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Gut 62 , 630649 (2013)

doi: 10.1007/s004250100667 64 JinP.ZhengC.HuangY.WangX.LuoZ.ZhengY

But after six weeks

Category 2 removal can be a procedural step, but 503A compounding legality depends on the bulks list process and FDA actions (including rulemaking), plus compliance with sourcing requirements (FDA Law Blog)