A Dallas pharmacist pleaded guilty to adulterating a drug used in cataract surgeries after he compounded a drug that contained an ingredient that could damage sensitive eye tissue.
Jack Randall Munn is a licensed pharmacist and former owner of Guardian Pharmacy Services, which oversaw the drug compounding for two outpatient surgical centers in 2016 and 2017. Compounding drugs is often at the center of these fraud cases. It is the practice of combining, mixing, or altering medicine ingredients to create a new medication tailored to the patient’s individual needs. For drugs used in cataract surgery injected into the eye, compounding must be done with great precision.
The federal Medicare Fraud Strike Force includes analysts, investigators, and prosecutors from the Department of Justice and Office of the Inspector General who target emerging fraud schemes. The teams are based in Dallas, Miami, Los Angeles, Detroit, southern Texas, Brooklyn, southern Louisiana, Tampa, and Chicago. According to the Food and Drug Law Institute, these teams focus their efforts on compound pharmaceuticals that may be reimbursed at a higher rate under federally funded healthcare programs, meaning they become more lucrative for fraud.
For years, the surgery center in question had purchased the compounded drug, called Tri-Moxi, from an out-of-state company that made it. The medicine was intended to reduce inflammation and prevent infection during the procedure. But in 2016, the surgical center contracted Guardian to produce the drug.
According to court documents, Guardian sought advice from a pharmaceutical consulting company about making Tri-Moxi and was advised to use an inactive ingredient in the compounding process. Still, Guardian’s ratios were off, and the resulting Tri-Moxi had too much of the inactive ingredient, making it dangerous for patients. The surgical center used Guardian’s compound on 15 patients in 2016.
In 2017 Munn pursued other business and leveraged the contract with the first surgical center to make a deal for Tri-Moxi with a second surgical center. Munn claimed that the compounded drug would be of the same standard as their previous arrangements for Tri-Moxi, but Guardian’s version was again unsafe. This time, the surgical center used the medication on 85 cataract surgeries. According to the FDA, the drug did not meet the standards Guardian was marketing.
This isn’t the first run-in with the feds for Guardian. The federal government found in 2019 that Guardian unsafely stored its medicines, and gave unsafe compounded drugs to 43 patients that resulted in symptoms including vision impairment. It resulted in an injunction that stopped the defendants from distributing misbranded and unapproved drugs.
Munn pleaded guilty to one count of distributing an adulterated drug in violation of the Federal Food Drug and Cosmetic Act. The maximum penalty is one year in prison and a fine of $100,000. Sentencing will take place on Feb. 3, 2022.
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