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What You Need to Know about USP <800>

Grainger Editorial Staff

Key points that healthcare facilities handling hazardous drugs should be aware of according to the recommendations under USP <800>.

Healthcare workers can face serious health risks when exposed to hazardous drugs, even at low doses. In the U.S., roughly 8 million healthcare workers are potentially exposed to hazardous drugs or drug waste while at work, according to The National Institute for Occupational Safety and Health (NIOSH).

These workers include pharmacy and nursing personnel, physicians, operating room personnel, veterinary personnel, shipping and receiving personnel, laundry workers, waste handlers and maintenance workers. According to NIOSH, these employees may be exposed to hazardous drugs when they handle drug vials, compound, administer or dispose of hazardous drugs, clean spills or touch contaminated surfaces.

To help minimize workers’ exposure to these drugs and potential interactions with these substances, the US Pharmacopeia (USP) in 2016 published a new standard known as USP <800>. This new USP general chapter goes into effect December 1, 2019 and includes controls to protect workers and their environments against hazardous drug compounds. Different from USP <797>, which focuses on protecting sterile compounds and spaces from contamination, USP <800> takes a more holistic approach to processing and handling hazardous drugs. Worth noting is that while previous standards, such as USP <797> and USP <795>, are being revised, USP <800> remains purely informational. Healthcare facilities are encouraged to follow the recommendations under USP <800> and to be aware that it could be enforced in the future. 

The Six Characteristics of Hazardous Drugs

USP General Chapter <800> describes the responsibilities of personnel handling hazardous drugs. These standards apply to all healthcare personnel who, according to the site, "receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled."

According to the NIOSH, as of 2019 there are currently 217 drugs that meet one or more of the NIOSH criteria for hazardous drugs, including those that produce one or more of the following six characteristics in humans or animals:

  • Carcinogenicity (those that produce radiation that promotes carcinogenesis, the formation of cancer)
  • Teratogenicity or other developmental toxicity (disturbs the development of the embryo or fetus)
  • Reproductive toxicity
  • Organ toxicity at low doses
  • Genotoxicity (destructive effect on a cell's genetic material)
  • Structure and toxicity profiles of new drugs similar to existing drugs that are also seen as hazardous 

Prior to USP <800>, many clinicians used a biosafety cabinet and personal protective equipment for handling hazardous drugs, according to Pharmacy Times. While it notes that these options provided some protection, formal education about hazardous drug management was all but nonexistent.

When USP <800> becomes enforceable, healthcare facilities handling hazardous drugs will be expected to meet its requirements or risk facing fines and penalties for non-compliance. Enforcement will vary by state and will depend on medicine and pharmacy board rules and regulations.

What to Know About USP <800>

The Ready for <800> website features a short video and an expert Q+A to help healthcare facilities understand what they need to know about the new standard. Experts recommend thinking about the entire journey of hazardous drugs through your organization in order to help conceptualize USP <800>. USP <800> is relevant to all healthcare facilities and personnel who prepare, transport or administer hazardous drugs, regardless of the volume being handled or the size of the facility.

All of the recommendations for hazardous drug handling are defined in USP <800>, which provides references to other source documents. One of the first steps personnel designated to handle hazardous drugs will have to complete, will be to identify which drugs in their inventory fall on the list of the 217 identified by the NIOSH (more drugs are under review and could be added to the list in the future). By conducting hazard assessments of each of the drugs in your inventory, the exposure can be determined and controlled against by using the NIOSH Hierarchy of Controls. If additional training for personnel is required, many professional organizations conduct training and continuing education programs on the subject.

Be Informed

Make sure you get up to speed on USP <800> and the requirements associated with this new standard. Covering everything from the handling of the drugs to the building's HVAC systems to the physical space where the substances are stored—and everything in between—this substantive chapter of USP’s compounding standards is important for the health and wellbeing of both patients and staff.

The information contained in this article is intended for general information purposes only and is based on information available as of the initial date of publication. No representation is made that the information or references are complete or remain current. This article is not a substitute for review of current applicable government regulations, industry standards, or other standards specific to your business and/or activities and should not be construed as legal advice or opinion. Readers with specific questions should refer to the applicable standards or consult with an attorney.

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