Can a Compounding Pharmacy Save You Money? Experts Weigh in on Safety and Cost
Experts explain who can benefit from a compounding pharmacy and how to find a reputable one
With the rising demand for weight-loss medications, compounding pharmacies have been making headlines lately. On October 30, the FDA announced that all doses of Novo Nordisk’s Ozempic and Wegovy medications are now available in the U.S. after prolonged shortages. This could lead the FDA to remove the injections from its shortage list, potentially stopping compounding pharmacies from offering customized—and often cheaper—versions of these drugs. The news comes just a week after the pharmaceutical giant requested that the FDA bar these pharmacies from making GLP-1 medications, citing concerns about the complexity and safety of replication. But what is a compounding pharmacy exactly, and is it safe to use?
For those unfamiliar, compounding pharmacies operate differently from traditional ones, creating medications tailored to individual needs. Here, we’ll break down what compounding pharmacies are, why people use them and what you should know before considering one.
What is a compounding pharmacy?
Woman's World Answers
Compounding pharmacies “create patient-specific medications and formulations not available as a ‘mass-produced’ medication,” explains Elizabeth Hageman, Pharm D, BCPS, BCOP, Professor of Pharmacy Practice at Binghamton University, State University of New York. Unlike traditional pharmacies, which dispense FDA-approved medications manufactured in bulk, compounding pharmacies mix ingredients on-site based on a prescription.
“Prescriptions filled at traditional pharmacies are standard doses and formulations that meet the needs of most of the general population,” continues Hageman. While most of us don’t require specialized compounded medication, they can benefit those with specific needs. For example, they may alter a medication’s dosage, ingredients and form, or combine it with other medications.
In some cases, a compounding pharmacy can create a medication at a less-expensive dosage, saving patients money. As for GLP-1 medications, some experts estimate patients could pay as little as one third of the price of the brand name medication at a compounding pharmacy.
Compounding has a long history in healthcare and was the standard for preparing medicine before large-scale pharmaceutical manufacturing began. “These pharmacies have specialized equipment and must adhere to additional regulations. In addition, pharmacists and pharmacy technicians have additional training that helps them to compound these medications,” adds Hageman.
Why do people use compounding pharmacies?
“Compounding pharmacies are used for a variety of reasons,” explains Hageman. Most often, they offer solutions for patients who have unique healthcare needs that can’t be met by commercially available medications. Hagemen cites some examples, including:
- Patients who can not swallow pills, seeking a liquid version (or a cream instead of an oral tablet)
- Patients with allergies or sensitivities to excipients in a mass-produced product such as gluten
- Patients who take a drug that needs to be titrated (increasing the dose) for a response
- Patients who require combination medications, which create a single dose and simplify a patient’s treatment regimen
In the case of medications like Ozempic, some patients may turn to compounding pharmacies for more affordable options or to access lower doses than what’s commercially available.
What types of medications are compounded?
Compounding pharmacies can prepare a wide range of medications, but there are specific guidelines about what they’re allowed to create. “Commonly compounded prescriptions include pain medications, hormone replacement therapy, topical dermatological compounds and even veterinarian-focused compounds,” says Hageman.
However, there are limitations. For example, pharmacies are not permitted to compound commercially available drugs unless they have a valid medical reason to do so, such as a shortage. This is part of the reason why Novo Nordisk and the FDA have been scrutinizing compounded versions of Ozempic—its active ingredient, semaglutide, is complex, and the FDA has not approved compounded versions for weight loss.
Are compounded pharmacies safe?
According to Hageman, compounding pharmacies are safe. “Using a reputable compounding pharmacy is important. The Accreditation for Health Care offers specialty accreditation for compounding pharmacies.” If you’re unsure, she advises asking your pharmacist if they are compliant with United States Pharmacopeia (USP) guidelines, “if they source their ingredients from an FDA- registered facility as required by federal law and how often their medications are sent to a third party for testing.”
Another way of checking is to “ask if the staff has received additional training for compounding and how often. Pharmacists working at a reputable compounding pharmacy should have no issue with answering these questions quickly and accurately,” adds Hageman.
While compounding pharmacies are licensed and follow regulatory guidelines, compounded drugs don’t receive the same FDA oversight as commercially manufactured medications. This means they are not tested in clinical trials and may not have the same rigorous quality assurance.
What to consider before using a compounding pharmacy
“Choosing a compounding pharmacy may be a reasonable option for some patients. At times due to drug shortages, patients must rely on compounding pharmacies to fill the void,” says Hageman.
If you’re considering a compounded medication, she shares a few important factors to keep in mind. “Consider the potential cost of the medication if it is not covered by a patient’s insurance, acquisition of the drug through the mail and the reputation of the pharmacy,” says Hageman.
Notably, she reminds us that the FDA has previously issued warnings regarding unapproved versions of medications such as GLP-1 medications. “The FDA has a campaign entitled ‘BeSafeRx’ which outlines considerations and guidance for patients interested in using an online pharmacy. Start here to see if the compounding pharmacy is listed and to read other helpful tips,” says Hageman.
Always consult your doctor first about why you need a compounded medication and whether it’s the best choice for your condition. They can help determine if there are suitable alternatives in FDA-approved forms.
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