Key Takeaways
- USP <795> governs non-sterile compounding; USP <797> governs sterile compounding.
- Beyond-use dates (BUDs) differ from expiration dates and are assigned by the compounder.
- Aseptic technique requires proper hand hygiene, garbing, and working in a laminar airflow hood.
- ISO Class 5 environment is required for sterile compounding in the primary engineering control.
- Hazardous drug compounding follows USP <800> with additional safety requirements.
Last updated: January 2026
Compounding and Sterile Preparation
Quick Answer: Non-sterile compounding follows USP <795> while sterile compounding follows USP <797>. Sterile products require ISO Class 5 environment, proper aseptic technique, and appropriate beyond-use dating. USP <800> covers hazardous drug handling.
USP Compounding Chapters
| Chapter | Coverage | Examples |
|---|---|---|
| USP <795> | Non-sterile compounding | Creams, ointments, capsules, oral liquids |
| USP <797> | Sterile compounding | IV solutions, injections, ophthalmic preparations |
| USP <800> | Hazardous drug handling | Chemotherapy, hormone preparations |
Non-Sterile Compounding (USP <795>)
Types of Non-Sterile Preparations
| Type | Description | Example |
|---|---|---|
| Simple | Follows manufacturer's instructions | Reconstituting antibiotic suspension |
| Moderate | Requires calculations, special equipment | Compounding cream with multiple ingredients |
| Complex | Special training, complex preparation | Transdermal preparations, suppositories |
Equipment for Non-Sterile Compounding
- Class A prescription balance (sensitivity 6 mg)
- Graduated cylinders
- Mortar and pestle
- Ointment slab or parchment paper
- Spatulas (metal and plastic)
- Weighing boats or papers
- Compounding log and formula records
Beyond-Use Dating for Non-Sterile Compounds
| Type | Maximum BUD (no stability data) |
|---|---|
| Water-containing oral | 14 days (refrigerated) |
| Water-containing topical | 30 days |
| Non-aqueous preparations | 180 days or earliest expiration |
| Solid dosage forms | 180 days or earliest expiration |
Important: Beyond-use date (BUD) is different from expiration date. BUD is assigned by the compounder; expiration date is from the manufacturer.
Sterile Compounding (USP <797>)
ISO Classifications
| ISO Class | Max Particles (0.5 mcm) per m3 | Use |
|---|---|---|
| ISO Class 5 | 3,520 | Primary engineering control (hood) |
| ISO Class 7 | 352,000 | Buffer area/clean room |
| ISO Class 8 | 3,520,000 | Ante area |
Primary Engineering Controls (PECs)
| Type | Description | Use |
|---|---|---|
| Horizontal Laminar Airflow Hood (LAFW) | HEPA-filtered air flows toward worker | Non-hazardous sterile compounding |
| Biological Safety Cabinet (BSC) | Air exhausted through HEPA filter | Hazardous drugs |
| Compounding Aseptic Isolator (CAI) | Enclosed, negative pressure | Hazardous drugs |
| Compounding Aseptic Containment Isolator (CACI) | Enhanced containment | Hazardous drugs |
Aseptic Technique Requirements
Proper Hand Hygiene:
- Remove jewelry and artificial nails
- Wash hands and forearms with antimicrobial soap for 30 seconds
- Apply alcohol-based hand rub before gloving
- Don sterile gloves (change every 30 minutes or when contaminated)
Proper Garbing Order:
- Shoe covers
- Head cover (hair cover)
- Face mask
- Hand washing
- Non-shedding gown
- Sterile gloves (in ante-area or buffer area)
Beyond-Use Dating for Sterile Compounds (CSPs)
Category 1 CSPs (12 Hours or Less at Room Temp):
| Storage | BUD |
|---|---|
| Room temperature | 12 hours |
| Refrigerated | 24 hours |
Category 2 CSPs (Prepared in ISO 5 with ISO 7 Buffer):
| Storage | BUD |
|---|---|
| Room temperature | 4 days |
| Refrigerated | 10 days |
| Frozen (-25 to -10 C) | 45 days |
Clean Room Behavior Rules
- No food, drink, or gum
- No cosmetics or perfume
- Speak minimally
- Move slowly and deliberately
- Never cough or sneeze toward work area
- Keep hands away from face
- Work at least 6 inches inside hood
- Never block HEPA filter airflow
IV Preparation Basics
Common IV Solutions
| Abbreviation | Full Name | Uses |
|---|---|---|
| NS | Normal Saline (0.9% NaCl) | Most common, isotonic |
| 1/2 NS | Half Normal Saline (0.45% NaCl) | Maintenance fluids |
| D5W | 5% Dextrose in Water | Caloric supplementation |
| D5NS | 5% Dextrose in Normal Saline | Fluid and calories |
| LR | Lactated Ringer's | Resuscitation, surgery |
| D5LR | 5% Dextrose in LR | Combination therapy |
IV Flow Rate Calculations
Formula: gtt/min = (Volume x Drop Factor) / Time in minutes
| IV Set Type | Drop Factor |
|---|---|
| Microdrip | 60 gtt/mL |
| Macrodrip (standard) | 10-20 gtt/mL |
Worked Example: IV Flow Rate
Order: 1000 mL NS over 8 hours using 15 gtt/mL tubing
Step 1: Convert hours to minutes
- 8 hours x 60 = 480 minutes
Step 2: Apply formula
- gtt/min = (1000 mL x 15 gtt/mL) / 480 min
- gtt/min = 15,000 / 480 = 31.25 gtt/min (round to 31)
Hazardous Drug Handling (USP <800>)
Requirements for Hazardous Drugs
| Requirement | Details |
|---|---|
| Negative pressure room | Prevents contamination spread |
| Double gloving | Chemotherapy-rated gloves |
| Closed-system transfer devices | For administration |
| Dedicated equipment | Do not share with non-hazardous |
| Spill kit | Readily available |
| Medical surveillance | For personnel exposure |
Categories of Hazardous Drugs
- Antineoplastic agents (chemotherapy)
- Hormones and hormone antagonists
- Some antivirals
- Immunosuppressants
- Bioengineered drugs
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Test Your Knowledge
Which USP chapter governs sterile compounding of non-hazardous medications?
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B
C
D
Test Your Knowledge
What is the proper garbing order for entering a sterile compounding area?
A
B
C
D
Test Your Knowledge
An IV bag is compounded in an ISO Class 5 hood within an ISO Class 7 buffer room. If stored refrigerated, what is the maximum beyond-use date for a Category 2 CSP?
A
B
C
D