USP 800 is a quality standard that promotes patient safety, worker safety, and environmental protection when handling hazardous drugs (HDs). It applies to all healthcare personnel who handle HDs, and all entities that store, prepare, transport, and administer HDs.
As of November 1, 2023, USP 800 is required and compendially applicable to USP 795 and 797 when a practitioner is compounding HDs.
An HD is a drug identified as hazardous or potentially hazardous by the National Institute of Occupational Safety and Health (NIOSH).
Exposure to HDs can occur through dermal, inhalation, ingestion, or injection. NIOSH published a hierarchy of controls with five actionable levels to reduce or remove hazards. In compounding, the first line of defense against HD exposure is in engineering controls within containment areas and hoods. The second line of defense is administrative controls, followed by personal protective equipment (PPE).
Pharmacies can determine the effectiveness of their HD engineering controls by performing surface wipe sampling to detect HD residue. USP 800 recommends performing sampling routinely, initially as a benchmark and at least every 6 months. Pharmacies may also perform these tests more frequently to ensure the effectiveness of containment strategies and work practices.
There is no pass rate for surface wipe sampling; however, an acceptable surface limit can be established from the occupational exposure limit in a pharmaceutical manufacturer’s safety data sheet.
The suggested sampling areas include the interior of the Containment Primary Engineering Control (C-PEC) and equipment in it, pass-through chambers, surfaces in staging or work areas near the C-PEC, areas adjacent to C-PECs, areas immediately outside the HD buffer room or Containment Segregated Compounding Area (C-SCA), and patient administration areas.
Pharmacies need to be prepared to evaluate and investigate contamination. USP states that if any measurable contamination is found, designated individuals must identify, document, and contain the cause of contamination. This can be achieved by reevaluating work practices, re-training personnel, performing thorough deactivation, decontamination, and cleaning, and improving engineering controls. It is important to repeat the wipe-sampling process to ensure that the deactivation, decontamination, and cleaning steps are effective.
To send a surface wipe sample to ARL for testing, follow these steps:
- Purchase a swab (TEXWIPE SWAB PART No. TX714K).
- Swab the area to be tested.
- Submit the swab for analysis. Please do not submerge the swab in any liquid.
The cost for testing is $200 per swab, and only one hazardous drug can be tested per swab.
Once the testing is complete, a certificate of analysis will be issued with a quantitative result based on the amount of the drug detected on the swab.
For more information on surface wipe sampling, contact ARL at info@arlok.com or 800-393-1595.
Resources:
- USP 800 Hazardous Drugs – Handling in Healthcare Settings
- National Institute for Occupational Safety and Health
- National Institute for Occupational Safety and Health Hierarchy of Controls
- ASHP Hazardous Drug Compounding Pharmacy Technician Toolkit
- Oncology Nursing Society
- American Industrial Hygiene Association (AIHA) Hazardous Drug Surface Contamination Guidance Document
- ARL Bio Pharma Wipe Sampling Test Document
