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FDA has repeatedly warned about the risks of compounded and non-approved injectables precisely because sterility and quality cannot be assumed outside a controlled pharmaceutical process

The 2018 FTC action against a Myers cocktail marketer for deceptive and unsupported health claims is a relevant precedent for clinic owners building service menus around this formulation

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[DOI] [PubMed] [Google Scholar] 80.Koffler B.E., Bloem E., Zellnig G., Zechmann B