What are the concerns with obtaining compounded GLP-1 medications?

There are many online pharmacies and in-person clinics claiming to provide GLP-1 medications identical to the brand name prescription medications, but for a much lower cost. While there are compounding pharmacies that follow strict quality and safety protocols, providing an important service to patients, practices at some compounding pharmacies raise serious concerns. Some compounded products contain combinations of multiple medications, and there have been instances where companies are not fully disclosing what they are selling. There is no way to tell from looking at the vial what it contains. This can be potentially dangerous if the bottle contains: a higher concentration of the medicine than stated, raising a risk of overdose and increased side effects a lower concentration of the medicine than stated, which then may not work, or contaminants or other undisclosed medicines/ingredients, which could lead to risks of interactions with your other prescribed medicines, or other side effects/risks that you might not be aware of.Some sites sell products that have never been formally evaluated by the FDA for safety and effectiveness (for example, websites selling “tirzepatide pills”). Tirzepatide has only been evaluated and approved (as Zepbound) as an injection for weight management. Others may combine a GLP-1 with other vitamins or supplements, although data are lacking on the safety of such combinations. A well-publicized case of harm from injectable compounded medications was an outbreak of fungal meningitis in 2012, due to unsterile conditions at the New England Compounding Center in Framingham, MA. More than 750 people were affected and 64 people died.

Compounded Medications Silver Spring - GLP-1 Medications Silver Spring, MD

The cost of brand name weight loss medications can be overwhelming! Many people who are seeking access to these treatments are concerned about the cost – which may lead them to consider compounded medications. Compounded medications are made by a licensed pharmacist or physician, who may combine, mix or alter ingredients of a drug to create a medication for a specific patient.

We currently do not recommend or prescribe compounded GLP-1 medications.

U.S. Food and Drug Administration-approved medications are evaluated for their safety, effectiveness, purity, and potency. This means that in addition to making sure that the medication works and that potential side effects have been studied, FDA evaluates the manufacturing process to ensure that the facilities making the product are adhering to necessary standards, ensuring the final product is safe, stable and – especially important for injected medications –sterile.

While there are rules governing good practice at compounding pharmacies, compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed. Compounded drugs are not subject to the same regulations and inspections as FDA-approved medications.

There are many online pharmacies and in-person clinics claiming to provide GLP-1 medications identical to the brand name prescription medications, but for a much lower cost.

While there are compounding pharmacies that follow strict quality and safety protocols, providing an important service to patients, practices at some compounding pharmacies raise serious concerns. Some compounded products contain combinations of multiple medications, and there have been instances where companies are not fully disclosing what they are selling. There is no way to tell from looking at the vial what it contains.

This can be potentially dangerous if the bottle contains:

a higher concentration of the medicine than stated, raising a risk of overdose and increased side effects
a lower concentration of the medicine than stated, which then may not work, or
contaminants or other undisclosed medicines/ingredients, which could lead to risks of interactions with your other prescribed medicines, or other side effects/risks that you might not be aware of.

Some sites sell products that have never been formally evaluated by the FDA for safety and effectiveness (for example, websites selling “tirzepatide pills”). Tirzepatide has only been evaluated and approved (as Zepbound) as an injection for weight management. Others may combine a GLP-1 with other vitamins or supplements, although data are lacking on the safety of such combinations.

A well-publicized case of harm from injectable compounded medications was an outbreak of fungal meningitis in 2012, due to unsterile conditions at the New England Compounding Center in Framingham, MA. More than 750 people were affected and 64 people died.

We recognize how frustrating it is to be unable to access medications that are recommended by your doctor due to cost and coverage barriers. If a GLP-1 medication may be right for you, we will work with you to explore the available options which might include rebate programs from manufacturers, purchasing the medication directly from the manufacturer (both Zepbound and Wegovy now offer discounted pricing for patients without insurance coverage), or considering other medications or treatments that may be more affordable.

The good news is that additional changes to pricing and coverage of weight-loss medications may be coming soon!

More information on the safety and risks of compounded GLP-1 medications

FBI Safety Warning about counterfeit semaglutide
FDA Information on unapproved GLP-1 Drugs

Compounded Medications

We currently do not recommend or prescribe compounded GLP-1 medications.

What are the concerns with obtaining compounded GLP-1 medications?

My insurance doesn’t cover GLP-1 medications, and they are so expensive! What should I do?

More information on the safety and risks of compounded GLP-1 medications

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