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 today against JMA Partners, Inc., doing business as Guardian Pharmacy Services, located in Dallas, Texas, as well as the company’s owner, Jack R. Munn.
The government alleges that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under unsanitary conditions and in violation of current good manufacturing practice requirements. According to the complaint, Guardian also manufactured and distributed drugs that were misbranded.
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 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 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 unsanitary 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.
Source: FDA, March 12, 2019