Long-awaited revisions to USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, were released last November, and those responsible for the physical environment will find that the changes have very little impact on pharmacy design other than requirements previously spelled out when the first set of revisions dropped in 2019.
The 2022 revisions mainly touch on the newly required method used to assign “beyond useful dates,” or BUDs, for compounded sterile preparations. Mike Zorich, PE, LEED AP, principal, director of health care for international design and engineering firm IMEG Corp., says that with no new changes required for pharmacy physical environments, most health care organizations are well-primed for compliance with USP <797>.
“Most of the pharmacies we’ve designed over the last five years, they really positioned themselves in preparation for the original deadline for USP <797>,” Zorich says. “So, for these recent changes, it’s about spending time with the pharmacist to understand what impact the BUD will have on them. My take on it is that we are going to see the designs of these spaces remain very similar.”
For those who may have gotten a late start on renovating their pharmacies to comply with the final standard, Zorich gives two pieces of advice, and the first is to start now.
Today’s supply chain landscape poses a unique challenge to hospitals that may be scrambling to get their pharmacies up to USP <797> standards, making it imperative to begin renovations as soon as possible before enforcement of the standard begins.
“Electricals components, such as electrical panels, are still the items we are seeing with huge delays,” Zorich says. “Not every pharmacy renovation is going to need that, but that is where we are seeing the biggest delays if they are required.”
The second piece of advice Zorich gives is to pay close attention to state rules. While some state pharmacy boards are ready to begin enforcing USP <797>, others may not be or may have a unique set of standards.
“Consult your state’s board of pharmacy because they may have some other requirements that may allow you to get a variance if you cannot be compliant in time,” Zorich says. “We have worked in some states where that was allowed, and we’ve had other states that say, ‘No, that’s not the case.’ So, make sure you have those conversations.”