Friday, February 16, 2024

 

Data transmission errors in the VA's new commercial health record could potentially lead to providers missing important prescription information on patients who visit multiple agency facilities.   // By Edward Graham

 

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.

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Tuesday, February 13, 2024

 

AN ACT relating to purchase limits for pseudoephedrine.

1 day ago — registered pharmacist, a pharmacy intern, or a pharmacy technician. 7. (2) Any ... pharmacy may dispense or sell any compound, mixture, or preparation containing.

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

4 days ago — medicines (“Unapproved Compounded Drugs”). 6. Without the consent of plaintiff ... that: (a) the Unapproved Compounded Drugs are compounded drugs that have

 

Regulatory Agenda

5 days ago — ... compounded human drug products. It will also, if finalized, include ... drug supply chain and ensuring safety, effectiveness, and quality of imported drugs.

 

Business Impact Analysis - Ohio Board of Pharmacy

3 hours ago — diversion and to prepare compounded drugs in accordance with federal standards. Additionally, drug distributors may experience an increase in costs due to the.

 

Drug Control Division - Department of Consumer Protection

5 hours ago — Section 5: Perpetual inventory for Schedule II medications with monthly reconciliation; Section 6: Sterile compounding. 2017. Public Act 17-131 An Act ...

 

2024 Regular Session - House Bill 1099 First Reader

7 days ago — FOR the purpose of authorizing certain veterinary practitioners and veterinary technicians. 4 to compound prescription drugs under certain circumstances; ...

 

General Law - Part I, Title XVI, Chapter 112, Section 39G

2 days ago — A retail sterile compounding pharmacy that ships compounded drug preparations outside of the commonwealth shall, in addition to the requirements in this

Novo Nordisk settles two lawsuits over copycat versions of Ozempic and Wegovy The settlements come as states have been cracking down on compounded versions of the drugs.

 Novo Nordisk settles two lawsuits over copycat versions of Ozempic and Wegovy (nbcnews.com)

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.

Updated February 12, 2024

 

  • 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. 

Friday, January 26, 2024

 

North Texas pharmacy kickback case ends in convictions

Jan 17, 2024 — Compounding pharmacies fell under intense federal scrutiny beginning around 2014 due to allegations of massive fraud. North Texas pharmacies were among those .

 

FDA Releases Draft Interim Guidance on Bulk Drug ...

Jan 10, 2024 — The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under ...

 

Section 535:15-10-8 - Drug compounding controls, Okla. ...

Jan 2, 2024 — Okla. Admin. Code § 535:15-10-8 · (1) Compounding a drug product that is commercially available in the marketplace or that is essentially a copy of an available .