USP 800 New Release Date and Important Facts

USP 800 New Release Date and Important Facts

Do you work in healthcare or occupational safety and health? If so, you should absolutely know what USP 800 is and be aware of the new proposed release date. Knowing the ins-and-outs of how it works and why it matters is essential to protecting healthcare employee’s standards and managing healthcare quality standards.

New USP 800 Release Date

  • December 1, 2019: USP General Chapter <800> expected official date

Important Updates

On September 29, 2017, a postponement of USP 800 was announced by The United States Pharmacopeial Convention. According to USP, the purpose of the postponement is to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797> Pharmaceutical Compounding — Sterile Preparations, and ultimately provide a unified approach to quality compounding.

What Is USP 800?

USP 800 is a government standard that outlines how to care for and dispose of hazardous drugs and pharmaceuticals. It covers what to do when receiving and storing them, as well as how to dispense, administer, and disposal of hazardous drugs. It exists to reduce risks of exposure for healthcare personnel and make healthcare facilities safer for everyone involved.

USP is established by a not-for-profit, science organization made up of independent industry experts. Their job is to create processes that help to develop and maintain health quality standards. They do this by leveraging current science and healthcare technology and using industry expertise and public input.

What Is a Hazardous Drug?

An important part of understanding USP 800 is knowing what a hazardous drug is. A drug is considered hazardous if it exhibits one or more of these characteristics in either animals or people” carcinogenicity, developmental toxicity, or reproductive toxicity. These drugs often include things like chemotherapy drugs and radiopharmaceuticals.

Who Does USP 800 Standard Apply to?

This standard applies to any healthcare personnel who receives, prepares, administers, or disposes of hazardous drugs. Basically, anyone who comes in contact with a hazardous drug. Any facility that handles hazardous drugs must also factor this standard into their occupational safety program.

The National Institute for Occupational Safety and Health (NIOSH) documents which items and drugs are considered hazardous. This list is reviewed once a year, and each drug must be reviewed every time there are new agents or dosage levels.

They review the following things when assessing the risk level of a hazardous drug:

  • Type of hazardous drug
  • Dosage form
  • Risk of exposure
  • Packaging

It’s important to know that the enforcement of USP standards differs by location and federal regulatory agencies. Agencies like the Joint Commission make sure drugs are in compliance with USP compounding standards. Professional licensing boards also have the ability to enforce USP compounding standards in their states.

Why Does This Standard Need to be Implemented?

The desire to protect healthcare personnel from hazardous drugs isn’t new. In fact, it’s been a topic of concern for decades! That’s because statistics show occupational exposure to hazardous drugs can cause acute and chronic health effects.

NIOSH defines and identifies hazardous drugs, but USP creates standards for handling them in the safest way possible. By providing uniform guidance on how to handle these drugs, and determining better safety supplies, USP helps to protect patients and healthcare personnel.

How to Make USP Work for You

Planning and implementing isn’t easy. There are a lot of moving parts and people involved in the process.

The first thing you should do is set up an interdisciplinary hazardous drug working group. You can include representatives from Pharmacy, Risk Management, and Nursing Administration.  You’ll need to designate one person to take a leadership role in this process and make sure your work is aligned with USP standards.

Then you’ll need to review any drugs you handle that appear on the NIOSH list. You’ll need to do this to make sure what you’re doing is line with those standards. After that, you can determine the costs and resources needed to make sure you’re meeting these healthcare quality and safety standards.

Final Thoughts on USP

USP 800 is here to stay, so it’s important to know how it works and why it matters. By reviewing the information in this article, you can help create a safer work environment for everyone.

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