 1 CSP | Segregated Compounding Area (Unclassified SCA) | No | <=12 Hours | <=24 Hours |
| Category 2 (Sterile Components) | ISO Class 7 Buffer Room + ISO 7/8 Ante Room | No (Standard) | 4 Days | 10 Days |
| Category 2 (Sterility Tested) | ISO Class 7 Suite with continuous monitoring | Yes (USP <71>) | 30 Days | 45 Days |
| Category 3 CSP | ISO Class 7 Suite with enhanced personnel checks | Yes (Every batch) | Up to 60 Days | Up to 90 Days |
2. USP <800> Hazardous Drug Containment Engineering
USP Chapter <800> protects healthcare workers handling hazardous antineoplastic and cytotoxic pharmaceuticals:
- Containment Primary Engineering Controls (C-PEC): Compounding must take place within an externally vented Class II Type B2 or Class III Biological Safety Cabinet providing 100% exhausted HEPA-filtered air.
- Containment Secondary Engineering Controls (C-SEC): Compounding cleanrooms must operate under negative pressure relative to adjacent areas (-0.01 to -0.03 inches of water column) with at least 30 Air Changes Per Hour (ACPH).
- Closed System Drug-Transfer Devices (CSTD): CSTDs are mechanically required during patient administration by bedside nurses to prevent surface contamination and volatile aerosol release into patient care suites.