Wednesday, October 20, 2021

Doesn't the ruling that the percentage of compounded drugs sold interstate was arbitrary force the FDA to then use the amount selected by Congress which is 5% or more? Why or why not? More importantly doesn't it just fortify the argument that the federal government/FDA should regulate any compounded drugs sold in interstate commerce? Why or why not?

 

2 days ago — Most significantly, compounding pharmacies operating within the bounds of Section ... However, a health system pharmacy that compounds drug products without .

 

6 days ago — Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product (section ...

 Pharmacist Sentenced to Nearly 6 Years in Prison for Multimillion-Dollar Compounded Medicine Scam that Defrauded Health Care Plans

An Orange County pharmacist has been sentenced to 70 months in federal prison for submitting more than $13 million in claims for medically unnecessary compounded medication prescriptions, the Justice Department announced today.

 

4 days ago — Approval of July 15, 2021, Enforcement and Compounding Committee Meeting ... reporting requirements for pharmacies distributing compounded human drug ...

 

16 hours ago — Indian hospital pharmacies underscore US FDA norms on drug compounding at medical ... Some of these compounders seek to compound drugs under section 503A.

 

5 days ago — Calabasas Doctor Sentenced to 14 Months in Federal Prison for Accepting Bribes as Part of Compounded Medication Conspiracy.

 

5 days ago — Compounding drugs is often at the center of these fraud cases. It is the practice of combining, mixing, or altering medicine ingredients to create a new ..

 

1 day ago — Doctor sentenced in compounding scheme. A southern California doctor was sentenced to 14 months in prison for accepting nearly $800,000 in bribes and ...

 

Friday, October 15, 2021

 

Statutes and Regulations

3 days ago — Pharmacy Related Sections of Chapter 217 - Foods, Drugs and Poisons ... compounding, dispensing and repackaging of radiopharmaceuticals.

 Department of Justice

Office of Public Affairs

FOR IMMEDIATE RELEASE
Wednesday, October 13, 2021

Texas Pharmacist Pleads Guilty to Adulterating Drug Used in Cataract Surgeries

A Texas man pleaded guilty Tuesday to one count of adulterating a drug that was used in cataract surgeries.

According to court documents, Jack Randall Munn, 71, of Dallas, a licensed pharmacist and former owner of Guardian Pharmacy Services (Guardian), a Dallas pharmacy, oversaw the compounding of the drug for two outpatient Dallas surgical centers in 2016 and 2017. The drug, a combination of an antibiotic and a steroid, contained an excessive amount of an inactive ingredient that can damage sensitive eye tissue.

At the time of the events described in court documents, Munn represented to the surgical centers that Guardian could compound the drug in a manner safe for injection into patients’ eyes. However, the drug made by Guardian contained an excessive amount of the inactive ingredient, causing its purity and quality to fall below that which it was represented to possess.

Munn pleaded guilty to one misdemeanor count of distributing an adulterated drug in violation of the Federal Food Drug and Cosmetic Act. He is scheduled to be sentenced on Feb. 3, 2022 and faces a maximum penalty of one year in prison and a fine of up to $100,000. The federal magistrate judge who presided over Munn’s guilty plea will determine sentence after considering the U.S. Sentencing Guidelines and other statutory factors.

The U.S. Food and Drug Administration’s (FDA) Office of Criminal Investigations investigated the case.

Assistant Director John Claud, Senior Trial Counsel David A. Frank and Trial Attorney Sarah Williams of the Civil Division’s Consumer Protection Branch are prosecuting the case. Associate Chief Counsel for Enforcement Karen Towns with the FDA’s Office of Chief Counsel, and the U.S. Attorney’s Office for the Northern District of Texas provided valuable assistance in the case.

Topic(s): 
Prescription Drugs
Press Release Number: 
21-988

The former owner of a Texas-based compounding pharmacy has pleaded guilty to adulterating a drug after at least 43 patients were left blinded or had their ....

 

Pharmacist pleads guilty to adulterating drug linked to eye ...

2 days ago — The former owner of a Texas-based compounding pharmacy has pleaded guilty to adulterating a drug after at least 43 patients were left blinded or had their ...

Pharmacist Sentenced to Nearly 6 Years in Prison for Multimillion-Dollar Compounded Medicine Scam that Defrauded Health Care Plans

 Department of Justice

U.S. Attorney’s Office
Central District of California

FOR IMMEDIATE RELEASE
Tuesday, October 5, 2021

Pharmacist Sentenced to Nearly 6 Years in Prison for Multimillion-Dollar Compounded Medicine Scam that Defrauded Health Care Plans

          LOS ANGELES – An Orange County pharmacist has been sentenced to 70 months in federal prison for submitting more than $13 million in claims for medically unnecessary compounded medication prescriptions, the Justice Department announced today.

          Thu Van Le, 42, a.k.a. “Tony Le,” of Placentia, was sentenced Monday by United States District Judge R. Gary Klausner.

          In addition to the prison term, Judge Klausner ordered Le to pay $10,982,759 in restitution to Tricare, the U.S. military’s managed health care plan, and $768,488 in restitution to Amplan, Amtrak’s employee health care benefit plan.

          Le, a pharmacist who owned TC Medical Pharmacy in Corona, pleaded guilty on July 12 to one count of health care fraud.

          From March 2015 to December 2016, Le’s pharmacy submitted more than $13 million in total claims to Tricare and AmPlan, against which Tricare paid $10,982,759 and AmPlan paid $768,488. Le, in turn, paid so-called “marketers” handsome kickbacks of up to 50 percent of the Tricare reimbursements.

          The marketers used personal and insurance information to generate fraudulent prescriptions for compounded medications, according to court documents. Marketers who participated in the scheme solicited beneficiaries of the health plans through misleading cold calls that promised free compounded medications. In some cases, beneficiaries were not contacted at all and simply received expensive medications that they did not order.

          Compounded drugs are tailor-made products doctors may prescribe when the Food and Drug Administration-approved alternative does not meet the health needs of a patient.

          Le agreed to be bound by Tricare and AmPlan rules for reimbursement of claims for their beneficiaries. Tricare and AmPlan required that medications be medically necessary, that beneficiaries be examined by physicians, and that Le’s pharmacy collect co-payments. The prescriptions were supposed to be for unique patient needs, but they instead were formulated to maximize reimbursements and were prepared on an assembly-line basis. 

          The Defense Criminal Investigative Service, the FBI, IRS Criminal Investigation, Amtrak’s Office of Inspector General, the Office of Personnel Management’s Office of Inspector General, the United States Department of Labor – Employee Benefits Security Administration, the Department of Health and Human Services, and the California Department of Insurance investigated this matter.

          Assistant United States Attorney Mark Aveis of the Major Frauds Section prosecuted this case.

Topic(s): 
Health Care Fraud
Contact: 
Thom Mrozek Director of Media Relations thom.mrozek@usdoj.gov (213) 894-6947
Press Release Number: 
21-208
Updated October 5, 2021

 

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This week from FDA: “Baffling inconsistency,” says Brunner - APC

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The impact of prescription drug pricing on workers' comp claims Despite the decrease in opioid usage, injured workers are still too often prescribed unnecessary--and costly--prescription drugs.

ttps://www.benefitspro.com/2021/10/12/the-impact-of-prescription-drug-pricing-on-workers-compensation-claims-412-122193/?slreturn=20210915023229 

Pharmacist pleads guilty to adulterating drug linked to eye injuries By Nate Raymond

https://www.reuters.com/legal/government/pharmacist-pleads-guilty-adulterating-drug-linked-eye-injuries-2021-10-13/#:~:text=Compounded%20drugs%20are%20custom%2Dmade,regulated%20pharmacies%20for%20specific%20patients. 

 

FDA revises Hospital and Health System Compounding ...

6 days ago — Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. The FDA is continuing our efforts to .