USP 800 officially went into effect December 1, 2019. It is an excellent guide to protecting pharmacy techs, healthcare personnel, patients, cleanroom cleaning staff, and even our planet from contamination by hazardous drugs (HD). Note that for the federal government (OSHA, FDA, CMS, others) to be able to enforce USP 800, it must be named in another USP. This happened with the update of USP 797 and 795, but those updates were repealed so technically USP 800 while in force, cannot be enforced. But that is no reason to delay implementing and optimizing HD safety for your facility. Compliance is good for your staff and your business. State Boards of Pharmacy, Boards of Health, other state-level agencies as well as accreditation organizations support the USP 800 guidelines.
But USP 800 compliance is not a one-time certification or goal. It is an ongoing effort to continually evaluate, identify risks, mitigate, repeat. Plus, its scope is far-reaching from arrival of an HD in the pharmacy cleanroom to dispensing or disposal of the drug.
USP Guidelines & Supporting Documentation Change
In addition to the breadth of the challenge, as with most governance, the rules are continually changing as science, technological innovation, and other empirical evidence points to a better way. For example, NIOSH publishes HD lists to assist facilities in identifying HDs handled by their staff. 2016 brought significant changes to the NIOSH List https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf in which 34 drugs were added and some moved around its tables:
- Table 1 – Antineoplastics CSTD required
- Table 2 – Non-antineoplastics
- Table 3 – Reproductive toxins
A few 2016 changes of note:
- Antineoplastics appear on both Tables 1 and 2
- Immunosuppressants moved to Table 1
- Estrogens moved to Table 1
- Hormones moved to Table 2
- BCG no longer on the list, not because it is not dangerous, but because NIOSH has revised its focus on drugs and no longer includes biologics such as BCG.
And in May 2020, a draft NIOSH list was published with changes including adding 16 drugs are and refining table definitions. These are examples of how continual education and evaluation are required to work toward USP 800 compliance. It is easy for gaps to develop even after achieving an excellent level of compliance.
Common Areas for Gaps in USP 800
Policies and Standard Operating Procedures
Understanding the life cycle of processes and handling procedures that HDs go through within your organization, even outside your pharmacy cleanroom is vital to ensuring relevant policies and procedures are written, communicated, and enforced. Evaluate the HD handling in the pharmacy, surgical services, and supporting and ancillary medical areas.
Policies and procedures should cover every aspect of your operation from receiving HDs to PPE to risk assessment and mitigation to creation of an HD list and related engineering controls that apply to each such as Biological Safety Cabinet (BSC), Compounding Aseptic Containment Isolator (CACI), or Closed System Drug-Transfer Device (CSTD).
Read our additional tips about USP 800 compliance.
Note that HD handling in a cleanroom may also affect writing your cleanroom cleaning procedures.
Proficiency of Personnel
The most pivotal decision in USP compliance is designating a single person to have responsibility for oversight of the policies, procedures, education, and monitoring. That designated person should not only have general compounding training in USP 795 and 797, but also HD-specific training on current supporting publications, specific issues, and HD-handling techniques applicable to your facility. It is only with this breadth of knowledge and experience that the education of the staff, effective policies and procedures, and monitoring can be successful.
The good news is that there are many tools to help cleanroom staff and especially the USP 800 coordinator to make the best decisions possible. One such tool is the <800> HazRx® Mobile App. The convenient tool helps you identify hazardous drugs and get information on how to safely handle them and relevant procedures.
Personal Protective Equipment (PPE)
A complete understanding of what HDs are handled and how they are handled along with designing policies and procedures including transfer techniques that eliminate or minimize HD exposure are the first line of defense for pharmacy cleanroom staff.
But PPE is the final level of protection from any failure to contain HDs.
In general, USP 800 PPE includes:
- ASTM D6978-rated gloves
- Gowns intended for use with HDs
- Sleeves intended for use with HDs
- Hair/head covers or bouffant hood that includes beard cover, when applicable
- Shoe covers
- Masks and respiratory protection
- Goggles
We offer the contracted services of specialty pharmacy cleanroom consultants who can assist with the overall policy and procedure design. But PPE is the area that our cleanroom experts can help you everyday with complimentary advice about what PPE is best for your protocols. Plus, we offer free samples on all our cleanroom consumables so you can try them in your facility before you buy.
See our most popular cleanroom supplies for compounding pharmacies. We carry full lines of all our brands so ask if you do not see what you need.