August 13, 2019

Do’s and Don’t’s of USP Chapter <797> Personnel Training

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<em>Do</em>’s and <em>Don’t</em>’s of USP Chapter <797> Personnel Training

Ashley Duty, Pharm.D., M.S.

Clinical Pharmacy Operations Manager, Children’s Mercy, Kansas City, Missouri

Ashley Duty, Pharm.D., M.S., is Clinical Pharmacy Operations Manager at Children’s Mercy in Kansas City, Missouri. She earned a Doctor of Pharmacy degree from the Raabe College of Pharmacy at Ohio Northern University and a Master of Science in Health-System Pharmacy Administration degree from Northeast Ohio Medical University. She completed an ASHP-accredited PGY1/PGY2 Health-System Pharmacy Administration residency at the Cleveland Clinic in 2014.

At Children’s Mercy, Dr. Duty is responsible for 21 pharmacists in general medicine and hematology/oncology, as well as for USP Chapter <797> and USP Chapter <800> oversight for all sterile compounding operations. She also serves as the staffing preceptor for the accredited PGY1 and PGY2 residencies. 

Dr. Duty’s professional interests include operations, medication safety, and informatics. She is also very passionate about leadership development. Within ASHP, she is a member of the Educational Steering Committee for the Section of Pharmacy Practice Managers. Previously she served as Chair and Vice Chair of the New Practitioners Forum. On the local level, Dr. Duty is Programs Chair for the Greater Kansas City Society of Health-System Pharmacists. 

Dr. Duty completed the ASHP Advanced Sterile Product Preparation Certificate in 2017 and served as a planner and presenter for both the PTCB-recognized ASHP Sterile Product Preparation Certificate and the Compounded Sterile Products Certificate for Pharmacists in 2019.


Does your practice use an aseptic test that mimics the most difficult preparation needed for your patients?

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One of the topics that can easily be overlooked within the new USP Chapter <797> revision is the section on personnel training.1,2 I’ve found that you can spend many hours laboring over cleanroom design, air exchanges, flooring materials, and the like but miss the greatest source of contamination and error within the cleanroom: people. Many of those planning hours will be wasted if proper training and ongoing competencies are not followed.

Here are some do’s and don’t’s to get you started on enhancing your personnel training program.

Don’t: Assume your current staff understands the new USP <797> updates and are already competent.
Do: Re-train everyone on the new standards to ensure you have proper technique and updated documentation.

  • Garbing, hand hygiene, gloved fingertip/thumb test, and media fill testing must be assessed every 6 months. Other core competency must be demonstrated every 12 months according to the written process for evaluation of pass/fail (e.g., calculations, use of equipment, proper use of primary engineering controls)
  • For experienced compounders, this training may not need to be extensive. A combination of electronic teaching modules and observing of technique may be sufficient. Observation can include active workflow as to not take people offline.
  • The best way to see normal habits is to do frequent observations in your cleanroom space. Increased frequency of observation may also help minimize observer bias.
  • If you find that current personnel need more remediation, you may need to remove them from the sterile compounding area and have them practice with practice doses on a tabletop.

Don’t: Use the simplest aseptic technique test to ensure everyone passes.
Do: Ensure that the current aseptic technique testing mimics the most difficult/challenging process at your institution.

  • For example, those at pediatric sites may want to pool multiple vials of broth into an empty IV bag and then draw up many i.v. syringes of smaller volumes. This would mimic pediatric stock dilutions. A similar process could also be followed on a single-channel pump or a multi-channel automated compounding device.
  • Create a process that tests employees on a rolling 6-month basis. This will prevent staffing issues if staff must remediate after a failed test.
  • Remember that USP Chapter <797> now states that two different incubation periods are required. First, incubation should occur between 20-25˚C for 7 days, followed by 30-35˚C for 7 more days. Visual inspection and documentation of the media fill tests should be performed initially, after 7 days, and after 14 days.

Don’t: Assume new personnel have good habits and aseptic technique, even if they’ve completed sterile compounding at another institution.
Do: Have each new employee complete a thorough introductory period to form good habits and establish proper aseptic technique.

  • Depending on the site, proper sterile compounding training should take several weeks and progress from simple to complex at a rate that is appropriate for the learner.
    • Recognize that this pace may be different for everyone.
    • Don’t rush initial training because it will cause more harm than good.
    • Consider extending the employee’s introductory period if you are not comfortable with their progress and technique.
    • Training at my institution includes parenteral nutrition, chemotherapy, and pediatric dilutions and takes a minimum of 4 weeks.
  • Not all employees may be right for sterile compounding work and the attention to detail that it requires. It’s important to have enough employees trained to staff your sterile compounding areas at all times, but trying to train all employees may not be the best plan. It may be more prudent to spend more time training fewer employees than the same amount of time training everyone.

Don’t: Give all personnel the same open book, multiple choice, online pharmacy calculations exam upon hire.
Do: Proctor a pharmaceutical calculations exam every 12 months using real examples from your cleanroom. Ask employees to show their work on paper.

  • Pharmaceutical calculations can be a challenging task for compounding personnel who were not initially trained in math. In addition, many dose preparation systems have eliminated math skills that were previously exercised on a daily basis.
  • Having a thought process on paper from the written test can help you and the learner understand where they may have gone wrong in their calculations.
  • Consider asking pharmacists to train new pharmacy technicians in pharmaceutical calculations. I’ve found that many pharmacists have different ways of approaching calculations to all arrive at the same answer. This can help those who may be struggling to understand certain concepts.

Don’t: Allow all employees to train new employees without establishing minimum qualifications.
Do: Designate an educator(s) and/or preceptor(s) who can facilitate proper training.

  • A system we’ve found successful is a combination of a technician educator and technician preceptors.
    • The technician educator coordinates the training and competencies for new staff. She has a teaching background and is able to easily assess how new personnel learn.
    • Technicians who are experts in their given practice areas and have expressed interest have been designated as “preceptors.”
    • Preceptors should receive extra training on crucial conversations and learning styles. They can learn from a technician educator or supervisors to provide the necessary feedback to new personnel. At our institution, the Education Department was able to easily provide us with this training as it is already used for nursing educators.

Don’t: Expect the trainee to be responsible for their own training and documentation of competency.
Do: Create standard paperwork or electronic documentation for all employees (new and current).

  • Documentation is an area in which many organizations struggle to stay compliant. Web-based systems are increasingly more popular to keep up with changing regulations and employee turnover. They also prevent losing paperwork.
  • If you’d like to continue to use paper competencies, consider removing process details from training materials and referencing job aids and standard work instead. This will help keep the training information more sustainable and prevent the need for constant edits.


Paying close attention to these do’s and don’t’s will go a long way in improving your personnel training program and meeting the requirements of revised USP Chapter <797>. Hopefully these discussions will help you think of ways you can update your personnel training to be successful going forward.

More Information


The United States Pharmacopeial Convention. General chapter <797> pharmaceutical compounding—sterile preparations. In: USP Compounding Compendium. (accessed 2019 Aug 5). FAQs: <797> pharmaceutical compounding—sterile preparations. (accessed 2019 Aug 5).

Selected Resource

ASHP Sterile Compounding Resource Center. (accessed 2019 Aug 5).