Frequently asked questions about compounded medications

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When you think of prescription medications, you probably picture a pill bottle with your name on it, a standard dose approved by the Food and Drug Administration (FDA), and a stack of instructions listing when and how to take it and what side effects to watch for.

But sometimes, standard isn’t enough. Some people need a medication in a strength, form or combination that just doesn’t exist in a ready-made, mass-produced version. That’s when they’re likely to turn to compounded medications — personalized prescriptions prepared by specially trained pharmacists or physicians to meet unique needs.

Most people don’t know much about compounded medications until they or someone they care for needs one. If you have been prescribed a compounded medication — or are wondering if it could help — you probably have questions. Here are answers to some of the most common questions, explained by Megan R. Handley-Kelly, Pharm.D., R.Ph., a pharmacist at Mayo Clinic in Phoenix, Arizona.

What is a compounded medication?

A compounded medication is a drug that a licensed pharmacist or physician mixes, alters or customizes for an individual patient — in contrast to conventional medications that come in limited, standardized doses and forms.

Why would someone need a compounded medication?

There are several reasons. One common example is an allergy to an ingredient in a standard version. Progesterone, for example, is typically made in peanut oil. So if the patient has a peanut allergy, they need to get a compounded version of progesterone.

Compounding also helps when people can’t swallow pills. At Mayo, we’ve done a lot of compounded suspensions and things like that for patients that can’t swallow tablets or capsules.

Another reason: supply shortages, as was recently the case with the weight-loss drugs semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound). When the supply of an FDA-approved drug cannot meet demand, the FDA may allow compounding pharmacies to prepare compounded versions of the drug until production of the drug is ramped up to meet demand.

Compounded medications also can help when people need a dose or formulation that doesn’t exist in a commercial product, such as preservative-free versions for people with preservative sensitivities.

Who can prepare compounded medications?

Only licensed professionals — a pharmacist or physician — can legally prepare compounded medications. So it can be done by a pharmacist in a state-licensed pharmacy or federal facility, or a licensed physician, but it has to be based on a valid prescription.

Large outsourcing facilities also can compound medications under special federal rules: There are also big outsourcing facilities, like big compounding centers that are regulated under the FDA 503B regulations.

Are compounded medications FDA approved?

No. While the individual ingredients may be FDA approved, the final compounded product is not tested or approved by the FDA for safety or effectiveness the way mass-produced drugs are.

How is compounding regulated?

Unlike mass-produced drugs, compounded medications do not undergo routine FDA review. But there are standards. The U.S. Pharmacopeia (USP) is an independent organization that sets quality and safety standards for medicines, supplements and ingredients used in healthcare in the U.S. The USP oversees sterile and nonsterile compounding standards to ensure quality, safety and consistency of compounded medications. Pharmacies must follow these standards and state or federal rules, but there is no FDA quality check on the final products.

Are compounded medications safe?

When made correctly by qualified professionals, compounded medications can be safe and effective for people who need them. However, because they are made one at a time, there’s more room for human error. That’s why it’s critical to use a reputable pharmacy.

How do I know if my pharmacy is qualified?

I would start with your doctor’s recommendation. That’s the first place to start. They usually have some pharmacies that they’re used to working with.

You also can check for yourself. The FDA’s webpage “BeSafeRx: Your Source for Online Pharmacy Information,” enables you to check whether your pharmacy is regulated, she says.

How does the cost compare to FDA-approved drugs?

Cost varies. Insurance usually does not cover compounded medications, so many people pay out of pocket. Sometimes compounded medications are cheaper than paying cash for a brand-name version, especially during shortages. But when insurance covers a standard version, that’s usually less expensive.

What should I ask about risks?

Good communication is key. I think the biggest thing is making sure the directions are very clear. How much am I using each day, what’s my dose, how often am I using it? Unlike mass-produced medications, compounded products don’t come with a detailed package insert or drug website, so clear instructions and ongoing pharmacist support matter.

What are some common examples of compounded drugs?

Common compounded medications include hormone therapies, preservative-free versions of standard drugs and liquid suspensions for people who can’t swallow pills. They also include custom creams for pain or skin conditions, suppositories, numbing creams for dental or medical procedures, mouthwashes, and veterinary medications.

Should I try a compounded medication?

Compounded medications can be the right choice when FDA-approved options don’t meet your needs — but they require extra care. Talk with your healthcare professional, ask clear questions, follow instructions exactly, and only use reputable, licensed pharmacies. When in doubt, your pharmacist should be ready to help.

Mayo Clinic does not endorse companies or products. Advertising revenue supports our not-for-profit mission.