USP 800 Testing
What is USP 800?
USP <800> was published on February 1, 2016 with an implementation date of December 2019.
The purpose of the USP <800> was written to protect all workers, patients and the general public who may be accessing facilities where hazardous drugs (HDs) are prepared in healthcare settings.
MSE Environmental can help assist in setting up your facilities USP <800> testing program so you are in compliance with USP 800 testing and environmental monitoring procedures.
USP <800> Standards aim to minimize exposure to hazardous drugs in healthcare settings including: pharmacies, hospitals, clinics, physician practice facilities, and veterinary offices where hazardous drugs are compounded.
USP <800> Summary: https://www.usp.org/sites/default/files/usp/document/our-work/healthcare-quality-safety/general-chapter-800.pdf
Why USP 800 Compliance and Sampling Objectives?
USP <800> Testing & Monitoring - Surface sampling for hazardous drug residue
Hazardous Drug Environmental Sampling Programs
3D Virtual Capture of Facilities and Sampling Locations
USP <800> Program Sampling - Quarterly and Semiannually
Preliminary and Post Third Party Validation
Laboratory Results - Standard and Rush Turnaround Times
USP <800> Education
NIOSH Hazardous Drug List Guidance Assessment of Risk
What is a Hazardous Drug?
A hazardous drug (HD) is a drug that can potentially impair reproduction in humans, harm fetuses, cause cancer, poison the organs of humans or animals, or damage/alter genes. USP <800> states, “There is no acceptable level of personal exposure to [hazardous drugs].” Even in low doses, hazardous drugs are not safe humans or animals. As a result, any potential exposure to hazardous drugs must be minimized. You can find a sample list of hazardous drugs at: https://www.cdc.gov/niosh/topics/hazdrug/default.html
Hazardous Drug Routes of Exposure
Inhalation
Skin Absorption
Ingestion
Injection (Needle Stick)
USP 800 Testing Compliance
New USP 800 Testing regulation for these industries:
Hospitals
Pharmacy
Urgent Care
Clinics and Medical Offices
Who is Enforcing this USP 800 Regulation?
Hazardous Drugs Compliance – State board of Pharmacy
Hazardous Drugs – U.S. Health and Human Services
Hazardous Materials – U.S. Department of Transportation
Hazardous Waste – Environmental Protection Agency and State Department of Environmental Protection
USP <800> - RISKS Handling Hazardous drugs
Headaches
Nausea and Vomiting
Organ Damage
Skin Rashes
Allergic Type Reactions
Hair Loss
Infertility
Birth Defects
Miscarriage
Cancer
USP <800> Resource Links and Downloads:
USP <800> NIOSH List of Hazardous Drugs in Healthcare Settings
What Areas will be sampled during USP 800 Compliance Assessment?
USP 800 Minimum Sampling Locations
Interior of the C-PEC (Containment-Primary Engineering Control) and equipment
Pass-through chambers
Surfaces in staging or work areas near the C-PEC
Areas adjacent to C-PEC (floors under staging and dispensing area)
Patient administration areas
USP 800 Additional Best Practice Sampling Locations
Drug compounding worktops
Hoods
Floor in Front of the safety cabinet
Refrigerator Door (Including handling)
Keyboard and Mouse
Door handles in compounding rooms and to/from pharmacy\
Tabletops
Carts
Countertops
Work benches
Floors inside and outside preparation areas
Floors and equipment around patients' beds
Floors & equipment around patients' treat areas
Reception desks
Spill Areas