FDA says natural thyroid medicine
is a biologic and pharmacies
can no longer compound it.
The implications are serious for patients
who rely on that therapy.
FDA has arbitrarily reclassified Desiccated Thyroid Extract (DTE) as a biologic, prohibiting it from use in compounding.
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Bad science that contradicts FDA's own policy
- The FDA’s rationale hinges on the presence of thyroglobulin, a protein in pig thyroid glands. But thyroglobulin is an inactive ingredient — it’s broken down in the stomach and does not treat hypothyroidism.
- The active ingredients in DTE are levothyroxine (T4) and liothyronine (T3), well-studied small molecules that have been used in thyroid care for generations.
- No precedent exists for reclassifying a drug solely because it contains an inactive protein.
- FDA’s reclassification violates its own guidance document, which states that a drug product that contains a protein only as an inactive ingredient is not considered to be a “protein” for purposes of the statutory definition of “biological product.”
- FDA has acted unilaterally, with no rulemaking and no public comment period, via an unorthodox series of letters to NABP and to DTE suppliers. This is not how such decisions should be made.
Patient impact:
Impeded access to an essential therapy + likely higher cost
Do you currently take DTE? Tell us how this prohibition impacts you.
