Beyond use dating
The flip side to that would be to use an actual expiration date which would require a stability indicating study to be performed and can easily cost upwards of ,000 for a single API compound.
I recently received a question from another pharmacist: “I wanted to get your thoughts on the current proposed revised USP standard.
Not a beyond use date study, not potency over time study but a real stability study seeing what every component is getting degraded into and the percentages of each, container closure studies, sterility/fungal/endotoxin at time points…etc.
One recent story, the compounding pharmacy Imprimis that made curcumin in PEG 40 castor oil; they weren’t using USP grade and degraded (no stability study done on this obviously).
We, myself included, historically have given 180 day beyond use dating to our products without a second thought and no real scientific data to back up that claim.
You could also leave me a voicemail to ask a question. Do you think this will bankrupt us all and put compounders out of business? About the Author: Seth De Pasquale is a pharmacist and co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction.
Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon.
My point being is that stability studies, in the case of the imprimis compound, would’ve prevented the death of a few people.
So, that’s why stability studies and BUD are a real point of contention for USP and FDA, and I don’t think they’re backing down on this an inch.