Each year, Patricia Kienle, RPh, MPA, BCSCP, FASHP, the director of accreditation and medication safety at Cardinal Health, shares 10 strategies that she believes pharmacies need to follow to ensure compounding safety and compliance with USP, state boards of pharmacy, and other regulatory bodies and accreditation organizations.
Ensure the competency of your compounding staff. Documenting the proficiency of the compounding staff remains a major consideration. USP General Chapters <795>, <797> and <800> include a list of initial and requalification core competencies for those who compound (Table). Personnel who compound sterile preparations also must complete two hands-on tests initially and at a requalification frequency, based on the categories of sterile compounded preparations they mix.
Another key competency focuses on observed hand hygiene and garbing, including gloved fingertip tests (GFTs). Three sets of GFTs are required initially (total of six plates) and one set (two plates) for the requalification. No identification of any growth is required, but the observation and GFTs need to be repeated if either the observation shows insufficient procedural issues or the GFTs show any microbial growth.
| Table. Core Competencies For Compounding Safety |
| Nonsterile compounding |
|---|
| Handling and transporting CNSPs |
| Measuring and mixing |
| Proper use of equipment and devices |
| Hand hygiene and garbing |
| Documentation of the compounding process |
| Cleaning and sanitizing |
| Sterile compounding |
| Calculations, measuring and mixing |
| Principles of HEPA airflow |
| Movement of materials and personnel within the compounding area |
| Achieving and/or maintaining sterility |
| Use of PECs and other equipment |
| Hand hygiene and garbing |
| Aseptic technique |
| Documentation of master formulation and compounding records |
| Cleaning and disinfection |
| Staff who handle hazardous drugs |
| Overview of the organization’s hazardous drug list and their risks |
| Review of the organization’s policies related to handling of hazardous drugs |
| Proper use of personal protective equipment |
| Proper use of equipment and devices |
| Response to known or suspected hazardous drug exposure |
| Spill management |
| Proper disposal of hazardous drugs and trace contaminated materials |
| CNSPs, components and compounded nonsterile preparations; HEPA, high efficiency particulate air; PECs, primary engineering controls. Source: Nonsterile list is from USP Chapter <795>, sterile list is from <797>, and hazardous list is from <800>. |
Yet another important area of competency involves aseptic manipulation, which needs to be observed in primary engineering controls (PECs) and performed in this sequence:
- media-fill test simulating the most complex compounded sterile preparation (CSP) the compounder would be expected to make (to demonstrate the ability to aseptically mix a CSP);
- GFT of each hand (to demonstrate the ability to maintain sterility of the gloves during compounding); and
- a surface sample of the direct compounding area (to demonstrate the ability to maintain an aseptic work surface). No identification of any growth is required for this personnel surface sample, but the entire aseptic processing triad (media fill, GFT, surface sample) must be repeated if any of the three tests are failed.
Ensure the competency of other staff. Personnel who mix CSPs under USP <797>’s immediate-use provision need to have competency defined by the organization. (Immediate-use standards refer to the compounding of sterile preparations for administration to a patient within four hours of the start of the compounding process.) Traditionally, this competency assessment has been done with nursing staff, but there are others in your organization who likely mix immediate-use CSPs: anesthesia personnel, imaging clinicians, perfusionists, paramedics and others. Competency requirements for nuclear medicine technologists are defined in USP <825>. There has been an increased focus from the accreditation organizations (the Accreditation Commission for Health Care, the Center for Improvement in Healthcare Quality, DNV Healthcare and The Joint Commission [TJC]) to check for competency documentation for anesthesia personnel. In addition to initial competency, develop a policy concerning requalification. Many organizations’ policies dictate that they perform and document requalifications at least every three years.
Be aware of regulatory and accreditation organization expectations. Here are some key organizations to track:
Centers for Medicare & Medicaid Services. Sterile compounding is listed in the pharmaceutical services section of CMS’s Conditions of Participation for Hospitals (see §482.25[b][1]).
FDA. Read the agency document concerning insanitary conditions and hospital/health-system compounding. Also be sure to monitor the FDA Human Drug Compounding website for new and revised compounding-related documents, including those related to insanitary conditions, which were updated in November 2020, and a revised draft version of hospital and health-system expectations, which were updated in October 2021. Other FDA documents address repackaging, compounding from bulk substances and outsourcing facilities. These documents may be in draft or final form, so be vigilant and make sure you have the most recent revisions.
State boards of pharmacy. Most boards have established a checklist used during their inspections. These are often available on the board’s website.
Accreditation organizations. Each of the hospital accreditators has compounding-specific language. TJC also has a Compounding Surveyor Guidance Checklist that can be accessed on your hospital’s extranet site. Compounding accreditation standards aren’t limited to the medication management chapters; be sure to also look for compliance requirements in the chapters, including Leadership/Governance (for contracted services such as 503B and nuclear pharmacies), Human Resources (for competence documentation requirements), Infection Control (for microbial and fungal excursion management) and Environment of Care/Physical Environment (for air handling).
Read and react to your certification reports and plan ahead for renovations. Surveyors and state board inspectors have become much more savvy concerning reviewing certification reports. Now is the time to evaluate what’s in the reports and take action based on the results:
- Make sure your certification reports summarize all the key required elements, and have your certifier review the areas that pass, fail, or need attention after their evaluation.
- Be sure you receive a written report within a few days of the certifier’s visit and schedule the return visit within six months so you will have the certification completed before six months elapse, per USP requirements.
- Discuss your engineering controls with your certifier. Ask about the expected life cycle of your PECs and plan for replacement of the HEPA (high efficiency particulate air) filters or entire device if necessary. Inquire if there is other equipment in your compounding rooms that could be improved and develop documentation for capital expenses, if necessary.
- Evaluate IV workflow hardware and software, and determine what future adjustments in your PECs or secondary engineering controls will be needed to implement automated processes.
Plan for potential supply disruptions. Drug and supply shortages are a constant occurrence. Include these issues in the hospital’s emergency preparedness plans. Learn from past disruptions: Were there changes in practice made to conserve supplies that continue to make sense to employ once the shortage has resolved? What lessons were learned that can help pharmacy and other departments deal with similar issues in the future?
Address the new National Institute for Occupational Safety and Health List of Hazardous Drugs in Healthcare Settings. The long-awaited update of the NIOSH hazardous drugs list was published in December 2024. Your Assessment of Risk concerning these agents needs to be updated at least annually. This year’s update will be more challenging than recent years because of the change in Table assignments for many agents on the list. This needs to be an interdisciplinary process, including pharmacy, nursing, risk management, industrial hygienists (if available to you), and others in your organization. (For more details on the updated NIOSH list, see “Does Your Hazardous Drug List Have Holes?”)
Exposure to hazardous drugs is a known risk. Two key strategies are to use closed system drug-transfer devices (CSTDs) and hazardous drug wipe sampling. CSTDs are required in the chapter for administration of NIOSH Table 1 antineoplastic agents and recommended for compounding. Evaluation of CSTD use needs to be part of your risk evaluation and review assessment. As for sampling for hazardous drug contamination, this practice is a form of environmental monitoring and is a way to monitor for contamination and mitigate potential exposure to personnel and patients. A summary of strategies from the 2020 Safe to Touch Consensus Conference on Hazardous Drug Surface Contamination (Am J Health Syst Pharm 2021;78[17]:1568-1575) can form the basis for your organization’s interprofessional approach.
Read and react to your environmental monitoring results. Your microbial environmental monitoring program must be designed to adequately detect excursions. The minimum elements need to include staff training and competency, frequency of monitoring at least as much as defined in the USP chapters, and reaction to results. The USP chapters are minimum standards, and many best practices exceed the minimum frequency.
Comply with the requirement for monthly facility surface sampling. The requirement for monthly surface sampling for personnel compounding Category 1 and 2 CSPs realistically means that most pharmacies need to do this in-house. (Those compounding Category 3 CSPs have even more surface sampling requirements.) Culture media and incubators are needed. Most organizations are likely to need two incubators (for two separate temperature ranges), which must be located outside the sterile compounding areas. If the number of colony-forming units recovered on any plate exceeds the action level, a microbiologist must be available to assist in identifying the microorganisms to the genus level. Pharmacy personnel who perform surface sampling and/or colony counting must have documented competency to do so. Your infection control practitioners or microbiology staff may be able to assist with the competency evaluation.
Evaluate your decontamination, cleaning and sanitizing/disinfecting procedures. Ensure your cleaning process meets USP Chapter <797> requirements and facility needs. This chapter has details (see USP Table 10) concerning cleaning, disinfecting and applying sporicidal disinfectants. USP Chapter <800> adds details on decontaminating areas exposed to hazardous drugs. Be sure your cleaning solutions are approved by your organization’s infection control committee. Ready-to-use solutions are preferred because they eliminate the need to mix concentrates and record those details. Be sure your staff are using proper techniques, including complying with the manufacturer’s time, which can be found in the solution manufacturers’ instructions for use.
Provide advanced training for your Designated Person. That person may have responsibilities for nonsterile, sterile and/or hazardous compounding at one or multiple sites in your system. Didactic and hands-on education and training is available from sources such as ASHP’s Pharmacy Futures meeting (to register for the 2025 meeting, in Charlotte, N.C., visit bit.ly/4gBDPew), Pure Microbiology (www.puremicrobiology.com), and others.
Perform a gap analysis. Consider completing a gap analysis annually, using your certification reports, environmental monitoring, staff competency documentation and future plans. Helpful resources are available at the ASHP Compounding Resource Center. For details on how to ensure safe handling of cell and gene therapies, see bit.ly/3vpeUZi-PPN.
Ms. Kienle is an employee of Cardinal Health and a member of the USP Compounding Expert Committee. The comments in this article are her own.
This article is from the April 2025 print issue.