A Short Law Lesson: Compounding Batches Under 25 Batches

When batches of compounds are less than 25,  a compounding pharmacist or pharmacy  is not required to perform a sterility test.   The batches, however, may not be assigned a beyond use date (BUD) that exceeds the default BUDs in U.S. Pharmacopeia (797)  when the batch is under 25 and sterility testing has not been done. The chapter requires sterility testing according to USP Chapter 71 before compounded sterile preparations are dispensed or administered for:

-high-risk level compounded sterile preparations that are prepared in groups of more than 25 identical individual single-dose pack- ages (eg, ampuls, bags, syringes, vials),
-multiple-dose vials for administration to multiple patients, or
-compounded sterile preparations that are exposed longer than 12 hours at 2°C to 8°C and longer than six hours at warmer than 8°C before they are sterilized. 

source USP; Virginia Board of Pharmacy July 2013 Newsletter;