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.
Exam Tip
Know USP 795 (non-sterile) vs. USP 797 (sterile). Class A balance minimum = 120 mg. Geometric dilution = mix equal parts progressively. Always label with BUD on the ExCPT.
What Is Compounding Pharmacy?
Compounding is the practice of creating personalized medications tailored to individual patient needs when commercially manufactured products are unavailable or unsuitable. Pharmacy technicians play a key role in both non-sterile and sterile compounding under pharmacist supervision.
Non-Sterile vs. Sterile Compounding
| Feature | Non-Sterile (USP 795) | Sterile (USP 797) |
|---|---|---|
| Examples | Capsules, creams, ointments, suspensions | IV admixtures, ophthalmic solutions, injectables |
| Environment | Dedicated compounding area | ISO-classified clean room with LAFW |
| Garbing | Clean clothing, gloves, hair cover | Full sterile garbing (gown, mask, sterile gloves) |
| Testing | Visual inspection | Sterility testing may be required |
| BUD | Up to 180 days (solid forms) | Hours to days depending on category |
Common Non-Sterile Dosage Forms
| Dosage Form | Description |
|---|---|
| Suspension | Drug particles dispersed in liquid; "Shake Well" |
| Emulsion | Two immiscible liquids (oil + water) mixed with emulsifier |
| Ointment | Semi-solid for topical use (oil-based, occlusive) |
| Cream | Semi-solid emulsion (water-washable) |
| Capsule | Drug powder in gelatin shell |
| Troche/Lozenge | Dissolves slowly in mouth for local effect |
Compounding Equipment
| Equipment | Use |
|---|---|
| Class A balance | Weighing ā„120 mg (sensitivity 6 mg) |
| Electronic balance | Precise weighing of small quantities |
| Mortar and pestle | Grinding/mixing (glass, porcelain, or Wedgwood) |
| Ointment slab | Mixing ointments and creams |
| Graduated cylinder | Measuring liquids (read at meniscus) |
Key Compounding Principles
- Geometric dilution: Mix smallest quantity of drug with equal amount of diluent, then double progressively
- Levigation: Reduce particle size by grinding with a small amount of liquid
- Spatulation: Mixing on an ointment slab with a spatula
- Trituration: Grinding in a mortar to reduce particle size
Exam Alert
Compounding is a major topic in the Dispensing Process domain (55% of ExCPT). Know the difference between USP 795 and 797, common dosage forms, equipment (especially the Class A balance minimum of 120 mg), and techniques like geometric dilution.
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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.
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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