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I meant to ask this weeks ago before I left for my long-ass vacation and it just popped into my head.
I noticed that all of the USP <797> rules concerning beyond-use dating seemed arbitrary in nature. Have there ever actually been trials done to prove this new bible of sterility? I've asked some people around town and they all seemed to think it really is all just arbitrary. I mean, sure its common sense that the higher the risk, the less likely sterility can be guaranteed, but who's the guy that determined that a low risk parenteral was only good for 9 days in a fridge and what led him to this conclusion? Is there a paper, trial, digital picture of the ouija board - something?
I noticed that all of the USP <797> rules concerning beyond-use dating seemed arbitrary in nature. Have there ever actually been trials done to prove this new bible of sterility? I've asked some people around town and they all seemed to think it really is all just arbitrary. I mean, sure its common sense that the higher the risk, the less likely sterility can be guaranteed, but who's the guy that determined that a low risk parenteral was only good for 9 days in a fridge and what led him to this conclusion? Is there a paper, trial, digital picture of the ouija board - something?
