Frequently Asked Questions (FAQs) about USP <797>
What is the immediate-use provision in USP <797>?
This is basically an exemption to USP <797> that allows certain sterile products to be prepared (compounded) without the need for special facilities (e.g., clean room or ISO Class 5 hood) and practices (e.g., full cleansing or gowning). Two key criteria for immediate-use exemption are avoidance of touch contamination and administration within 1 hour. Nevertheless, it is prudent to carry out immediate-use compounding in an area that is kept clean and orderly. Additionally, common aseptic techniques should be followed.
The immediate-use provision in USP <797> allows the preparation and dispensing of CSPs without the need to be in compliance with the requirements as stipulated in USP <797> for low-risk level CSPs (e.g., ISO Class 5 hood or isolator, facility design and environmental controls, and personnel cleansing and garbing). However, the handling of immediate-use CSPs must meet all of the following criteria:
- Immediate-use CSPs are used in those situations where there is a need for emergency or immediate patient administration of a CSP.
- Immediate-use CSPs are not intended for storage for anticipated needs or batch compounding.
- Preparations that are medium-risk level and high-risk level CSPs shall not be prepared as immediate-use CSPs.
- The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products or diagnostic radiopharmaceutical products from the manufacturers’ original containers and not more than two entries into any one container or package (e.g., bag or vial) of sterile infusion solution or administration container or device.
- During preparation, aseptic technique is followed and, if not immediately administered, the finished CSP is under continuous supervision to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, mix-ups with other CSPs, and direct contact of outside surfaces.
- Administration begins not later than 1 hour following the start of preparing the CSP.
- Unless immediately and completely administered by the person who prepared it, or immediate and complete administration is witnessed by the preparer, the CSP shall bear a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the CSP, and the exact 1-hour beyond-use date (BUD).
- If administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safely discarded.
These FAQs reflect the authors' views only. They have not been provided or endorsed by the USP Convention or the USP Expert Committee on Sterile Compounding, nor do they necessarily reflect the views of the authors' institutions, SNM, or any other entities. This document is provided for informational purposes only and is not intended as legal advice. It should not be used to replace the advice of your own legal counsel.