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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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 FD&C Act. Drugs prepared, packed or held under insanitary conditions may have been contaminated with filth or rendered otherwise harmful to patients.
According to the complaint, Guardian also manufactured and distributed drugs that were misbranded because their labels did not include adequate directions for patient use, which describe how to use a drug safely and effectively for its intended purposes. Some of Guardian’s drugs were also misbranded because their labels were false or misleading.
Under the law, compounding facilities that are not registered as outsourcing facilities can only compound drugs pursuant to valid patient-specific prescriptions. The prescription requirement helps to ensure that drugs, which are not FDA-approved, that are compounded in these facilities, are provided to patients based on individual patient needs. Despite repeated warnings that Guardian was in violation of the law, they continued to distribute more than half of their drugs for “office-stock” throughout the country even though they did not produce those drugs in compliance with current good manufacturing practice regulations, nor did they receive new drug approval, or provide adequate directions for use.
The consent decree requires Guardian to cease sterile operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure the company is complying with the FD&C Act. Under the consent decree, Guardian may not resume sterile compounding operations until it establishes and implements, among other things, a comprehensive quality control system and receives authorization from the FDA.
The 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. The FDA’s investigation into Guardian’s compounded triamcinolone-moxifloxacin product revealed a high percentage of an excipient, poloxamer 407, and the presence of potential process degradation products. The 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 including Arizona, Colorado, Iowa and Oklahoma.
The U.S. Department of Justice filed the complaint on behalf of the FDA.