Look for New Risk Categories and Beyond-Use Dates With USP <797>

The clock is ticking for your hospital to update sterile compounding policies to comply with the latest USP <797> standards.

Be prepared for changes by the "go-live" date...December 1, 2019.

Risk categories and beyond-use dates (BUDs). Be aware that the low-, medium-, and high-risk compounding categories will be replaced by Category 1 and 2. These new designations focus on where the prep is made.

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.

Consider sterile preps made in a clean room suite as Category 2. Assign a BUD of up to 4 days at room temp to most...compared to previous standards of 48 hours for low-risk or 30 hours for medium-risk.

And give most refrigerated Category 2 preps a BUD of up to 10 days.

Continue to check published stability data before automatically using <797> guidance. For example, assign an ampicillin piggyback a BUD of 8 hours at room temp...due to its short stability after prepping.

Immediate-use preps. Continue to save these for urgent situations. But now you can use them within 4 hours of prepping...instead of 1 hour.

Keep in mind that immediate-use preps are for one patient only and contain no more than 3 different sterile components.

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

Competencies. Be ready to perform these more frequently.

Expect to do fingertip testing, media fills, and demonstrations of hand hygiene and garbing every SIX months. Plus ANNUALLY you'll be tested on core skills...aseptic technique, calculations, cleaning, etc.

Get our What's New in Sterile Compounding? chart and our CE, Compounding: Sterile Compounding and USP Chapter <797>, for garbing order, surface sampling, cleaning, rules for jewelry, and more. And give techs our tutorial, Sterile Compounding: Keeping It Clean.

Also see our USP <795> article on NON-sterile compounding...and stay tuned for guidance on USP <800> hazardous meds in our next issue.

Key References

  • www.usp.org/compounding/general-chapter-797 (07-25-19)
  • www.usp.org/frequently-asked-questions/pharmaceutical-compounding-sterile-preparations (07-25-19)
Hospital Pharmacist's Letter. August 2019, No. 350818



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