Tackle USP 797 Sterile Compounding Updates

Your hospital will update sterile compounding policies and procedures to reflect the latest USP <797> standards.

In 2019, USP released updates to their 2008 chapter of <797>. But concerns and questions led to postponing the updates. Some hospitals adopted 2019 guidance...while others stuck with 2008.

The new standards replace both versions...and become official on November 1, 2023. But state boards may choose a different date...and The Joint Commission plans to enforce them on January 1, 2024.

Beyond-use dates (BUDs). In 2019, risk groups for sterile compounds were changed to Categories 1 and 2...based on where they’re prepped. These remain the same...but now there’s a Category 3.

Think of Category 1 sterile preps as those made in a hood, cabinet, or isolator OUTside of a clean room suite. Use a BUD of up to 12 hours at room temp...or up to 24 hours in the fridge.

Educate that this means to begin infusing the sterile prep by the BUD...not finish the infusion by the BUD. Ensure labels for these infusions say “Start by” instead of “Expires by” or “Use by.”

Category 2 and 3 preps are made in a clean room suite. The difference is that Category 3 BUDs are longer...up to 90 days at room temp versus up to 4 days at room temp for most Category 2 preps.

But don’t expect many hospitals to do Category 3...due to more stringent requirements for garbing, surveillance, sterility testing, etc.

When assigning BUDS for any sterile prep, also keep stability in mind. For example, infuse a phenytoin piggyback within 4 hours.

Immediate-use preps. The latest guidance for these is the same as 2019. Continue to save them for urgent situations. Start within 4 hours of prepping...instead of 1 hour per 2008 guidance.

Save immediate-use preps for a single patient...and ensure they contain no more than 3 different sterile products.

For example, you can make a norepinephrine drip in the ED using 4 vials plus a bag of normal saline...this counts as 2 products.

Competencies. Expect to do fingertip and media-fill testing and demonstrate hand hygiene and garbing every 6 months for Category 1 and 2 preps, similar to 2019...or every 3 months for Category 3.

Plus every 12 months you’ll be tested on core skills...aseptic technique, calculations, cleaning, etc.

Also verify that your policy outlines training for staff who only make immediate-use preps (nurses, radiology techs, etc).

Keep in mind, when USP <797> becomes enforceable, so will USP <800> on handling hazardous meds, including sterile compounds.

See our updated What’s New in Sterile Compounding? resource for more on bag and vial systems, surface sampling, and garbing.

Key References

  • https://www.usp.org/compounding/general-chapter-797 (12-22-22)
  • https://go.usp.org/2022_Revisions_795_797 (12-22-22)
Hospital Pharmacist's Letter. January 2023, No. 390118



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