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Legality: Compounding from bulk substances that arent on the FDAs approved list may violate Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act, exposing providers to enforcement risk
However, researchers must remain cognizant of the critical distinction between laboratory research applications and any form of clinical, therapeutic, or diagnostic usewith FDA Category 2 classification establishing these materials strictly for research purposes in qualified laboratory and academic settings
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