Do you know what a compounding pharmacy is? Or does?

Most people don’t, according to Jennifer Burch, PharmD, RPh, chair of the board of directors for the Alliance for Pharmacy Compounding.

But compounding pharmacies play an important role in meeting consumers’ medical needs. Because compounding pharmacists create medications the old-fashioned way – by combining ingredients – they can make custom preparations to fulfill unique demands. Understanding what compounding pharmacies do can help you access safe, appropriate medication.

Reasons to Use a Compounding Pharmacy

If you need a loaf of bread, you probably go to the store and buy one. Purchasing commercially manufactured bread is cheap and convenient. Imagine, though, that you’re allergic to an ingredient in the pre-packaged bread – or you’re craving an unusual flavor combination that’s not readily available. If you keep looking, you may be able to find bread that meets your needs. If not, your best option might be to bake your own from scratch.

Compounding is similar. “The number one reason people use compounding pharmacies is because the drug they’re looking for is not commercially available,” Dr. Burch said. The desired medication may be unavailable because the pharmaceutical company that previously manufactured it stopped producing it. Or, there may be drug shortage. In other cases, the patient might need a dosage that’s not readily available.

Compounding pharmacists use raw ingredients to make medication. With a prescriber’s order, they can mix up medicines, just as you can combine ingredients at home to make bread. These medicines can be tailored to the specific needs of the patient.

Some people use compounding pharmacies because they can’t take commercially available drugs. A person who is allergic to milk, for instance, may not be able to tolerate a mass-produced medication that includes lactose, an inactive ingredient that makes it easier for manufacturers to form medicine into tablets. A compounding pharmacist may be able to make a preparation for the patient that includes the desired active ingredients and leaves out the lactose.

Compounding pharmacists can also work closely with physicians and patients to create unique preparations. “Sometimes a doctor will call me and say, ‘We’ve tried Drug A and we’ve tried Drug B with Mrs. Smith and we didn’t get the expected outcome. What can we do?’” said Dr. Burch, owner of Central Compounding Center South in Durham, N.C. In some cases, adding or subtracting ingredients, or tweaking the dosage, may lead to the desired outcome.

There are two types of compounding pharmacies, those that create medications for individual patients and those that produce bulk quantities of medication for hospitals and clinics, often to meet demand created by drug shortages. Pharmacies that compound large quantities are held to strict regulatory and manufacturing standards; they do not sell to individual patients. Both types of pharmacies use active pharmaceutical ingredients that have been approved by the United States Food and Drug Administration (FDA).

How to Choose a Compounding Pharmacy

Unlike commercially produced medication, compounded drugs are not FDA-approved. The FDA does not check the safety or effectiveness of compounded preparations, so consumers must choose carefully. Improperly compounded drugs can cause injury and death.

When choosing a compounding pharmacy, look for:

Regulatory compliance. First, check if the pharmacy is licensed by your state board of pharmacy. (You can usually find this information online.) Do an online search for the pharmacy’s name as well. If the pharmacy has previously received warnings for unsanitary conditions, for instance, you’ll likely find a news story. Be alert for FDA warning letters. Although the FDA does not regulate compounding, the agency conducts facility inspections “to identify compounders who produce drugs under substandard conditions or use inappropriate practices that could lead to serious harm,” according to a 2019 statement from the FDA Commissioner Scott Gottlieb, MD and Deputy Commissioner Anna Abram.

In 2020, the FDA send 19 warning letters to difference pharmacies as of September 30, citing issues such a dirty equipment, exposed skin and improper air filtration.

Accreditation. The Accreditation Council for Healthcare (ACHC) offers a Pharmacy Compounding Accreditation. According to Dr. Burch, articipating pharmacies agree to a two-day inspection every two years and must meet rigorous quality standards to maintain accreditation. You can find a list of accredited compounding pharmacies at the Pharmacy Accreditation Board website.

Cleanliness and professionalism. “The best way to vet a pharmacy is to ask, ‘can I see your lab?’” Dr. Burch said. Look for general cleanliness, just as you do when checking out a new restaurant. Staff should be wearing gowns and gloves. Ask questions if you don’t understand what you see.

The takeaway

High-quality compounding pharmacies provide personalized medicine to patients when needed.

Jennifer L.W. Fink, RN, BSN is a Registered Nurse-turned-writer. She’s also the creator of and co-creator/co-host of the podcast On Boys: Real Talk about Parenting, Teaching & Reaching Tomorrow’s Men.