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

The clock is ticking for your hospital to update its 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). Look for low-, medium-, and high-risk compounding categories to 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 that's NOT in 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 most a BUD of up to 4 days at room temp...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 they can be used 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 6 months. Plus ANNUALLY you'll be tested on core skills...aseptic technique calculations, cleaning, etc.

Use this opportunity to enhance your knowledge and skills. Stay current with our CE courses...or consider becoming a Certified Compounded Sterile Preparation Technician (CSPT).

Get our What's New in Sterile Compounding? chart and our tech tutorial, Sterile Compounding: Keeping It Clean, for more on cleaning, garbing, rules for jewelry, etc.

Key References

  • www.usp.org/compounding/general-chapter-797 (07-26-19)
  • www.usp.org/frequently-asked-questions/pharmaceutical-compounding-sterile-preparations (07-26-19)
Hospital Pharmacy Technician's Letter. August 2019, No. 350818



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