USP 795, 797 and 800: Diversion Controls for Compounding Areas
The USP compounding chapters set standards for how preparations are made. They do not, by themselves, account for every milliliter of a controlled substance that enters the compounding area. These guides cover where diversion hides in each kind of compounding, and the access and waste controls that close the gap.
Hospital version: 8 sections, 63 weighted items. No account or login.
The guides, in order
6 guides on this topic.
By USP chapter
Nonsterile compounding, sterile compounding and hazardous drugs.
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USP 795 Nonsterile Compounding: Diversion Risks in the Compounding Area
How USP 795 nonsterile compounding workflows create diversion risk — and the controls that keep compounded preparations accountable.
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USP 797 and Sterile Compounding: Where Diversion Hides in the IV Room
How diversion happens in sterile compounding — high-value injectables, partial doses, and waste documentation gaps — and the controls that close it.
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USP 800 Hazardous Drugs: Safe Handling Meets Diversion Prevention
The overlap between hazardous drug handling standards and controlled substance diversion prevention in oncology and beyond.
Access and waste in the compounding room
Logging who enters the room, and witnessing every waste event.
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Compounding Room Access Needs a Real Audit Trail
If anyone can enter the compounding room without a logged badge swipe or witness signature, controlled substance waste and overfill are eff…
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Compounding Room Accountability: Witness Every Waste Event
Require two staff to witness and sign every controlled-substance waste event in the compounding room—single-signature logs are the easiest…
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Controlled Substance Waste & Discrepancy Documentation: Policies That Pass Audits
How to document medication waste, partial doses, and discrepancies so your diversion prevention program survives an audit.
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Camera Setup
Placement guides, retention requirements, OR strategy, and maintenance schedule
What the assessment checks
The hospital assessment has 8 sections. These are the 9 items it scores under Controlled Substance Lifecycle Management:
- Automated dispensing cabinets (ADC) in all controlled substance storage areas
- Two-person verification for ADC restocking and narcotic waste
- Barcode scanning at administration for all controlled substances
- Real-time discrepancy detection and alerting on ADC transactions
- Waste and partial dose documentation with witness verification
- Controlled substance returns reconciled within 72 hours
- Sterile compounding areas have separate controlled substance logs
- Controlled substance delivery from pharmacy to floor uses tamper-evident packaging
- Sample medications tracked with same rigor as dispensed inventory
The other sections: Governance & Program Oversight (7), Perioperative & Procedural Areas (6), Data Analytics & Surveillance (9), Personnel & Access Controls (8), Physical Security (7), Incident Reporting & Investigation (9), Regulatory Compliance (8). Each item is weighted, the score updates as you answer, and the result exports to PDF or CSV.