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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:

  • USP <800> Testing & Monitoring - Surface sampling for hazardous drugs

  • Hazardous Drug Environmental Sampling Programs

  • 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?

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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:

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Hazardous Drug Routes of Exposure

  1. Inhalation

  2. Skin Absorption

  3. Ingestion

  4. 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

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Nausea and Vomiting

Organ Damage

Skin Rashes

Allergic Type Reactions

Hair Loss


Birth Defects