USP 800 Compliance Program Updates: NIOSH 2024 List
USP 800 outlines the standards for healthcare providers that handle hazardous drugs, as defined by the National Institute for Occupational Safety and Health (NIOSH). Pharmacies that handle hazardous drugs (including carbamazepine, clonazepam, colchicine, and cyclosporine – these are just a few of the “C” drugs – there are over 400 unique drug/dosage forms in all that must be considered) should have a list of all hazardous drugs in their pharmacy, specific policies and procedures on how they will receive, store, and dispense these drugs, and provide staff training on specific policies and procedures. Pharmacies are also required to label the hazardous drugs to ensure staff are aware of occupational risks. Additionally, an “assessment of risk” must be performed and documented for each unique hazardous drug and dosage form to determine appropriate safety measures and minimize exposure.
NIOSH recently released the updated 2024 List of Hazardous Drugs in Healthcare Settings in December 2024. This list replaces the previously official 2016 list and must be incorporated into the USP 800 compliance programs for all healthcare entities as soon as possible.
The “2024 list” has various changes including:
- Adding 25 drugs
- Removing 7 drugs
- Reducing the number of tables (from 3 to 2)
- Reorganizing which drugs fall into the 2 tables
PAAS National®’s USP 800 Compliance Program has been updated to incorporate these changes and pharmacies utilizing the PAAS program will need to login to the Member Portal and perform the following steps to maintain compliance:
- Review your drug inventory for currently defined hazardous drugs using the PAAS’ Master Hazardous Drug formulary
- Review and finalize your Assessments of Risk and ensure staff are using these updated versions
- Review the updated Program Guide and print an updated Policy and Procedure Manual
- Educate staff about the NIOSH 2024 List changes. PAAS’ USP 800 Training module has been updated to reflect these changes, and quiz competency can be reset, if desired.
PAAS Tips:
- Numerous entities can have oversight/enforcement of USP 800 including: state boards of pharmacy and OSHA
- Pharmacies may be prompted to provide USP 800 policies and procedures to NCPDP during annual re-credentialing
- USP 800 Compliance Program members should refer to the separate email communication for additional details.
- Pharmacies interested in a turnkey USP 800 Compliance Program should review program details on the PAAS National® website or call (608) 873-1342 for additional information. Please note, the PAAS program is not intended for pharmacies that are compounding with hazardous drugs.
I obtained my PharmD from the University of Wisconsin-Madison School of Pharmacy and worked for a major chain as well as various LTC and independent pharmacies, before coming to PAAS.
I am passionate about learning and teaching. I strive to learn something new about PBM audits every day, so that PAAS can be more knowledgeable to better serve our members! In 2018, I started traveling to state pharmacy conferences to present audit seminars and meet our wonderful members in person.
