USP 800 Hazardous Drug Compliance

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USP 800, USP 800 pharmacy compliance

USP 800 Compliance Program (Hazardous Drug)

What is USP <800>?

The USP <800> Hazardous Drugs – Handling in Healthcare Settings were created by United States Pharmacopeia (USP) to provide a set of practices that would minimize and prevent the potential hazardous drug exposure to personnel, patients, and the greater community.  The standards have their most significant impact on Pharmacy Compounders, however, they also have a place in those pharmacies that may be dispensing hazardous drugs only in the final dosage forms that do not require further manipulations before dispensing (typically tablets, capsules, and solutions).

USP 800 pharmacy COMPLIANCE, cultural competency compliance program for pharmacy

Who requires USP <800> Compliance?

The USP is an international organization that creates standards like USP <795>, <797>, and <800>, but USP does not enforce these standards.  Enforcement is left to regulatory and credentialing entities who have decided to require USP <800> compliance.  The following entities may require your pharmacy to follow USP <800>:

  • State Boards of Pharmacy
  • State Labor Departments
  • Business and Liability Insurances
  • Accreditation Organizations
  • Payers
  • Other Contracting Entities

Additionally, entities like NCPDP are now asking whether your pharmacy is compliant with USP <800>.

What are hazardous drugs?

Drugs are considered Hazardous, according to NIOSH, if they exhibit any of the following:

  • Carcinogenicity
  • Teratogenicity or developmental toxicity
  • Reproductive toxicity
  • Genotoxicity
  • Structure and toxicity profiles of new drugs that mimic existing drugs deter­mined hazardous by the above criteria

There are currently over 220 hazardous drugs on the NIOSH list. While many of these medications are antineoplastic medication, there are some very common medications that your pharmacy probably dispenses every day, including:

  • carbamazepine
  • divalproex
  • estrogens
  • fluconazole
  • medroxyprogesterone
  • paroxetine
  • phenytoin
  • tamoxifen
  • testosterone
  • warfarin

What is the PRS USP800Track Program?

The PRS USP800Track Compliance Program is designed to make your Pharmacy Compliant.  The program contains all the policies, procedures, forms, and training (based on the regulation and the policies and procedures) to ensure you have the tools to be compliant.  The comprehensive USP800Track Program from PRS includes the following:

  • Customizable Policies and Forms
  • Personnel Designations
  • Hazardous Drug Inventory
  • Customizable Assessment of Risk Templates
  • Personal Protective Equipment
  • Engineering Controls
  • Spills and Cleanup
  • Reproductive Acknowledgements
  • Medical Surveillance
  • Online Documentation of Your Hazardous Drug Inventory
  • Online Trackable Training For Your Employees

Reach out to our team today to find out more about our USP 800 Program!


Quick Fact: The main differences between USP 795, USP 797, and USP 800 are in the purposes of each standard:

USP 795 – promote and ensure patient safety in the compounding of non sterile compounded preparations (NSCP).

USP 797 – ensure patient safety in the compounding of sterile compounded preparations (SCP).

USP 800 – protect employees who may be exposed to Hazardous Drugs during their daily routines.

Check out part one of our comprehensive USP 800 article HERE.

We also have a great webinar on USP 800 that you can watch HERE.

For a Complete NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (including the 1/21/2020 update) CLICK HERE.

Need additional information about this program or any other Pharmacy Compliance and Credentialing services or products?

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