Opinion: The Pseudoscience of Personalized Compounding Prioritizes Convenience and Cost Over Science and Safety

Drug compounding plays an essential role in patient care. It always has. Whether modifying dosage of a weight-based medication, removing an allergenic ingredient, or improving palatability for a child, compounding meets clinical needs that FDA-approved medications sometimes cannot. This is especially true in times of medication shortages or in health systems where compounding plays an indispensable role in chemotherapy, critical care, and other clinical settings.

Recently, however, compounding practices have strayed from their intended indications—from small quantities for individual patients with specific needs to mass production for the consumer market. The FDA approval process was meticulously designed to prove that a medication is efficacious and safe. The FDA’s “essential copy” rule protects the integrity of approved medications by preventing compounding pharmacies from creating close replicas.¹ Increasingly, however, compounding pharmacies circumvent this regulation by adding ingredients such as vitamin B₁₂ for “personalization,” and protocols evaluating safety are bypassed in favor of manufacturing speed and volume. The lack of validated pharmacological or clinical rationale behind “personalized” products not held to FDA standards exposes unknowing consumers to significant risks.

In 2021, the FDA approval of semaglutide 2.4 mg (Wegovy; Novo Nordisk), the first obesity medication to achieve greater than 10% weight loss, made glucagon-like peptide-1 (GLP-1) receptor agonists a household name. Finally, individuals with obesity had a highly effective medication to treat their cardiometabolic disease. Increasing demand for GLP-1 medications (even among healthy individuals of normal weight) outpaced supply, and the shortages began. The explosion of mass-market GLP-1 compounding continues despite the official end of the semaglutide and tirzepatide shortages in May 2025,² and it evades FDA safeguards designed to protect patients, many of whom assume compounded products are regulated like approved generic versions of branded medications.

There are documented cases of compounded GLP-1s prepared in nonsterile environments, without proper equipment, and by individuals without adequate training. Just look at the recent recall of 1300 syringes of compounded tirzepatide (Mounjaro, Zepbound; Lilly) in Colorado. The product was mixed in a nonsterile room by unqualified staff.³ Although mass-production compounding is most pronounced with high-demand GLP-1 therapies, this global challenge extends beyond any single drug class. The rapid rise is reshaping consumer behavior and emboldening patients to look beyond FDA-approved brand-name and generic medications, which were tested in thousands of patients in multiple clinical trials over many years to prove efficacy and safety. Large-scale compounding bypasses this rigorous process and sets a dangerous precedent.

Mass-produced compounded drugs lack the product quality that comes from FDA inspections and current Good Manufacturing Practice requirements, and they are frequently made from foreign active pharmaceutical ingredients. Without supply chain security and manufacturing information, it is difficult to verify the identity, integrity, and origin of compounded products and their ingredients. Moreover, these unapproved drugs are often marketed with false or misleading claims. Consumers assume efficacy, safety, and quality control, and they may be unaware of inherent risks. The 2012 New England Compounding Center incident is an example of the grave consequences that can occur. More than 100 people died, and hundreds more were sickened when a mass-compounding entity distributed contaminated injections.⁴

The health care community has an ethical obligation to prioritize science and safety over convenience and cost. Personalization claims must be supported by peer-reviewed research that provides clarity around untested ingredients and slight alterations in dosing. Anecdotal support for these practices does not meet the standard required to make clinical decisions, nor does it outweigh potential risks to patients. Improving and maintaining access to safe and effective medications that are held to the highest standards should always be the priority. This will require enforcement of rules that already exist and education for patients and health professionals.

The integrity of medication development and distribution is paramount for global health. The goal must be to protect patients from harm, empower clinicians to provide evidence-based care, and sustain the pipeline of innovative and affordable therapies rooted in science.

REFERENCES

1. US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Office of Compliance. Compounded drug products that are essentially copies of approved drug products under Section 503B of the Federal Food, Drug, and Cosmetic Act: guidance for industry. FDA. January 2018. Accessed March 13, 2026. https://www.fda.gov/media/98964/download

2. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. FDA. April 28, 2025. Accessed March 13, 2026. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

3. Wingerter M. Colorado med spa recalls weight-loss and vitamin injections because of unsterile conditions. Denver Post. July 15, 2025. Accessed March 13, 2026. https://www.denverpost.com/2025/07/15/thrive-health-solutions-med-spa-recalls-weight-loss-drugs/

4. Kastango ES. Lessons learned from compounding tragedies. Can J Hosp Pharm. 2013;66(3):152-156. doi:10.4212/cjhp.v66i3.1250