Dr.PeteFamMed said:Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured…
Same experience, arrived at from the opposite direction. Nothing to add that would improve it.
Dr.PeteFamMed said:Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured…
Coming at Dr.PeteFamMed’s question from a different direction. 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. Give anything pharmacological four weeks before you judge it, and give anything measured weekly a four-point rolling average before you call it a trend.
Worth separating that from compounded supply, which this thread keeps folding into the same question. They behave differently and the advice does not transfer.
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Browse GL BiochemFollowing on from Dr.PeteFamMed — and this may be the naive question:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
dave_SLC said:Give anything pharmacological four weeks before you judge it, and give anything measured weekly a four-point rolling average before you call it a…
I do not accept the framing. The question has been narrowed to the version that has a tidy answer, and the part that was dropped is the part the OP actually asked about.