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# Lax GLP-1 Compounding Regulation Hurts Patients: Report
- URL: https://www.fdaweb.com/lax-glp-1-compounding-regulation-hurts-patients-report/
- Published: 2025-07-22T12:00:00.000Z
- Updated: 2026-09-14T15:17:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159550

A Center for Medicine in the Public Interest (CMPI) report says FDA regulatory failures in enforcing limits on GLP-1 compounding put patients at risk. The [report](https://mr.cdn.ignitecdn.com/client%5Fassets/cmpiorg/media/attachments/687e/a93b/8bf7/5526/a476/a1e5/687ea93b8bf75526a476a1e5.pdf?1753131323&ref=fdaweb.com) was written by former FDA associate commissioner **Peter Pitts**, CMPI president.

Pitts says a temporary shortage of the GLP-1 drugs that have become popular as treatments for diabetes and obesity “opened the door to a flood of unapproved knock-offs from compounding pharmacies looking to cash in. The shortage has ended, but some compounders continue to mass produce compounded knock-offs, which ignores longstanding limits on compounding and puts patients at risk.”

The report calls for these actions to protect patients:

- FDA should put a stop to phony “personalization,” in which compounders mass produce manipulated GLP-1 drugs;
- FDA must require compounding pharmacies that act like drug manufacturers to register as drug manufacturers;
- FDA and Customs and Border Protection must enforce restrictions on illicit foreign active pharmaceutical ingredients;
- Congress must require FDA to enforce the rule that prohibits interstate distribution of more than 5% of a compounder’s products unless and until the state enters into a memorandum of understanding with FDA; and
- Congress must increase FDA resources to enforce the law as it stands.

“The GLP-1 shortage is over, but the illegal, unsafe, and venal exploitation of the American public by mass-scale ‘corporate’ compounders masquerading as pharmaceutical companies continues,” Pitts concludes…. “Corporate compounding of GLP-1 medicines is a growing part of the misinformation crisis facing FDA. Attention must be paid.”