Compounded Medications: Semaglutide & Tirzepatide
The following is designed to be as transparent as possible regarding the potential benefits, risks, and limitations of using compounded semaglutide and tirzepatide. We value your autonomy to make informed healthcare decisions.
These issues are common to all compounding pharmacies and suppliers that offer compounded versions of semaglutide and tirzepatide.
What Are Compounded Medications?
Compounded medications are custom-made by licensed pharmacies to meet specific individual needs when:
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A patient needs a medication in a different dose, formulation, or combination that is not available in FDA-approved products.
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The FDA-approved medication is temporarily unavailable due to a shortage.
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The patient has an allergy to the commercial version.Important
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Note: Compounded medications are not FDA-approved, and are not reviewed for safety, efficacy, or quality in the same manner as commercially manufactured drugs.
Is Compounding Allowed by the FDA?
Yes! Compounding is a allowed by the FDA if:
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A valid prescription is present from a licensed physician
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The medication is not "essentially a copy" of an FDA-approved drug (i.e., it must differ in active ingredients, strength, or dosage form)
A compounded drug may include clinically necessary modifications (e.g., different concentration, dosing or added ingredients) documented by the prescribing provider.
Compounding Semaglutide & Tirzepatide
Semaglutide and tirzepatide are active pharmaceutical ingredients (APIs) used in the brand-name, FDA-approved drugs Ozempic®, Wegovy®, Mounjaro® and Zepbound®.
Compounded versions of these medications may be requested for:
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Supply shortages
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Alternative dosing or formulations to improve compliance
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Cost concerns and insurance issues
Important Note: As of the latest update, these drugs are not on the FDA Drug Shortages List. The FDA does not consider costs savings or insurance denial legitimate reasons to produce "essentially a copy" of an FDA-approved drug. Therefore, a compounded version must differ from the FDA-approved version in a significant way, whether it be dosing or formulation.
What Claims Cannot Be Made
Compounded semaglutide and tirzepatide from U.S. licensed pharmacies:
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Cannot be claimed to be chemically identical to FDA-approved drugs
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May differ in molecular form, purity, and manufacturing process
While compounding pharmacies are licensed, the raw ingredient (API) is sourced from bulk API suppliers that are not regulated by the FDA.
No claims are made that they are identical to, substitutable for, or bioequivalent to FDA-approved versions.
These regulations and limitations are common to all compounding pharmacies and prescribing providers using compounded semaglutide and tirzepatide.
Use of Additional Ingredients
Compounded versions may include B vitamins, such as B12 or other ingredients (L-carnitine or NAD+), to improve an individual's health.
These ingredients are not in FDA-approved versions and:
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Serve a documented clinical purpose
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Are not supported by large-scale studies
You will always be informed of what additional ingredient is in the compounded medication if you choose compounded medication from Potere Health MD.
Medication Quality & Clinical Practices
At Potere Health MD, we take medication quality seriously and implement safeguards to reduce patient risk:
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We partner only with licensed U.S. compounding pharmacies that meet strict compounding standards.
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We confirm that semaglutide salt forms (such as semaglutide sodium or acetate) are not used in the preparations we prescribe. Instead, we require use of semaglutide base, consistent with FDA-approved medications.
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Pharmacies must provide a Certificate of Analysis (COA) to verify identity, potency and sterility of the bulk drug substance.
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We work with suppliers that maintain robust quality assurance protocols, though the FDA does not independently verify the safety or efficacy of compounded drugs.
Despite our diligence, compounded medications carry inherent risks related to variability, sterility, and ingredient sourcing.
Note on COAs: The quality and consistency of Certificates of Analysis (COAs) for compounded semaglutide and tirzepatide may vary between pharmacies. The FDA does not establish a COA standard for these medications.
Potential Benefits
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Customization of strength and formulation
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Availability during shortages or insurance denial
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Lower cost compared to brand-name drugs
Potential Risks
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Variability in strength or purity
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Sterility concerns
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Side effects or allergic reactions
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Sourcing inconsistencies
Recap
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Compounded medication is not FDA-approved
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It is not chemically identical to Ozempic®, Wegovy®, Mounjaro® or Zepbound®
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It may include additional, clinically justified ingredients
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At Potere Health MD, you always have the option of being treated with FDA approved semaglutide or tirzepatide (Ozempic®, Wegovy®, Mounjaro® or Zepbound®). You may always request a prescription for one of these at any time during your treatment.