05/09/2022	05/04/2022	Assault Labs	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	New York Nutrition Company	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Ironmag Labs	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Advanced Nutritional Supplements LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Exclusive Nutrition Products, LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Steel Supplements Inc	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated

05/10/2022	04/11/2022	Brigham and Women’s Hospital Inc.	Office of Pharmaceutical Quality Operations Division I	CGMP/Positron Emission Tomography (PET) Drugs/Adulterated
05/10/2022	04/21/2022	MCACO, LTD	Division of Human and Animal Food Operations West III	CGMP/Dietary Supplement/Adulterated
05/10/2022	03/08/2022	Purina Animal Nutrition LLC	Division of Human and Animal Food Operations West III	CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
05/10/2022	05/04/2022	Inhousepharmacy.vu	Center for Drug Evaluation and Research | CDER	Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
05/10/2022	05/02/2022	David Cosmetic Co., Ltd.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceutical/Adulterated
05/10/2022	04/29/2022	Beachside Vapors LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
05/09/2022	05/04/2022	Nutritional Sales and Customer Service, LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Max Muscle	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Complete Nutrition	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Performax Labs Inc	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated

New York Racehorse Veterinarian And Standardbred Trainer Plead Guilty In Federal Doping Case Veterinarian Louis Grasso and Racehorse Trainer Richard Banca Used Their Positions to Acquire, Distribute and Administer Prohibited Performance Enhancing Drugs

New York Racehorse Veterinarian And Standardbred Trainer Plead Guilty In Federal Doping Case Veterinarian Louis Grasso and Racehorse Trainer Richard Banca Used Their Positions to Acquire, Distribute and Administer Prohibited Performance Enhancing Drugs Damian Williams, the United States Attorney for the Southern District of New York, announced that defendants LOUIS GRASSO and RICHARD BANCA pled guilty to their respective roles in the distribution of adulterated and misbranded drugs with the intent to defraud and mislead, in connection with the charges filed in United States v. Grasso et al., 20 Cr. 163 (OKC). Both GRASSO and BANCA pled guilty before U.S. District Judge P. Kevin Castel. GRASSO and BANCA will each be sentenced by Judge Castel on September 6, 2022. Read More Button

Oklahoma Board of Pharmacy Needs Volunteers

 Task Force/Committee Volunteers Needed 

 

The Board of Pharmacy is needing volunteers to create a Task Force/Committee for evaluating temperature excursions and the shipping of prescriptions by pharmacies to patients who are located in state and out of state.

This Task Force/Committee will more than likely need to evaluate the potential of creating rule changes to the existing rules.

All interested parties will need to submit the below items to Marty Hendrick via email at Mhendrick@pharmacy.ok.gov to be considered for this task force. 

 

• Letter of interest on serving on the Task Force/Committee.
• Resume of pharmacy work experience.
• Past experience in a pharmacy practice that involves shipping prescriptions to patients.

 

535:15-3-11. Prescription drugs 

(f) Prescription shipping. The pharmacy shall maintain and use adequate storage or shipping containers and use shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process. 

 

(1) No prescription shipped to a citizen of Oklahoma should have a temperature excursion that exceeds the temperature storage conditions outlined within the package insert or by the manufacturer of the drug product. 

 

(2) A pharmacy or pharmacist shall refuse to deliver by mail or common carrier a prescription drug which, in the professional opinion of the pharmacy or pharmacist may be therapeutically compromised by delivery by mail or common carrier. 

 

(3) A mail order or non-resident pharmacy shall make available to the patient or patient's caregiver the contact information for the Oklahoma State Board of Pharmacy.

 

Court

Jury Convicts Lisa Giannelli For Marketing and Selling Hundreds of Untestable Performance Enhancing Drugs to Racehorse Trainers Across the United States

Damian Williams, the United States Attorney for the Southern District of New York, announced the conviction at trial of defendant LISA GIANNELLI, on one count of drug adulteration and misbranding, with intent to defraud and mislead, in connection with a nearly twenty-year scheme to create and distribute “untestable” performance enhancing drugs for use in professional horseracing. GIANNELLI was one of over thirty defendants charged in four separate cases in March 2020, each arising from this Office’s multi-year investigation of the abuse of racehorses through the use of performance enhancing drugs.

 Horse racing is on the cusp of major changes in the U.S. after years of scandal

A newly formed regulatory authority for horse racing is introducing new standards for the sport. Some stakeholders are pushing back.

Read in NPR: https://apple.news/AkI0lXcNBSyupVv7Bte8c9w

 Trainer Bob Baffert Won’t Be at the Kentucky Derby, but Racing Still Can’t Shake Him

One of the most successful—and now controversial—trainers received a stark message: No one is bigger than Churchill Downs. But his presence still looms.

Read in Sports Illustrated: https://apple.news/AAoyOo5KbRSy8JbEYUf9dXw

 Department of Justice

Office of Public Affairs

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FOR IMMEDIATE RELEASE

Tuesday, April 26, 2022

Pharmacist Sentenced for $180 Million Health Care Fraud Scheme

A former Mississippi pharmacist was sentenced today to 10 years in the Southern District of Mississippi for a multimillion-dollar scheme to defraud TRICARE and private insurance companies by paying kickbacks to distributors for the referral of medically unnecessary prescriptions. The conduct resulted in more than $180 million in fraudulent billings, including more than $50 million paid by federal health care programs. 

According to court documents, Mitchell “Chad” Barrett, 55, now of Gulf Breeze, Florida, and formerly of Mississippi, participated in a scheme to defraud TRICARE and other health care benefit programs by distributing medically unnecessary compounded medications. Barrett was licensed as a pharmacist in Mississippi and was a co-owner of various compounding pharmacies. As part of this scheme, Barrett adjusted prescription formulas to ensure the highest reimbursement without regard to medical necessity. He solicited recruiters to procure prescriptions for high-margin compounded medications and paid those recruiters commissions based on the percentage of reimbursements paid by pharmacy benefit managers and health care benefit programs, including commissions on claims reimbursed by TRICARE. He further routinely and systematically waived and/or reduced copayments to be paid by beneficiaries and members, and utilized a purported copayment assistance program to falsely make it appear as if his pharmacy and its affiliate compounding pharmacies had been collecting copayments. 

Barrett pleaded guilty on Aug. 25, 2021, to conspiracy to engage in monetary transactions in criminally derived property. In addition to the term of imprisonment, Barrett was ordered to pay restitution and forfeit all assets traced to his ill-gotten gains.

Assistant Attorney General Kenneth A. Polite, Jr. of the Justice Department’s Criminal Division; U.S. Attorney Darren J. LaMarca for the Southern District of Mississippi; Assistant Director Luis Quesada of the FBI’s Criminal Investigative Division; and Special Agent in Charge Cyndy Bruce of the Department of Defense Office of Inspector General’s Defense Criminal Investigative Service (DoD OIG-DCIS) Southeast Field Office made the announcement.

The FBI Jackson Field Office and DoD OIG-DCIS are investigating the case.

Trial Attorneys Emily Cohen and Alejandra Arias of the Criminal Division’s Money Laundering and Asset Recovery Section and Assistant U.S. Attorney Kathlyn Van Buskirk of the Southern District of Mississippi are prosecuting the case with assistance from Sara Porter and Dustin Davis from the Criminal Division’s Fraud Section.

Topic(s): 

Health Care Fraud

Component(s): 

Criminal Division

Criminal - Criminal Fraud Section

Criminal - Money Laundering and Asset Recovery Section

Press Release Number: 

22-429

 Department of Justice

Office of Public Affairs

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FOR IMMEDIATE RELEASE

Thursday, April 28, 2022

Pharmacy Owner Pleads Guilty in Health Care Fraud and Kickback Scheme

A New York man pleaded guilty today to conspiracy to commit health care fraud and unlawfully spending the proceeds of his $6.8 million fraud.

According to court documents, Robert John Sabet, 46, of Brooklyn, the owner of two New York City pharmacies, conspired to bill Medicare and Medicaid for expensive prescription drugs that were not needed by patients, were dispensed in connection with kickbacks, or, in some cases, not dispensed at all. As part of the conspiracy, Sabet and others paid kickbacks and bribes to customers to convince them to fill prescriptions at his pharmacies, and paid customers cash in exchange for the ability to bill Medicare and Medicaid for over-the-counter health care-related products on their behalf. Sabet used proceeds of the scheme to purchase luxury items, such as a 2020 Porsche Taycan worth over $250,000.

Sabet pleaded guilty to conspiracy to commit health care fraud and committing unlawful financial transactions. He is scheduled to be sentenced on July 29 and faces a maximum penalty of 10 years in prison. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

Assistant Attorney General Kenneth A. Polite, Jr. of the Justice Department’s Criminal Division; U.S. Attorney Breon Peace for the Eastern District of New York; Special Agent in Charge Scott J. Lampert of the U.S. Department of Health and Human Services Office of Inspector General’s (HHS-OIG) Office of Investigations, New York Regional Office; Special Agent in Charge Thomas Fattorusso of IRS-Criminal Investigation (IRS-CI), New York; and Acting Medicaid Inspector General Frank T. Walsh Jr. of the New York State Office of the Medicaid Inspector General (OMIG) made the announcement.

HHS-OIG, IRS-CI, and OMIG investigated the case.

Trial Attorney Miriam Glaser Dauermann of the Criminal Division’s Fraud Section and Assistant U.S. Attorney Brendan King for the Eastern District of New York are prosecuting the case.

Topic(s): 

Health Care Fraud

Component(s): 

Criminal Division

Criminal - Criminal Fraud Section

Press Release Number: 

22-445

 Wednesday, May 4, 2022

Speech

Assistant Attorney General Kenneth A. Polite, Jr. Delivers Remarks on 2022 Opioid Enforcement Action

Wednesday, May 4, 2022

Press Release

Justice Department Announces Enforcement Action Charging 12 Medical Professionals with Opioid Distribution Offenses