Beyond use dating usp 795
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.
” From how I understand the revisions within 797, there isn’t much leeway on BUDs.
With the previous version there was quite a bit of confusion and they made reference to for direction.
BUDs are best assigned on the basis of direct testing or extrapolation from reliable literature sources and other documentation (see Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding-Nonsterile Preparations ) or, if not available using the default dates provided in the chapters.Trissel's 2 Clinical Pharmaceutics Standard Operating Procedures Formulas Physicochemical Flavorings Discontinued Medications Filter Membrane Compatibility Oral Vehicles Base-Salt-Ester Weight Conversion Na Cl Equivalent Values Veterinary Transdermals p H Adjustment Chemotherapy Vial Reconstitution and Stability Preservatives and Antioxidants Article Search Interactive Claim Form , the long-standing concept of drug stability (beyond-use dates and expiration dates) came to the forefront of pharmacy compounding practice.This includes the issue of increased waste and the cost associated with it.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.