Dallas Company Enjoined from Compounding Drugs

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Dallas Company Enjoined from Compounding Drugs

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,” FDA Commissioner Dr. Scott Gottlieb said.

The U.S. Food and Drug Administration announced March 12 that a federal judge has issued a consent decree of permanent injunction against JMA Partners, Inc., doing business as Guardian Pharmacy Services, located in Dallas, Texas, as well as the company’s owner, Jack R. Munn. They are ordered to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements. According to the complaint filed by the U.S. Department of Justice on behalf of FDA, despite previous warnings from FDA, Guardian Pharmacy Services continued to violate that law.

U.S. Chief District Judge Barbara M.G. Lynn for the Northern District of Texas entered the consent decree. The government alleges that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the act, and that drugs prepared, packed, or held under insanitary conditions may have been contaminated with filth or rendered otherwise harmful to patients.

“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,” FDA Commissioner Dr. Scott Gottlieb said. “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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