USP <800> Compliance: What Your Facility Needs to Know


As we approach a year of operating under USP <800> compliance requirements, it’s important to look back on your facility’s efforts. Here, we provide a high-level USP <800> overview and guidelines for compliance along with some tools to help make compliance more seamless.

It is estimated that more than 8 million US healthcare workers are exposed to hazardous drugs in the workplace each year. To help mitigate this risk, the United States Pharmacopeia (USP) rolled out USP Standard <800> in 2019, aimed to regulate employee protection. Now, nearly a year on, it is crucial to ensure everyone at your facility understands the guideline, and to examine your organization’s compliance to date.

This article will help facilities understand the technology and resources necessary to comply with USP <800> guidelines and offer solutions on how to reach compliance quickly and efficiently.

USP 800 Summary

USP <800> standards aim to help facilities properly handle hazardous drugs in order to promote patient safety, employee safety and environmental protection. According to USP, this includes the “receipt, storage, compounding, dispensing, administration and disposal of sterile and nonsterile products and preparations.” Because many hazardous drugs are found in hospital facilities, nurses, physicians and other healthcare staff are often at risk of exposure. USP < 800> guidelines will ensure that facilities properly store and dispose of these materials to enhance the health and safety of employees.

In order to comply with the guidelines, USP outlines the requirements facilities will need to meet, which include but are not limited to:

  • Inventory of hazardous drugs
  • How responsible parties will handle hazardous drugs
  • Facility and engineering controls
  • Environmental and quality controls
  • Proper use of appropriate Personal Protective Equipment (PPE)
  • Proper hazardous waste disposal and storage
  • Personnel Training
  • Receiving
  • Labeling, packaging, transport and disposal
  • Dispensing final dosage forms
  • Compounding
  • Administering
  • Deactivating, decontaminating, cleaning and disinfecting
  • Spill control
  • Documentation and standard operating procedures
  • Medical Surveillance for employees handling hazardous drugs

As of December 2019, all facilities are expected to be in compliance with these standards. Below we will explore the best practices facilities should implement to maintain compliance with USP <800>.

Foundations for Compliance

It is likely that your facility was overwhelmed during the push to meet somewhat costly and even challenging requirements within USP <800> guidelines, which is why it is important to reassess your efforts to ensure nothing slipped through the cracks. Ready for <800>, an educational resource, has put together a USP compliance checklist to educate on the requirements necessary to reach compliance.

Bringing Key Stakeholders on Board

First, facilities should look to implement an interdisciplinary team that includes pharmacy staff, nurses, administration and quality control employees. Facility managers should start by creating a list of all hazardous drugs housed in the facility. As new or different drugs enter the facility walls, administrators will need to evaluate hazards utilization forms to assess risk. Because the USP requirements are extensive, it will be helpful to train staff and rely on your interdisciplinary team to help handle these hazardous drugs and the tasks that come with it.

Hazardous Drug Storage

A key component in complying with USP <800> is proper drug storage, receiving and transport. To prevent spills and exposure, hazardous drugs should be stored in well ventilated, negative-pressure rooms. Facilities should also ensure the proper labeling, storage and handling of these drugs in compliance with state and federal regulations.

The OneVue Sense temperature sensors and probes and differential pressure sensor solutions, combined with the OneVue Monitor System can ensure your facility is in compliance with regulations and protect your inventory. The OneVue solution eliminates the use of manual data logging, enabling you to capture and document vital monitoring data without placing a strain on caregivers’ bandwidth.

Compounding & Proper Ventilation

Part of the USP <800> guidelines help to protect hazardous drugs from cross-contamination and microbial contamination during the compounding process. Facilities must implement containment primary engineering controls (C-PECs), including:

  • Externally vented
  • Physically separated
  • Have appropriate air exchange
  • Have a negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas

Facilities will need to monitor air flow quickly. The Primex OneVue Sense Differential Pressure and Temperature and Humidity Sensors can help monitor key parameters in hospital negative pressure rooms, alerting you to any changes.

Primex OneVue Provides the Tools You Need for Compliance

Primex OneVue Sense Differential Pressure Sensors are easy to install and provide you with the assurance that your facilities are maintaining negative pressure to prevent containments from spreading. You can remain at ease knowing that the solution will alert you to any pressure changes, keeping you in compliance 24/7. The OneVue system provides you with the ability to continuously track and document pressure differentials, reducing headaches. Learn more about how these solutions can help protect your environment from contamination by downloading our PDF on how to monitor pressure with differential pressure sensors.

The Primex OneVue solution creates on-demand reports, customized alerts and top-notch security, you can rest easy knowing your facility has all your documents and reports in one place, allowing you to show you’re in compliance with regulations. . The system also logs and stores data and alerts you to any conditions that may warrant attention. Automated tracking allows facilities to focus on improvement and providing the best care possible to patients.

Think you’re ready for USP <800>? Download the Ready for <800> Checklist here.

Resources:

https://www.readyfor800.com/what-is-usp-800/#:~:text=USP%20was%20published%20on,worker%20safety%2C%20and%20environmental%20protection

https://www.msdsonline.com/2019/12/04/usp-800-osha-hazcom-understanding-your-requirements-for-handling-hazardous-drugs-in-the-healthcare-industry/

https://www.halyardhealth.com/industry-news/2019/november/4-things-you-can-do-right-now-to-get-ready-for-usp-800.aspx

https://www.usp.org/sites/default/files/usp/document/our-work/healthcare-quality-safety/general-chapter-800.pdf

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