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It prohibits specific formulations, marketing claims, and delivery methods that cross from supplement territory into unapproved drug territory

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Controlled freezing studies of recombinant hGH demonstrated that insoluble particulate aggregation increases sharply with cooling rate, with pH 7.4 formulations producing markedly more light-scattering particulates than pH 7.8 formulations after freeze-thaw (Eckhardt, Oeswein & Bewley, 1991)

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