What is a compounding pharmacy?

When you think of a pharmacy, odds are you imagine either a neighborhood, mom-and-pop drugstore or a national chain. You may even just see the digital storefront of an online operation. But there’s yet another type: compounding pharmacies. And while many people aren’t familiar with them, they’ve been getting more and more attention lately because of the role they play in countering shortages of GLP-1 medications like Wegovy and Zepbound.

Compounding pharmacies are a small percentage of the larger pharmacy industry — only around one percent of people use them, according to one study — but they serve an important role in medication supply and can offer a lot of benefits to certain patients. Here’s what you should know.

What is the difference between a compounding pharmacy and a regular pharmacy?

Unlike traditional pharmacies you’re familiar with that supply FDA-approved medications made by pharmaceutical companies, compounding pharmacies “create customized medications from scratch for patients that need them,” says Tenille Davis, PharmD, a pharmacist and the chief advocacy officer for the Alliance for Pharmacy Compounding, an advocacy group for compounding pharmacists.

In doing so, they can “address specific patient needs that aren’t met by standard retail options,” says Nathan Hagen, PharmD, the director of community pharmacy at University of Utah Health. For instance, Hagen says, compounding pharmacies can provide medications in customized strengths, creating doses tailored to individual needs — something that can improve patient health outcomes.

One thing to know is that compounding pharmacies usually take a little longer to prepare your medication. “Unlike a typical prescription for amoxicillin that you could pick up in a few hours, compounded medications are sometimes made-to-order,” says Davis. So it can take a day or two before it’s ready “because it’s essentially being made from scratch in the pharmacy's labs.”

Why do people use compounding pharmacies?

There are two main reasons people use compounding pharmacies. First, if you can’t take an FDA-approved medication for whatever reason, then a compounding pharmacy can modify it in a way that makes it tolerable. For example, says Davis, a toddler might need a liquid version of a medication that’s only FDA approved in a pill form, or a patient could have an allergy to an inactive substance in a drug. Having the option to use a compounded pharmacy and take a medication custom made for your needs can have big repercussions for someone’s health: One paper found that compounded drugs can increase medical adherence, meaning people actually take their prescribed medications as directed.

The second reason a compounded medication may be prescribed is when an FDA-approved medication isn’t accessible to a patient. During these situations, compounding pharmacies can create medications in bulk so that they’re ready when someone needs them. “If something's on the FDA’s shortage list, a compounding pharmacy can jump in and create what's essentially a copy of it,” says Davis. “The entire ‘recipe’ or formulation of, say, a semaglutide or tirzepatide injection is listed in the package insert of those products. And during times of shortages, pharmacies can create copies of those formulations.” This is only legally allowed during times of FDA-deemed shortages. Once a drug comes off the shortage list, compounding pharmacies have to stop making them.

503A compounding pharmacies vs. 503B compounding pharmacies

There are some variances within the category of compounding pharmacies, with two different types: 503A and 503B. “503A pharmacies are the traditional compounding pharmacies where they dispense medications based on a physician's order to an individualized patient,” says Davis. So, if your healthcare provider writes you a prescription for a compounded medication, you could bring or send it to one of these pharmacies, where they’ll compound it and custom-make it for you according to your provider’s instructions.

503B compounding pharmacies, says Davis, compound large amounts of medications that are then distributed (rather than dispensed, prescription by prescription) for places like hospitals and medical clinics to fill prescriptions. “They're a special category of compounders that was created by the FDA in the 2013 Drug Quality and Security Act as kind of a stopgap for the drug supply chain, because they can fill in during those times of shortages and try to shore up supply,” says Davis.

Types of compounded medicines

While compounded medicines run the gamut from injections to nasal sprays, they can be separated into two main categories.

Sterile compounded drugs

Sterile compounded drugs are anything that will be used in a way that has a high risk of infection, such as eye drops or an injection. “Things that carry risk of microbial contamination have to be made in a sterile compounding pharmacy,” says Davis. The drawback is that sterile labs can be harder to find, because “the facility requirements are quite extensive, obviously, to make sure that they're producing products that are free from bacterial contamination,” she says.

Non-sterile compounded drugs

The majority of compounding pharmacies are non-sterile compounding pharmacies, where they make topical creams, capsules, sublingual dosages (which are applied under the tongue), nasal sprays, and ear drops, according to Davis. Since there’s less risk of bacterial infection when you’re applying medication to these areas, they aren’t required to be prepared in a sterile lab.

What types of drugs are compounded most often?

The most commonly compounded medications include those used in hormone therapy for both men and women, dermatological medications for skin conditions, and pain-relieving creams, says Hagen.

Compounded hormone therapy is done so that the medication can come in different delivery methods, like patches, creams, and capsules, as well as different dosages and combinations of active ingredients that aren't available as FDA-approved medications. These include estriol (a type of estrogen), estradiol (another form of estrogen), progesterone, testosterone, and dehydroepiandrosterone (a hormone that helps produce estrogen and testosterone).

Pain medications, on the other hand, tend to be compounded into topical creams with the idea that they can deliver targeted relief, which might be helpful for people who have only pain in one area (although at least one study has called their efficacy into question). There are some FDA-approved pain creams, but compounded pharmacies can make them in different strengths and make unique combinations of active ingredients including ketamine, gabapentin, clonidine, and lidocaine.

You may also be able to use compounding pharmacies to get certain GLP-1 medications that are on the FDA shortages list. At different times, these have included Ozempic, Wegovy, Mounjaro, and Zepbound.

Are compounded medications safe?

Unlike FDA-approved prescription medications, compounded medications don’t undergo the same testing for safety and efficacy, although they contain similar active ingredients. That’s because they’re usually made on a one-off basis, “and the drug approval process requires double-blind placebo controlled trials that can't be performed on one-off medications,” says Davis. “They're not allowed to call themselves ‘safe and effective’ because the FDA hasn’t done their typical approval process, but that does not inherently mean that they're unsafe.”

There are some risks to know about, however. As with any business, there can be people who cut corners, which has led to a spate of FDA warnings about compounded semaglutide (among other medications) in recent years. They recommend ensuring your compounding pharmacy is legitimate, like that it requires a doctor's prescription, provides a physical, U.S.-based address and phone number, offers a licensed pharmacist to answer questions and has a license with your state's board of pharmacy.

If you go through WeightWatchers, you can rest assured that the 503B compounding facility meets all safety requirements and puts patient safety first, including being registered with the FDA. If you’re seeking out a 503A compounding pharmacy on your own, check the National Association of Boards of Pharmacy, which links to the boards of pharmacy in each state and has a tool that helps verify whether the pharmacy is "safe" or "not recommended."

Are compounded drugs as effective?

Compounded drugs can be as effective as FDA-approved medications because they use the same active ingredients, but when they are made in one-off batches, their efficacy often depends on your provider. In most cases, the healthcare providers prescribing compounded drugs are responsible for specifying the amount and combination of active ingredients. “Some providers are highly knowledgeable about compounded medications within their specialty, while others may have had limited exposure to these options in their training or practice,” says Hagen, adding that in many cases, the pharmacist and provider will discuss a specific case or condition and work together to develop a compounded medication that meets the patient’s needs. In the case of GLP-1 compounded drugs, there is no published literature to date on the efficacy of compounded semaglutide or tirzepatide.

How do you find a compounding pharmacy near you?

Your provider can likely recommend a compounding pharmacy. “If your doctor has worked with a particular compounding pharmacy for years or decades and had success with their patients using those compounded meds, that's a really good first sign,” Davis says. If you are a member of WeightWatchers, the legwork is done for you. WeightWatchers has partnered with a 503B compounding facility that meets stringent quality standards to ensure patient safety comes first.

If you want to find one on your own to recommend to your provider, the Alliance of Pharmacy Compounders also has a search tool for compounding pharmacies, which only includes pharmacies licensed by their state. “Patients and prescribers can use it to determine if a pharmacy is a legitimate, state-licensed compounding pharmacy,” Davis says.

The bottom line

Compounding pharmacies serve an important purpose in providing medications to patients. They can be used when a medication is in short supply or when someone is unable to take an FDA-approved medication for certain reasons, like if they have an allergy to an inactive ingredient. Compounded medications use the same active ingredients as the FDA-approved versions, but they do not always undergo the same safety and efficacy tests. That’s why it’s important to only use reputable compounding pharmacies and follow the guidance of a trusted healthcare provider.