Pharmacists and doctors can make compounded medications by combining, mixing, or altering various ingredients to meet a specific need. But because these medications don’t have Food and Drug Administration (FDA) approval, there are some risks.

Compounded medications are customized medications that healthcare professionals (HCPs) formulate for your specific needs. People who can make compounded medications include:

  • licensed pharmacists
  • licensed doctors
  • people under the supervision of a licensed pharmacist

Because HCPs tailor the formulation of a compounded medication to you, and because this process often involves prescription medications, you’ll typically need a prescription to get these. You may be able to fill this at your local pharmacy.

However, it’s also possible that your regular pharmacy may not have access to all of the specific ingredients needed for your compounded medication. In this situation, you may fill your prescription through a compounding pharmacy.

A compounding pharmacy specializes in making compounded medications. The American Pharmacists Association estimates that out of 56,000 community-based pharmacies in the United States, about 7,500 specialize in compounding.

The FDA doesn’t approve compounded medications, which means they don’t assess their safety, effectiveness, or quality. However, these medications can be safe when a reputable pharmacy makes them.

Compounded medications are useful because HCPs tailor them to your specific needs. There are several circumstances in which compounded medications may be useful.

When you need a certain dosage or strength

You may need a specific dosage or strength of a medication that’s unavailable in a commercial product. In this scenario, an HCP may use a compounded medication with a customized strength or dosage.

When you need a certain drug combination

An HCP may create a compounded medication if you need a certain combination of drugs that isn’t available commercially. An example of this is a compounded topical cream for treatment-resistant neuropathic pain that includes:

When you need a different route of administration

Many medications are available in the form of pills, capsules, or tablets. However, some people may not be able to safely swallow these, including:

In these situations, a compounded liquid formulation of the medication might be better.

Sometimes, an HCP may compound oral medications to provide flavoring or sweetening. This can help make them more palatable, especially for young children.

When you have an allergy

Some people are allergic or sensitive to certain inactive ingredients, such as dyes or binding agents, in commercially available medications. Because of this, a compounded medication that doesn’t contain these ingredients may be better.

When a medication is expensive or unavailable

It’s possible that some people use compounded medications when they’re more affordable than a commercially available preparation. Also, HCPs may prefer them to help during drug shortages, such as during the COVID-19 pandemic.

Compounded medications make up only a small percentage of prescriptions. It’s estimated that 1–3% of prescriptions in the United States are for compounded medications.

A 2016 study found that the most commonly compounded drugs were those that treat pain and those for hormone-based therapy.

Some examples of drugs that HCPs may use in formulations to treat pain include:

  • baclofen
  • cyclobenzaprine
  • gabapentin
  • ketamine
  • lidocaine

Formulations for hormone-based therapy may contain active ingredients like progesterone, estradiol, or testosterone.

The researchers also found that compounded medications for children had more diverse applications. These included medications for:

Generally speaking, compounded medications can be safe when a reputable compounding pharmacy prepares them. However, as mentioned earlier, it’s not possible to ensure their safety, effectiveness, and quality since they don’t carry FDA approval.

Due to this, there are risks involved with compounded medications. This can include a risk of contamination with germs or other harmful substances. Also, medications could contain too much or too little of an active ingredient.

For example, researchers linked an outbreak of serious fungal infections to steroid injections that HCPs made at a compounding facility in 2012. In total, 753 people got sick, and 64 died.

To help reduce the risk to consumers, a variety of laws and policies apply to medication compounding. The FDA has a list of inspections, recalls, and other actions associated with medication compounding.

It’s also important to note that some insurers may not cover compounded medications. If your doctor recommends a compounded medication, be sure to check with your insurance provider to see what’s covered and what’s not.

Compounded medications are those that HCPs tailor to your individual needs. They make them by mixing, combining, or altering different ingredients.

A compounded medication may be more suitable than other products for several reasons. Examples include needing a specific strength or dosage that’s not commercially available, needing to adjust a drug’s route of administration, and needing to remove ingredients that you’re allergic to.

Compounded medications don’t have FDA approval, so there are some risks related to their safety, effectiveness, and quality. However, there are laws and policies in place to help protect consumers using compounded medications.