March 14, 2019

FDA: Guardian Pharmacy ordered to stop producing sterile compounded drugs

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration on March 12 announced that a federal judge entered a consent decree against Guardian Pharmacy Services (Dallas, Texas) to stop the company from producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements.

The government alleges that Guardian Pharmacy manufactured and distributed purportedly sterile drugs that were adulterated because they were made under insanitary conditions and in violation of manufacturing requirements under the FD&C Act.

Guardian also distributed drugs that were misbranded because their labels did not include adequate directions for patient use, or their labels were false or misleading.

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