Proposed changes to USP 797 Pharmaceutical Compounding – Sterile Preparations have been posted on the USP website. This is your chance to influence how these proposals are considered.
The chapter has been significantly reorganized. All information pertaining to hazardous drugs has been moved to USP 800 Hazardous Drugs – Handling in Healthcare Settings, which will be published on February 1, 2016.
Current 797 standards focuses on the components of a compounded sterile preparation (CSP) and bases the beyond-use date (BUD) on the ingredient (nonsterile or sterile), storage time, and temperature (room temperature, refrigerator, or freezer) at which the CSP is stored. The proposed chapter changes that focus to the facility type in which the CSP is mixed, as well as the storage time and temperature.
Two types of facilities are defined: Category 1 and Category 2. A Category 1 facility is what we now refer to as a Segregated Compounding Area – essentially a certified Primary Engineering Control (PEC) placed in an area that isn’t a cleanroom. A Category 2 facility is a certified PEC within a cleanroom.
Category 1 facilities are limited to using BUDs of 12 hours at room temperature or 24 hours refrigerated. In order to use the full BUDs listed in the proposed chapter, a facility must meet all of the Category 2 criteria. Of particular note is that either a traditional laminar air flow workbench or a compounding isolator needs to be placed in a cleanroom to use the full BUDs.
Another significant change is in the frequency of personnel and environmental monitoring. Facility monitoring in current 797 is annually for pharmacies mixing low- and medium-risk CSPs and every six months for those facilities mixing high-risk CSPs. The proposed changes still requires these three types of tests, but changes the frequency of two of the tests (viable air sampling and surface sampling) to monthly. The requirement for nonviable (particle) air testing remains the same at every six months.
The frequency of personnel monitoring is also increased in the proposed changes. The current requirements for annual (or every six months if high-risk) media-fill and gloved-fingertip testing is increased to monthly.
Public comments are being accepted until January 31, 2016. I encourage you to participate with your feedback on these new changes.