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Description
The Phase 2 clinical data makes the case numerically

For a bulk drug substancethe raw Active Pharmaceutical Ingredient (API)to be legally compounded under Section 503A, it must possess an official USP/NF Monograph, be a component of an FDA-approved drug, or appear on the FDAs Bulks List as Category 1

Weidele, K., Kunzmann, A., Schmitz, M., Beneke, S

clinically, it isnt
