USP <800>: Educational Programs:
A Few Helpful Ideas
Acquiring expertise on proper aseptic processes that significantly enhance the quality of your compounding practices and the safety of your CSPs.
Introduction:
Pharmacy clinical staff serving oncology settings are charged with the task of providing clinically sound guidance so that the care of their patients achieves expected outcomes. However, institutions and designated persons (DPs) in charge of USP <800> hazardous sterile compounding operations must also provide a comprehensive and robust educational program for HD training and thus, maintain a high level of staff competency. The challenge in HD compounding stems from maintaining CSP sterility while safely managing the risk caused by the presence of hazardous pharmaceuticals.
“Basic Training” is essential before compounding HD. Many institutions train their employees simultaneously on both sterile compounding and HD compounding to fast-track the availability of cross-trained personnel. All things considered, if we care about the employee, we allow sufficient time (about a year) of consistent sterile compounding before making their job function more hazardous. Training should follow a “layering” or stacking of skill sets to make it progressive. HD compounding is a specialty of sorts.
The critical elements of training (assuming one year of experience in sterile compounding) that a candidate will be involved in:
1. Didactic Training
This is foundational and critically important to understanding the “culture” of safe handling. Glossaries are used to introduce terms and their meanings. Speaking of the risks of occupational exposure and the hierarchy of controls is critical to heighten the alert level of pharmacists and technicians and hard-wire a sense of distinction between non-HD and HD compounding.
a. “Right to Know”: What drugs are considered HD and why? Release of the official HD list for your institution, including NIOSH tables, their interpretation, occupational health considerations, use of SDSs, and exclusions from HD compounding, among others.
b. USP <800> sections overview
c. Negative pressure engineering controls: primary, secondary, and supplemental.
d. Deactivation and decontamination: HD residue removal and spills management.
e. Negative pressure aseptic technique, use of CSTD, and compounding in vertical flow PECs
f. “Law of doubles” garbing in and doffing out of HD areas
g. HD Waste Management (trace vs. bulk)
h. Written test for the content discussed above.
i. Hazards Risk Acknowledgement Form (Filled and signed)
A word about slide decks: limit the amount of information in your presentation to the most critical aspects and principles. The slide deck content and duration are used to bridge the knowledge gap and drive the most critical elements as they relate to occupational, patient, and environmental safety.
2. Hands-on “Boot Camp” With Simulated HD Components(fluorescein) and UV Lighting
Workshops on HD compounding lay a solid foundation utilizing a “skills lab”. Here, a participant learns by doing and is exposed to “simulated” HD compounding, which can be experienced by them and assessed in real time by the “instructor-coach”. Participants learn HD sterile compounding in a fun and interactive fashion.
a. HD garbing in and doffing out of HD zones
b. Introducing HD components: materials transfer in and out of HD zones
c. Negative pressure aseptic technique
d. CSTD use (your facility’s) for preparation and administration
e. Deactivation and Decontamination process
f. Use of Spill kits
g. Other-as applicable to the institution
3. Assessments
You may conduct assessments that test both aseptic technique and HD containment, or just containment. This is a trainer’s choice. The former is more labor-intensive and requires incubation, which increases processing time. In favor of the latter, it can be said that if the participant already has a good track record as a sterile compounder, it may be to their advantage, and for the sake of efficiency, to focus on HD. The high points of the assessment should take into consideration workflows, cleanroom configuration, and other factors, and be based on the DP’s judgement.
It is noteworthy that, with respect to gowning, the real problem is proper doffing, such as the outer gloves, since the operator’s PPE would have been exposed to potentially HD-contaminated surfaces. Therefore, traces of HD may travel out into non-HD areas if not all HD components are wasted within the HD buffer—food for thought. Some essential assessment points include:
a. Hand hygiene and HD garbing IN
b. Compounding area preparation:
I. Materials transfer into the HD buffer
II. Decontamination of C-PEC
III. Introduction of components into C-PEC
c. Negative pressure aseptic technique and proper CSTD application (test both!)
d. Finished CSP decontamination, labeling, and packaging for transport to patient care areas
e. Line clearance, HD residue post-compounding removal, and HD waste management
f. Outer glove BSC removal and Doffing OUT of HD buffer
g. Doffing out of the non-HD anteroom
h. Spills management
Regarding spill management, train staff to differentiate between minor spills occurring within the BSC, which can be easily managed with materials like wipes and deactivating solution already available in the buffer, rather than opening a commercially available spill kit, which is usually reserved for larger spills during delivery to nursing areas or administration to patients.
4. Format and Duration
Every educator has their own custom approach to teaching and different expectations for learning. What works best may be different for different training venues. Read the room. Know that not everyone will be as interested as you are. The purpose of teaching with three modes in mind is to create a positive learning environment that encompasses cognitive and comprehension (didactic), “doing” (skills lab), and demonstration (assessments and observations), thereby providing immediate feedback. All three are needed, and many of us learn better using all modes.
The more senses are involved, the better. Try to allocate similar amounts of time to all formats. The use of video during the lab to quickly show a participant what the instructor’s eyes are seeing is very telling and beneficial. The training can take up to two full days for a group of five candidates.
Conclusion
In conclusion, the successful implementation of a USP <800> educational program requires more than just compliance—it requires a deep-rooted cultural shift in how hazardous drugs are handled in healthcare environments. By emphasizing progressive training, hands-on skill development, and real-time assessments, institutions can foster a workforce that is both confident and competent in managing the dual priorities of sterility and safety. This comprehensive approach not only safeguards healthcare personnel and patients but also strengthens institutional readiness and commitment to excellence in sterile compounding practices. *
References
- United States Pharmacopeia (USP). *USP General Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings.* United States Pharmacopeial Convention. https://www.uspnf.com
- National Institute for Occupational Safety and Health (NIOSH). *NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.* U.S. Department of Health and Human Services, CDC. https://www.cdc.gov/niosh/docs
- Occupational Safety and Health Administration (OSHA). *Occupational Exposure to Hazardous Drugs in Healthcare Settings.* https://www.osha.gov/hazardous-drugs
- American Society of Health-System Pharmacists (ASHP). *ASHP Guidelines on Compounding Sterile Preparations.* Am J Health Syst Pharm. https://www.ashp.org
- Institute for Safe Medication Practices (ISMP). *Guidelines for Safe Preparation of Compounded Sterile Preparations.* https://www.ismp.org
- NIOSH Hierarchy of Controls. National Institute for Occupational Safety and Health. https://www.cdc.gov/niosh/topics/hierarchy
- OpenAI. (2025). ChatGPT (Sep 7 version) [Large language model]. https://chat.openai.com/
Released October 2025
About the Author
Luis Hernandez, RPh, BCSCP, is a certified sterile compounding pharmacist and the founder of Seven97 Training Solutions. Dedicated to advancing USP 797 pharmaceutical training, validation, and certification, Luis aims to promote and inspire excellence in aseptic processing, medication and patient safety, and regulatory compliance.