Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, October 20, 2021
Doesn't the ruling that the percentage of compounded drugs sold interstate was arbitrary force the FDA to then use the amount selected by Congress which is 5% or more? Why or why not? More importantly doesn't it just fortify the argument that the federal government/FDA should regulate any compounded drugs sold in interstate commerce? Why or why not?
| HotHead Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| DENTON VAPE SHOPPE | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| E-Cig Mania LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| Jon B. Cole, MD | Center for Drug Evaluation and Research | CDER | Failure to obtain Investigational New Drug Applications | |||
| Lauren R. Klein, MD, M.S. | Center for Drug Evaluation and Research | CDER | Failure to obtain Investigational New Drug Applications | |||
| AriBio H&B Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | |||
| The Camel Milk Co. LLC dba Camel Culture | Office of Human and Animal Foods Operations – Division West 4 | New Drug/Misbranded | |||
| Magnolia Medical Technologies, Inc. | Office of Medical Devices and Radiological Health, Division 3 | CGMP/QSR/Medical Devices/Adulterated | |||
| Sircle Laboratories, LLC | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Marcus Research Laboratory, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
Friday, October 15, 2021
Department of Justice
Texas Pharmacist Pleads Guilty to Adulterating Drug Used in Cataract Surgeries
A Texas man pleaded guilty Tuesday to one count of adulterating a drug that was used in cataract surgeries.
According to court documents, Jack Randall Munn, 71, of Dallas, a licensed pharmacist and former owner of Guardian Pharmacy Services (Guardian), a Dallas pharmacy, oversaw the compounding of the drug for two outpatient Dallas surgical centers in 2016 and 2017. The drug, a combination of an antibiotic and a steroid, contained an excessive amount of an inactive ingredient that can damage sensitive eye tissue.
At the time of the events described in court documents, Munn represented to the surgical centers that Guardian could compound the drug in a manner safe for injection into patients’ eyes. However, the drug made by Guardian contained an excessive amount of the inactive ingredient, causing its purity and quality to fall below that which it was represented to possess.
Munn pleaded guilty to one misdemeanor count of distributing an adulterated drug in violation of the Federal Food Drug and Cosmetic Act. He is scheduled to be sentenced on Feb. 3, 2022 and faces a maximum penalty of one year in prison and a fine of up to $100,000. The federal magistrate judge who presided over Munn’s guilty plea will determine sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
The U.S. Food and Drug Administration’s (FDA) Office of Criminal Investigations investigated the case.
Assistant Director John Claud, Senior Trial Counsel David A. Frank and Trial Attorney Sarah Williams of the Civil Division’s Consumer Protection Branch are prosecuting the case. Associate Chief Counsel for Enforcement Karen Towns with the FDA’s Office of Chief Counsel, and the U.S. Attorney’s Office for the Northern District of Texas provided valuable assistance in the case.
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 ....
Pharmacist pleads guilty to adulterating drug linked to eye ...
Pharmacist Sentenced to Nearly 6 Years in Prison for Multimillion-Dollar Compounded Medicine Scam that Defrauded Health Care Plans
Department of Justice
Pharmacist Sentenced to Nearly 6 Years in Prison for Multimillion-Dollar Compounded Medicine Scam that Defrauded Health Care Plans
LOS ANGELES – An Orange County pharmacist has been sentenced to 70 months in federal prison for submitting more than $13 million in claims for medically unnecessary compounded medication prescriptions, the Justice Department announced today.
Thu Van Le, 42, a.k.a. “Tony Le,” of Placentia, was sentenced Monday by United States District Judge R. Gary Klausner.
In addition to the prison term, Judge Klausner ordered Le to pay $10,982,759 in restitution to Tricare, the U.S. military’s managed health care plan, and $768,488 in restitution to Amplan, Amtrak’s employee health care benefit plan.
Le, a pharmacist who owned TC Medical Pharmacy in Corona, pleaded guilty on July 12 to one count of health care fraud.
From March 2015 to December 2016, Le’s pharmacy submitted more than $13 million in total claims to Tricare and AmPlan, against which Tricare paid $10,982,759 and AmPlan paid $768,488. Le, in turn, paid so-called “marketers” handsome kickbacks of up to 50 percent of the Tricare reimbursements.
The marketers used personal and insurance information to generate fraudulent prescriptions for compounded medications, according to court documents. Marketers who participated in the scheme solicited beneficiaries of the health plans through misleading cold calls that promised free compounded medications. In some cases, beneficiaries were not contacted at all and simply received expensive medications that they did not order.
Compounded drugs are tailor-made products doctors may prescribe when the Food and Drug Administration-approved alternative does not meet the health needs of a patient.
Le agreed to be bound by Tricare and AmPlan rules for reimbursement of claims for their beneficiaries. Tricare and AmPlan required that medications be medically necessary, that beneficiaries be examined by physicians, and that Le’s pharmacy collect co-payments. The prescriptions were supposed to be for unique patient needs, but they instead were formulated to maximize reimbursements and were prepared on an assembly-line basis.
The Defense Criminal Investigative Service, the FBI, IRS Criminal Investigation, Amtrak’s Office of Inspector General, the Office of Personnel Management’s Office of Inspector General, the United States Department of Labor – Employee Benefits Security Administration, the Department of Health and Human Services, and the California Department of Insurance investigated this matter.
Assistant United States Attorney Mark Aveis of the Major Frauds Section prosecuted this case.