The Rundown: USP <800> and Your Pharmacy

What is USP <800>?

The United States Pharmacopeia (USP) and the Food and Drug Administration (FDA) have written a new safety standard with the intent to minimize the exposure to hazardous drugs from healthcare personnel, patients, and anyone else coming into contact with these drugs. This standard was enforced nation-wide on December 1, 2019 and all pharmacy owners must comply or risk their pharmacy license and their pharmacist-in-charge license.

By definition, USP <800> regulates the practice and quality standards of handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection. Handling HDs includes but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal of sterile and non sterile products and preparations.

This standard describes requirements including responsibilities of personnel handling hazardous drugs, procedures for decontaminating and cleaning, and documentation.

Frequently Asked Questions

A hazardous drug is any drug identified as hazardous or potentially hazardous by the National Institute for Occupational Safety and Health (NIOSH) on the basis of at least six of the following criteria:

  1. Carcinogenicity
  2. Teratogenicity or developmental toxicity
  3. Reproductive toxicity in humans
  4. Organ toxicity at low doses in humans or animals
  5. Genotoxicity
  6. New drugs that mimic existing HDs in structure or toxicity

This ​standard ​impacts all pharmacy operations across the country, with absolutely no exceptions. The​y apply to all healthcare personnel who receive, prepare, administer, transport, or otherwise come into contact with HDs and all the environments in which they’re handled.

The risk of ignoring ​USP <800> is steep. ​Non-compliance is not only placing your staff and patients at risk of exposure to HDs, your pharmacy and pharmacist-in-charge licenses can also be impacted if you are in breech of compliance with USP <800>. Enforcement will come from your state board of pharmacy,​ with the FDA training the state pharmacy boards. In fact, some states have already adopted these standards and are enforcing them now, such as California and Minnesota.

​The clock is ticking! December 1, 2019 is the date USP <800> will take effect. Don’t wait until the last minute to get your pharmacy in compliance.

USP <800> is in effect NOW. Are you compliant?

​​December is right around the corner. Now that you have the rundown, you must take action to make sure your pharmacy and team are compliant. Jeffrey Hedges, President and CEO of R.J. Hedges & Associates joins us as he facilitates a​​ critical webinar that​ details everything you need to know about USP <800>, the risks involved, and the steps you need to take. Jeffrey leaves no stone un-turned ​in providing this important information to you. Take a listen, and then take action! Once you finish the webinar, read our blog, USP <800> and the Steps to Comply, for the exact steps you need to take broken down here.


For​ a complete list of steps you must take to comply with USP <800>, read our latest blog USP <800> and the Steps to Comply.

If you​ would like more information on how you can get help preparing your pharmacy for USP <800>, contact R.J. Hedges ​& Associates at:

For more information on USP <800>, visit the United States Pharmacopeia ​website.

Chat with your fellow pharmacy owners  about how they’re making strides towards the deadline.

What You’ll Learn

  • Understand the what, who, where and why of USP <800>

  • Discover how this standard impacts your pharmacy

  • Know the risk you take if you ignore USP <800>

  • Learn the exact steps you must take

Watch the Webinar

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Have Questions?
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