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(Reuters) - The former owner of a Texas-based compounding pharmacy has pleaded guilty to adulterating a drug after at least 43 patients were left blinded or had their vision impaired after their eyes were injected with a botched medication it produced.
Jack Munn, a pharmacist and former owner of Guardian Pharmacy Services, pleaded guilty on Tuesday in federal court in Dallas to the misdemeanor charge in connection with his oversight of the production of the drug for two outpatient surgical centers.
Munn, 71, faces up to a year in prison and a fine of up to $100,000 when he is sentenced on Feb. 3 by U.S. Magistrate Judge David Horan. His lawyer, William Wade of The Wade Law Firm, did not respond to a request for comment.
Compounded drugs are custom-made medications that traditionally were formulated by state-regulated pharmacies for specific patients.
In recent decades, the practice has mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures for physicians to keep for future use, even across state lines.
Prosecutors said that Guardian's drug, a combination of an antibiotic and a steroid, contained an excessive amount of an inactive ingredient that could damage sensitive eye tissue and was sold to the surgical centers in 2016 and 2017.
According to charging papers, the medication, a version of a drug called Tri-Moxi, was used in about 100 surgeries at the two centers from November 2016 to February 2017, even though its quality fell below the standards Munn had pledged.
The U.S. Food and Drug Administration in July 2017 alerted health care providers that it had been notified of adverse events involving at least 43 patients who were administered the compound.
The agency said the investigation ultimately found that Guardian manufactured drugs under unsanitary conditions and that the drugs may have been contaminated with filth or otherwise been harmful to patients.
The FDA said that despite several warnings, Guardian distributed drugs for "office stock" at clinics and health care providers nationally while not producing medications in compliance with good manufacturing practice regulations.
Former FDA Commissioner Scott Gottlieb in 2018 cited the incident as demonstrating the risks still posed by compounding pharmacies after Congress in 2013 passed a law aimed at bring more of them under the oversight of the FDA, rather than states.
That law was passed following a deadly fungal meningitis outbreak in 2012 linked to tainted drugs made by Massachusetts compounding pharmacy New England Compounding Center that sickened 793 people, more than 100 of whom died.
The case is U.S. v. Menn, U.S. District Court, Northern District of Texas, No. 21-cv-00442.
For the United States: Marcus Busch and Katherine Miller of the U.S. Attorney's Office for the Northern District of Texas and David Frank and Sarah Williams of the U.S. Justice Department.
For Menn: William Wade of The Wade Law Firm
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