What is a compounding pharmacy? And can they make weight loss drugs?

As U.S. shortages of injectable weight-loss receptor agonist drugs persist—even patients who can afford Wegovy® or Zepbound® can’t always find the dose they need—interest is growing in getting medication by compounding pharmacies. 

But what exactly is a compounding pharmacy? And how do you know if compounded semaglutide or tirzepatide is legit?

If you find compounding rather, well, confounding, read on. We’ve consulted U.S. Food and Drug Administration (FDA) regulations and federal laws, leading pharmacist groups and compounding pharmacy organizations, and the Found clinical health team to better understand key issues and facts about compounded medications for weight loss.

Top takeaways: 

1. Compounded medications are created by state-licensed traditional compounding facilities (these are licensed pharmacists, physicians, and compounding pharmacies that create custom medication for individuals). Compounded medications can also be made by FDA-registered outsourcing facilities that offer bulk compounding services.
2. Compounded medications are not FDA-approved. However, they are regulated by the FDA and have to comply with United States Pharmacopeia (USP) and the FDA’s Current Good Manufacturing Practice (CGMP) standards. The FDA does not review compounded medications for safety, efficacy, or quality before they are marketed, which is one reason such drugs pose additional risks. But state-licensed traditional compounding pharmacies and FDA-registered outsourcing facilities can help patients access necessary treatment.

What is drug compounding?

According to the FDA and the American Pharmacists Association, compounding is generally when a licensed pharmacist or physician—or a person at an outsourcing facility who is supervised by a licensed pharmacist—“combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.” 

A health care provider might prescribe, and a pharmacist at a community pharmacy might make a compounded medication for:

• a patient with an allergy or intolerance to gluten in a commercially available drug
• a patient who needs a different strength than is available in existing dosage forms
• a patient who has difficulty swallowing and needs an oral gel or a topical cream or ointment instead of a pill
• a child (or pet) who needs a medication flavored to make it more palatable

Federal law permits producing a compounded medication—for individual patients at a compounding pharmacy, or in larger batches at an FDA-registered outsourcing facility—when a commercially available drug is on the FDA Drug Shortages list.

Though the FDA fields complaints about and investigates adverse outcomes from compounded medications, it does not approve them or review their safety, efficacy, or quality before they are marketed or sold.

Why are compounded medications for weight loss (like semaglutide) trending? 

Injectable medications in the GLP-1 and GLP-1/GIP drug classes have shown dramatic results during clinical trials in weight loss, type 2 diabetes treatment, and, more recently, in reducing cardiovascular risk in some patients.

Increased demand for the drugs—coupled with short supplies and high prices while brand-name drugs are under patent—has patients, health care providers, pharmacists, and even lawmakers looking for alternatives. 

Sen. Bernie Sanders—the chair of the U.S. Senate Committee on Health, Education, Labor, and Pensions—has called for drugmaker Novo Nordisk to lower prices for its brand-name semaglutide in the U.S., where these drugs often cost more than $1,000 a month for those without insurance.

But price isn’t the only obstacle for patients. For drugs prescribed in increasing dosages until patients reach a maintenance stage. Regular month-to-month availability is also critical.

And some injectable weight-loss medications have been in shortage for more than two years. Injectable semaglutide (the active ingredient in Wegovy) has been on the FDA Drug Shortages list since March 2022. Injectable tirzepatide (the active ingredient in Zepbound) has been on the list since December 2023, almost immediately after Zepbound received FDA approval as a treatment for obesity.

“This has been a challenge at Found and nationally due to short supply, lack of coverage, and the high cost of these medicines,” says Rekha Kumar, MD, chief medical officer at Found. “Patients tend to give up if access to the medicine is a barrier.”

What is a compounding pharmacy? 

The U.S. Federal Food, Drug, and Cosmetic Act (FDCA) allows pharmaceutical compounding in certain situations at two types of compounding pharmacies or facilities, often referenced according to their section of the FDCA:

• Section 503a traditional compounding pharmacies: These are state-licensed pharmacists or physicians who prepare customized medications for individual patients to meet a unique patient need, generally in limited quantities, for a patient-specific benefit.
• Section 503b outsourcing facilities: Companies that prepare compounded medications under the direction of a pharmacist in bulk for other pharmacists or health care providers to dispense when an FDA-approved medication is not commercially available or is in shortage or under other circumstances allowed by the regulations.

How are compounding pharmacies regulated?

Traditional compounding pharmacies are regulated under Section 503A of the FDCA and by their state boards of pharmacy. They may also be accredited or certified for nonsterile or sterile compounding services. The FDA does not inspect or approve them. Still, state and federal authorities can issue warning letters and injunctions, seize products, or otherwise prosecute compounding pharmacies for violating the FDCA or state laws and regulations, as may be applicable.

Outsourcing facilities that compound drugs—regulated under Section 503B of the Federal Food, Drug, and Cosmetic Act—must: 

• Register with the FDA each year (which inspects them on a risk-based schedule) and report adverse events.
• Report details to the FDA twice a year about the compounded drugs they make (including the source and strength of active ingredients).
• Adhere to current good manufacturing practice requirements for medications and meet minimum labeling standards.

What are compounded medications for weight loss made of?

That depends on the compounding pharmacy and the prescribed active ingredient. 

Since commercially available brand-name medications are protected by patent, compounded versions cannot be exact copies of the brand-name medications, except when the FDA recognizes a shortage of the commercially available drug.

“Compounding pharmacies are authorized by federal law and follow FDA Guidance for Industry in preparing copies of FDA-approved drugs when that drug is listed as ‘currently in shortage’ on FDA’s Drug Shortage list—as semaglutide and tirzepatide currently are,” explained Scott Brunner, CEO of the Alliance for Pharmacy Compounding, in a 2024 media briefing.

That said, a compounding pharmacy may create a compound drug using a method different from the originating drug manufacturer’s or mix the active ingredient with something different from the brand-name FDA-approved drug. 

What is the problem with compounded semaglutide?

Drugmakers and the FDA have raised concerns in the past year about counterfeit versions of brand-name injectable semaglutide and about some companies marketing salt forms of the semaglutide as “compounded semaglutide.”

The FDA explained that Wegovy and Ozempic use the base form of semaglutide as their active ingredient and that the salt forms are distinctly different active ingredients: “Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”

How can I find out what’s in my compounded medication? 

One way is to request the certificate of analysis for the active pharmaceutical ingredients (or API) in your medication.

“Under federal law, compounding pharmacies must purchase API manufactured by facilities that are FDA registered. That API comes with a certificate of analysis [or COA] documenting that the substance is what it says it is, as well as the exact potency and purity of the drug,” says Brunner. “While that COA is a rather dense read, patients and prescribers who want some greater assurance that the drug they’re being dispensed is what the pharmacy says it is, can ask to see the COA.”

In addition, Brunner adds, patients and prescribers can ask whether compounded medications from a given pharmacy or facility have undergone third-party testing for potency and sterility.

What are the risks of taking compounded medication? 

All medications carry some level of risk and potential for side effects. 

Even the rigorously tested, clinically studied, FDA-approved brand-name formulations of GLP-1 and GLP-1/GIP medications have some known potential side effects. The most common are nausea, vomiting, diarrhea, and acid reflux. More serious but less common side effects include pancreatitis, gallbladder disease, and worsening of diabetic eye disease. Those with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasias should not use them. Find detailed side effect and risk information for specific medications by name on our dedicated medication page.

Compounded medications carry additional risks since their exact formulations, dosages, or ingredient combinations may differ and the FDA does not review them for safety, efficacy, or quality.

In addition, according to the FDA, “poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much active ingredient. This can lead to serious patient injury and death.” 

(In 2012, almost 800 patients got fungal meningitis, and more than 100 people died after a Massachusetts pharmacy shipped contaminated compounded medication. As a result, new regulations for outsourcing facilities were enacted under the Drug Quality and Security Act of 2013.)

Compounded medications may also increase patient self-dosing errors. Injectable compounded medication is typically dispensed in a vial with separate syringes (vs. the pre-filled injector pens used for brand-name injectable drugs for weight loss). So, dosages may differ from those of a prescribed brand-name drug, and patients injecting compounded medications must follow instructions carefully to ensure they draw up and inject the correct amount.

“Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients,” notes the FDA, which advises against using compounded medications unless necessary.

How can I find out where my compounded medication was made? 

Ask your health care provider and pharmacist (or whoever dispensed your compounded medication) for the name and location of the pharmacy or facility that made it.

• If it was made at a compounding pharmacy, be sure it is licensed to practice or ship to your state by your state board of pharmacy (find the FDA’s list of state pharmacy boards here). And ask whether it is accredited by the Pharmacy Compounding Accreditation Board (PCAB). You can check for PCAB compounding pharmacies by state at the Accreditation Commission for Health Care’s website.
• If the drug was made at an outsourcing facility, be sure the facility is on the FDA list of Registered Outsourcing Facilities, where you can also see any objectionable findings or recalls from its past inspection reports before deciding whether or not to take the compounded medication.

What red flags should I look for with drugs billed as “compounded” medications?

As demand for weight-loss drugs continues, so do the opportunities for fraudsters to sell potentially harmful and illegal counterfeits under the guise of FDA-approved brand-name drugs or FDA-permitted and legally compounded medications. 

“If your doctor didn’t write you a prescription for a compounded GLP-1 and send it to a legitimate, state-licensed pharmacy,” explains Brunner, “beware the seller of that substance—and the substance itself.”

Found is among the largest medically-supported telehealth weight care clinics in the country, having served more than 250,000 members to date. To start your journey with Found, take our quiz.

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While GLP-1s are effective for weight loss, they are not clinically appropriate for everyone. Eligibility for a GLP-1 is based on a provider’s evaluation of your medical history, MetabolicPrint^TM, and lab work. If a GLP-1 is not appropriate for you, a provider will work with you to determine an effective medication for your health profile. Prescriptions are up to a medical professional's discretion.