One of the major new components of USP General Chapter <797> on sterile compounding requires the establishment of a “designated person” (DP) who is responsible for the operation and performance of the compounding facility and personnel. Although the chapter lays out specific DP responsibilities, one thing it does not prescribe is who exactly must be the DP.
“Chapter <797> does not require that your designated person be a pharmacist,” said Patricia Kienle, RPh, MPA, BCSCP, FASHP, the director of accreditation and medication safety at Cardinal Health, during the ASHP Pharmacy Futures 2024 meeting, in Portland, Ore. “This creates an outstanding opportunity for an advanced-level technician to take on a leadership role. You can also have a DP tasked with covering more than one site, if that is stated in your policies and procedures [P&Ps]. You have a lot of leeway on that.”
“The DP must have oversight of your policies and procedures, and ensure that they are appropriate, comprehensive and implemented. That person must review the P&Ps every year and document that review,” Ms. Kienle said. But she warned against “just pulling something from the web because it looks good; make sure that it actually matches your facility.”
Quality assessment must be a written program, with elements that include the following:
- adherence to standard operating procedures for personnel, facilities and environmental monitoring;
- evaluation of complaints and adverse drug events, including medication errors, adverse drug reactions and incompatibilities;
- investigation and corrective action; and
- reports, which should go to a defined committee, include positive and negative findings, and summarize the results of any actions taken.
DPs should be prepared for common areas of interest that accreditors and inspectors may be looking for. “Remember, what we do in sterile compounding is affected by more than just <797>,” Ms. Kienle said. “Standards from bodies such as the Occupational Safety and Health Administration and the American National Standards Institute also apply. I have seen a huge uptick in the last six months with accreditors asking about eyewash stations—usually an environmental surveyor—which are required if you have caustic or corrosive chemicals.”
She noted that eyewash stations are required to be accessible within 10 seconds, on the same level as the chemicals being used, and the path to them cannot be obstructed. “A door is considered an obstruction, which is tricky from our perspective in sterile compounding,” she said. “There is an allowance, however, if you’re not dealing with corrosive chemicals, which we typically are not: You can have one intervening door, only if it is going in the direction of travel.”
However, “there may be an acceptable intermediary process if you aren’t strictly required to have an eyewash station,” Ms. Kienle said. “But it’s important to talk to your facilities folks and take a look at your design prior to getting a visit, because lately at almost every accreditation, someone has asked about it.”
Checklists Can Help
The DP should always use a checklist when working on your facility’s certification report, said Ashley Duty, PharmD, the DP for Nationwide Children’s Hospital, in Columbus, Ohio. “There are a lot of different elements to review and every certification company has a different format, so having a checklist allows you to clearly demonstrate thorough review and assessment of your reports, and easily find information later.”
In some cases, she added, “I will have an operations manager do the first pass with them, to teach others things they should look for, such as humidity and temperature parameters, and help them get experience. Then I’ll do the second check. But the DP absolutely has to do it at some point; that should also be outlined in your policies.”
Ms. Duty and Ms. Kienle reported no relevant financial disclosures.
This article is from the April 2025 print issue.