USP 797 vs USP 800: two chapters of the United States Pharmacopeia that are often confused, yet have profoundly different goals, scopes and requirements. USP <797> governs the compounding of sterile preparations (Compounded Sterile Preparations, CSPs) and protects the patient from contamination risk; USP <800> governs the handling of hazardous drugs (HDs) and protects workers and the environment from exposure. Anyone working in hospital pharmacy, a compounding center or QA needs to know both, because many preparations — injectable chemotherapy is the classic example — fall under both at the same time. This guide compares the two chapters: purpose, scope, facility and process requirements, with a summary table ready for internal training.
USP 797 vs USP 800: different goals, one workflow
The conceptual difference is sharp. USP <797> "Pharmaceutical Compounding – Sterile Preparations" is a product-quality standard: it defines the minimum conditions for preparing CSPs that do not harm the patient through microbial contamination, endotoxins, strength errors or substandard components. USP <800> "Hazardous Drugs – Handling in Healthcare Settings" is a protection standard: it defines requirements to reduce occupational and environmental exposure to hazardous drugs across their entire life cycle in the facility, from receipt to disposal.
In short: 797 looks inside the preparation (sterility and quality of the CSP), 800 looks outside (workers, healthcare personnel, the environment). That is why the requirements can seem to pull in opposite directions: 797 prioritizes product protection (first air, unidirectional flow), while 800 mandates containment (negative pressure, external venting). Facilities must design rooms and procedures that satisfy both.
What USP <797> requires (2023 revision)
The revised USP <797> became official on November 1, 2023 and replaced the old three risk levels (low/medium/high) with three CSP categories based on compounding conditions and the beyond-use date (BUD):
- Category 1: CSPs prepared in a Segregated Compounding Area (SCA) with an ISO Class 5 PEC, with a maximum BUD of 12 hours at controlled room temperature or 24 hours refrigerated.
- Category 2: CSPs prepared in a cleanroom suite (ISO 7 buffer room with ISO 8 ante-room), with longer BUDs depending on the compounding method, sterilization and any sterility testing.
- Category 3: CSPs with further extended BUDs, in exchange for additional requirements on garbing, more frequent environmental monitoring, sterility testing and stability studies.
The chapter also covers personnel qualification (garbing competency, gloved fingertip/thumb sampling, media-fill testing at a category-defined frequency), viable air and surface environmental monitoring, cleaning and disinfection, component controls and the quality program. It applies to all persons who prepare CSPs and all places where CSPs are prepared: hospital and community pharmacies, clinics, physician offices. It does not apply to industrial manufacturing, which remains under GMP.
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What USP <800> requires
USP <800> has been official since December 1, 2019, but it became compendially applicable — i.e. enforceable through the references in the revised USP <795> and <797> — on November 1, 2023. Its perimeter is much broader than compounding alone: it covers all healthcare personnel who handle hazardous drugs and every phase of their life cycle in the facility, including receipt, storage, sterile and nonsterile compounding, transport, administration and waste disposal.
Key requirements include:
- The facility's hazardous drug list, based on the NIOSH list (the current edition is the NIOSH List of Hazardous Drugs in Healthcare Settings, 2024, Publication 2025-103, organized into Table 1 and Table 2).
- A documented assessment of risk for dosage forms handled under alternative containment strategies.
- A designated person accountable for overall compliance with the chapter.
- Dedicated rooms: HD storage and compounding in negative-pressure areas with at least 12 air changes per hour and external venting; sterile HD compounding requires a C-PEC (e.g. a Class II biological safety cabinet or a containment isolator) located in a negative-pressure C-SEC.
- PPE and devices: gloves tested to ASTM D6978, dedicated gowns, and closed system drug-transfer devices (CSTDs) recommended for compounding and required for administration when the dosage form allows.
- Deactivation and decontamination, spill management and medical surveillance of exposed personnel.
Comparison table: USP <797> vs USP <800>
| Aspect | USP <797> | USP <800> |
|---|---|---|
| Goal | Quality and sterility of the preparation (patient protection) | Containment of exposure (protection of workers and environment) |
| Scope | Sterile preparations (CSPs) only | Hazardous drugs, sterile and nonsterile, across the whole life cycle |
| Status | Revision official since November 1, 2023 | Official since December 1, 2019; compendially applicable since November 1, 2023 |
| Room pressure | Positive-pressure buffer room (non-hazardous CSPs) | Negative pressure mandatory for HD storage and compounding |
| Hoods | ISO Class 5 PEC (LAFW, RABS, isolators) | Externally vented C-PEC (Class II BSC, CACI) |
| Substance reference | All compounded sterile medicines | NIOSH list of hazardous drugs |
| Personnel | Aseptic qualification (garbing, media fill, fingertip sampling) | Containment training, PPE, medical surveillance |
When both apply
The typical case is compounding injectable chemotherapy: as a CSP it falls under USP <797> (categories, BUDs, aseptic qualification, environmental monitoring), and as an HD it falls under USP <800> (externally vented C-PEC, negative-pressure C-SEC, PPE, CSTDs). The standard design solution is a negative-pressure cleanroom with a positive-pressure ante-room: it protects the product without giving up containment. For European readers, the useful parallel is EU GMP Annex 1 for sterile product protection and the PIC/S guidance for hospital pharmacy: the contamination-control and risk-assessment logic is the same, and many inspectorates use the USP chapters as a technical reference outside the US as well.
GuideGxP recommendation
Do not treat 797 and 800 as two separate projects: start from a single map of flows (people, materials, waste) and give every room a pressure and classification target consistent with both chapters. Three recurring mistakes to avoid: compounding HDs in positive-pressure rooms "because the hood is ISO 5" (a direct violation of 800); using one generic assessment of risk for every dosage form; forgetting that the category BUD also depends on where you compound, not only on how. Document every choice with a risk rationale: it is the first thing an inspector — FDA, State Board or a European inspectorate — will ask to see.
If you run cleanrooms and classified areas, GuideGxP's ISO 14644-5:2025 Cleanroom Operations Operational Guide — with a toolkit of ready-to-use templates — helps you set up gowning, cleaning and operational control of your rooms in an audit-ready way.
