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# Mass Compounding Threatens FDA Enforcement: Column
- URL: https://www.fdaweb.com/mass-compounding-threatens-fda-enforcement-column/
- Published: 2026-04-08T12:00:00.000Z
- Updated: 2026-09-14T13:36:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160953

While individualized and shortage drug compounding are necessary exceptions to FDA standards, mass compounding of commercially available drugs is not. That’s the view of *FDA Matters* founder **Steven Grossman** and **Nancy Glick**, director of food and nutrition policy at the National Consumers League. In an *FDA Matters* [column](https://www.fdamatters.com/compounding-patient-safety-and-the-vital-role-of-fda-enforcement/?ref=fdaweb.com), the two review the history of drug compounding for individual patients, to address shortages of FDA-approved drugs, or to fulfill certain hospital and specialty care needs.

Outside of those situations, they write, “mass compounding of commercially available drugs is not permitted by law. This is because FDA considers compounded medicines as ‘unapproved drugs’ that are exempt from strict safety rules due to their limited intended use.”

Controversy has arisen, Grossman and Glick say, over the ongoing mass compounding of GLP-1 weight loss drugs despite FDA declaring an end to the shortage of the branded Novo Nordisk and Lilly drugs a year ago. “The result is a situation never anticipated by regulators,” the column says, “a loosely regulated market in which untested, unapproved drugs compete with FDA-approved drugs (both branded and generic) that have undergone clinical testing, obtained FDA approval, and bear labels that include safety risks.”

The authors also review the change some compounders have implemented to combine GLP-1s with vitamin B 12 or vitamin B-6, arguing without clinical evidence that the combination offers a medical or material advantage not present with the commercially available GLP-1 drugs alone.

“Leaving aside that this new trend is a thinly veiled approach to justify mass compounding of commercially available products,” they say, “the practice raises serious concerns for consumer, patient safety, and safe medication use advocates.”

The authors note that under the law, a patient requiring a compounded GLP-1 with a separate ingredient like vitamin B-12 added for a medical purpose would be treated and monitored closely by a doctor and a pharmacist jointly under FDA’s individual needs exception.

Yet, they say, telehealth platforms and med-spas promote the wellness and longevity benefits of adding vitamins and specific ingredients to GLP-1s without telling consumers that these combinations have not been studied, that there are potential safety risks from off-label use, and that monitoring is needed.

Grossman and Glick conclude that when compounding is used to treat individual needs or to alleviate documented shortages, it is an important professional activity. But, they say, mass compounding of a commercially available product is another story. “It is not legal,” they declare. “Furthermore, compared with the manufacturing of FDA-approved branded and generic drugs, mass-compounded products are untested, uninspected, underregulated, and unproven, posing a threat to patient safety. FDA exists for a reason. When the agency doesn’t fully enforce the Federal Food, Drug, and Cosmetic Act, we are all vulnerable to unsupported product claims and clever marketing that plays on our dreams of quick, effective, and cheap solutions.”