Switching from a compounded to a commercial GLP-1 drug

A compounded drug is a drug that is custom made for an individual. The U.S. Food & Drug Administration (FDA) defines compounding as “the combining, mixing, or altering of ingredients to create a customized medication for an individual patient in response to a licensed practitioner’s prescription.” This is done when the commercially available versions of a medication do not meet the specific needs of a specific person.

A few examples of when a compounding drug can be needed:

• A person has difficulty swallowing pills and needs a liquid version of a drug.
• A person needs a version of a drug without an ingredient in the commercially produced version (such as a dye that they are allergic to).
• A person needs a drug at a different dosage than the commercially produced versions.
• It’s helpful to a patient to combine several medicines into a single dose.

Compounded drugs are made at facilities called compounding pharmacies. Compounding pharmacies can be a part of a community pharmacy, hospital, or physician’s office. There are also outsourcing facilities, which produce compounded drugs in larger amounts.

While compounded pharmacies fill an important need in individualized healthcare, there are some additional risks and concerns that need to be considered. Compounded drugs are not approved by the FDA, which means these drugs do not undergo the same evaluation for safety, quality, purity, and effectiveness as mass-produced drugs. This means there is a greater risk for contamination, errors, and quality issues when taking a compounded drug.

A person should use a compounded drug only when absolutely necessary, and it’s important to always select a reputable compounding pharmacy. Look for pharmacies that are licensed by your state, accredited by the Pharmacy Compounding Accreditation Board, have been inspected by the FDA, and are recommended by your healthcare provider.

Compounded GLP-1 and GLP-1/GIP drugs

There are laws regarding what drugs can be produced at a compounding pharmacy—and what drugs cannot. Between 2022 and 2024/2025, compounding pharmacies were granted permission to produce compounded versions of several drugs used in the management of type 2 diabetes and overweight/obesity:

• GLP-1 agonists, drugs that help control blood sugar and promote weight loss. These drugs mimic a hormone called glucagon-like peptide-1.
• Dual action medications that mimic both GLP-1 as well as a hormone called GIP (glucose-dependent insulinotropic polypeptide), a different hormone that plays an important role in blood glucose control.

There was a shortage of commercially available GLP-1 and GLP-1/GIP drugs starting in 2022. Many people utilized compounding pharmacies to access these drugs during this shortage. This practice is allowed by the FDA when a drug is in shortage (though the first choice is always an approved drug).

The shortage of commercially available drugs is now resolved, and there are now legal restrictions and limitations on producing compounded versions of these drugs.

Switching from a compounded drug

If you were receiving a GLP-1 medication from a compounding pharmacy and that is no longer an option, you will need to switch to taking a commercially produced medication. The process of switching will be a little bit different for everyone.

Here are a few strategies to help you get started:

Talk to your healthcare provider

Any change to your medication should always be done under the guidance of the healthcare provider that is prescribing the medication. Your healthcare provider will need to write you a new prescription for the medication you are taking.

Your healthcare provider can review the medications that are available and what medication best meets your needs. Some factors to consider:

• Differences between the drugs that are available, including additional health benefits that certain drugs may offer.
• The dosages you will be taking and the dosing instructions—which can be different from a compounded version.
• Potential side effects and drug interactions.

Check with your insurance company

Cost and coverage for specific medications can vary between different insurance plans. You may need to contact your insurance provider to find out what medications are covered and what out-of-pocket costs you’ll be expected to cover.

Explore discounts, copay cards, and PAPs

If you are concerned about the cost of a medication, talk to your healthcare provider. This is a common barrier to treatment that many people experience. Your healthcare provider may have ideas or strategies that can help.

There are programs in place to help reduce the cost of medications for individuals. Programs are not available for every drug, and a person must meet certain criteria to qualify. However, this is something that is definitely worth discussing with your healthcare provider and looking into on your own.

Types of programs to look for:

• Copay cards. Also known as copay savings programs, copay cards are typically issued to people who have insurance through a provider or insurance they have purchased on their own. Copay cards have a discount code that will be presented to a pharmacist to apply a discount to a specific drug.
• Patient assistance programs (PAPs). These are usually for people who are uninsured or underinsured and cannot cover the cost of a medication. Eligibility and enrollment processes vary from program to program.
• Direct-to-consumer programs. These are telehealth programs offered by several GLP-1 manufacturers. Prescriptions through these services are often more affordable.

Additionally, many states have State Pharmaceutical Assistance Programs (SPAPs). These are state assistance programs that help individuals cover the cost of medications. Eligibility can vary from program to program and medication to medication.