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The FDA has issued guidance documents, warning letters, and taken enforcement actions against companies making inappropriate drug claims or selling adulterated products

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[DOI] [PubMed] [Google Scholar] 68.Kublaoui BM, Holder JL Jr, Gemelli T, Zinn AR

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This medication is not made for resale, bulk distribution, or office use, and is compounded exclusively to meet the clinical needs of individual patients when commercially available alternatives are not appropriate