The USP National Formulary, USP <797> refers to chapter 797 “Pharmaceutical Compounding – Sterile Preparations”. USP <797> describes the guidelines, procedures, and compliance requirements for CSPs and sets the standards that apply to settings in which sterile preparations are compounded. USP <797> applies to individuals who prepare CSPs and places where CSPs are prepared (e.g., healthcare institutions, patient treatment clinics, pharmacies, etc.).
Per USP <797>, the environmental sampling (ES) program should provide information to staff and leadership to demonstrate that the primary engineering control (PEC) is maintaining an environment within the compounding area that consistently ensures acceptably low viable and nonviable particle levels.
A-Tech was called out to the Oncology Department of a healthcare facility in the Los Angeles area to perform routine ES via viable air sampling, viable surface sampling, and temperature and humidity checking. A-Tech’s industrial hygienist performed appropriate hand hygiene, garbing, and consideration of needed materials to be brought into the compounding area(s). The exterior of the sampling pump, sampling media, and additional equipment was sanitized with 70% isopropyl alcohol wipes and spray both before and after entering the Ante room space to ensure that the sampling activity did not introduce any additional contaminants in the compounding area(s).
Key Points
• The ES program shall occur as part a comprehensive quality management program and comply with the most current chapter of USP – USP <797>, March 2020.
• The revised chapter of USP was released in January 2023 and provides new requirements and changes. This chapter becomes official in November 2023, and has some of the following changes:
-For entities compounding Category 1 and Category 2 CSPs, viable air sampling must be completed at least every six (6) months.
-For entities compounding any Category 3 CSPs, this must be completed within thirty (30) days prior to the commencement of any Category 3 compounding and at least monthly thereafter regardless of the frequency of compounding Category 3 CSPs.
-For entities compounding Category 1 and Category 2 CSPs, surface sampling of all classified areas, and pass-through chambers connecting to classified areas, must be conducted at least monthly.
-For entities compounding any Category 3 CSPs, surface sampling of all classified areas, and pass-through chambers connecting to classified areas, must be completed prior to assigning a beyond-use date (BUD) longer than the limits established in Table 13 of USP <797>, Nov. 2023, and at least weekly on a regularly scheduled basis regardless of the frequency of compounding Category 3 CSPs.
