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General Chapter USP <797> and USP <800>

This has been updated in our 26 SEP 2019 posting. On June 1, 2019, the United States Pharmacopeia (USP) released updates to the General Chapter USP <797> Pharmaceutical Compounding - Sterile Preparations. The official date for the revised standard was set for December 1, 2019 but formal appeals to the revision require postponement of the official date until further notice (https://www.uspnf.com/notices/compounding-chapters-postponement). In the meantime the 2008 version of General Chapter USP <797> remains official.

The USP General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings, which was published in February 2016 is on track to go into effect on December 1, 2019.

Eurofins EMLab P&K are currently preparing to adjust our services to accommodate the new requirements.  Below is our Frequently Ask Questions [FAQ] to start a series of communication and updates with our USP clients to make sure that we capture everything and share it with you.

We are also hosting a Webinar on this topic on Oct.23rd, presented by Dr. Michael Berg.  To register for this webinar, click here.

USP <797> Chapter Revision

Frequently Asked Questions

Q: Do I need to make changes in my environmental sampling procedures and when do I need to make those changes?

A: The revision of the chapter <797> was published on June 1st, 2019 and the effective date has been postponed until further notice due to formal appeals. We will work with our clients to make any needed adjustments but we recommend caution against any pre-mature changes.

Q: What are the changes in the new revision of USP Chapter <797>?

A: We recommend downloading a copy of the revised chapter at USP.org for a review and/or to participate in the training program at USP for details and a comprehensive assessment. Some of the changes affecting the environmental monitoring program are listed below:

  • Sample volume: Air samples in all cleanroom categories (ISO 5, ISO 7 and ISO 8) now need to have a samples volume of at least 1000 liters (previously 400 to 1000 liters).
  • Frequency of testing: The frequency for environmental air monitoring and some aspects of personnel training (hand hygiene and garbing) is still required every 6 months. Surface monitoring to evaluate cleaning, disinfection and personnel competency has changed to a monthly schedule (every 30 days).
  • Media and incubation conditions: Tryptic Soy Agar medium (TSA) remains the most commonly used and recommended media for microbial assessment although other media are allowable. Because the risk categories have been revised, we no longer have the requirement of using additional fungal media for the “high risk” category. However, default incubation conditions are now at least 48 hours at 30 – 35°C followed by a minimum of 5 days at 20 – 25°C. A colony count is performed before the change of incubation conditions and pass/fail criteria are applied after completing both incubations. Alternatively, two sampling plates may be submitted and incubated at each of the conditions separately. Both samples could be TSA or one sample could be TSA and the other fungal media (e.g., MEA or SDA).
  • Genus identification: Identifications to at least genus level are no longer required for samples with counts below the thresholds for colony counts.
  • Threshold levels: Colony counts that trigger investigation and corrective action remain largely the same with the exception of surface samples in ISO 8. The limit for surface samples in ISO 8 classified cleanroom environments is now 50 cfu (previously 100 cfu).

Q: How is Eurofins EMLab P&K going to support USP <797> testing going forward?

A: As leader in this industry Eurofins EMLab P&K is committed to provide highest quality service and data. We are in the process of implementing operational and IT changes to accommodate the changing needs of our USP <797> clients. For more details and questions please contact our client service team or Dr.  Michael Berg at (mberg@emlabpk.com).