April 25, 2024
Nonsterile compounders: Check your water
Be aware: FDA has issued a number of 483s related to the water used in nonsterile compounding. Water for nonsterile compounds needs to be USP-grade purified water. If you use a water purification system to produce “purified water” for your nonsterile compounds, make sure to test the water produced for compliance with the USP Purified Water monograph. This includes testing for Total Organic Carbon (TOC), conductivity, and microbial content. If you are not or cannot test the water to ensure it falls within appropriate parameters, discontinue the use of the water system and buy USP grade purified water instead.
