USP 800 – The Struggle is Real…

Are you compliant with USP 800? While USP 800 became official on December 1, 2019, it was informational only and not compendially applicable. With the recent updates to USP 795, Nonsterile Compounding and USP 797, Sterile Compounding in November 2022, USP 800 was effective as of November 1, 2023.

USP 800 is not just for compounding pharmacies as it defines the quality standards for the safe handling of hazardous drugs in all healthcare settings, with the goal to minimize exposure to healthcare personnel, the patients in your pharmacy, and to the environment.

You might still be asking, does my pharmacy need a USP 800 program?

The answer is yes! All healthcare settings, including community pharmacies, should now have a “handling of hazardous drugs” program in place and while, USP itself is not an auditing entity, there are other agencies that may audit including OSHA, EPA and most likely State Boards of Pharmacy, many of which have already committed to doing so. The safe handling of hazardous drugs is now considered a “standard of practice” so implementation is essential to protect the health and safety of your employees.

Are you struggling with the multitude of requirements?

This isn’t one of those “throw it together in an afternoon” type of programs. PAAS can help! PAAS’ customized USP 800 Compliance Program provides:

  • A detailed Program Guide walking you through everything from the why to the how
  • Annual web-based training to keep the team up to date including a quiz to assess competency
  • A USP 800 Compliance Program Policy & Procedure manual tailored to the unique needs of your pharmacy with minimum interruption to workflow
  • An easy-to-use Assessment of Risk (AoR) tool to help you create custom containment strategies for each drug and its unique dosage form.

Call (608) 873-1342 to sign up for PAAS’ USP 800 Compliance Program and you can immediately get started on setting up your program in hours, not days!