Sterility expiration dating

sterility expiration dating-5
Change isn’t a bad thing; we need to make a few and embrace them.It can only benefit everyone involved in the end; most notably: the patient.If you have more questions, and there’s much more that could be dissected on this topic; head over to the forum topic Beyond Use Dating and let’s discuss.

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The Exten DATE™ System produces not only fast and efficient compendial sterility testing of these products, but also includes systematic, step-by-step instruction in performing both this type of compounding, and it's testing in a manner that is meaningful and valid.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.BUT, the upside to that is that if you actually did do a full scale stability study and you figured out the dating was a year, 2 years…whatever; that’s the dating you could use.I recently received a question from another pharmacist: “I wanted to get your thoughts on the current proposed revised USP standard.Specifically, the lack of reference to extended BUD’s when stability/sterility literature references or method suitability studies have been performed.The system that most pharmacies use to assign a date beyond which it should no longer be used seems to be a point of confusion.The general guidelines for assigning beyond use dates have been laid out in USP chapter and will be changed with the revision that is coming.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.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.That being said, the only TRUE way to extend dating is to do a stability study.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.


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