USP <800>, why should you test?

Kathy Heatherly, MSFS, Technical Sales

As a compounder, protecting yourself and your staff from exposure to hazardous drugs should be important both from a safety and monetary perspective.  USP <800> applies to sterile and non-sterile compounding pharmacies and anywhere that hazardous drugs are received, stored, or administered.   It is also designed to prevent compounders from incurring fines from OSHA (Occupational Safety and Health Administration) for not providing a safe workspace and not complying with the information in USP <800> or on the NIOSH list.  Compliance with regulations includes having: a negative pressure lab to compound hazardous drugs, the appropriate design, layout, or equipment in the pharmacy to compound these materials, and appropriate controls for handling finished dosage forms.  If a facility is compounding or handling hazardous drugs in a state not enforcing USP <800> but is shipping to a state that is, they must comply.  Even if a state board of pharmacy has chosen not to adopt USP <800>, OSHA is still the regulating agency and can inspect a facility that handles or compounds hazardous drugs and levy a fine if they do not comply. 

Wipe sampling is best practice.  Environmental wipe sampling for hazardous drug surface residue should be performed to verify containment.  Contamination in any amount indicates a lack of containment.  Although described in as a “SHOULD” versus a “MUST,” some type of environmental wipe sampling is strongly recommended.  A facility cannot assess its success in controlling environmental contamination if it cannot measure the extent of such contamination.  The testing that ARL offers is easy and inexpensive to do.  Purchase a swab (TexWipe TX714K), swab area to be tested, collect sample, and submit sample for analysis.  The cost is per swab - $200. One hazardous drug per swab.  A list of hazardous drugs (including hormones and cancer treatments) can be found in USP <800> and on the NIOSH Hazardous Drug List. 

Avoid OSHA fines and reduce potential employee claims for an unsafe workplace by testing with ARL.

For more information on USP <800> Surface Wipe Sampling Test, visit