USP <800>: What healthcare organizations should know

With the United States Pharmacopeia (USP) General Chapter <800> becoming official in December 2019, ensuring compliance is top-of-mind for many hospitals, health systems and pharmacies as poor adherence to the regulations can harm staff health. 

Although compliance may seem daunting, it is necessary to implement USP <800> standards and procedures to protect patients, healthcare workers and the environment, explained Patricia Kienle, RPh, MPA, FASHP, director of accreditation and medication safety at Cardinal Health Innovative Delivery Solutions [1].

“Some people are looking at this like it’s another regulation that’s coming down the pike. But what they don’t realize is that we shouldn’t need a federally enforceable regulation to keep healthcare workers safe; it should be something all healthcare organizations strive for,” Ms. Kienle said.

Here, Ms. Kienle discusses the importance of USP <800>, the organizations that will have oversight of the new standards and what the standards seek to protect, among other must-know topics about USP <800>.

Editor’s Note: Responses were lightly edited for length and clarity.

Question: What is the importance of USP <800>?

Ms. Patricia Kienle: The point of USP <800> is to protect three things: patients, the environment and healthcare personnel. What <800> provides is a comprehensive look at all the healthcare organization’s policies and helps them set up compliance programs and educate the people involved. It’s there for healthcare workers’ protection. Even if regulators decide not to enforce it on Dec. 1, it’s a good process to ensure workers are safe.

Q: USP recently announced that Chapters <795>, <797> and <825> have been postponed. Will this affect Chapter <800>? 

PK: Despite the postponement of three chapters, USP Chapter <800> becomes official Dec. 1. Generally, when a chapter becomes official, it becomes federally enforceable. This is an unusual situation where most organizations could delay enforcing Chapter <800> until the two chapters it is linked to, <795> and <797>, become official. People need to know, very clearly, that <800> still becomes official this year. The point of <800> is to protect patients, the environment and healthcare workers, so the sooner we comply with the standards set by <800>, the safer everyone is going to be.

Q: What organizations have oversight of USP <800>?

PK: Various regulators and accrediting organizations will be the enforcers of USP <800>. Regulators could be from the federal government or state government. From a federal perspective, regulators like CMS, the FDA or the Occupational Safety and Health Administration (OSHA) could get involved.

From the state regulator perspective, state pharmacy boards will be involved. Some boards have already notified their licensees that they expect compliance by Dec. 1. It could also be state health departments or a state OSHA agency. I think another big driver is going to be accrediting organizations, such as The Joint Commission, which may work some of these requirements into their own standards.

Q: What types of hazardous drug exposure does Chapter <800> seek to protect against?

PK: Chapter <800> is based on the National Institute for Occupational Safety and Health (NIOSH) list [2], which are hazardous drugs that are harmful to healthcare professionals. Very simply put, these are carcinogens and reproductive toxins. Drugs in those classes need to be controlled so exposure doesn’t occur. The most common way drug exposure happens is through touch contamination like spreading any hazardous drug residue from gowns or gloves. The better we can protect against this exposure pathway, the safer workers will be.

Q: Who could be exposed to hazardous drugs in a hospital?

PK: Anybody who encounters hazardous drugs, which requires thinking about the whole lifecycle of a hazardous drug as it is transported through the healthcare setting. The primary people who are likely to be exposed in most organizations are pharmacists, pharmacy technicians and nurses. Those are the healthcare professionals who would be compounding and administering the drugs, so they have the largest risk of exposure to hazardous drugs. However, we can’t lose sight of the folks who clean up drugs or help move the drugs through the system. For example, if a shipping container was broken, leaking, or crushed, anyone in materials management who may be receiving that shipment of drugs could be potentially contaminated. In addition, environmental services people who clean up could be exposed if there was a hazardous drug spill or even through routine cleanup activities.

Q: With regard to the NIOSH List of Antineoplastic and Other Hazardous Drugs, can you describe how the handling of Table 1 hazardous drugs differs from the handling of Table 2 and Table 3?

PK: Table 1 drugs are primarily antineoplastics, which are carcinogenic. There are also some organizations that order raw powder or the active pharmaceutical ingredient (API) to manipulate at the pharmacy. If it’s the API of any hazardous drug — or if it’s a Table 1 antineoplastic that they’re going to manipulate, mix or draw a dose out of — those are the drugs that have the highest potential for contamination. In those situations, an organization must follow all the containment strategies and work practices listed in Chapter <800>. In comparison, any finished dosage form of Table 2 or Table 3 medications can be treated differently in an organization. For Table 2 and 3 medications, Chapter <800> allows organizations to complete an assessment of risk to recognize any current practices that are working and identify alternative strategies to improve the practice. Each organization needs to look at their own risk levels and identify strategies that work for them. For example, some organizations may place chemotherapy drugs in a yellow-lidded bin so staff know it is a drug that needs chemotherapy gloves and that specific protocols must be taken if it spills. It’s up to each organization to design procedures and strategies to ensure compliance.

[1] Patricia C. Kienle is a member of the USP Compounding Expert Committee, but these comments are her own and not those of USP.

[2] The National Institute for Occupational Safety and Health (NIOSH). 2016. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016. Centers for Disease Control and Prevention 161.

Cardinal Health has a comprehensive portfolio of products to help organizations comply with USP <800>. For more information, visit

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