OPINION:
The Food and Drug Administration has taken an important and overdue step to rein in the mass marketing of compounded drugs that have never been reviewed or approved by the agency.
In a Feb. 6 statement, the FDA made clear that it would take steps to limit importation of API for mass compounded copycat drugs and that companies cannot sell unapproved products as substitutes for FDA-approved medicines. That clarity matters, because it reaffirms a basic expectation patients have when they take a prescription drug: that it has been tested for safety and effectiveness, manufactured under appropriate quality standards and independently reviewed before reaching the market.
For FDA-approved medicines, that expectation is well founded. But a growing number of Americans are now taking compounded drugs that never went through that process often without realizing it.
Compounding serves and important but limited role in medicine when it is used to meet individualized patient needs that cannot be met by FDA-approved drugs, such as when a patient has a documented allergy to an inactive ingredient in an approved drug. But what has emerged in recent years is something very different. Under the guise of compounding, some companies have moved far beyond individualized care particularly for high-demand therapies like weight-loss and diabetes drugs, hormone treatments and other popular medications.
These actors are mass-producing unapproved drug copies with API from foreign sources some of which are selling illicit ingredients that cannot legally be used in drugs intended for humans. They then sell these substandard products nationwide through telehealth platforms and med spas and promoting them directly to consumers through social media and digital advertising. The products are often described as “the same as” or “just like” FDA-approved medicines but the truth is they are not remotely the same thing.
Let’s be clear: this isn’t customization for a unique patient need. It’s industrial-scale unapproved drug production marketed as “personalized” to evade the rules.
Unlike FDA-approved drugs, these compounded products have not been independently reviewed to confirm that they contain the correct amount of active ingredient, are sterile and uncontaminated, will work as intended, or are produced, stored, and shipped under appropriate quality standards. Many compounded GLP-1 products also include added ingredients such as vitamins, amino acids, or other substances that have never been clinically tested in combination with these drugs. That means patients are effectively participating in an uncontrolled experiment, with no reliable data on safety, effectiveness, interactions or long-term risks. Instead of FDA oversight, patients are left to rely on compounders’ claims alone.
The result is a two-track marketplace: one set of rules for FDA-approved medicines, and another for products operating outside FDA review while being marketed as equivalent alternatives. This uneven system undermines patient confidence and erodes trust in the drug supply.
The risks are not theoretical. Investigations and reports have documented compounded drugs with incorrect dosing, contamination and ingredients that do not match their labels. Some patients have experienced serious side effects while others have paid for medicines that simply did not work. FDA also recently cited one of the largest suppliers of API for compounding, noting that it imported illicit API, destroyed the original label and then resold it to compounders.
Confusion is further fueled by marketing practices that obscure whether a product is FDA-approved. Phrases like “contains semaglutide” can give patients the impression they are receiving the same treatment as an approved GLP-1 medication, even when they are not. Clinicians, too, can struggle to track what their patients are taking when products are shipped directly to homes without clear disclosure.
The FDA’s Feb. 6 action including its plan to restrict access to certain active pharmaceutical ingredients used for mass-marketed, non-approved compounded drugs and to address misleading promotional claims was both necessary and appropriate. It reinforces a simple principle: companies cannot sidestep FDA review while making the same claims as approved manufacturers.
Clarity, however, must be followed by consistent enforcement. The FDA has a range of tools at its disposal from inspections and warning letters to seizures, injunctions and referrals when warranted. Those tools exist to ensure that regulatory exceptions are not exploited as commercial loopholes and that the law applies equally to all.
Congress has begun to recognize the consequences of regulatory drift as well. Bipartisan proposals introduced by lawmakers reflect growing concern that compounding exceptions have been stretched far beyond their intended scope and that clearer guardrails are needed to protect patients.
America’s drug approval system is respected around the world because it is grounded in science, safety, and regulatory rigor. That system works only if its standards are applied consistently. The FDA has drawn an important line. The task now is to ensure it is enforced for patients, for providers, and for the integrity of the U.S. drug supply.
• 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).
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