Wednesday, October 17, 2018

The Law of Compounding Medications And Drugs: FDA Warns Two Firms about Monensin Contamination i...

The Law of Compounding Medications And Drugs: FDA Warns Two Firms about Monensin Contamination i...: The U.S. Food and Drug Administration has issued warning letters to two feed mills, Gilman Co-Op Creamery in Gilman, Minnesota, and Fa...

Today, the federal government published the Fall 2018 Unified Agenda, which provides federal agencies the opportunity to share the government’s top regulatory priorities with the American public. For the U.S. Food and Drug Administration (FDA), the Agenda reflects our ongoing commitment to protecting and promoting the public health through science-based decision-making that informs new regulations that advance the public health and promote innovative, efficient oversight of our key areas of influence.
At the beginning of the year, we unveiled FDA’s 2018 Strategic Policy Roadmap. This plan was the product of a close collaboration among the Agency’s centers. Our Strategic Roadmap encompasses four key priorities the Agency is pursuing to advance our public health mission:
  • 1.       Reducing the burden of addiction crises that are threatening American families;
  • 2.       Leveraging innovation and competition to improve health care, broaden access, and advance public health goals;
  • 3.       Empowering consumers to make better and more informed decisions about their diets and health and expand the opportunities to use nutrition to reduce morbidity and mortality from disease; and,
  • 4.       Strengthening FDA’s scientific workforce and its tools for efficient risk management.
The Fall 2018 Unified Agenda reflects our continued commitment to these priorities as well as other new steps to enable us to advance these and some additional goals

FDA Warns Two Firms about Monensin Contamination in Horse Feed


The U.S. Food and Drug Administration has issued warning letters to two feed mills, Gilman Co-Op Creamery in Gilman, Minnesota, and Farmers/Ranchers Cooperative Association of Ainsworth in Ainsworth, Nebraska, that mixed horse feed containing monensin. Monensin is an animal drug approved for use in cattle, swine, and poultry that is highly toxic and potentially lethal to horses, even at relatively low levels.

These firms did not adhere to the Current Good Manufacturing Practice (CGMP) requirements for medicated feed mills. They are also subject to FDA’s Preventive Controls for Animal Food regulations. The medicated feed CGMPs require firms to conduct appropriate sequencing or adequate equipment cleanout procedures when switching from mixing a medicated animal food to a non-medicated one. These regulations are designed to prevent unsafe cross-contamination between medicated feed and non-medicated feed or other medicated feed.

Continue reading.

Tuesday, October 16, 2018

Seven Companies, Four Individuals Indicted in Billion-Dollar ...

Healthcare Informatics-3 hours ago
Roix and HealthRight also pleaded guilty to conspiring to commit wire fraud in a separate scheme for fraudulently telemarketing dietary supplements, skin ...

Dietary supplements may contain potentially harmful active drugs

MinnPost-7 hours ago
Since 2007, hundreds of dietary supplements — particularly ones used for erectile dysfunction, weight loss or muscle building — have been identified by the ...

Pharmacy Manager Accused of Illegally Dispensing Drugs

U.S. News & World Report-8 hours ago
Authorities say a pharmacy manager at a Rite Aid in Kentucky has been indicted on charges including dispensing a controlled substance without a proper ..

China slaps monstrous $1.3B penalty on vaccine scandal culprit ...

FiercePharma-7 hours ago
Changsheng's vaccine scandal first emerged in July after Chinese drug ... It soon progressed into a nationwide outcry, compounded by previous reports that the 

Stafford Woman Admits Fraud With Unnecessary Prescription

Patch.com-7 hours ago
Masucci convinced public workers to obtain the compounded drugs from the out of state pharmacy, so the pharmacy would be reimbursed thousands of dollars ...

UnitedHealthGroup subsidiary gobbles up Avella Specialty Pharmacy

Phoenix Business Journal-3 hours ago
He immediately changed the name to Apothecary Shop of Scottsdale, focusing on compounding while expanding to other states. That name stuck until some .

Five Tampa Bay area men charged in what prosecutors describe as a ...

Tampa Bay Times-1 hour ago
Andrew Assad, 33, of Palm Harbor; Peter Bolos, 41 of Lutz; and Michael Palso, 44, of Odessa were indicted along with their compounding pharmacies: Synergy ...
7 pharmacies indicted in $1B telemedicine fraud scheme
Becker's Hospital Review-2 hours ago

NJ woman admits recruiting state workers for massive prescription ...

NJ.com-9 hours ago
The guilty plea is part of a wide-ranging federal probe into the prescription fraud scam involving an out-of-state compounding pharmacy that supplied $50 million ...
Anthem to pay $16M in record data breach settlement
In the largest HIPAA settlement ever, Anthem will pay the federal government $16 million over its 2015 data breach that affected nearly 79 million people.  READ MORE
Posted: 15 Oct 2018 08:25 PM PDT

Is Pa. getting shortchanged on drug costs? Legislators want to know

Philly.com-14 hours ago
The Department of Human Services reported that it paid pharmacy benefit managers $2.84 billion in 2017, compared with $1.8 billion in 2013, according to the

Question of the Day October 16, 2018 Should Members of Congress and any elected state officials have to return political contributions/donations that are tied to fraudulent compounding pharmacy activities? Why or why not?


Telehealth company HealthRight charged in $1B fraud scheme

FierceHealthcare-16 hours ago
Telemedicine physicians approved the prescriptions without knowing that several compounding pharmacies were marking up the prices of the drugs, which was 

Ex-NECC Workers Blame Boss In Fraud Case

Law360-14 hours ago
Law360, Boston (October 15, 2018, 6:56 PM EDT) -- ​Attorneys for six former New England CompoundingCenter employees accused of misleading regulators ...

Express Scripts Not Hurt By Alleged Breach, Pharmacies Say

Law360-11 hours ago
Law360 (October 15, 2018, 9:32 PM EDT) -- Two compounding pharmacies are fighting back against Express Scripts Inc.'s claims that they withheld prescription ...

DOJ Indicts 4 Florida Men in $1B Telemedicine Fraud Conspiracy involving compounded drugs


DOJ Indicts 4 Florida Men in $1B Telemedicine Fraud Conspiracy

HealthLeaders Media-16 hours ago
Private payers, including Blue Cross Blue Shield of Tennessee, were bilked out of about $174 million in the compounding pharmacy scam, which inflated prices ...

NJ woman admits recruiting state workers for $50M prescription fraud involving compounded pain creams

NJ woman admits recruiting state workers for $50M prescription fraud ...

NJ.com-15 minutes ago
The guilty plea is part of a wide-ranging federal probe into the prescription fraud scam involving an out-of-state compounding pharmacy that supplied $50 million ...

A former pharmaceutical representative from Ocean County became the 21st person to admit to defrauding the state health benefits system as part of multi-million dollar scheme involving compounded cream medications"

https://www.pressofatlanticcity.com/news/crime/prescription_fraud/ocean-county-woman-admits-role-in-state-health-benefits-fraud/article_3c4501d0-6ad7-5c64-b602-2ced46764516.html

Monday, October 15, 2018

Huge Compounding Pain Cream Scheme Indictment unsealed in the Eastern District of Tennessee

Office of Public Affairs

FOR IMMEDIATE RELEASE
Monday, October 15, 2018

Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

On October 12, 2018, the District Court for the Eastern District of Tennessee unsealed a 32-count indictment charging four individuals and seven companies in a $1 billion health care fraud scheme. The court also unsealed an additional two plea agreements and an information charging another individual and his company for their role in the scheme.
Andrew Assad, 33, of Palm Harbor, Florida, Peter Bolos, 41, of Lutz, Florida, and Michael Palso, 44, of Odessa, Florida, were indicted along with their compounding pharmacies, Synergy Pharmacy Services, located in Palm Harbor, and Precision Pharmacy Management, located in Clearwater. Co-conspirator Larry Everett Smith, 48, of Pinellas Park, Florida, also a pharmacy compounder, and his companies Tanith Enterprises, ULD Wholesale Group, Alpha-Omega Pharmacy, all located in Clearwater, Germaine Pharmacy located in Tampa, Florida, and Zoetic Pharmacy located in Houston, Texas, were all also named as defendants. All the defendants were charged with conspiracy to commit health care fraud, mail fraud, and introducing misbranded drugs into interstate commerce.
On September 26, 2018, HealthRight LLC, a telemedicine company with locations in Pennsylvania and Florida, and Scott Roix, 52, of Seminole, Florida, and the CEO of HealthRight, pleaded guilty to felony conspiracy for their roles in the telemedicine health care fraud scheme in a criminal information. Roix and HealthRight LLC, also pleaded guilty to conspiring to commit wire fraud in a separate scheme for fraudulently telemarketing dietary supplements, skin creams, and testosterone.
The indictment alleges that from June 1, 2015 through April 1, 2018, these individuals and companies, together with other persons and companies known to the grand jury, conspired to deceive tens of thousands of patients and more than 100 doctors located in the Eastern District of Tennessee and across the country for the purpose of defrauding private health care benefit programs such as Blue Cross Blue Shield of Tennessee out of approximately $174,000,000. The indictment further alleges that the defendants submitted not less than $931,000,000 in fraudulent claims for payment.   
According to the indictment, the defendants set up an elaborate telemedicine scheme in which HealthRight fraudulently solicited insurance coverage information and prescriptions from consumers across the country for prescription pain creams and other similar products. The indictment states that doctors approved the prescriptions without knowing that the defendants were massively marking up the prices of the invalidly prescribed drugs, which the defendants then billed to private insurance carriers.
Assad, Bolos, Palso, and Smith appeared in court on October 11, 2018 before U.S. Magistrate Judge Anthony E. Porcelli in the U.S. District Court for the Middle District of Florida. All four individual defendants were released on bond and are scheduled for an initial appearance and arraignment in the U.S. District Court in the Eastern District of Tennessee before U.S. Magistrate Judge Clifton Corker on October 25, 2018.
If convicted, Assad, Bolos, Palso, and Smith face a term of up to 20 years in prison as to each mail fraud charge, up to 10 years in prison for the conspiracy, and up to three years in prison for introducing misbranded drugs into interstate commerce. Additionally, they face fines of up to $250,000 and up to three years of supervised release as to each count. The companies face fines of up to twice the gross loss sustained as a result of the conspiracy. The indictment also seeks forfeiture of approximately $154,000,000.
In addition to their roles in the health care fraud conspiracy, the Information filed against Roix and HealthRight charged each of them with conspiring to commit wire fraud as part of a scheme to use HealthRight’s telemarketing facilities to fraudulently sell millions of dollars’ worth of products such as weight loss pills, skin creams, and testosterone supplements through concocted claims of efficacy and intentionally deficient customer service designed to stall consumer complaints.
Roix and HealthRight pleaded guilty before U.S. District Judge J. Ronnie Greer of the Eastern District of Tennessee. Roix faces a statutory maximum sentence of 5 years of imprisonment for each conspiracy. The Court set sentencing for February 13, 2019.
The investigation was coordinated by Assistant U.S. Attorneys T.J. Harker, David Gunn, and Anne-Marie Svolto of the U.S. Attorney’s Office for the Eastern District of Tennessee, and Trial Attorney John Claud for the Department’s Consumer Protection Branch. Assistant U.S. Attorneys T.J. Harker and David Gunn will prosecute the telemedicine conspiracy for the U.S. Attorney's Office for the Eastern District of Tennessee. Trial Attorney John Claud will represent the Department's Consumer Protection Branch in court proceedings.
The investigation was conducted by the Nashville, Tennessee office of the U.S. Department of Health & Human Services Office of Inspector General; the Nashville office of the Food and Drug Administration Office of Criminal Investigations; the Buffalo, New York, office of the U.S. Postal Inspection Service; the Knoxville and Johnson City, Tennessee, offices of the Federal Bureau of Investigation; the Atlanta, Georgia, Office of Personnel Management Office of the Inspector General; and the Tampa, Florida, office of Homeland Security Investigations. The U.S. Marshals Service also assisted in the investigation and the forfeiture of assets.
Members of the public are reminded that an indictment constitutes only charges and that every person or company is presumed innocent until guilt has been proven beyond a reasonable doubt.
For more information about the U.S. Attorney’s Office for the Eastern District of Tennessee, visit its website at https://www.justice.gov/usao-edtn. Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.
Topic(s): 
Consumer Protection
Health Care Fraud

Two Companies Ordered to Pay More Than $7 Million for Adulterated and Misbranded Pet Food Ingredients ST. LOUIS, MO – Two companies were sentenced in federal court today relating to their introduction of adulterated and misbranded pet food ingredients into interstate commerce. Wilbur-Ellis Company is a California limited liability company with headquarters in San Francisco, California. The Feed Division of Wilbur-Ellis marketed and distributed products and ingredients for use in the pet food industry, including animal proteins used in the manufacture of dog food and cat food. Diversified Ingredients, Inc., a Missouri corporation with headquarters in Ballwin, Missouri, is a commodities broker, merchandiser, and distributor whose customers included a number of pet food companies and manufacturers. Continue reading.

ST. LOUIS, MO – Two companies were sentenced in federal court today relating to their introduction of adulterated and misbranded pet food ingredients into interstate commerce.
 
Wilbur-Ellis Company is a California limited liability company with headquarters in San Francisco, California.  The Feed Division of Wilbur-Ellis marketed and distributed products and ingredients for use in the pet food industry, including animal proteins used in the manufacture of dog food and cat food. Diversified Ingredients, Inc., a Missouri corporation with headquarters in Ballwin, Missouri, is a commodities broker, merchandiser, and distributor whose customers included a number of pet food companies and manufacturers.

Continue reading.

Question of the Day October 15, 2018 The indictments in the compounding pharmacy world keep coming. DOJ and the FDA are trying to do their part in reining in bad compounder and stopping the fraud and abuse. What is Congress doing or going to do to especially to show that the public's health, safety and welfare is more important that political contributions and donations from those in the compounding industry?


ANALYSIS DOJ INDICTS 4 FLORIDA MEN IN $1B TELEMEDICINE FRAUD CONSPIRACY-- Private payers, including Blue Cross Blue Shield of Tennessee, were bilked out of about $174 million in the compounding pharmacy scam, which inflated prices for invalidly prescribed pain creams and other drugs. BY JOHN COMMINS | OCTOBER 15, 2018

https://www.healthleadersmedia.com/doj-indicts-4-florida-men-1b-telemedicine-fraud-conspiracy

Saturday, October 13, 2018

Ohio Board of Pharmacy wants to ban Kratom

Very Interesting discussion!!! (Regarding pharmacist not doing the actual compounding and it being done by techs; big money in animal compounding and high margins in HRT)


23 hours ago · 6 posts · 5 authors
[–]stoichiometristsdn 1 point 3 hours ago. Try to get into a store that does a lot of compounds. [–]itsmark101 1 point 3 hours ago. You'll have to find a market that would have a niche for compounding pharmacy. I know someone who started a compounding pharmacy for horses.

Excellent resources still available on AVMA regarding animal compounding

A civil lawsuit in the case alleges violations of the Connecticut False Claims Act through a scheme involving a Florida compounding pharmacy and Connecticut state employees, whose prescription drug co...
Law360 (October 11, 2018, 9:50 PM EDT) -- Federal prosecutors can tell a Boston jury about the income of a former part-owner and director of the shuttered New England Compounding Center linked to a fa...
Law360 · 1d
  1. Deadly Meningitis Outbreak: Jurors will hear of NECC ...

    https://www.tennessean.com/story/news/health/2018/10/12/new...
    1 day ago · The VP of a company linked to a deadly meningitis outbreak earned $20 million in profits at New England Compounding Center, prosecutors say.
  1. Deadly Meningitis Outbreak: Jurors will hear of NECC ...

    https://www.tennessean.com/story/news/health/2018/10/12/new...
    1 day ago · The VP of a company linked to a deadly meningitis outbreak earned $20 million in profits at New England Compounding Center, prosecutors say.

Friday, October 12, 2018