Dr.Martinez said:The useful move here is to separate what is established from what is widely repeated.
Same experience, arrived at from the opposite direction. I had assumed I was the exception until I read this.
Dr.Martinez said:The useful move here is to separate what is established from what is widely repeated.
Adding the part of the answer the thread has not reached. They are two different exemptions from the same federal requirements and they buy different things. A 503A pharmacy is regulated primarily by the state board, needs a patient-specific prescription, is exempt from CGMP, and may use a bulk substance that has a USP monograph, is a component of an approved drug, or appears on the 503A bulks list — three independent doorways. A 503B outsourcing facility registers with the FDA, is inspected on a risk basis, must comply with CGMP, may compound for office stock without a patient-specific prescription, and has one doorway to a permitted bulk substance: the 503B bulks list, or the drug shortage list.
One concrete data point for the thread. One habit that pays for itself: post the method alongside the number. A figure without its method cannot be checked, and an unchecked figure is how this community accumulates folklore.
Happy to go further on any of that.
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Shop Reference StandardsA narrower follow-up, since the general answer is now clear:
How would you tell the difference between that and the alternative explanation?
Dr.RaviCardio said:One habit that pays for itself: post the method alongside the number.
This is where I part company with the consensus forming above. This treats a plausible mechanism as a demonstrated one. Plausible is where you start looking, not where you stop.