Keeping Pace^® with Analytical Services

In 2023, the USP <797> standard for compounded sterile preparations was significantly revised to improve patient safety. Not only are there more protocols to follow, but pharmacies may need to demonstrate their adherence to USP <797> to various Authorities Having Jurisdiction (AHJ). Proving adherence includes documenting standard operating procedures (SOPs), but it also includes providing ample evidence that these SOPs are followed and effective.

According to the Centers for Disease Control (CDC), Legionnaires’ disease is on the rise in the United States. In 2000, roughly 1000 cases were reported. That number ballooned to 10,000 cases in 2018, the last year for which data is available. The CDC issued a 2021 report on waterborne diseases, but this report only looks at cases of Legionellosis associated with an outbreak. Most cases of waterborne diseases, including Legionnaires’ disease, are sporadic, i.e., not epidemiologically linked to other cases by time, location of exposure to water, and type of illness.