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# Consent Decree Against Violative Drug Compounder
- URL: https://www.fdaweb.com/consent-decree-against-violative-drug-compounder/
- Published: 2018-04-20T12:00:00.000Z
- Updated: 2026-09-15T00:00:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141271

A federal judge in Arkansas has entered a consent decree of permanent injunction between FDA and drug compounder Cantrell Drug Co. and its CEO **James L. McCarley, Jr.** The action prohibits Cantrell and McCarley from manufacturing, processing, packing, holding, or distributing drugs until they comply with FDA regulations and requirements.

The government’s complaint alleges that Cantrell manufactured and distributed purportedly sterile drug products, such as injectable opioids and antibiotics, that were adulterated because they were made under insanitary conditions and in violation of GMP requirements. The decree requires Cantrell to stop operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility.

Last month, FDA issued a safety alert ([see story](https://www.fdaweb.com/safety-alert-on-cantrell-drug-co-compounded-products/)) warning health care professionals and patients not to use the firm’s compounded drug products. “The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk,” the alert said.