Understanding USP <800> and Hazardous Drugs: A Closer Look

by Jessica Czapnik


With the upcoming implementation of USP <800> on December 1, 2019, the practice for handling hazardous drugs will be impacted across the continuum of care.  SoftWriters is committed to keeping your pharmacy informed of future changes in regulations.


Hazardous Drugs

The Centers for Disease Control and Prevention (CDC) has posted the list of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 and the 2018 update as completed by the National Institute for Occupational Safety and Health (NIOSH). 

Additional updates since publication can be found at this website under Notice. The medications on this list include carcinogens, and drugs that cause developmental, reproductive, organ and genotoxicity. Oral, intravenous and topical formulations of these drugs are all considered hazardous.

Identify Your Compliance Manager

The Accreditation Commission for Health Care (ACHC) hosts workshops to assist pharmacies in becoming USP <800> ready and become certified by the Pharmacy Compounding Accreditation Board (PCAB) for Handling of Hazardous Drugs. All facilities will be required to name a compliance manager to oversee and ensure compliance.

A hazardous drug designated person (HDDP) will be responsible for creating, implementing, reviewing and updating policies and standard operating procedures (SOPs), employee training and competencies, and ensuring “environmental control” of locations where HDs are stored and handled. These documents should be reviewed annually.

The PCAB has a certification course for the employee to become the HDDP.

Identify Medications

Pharmacies should identify medications included on the NIOSH list in inventory and assess the risk of handling these HDs. Assessment of Risk should include the considerations of receiving, storage, compounding, transporting and disposal.

Additionally, administration could be an additional risk for anti-neoplastics that do not come as final dosage forms. Closed-system drug-transfer devices (CSTD) are required for administration and should be attached prior to addition of the hazardous drug.   

Although not all drugs defined as hazardous may pose a definite risk based on their final dosage form, any manipulations of these forms may involve risk - including cutting, crushing, dissolving, opening or compounding. 

An important consideration is that tablet and capsule forms of antineoplastic hazardous drugs must NOT be placed in automated counting or packaging machines, which subject them to stress and may create powered contaminants. 

For compounding pharmacies, there are many new requirements for cleanrooms, which may result in existing cleanrooms needing to be redesigned. USP <800> does not replace USP <797> for sterile compounding or USP <795> for non-sterile compounding, but rather provides additional guidelines for hazardous drugs.

Handling Hazardous Drugs

Medications that are on the Hazardous drug list are to be labeled, stored and handled according to regulations. Containers that are resistant to breakage and leakage should be used in the transporting of these hazardous medications and prevent the exposure of the individuals transporting the drugs.  If a container contains a hazardous drug, it should be labeled as such. 

Team SoftWriters is continuously monitoring the ever-changing landscape of regulatory requirements.  At present, we are reviewing the potential impact of USP <800> regulations on LTC Pharmacy Operating System workflows. Enhancements to the FrameworkLTC suite of products, if any, to support these changes are being investigated. Stay tuned for more updates on this issue and other relevant topics.


For additional information on the USP <800> chapter, pharmacies can consult



Jessica Czapnik is an Associate Clinical Business Analyst at SoftWriters, a Pittsburgh-based company that offers pharmacy management software solutions to pharmacies serving the long-term care community.  Jessica is a pharmacist with a background in sterile compounding and home infusion. She has also conducted graduate research at the National Institutes of Health in the field of molecular biology. Jessica is part of the SoftWriters Product Team where she helps to identify and develop solutions for the LTC pharmacy market.