USP 795 and USP 797 (Compounding Standards)
USP 795 and USP 797 are United States Pharmacopeia chapters that establish minimum standards for non-sterile compounding (795) and sterile compounding (797), including personnel training, facilities, equipment, and quality assurance requirements.
Exam Tip
USP 795 = non-sterile compounding, USP 797 = sterile compounding, USP 800 = hazardous drugs. Know ISO classes (5 = hood, 7 = buffer, 8 = ante-area) and default BUDs for non-sterile (aqueous = 14 days refrigerated).
What Are USP 795 and USP 797?
The United States Pharmacopeia (USP) publishes enforceable standards for pharmaceutical compounding. USP General Chapter 795 covers non-sterile compounding, while Chapter 797 covers sterile compounding. Both chapters are legally enforceable in most states through state boards of pharmacy. USP 800, which addresses hazardous drug handling, works alongside these standards.
USP 795 (Non-Sterile Compounding)
| Requirement | Details |
|---|---|
| Personnel | Training and competency assessment required |
| Facilities | Designated compounding area, adequate lighting, clean surfaces |
| Equipment | Properly calibrated (Class A balance: ≥120 mg minimum weighable quantity) |
| Master formulation record | Written procedure for each compounded preparation |
| Compounding record | Documentation of each preparation compounded |
| Quality control | Visual inspection and weight/volume verification |
| Labeling | Drug name, strength, BUD, storage, and lot number |
USP 795 Beyond-Use Dates (Default)
| Dosage Form | Default BUD (No Stability Data) |
|---|---|
| Aqueous (water-based) | 14 days refrigerated |
| Non-aqueous | 90 days |
| Solid (capsules, tablets) | 180 days |
USP 797 (Sterile Compounding)
| Requirement | Details |
|---|---|
| Personnel | Initial and annual competency testing (media fill, gloved fingertip, garbing) |
| Cleanroom | ISO-classified rooms (ISO 5 PEC, ISO 7 buffer, ISO 8 ante-area) |
| Primary Engineering Control (PEC) | LAFW (horizontal or vertical), BSC, CACI, or isolator |
| Garbing | Full sterile garbing in correct order |
| Environmental monitoring | Viable and non-viable air and surface sampling |
| Quality assurance | Sterility testing for higher-risk preparations |
USP 797 ISO Classifications
| Area | ISO Class | Particles/m³ (≥0.5 µm) | Purpose |
|---|---|---|---|
| PEC (inside hood) | ISO 5 | 3,520 | Where compounding occurs |
| Buffer room | ISO 7 | 352,000 | Room containing the PEC |
| Ante-area | ISO 8 | 3,520,000 | Gowning/staging area |
USP 797 Categories and BUDs
| Category | Conditions | BUD |
|---|---|---|
| Category 1 | Compounded in ISO 5 PEC | 12 hours (room temp), 24 hours (refrigerated) |
| Category 2 | Per stability-indicating methods | Up to 9 days refrigerated (or longer with testing) |
USP 795 vs. USP 797 Comparison
| Feature | USP 795 (Non-Sterile) | USP 797 (Sterile) |
|---|---|---|
| Products | Creams, capsules, solutions | IV admixtures, injectables, ophthalmic |
| Environment | Dedicated area | ISO-classified cleanroom |
| Garbing | Minimal (gloves, hair cover) | Full sterile garbing |
| Competency testing | Required | More rigorous (media fill, gloved fingertip) |
| BUDs | Up to 180 days | Hours to days (without extended stability data) |
| Equipment | Balance, mortar/pestle | LAFW, BSC, or isolator |
USP 800 (Hazardous Drugs)
| Requirement | Details |
|---|---|
| Applies to | All personnel handling hazardous drugs |
| PPE | Chemotherapy-rated gloves, gown, eye protection, respirator |
| Engineering controls | CPEC (containment PEC) for compounding |
| Spill management | Spill kit and trained personnel required |
| Medical surveillance | Recommended for exposed personnel |
Exam Alert
USP 795 and 797 are high-yield topics across the Dispensing Process domain. Know the ISO classifications (5, 7, 8), default BUDs for non-sterile preparations, garbing requirements, and that USP 797 requires a cleanroom while USP 795 does not. Also know that USP 800 addresses hazardous drug handling.
Study This Term In
Related Terms
Compounding Pharmacy
A compounding pharmacy prepares customized medications by mixing, combining, or altering ingredients to create preparations not commercially available, following USP 795 (non-sterile) and USP 797 (sterile) standards.
Aseptic Technique
Aseptic technique is a set of practices and procedures used in sterile compounding to prevent microbial contamination of compounded sterile preparations (CSPs), including proper gowning, hand hygiene, and manipulation within a laminar airflow hood.
Beyond-Use Dating (BUD)
Beyond-use dating (BUD) is the date after which a compounded preparation should not be used, determined by the pharmacy based on USP standards and the stability characteristics of the specific formulation.
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