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
Monday, February 26, 2024
Friday, February 16, 2024
Department of Justice News: Collegeville Man Sentenced to 97 Months in Prison for Scheme to Sell Fraudulent Canine Cancer Drugs to Pet Owners
Promising to restore the health of terminally ill dogs, defendant defrauded approximately 900 pet owners out of nearly $1 million
PHILADELPHIA – United States Attorney Jacqueline C. Romero announced that Jonathan Nyce, 73, of Collegeville, Pennsylvania, was sentenced today to 97 months in prison, three years of supervised release, and a $500 special assessment for carrying out a years-long scheme to defraud pet owners of money by falsely claiming to sell drugs that could cure canine cancer. A federal jury convicted Nyce of wire fraud and the interstate shipment of misbranded animal drugs in December 2022.
Tuesday, February 13, 2024
Final Judgment and Permanent Injunction on Consent in NOVO NORDISK A/S AND NOVO NORDISK INC., Plaintiffs, v. EFFINGER HEALTH, P.A. D/B/A NUVIDA RX WEIGHT LOSS – TALLAHASSEE CLINIC, Defendant.
in the united states district court
Covetrus Pleads Guilty to Criminal Misbranding of Veterinary Prescription Drugs: Ohio-based Company Will Pay More Than $23 Million in Fines and Forfeiture
ABINGDON, Va. – Covetrus North America LLC, a company based in Dublin, Ohio, which sells veterinary products to customers across the United States, pled guilty today to causing the introduction and delivery of misbranded veterinary prescription drugs into interstate commerce. As part of the agreement, Covetrus will pay over $23 million in criminal fines and forfeitures.
“The United States Attorney’s Office for the Western District of Virginia takes the distribution of misbranded prescription drugs seriously,” United States Attorney Christopher R. Kavanaugh said today. “Covetrus shipped over $20 million in prescription drugs to unauthorized end-users in violation of federal laws that are designed to ensure prescription drugs are kept within a controlled chain of distribution and to prevent diversion and inappropriate use. Today’s result demonstrates my Office’s commitment to holding those companies and corporations accountable when they seek to profit by breaking the law.”
“The FDA recognizes the importance of controlling the prescription drug supply for animals. The careless or uncontrolled distribution of prescription animal drugs poses a danger not only to the medicated animals but to the U.S. public health by increasing the risk that humans will become resistant to antibiotics that we unknowingly consume through our food supply.” said Special Agent in Charge George Scavdis, FDA Office of Criminal Investigations - Metro Washington Field Office. “We will continue to pursue and bring to justice those who distribute prescription animal drugs unlawfully.”
According to court documents, from March 2019 to December 2021, Covetrus shipped over $20 million in prescription drugs from their non-pharmacy locations throughout the United States to end-users that were not authorized to receive prescription drugs. Shipments from non-pharmacy locations to non-authorized end-users or locations are deemed “misbranded.”
Covetrus will forfeit $21,534,091, pay $1,000,000 to the Virginia Department of Health Professions, as well as a fine of $1,000,000. In addition, Covetrus is obligated to keep in place appropriate compliance measures to prevent future violations.
Sentencing is scheduled for May 8, 2024 at 10:30 a.m.at the United States Federal Courthouse in Abingdon.
The U.S. Food and Drug Administration – Office of Criminal Investigations and the Virginia State Police investigated the case, with the assistance of the Virginia Department of Health Professions.
Assistant U.S. Attorney Randy Ramseyer is prosecuting the case.
- From FDA Roundup dated 2/13/2024
- Today, the FDA posted warning letters to US Chem Labs and Synthetix Inc. doing business as Helix Chemical Supply for introducing unapproved and misbranded semaglutide and tirzepatide products into interstate commerce.
US Chem Labs offers for sale semaglutide and tirzepatide “for research purposes.” However, the products are accompanied by claims such as weight loss, reducing the risk of stroke, heart attack, or heart disease. In addition, the firm offers a product called “thymalin” (not related to semaglutide or tirzepatide) for both adults and children, for treatment of various conditions, such as immunosuppression after chemotherapy in cancer patients.
Helix Chemical Supply also offers semaglutide and tirzepatide for sale for “research purposes.” However, the products include claims such as treatment of Alzheimer’s disease, lowering blood sugar, or enhancing insulin secretion.