Beyond use dating interacial dating something new black men
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.However, reliable, published stability information is sometimes lacking for many types of drugs.In these instances, pharmacists should consult with the drug's manufacturer to establish a beyond use date.In addition, federal and state (NC) regulations require that the following information appear on the label."Where possible, the beyond use date should be in accordance with allowances specified in the approved labeling.The major problem for pharmacists is that the stability of compounded formulations often is not known.
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.
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.
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.