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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.This means that the product was formulated according to the manufacturer's directions, or that the formulation contains the same concentration of drug, in the same diluent, in the same packaging, for the same intended period of use, and so on. When this is not possible, a pharmacist ideally consults with the manufacturer to establish a beyond use date.
Beyond use dates should be in accordance with the manufacturer's approved labeling.
What’s ironic is that this is a slap in the face to the FDA in my opinion and is their “origin” story (one of); in 1930s the company Massengil was making sulfanilamide and needed a solvent, used diethylene glycol, killed hundreds.
My point being is that stability studies, in the case of the imprimis compound, would’ve prevented the death of a few people.
” 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.