USP 797 and 800

USP 797 and USP 800 are United States Pharmacopeia General Chapters that set practice standards for compounding. USP 797 governs sterile compounding (air quality classifications, beyond-use dates, personnel competency, facility design, environmental monitoring). USP 800 governs handling of hazardous drugs across the pharmacy workflow. The November 2023 USP 797 revision is the current operative version, with substantial procedural changes to BUDs, personnel competency assessment, and environmental monitoring cadence.

How USP 797 and 800 work

USP 797 categorizes sterile compounding into Category 1, Category 2, and Category 3 preparations based on the controls applied and the risk profile, each carrying a defined BUD ceiling. Category 1 (segregated compounding area, lowest controls) has a 12-hour BUD. Category 2 (ISO Class 7 buffer room) ranges by storage conditions from 4 days room temperature to 90 days frozen for sterile-source preparations. Category 3 (the most rigorous controls, sterility testing, extended monitoring) can support BUDs up to 180 days room temperature. Personnel competency assessment, garbing, hand hygiene, surface disinfection, and environmental sampling all carry defined frequency requirements.

USP 800 applies to any compounding facility that handles drugs on NIOSH's hazardous drug list, which includes many oncology, antiviral, and hormone preparations. The standard requires receiving area controls, containment primary engineering controls, containment secondary engineering controls (negative pressure rooms), personal protective equipment, surface monitoring for hazardous drug contamination, and spill response protocols. Both chapters become legally enforceable when adopted by reference into state pharmacy practice acts; most states have adopted them in some form.

When USP 797 and 800 apply

USP 797 applies wherever sterile compounding is performed: hospitals, ambulatory infusion centers, 503A pharmacies, 503B outsourcing facilities, and physician offices that compound sterile preparations. USP 800 applies to any pharmacy or facility handling NIOSH-listed hazardous drugs at any stage from receiving to dispensing to disposal. State boards of pharmacy enforce USP compliance through inspection. FDA enforces parallel requirements through cGMP for 503B facilities and through the Federal Food, Drug, and Cosmetic Act for compounding violations that cross federal jurisdiction.

The compounder's exposure under USP 797 and 800

State board exposure includes inspection findings, license suspension or revocation, fines, and required corrective action plans. FDA exposure runs through Form 483, Warning Letter, consent decree, injunction, and criminal referral, with the highest acute risk in 503B inspections. Civil exposure includes patient-injury litigation where contamination events have produced documented harm, and False Claims Act exposure where compounding billing diverges from documented USP compliance. The defense framework focuses on the contemporaneous record: environmental monitoring data, personnel competency files, BUD documentation, USP-specific procedural records.

Related terms

• 503A and 503B The two compounding regulatory pathways whose operations must comply with USP 797 and 800.
• False Claims Act The civil enforcement track where USP non-compliance is alleged to support billing fraud.
• Inventory reconciliation The audit technique that intersects with USP-related variance findings in hazardous drug or sterile preparation contexts.

See also

• Practice area
  USP 797/800 Compounding Defense

  The full defense framework for USP compliance audits and the November 2023 USP 797 revision impact on sterile compounding operations.

• Practice area
  Compounding Pharmacy Defense

  The compounding defense pillar spanning 503A and 503B regulatory pathways and the full USP compliance framework.