Medication - Sterile Compounding - Segregated Compounding Area (SCA) (USP 797 2008 Version Only)
Our hospital has a segregated compounding area in the Emergency Department with an IV hood. Are there any restrictions on what medications can be compounded in that area ?
Any examples are for illustrative purposes only.
Organization may utilize a segregated compounding area to prepare items classified as Low Risk Level Compounding as long as the beyond use date does not extend beyond 12 hours. Low Risk items are defined as those items prepared in an ISO 5 environment which:
Organization may utilize a segregated compounding area to prepare items classified as Low Risk Level Compounding as long as the beyond use date does not extend beyond 12 hours. Low Risk items are defined as those items prepared in an ISO 5 environment which:
- The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package (e.g., bag, vial) of sterile product or administration container/device to prepare the CSP.
- Manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.
Manual:
Home Care
Chapter:
Medication Compounding MC
Last reviewed by Standards Interpretation: April 26, 2023
Represents the most recent date that the FAQ was reviewed (e.g. annual review).
First published date: January 23, 2018
This Standards FAQ was first published on this date.
This page was last updated on November 05, 2024
with update notes of: Editorial changes only
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