Information for Patients & Prescribers
We are writing to inform you of an important regulatory change affecting compounded porcine thyroid medications, also known as Desiccated Thyroid Extract (DTE), or thyroid porcine. DTE has been prescribed safely for over a hundred years treating millions of Americans with Hypothyroidism. The Alliance for Pharmacy Compounding has stated that, “The FDA has arbitrarily reclassified DTE as a biologic drug, prohibiting it from use in compounding and clearing the field for a drugmaker to have a monopoly on the therapy (and surely raise the price).”
The FDA’s rationale is that thyroid porcine includes thyroglobulin, a protein in pig thyroid glands. But this is an inactive ingredient that is broken down in the stomach and does not treat hypothyroidism. The active ingredients in DTE are levothyroxine (T4) and liothyronine (T3), which are small molecules that are well studied and have been used in thyroid care for generations.
Due to evolving federal regulatory guidance from the U.S. Food and Drug Administration (FDA), our pharmacy will no longer be able to compound and dispense porcine-derived thyroid products after August 1, 2026.
This change impacts all compounded preparations containing porcine thyroid powder. Up to 1.9 million patients could lose access to DTE and face possible soaring prices from pharma companies. This is a nationwide regulatory issue affecting all compounding pharmacies and is not unique to our pharmacy.
What Does This Mean for Patients?
If you are currently taking a compounded porcine thyroid medication from our pharmacy, we strongly encourage you to contact your prescribing provider as soon as possible. This will allow adequate time for prescription changes if needed and dose conversion.
We recommend requesting a refill in advance when appropriate. If possible, patients may order up to a 6 month supply to sustain therapy until you and your provider determine the most appropriate next step in care.
To ensure we can continue to meet patient needs safely and in compliance with evolving FDA guidance, we are requesting that your final refill request be submitted by 7/15/2026. This will allow our pharmacy adequate time to prepare prescriptions appropriately and remain compliant with regulatory requirements.
Please note that we will not be able to guarantee emergency refills after 7/15/2026.
Please do not abruptly discontinue thyroid medication without guidance from your healthcare provider.
Possible Alternative Options
Depending on your provider's clinical judgment and your individual needs, several alternative thyroid treatment options may be available. For many patients, a primary alternative may be a compounded synthetic thyroid preparation containing levothyroxine (T4), liothyronine (T3), or a customized combination of both hormones. These compounded formulations may continue to offer:
Customized dosing strengths
Additionally, commercially available desiccated thyroid extract (DTE) products such as NP Thyroid® and Armour Thyroid® are expected to remain available beyond the August 2026 enforcement deadline. It is important to note that commercially available DTE products, including NP Thyroid and Armour Thyroid, are expected to remain available beyond August 2026. The FDA has indicated that it intends to continue allowing currently marketed DTE products to remain on the market while manufacturers work toward full approval of these products.
The most appropriate option for you will depend on your individual health history, laboratory findings, symptoms, treatment goals, and your provider's clinical assessment. We encourage patients to discuss these options with their healthcare provider well in advance to ensure a smooth transition if needed.
Support During This Transition
We understand that this change may feel disruptive, and we want to assure you that we are here to support both patients and prescribers during this transition period. We are happy to collaborate to make sure everything flows smoothly during this time of change.
Our pharmacy team is available to answer questions, provide guidance, and collaborate with your healthcare provider. You are welcome to call us at any time, and we can assist with:
Thank you for your understanding and continued trust.
We are writing to inform you of an important regulatory change affecting compounded porcine thyroid medications, also known as Desiccated Thyroid Extract (DTE), or thyroid porcine. DTE has been prescribed safely for over a hundred years treating millions of Americans with Hypothyroidism. The Alliance for Pharmacy Compounding has stated that, “The FDA has arbitrarily reclassified DTE as a biologic drug, prohibiting it from use in compounding and clearing the field for a drugmaker to have a monopoly on the therapy (and surely raise the price).”
The FDA’s rationale is that thyroid porcine includes thyroglobulin, a protein in pig thyroid glands. But this is an inactive ingredient that is broken down in the stomach and does not treat hypothyroidism. The active ingredients in DTE are levothyroxine (T4) and liothyronine (T3), which are small molecules that are well studied and have been used in thyroid care for generations.
Due to evolving federal regulatory guidance from the U.S. Food and Drug Administration (FDA), our pharmacy will no longer be able to compound and dispense porcine-derived thyroid products after August 1, 2026.
This change impacts all compounded preparations containing porcine thyroid powder. Up to 1.9 million patients could lose access to DTE and face possible soaring prices from pharma companies. This is a nationwide regulatory issue affecting all compounding pharmacies and is not unique to our pharmacy.
What Does This Mean for Patients?
If you are currently taking a compounded porcine thyroid medication from our pharmacy, we strongly encourage you to contact your prescribing provider as soon as possible. This will allow adequate time for prescription changes if needed and dose conversion.
We recommend requesting a refill in advance when appropriate. If possible, patients may order up to a 6 month supply to sustain therapy until you and your provider determine the most appropriate next step in care.
To ensure we can continue to meet patient needs safely and in compliance with evolving FDA guidance, we are requesting that your final refill request be submitted by 7/15/2026. This will allow our pharmacy adequate time to prepare prescriptions appropriately and remain compliant with regulatory requirements.
Please note that we will not be able to guarantee emergency refills after 7/15/2026.
Please do not abruptly discontinue thyroid medication without guidance from your healthcare provider.
Possible Alternative Options
Depending on your provider's clinical judgment and your individual needs, several alternative thyroid treatment options may be available. For many patients, a primary alternative may be a compounded synthetic thyroid preparation containing levothyroxine (T4), liothyronine (T3), or a customized combination of both hormones. These compounded formulations may continue to offer:
Customized dosing strengths
- Individualized T4 ratios
- Hypoallergenic or filler-sensitive formulations
- Personalized treatment approaches based on provider preference and patient-specific needs
Additionally, commercially available desiccated thyroid extract (DTE) products such as NP Thyroid® and Armour Thyroid® are expected to remain available beyond the August 2026 enforcement deadline. It is important to note that commercially available DTE products, including NP Thyroid and Armour Thyroid, are expected to remain available beyond August 2026. The FDA has indicated that it intends to continue allowing currently marketed DTE products to remain on the market while manufacturers work toward full approval of these products.
The most appropriate option for you will depend on your individual health history, laboratory findings, symptoms, treatment goals, and your provider's clinical assessment. We encourage patients to discuss these options with their healthcare provider well in advance to ensure a smooth transition if needed.
Support During This Transition
We understand that this change may feel disruptive, and we want to assure you that we are here to support both patients and prescribers during this transition period. We are happy to collaborate to make sure everything flows smoothly during this time of change.
Our pharmacy team is available to answer questions, provide guidance, and collaborate with your healthcare provider. You are welcome to call us at any time, and we can assist with:
- discussing available transition options
- helping providers understand formulation alternatives
- offering general recommendations based on prescription needs
- coordinating care to support continuity of therapy
Thank you for your understanding and continued trust.
