WHAT IS USP <797>?

USP 797 is a general chapter in the United States Pharmacopeia (USP) that outlines the requirements for the compounding of sterile preparations. These guidelines are designed to protect patient safety by preventing contamination. The latest revisions include several changes that impact environmental monitoring for pharmacies and other entities involved in the preparation of Compounded Sterile Preparations (CSPs).

Are You Ready for the New USP 797 Testing Requirements?

The upcoming changes to USP 797 standards underscore the critical importance of environmental monitoring in ensuring patient safety. Pace® microbiology services are performed by Aerobiology, part of the Pace® network of labs and a leader in providing environmental monitoring services for USP 797 compliance.

Primary Environmental Monitoring Changes to USP 797

The 2023 revisions include several changes to USP 797 environmental monitoring requirements for CSPs. We’ve highlighted some of the most critical changes here. If you have questions or need more information, one of our environmental monitoring specialists would be happy to help.

Changes to CSP Categories

The 2023 revisions to USP Chapter 797 bring a significant change in the categorization of CSPs. The revised framework outlines three distinct categories based on the associated risk level: Category 1 for low-risk, Category 2 for medium-risk, and Category 3 for high-risk level CSPs. These categories replace the previous “low-, medium-, and high-risk level” terminology to provide a clearer understanding of the potential risks tied to each CSP. Furthermore, the revisions introduce specific beyond-use dating (BUD) and testing frequency requirements for each category, taking into account preparation and storage conditions.

Revised USP 797 CSP Categories

Environmental Control & Type of Media Fill Kit
Additional Information
Low risk
Requires the LEAST controlled environmental conditions and are assigned a BUD of 12 hours or less at room temperature or 24 hours when refrigerated.
Medium risk
Requires more environmental controls and testing than category one and may be assigned a BUD greater than 12 hours at controlled room temperature or more than 24 hours refrigerated.
High risk
Perform sterility testing, endotoxin when applicable, more stringent personnel qualifications, use of sterile garb, disinfectants, frequency of environmental monitoring and stability determination. They also are assigned longer BUDs.

Surface Sampling Added to USP 797

One of the main changes to USP 797 is the addition of surface sampling requirements. For Category 1 and 2 CSP, bacterial and fungal surface sampling needs to be done monthly. For Category 3 CSPs, surface sampling needs to be done prior to assigning a Beyond Use Date (BUD) and weekly after that. Surface sampling also need to be done after each CSP category 3 batch, but before cleaning.

Gloved Fingertip Testing for USP 797

Studies show that those working with and around sterile compounds pose the greatest risk of contamination. Gloved fingertip sampling as well as changes to garbing requirements are designed to lower those risks. Separate gloved fingertip testing competency evaluations should be successfully completed 3 times (0 cfu/ml on all 3) before personnel are allowed to compound Category 3 preparations. As with other sampling changes, frequency required thereafter is based on risk. High-risk CSPs (Category 3) require at least once every 3 months, while semiannual sampling suffices for medium and low risk compounds (Categories 1 and 2). Competency testing must be documented per the revised USP Guidelines.

Aseptic Technique Competency Testing (Media fill testing)

Aseptic manipulation competency includes visual observation and media fill test followed by glove fingertip testing and surface sampling of the direct compounding area. CSP personnel are required to successfully complete independent media fill testing before compounding Category 1, 2 and 3 CSPs. The testing procedure should follow the most stringent methods the personnel will encounter while compounding, using growth media such as SCDA (Soybean Casein Digest Agar).

Aseptic manipulation competency testing should be performed initially for all 3 categories. Thereafter, Category 1 and 2 should be done at least every 6 months and Category 3 at least every 3 months. Individuals overseeing compounding personnel are also required to do an annual competency manipulation. A failure of gloved fingertip test, media fill test, or surface sample results in failure of the aseptic manipulation for that CSP personnel.

Changes to Air Sampling Requirements

Air sampling continues to be a focus of USP 797. Air sampling frequency requirements for Category 1 and 2 CSPs continue to be every six months. Air sampling for Category 3 CSPs needs to be performed within 30 days before the start of any Category 3 compounding, and at least monthly thereafter regardless of compounding frequency. In addition, minimum sample volume will now be 1000 ML.

USP 797 Environmental Analysis Specifications

Bacterial Counts to genus level as per new revision
Fungal Counts to genus level as per new revision
TSA petri plates or contact plates
SabDex petri plates or contact plates
Bacterial Counts to genus level as per new revision
Fungal Counts to genus level as per new revision
TSA contact plates, 15x65mm
SabDex contact plates, 15x55mm
Glove Fingertip (GFT)
Bacterial culture with counts
Fungal culture with counts
TSA petri plates, 15x100mm
Media Fill
Sterility competency for media fill
(GFT and surface sampling must be performed immediately following the media fill test.)
Kits include:
Empty sterile bags
Empty sterile vials
Sterile tryptic soy broth bag
Sterile tryptic soy broth vials syringe(s)

Order Sampling Kits

Pace® USP 797 Compliance Kits ensure you have the materials you need to meet the revised USP 797 sampling requirements. These kits are available on a configurable subscription basis and include all the materials needed to conduct surface, gloved fingertip, and media fill kit sampling. Kits also include packing materials to ensure fast shipping and that samples arrive intact.

All USP 797 Compliance Kits are sold through the Aerobiology ordering site.