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That leaves the 503A Bulks List as the only legal pathway for compounding pharmacies to work with these substances

As with all applications, this requires careful medical oversight due to the compounds potency and the limited long-term human safety data available

Considerations No clinical validation: There is no evidence-based guidance on what is safe or effective in humans

You just need to make sure a follow-up test has confirmed better vitamin B12 levels, and then you can work with the doctors to find the right maintenance dose to prevent future vitamin B12 deficiency

However, we plan to have one in the current year