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News & Press: Compounding

Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services

Tuesday, March 12, 2019   (0 Comments)
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A federal court ordered a Texas-based company to stop producing compounded 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 Services continued to violate the law, putting patients at risk.

U.S. Chief District Judge Barbara M.G. Lynn for the Northern District of Texas entered a consent decree of permanent injunction against JMA Partners, Inc., doing business as Guardian Pharmacy Services, located at 7920 Elmbrook Dr., Suite 108, Dallas, Texas, as well as the company’s owner, Jack R. Munn.

“Although compounded drugs can serve an important role for certain patients whose medical needs cannot be met by an FDA approved drug product, compounded drugs can also pose unique risks. They’re not FDA approved and do not undergo premarket review for safety, effectiveness or quality. All drug compounders must comply with certain requirements, which can include current good manufacturing practice requirements, to avoid product quality problems and potential patient harm. The FDA is committed to helping ensure that compounded drugs are made under appropriate production standards. When we find compounders that violate the law by not adhering to requirements, and put patients at risk, we’re going to hold them accountable under the law,” said FDA Commissioner Scott Gottlieb, M.D. “We’ve continued 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. In this case, despite our warnings, Guardian continued to violate the law by distributing purportedly sterile drug products under poor conditions and numerous drugs were compounded and distributed without a specific-patient prescription. This case is yet another reminder of why unlawful compounding is fraught with risk, how bad actors who have the potential to significantly harm people persist and why the FDA’s work in collaboration with our state partners remains critical to protecting consumers. The FDA will invest in these oversight efforts to help assure appropriate safeguards for patients and to expedite enforcement actions against drug compounders that threaten the public health.”

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