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It is not for everyone, and it requires working with a healthcare provider who is open to non-standard dosing strategies

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The solubility of the fermented matrices could be improved, as the particulate tended to agglomerate, creating difficulties during processing and filtration, and some traces of unfermented matrix were occasionally recovered in the final freeze-dried product

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