What are the potential risks of non-compliance with USP 797 standards?

Non-compliance with USP 797 standards poses significant risks primarily related to patient safety and the effectiveness of sterile compounded medications. One of the main objectives of USP 797 is to minimize the possibility of contamination, which can lead to infections and the administration of unsafe medications to patients. When compounding practices deviate from these established standards, the likelihood of microbial contamination increases, which can result in serious patient harm, such as bloodstream infections, surgical site infections, and other health complications associated with contaminated products.

In addition to the direct risks posed to patients, non-compliance can have broader implications for healthcare facilities, potentially leading to a loss of trust, legal ramifications, and increased scrutiny from regulatory bodies. Additionally, addressing the consequences of non-compliance, like treating infections resulting from unsafe compounding, can lead to increased healthcare costs and resource allocation to mitigate these issues, further emphasizing the importance of adherence to USP 797 standards.