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The familiar "Expiration Date" terminology was replaced with "Beyond-use Date" (BUD).Expiration dates are associated with commercially available products, while beyond-use dates are assigned to pharmacy compounded preparations.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.I try to take a common sense approach on all of this and come to logical conclusions.Does it really make sense for us to have this kind of dating without any REAL data behind it?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.
It can only benefit everyone involved in the end; most notably: the patient.
” 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.
Seems the revised BUD guidance gives some credence to preservatives, sterilization methods, etc, but with a maximum BUD of 45 days.
Do you feel the USP revision, coming out the end of next year, will allow for extended BUD’s for 503A pharmacies with adequate references/testing?