USP 797 Immediate-Use Rules Explained
Apr 7, 2025
USP 797 Immediate-Use Rules are essential for safe and sterile medication preparation in emergencies. Here's what you need to know:
Purpose: Protect patient safety during urgent compounding.
Time Limit: Medications must be prepared, administered, and used within 4 hours to avoid contamination.
When to Use: For critical care, surgeries, or emergencies requiring immediate medication.
Key Steps:
Follow strict aseptic techniques (hand hygiene, sterile gloves, clean workspace).
Use sterile components and disinfect critical sites.
Label clearly with "IMMEDIATE-USE ONLY" and "USE WITHIN 4 HOURS."
Staff Requirements:
Training: Initial and ongoing education in aseptic methods.
Competency: Regular testing, including media-fill and fingertip sampling.
Documentation: Maintain detailed records of training, preparation, and quality checks.
Compliance Matters: Accurate documentation, proper labeling, and rigorous training ensure adherence to USP 797 standards, prioritizing patient safety in emergencies.
Basic Rules for Immediate-Use CSPs
What Qualifies as Immediate-Use
Immediate-use Compounded Sterile Preparations (CSPs) are meant for emergencies or urgent situations where delaying medication could harm the patient. These are prepared for a single patient and administered right away.
Once deemed necessary, strict preparation protocols are followed to maintain sterility.
Required Preparation Steps
Using aseptic technique is a must. This includes proper hand hygiene, wearing sterile gloves, and keeping the workspace clean.
Here are the key steps:
Pre-preparation checks
Inspect all components for intact packaging, no visible contamination, valid expiration dates, and correct storage conditions.
Aseptic technique
Disinfect all critical sites and maintain a sterile environment throughout the process.
Handling components
Use sterile components, ensure sterility during transfers, and label the final preparation accurately.
4-Hour Time Limit
To reduce contamination risks, there’s a strict 4-hour window for immediate-use CSPs. This starts when the first component is prepared and ends when the medication is fully administered.
To stay within this time frame:
Record the start time as soon as preparation begins.
Complete administration within 4 hours.
Discard any unused portions after 4 hours.
Compounding and clinical teams must work together to ensure the preparation is used within this timeframe.
Immediate Use Compounding Training
Staff Training and Aseptic Methods
Maintaining sterility during compounding isn't just about following preparation procedures - it also requires proper aseptic techniques and thorough staff training.
Correct Aseptic Technique
Proper aseptic technique is critical for maintaining sterility during immediate-use compounding. Key practices include:
Hand Hygiene and Personal Protection
Wash hands with antimicrobial soap for at least 30 seconds.
Wear sterile gloves, masks, and hair covers.
Use dedicated compounding attire to minimize contamination.
Critical Site Management
Disinfect vial stoppers, ampule necks, and injection ports using 70% isopropyl alcohol.
Allow the disinfectant to remain in contact for 30 seconds.
Ensure critical sites remain exposed to first air at all times.
Workspace Standards
Maintain an ISO Class 5 environment.
Disinfect all work surfaces before and after compounding.
Regularly monitor air handling and filtration systems.
These techniques are reinforced through regular, hands-on training sessions to ensure consistency and accuracy.
Staff Training Requirements
To meet USP 797 standards, staff must undergo detailed training before handling immediate-use compounded sterile preparations (CSPs).
Initial Qualification
Learn the principles of aseptic technique.
Gain hands-on experience in sterile compounding.
Pass written tests, practical evaluations, and direct observation assessments.
Competency Assessments
Complete media-fill testing every six months.
Perform gloved fingertip sampling.
Undergo supervisor evaluations to confirm proper technique.
Ongoing Education
Participate in annual USP 797 refresher courses.
Keep detailed records of training activities.
Stay informed about updates to procedures and standards.
Training documentation must be retained for three years and include:
Training dates
Topics covered
Assessment results
Names of trainers and trainees
Competency verification
For additional guidance on USP 797 compliance and training programs, 503Pharma provides resources to help your facility maintain the highest levels of safety and quality.
Records and Compliance Steps
Keeping detailed records is a must for meeting USP 797 standards in immediate-use compounding. Along with proper staff training and aseptic techniques, accurate documentation plays a crucial role in demonstrating compliance. Here’s what you need to know:
Required Label Information
Every immediate-use preparation must include a label with the following details:
Patient information: Name and identifier
Ingredients: Names and amounts
Beyond-use date (BUD) and time
Preparation details: Date and time
Storage instructions
Administration route
Compounder’s initials
Unique identifier or prescription number
The labels should also clearly state: "IMMEDIATE-USE ONLY" and "USE WITHIN 4 HOURS" to guide proper usage and handling.
Required Documentation
To stay compliant, you’ll need to maintain several types of records:
Master Formulation Records
These outline the preparation process, including:
Instructions for compounding
Ingredients and their quantities
Expected yields
Quality control steps
Stability information
Compounding Records
These track each preparation and include:
Lot numbers of components
Quantities used
Personnel involved
Date and time of preparation
Any deviations from standard procedures
Quality Assurance Records
These focus on maintaining standards and include:
Equipment calibration logs
Temperature monitoring
Cleaning schedules
Accurate and thorough documentation, supported by tools like those from 503Pharma, ensures compliance while prioritizing patient safety.
Summary
Key Immediate-Use Guidelines
Here’s what you need to know about immediate-use requirements:
Must be prepared in ISO Class 5 or cleaner environments.
The beyond-use date (BUD) is limited to 4 hours.
Containers or ampules can only be punctured once.
No batch preparations are allowed.
Processes must be completed without interruption.
Restricted to simple transfers and reconstitutions.
Ensuring USP 797 Compliance
Meeting USP 797 standards involves several critical steps:
Staff Training
Training in aseptic techniques must be documented.
Competency is assessed annually.
Staff should stay informed on updates to USP 797.
Documentation
Maintain master formulation records.
Keep detailed compounding logs.
Track equipment maintenance and calibration.
Document temperature monitoring.
Conduct and record quality control checks.
Facility Requirements
Perform regular environmental monitoring.
Use proper air handling systems.
Follow documented cleaning procedures.
Ensure equipment is calibrated and records are up to date.
These steps create a strong compliance framework, with additional support available through resources like those offered by 503Pharma.
Additional Support
503Pharma offers tools to simplify compliance with USP 797. Their platform provides validated formulas and standardized documentation templates, helping streamline workflows and reduce the time spent on preparation research. These resources are especially useful for pharmacies implementing or updating immediate-use compounding procedures.