Written by Megan Chamberlain
12 Jun 2019

USP <800> Guidelines: the basics

It’s coming. Most of us have heard about it but few of us understand it – myself included. So I spoke with our residential hazardous waste expert, Adam Thompson, to get the “for dummies” version on USP <800>.


Need a Consult?


Why has USP <800> been put into place?

“To protect people from the dangers of drugs that can cause reproductive health issues. This standard has identified a list of “hazardous drugs” which are separate from what we have previously understood as hazardous. Think of this as a brand-new list in addition to what you already know. If a medication is on this list, there are specific standards for how you have to handle it and how it has to be packaged. The standard is subtitled “Hazardous Drugs – handling in Healthcare Settings.” This does not elaborate on best methods of disposal; however, Daniels Health has provided a recommendation on best disposal methods.”


Poster: Understanding USP <800>



Who does this impact in healthcare and what do they need to do?

“This impacts everyone in healthcare – anyone who may potentially handle a hazardous drug. Essentially USP <800> sets the framework for creating Standard Operating Procedures for each facility for how they need to handle these drugs. The main takeaway is that your facility should develop a safe plan and train their staff on how to handle and package USP <800> drugs.”


Where can people read more about USP <800>?

Here. For example, on page 4 you can ready about Facilities and Engineering Controls. In this section you learn that hazardous drugs under this standard:

  • Can’t be stored on the floor or in areas prone to specific types of natural disasters. Kind of a no brainer but still important!
  • If stored on a shelf, the shelves must have raised lips so it can’t fall or be knocked off.
  • You cannot store sterile and non-sterile hazardous drugs together.


For handling of these hazardous drugs, you have to wear PPE including double gloves. Two pairs of chemotherapy gloves are required for administering antineoplastic Hazardous Drugs (HDs). Reference your site’s occupational safety plan. It is the responsibility of your facility to train you and your colleagues on the appropriate PPE to wear and safe handling methods.


Appropriate PPE must be worn when handled HDs including during:

  • Receipt
  • Storage
  • Transport
  • Compounding (sterile and nonsterile)
  • Administration
  • Deactivation/decontamination, cleaning, and disinfecting
  • Spill Control
  • Waste Disposal


In section 11.1 Labeling, you can learn that all HDs must have a special label on them that say they’re hazardous drugs. This is very clear.

Following right after that, section 11.4 Disposal states, ‘Disposal of all HD waste, including, but not limited to, unused HDs and trace-contaminated PPE and other materials, must comply with all applicable federal, state, and local regulations.’ So while USP <800> is not enforced by RCRA, it is the new standard of safety that all sites need to adopt to protect their staff.”


What other trainings may be beneficial for staff?

“Global Harmonized System training could be helpful. I know Daniels offers this training with their Compliance Program. This ensure staff can quickly read and understand hazard pictograms and the labeling of chemicals. Staff must also have an SDS for each hazardous chemical they use – a SDS database is also available in Daniels’ Compliance Program.”


Daniels is recommending the Chemosmart container as a cost-effective and compliant solution for USP <800> items and PPE, why?

“Many of the items on the HD list are chemotherapy drugs. Anything that is trace has less than 3% volume of original material and is no longer regulated by RCRA. So that’s why those can go in Chemosmart. Again, this is the best recommended practice by Daniels but ultimately the site’s decision. The PPE used could also have trace amounts on it. It is simpler to discard all PPE as trace. Disposing of items in the Chemosmart would be more cost-effective than over-classifying the items and putting them in a black bin.. ”


Poster: Understanding USP <800>



I don’t know about you, but I definitely feel less intimidated after Adam’s explanation and overview. If you’re still having questions, feel free to contact us. We also have an entire webpage dedicated to USP <800> with resources made for you.



Header Style: 
Megan Chamberlain

Megan Chamberlain

Compliance and Digital Solutions Specialist

With a little bit of knowledge about a lot of things and a quick wit, Megan was the recipient of the Daniels Pun-Master Award 2017 and is the go-to girl for all things compliance.