FDA to Remove APIs from list

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On August 28, 2018, the FDA published a federal register notice of their intent to remove 3 active ingredients (Bumetanide, Nicardipine HCl, and Vasopressin) from the List of Bulk Drug Substances that can be used to compound drug products under 503B of the FD&C Act.  Their stated reasons are, (1) a lack of evidence of clinical need and (2) availability of a commercial alternative which can be used to produce compounds.

This notice marks the FDA’s first attempt to reject a nomination for actives initially placed on the interim list.  It’s likely that these actives were removed from the list because they were nominated without supporting documentation, or evidence substantiating a clinical need.  In addition, the FDA states that additional substances that are currently on the list are under consideration, and will be the subject of future notices.

The federal register notice will be open for public comment for a total of 60 days following the official publish date. If you currently produce compounds using one of the three substances mentioned above, we encourage you to submit a formal public comment in support of maintaining these substances on the approved bulks list. It’s important to provide supporting documentation, including why the commercially available products are not appropriate, to substantiate the need to produce compounds using these bulk substances.