USP 800 Surveillance: The Compliance Standard You're Not Required to Follow—But Should

Across healthcare environments (pharmacies, hospitals, outpatient clinics, and infusion centers) thousands of healthcare professionals are exposed daily to drugs classified as hazardous. These include not only chemotherapy agents, but also certain antivirals, immunosuppressants, and hormone therapies—medications that require extra precautions due to their potential health risks with prolonged or repeated exposure.

To safeguard the health of these workers, the United States Pharmacopeia (USP) developed General Chapter 800, titled “Hazardous Drugs—Handling in Healthcare Settings.” First published in 2016 and made official in December 2019, USP 800 provides a comprehensive framework for minimizing occupational exposure to hazardous drugs (HDs).

What Is USP 800?

USP 800 is part of a broader set of pharmaceutical quality standards maintained by USP, a nonprofit scientific organization that sets official quality benchmarks for medicines, supplements, and healthcare practices in the U.S. While USP itself does not enforce laws, its standards are often adopted or referenced by accrediting bodies and regulatory agencies. In fact, USP 800 aligns with OSHA’s General Duty Clause, which requires employers to provide a safe workplace free from recognized hazards.

USP 800 addresses a wide range of safety requirements from facility design and ventilation controls, to PPE protocols, staff training, and critically, medical surveillance. It categorizes requirements into three key areas:

• Engineering controls (e.g., negative pressure rooms, ventilated hoods)

• Administrative controls (e.g., SOPs, training, spill response)

• Personal protective equipment (PPE)

Perhaps most importantly for Employee Health teams, USP 800 emphasizes the need for medical surveillance to protect workers over time.

Why Medical Surveillance Matters

Unlike accidental injuries or visible hazards, hazardous drug exposure is often silent and cumulative. Over time, repeated contact with HDs can lead to significant health consequences.

Without proper tracking and documentation, early signs of harm may go unnoticed. This puts both the employee and the organization at risk, opening the door to preventable illness, legal liability, and regulatory violations.

USP 800 recommends a robust surveillance program that includes:

• Baseline health assessments at the time of job placement

• Periodic evaluations based on job function and exposure level

• Post-exposure assessments for any known incidents

• Exit evaluations when an employee leaves or stops working with HDs

However, many organizations still rely on manual processes or disjointed spreadsheets, making it difficult to stay organized and compliant.

TrackMy: A Smarter Way to Manage USP 800 Surveillance

To address these challenges, healthcare organizations are increasingly turning to digital platforms like TrackMy, an employee health compliance solution built to simplify and automate surveillance workflows.

“Through TrackMy, we are able to flag specific work groups of individuals with potential exposure to hazardous drugs. TrackMy is used to collect medical surveillance data, including baseline assessments at hire, annually, following exposure, and upon changes in employment status. While medical surveillance is not legally required, both OSHA and NIOSH recommend such programs to minimize health risks, detect early health changes, monitor trends over time, and identify potential failures in control measures. All medical surveillance surveys are kept confidential and are reviewed by a provider for any areas of concern through the TrackMy application.”

–Christy McNease MSN, RN, PHN, COHN, CENP

System Director of Employee Health (PIH Health)

Here’s how TrackMy helps:

✅ Custom Health Forms

Easily create and assign digital forms for baseline, periodic, and post-exposure evaluations. Collect medical history, workplace exposure data, and reproductive health info in a standardized format across teams.

✅ Automated Compliance Rules

Set custom reminders to assign evaluations based on onboarding, job roles, or exposure incidents. Get real-time insight into compliance status and overdue requirements.

✅ Laboratory Test Documentation

Track lab orders and upload secure test results directly to employee profiles—ensuring audit readiness and long-term data visibility.

✅ Centralized Employee Records

Keep everything in one place: assessments, evaluations, communications, and documentation. Reduce paperwork and ensure nothing slips through the cracks.

Protecting Workers, Meeting Standards

USP 800 represents a new era of safety in healthcare—one where the risks of hazardous drug exposure are taken seriously and addressed proactively. But meeting those standards doesn’t have to mean more paperwork or administrative burden.

With TrackMy, organizations can implement a modern, scalable, and OSHA-aligned surveillance program—protecting employees and maintaining compliance with confidence.

Ready to upgrade your USP 800 surveillance process? Connect with the TrackMy team today for a personalized demo.