Comment from Fagron North America
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Summary: Fagron North America is responding to an FDA request for clarification regarding its nomination of alpha lipoic acid (ALA) for use in compounding. The company argues that the base form of ALA is the appropriate substance for inclusion because it can be buffered to achieve solubility and stability, similar to other FDA-approved injectable products.
Response to FDA request for information and clarification related to Fagron, Inc. nomination of alpha lipoic acid (https://www.regulations.gov/comment/FDA-2013-N-1524-2219)