The Food and Drug Administration recently reclassified desiccated thyroid extract (DTE) as a biologic. As conversations grow around how this FDA thyroid medication is categorized, many clinicians and patients are watching how these adjustments may shape future availability and regulatory expectations.
What the Reclassification Means for Patients Who Use Compounded DTE
The key issue is that pharmacies will no longer be permitted to compound desiccated thyroid extract starting in August 2026. This change affects patients who may have benefited from compounded DTE formulations and rely on them as part of their individualized thyroid care.
One major concern is access:
Patients who currently use compounded DTE will no longer be able to receive it — only manufactured versions will remain available.
DTE naturally contains T4 and T3 in a specific ratio, and some patients prefer or respond well to that profile. Because the FDA specifically cited the globulin component in DTE as the problem, pharmacists can still prepare alternatives without that component.
If the FDA does not reverse course, compounding pharmacies will continue to be able to offer T4 and T3 compounded in ratios that mirror a patient’s previous DTE prescription. These versions contain pure T4 and T3 — not the globulin component — allowing prescribers to maintain a familiar therapeutic approach without relying on DTE itself.
Understanding the Role of DTE in Thyroid Care
Hypothyroidism develops when the thyroid gland doesn’t produce enough hormone. Many people don’t notice much at first, since early signs can be subtle, but if unaddressed, it may lead to health concerns over time. In the United States, close to 5% of individuals live with this condition.
“Untreated hypothyroidism increases morbidity and mortality.”
Most care plans begin with medications that supply levothyroxine (T4) or a combination of T4 and liothyronine (T3). These options work for many. However, some people and their clinicians sometimes consider alternatives depending on specific care goals.
DTE has a long history in thyroid therapy. It’s prepared from pig thyroid tissue and contains a naturally occurring mix of T4, T3, and other components found in thyroid glands.
“From the early 1890s through the mid-1970s, desiccated thyroid was the preferred form of therapy for hypothyroidism. In 1965, approximately 4 of every 5 prescriptions for thyroid hormone in the USA were for natural thyroid preparations.”
Compounding pharmacies step in when a prescriber needs a strength, dosage form, or combination that isn’t available commercially. In Michigan, that might mean adjusting a capsule strength, preparing a version without certain dyes, or creating a formulation that supports a clinician’s specific plan for a patient.
FDA Thyroid Medication Reclassification: How It May Affect Availability
The latest move to place DTE under the biologic category shifts the regulatory framework surrounding it. Because of this, changes in how FDA thyroid medication is classified may affect manufacturing steps, sourcing requirements, and the overall pathways companies follow when producing certain formulations.
A few areas that may be influenced include:
- A biologic classification places DTE under a different approval pathway than standard drug applications. This process usually involves extra steps for manufacturers and may influence overall production demands.
- Because biologics don’t have traditional generics, any future versions of DTE would move through biosimilar pathways, a route that may involve additional resources for companies developing them.
- If fewer manufacturers choose or are able to produce DTE under the new framework, people who rely on it may notice changes in availability.
For compounded medications, the implications are more direct: pharmacies will not be allowed to compound DTE after August 2026, regardless of prescription need.
Compounding Medication for Thyroid Care
Many people appreciate having options when discussing their thyroid care with a clinician, especially when a specific dosage form or ingredient profile aligns better with their comfort or needs.
At Healing Dose Compounding Pharmacy (HDRx), we prepare compounded medications that a prescriber may include as part of an individualized care plan. This is especially true when a commercially available product doesn’t fit well for a particular situation.
Our pharmacists work closely with healthcare providers to support those decisions and to ensure the requested formulation meets the prescriber’s specifications
T3 and T4 Tablets
Even though DTE itself will no longer be eligible for compounding, prescribers may still request individualized combinations of T4 and T3 that reflect the therapeutic ratios their patients previously received.
Compounded medication offers potential benefits
Dessicated thyroid contains T4 and T3 in a specific ratio. For patients who wish to continue with a compounded option, if FDA doesn’t change course, we can compound T4 and T3 in a ratio that reflects what was received through their dessicated thyroid extract compound. This compound does not contain the globulin that FDA is citing as problematic, so we can compound with the pure T4 anT3 still
- Customized T4/T3 ratios (replicating the hormone balance of a patient’s prior compounded DTE)
- Pure hormone preparations without the globulin component the FDA identified
- Allergen-aware formulations that avoid certain dyes, fillers, or ingredients when a prescriber identifies sensitivities
- Modified-release preparations when a clinician requests a specific release profile
- Multiple delivery forms such as capsules, tablets, liquid suspensions, or sublingual drops, depending on what the prescriber selects
For Michigan prescribers, our order forms offer a clear way to communicate the details needed for a compounded preparation.
Within Michigan, we support Oakland, Wayne, Macomb, Genesee, Livingston, Kent, Eaton, and Grand Traverse Counties, with local delivery and shipping available. We serve patients and healthcare providers across Ohio, Indiana, Illinois, Wisconsin, Minnesota, and Florida.
References:
- Patil, N., Rehman, A., Anastasopoulou, C., & Jialal, I. (2024b, February 18). Hypothyroidism. StatPearls – NCBI Bookshelf. Link
- Heald, A. H., Taylor, P., Premawardhana, L., Stedman, M., & Dayan, C. (2024b). Natural desiccated thyroid for the treatment of hypothyroidism? Frontiers in Endocrinology, 14, 1309159. Link
- Hoang, T. D., Olsen, C. H., Mai, V. Q., Clyde, P. W., & Shakir, M. K. M. (2013). Desiccated thyroid extract compared with levothyroxine in the treatment of hypothyroidism: a randomized, Double-Blind, crossover study. The Journal of Clinical Endocrinology & Metabolism, 98(5), 1982–1990. Link
- Shakir, M. K. M., Brooks, D. I., McAninch, E. A., Fonseca, T. L., Mai, V. Q., Bianco, A. C., & Hoang, T. D. (2021). Comparative effectiveness of levothyroxine, desiccated thyroid extract, and Levothyroxine+Liothyronine in hypothyroidism. The Journal of Clinical Endocrinology & Metabolism, 106(11), e4400–e4413. Link
- Toloza, F. J. K., Suarez, N. R. E., Kawkgi, O. E., Golembiewski, E. H., Ponce, O. J., Yao, L., Maraka, S., Ospina, N. M. S., & Brito, J. P. (2020). Patient Experiences and Perceptions Associated with the Use of Desiccated Thyroid Extract. Medicina, 56(4), 161. Link
