Good Compounding Practices
Good Compounding Practices are the minimum professional standards established by USP chapters 795 (non-sterile) and 797 (sterile) that pharmacies must follow when preparing compounded medications, covering personnel, facilities, equipment, and quality assurance.
Exam Tip
GCPs are governed by USP 795 (non-sterile) and USP 797 (sterile). Know the documentation: master formulation record (the recipe) and compounding record (the batch log). Class A balance minimum = 120 mg.
What Are Good Compounding Practices?
Good Compounding Practices (GCPs) are the set of standards and procedures that pharmacies must follow when compounding prescription medications. These practices are primarily defined by the United States Pharmacopeia (USP) and enforced by state boards of pharmacy.
Governing Standards
| Standard | Scope | Key Requirements |
|---|---|---|
| USP 795 | Non-sterile compounding | Personnel training, ingredient selection, BUD assignment, quality control |
| USP 797 | Sterile compounding | Cleanroom design, garbing, aseptic technique, environmental monitoring, BUD |
| USP 800 | Hazardous drug handling | Containment, PPE, deactivation/decontamination, spill management |
Key Components of Good Compounding Practices
| Component | Requirements |
|---|---|
| Personnel | Training, competency assessment, hand hygiene, proper garbing |
| Facilities | Appropriate workspace (cleanroom for sterile, designated area for non-sterile) |
| Equipment | Calibrated balances, proper glassware, LAFW for sterile compounding |
| Ingredients | USP/NF grade chemicals, proper storage, within expiration dates |
| Master Formulation Record | Written procedure for each compounded preparation |
| Compounding Record | Documentation of each batch prepared |
| Quality Assurance | Physical inspection, potency testing (when applicable), BUD assignment |
| Labeling | Drug name, strength, BUD, storage conditions, lot number |
Non-Sterile vs. Sterile Compounding
| Feature | Non-Sterile (USP 795) | Sterile (USP 797) |
|---|---|---|
| Environment | Designated compounding area | ISO-classified cleanroom |
| Garbing | Clean clothing, gloves, hair cover | Full sterile garbing (shoe covers to gloves) |
| Key Equipment | Class A balance, mortar/pestle, ointment slab | LAFW/BSC, ISO 5 PEC |
| BUD (default) | Up to 180 days (solid) | Hours to days depending on category |
| Testing | Physical inspection | Sterility testing may be required |
Exam Alert
Good Compounding Practices are tested under the Patient Safety and Quality Assurance domain on the PTCE. Know the difference between USP 795 and 797, the required documentation (master formulation record and compounding record), and the personnel training requirements.
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Related Terms
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.
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.
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.
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