Patricia Kienle, BSPHARM, MPA, FASHP director of Accreditation and Medication Safety for Cardinal Health in Dublin, OH discusses the application of sterile compounding standards in hospital areas outside the pharmacy. This video was filmed during the 2019 American Society of Health-System Pharmacists Summer Meeting in Boston, MA.


Patricia Kienle, BSPHARM, MPA, FASHP: We have to remember that (USP) 797 applies to all health care personnel and in whatever health care setting they’re at. So, they apply everywhere, wherever there are sterile compounds being made. So, outside the pharmacy, you have to think of those procedural areas that are within the hospital setting but you also have to think of clinics and physician offices and any other place where that mixing may be done. The issues that come up there are you don’t have the controls around it. Sometimes you don’t have a hood. Often, you would rarely have a room around that as well. So, you have to understand that there’s issues of preparation for administration, which is 1 issue in 797. And another 1 that’s there is the immediate use provision, which people are familiar with because that’s been in 797 since 2008 and that last iteration of 797 that was out. So, you have to understand that there’s controls that need to be put around there. We need to keep patients safe because that’s the whole point of this, but they’re not going to have the same controls they would have in an IV room.