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FDA evaluates substances proposed for the 503A list using four criteria: Physical and chemical characterization Safety concerns associated with compounded products Available evidence of effectiveness or lack of effectiveness Historical use in compounding, including the conditions treated and references in peer-reviewed literature FDA then balances those factors on a substance-by-substance basis

But these high doses are necessary to help treat people with a deficiency

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For more in depth information on potential side effects, read this article from WebMD