How will revised USP 797 guidelines affect you?

January 28, 2008

The revision emphasizes training and competency of pharmacists.

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

"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.

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.

Ken Speidel, Pharm.D., consultant for PharmaCare Rx Inc., applauded the revision for definitively stating that the guidelines apply to all persons who are compounding sterile preparations. "It's not just pointing to the pharmacist in the home infusion company or the institutional area. It applies to the ambulatory infusion suite, infusion centers, and physician suites," he said.

Speidel also praised USP for permitting compounded parenteral nutrition to be considered stable from a sterility sense when kept in the refrigerator for nine days, instead of seven.

Viable air testing

Speidel expressed concern about USP's viable air testing requirements because the equipment is expensive, especially for smaller organizations. "We are required by USP to test our clean rooms every six months. We have a company that comes in. We need to push testing companies to include viable air testing in their service offerings, so that when they come in to test our particulates, they will also look for pathogens, bacteria, or fungi that are in the air," said Speidel.

Finally, Speidel praised USP, stating, "Oftentimes in home infusion we are asked to prepare certain chemotherapy products that are used on a pump for a patient in the home. To require that these products be prepared in a negative pressure room would be cost prohibitive to organizations that do a very small volume. USP said that small organizations can use closed-system transfer devices, which aren't as costly."

Meanwhile, the Pharmacy Technician Certification Board has revealed that an exam that will give certified technicians an additional designation in IV admixture is on the drawing boards. According to Melissa Murer Corrigan, CEO of PTCB, this additional credential will give technicians new room for moving up the career ladder.