How Will Revised USP 797 Guidelines Affect You?

By Levy, Sandra | Drug Topics, January 28, 2008 | Go to article overview

How Will Revised USP 797 Guidelines Affect You?


Levy, Sandra, Drug Topics


The United States Pharmacopeia released its revision of Chapter <797>, "Pharmaceutical Compounding-Sterile Preparations," in December. The new standards become official June 1, 2008.

How will the guidelines affect pharmacists? Eric Kastango, R.Ph., CEO of Clinical IQ, LLC, Florham Park, N.J., who served on the Sterile Compounding Expert Committee, told Drug Topics that the revision emphasizes training and competency of pharmacists and technicians.

"Attention has been focused on facilities, clean rooms, cleanliness, and air classification, but the most important factor that determines whether a product is going to be sterile is the person who is compounding the product. The chapter is much more employee centric. There has to be a greater focus on training, competency, and documentation of the training and holding people accountable," said Kastango.

Preventing contamination

Kastango explained that the revision highlights the importance of finger tip sampling, and surface sampling of hoods and other components as well as other sources of contamination. It also explains the importance of wiping vials and components before using them, and routinely disinfecting gloves with sterile alcohol.

Kastango added that Chapter <797> is now aligned with existing evidence-based standards such as the Centers for Disease Control & Prevention's hand hygiene guidelines.

Luis Hernandez, R.Ph., sterile admixtures supervisor at Baptist Hospital Miami, in Florida, said, "Making sterile products in a hospital environment has been something that everybody has gone about in whatever way they thought was best."

Hernandez went on to explain that many people haven't followed guidelines for gowning, cleaning, and using aseptic technique. "You have to have some kind of enforcement. Touch contamination is the No. 1 reason why we have line infections in patients. You can be totally gowned and gloved and if you do not avoid touching critical sites and if you do not disinfect critical sites prior to injecting anything through them, you will contaminate IVs," said Hernandez. …

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