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.
(Guardian Pharmacy Services in Dallas is not affiliated with Guardian Pharmacy of Dallas-Fort Worth in Arlington, a member of the national long-term care Guardian Pharmacy Services headquartered in Atlanta.)
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."
According to the complaint, Guardian also manufactured and distributed drugs that were misbranded because their labels did not include adequate directions for patient use, and some of Guardian's drugs were misbranded because their labels were false or misleading.
FDA conducted an initial inspection of Guardian in 2016 that resulted in a warning letter for insanitary conditions and other violations of the FD&C Act. In 2017, the FDA received adverse event reports concerning at least 43 patients who were administered eye injections of a drug compounded by Guardian containing triamcinolone (steroid) and moxifloxacin (anti-infective) during cataract surgery. These 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, according to the agency's news release. FDA conducted a follow-up inspection in April 2018 and issued a risk alert to inform patients about these products in July 2018.
In addition to operating in Texas, the company is licensed in other states that include Arizona, Colorado, Iowa, and Oklahoma.