Pharmacy Purchasing & Products recently held a webinar entitled:
USP <797> Quality Control Elements
Presented by Patricia C. Kienle, RPh, MPA, BCSCP, FASHP

The following questions were submitted by attendees.
The webinar slides and full presentation can be downloaded at pppmag.com/webinars.

Q: Can a 503A pharmacy outsource from a 503B for resale?

A: Yes, a 503A pharmacy can outsource from a 503B for resale unless there is a specific prohibition by your state board of pharmacy. Any 503A, whether it is a hospital or a community pharmacy, can purchase from a 503B if the 503B allows it and the entities have a contract. However, there is a limitation to this relationship, as the accepting 503A pharmacy cannot wholesale the drug that it receives from the 503B; the outsourced medication has to be dispensed under a patient-specific prescription consistent with your local board of pharmacy regulations.

Q: Now that the use of sterile cleaning agents is required in the C-PECs, is it acceptable to leave pre-saturated sterile wipes and/or a cleaning agent spray bottle in the hood?

A: Space and preservation of appropriate airflow are the key factors to consider when cleaning the containment primary engineering control (C-PEC). You do not want to introduce anything to the C-PEC that would impede proper airflow. In most cases, a sealable package of pre-saturated sterile alcohol wipes is fine to use, as long as it is placed against the side of the primary engineering control (PEC) or C-PEC. No spray bottles of any solution should be left inside the C-PEC since the use of a spray could aerosolize hazardous drug residue. I recommend against allowing any spray bottles inside the containment secondary engineering control (C-SEC), since they could be inappropriately used.

Q: Can you provide guidance on the use of UV purification systems in the cleanroom?

A: There is no good data for utilizing these systems in sterile compounding areas, although some have leveraged them as a last resort to address persistent microbial contamination. I am aware of one article in the American Journal of Infection Control in 2018, but a later response to that study provides more information on what would be needed to prove efficacy.1

Q: For high-alert medications, do you recommend a mid-prep check before the drug is injected into the bag versus a retrospective check upon CSP completion?

A: Yes, and that practice is consistent with recommendations in ISMP’s 2016 Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology.

It is always best to incorporate a prospective check rather than a retrospective one. Furthermore, bar code scanning and other available technology should be used when possible for the additional safety measures they provide.

Q: If equipment is going to be utilized in the hood, does it need to be in place during certification?

A: Yes, any equipment that will be routinely used in the PEC, such as repeater pumps, scanners, and IV workflow stations, must be in place during the certification process. The certifier needs to know how the PEC will be used and where the equipment will be placed to accurately conduct the appropriate tests.

Should equipment be added to the PEC after the certification has been completed (eg, a new workflow station is purchased), the PEC must be recertified prior to commencing compounding. The certifier needs to attest that the unidirectional airflow remains appropriate with the addition of the new equipment.

Q: Is a compounding record required for every patient-specific CSP?

A: USP <797> requires a compounding record (CR) for all Category 1, Category 2, and Category 3 CSPs and for any immediate-use CSPs prepared for more than one patient. The rationale behind the CR requirement is that should a problem arise, one must be able to trace exactly what was done, the manufacturer used, the expiration date, etc.

For facilities with IV workflow management systems (IVWFMS), this information may be easy to access. Using the IVWFMS for the CR is completely acceptable, as long as it includes all of the elements required by USP <797> and the information is retrievable. However, for those without this technology, compiling these records manually is a very time-consuming process. Nevertheless, we owe this level of safety to our patients.

This does raise an interesting point that eliminating the need to manually compile this data can be leveraged as yet another factor in favor of adding an IVWFMS or incorporating other safety technology. However, when using an IVWFMS as the CR, it is vital to have a backup plan in place for downtime. Ensure that the template records for both the master formulation record (MFR) as well as the compounding record are accessible during any downtime, scheduled or unscheduled.

I recommend following best practice in this situation which translates to providing both an MFR and a compounding record for every CSP. The question to ask in this situation is: Why would you not want to have access to those records? Some state boards of pharmacy and accreditation organizations already expect or require this. It is not enough to simply be careful; as pharmacists, we need to be able to provide proof of the care that was taken.

It is time that pharmacy moves past the patient-specific versus non-patient-specific dichotomy. Instead, consider the MFR and CR as methods to ensure that you have the recipe and a record of the exact elements that were dispensed to the patient.

Q: Do we need a specific policy dedicated to QA/QC that refers back to each of the applicable SOPs, or does having SOPs that incorporate the QA/QC elements meet the requirement?

A: While the latter practice is certainly acceptable according to USP <797>, remember that USP standards are minimum standards or a baseline for safety; they are not stretch goals. Depending on your location, your state board of pharmacy and your accreditation organization may require a more stringent approach. It is important to review their requirements in addition to those under USP <797>.

Q: Is an MFR required when a vial/bag system is attached in the hood?

A: With vial and bag systems, the location of the docking will determine the requirement. If nursing is conducting the attaching of the vial and the bag, and then immediately administering the drug, USP <797> does not consider that to be compounding; as such, this scenario would not require an MFR.

However, it is a common practice for pharmacy to attach the vial and the bag in the hood and then store it for later activation. This approach is considered compounding and therefore, does require an MFR. Most of the information that is required for an MFR will be included in the provided manufacturer’s information.

Q: Is it required that hand sanitizer be applied in the anteroom and sterile gloves donned before entering the buffer room?

A: When entering an ISO 7 space, it is important to minimize the amount of exposed skin. Therefore, utilize hand sanitizer in the anteroom, and then put on sterile gloves prior to entering the buffer room. The 2023 version of USP <797> allows you to design your hand hygiene and garbing process to meet your facility design.

Q: For PRN pharmacists, is it acceptable to rely on competencies conducted at another hospital?

A: This would only be acceptable if the facility, supplies, and procedures are exactly the same and the state board of pharmacy (or other regulator) allows it. That would be quite unlikely, so this approach is not practical. Staff competencies prove two things: an understanding of the requirements and an ability to apply them within the parameters of the given operation. Thus, all staff competencies need to be site-specific.

Q: Are antifatigue mats acceptable in cleanrooms?

A: Antifatigue mats are not prohibited by USP <797>; however, I would strongly discourage their use in the cleanroom because they can lead to cleaning challenges. When antifatigue mats are in the cleanroom, they must be cleaned daily. That requires picking them up, cleaning both sides, cleaning the floor underneath the mat, and allowing both the mat and the floor to dry thoroughly before replacing the mat.

When observing cleaning practices at a site a few years back, the housekeeping staff member had not been properly trained in how to clean the mat. Unfortunately, her daily ritual included carefully lifting the mat, rolling it up, and placing it in the hood so she could clean the floor under it. Rather than introduce this level of risk to the cleanroom, I would suggest providing comfortable cleanroom shoes that serve the same purpose as antifatigue mats.

Q: Is it acceptable to locate the repeater pump on a cart outside of the hood if the pump tubing and critical site is within the hood?

A: This is a concerning setup. You need to follow both USP <797> and the pump manufacture’s information. Unless there is very specific information allowing this, all equipment needs to be inside the ISO 5 PEC. An overcrowded hood is not going to be effective. You cannot start with a 3-foot hood and add a repeater pump and then a camera and scanner pad and still maintain appropriate airflow. The hood must be appropriately sized for the equipment that will be utilized. Your certifier is an excellent resource for planning what size hoods you will need for the equipment you have currently as well as the equipment you are planning to acquire. Ultimately, your hood must have the capacity for the equipment it will hold.

Reference

1. Roth A, Douglass K, Wagner J. Letters to the Editor [“Effectiveness of a shielded ultraviolet C air disinfection system in an inpatient pharmacy of a tertiary care children’s hospital” Lacks scientific evidence]. Am J Infect Control. 2018;46(6):P730-731.

Patricia C. Kienle, RPh, MPA, BCSCP, FASHP, is the director of accreditation and medication safety for Cardinal Health. She received her pharmacy degree from the Philadelphia College of Pharmacy and Science and a master’s in public administration from Marywood University in Scranton, Pennsylvania. She is board certified as a sterile compounding pharmacist, completed an executive fellowship in patient safety from Virginia Commonwealth University in Richmond, Virginia, and is an adjunct clinical faculty member at Wilkes University in Wilkes-Barre, Pennsylvania. Her comments herein are her own and not official information from USP.