What Are Compounding Pharmacies?

When you think of a pharmacy, you likely think of a community pharmacy. This can range from nationwide chains to single-location independent pharmacies. You may even think of a pharmacy that's found in a hospital.

These are common and important examples, but many other pharmacy types also exist. A compounding pharmacy is another type of pharmacy that can benefit many people.

Compounding pharmacies offer extra services that other pharmacies may not be able to. These pharmacies mix and combine ingredients to make customized medications.

Here, we’ll talk more about compounding pharmacies — why they exist, who can benefit from them, and where to find them.

What is a compounding pharmacy?

A compounding pharmacy is a specific type of pharmacy. They can make customized medications for you, a family member, or even your pet.

Some people and animals need medications that aren’t commercially available. That is, medications that aren’t mass-produced and available at a standard pharmacy. There are many possible reasons for this need, and this is discussed later on. That’s where compounding pharmacies come in.

Compounding pharmacies can make two types of compounds: sterile and non-sterile. Some pharmacies specialize in one type of compounding, whereas others may offer services for both.

Sterile compounds include dosage forms like injections, eye drops, and infusions. Because of this, there’s a higher risk of infection or serious problems if contaminants get into the medication. So, sterile compounds are made in a special environment with additional requirements to minimize this risk. 

Non-sterile compounds come with a lower risk of infection. Their dosage forms include creams, capsules, and suppositories. 

There are also two general categories of compounding pharmacies. These two categories exist because of legislation enacted by the U.S. government.

• 503A compounding pharmacies: These pharmacies can compound medications based on a prescription from your healthcare provider.

• 503B compounding pharmacies: These pharmacies, too, can compound medications based on a prescription. But they can also compound sterile medications in large amounts and sell them to healthcare locations, such as hospitals or doctor’s offices. These are also sometimes called “outsourcing facilities”.

How is it different from a traditional pharmacy?

Many community and hospital pharmacies offer compounding services. But they often don’t have the same specialized equipment or certifications as compounding pharmacies. So the medications they make are more simple.

For example, it’s common for a community pharmacist to combine two or more creams to make a compounded cream. They could also combine two or more oral liquid medications. Hospital pharmacies also commonly prepare sterile medications that will be infused into a person’s vein.

Compounding pharmacies can compound medications like these. But they can also make more complex ones.

Plus, certain federal laws dictate what type of compounding services a pharmacy can offer. Many U.S. states also have different regulations and licensing requirements for compounding pharmacies compared to community or hospital pharmacies.

Are compound pharmacies common?

Somewhat. The American Pharmacists Association says there are about 56,000 community pharmacies in the U.S. Of these, about 7,500 “specialize” as compounding pharmacies. Because of this, you may not always have a local option that’s able to make your specific compound. But some compounding pharmacies are licensed in many different states — so they may be able to ship medication to you.

On top of this, about 70 U.S. companies are FDA-registered as outsourcing facilities. Not all of these pharmacies dispense individual prescriptions. Instead, they supply sterile medications to hospitals and provider offices to administer them.

Why would I need compounded medications?

There are many reasons why you might want or need a compounded medication. Depending on your situation, your health needs may not be met by a medication that’s premade by a drug company. This includes situations like:

• Adding flavoring to a poor-tasting medication

• Having an allergy to inactive ingredients in a premade medication

• Needing access to a critical medication that’s unavailable or on backorder

• Needing a different medication dosage form (e.g. a liquid instead of pills)

• Needing a specific medication strength

What type of medications do compounding pharmacies dispense?

In general, compounded medications take on many forms.

To illustrate, let’s say that you or your child has trouble swallowing pills. A compounding pharmacy may be able to turn a medication into a gummy, hard candy, or chewable tablet. This may make it easier to use the medication.

It’s also possible that you could need a different strength of a medication compared to what’s already available. Compounded liquids — like suspensions, solutions, or syrups — could give you a dose that better suits your needs.

But specific services vary for every compounding pharmacy. Compounding pharmacies may specialize in making medications that treat certain health conditions. For example, some can specialize in areas like veterinary medicine, men’s health, or dermatology.

What are some specific medication examples? 

There are plenty of formulas (recipes) that a pharmacist or technician can follow to make compounded medications. Compounded medications may be made from bulk ingredients, commercial drug products, or a combination of the two.

Examples of medications made by a compounding pharmacy include:

• Multi-ingredient topical pain creams 

• Hormone creams, capsules, and suppositories that contain estradiol and progesterone

• Rectal suppositories for hemorrhoids or anal fissures

• Topical nipple ointment for irritation from nursing

• Magic mouthwash

• Omeprazole or lansoprazole liquid for kids

• Diazepam suppositories for chronic pelvic pain

• Sterile antibiotic eye drops 

• Sterile nutrition therapy infusions

How do I find a compound pharmacy near me?

There are a few ways to locate a compounding pharmacy in your local area.

First, ask your healthcare provider if they have any that they prefer to use. They may be able to direct you to a compounding pharmacy that they’ve worked with in the past or like to use. They may also refer you to a compounding pharmacy that specializes in a certain area.

Another way is by utilizing the Alliance for Pharmacy Compounding’s website. Enter your city and state, and their directory will point you to nearby compounding pharmacies.

You can also find a compounding pharmacy by using the Professional Compounding Centers of America’s website. Enter your zip code or your city and state to find one.

And remember, your local community pharmacy may be able to compound your medication. If you’re unsure, ask your pharmacist.

Who ensures that the medications in compounding pharmacies are safe?

Compounded medications aren’t FDA-approved. This means the FDA doesn’t directly evaluate these medications for safety and effectiveness. But the FDA allows for compounded medications to be given by pharmacies when there is a medical need.

In short, three groups take the driver’s seat when it comes to ensuring the quality of compounded medications. These are the FDA, state Boards of Pharmacy, and an organization called the United States Pharmacopeial (USP) Convention.

There are regulatory standards in place to make sure that compounded medications are safe. Only certain healthcare professionals, like licensed pharmacists or physicians, can make these medications.

USP also created standards to ensure compounded medications are high quality. USP guidelines set the quality standards for ingredients used in compounds. They also establish standards for how compounds are made, tested, and verified. Most states require compounding pharmacies to fully comply with USP standards.

Compounding pharmacies are regulated by their state Board of Pharmacy. They’re also subject to inspection to make sure that they’re meeting all expectations. If a compounding pharmacy doesn’t follow these quality standards, corrective action may take place. 

Some pharmacies may also be inspected by the FDA. Plus, the FDA inspects facilities that make the ingredients used by compound pharmacies. 

Unlike a standard compounding pharmacy, 503B outsourcing facilities are required to register with the FDA. They’re inspected by the FDA against stricter quality controls called current Good Manufacturing Practices (cGMP). This helps to ensure that quality assurance processes are in place. 

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Written by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

Reviewed by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

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