As millions of Americans use GLP-1s to manage their weight, the makers of cheaper, non-name-brand alternatives to the drugs are facing pressure from regulators and major pharmaceutical companies amid recalls, lawsuits, and concerns about safety.
An estimated 11% of U.S. adults reported using a GLP-1 for weight loss in 2026, up from just 3% in 2024, according to a September Gallup poll. In 2021, the appetite to use the medications for weight loss, not as a diabetes management tool, exploded with the approval of Wegovy, the first GLP-1 approved specifically for that purpose.
Since then, the pharmaceutical industry has scrambled to meet the insatiable demand for tirzepatide and semaglutide, the active ingredients in the name-brand GLP-1 medications Zepbound and Wegovy. Some customers facing high costs, lagging insurance coverage, and difficulty obtaining prescriptions turned to online providers to fill the hole.
Compounding pharmacies, or those creating custom versions of medications, have been a particularly large piece of the puzzle.
These pharmacies were once given permission by the Food and Drug Administration to produce the drugs during a shortage, but were expected to stop after supply rebounded. Still, millions of users opt for compounded versions of the medication supplied by these pharmacies, which have provided widespread, affordable access but have also drawn warnings and recalls, such as a recent recall of compounded tirzepatide made by compounder Apothecary Pharma.
While agencies such as the FDA have raised concerns about the practice, experts say that compounded prescriptions through telehealth providers will stay popular as long as they are available. If you rely on an online prescriber or compounding pharmacy for your GLP-1 or other medications, here’s what to know about checking your pick for legitimacy, safety and quality.
What Are Compounding Pharmacies?
Compounding pharmacies, or special pharmacies that create customized versions of drugs from raw ingredients, have sparked renewed interest in recent years thanks to the surge of GLP-1s and the peptides industry.
Unlike a commercial pharmacy, which sells mass-produced drugs, a compounding pharmacy can develop specific medications to meet a patient’s needs, including adjusting the dose or removing allergens like dyes. Compounding pharmacies are often used for pediatric and veterinary cases where a medicine needs a different format, such as a lower-concentration liquid for a small animal.
These pharmacies are also sometimes used during drug shortages, as the FDA grants temporary approval for them to produce a drug in bulk to fill the void.
This happened in 2022 when the FDA gave compounders the go-ahead to begin producing their own versions of GLP-1 medications amid a shortage. Tirzepatide and semaglutide were removed from the official drug shortage list in late 2024 and early 2025, but compounding pharmacies have continued to produce their own versions and sell them to millions, particularly through telehealth platforms such as His/Hers.
“Compounded medications have become increasingly common in primary care, specialty care, hospice, weight management, pediatric, and infusion settings and play an important role in expanding access to therapy when commercially available products are unavailable, unsuitable, or prohibitively expensive,” Dr. Patricia Strobehn, associate professor at Touro University Nevada, told USA TODAY.
Compounding pharmacies must use FDA-approved ingredients by law, but the actual formulations themselves aren’t evaluated for purity, safety, or effectiveness. Compounding pharmacies also aren’t routinely FDA-regulated, which has led to sanitation and contamination issues in the past, such as a 2012 case in which nearly 800 people became ill and 64 died of a fungal meningitis outbreak caused by unsanitary injections from the New England Compounding Center, or 2023 FDA reports of compounders using unapproved salt forms of ingredients in their formulations.
“Unlike commercially manufactured medications, compounded medications are not individually evaluated or approved by the FDA before they are dispensed,” explained Strobehn. “Compounded medications may vary in dose, concentration, formulation, and beyond-use date (BUD), which can increase the risk of medication errors and adverse events when compared to commercially manufactured products.” These factors have become increasingly controversial, with pharmaceutical giants like Eli Lilly and Novo Nordisk suing compounders to stop or limit the practice.
The FDA has warned against the use of compounded GLP-1s obtained through popular online platforms, saying they cannot be guaranteed to be safe. Consumers and organizations like the trade group Alliance for Pharmacy Compounding have refuted this, saying legitimate compounding is regulated and has made often cost-prohibitive medication accessible to millions of customers.
What’s Going On With GLP-1s and Compounding Pharmacies?
Several lawsuits and legal challenges have marked the battle between compounders and the name-brand drugs’ patent holders.
Earlier this year, Novo Nordisk filed a federal lawsuit against telehealth provider Hims & Hers, alleging that the company infringed on Novo’s patent by producing a compounded version of its Wegovy pill.
The lawsuit accused the telehealth provider of “mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA’s gold standard review process.” In response, Hims & Hers alleged that “Big Pharma” was “weaponizing the U.S. judicial system to limit consumer choice.”
In February, the FDA also said it would take “decisive steps” against companies using GLP-1 ingredients for mass-market sales of compounded drugs, and referred Hims & Hers to the Justice Department for investigation, USA TODAY reported.
As of April, the FDA’s position was that shortages no longer justified widespread compounding of semaglutide and tirzepatide and that compounders could not skirt copycat restrictions simply by adding ingredients such as vitamins B12 or B6.
Enforcement action has also continued. In September, the agency issued a warning letter to Empower Pharmacy alleging that its compounded semaglutide and tirzepatide products remained “essentially copies” of approved drugs despite added ingredients.
Some consumers have reported having to swap pharmacies or providers as some respond to such warnings. Still, a Gallup poll updated on Sept. 8 estimated that 15% of Americans have used a GLP-1 for weight loss, and 18% of those GLP-1 users were on compounded drugs.
How to Check If Your Compounding Pharmacy Is Legitimate
Talking to a trusted health care provider and filling prescriptions only from reputable prescribers you are familiar with are the first steps to ensuring that the place making your drugs is legitimate.
“Safety comes down to quality and oversight. I want to know who made the medication, where the ingredients came from, how it was tested, how it was stored, and whether a qualified medical professional is actually managing the patient,” pharmaceutical scientist Sanjiv Lal told USA TODAY. “If those pieces are in place, you have a very different situation than someone buying an injectable product from an unknown source online.”
To find out whether your pharmacy is state licensed, use your state’s board of pharmacy website. Each state has its own searchable database, all of which are listed on the FDA’s website here.
The Alliance for Pharmacy Compounding also offers a tool that allows you to easily reach your state’s board of pharmacy site.
When browsing, make sure you search by “pharmacy” (states generally let you choose from many different kinds of businesses) and for the pharmacy itself, not an individual pharmacist (though you can also verify this online through the same portal). If you cannot find your provider or have more questions, you may fill out this form from the National Association of Boards of Pharmacy, which will then get back to you with information about the pharmacy’s accreditation status.
The Alliance for Pharmacy Compounding also maintains a searchable list of compounding pharmacies in your area. The list indicates when a pharmacy is a member of the organization.
Additionally, the Accreditation Commission for Health Care and the Coalition for Compounding Excellence offer a special accreditation for compounding pharmacies known as PCAB or CCE accreditation. These are considered the “gold standard” of additional certification for these organizations. You can check the ACHC directory or lookup tool to see if your provider is accredited. You may also ask the pharmacy itself or search its website for proof of these accreditations.
You can likewise find information about compounding pharmacies that are regularly inspected by the FDA. The agency keeps a running list of compounding organizations and related inspections, recalls, warnings and other actions, which can be found here. Included under each listing are links to relevant documents that can include information like any violations or issues the FDA has noted (sanitation concerns, mislabeling, undisclosed ingredients, for example) or confirmations that the pharmacy has been inspected and is in good standing.
“Consumers should ask questions like: Who is the pharmacy? Is it properly licensed? What are its quality standards? Is there a real physician or qualified provider involved? Is someone monitoring your response, your labs, your body composition, and your overall metabolic health?” said Lal. “Once you can answer those questions, it should relieve everyone’s concerns in the decision-making process. We should be raising the standard, not restricting responsible access.”
Contributing: Ken Alltucker, USA TODAY
Reporting by Mary Walrath-Holdridge, USA TODAY / USA TODAY
USA TODAY Network via Reuters Connect
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