Beyond use dating usp 795

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.I’m really not the authority on these matters by no stretch of the imagination.However, I’ve gained a lot of insight on how to interpret a lot of these standards.The extemporaneous compounding of pharmaceuticals is not part of routine practice in most pharmacies yet it is still an integral part of pharmacy practice.

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.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.The child became less responsive and was taken to the local emergency department and then transferred to another hospital for further treatment.Thankfully, the patient recovered and was discharged the next day.

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