FDA has declared desiccated thyroid extract (DTE) to be a biologic drug and therefore ineligible for compounding.
In a September 16 letter to National Association of Boards of Pharmacy CEO Al Carter, FDA states that DTE products “can put patients at harm” and that “therapies containing DTE are biological products subject to licensure under Section 351(i) of the PHS Act.”
The letter encourages NABP to share the letter with its members, the state boards of pharmacy, which Carter did in a memo to boards of pharmacy on September 22.
“This is a baffling move by FDA, both the substance of their categorization of DTE as a biologic and the back-door path they’ve taken in declaring it so,” said APC CEO Scott Brunner. “The letter to NABP comes not from FDA CDER leadership but from a branch chief in that division, and no public communication or announcement by FDA has yet been issued.”
“Can state boards of pharmacy be expected to use the letter to cite or otherwise restrict 503A compounding pharmacies that compound with DTE?” Brunner asked.
“We are concerned that states may do just that, but at this time, with so little information, we do not know the approach boards may take on DTE, especially given the significant patient access issues to this important medication that such state action will create.”
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