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
Friday, July 29, 2022
Wednesday, July 27, 2022
Baxter recalls software that may mislabel compounded drugs | AHA News
Baxter recalls software that may mislabel compounded drugs | AHA News: Baxter Healthcare Corp. recently recalled its Abacus software for ordering compounded liquid medications due to a risk the printed bag labels may contain incorrect information, the FDA announced.
| Everyday Import & Export, Inc. dba Everyday Group LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| Jost Chemical Co. | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||
| Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records | |||
| Custom Research Labs Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Zhang Medical P.C. dba New Hope Fertility Center | Office of Biological Products Operations – Division 1 | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||
| Bolive, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||
| Bi-Coastal Pharma International | Office of Pharmaceutical Quality Operations Division I | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Daniel Fred Goodman, M.D./Goodman Eye Center | Center for Drug Evaluation and Research | CDER | Bioresearch Monitoring Program/Institutional Review Board (IRB) | |||
| Blackout Vapors Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| M & K On Cumberland, Inc. dba Big Cloud Vape & Tobacco | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| Jose Miguel Gutierrez Salas | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated/Failure to Register and List |
Thursday, July 21, 2022
epartment of Justice
U.S. Attorney’s Office
District of Minnesota
FOR IMMEDIATE RELEASE
Wednesday, July 20, 2022
Pharmacist Pleads Guilty to Misappropriating and Adulterating Prescription Pain Medication
MINNEAPOLIS – A Minneapolis woman has pleaded guilty to misappropriating and adulterating prescription morphine while working as a pharmacist, announced U.S. Attorney Andrew M. Luger.
According to court documents, on October 30, 2019, Jennifer Lee Draheim, 42, a pharmacist at Coburn’s Pharmacy in Ramsey, removed a bottle of morphine sulfate from the Scheduled Drug Cabinet and poured a quantity of the morphine from the stock bottle into a small container for her own personal use. She added water to the bottle to replace the morphine she took, thereby reducing the drug’s quality and strength. Draheim returned the diluted bottle of morphine to the Scheduled Drug Cabinet, where it was held in the pharmacy’s inventory for the purpose of filling customer prescriptions.
“The FDA oversees the U.S. drug supply to ensure that it is safe and effective, and those who knowingly adulterate medicines put patients’ health at risk,” said Special Agent in Charge Lynda M. Burdelik, FDA Office of Criminal Investigations Chicago Field Office. “We will continue to protect the public health and bring to justice health care professionals who take advantage of their unique position and compromise their patients’ health and comfort.”
“The diversion of pharmaceuticals is a dangerous path that can lead to addiction, overdose and even death,” DEA Omaha Division Special Agent in Charge Justin C. King said. “We take diversion seriously as it impacts the person misusing the medication and also those for whom the prescription was intended. In this case, Jennifer Draheim’s actions put her life in danger and also affected those who were in need of morphine sulfate but instead received a tainted, watered-down medication. We applaud Coborn’s Inc., for alerting authorities to the diversion and our partners in the FDA for their work on this investigation.”
Draheim pleaded guilty yesterday before U.S. District Judge Nancy E. Brasel to one count of adulteration of a drug. A sentencing hearing will be scheduled at a later time.
This case is the result of an investigation conducted by the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration.
Assistant U.S. Attorney Lauren O. Roso is prosecuting the case.
Topic(s):
Opioids
Prescription Drugs
Component(s):
Updated July 20, 2022
Department of Justice
U.S. Attorney’s Office
District of New Jersey
FOR IMMEDIATE RELEASE
Thursday, July 14, 2022
Two New Jersey Men Admit Health Care Fraud Conspiracy Targeting State Health Benefits Programs
CAMDEN, N.J. – Two New Jersey men today admitted defrauding New Jersey state and local health benefits programs and other insurers by submitting fraudulent claims for medically unnecessary prescriptions, Attorney for the United States Vikas Khanna announced.
Brian Pugh, 45, of Absecon, New Jersey, and Thomas Schallus, 45, of Northfield, New Jersey, pleaded guilty before U.S. District Judge Robert B. Kugler to one count each of conspiracy to commit health care fraud.
According to documents filed in this case and statements made in court:
Pugh and Schallus were part of a criminal conspiracy in which state and local government employees were recruited and compensated to receive medically unnecessary compound prescription medications. Pugh and Schallus caused the pharmacy benefits administrator to pay approximately $1.47 million and $477,958.00, respectively, for medically unnecessary compounded prescription medications for individuals they recruited into the scheme.
Pugh and Schallus were previously charged alongside others in an indictment with conspiracy to commit health care fraud and wire fraud and other offenses. Conspiracy leader William Hickman pleaded guilty in June of 2020 to defrauding New Jersey health benefits programs and other insurers out of more than $50 million and is awaiting sentencing. Charges remain pending against co-defendants John Sher, Thomas Sher, and Christopher Broccoli, who are set to proceed to trial before Judge Kugler in Camden federal court on Aug. 15, 2022. The charges against those three defendants are merely accusations, and they remain innocent unless and until proven guilty.
Pugh and Schallus each face a maximum penalty of 10 years in prison and a $250,000 fine, or twice the gross gain or loss from the offense. Sentencing for Pugh is scheduled for Nov. 17, 2022, and for Schallus, Nov. 14, 2022.
Attorney for the United States Khanna credited agents of the FBI’s Atlantic City Resident Agency, under the direction of Special Agent in Charge Jesse Levine in Newark; special agents of IRS Office of Criminal Investigation, under the direction of Acting Special Agent in Charge Tammy Tomlins in Newark; and special agents of the U.S. Department of Labor Office of Inspector General, New York Region, under the direction of Special Agent in Charge Jonathan Mellone, with the investigation leading to today’s guilty pleas.
The government is represented by Assistant U.S. Attorney Christina O. Hud of the Criminal Division, Deputy Chief of the Criminal Division Desiree Grace, and R. David Walk Jr., Chief of the Opioid Abuse Prevention & Enforcement Unit.
Defense counsel:
Pugh: Michael A. Baldassare Esq. and Jennifer Mara Esq., Newark
Schallus: John C. Whipple Esq., Moorestown, New Jersey
Updated July 14, 2022
Former co-owner of Tony’s Baltimore Grill and ex-Ventnor cop plead guilty in vast Shore benefits-plan conspiracy They are the latest to plead guilty in a $53 million prescription drug benefits scheme that involved Jersey Shore doctors, firefighters, police officers and teachers with state health-care plans.
| Swan Brothers Dairy Inc | Office of Human and Animal Food Operations West Division 3 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | ||||
| H2 Beverages, Inc. | Division of Human and Animal Food Operations West III | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||||
| Jap Inc. dba Intercontinental Foods | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Regino Produce LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Free Range Vapor LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| USA Vapor Trails | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Imprimis Rx LLC | Division of Pharmaceutical Quality Operations IV | False & Misleading Claims/Misbranded | ||||
| Living Foods LLC | Office of Human and Animal Food- West Division II | Unapproved New Drugs/Misbranded |
| Rockwall Vaporstop LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Young Living Essential Oils Corporate | Office of Human and Animal Food Operations – West Division 4 | New Drug/Misbranded | ||||
| Genlabs Corporation | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| New Sun Inc. | Office of Human and Animal Foods- East Division 3 | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | ||||
| Bioiberica, SAU | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | ||||
| Greenfield Produce Imports | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Brad Grate Dairy Farm | Office of Human and Animal Food Operations East Division 6 | New Animal Drug/Adulterated | ||||
| Dara Food LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Flores Produce, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| North30 LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
Monday, July 18, 2022
- Adam's Secret Extra Strength Blue contains hidden drug ingredient
- Adam’s Secret Extra Strength Purple contains hidden drug ingredients
- Adam’s Secret Extra Strength Amazing Black contains hidden drug ingredient
- Adam’s Secret Extra Strength 3000 Platinum (White Packaging) contains hidden drug ingredient
- Dr. Reade Slim Sense contains hidden drug ingredient
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