Drugs

Compounding Group Questions Thyroid Extract Classification

The Alliance for Pharmacy Compounding (APC), representing both state-licensed compounding pharmacies and FDA-registered outsourcing facilities, has petitioned FDA asking that it reverse its classification of desiccated thyroid extract (DTE) as a biologic product.

Under current FDA guidance, DTE products — which contain thyroglobulin from porcine or bovine thyroid tissue — are considered biological products subject to approval through the BLA pathway, the petition says. APC argues this designation is overly burdensome, noting that no DTE BLAs are currently approved, effectively rendering all such products “unapproved biologics.”

The petition calls on the FDA to:

Reverse the biologics classification of DTE.
Clarify that its 8/2025 “Notice to Industry” does not constitute a ban on compounded ADT preparations for individual patients.
Route natural thyroid products through the traditional drug approval pathway under the Federal Food, Drug, and Cosmetic Act rather than the biologics pathway.
Engage stakeholders to develop a science-based framework for compounding ADT that balances quality and patient access.
Apply risk-based enforcement targeting only demonstrable safety or quality concerns rather than implementing categorical prohibitions.

APC CEO Scott Brunner emphasized that many patients cannot tolerate synthetic levothyroxine and rely on compounded ADT formulations. “FDA enforcement should prioritize patient access and safety, not the commercial interests of a single manufacturer,” Brunner wrote in the petition.

The group also raised concerns about FDA’s decision-making process, highlighting that the reclassification relied on internal interpretation rather than public notice-and-comment rulemaking, limiting opportunities for input from pharmacists, prescribers, and patients. APC additionally referenced the recent resignation of CDER director George Tidmarsh amid reports of “serious concerns about his personal conduct” as a factor questioning the agency’s internal decision-making.

The petition underscores the ongoing tension between regulatory oversight and compounding pharmacy practices, particularly for patients requiring individualized thyroid therapies.

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