Let’s correct misinformation about compounded drugs

Written By James Simpson

https://healthjournalism.org/blog/2025/02/lets-correct-misinformation-about-compounded-drugs/

“Do you really know what you’re injecting into your body?”

So reads a scary Novo Nordisk ad that challenges the safety of compounded versions of its glucagon-like peptide-1 (GLP-1) drugs, Wegovy and Ozempic. 

Novo Nordisk and Eli Lilly, which make the GLP-1 drugs Zepbound and Mounjaro, have been stoking fear about compounded versions of their drugs, which have boomed in popularity during shortages of the branded products. (The FDA recently declared those shortages over, although some compounding pharmacies are disputing the determinations.)

The companies filed lawsuits and petitioned the FDA to block the compounding of their products on safety grounds. Legally compounded drugs are not without safety issues, but there could be harm in exaggerating their risks. Compounding pharmacies play a crucial public health role, and irrational fears can hamper the ability of patients and clinicians to make informed treatment decisions. 

As always, journalists should verify claims in news releases and strive to provide the public with balanced and accurate information, including cautions about GLP-1 drugs. Here are some misleading messages to watch out for.

‘Compounded drugs are akin to counterfeit products’

Eli Lilly has issued statements warning of “potentially serious risks” from “counterfeit, fake, compounded, and other unsafe or untested versions” of its drugs. Similarly, Novo Nordisk called compounded drugs “potentially harmful…knock-off” products.

Such statements wrongly associate licensed compounders and telehealth companies whose clinicians prescribe compounded medications with illegal online sellers who hawk sketchy products, often without a prescription. Those scam enterprises have drawn warnings from the National Association of Boards of Pharmacy and the World Health Organization. 

By contrast, compounding pharmacies are authorized by the federal Food, Drug and Cosmetic Act to make versions of drugs that are on the FDA’s shortage list. They also dispense custom medications to patients who need a special dosage or formulation of an FDA-approved drug.

‘Lack of FDA approval means that compounded drugs are unsafe’

The drugmakers stress that compounded drugs are “not FDA-approved” and the FDA doesn’t verify their safety, quality or effectiveness.

That language, which appears on the FDA website, is more or less accurate: only approved drugs undergo regulatory reviews of their clinical trial data as well as their labeling, delivery mechanism and packaging. That extensive process isn’t practical for compounded drugs. 

How compounding is regulated

Congress strengthened oversight of compounding in 2013 following a deadly fungal meningitis outbreak attributed to safety lapses at a Massachusetts compounding facility.

  • Traditional compounders, known as 503A pharmacies, are licensed and inspected by state boards of pharmacy and must adhere to U.S. Pharmacopeia standards for making drugs.

  • Outsourcing facilities that produce large batches for use in hospitals or clinics, known as 503Bs, are held to more stringent Current Good Manufacturing Practice (CGMP) requirements enforced by the FDA — the same quality standards as traditional drug manufacturers. 

  • Federal law stipulates criteria for ingredients that can be used in compounding.

  • The FDA issues rules for compounding.

There have been reports of dosing errors and compounded drugs being given to patients without prescription labels or written instructions, according to Michael J. Gaunt, PharmD, senior manager of error reporting programs at the Institute for Safe Medication Practices, a nonprofit that runs its medication error reporting program. 

However, it doesn’t follow that compounded drugs are unsafe, Scott Brunner, chief executive officer of the Alliance for Pharmacy Compounding (ACP), which advocates for compounding pharmacies, said in an interview.

“I think you can say that there is a higher degree of risk if the drug is not FDA-approved, but compounding does have a rigorous enforcement framework,” Brunner said. (See sidebar.)

Brunner and Gaunt agree that commercially available drugs should always be the first choice. They advise patients to verify a compounding facility’s licensing and other credentials before filling out a script.

The ACP offers a search tool and tips for picking a compounding pharmacy. The FDA’s BesafeRx campaign has advice for buying medications online.

‘Compounded drugs don’t contain the same active ingredients as FDA-approved drugs’

Novo Nordisk has implied that it’s the only source of semaglutide, the active ingredient in Wegovy and Ozempic, and compounding pharmacies are using something different. 

Evidence doesn’t bear that out. According to a report by MedPage Today, compounding pharmacies buy semaglutide from FDA-registered manufacturers, which are required to provide a valid certificate of analysis.

In 2023 the FDA received reports that some compounders were using salt forms of semaglutide that differ from the active ingredient in the FDA-approved drugs. Brunner acknowledged that this practice violated federal regulations, adding that it was short-lived and ended when semaglutide production ramped up.

‘Compounded medications are linked to deaths and injuries’

Novo Nordisk has frequently pointed to deaths and hospitalizations of people who were taking compounded drugs, leading to stories like this one from CNN: “Compounded semaglutide associated with at least 10 deaths, Novo Nordisk CEO warns.”

That alarming headline fails to put those deaths in context and ignores whopping caveats with the data, which is from the FDA Adverse Event Reporting System (FAERS), a public repository of reports of drug adverse events and medication errors. 

Here are some of the data limitations listed on the FDA’s website:

  • The existence of a report does not mean that the drug caused the adverse event.

  • Information in reports hasn’t been validated.

  • Rates of occurrence can’t be established.

After the story ran in early November, the ACP noted in a statement that there had been 505 total reported deaths of patients taking semaglutide and all but 51 included a lot number for a commercially available drug. 

The group said adverse events reports for compounded semaglutide “largely mirror those for the FDA-approved products,” suggesting that bad outcomes are not related to how the drug was made.

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