Compounded vs. FDA-approved medications: What’s the difference and why it matters

compounded semaglutide on a conveyor belt

If you’ve been on a glucagon-like peptide-1 (GLP-1) medication or tried to get one over the past few years, you know it hasn’t always been easy. Medications like Ozempic® and Wegovy® seemed to become household names overnight. And then, suddenly, they were impossible to find.

In 2022, the FDA added Wegovy® (semaglutide), Ozempic® (semaglutide) and Mounjaro® (tirzepatide) to the FDA drug shortage list, followed by Zepbound® (tirzepatide) in 2024. This designation opened the door for state-licensed pharmacies and outsourcing facilities to produce compounded versions of these medications to meet patient needs. It’s also when ads for telehealth platforms started popping up everywhere.

But things have changed. As of April 1, 2026, the FDA issued updated guidance stating that the GLP-1 supply is stabilizing and, with that, prohibiting pharmacies and outsourcing facilities from mass-producing “copycat” compounded versions of these medications.

If you’re currently taking a compounded GLP-1, or thinking about starting one, this is a good time to understand the differences between compounded medications and those that are FDA-approved, and why those differences matter for your safety and for your care.

What are compounded medications?

Compounded medications are customized drugs made by a pharmacist or physician where they combine, mix or change ingredients of a medication to meet the specific needs of a patient. For example, a medication may be compounded if a patient is allergic to a specific ingredient in a commercially available medication, if a person needs a different dosage form (such as a liquid instead of a capsule) or if a specific medication strength isn’t available. Compounding is also permitted when commercially available medication is in short supply, which is exactly what happened early on with GLP-1 medications.

How are compounded medications different?

The key distinction is that compounded medications are not FDA-approved. This means the FDA has not reviewed the medication for safety, effectiveness or quality before it can be sold to a patient. FDA-approved medications go through a rigorous process, including clinical trials, reviews of manufacturing quality and consistency, labeling accuracy, and monitoring once the medication is in use. Compounded medications don’t go through this process, regardless of how similar they may appear to the commercially available medication.

It’s also important to clear up a common misconception between compounded and generic medications. While compounded medications are not FDA-approved, generic medications are FDA-approved. They go through the same review process and are determined to be therapeutically equivalent to their brand-name counterparts. Compounded medications do not go through this process, no matter how they are marketed.

Who can compound medications?

Not just anyone can compound medications. Under federal law, compounding is permitted by a licensed pharmacist in a state-licensed pharmacy, or by a physician, for an individual patient with a valid prescription. These facilities are overseen by state boards of pharmacy, not the FDA. Although the FDA does conduct some surveillance and inspections of these pharmacies, the day-to-day oversight happens at the state level, which means standards can vary from state to state.

There are also FDA-registered outsourcing facilities, which represent the highest level of oversight for compounded medications. These facilities are inspected by the FDA on a risk-based schedule and are subject to current good manufacturing practice (CGMP) requirements, the same quality standards that apply to traditional pharmaceutical manufacturing. However, these outsourcing facilities do not produce FDA-approved medications.

If you’re taking a compounded medication, it matters where it’s manufactured. A medication from an FDA-inspected outsourcing facility is going to be held to stricter standards than one made at a compounding pharmacy without FDA oversight. When in doubt, ask your provider or pharmacist exactly who made your medication and what oversight it was subject to.

If you purchased a GLP-1 medication through a telehealth platform, keep in mind that you may not always know where it was compounded or under what conditions. The FDA recommends verifying that any online pharmacy is properly licensed before you purchase any medication.

Understanding the risks of compounded medications

Because compounded medications skip the FDA’s premarket safety review, it’s important to understand the risks. They include:

Contamination – without strict sterile controls, harmful bacteria and fungi can become introduced into the medication.
Dosing inaccuracies – the active ingredient may be stronger or weaker than intended.
Labeling errors – incorrect instructions can lead patients to take the wrong dose of a medication or to take it the wrong way.
Ingredient variability – quality and consistency aren’t guaranteed and can be different from one batch to another or from one compounding facility to another.

These risks are not just theoretical. In rare instances, unsafe compounding practices have led to serious patient harm, particularly when pharmacies fail to follow established quality controls and standard operating procedures.

On the GLP-1 front specifically, the FDA received hundreds of reports from patients who accidentally injected 5 to 20 times their intended dose because of concentration differences in compounded formulations. Some products were found to contain unapproved foreign substances or fraudulent pharmacy labels. In 2025, the FDA issued more than 50 warning letters to compounders and telehealth companies for falsely marketing their GLP-1 medications as equivalent to their FDA-approved counterparts.

These issues underscore the importance of understanding where GLP‑1 medications come from and why FDA approval plays a critical role in protecting patient safety.

What this means for compounded GLP-1 medications now

When GLP-1 medications were in short supply, the FDA allowed compounding pharmacies to make their own versions to help patients who couldn’t get access to the FDA-approved medication. That legal permission was tied directly to the shortage, and once that shortage ended, the permission ended with it.

Now that commercially available GLP-1s are accessible again, compounding pharmacies are no longer allowed to make copies of them. That applies to both regular semaglutide and tirzepatide, as well as popular combination versions like semaglutide mixed with vitamin B12.

If you’re still receiving one of these compounded medications, it’s worth asking your provider or pharmacist whether what you’re taking is still being made legally and whether it’s time to transition to an FDA-approved option.

Navigating your medications with confidence

Compounding has a real place in medicine. It filled a genuine gap when GLP-1s were impossible to find, and it continues to serve patients with needs that FDA-approved medications can’t meet. But with the shortage behind us, the key difference between compounded and FDA-approved medications matters even more.

If you’re currently on a compounded GLP-1, or thinking about starting one, talk to your healthcare provider about whether your current treatment is still the right fit. Evernorth EnReachRx and Evernorth EnGuide^SM Pharmacy can help make this next step easier, providing dependable access to many FDA-approved GLP-1 medications, convenient 90-day home delivery and a clinical care model built around you, with specially trained pharmacists, proactive monitoring and the tools to help you stay on track.

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Posted date: May 19, 2026