Comment from Alliance for Natural Health USA
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Summary: The Alliance for Natural Health USA (ANH-USA), a nonprofit watchdog organization, supports the inclusion of Methylcobalamin and Alpha lipoic acid on the 503A bulk drug substances list. They argue that these substances are necessary for patients requiring individualized, compounded medications and object to the FDA's shift toward requiring specific disease indications for approval.
The Alliance for Natural Health USA (ANH-USA) is responding, via the attached, to FDA's questions regarding the nomination of Methylcobalamin and Alpha lipoic acid for inclusion on the 503A bulk drug substances list.
We would like to reiterate that the Agency's original request asked only for ingredients' proposed use, not the disease condition or indication.