USP <800> Standards

On December 1, 2019 a new standard for the handling of hazardous drugs (HDs) residue will be enforced. These drugs are defined in NIOSH HD Tables 1-3 and include drugs such as warfarin, oxytocin, ribavirin, fluconazole trace, and more.

This new standard is aimed to protect medical staff that administer hazardous drugs, as well as, minimize the risk of exposure to healthcare personnel, patients and the environment. It dictates new waste handling pathways for Personal Protective Equipment (PPE) and other items that have come in contact with these substances. Under the new NIOSH governed standard, gloves, masks, foot covers, bunny suits and gowns that are used in the administering of any USP800 classified substance are now defined ‘contaminated’, and therefore fall into a new disposal and waste containment category.

 

Summary of the new USP <800> standards:

    • Under the new NIOSH governed standard, gloves, masks, foot covers, bunny suits, and gowns that are used in the administering of any USP <800> classified substance are now defined ‘contaminated’ and fall into a new disposal and waste containment category.
    • All PPE used in the administering of drugs listed on the USP<800> list must be disposed in proper containment, such as a trace chemotherapy or hazardous waste container. (Review the NIOSH USP800 HD tables 1-3 to identify drugs that fall into the USP800 category).
    • Organizations must ensure that appropriate protocols are put in place to prevent the risk of exposure to healthcare workers in the handling and disposing of waste and PPE.
    • Healthcare workers handling or administering hazardous drugs that pose a threat to reproductive organs must ensure that their PPE is changed on a regular basis. (Review the CDC's proper protocols when it comes to donning PPE based on the form and types of HD’s that are being administered.)
    • Drug categorization itself does not change, EPA regulations still apply to some of the medications on the NIOSH hazardous drugs list and current pharmaceutical disposal procedures will need to be followed. The recommendation for drug packaging (wrappers, etc.) is that current pharmaceutical procedures are followed in disposing of packaging in a pharmaceutical or hazardous waste container.

     Review our USP 800 Preparation Checklist

    The December 1 deadline is quickly approaching. Whether you need to assess your organization’s compliance, order proper disposal products, or accelerate your organization’s preparedness, reach out to be connected with a Curtis Bay expert at [email protected]

    or (855) 228-1715.

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    Please consult the USP website for up-to-date and complete USP requirements.