Compounding without safeguards: A prescription for risk

By Philip J. Schneider & Ronald P. Jordan 

As trained pharmacists devoted to the safe, effective, and science-based care of patients, we rely on the U.S. Food and Drug Administration (FDA) as our nation’s final safeguard for medication quality. Compounding — the practice of tailoring medications for patients with unique needs — can be invaluable when there is a medically demonstrated need for it and done within the law. But recent proposals calling for sweeping changes to federal regulation would dismantle key protections. Such efforts risk repeating the dangerous mistakes of the past, when weak oversight led to contamination outbreaks and patient deaths.

As stewards of responsible pharmacy, we’ve seen firsthand how children who need liquid formulations, people with allergies to certain inactive ingredients, or cancer patients who require special dosing benefit from this time-honored practice. But there is a critical difference between individualized compounding and mass production by compounders who egregiously defy regulatory boundaries. When the latter occurs, patients face very real risks: contamination, inconsistent potency and lack of accountability when things go wrong.

That’s why recent proposals to roll back federal oversight of compounding should alarm every patient and provider. These changes, often framed as “modernization” or “efficiency,” would dismantle protections that exist to prevent tragedies. We’ve already seen what happens when oversight fails — deadly outbreaks linked to contaminated large scale compounded drugs have claimed lives in the past. Rolling back oversight isn’t reform; it’s a return to a deregulated past that puts patients’ lives at risk.

Interstate oversight keeps patients safe


One proposal would remove FDA’s authority to oversee interstate distribution of compounded drugs. This is not a minor tweak. Once drugs cross state lines, local regulators lose visibility. A single unsafe batch could quickly spread across the country, harming thousands before problems are detected. Federal coordination is the only way to prevent this. Rolling back oversight creates a blind spot that places patients at unnecessary risk.

Cutting edge drugs require strong safeguards

Another effort would narrow the FDA’s “Demonstrably Difficult to Compound” list so it applies only to individual drugs, not entire categories. On the surface, this might sound reasonable. In practice, it strips away critical protections. Certain drug classes — especially sterile injectables like insulin — carry common risks of contamination and instability. Treating them as isolated products ignores the broader safety standards. Weakening these protections gives compounders a green light to mass-produce high-risk drugs without necessary quality controls.

FDA Warnings Provide Essential Guidance for Health Care Providers

Compounding lobbyists have gone so far as to label FDA’s safety alerts “alarmist.” In fact, the opposite is true. These alerts are based on documented cases of dosing errors, contamination and real patient harm. with The FDA has received more than 1,000 reports of adverse events associated with compounded GLP-1s. This is more than double the number of adverse event reports received for all compounded drugs in 2022, Even more disturbing, the FDA has estimated the number is understated, because pharmacies are not required to submit adverse events to the agency.

When critics dismiss FDA’s evidence-based safety alerts, they erode trust in the agency and disrupt a system that patients and providers have long relied on for timely, life-saving information. The FDA does not issue warnings lightly; when it sounds the alarm, it is because patients are truly at risk.  In fact, as many health policy and consumer groups have underscored, if anything, FDA should be taking an even stronger stance against these risky knockoffs.

Bulk ingredients need rigorous review


It’s important to remember that compounded drugs don’t exist in a silo. Even hospitals and clinics sometimes depend on outsourcing facilities to prepare compounded drugs when no approved alternative is available — for  example, during shortages or for patients with unique medical needs. That reliance makes safety standards even more critical, and as such, proposals to fast-track bulk GLP-1 ingredient approvals without full FDA review are reckless. These are complex, high-risk drugs that require rigorous testing to confirm purity, stability, and clinical safety. Bypassing that process lowers the bar for what enters the supply chain, opening the door to contaminated, substandard, or unproven substances reaching patients who may already be medically vulnerable.

Unregulated Foreign Ingredients Undermine America’s Safe Drug Supply

Another underappreciated risk is the use of active pharmaceutical ingredients (API) — the core ingredients in a drug that fuel its therapeutic effect — sourced from overseas manufacturers, primarily in China and India, rather than FDA-approved drug products. Compounders turn to these sources because the bulk API is cheaper or because foreign sellers are more willing to ignore U.S. patent laws.

However, an API can come from rogue actors that are not registered with or inspected by the FDA, meaning there are no assurances whatsoever that the API is safe or that it will work as intended.  Even the registered supply compounders use present serious risks. According to FDA’s FY 2024 report on pharmaceutical quality, 72% of regulatory actions against API manufacturers involved sites supplying only compounding pharmacies, even though they represent just 18% of facilities. Over 80% of these violations were in China and India, where quality oversight is inconsistent, if not non-existent. These numbers highlight the disturbing reality that compounded products place already vulnerable patients at even greater risk.  

The American public recognizes these dangers too: a recent Fabrizio Ward poll found that 92% of Trump voters want the FDA to do more to protect Americans from unsafe prescription drugs, especially those from China, and 94% support mandatory country-of-origin labeling for medications. When it comes to the medicines that keep us healthy, the American public wants stronger — not weaker — oversight.

Aggressive and Deceptive Marketing Exacerbates Risks for Patients  

Deregulation efforts are being fueled by a flood of misleading marketing. From TikTok influencers to Super Bowl ads, compounders aggressively promote GLP-1s, and alternative forms like patches, shakes, and gummies, as safe and FDA-approved. Even more concerning, minors are deliberately targeted, with fake reviews and testimonials used to lure patients into subscriptions and purchases. The impact is real: a survey earlier this year found 85% of women living with obesity believed false claims made in online ads.

The bottom line: compounding should be a narrow, medically necessary practice


Compounding should remain what it was designed to be: a targeted, patient-specific service that complements FDA-approved medicines, not a back door for mass production. The FDA’s role is not to deny access, but to ensure that all medications, compounded or manufactured, meet the highest standards of quality. Stripping away that authority erodes patient safety and public confidence alike.

Policymakers should not weaken these safeguards. The FDA already has the authority it needs to protect patients, and it must use it to vigorously enforce existing laws, hold mass compounders accountable, and prevent unreviewed bulk drugs from entering the supply chain. Patients deserve medicines that are safe, effective, and trustworthy. Now is the moment for FDA to stand firm, protect the integrity of the drug supply, and put patient safety first. Patients’ lives depend on it.

• Philip J. Schneider, MS FASHP FFIP is a Professor at Ohio State University College of Pharmacy and Past President of the American Society of Health-system Pharmacists (ASHP). Ronald P. Jordan, RPh is the Founding and Emeritus Dean at Chapman University School of Pharmacy and former president of the American Pharmacists Association (APhA).