USP provisionally published their latest proposed revisions on Chapter 797–Sterile Preparations in September 2021. The proposed changes are currently open for pharmacies' feedback and will not be implemented until the March 17, 2022, deadline.
To ensure patient safety, USP 797 regulates compounding accuracy and sterility. Category 3 CSPs represent a new addition to the USP General Chapter 797. Category 1 and 2 CSPs were previously introduced to replace low-, medium-, and high-risk preparations. CSPs in Category 1 had beyond-use dates of 12 hours or less at controlled room temperature or 24 hours or less refrigerated.
Meanwhile, CSPs with beyond-use dates of more than 12 hours at controlled room temperature or more than 24 hours refrigerated were classified as Category 2. Beyond-use dates for the newly proposed Category 3 range from 60 to 90 days at controlled room temperature and 90 to 120 days refrigerated. The time frame varies due to the different preparation methods (aseptic processing or terminal sterilization). Therefore, it should be confirmed by an assay that indicates stability.
With the implementation of Category 3, endotoxin testing, garbing practices, and other factors must be considered. Endotoxin content must be tested in sterile injectable preparations made from one or more nonsterile components that fall into Category 3. Stricter guidelines have been established for garbing practices in this category. Skin cannot be exposed in the buffer room, and all disposable garb items must be discarded once the compounder exits the classified area. Glove fingertip and surface sampling of the direct compounding area are required every 3 months in this category. Cleaning the surfaces was also a prevalent topic in the proposed revisions. Unless an EPA-registered one-step disinfectant cleanser was used, surfaces must be cleaned before disinfecting. The disinfectant used must have sporadic properties, and once the cleaning and disinfecting is finished, a 70% sterile isopropyl alcohol should be used to remove any residuals.
There are significant differences in cleaning procedures for Category 3 preparations compared with Categories 1 and 2. A sporadic agent must be applied to the primary engineering control (PEC), the equipment in the PEC, work surfaces and equipment outside the PEC, and the floors at least once a week while preparing Category 3 preparations. The distinction between the three categories is in the frequency with which they are cleaned. For Category 1 and 2 preparations, the application of a sporadic agent on the appropriate areas was completed once a month.
After the deadline for all comments passes, all submissions will be reviewed, and further changes will be determined. There is currently no date for when the amended USP 797 will officially go into effect.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
« Click here to return to Compounding Update.