Advocacy · Compounded Thyroid USP
Help us stop the ban on compounded thyroid.
FDA Citizen Petition · Filed August 28, 2026
The Foundation supported a Citizen Petition asking the FDA to reverse its classification.
On August 28, 2026, a formal Citizen Petition was filed with the U.S. Food and Drug Administration by Blank Rome LLP on behalf of compounding pharmacists from across the country. It asks the agency to revoke its determination that animal-derived thyroid (ADT) is a “biological product,” to regulate ADT as a drug under the Federal Food, Drug, and Cosmetic Act, and to withdraw the 2022 and 2025 letters that describe ADT as a biologic.
The Thyroid Foundation supported the petition. It includes a statement of support from our Medical Director, Brittany Henderson, MD, Sarah J. Zielsdorf, MD, MS, compounding pharmacists, and patients whose lives were changed by compounded thyroid. It argues that thyroglobulin is a carrier protein, not the active ingredient, that the classification was made without the notice-and-comment process the law requires, and that roughly 1.5 million patients depend on continued access.
Status: Submitted. We are awaiting the FDA’s decision (FDA Docket No. FDA-2026-P-10231). Read the full 25-page petition here, or open it in a new tab.
Can’t see the document? Open the PDF in a new tab.
From our Medical Director
"A classification error with life-altering consequences."
Brittany Henderson, MD · August 1, 2026
I am a thyroid specialist and board-certified endocrinologist who has witnessed firsthand the incredible impact that compounded Thyroid USP has on my patients’ lives. These patients, many of whom have unique medical needs, rely on this medication as a tailored solution when standard thyroid treatments fail to work. However, due to a recent FDA ruling, we may be forced to watch helplessly as these life-saving medications become inaccessible, all because of a classification error.
The FDA has recently classified Thyroid USP as a “biologic medication,” which, according to federal law, means it can no longer be compounded. This decision, effective after August 6, 2026, poses a devastating threat to the thousands of thyroid patients who depend on this specific compound. These individuals are unable to tolerate other forms of thyroid medications, and removing access to compounded Thyroid USP will directly and adversely impact their quality of life, and for some, could be life-threatening.
The classification of compounded Thyroid USP as a biologic is not just a bureaucratic error. It is a dangerous oversight that disregards the unique needs of thyroid patients. Compounded medications like Thyroid USP have long provided essential, customized treatments that are not otherwise available through mainstream pharmaceuticals.
According to a survey conducted by the International Academy of Compounding Pharmacists, more than 30% of thyroid patients use compounded medications annually because they suffer from allergies or intolerances to mass-produced options.
We urge the FDA to reconsider and re-evaluate this classification. By recognizing the true categorization of Thyroid USP, not as a biologic but as an essential compounded medication, the FDA can ensure continued patient access to necessary treatments. Join us in calling on the FDA to halt this ban and secure access to critical compounded thyroid medications.
Where things stand
Under federal law, biologics cannot be compounded by 503A or 503B pharmacies.
Rep. Michael Rulli introduces H.R. 8630, the Protecting Equal Access to Thyroid Act, which would bar the FDA from classifying a product as a biologic based solely on a clinically inactive protein. Referred to the House Energy and Commerce Committee. Read the bill
Compounding pharmacies must stop dispensing compounded Thyroid USP.
UPDATE: FDA is using risk-based enforcement, and Thyroid USP remains available for the foreseeable future.
A formal Citizen Petition asking the FDA to reverse the classification was filed on behalf of compounding pharmacists nationwide. The Foundation supported the petition, which includes statements from physicians, pharmacists, and patients. Read the petition
The FDA has not yet responded to the petition. We will post updates here and email subscribers the moment there is news.
Four ways to help
It takes five minutes to make a difference.
1
Sign the petition
2
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3
Contact your representatives
4
Fund the fight
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