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It contains a preservative that prevents bacterial growth, allowing multi-use from a single vial
AOD-9604, a synthetic growth hormone analogue, has been studied as an investigational agent for several indications 1
doi: 10.2337/db14-1020 144 MarroquiLLopesMdos SantosRSGriecoFARoivainenMRichardsonSJet al
FDA explains that a bulk drug substance used through the 503A pathway generally must meet one of the following conditions: Comply with an applicable United States Pharmacopeia or National Formulary monograph Be a component of a drug product with federal marketing authorization when no applicable monograph exists Appear on the 503A Bulks List when the first two pathways do not apply Additional requirements also apply, including documentation and sourcing requirements for the bulk drug substance
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