FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Texas Compounder Hit With Consent Decree

March 21, 2019
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A federal court ordered Dallas, Texas-based drug compounder Guardian Pharmacy Services to suspend compounding activities, based on violations flagged by the FDA.

At the agency’s request, the U.S. District Court for the Northern District of Texas ordered the compounder to halt operations until it complies with regulatory requirements.

FDA Commissioner Scott Gottlieb said the agency continues to see “violative behavior among compounding pharmacies that put patients at risk, and we’re committed to taking enforcement actions when we identify significant issues.” Compounded drugs come with their own risks because they lack agency approval and don’t go through premarket review to test their quality, safety and effectiveness, he said.

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