Texas Compounder Ordered to Stop Production by Federal Court

MARCH 13, 2019
Jennifer Nessel, Assistant Editor
A federal judge has ordered Guardian Pharmacy Services, a Texas-based company, to stop producing compounded drug products intended to be sterile until it complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.

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 in Dallas, Texas, as well as the company’s owner, Jack R. Munn.

According to FDA Commissioner Scott Gottlieb, MD, although compounded drugs can serve a need for certain patients whose medical needs cannot be met by an FDA approved drug product, they do not undergo the same premarket review as FDA approved drug products. All drug compounders are required to comply with requirements, and compounders that violate the law by not adhering to requirements should be held accountable by law.

“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,” said Gottlieb, in a prepared statement.

According to the press release, Guardian manufactured and distributed drugs that were considered misbranded, since their labels did not include adequate directions for patient use. There was also evidence of false or misleading labels.

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 non-FDA approved drugs compounded in these facilities are provided to patients based on an individual-need basis. 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, despite not producing those drugs in compliance with current good manufacturing practice regulations, receiving new drug approval, or providing adequate directions for use.

Guardian is required through the consent decree to cease sterile operations until it completes corrective actions, such as 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 requirements, a comprehensive quality control system and receives authorization from the FDA.

The FDA conducted an initial inspection of Guardian in 2016 and issued a warning letter for insanitary conditions and other violations of the FD&C Act. In 2017, at least 43 patients filed adverse event reports, explaining that they were administered eye injections of a drug compounded by Guardian containing triamcinolone and moxifloxacin during cataract surgery. These patients reported 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.

“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,” said Gottlieb.

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.

Editor's Note: Guardian Pharmacy Services in Dallas is not affiliated with Guardian Pharmacy of Dallas-Fort Worth in Arlington, Texas, a member of the national long-term care company Guardian Pharmacy Services headquartered in Atlanta.


Reference

Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services [news release]. Silver Spring, MD; March 12, 2019: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633204.htm. Accessed March 12, 2019.
 

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