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We have exciting news for compounding pharmacies who compound for thyroid patients. In an email communication from the Alliance for Pharmacy Compounding (APC) – our industry partner — APC CEO Scott Brunner said statements made in identical letters the FDA sent to the National Association of Boards of Pharmacy (NAPB) and the Federation of State Medical Boards (FSMB) on November 16 were interpreted by APC “ to mean that FDA intends, at least for the foreseeable future, to take no action against compounders of DTE [desiccated thyroid extract] unless they receive a complaint about adverse events or product quality—in which case, the agency would commence an investigation of the pharmacy that prepared the DTE drug that is the source of the complaint.”
PCCA agrees with this interpretation and, as a result, reinstated sales of Thyroid USP Powder (Porcine) (PCCA #30-1467) starting Friday, December 2 . Orders may be placed immediately.
We are grateful for all of APC’s outreach to FDA, NABP and other entities as they worked to secure this clarification for our compounding industry. We also recognize that, given the FDA’s increased scrutiny of the compounding industry—specifically product quality—it’s more important than ever to provide quality thyroid ingredients sourced from quality-driven producers to your patients. To understand the quality of Thyroid USP Powder, please visit the Product Catalog..
Previously, a September 16 letter from FDA to NABP stated desiccated thyroid extract (DTE) – and Thyroid USP – were classified as biologic drugs and considered ineligible for compounding.