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Texas Compounder Guardian Pharmacy Ordered to Stop Compounding Sterile Drugs

This week, a federal judge entered a consent decree with Guardian Pharmacy Services, a Texas-based 503A state pharmacy, ordering it to cease compounding of drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements. According to the complaint, despite previous warnings from the FDA, Guardian Pharmacy continued to violate the law, putting patients at risk.

As a reminder, in 2017, 43 patients reported adverse outcomes after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields.

 

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