AARP Hearing Center
What Are Compounded Medications? 8 Things Older Adults Should Know
These custom-mixed meds can fill an important need, but experts caution that compounding is not without risks
Getty Images
Key takeaways
- Compounded drugs are typically used when FDA-approved versions cannot meet a patient’s specific needs — for example, if a patient has an allergy or cannot swallow a medication in pill form. They’re also used during drug shortages.
- Pharmacies that compound medications are regulated by states, with some oversight from the federal government.
- Compounded medications are not federally reviewed for safety and effectiveness, like their prescription counterparts, which is why experts say it’s important to work closely with your doctor and pharmacist if you’re taking one.
Though they’ve been around for decades, compounded medications have been getting a lot of attention lately with recent shortages of popular medications like GLP-1s and hormone patches.
About 1 to 3 percent of prescriptions written in the U.S. are for compounded drugs, according to the Alliance for Pharmacy Compounding (APC), a trade group that advocates for compounding pharmacies. And the market is expected to grow from just over $6 billion to more than $12 billion by 2036.
More Ways to Benefit
- Related Benefit 1
- Related Benefit 2
- Related Benefit 3
- Related Benefit 4
- Related Benefit 5
Here are eight things to know about compounded medications, including the potential risks and benefits for adults 50-plus.
1. Doctors prescribe them if patients have an allergy or other special need
Compounded medications are custom-made drugs prepared by specialized pharmacies for patients whose needs can’t be met by a standard, commercially available medicine.
The U.S. Food and Drug Administration (FDA) has criteria on when these medications are suitable. For example, if a patient has an allergy to an ingredient in their medication, it may be possible to omit that ingredient when preparing the medication. Or maybe they have trouble swallowing pills — as many as 33 percent of older adults do. A compounding pharmacist may be able to prepare the medication as a liquid instead.
If you have motion sickness, a topical version of an anti-nausea drug may work better because it won’t be vomited, says Joey Mattingly, an associate professor of pharmacotherapy and vice chair of research at the University of Utah. A drug shortage is another reason a doctor might prescribe a compounded medication.
2. Compounded medications are not FDA-approved
It’s important to know that since compounded medications are, in many cases, custom-mixed, they are not FDA-approved. This means that, unlike their conventional counterparts, they have not been studied for their safety and effectiveness. What’s more, the formulations of compounded medications can vary in quality and potency from one another and from their FDA-approved versions.
“It’s the Wild West. It’s buyer beware,” says Dr. Steven Simons, medical director of quality and performance improvement in the department of medical affairs at Cedars Sinai in Beverly Hills, California. “And you really need to do your homework” if you are buying a compounded drug, he adds, since they don’t have the degree of scrutiny that the FDA provides.
There’s one exception, however: During a drug shortage, compounding pharmacies can make an exact copy of the drug in shortage.
Compounded drugs are different from counterfeit drugs, since compounding is legal, explains Michael Ganio, senior director of pharmacy practice and quality at the American Society of HealthSystem Pharmacists. Counterfeit drugs are those that claim to be a specific drug but are not. For example, if a vial is filled with tap water instead of a medication, that’s a fake drug, he says. Compounded drugs are also not the same as generic medications, since generics are made by drug manufacturers, not pharmacies, the FDA notes.
3. There are benefits — and potential risks
A customized drug can be beneficial for many, but there are also some potential risks associated with compounded medications.
As noted above, unless there’s a drug shortage, compounding pharmacies are not allowed to make an exact copy of a commercially available medication. To get around this, some pharmacists mix in other ingredients to make the drug different from its FDA-approved version.
For example, GLP-1s mixed with B12 or niacinamide are sold by several online health companies. However, these combinations have not been tested in large clinical trials. What’s more, taking a medication that contains additional ingredients could pose health risks such as allergies, side effects and drug interactions, a particular concern for older adults who take multiple medications.
“Many of the additives people don’t need in the first place,” Simons says, adding that the only people who need vitamin B12 are those with deficiencies.
It’s also possible a compounded medication could be contaminated or have too much or too little of the active ingredient, making it stronger than intended or not as effective as it should be. What’s more, the labels on compounded drugs may not include important information on dosing and safety, the FDA says.
4. Hormone therapy, weight loss drugs are popular compounded medications
According to an APC report, the most popular compounded medications in the U.S. (36 percent) are hormone therapy drugs.
Though FDA-approved hormone therapies are available, Ganio says some patients seek compounded versions because they want a dose that isn’t offered by the manufacturer. For example, some may prefer to start with a lower dose of hormone therapy and take only as much as they need.
Ganio says he’ll be watching to see whether demand for compounded hormone therapies changes now that the FDA has removed the box warning from certain menopausal hormone therapy products.
Hormone therapy isn’t the only popular compounded drug. ACP data shows that in the past two years, 11 percent of compounded drugs were GLP-1s. Fourteen percent of compounded medications are veterinary medicines, 8 percent are dermatology drugs and 7 percent are men’s health medications.
The same report indicates that telehealth companies have contributed to the rise in compounded medications. Twenty percent of surveyed pharmacies reported contracting with telehealth companies to fill compounded prescriptions.
5. Their popularity is rising, but scrutiny is growing
In the past two years, 55 percent of compounded drugs were made and sold because their FDA-approved counterparts were on the national drug shortage list, 2025 APC data shows. GLP-1 medications are one notable example: Soaring demand led to shortages of the FDA-approved drugs and helped fuel a surge in compounded GLP-1s, which are often less expensive than their brand-name counterparts.
However, GLP-1s are no longer in shortage, which is why the FDA is seeking to stop compounders from making exact copies of semaglutide, tirzepatide and liraglutide — the active ingredients in Ozempic/Wegovy, Mounjaro/Zepbound and Victoza/Saxenda. Doing so would limit GLP-1 production at compounding pharmacies, pushing many consumers back toward the manufactured products — and their higher costs. Ganio expects the popularity of compounding to continue, especially with the rise of peptides being promoted on social media. These compounds are marketed for everything from weight loss to healthy aging, and an FDA advisory committee recently voted to recommend adding six peptides to the legal compounding list.
“As long as there’s a market, you’ll find there are those willing to compound and make those products,” Ganio says.
6. Regulations vary by state
Every pharmacy is regulated at the state level, including compounding and chain pharmacies, Mattingly says. Not all compounding pharmacies have an online presence, though some do. And not all online pharmacies may be licensed, which is where people should be most cautious, Mattingly says.
There are two types of compounding pharmacies:
- 503A pharmacies are state-regulated compounding pharmacies that make individually prescribed compounded drugs under the direction of a prescription and in accordance with U.S. Pharmacopeia (USP) standards. So if your doctor hands you a prescription for a compounded pill or cream, it would likely be filled at this type of pharmacy.
- 503B pharmacies are FDA-regulated outsourcing facilities that compound large batches of medication in accordance with Good Manufacturing Practices (cGMP). In other words, this is where large batches of compounded medications are made instead of individual prescriptions, which can be especially helpful during drug shortages, serving as a smaller manufacturer. Which type of compounding pharmacy should you use? If a product originates from a 503B facility, it is subject to more federal oversight than one made by a 503A. But some prescriptions can be filled only at a 503A, Simons says.
It’s also important to know that active ingredients in compounded drugs are regulated by the FDA, explains Tenille Davis, a pharmacist and chief advocacy officer for the APC. So compounding pharmacies must use pharmaceutical-grade ingredients produced at an FDA-registered facility.
7. There are things you can do to ensure quality and safety
Compounded medications are sometimes given a bad rap. But the goal isn’t to fear them, Ganio says — it’s to use them safely.
Start by doing your homework: You can look up state-licensed pharmacies, including online pharmacies, using this FDA website or the APC’s website. It’s also a good idea to ask your doctor or chain pharmacy to refer you to a compounding pharmacy. Your doctor should be your advocate, Simons says.
Look for a pharmacy that sticks to USP standards for compounding.
And if you have to get an injectable compounded medication, Simons recommends using a pen, if available, instead of a vial and needle, to reduce infection risk.
Possible red flags include compounding pharmacies that:
- Do not require a doctor’s prescription
- Have unusually low prices or major discounts
- Don’t share statements about safeguarding your personal and financial information
- Don’t display their license
- Have had previous disciplinary action
“Recognize that risks can exist, and do a little bit of homework or due diligence in understanding where your compounded drugs are coming from,” Ganio says.
8. Insurance coverage can vary
Wondering if your insurance will cover a compounded medication? That depends.
If at least one active ingredient in the compounded medication meets the definition of a Medicare Part D drug and doesn’t contain any ingredients covered under Part B, it may be covered under a Part D prescription drug plan.
If you had a kidney transplant covered by Medicare, Part B will cover transplant drug therapy, including compounded medications to prevent organ rejection. When it comes to private insurance coverage, APC data shows that 61 percent of 503A compounding pharmacies do not accept insurance for compounded preparations. Twenty-five accept some insurance for compounded drugs, but the circumstances in which insurance is accepted are limited.
The advice from experts: Ask your doctor or pharmacist about whether your compounded medication is covered by your insurance plan.
The key takeaways were created with the assistance of generative AI. An AARP editor reviewed and refined the content for accuracy and clarity.
AARP Membership
Join AARP for only $15 per year with automatic renewal. Get instant access to members-only products and hundreds of benefits, a free second membership, and a subscription to AARP The Magazine.
More From AARP
Does Microdosing GLP-1 Medications Work?
What the science says about the weight loss trend, including potential health risks
How to Tell if a Recall Affects Your Medication
Learn where to find FDA recall notices and how to confirm your product is included
Cutting Back on Medications Safely
A stuffed pill box could be harmful instead of helpful