raj_cambridge said:If you are going to change something, change one thing and give it long enough to express itself.
That is right, and it stops being right at the edges. The general case is well behaved; the interesting cases in this thread are all at the boundary where the general case breaks.
raj_cambridge said:If you are going to change something, change one thing and give it long enough to express itself.
Genuinely useful, thank you. I had the facts and not the framework. Adding it to my notes with a link back to this thread.
Adding the clinical framing, because it changes how the question reads. Whatever the answer turns out to be, the method for getting there is the same: state the assumption, do the arithmetic in public, and invite the correction. That is slower than asserting, and it is the only version that survives being wrong.
Correct me if the detail matters more than I have assumed.
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Browse GL Biochemcarl_compliance said:Whatever the answer turns out to be, the method for getting there is the same: state the assumption, do the arithmetic in public, and invite the…
Adding a me-too, because a thread of one person's experience is not much use. I had assumed I was the exception until I read this.
carl_compliance said:Whatever the answer turns out to be, the method for getting there is the same: state the assumption, do the arithmetic in public, and invite the…
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.