Safety First Blog

USP <797>: Are You Ready?

Posted by Laura Paxton on Feb 8, 2022 10:13:18 AM
Laura Paxton
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This blog has been updated since it was first published.

Early this year we heard accounts of citations around USP <797> requirements during discussions with healthcare systems and we are now hearing whispers that USP <797> will become fully enforceable around the end of this year. Because USP <797> and USP <800> are close cousins, when <797> becomes law, some portions of USP <800> around compounding will also be enforceable. Keep reading to ensure you are ready for the State Boards of Pharmacy, Centers for Medicare and Medicaid and accreditation inspectors.

The updated revision of USP <797> will move out of the final comments phase on March 31, 2022, making it that much closer to final. Once USP <797> is final it will also trigger some portions of USP <800> to be enforceable by the Joint Commission and state boards of pharmacy. In fact, we’re already hearing that citations will be issued starting as soon as February 2022 with fines coming down in August 2022. Your pharmacy or healthcare facility must be ready.

Developed originally in 2008 by the USP Compounding Expert Committee, the USP <797> seeks to protect patients and healthcare workers from harm during the sterile compounding process by reducing potential microbial contamination that can occur from an unclean environment. 

The 2019 revision of USP <797> was the last version enforced by the Joint Commission and state boards of pharmacy. It was remanded in March 2020 after a final appeals hearing. This pause provided pharmacies and healthcare organizations some leeway in how they were expected to clean and disinfect the typical sterile compounding environment. 

USP <797> identifies risk levels based on the likelihood of contamination of a compounded sterile preparation (CSP) - low, medium, or high-risk. The higher the risk level the greater the risk for patient harm. 

Different sterilization rules apply to each risk level and in this interim time period, the rules have been relaxed. The pandemic also altered how these risk levels were determined and governed. 

For instance, in the original USP <797> guidance, only low-risk, non-hazardous compounded sterile products may be prepared in the Segregated Compounding Area (SCA). Interim guidance from FDA and USP allowed organizations to perform medium-risk compounding in the SCA during the COVID-19 pandemic. Once USP <797> is final, guidance will revert back to the original USP <797>. 

Revisions will affect nearly all aspects of compounding including the environment, PPE, beyond use dates, quality control, packaging and more. All revisions can be found on the USP website here

So back up, way up to where we mentioned USP <800>. How is USP <800> related to USP <797>? 

If USP <797> had not been remanded in 2020, the USP <800> guidelines for safe handling and disposal of hazardous drugs would have been enforced by inspectors at that time. Because USP <797> was put on hold, so was the enforcement of USP <800> to many organizations’ relief. Once USP <797> is fully enforced, parts of USP <800 will also be enforceable including:

  • Training of staff
  • Garbing of personal protective equipment of compounding staff
  • Facility and engineering controls (including microbial sampling)
  • Beyond use dating

As mentioned above, we’re already hearing from clients that USP <800> citations are forthcoming and fines shortly after. If you aren’t ready, now is the time to make the necessary changes to ensure your pharmacy or healthcare facility meets all requirements for safe handling and disposal of hazardous drugs.

Rpharmy is here to help answer questions about both sterile compounding guidelines in USP <797> and the hazardous drugs guidelines of USP <800>. Also, be sure to check out “USP <800> Inspectors are Coming: Are you Ready?” on the blog. 

Topics: Rhazdrugs, Policy, USP <800>, Formweb

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