What Are Compounded Medicines — and Are They Safe?

Unless you’ve taken a lot of medications in your life, you might never have heard of compounded medications. Or maybe you heard about them during those infamous GLP-1 shortages and ensuing controversy.  

Despite some claims on the internet that compounded medications aren’t safe, the reality isn’t so simple. In fact, compounded medicines are a vital part of the way doctors care for patients — and the pharmacies they come from fill a need that regular neighborhood pharmacies can’t.  

What is compounded medicine?

A compounded medication is essentially any medication that has to be custom-made for a patient. Therefore, it’s a type of medication that isn’t mass-produced by drug companies.  

“Pharmacists have been doing this work for hundreds of years,” says Tenille Davis, PharmD, chief advocacy officer for the Alliance for Pharmacy Compounding “Think about the apothecary from the 1800s: that’s similar to compounding, except now we have much more robust safety checks and medical knowledge to pull from.”

Some compounded medications are in a different form than what’s mass produced — say, a medicine that’s usually in pill form is instead made into a liquid. Others are combinations or dosages of different medications.  

Still, there are a lot of questions and misconceptions out there about compounded medications and the pharmacies that make them. Here are some top questions, answered.  

Do compounding pharmacies only fill in during drug shortages?

In 2022, GLP-1 weight loss medications started to become so popular that the original manufacturers of the drugs experienced shortages. In response, compounding pharmacies began making exact copies of the drugs to help make them more accessible — as they’re allowed to do per the Food and Drug Administration (FDA).  

While compounding pharmacies are allowed to step in and help supply drugs during a shortage, this is just a small part of their purpose. Most often, the drugs being made at these pharmacies are to serve the unique needs of specific patients, either people who need something other than what their neighborhood pharmacy can give them, or people who are hospitalized and need special medicines to treat their illness.  

“In a dynamic healthcare system like the one I work for, where we see some of the most complex patients and also train medical students, our patient population often needs us to create medications for them, such as our newborn babies, for whom we dilute liquid medicines or create size-appropriate dosages,” says Steve Fijalka, PharmD, chief pharmacy officer for UW Medicine and associate dean of the UW School of Pharmacy.  

Other types of medications that compounding pharmacies can create are liquid formulas for people who have swallowing difficulties, corn- or gluten-free formulas for people who have an allergy, or suppositories for people who are nauseated and can’t keep oral medications down. These are just a few examples.  

“Compounded medications can help patients take the medication in the way a doctor tells them to,” says Dawn Ipsen, PharmD, clinical affiliate faculty member at the UW School of Pharmacy and CEO of two compounding pharmacies in the Seattle area. “By tailoring a medication to a patient’s exact needs, it can also make the experience more positive for that patient.”  

Compounded medications are also helpful during emergencies when the traditional formulation of a drug isn’t available immediately, and doctors and nurses need something similar to help save a patient’s life.  

Is it true that compounded medications are unsafe because they aren’t FDA-approved?

This blanket statement is not true. While the medications created in compounding pharmacies aren’t FDA-approved as a whole, they are made up of ingredients produced in FDA-registered facilities.  

Compounded medications’ ingredients are purchased from legal drug manufacturers. Compounding pharmacists simply take these ingredients and either convert them into a different formulation or combine different ingredients to make a customized treatment per a prescribing doctor’s request.  

So, compounded medicines are not significantly safer or more unsafe than any other prescription drug. As with any medication, there can be safety issues in certain people, depending on how their body reacts to the medication. For example, amoxicillin, a common antibiotic, isn’t safe for people with a penicillin allergy — but that’s because that person’s body creates an exaggerated immune response to the ingredient, not because the drug is made with dangerous ingredients.  

Because compounded medications as a whole aren’t FDA-approved, though, there is an increased risk for drug contamination. There have been serious contamination incidents in the past that led to serious illness and even death in some people. These incidents are rare, yet they do still happen, so it’s important to get your medications from a trustworthy compounding pharmacy and only do so when needed.

Are compounding pharmacies licensed?

Compounding pharmacies need to be licensed; they also must follow state laws, which are adopted from standards created by the US Pharmacopeia. The best compounding pharmacies will also pursue voluntarily accreditation.  

“Compounding is a specialty, and compounding pharmacies that elect to receive special accreditation from the Accreditation Commission for Healthcare — like the ones I work for — show that they’re dedicated to putting patient safety and product quality first,” Kyle Sullivan, PharmD, clinical assistant professor in the UW School of Medicine and pharmacy manager at a compounding pharmacy in Seattle. “We have to meet even more standards than a typical pharmacy.”

The safest compounding pharmacies are also accredited by the Pharmacy Compounding Accreditation Board (PCAB).

Are online pharmacies the same as compounding pharmacies?

You’ve probably seen ads on social media for those viral online stores that advertise how easily you can get a prescription for an antidepressant or Viagra. Many of these online pharmacies sell mass-produced medicines, though some may also do compounding.

Some of these places are legit — but others are actually illegal.

“It’s a big challenge for patients. We vet where we get our meds from, but if you’re working with an online pharmacy that doesn’t know your health history very well and doesn’t work with your doctors, that extra layer of protection is gone,” Fijalka says. “If it looks too good to be true, often it is.”  

Still, if you’re in a pinch, you might feel like you have few other options (it’s hard to get even a primary care appointment these days, after all). Before using an online pharmacy, you should confirm its legitimacy by doing some research or asking your doctor or pharmacist for guidance.  

“Not all online pharmacies are bad, but before using one, you should verify that they are licensed in Washington or whichever state you live in,” Sullivan says. “You should also determine if the pharmacy partners with local doctors or if they rely on doctors from other areas who do telehealth visits to write prescriptions.”  

One helpful resource you can use on your own is the Alliance for Pharmacy Compounding, which has a database you can search to find licensed compounding pharmacies in your area and check to make sure your local compounding pharmacy is licensed.

“FDA-approved drugs are always the first choice for a patient, but in the cases where those medications are not available, compounding pharmacies are here to help,” says Davis.