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Category 2 designation means the substance presents "safety concerns" and is prohibited from being used in compounding by licensed pharmacies

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From a toxicology standpoint, a pleiotropic, multi-pathway mechanism is a double-edged observation: it may explain the broad tissue tolerability seen so far, but it also widens the surface area of biology that a complete safety program would need to interrogate, because a molecule that touches many pathways has many pathways through which an unintended long-term effect could emerge