Tuesday, January 19, 2021

 Facility Licenses

A & G Pharmacy, PHY 52407, Administrative Case AC 6778
Winnetka, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 12/9/2020.

Alamo Pharmacy, PHY 51901, Administrative Case AC 6610
Simi Valley, CA
Through a disciplinary action of the Board, the license is revoked, the revocation stayed, and the license is placed on probation for five years subject to the terms and conditions in the decision.
Decision effective 11/25/2020.

Colorado Pharmacy, PHY 52413, Administrative Case AC 6562
Los Angeles, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 12/9/2020.

CVS Pharmacy #3079, PHY 49549, Administrative Case AC 6734
Riverbank, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 11/25/2020.

CVS Pharmacy #9919, PHY 49371, Administrative Case AC 6741
Turlock, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 11/25/2020.

CVS Pharmacy #09884, PHY 49751, Administrative Case AC 6742
Modesto, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 11/25/2020.

CVS Pharmacy #2994, PHY 50132, Administrative Case AC 6743
Turlock, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 11/25/2020.

CVS Pharmacy #1467, PHY 49075, Administrative Case AC 6744
Modesto, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 11/25/2020.

CVS Pharmacy #17183, PHY 54149, Administrative Case AC 6745
Riverbank, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 11/25/2020.

CVS Pharmacy #16082, PHY 54223, Administrative Case AC 6746
Modesto, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 11/25/2020.

E R Pharmacy Rx, PHY 50257, Administrative Case AC 6831
Northridge, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 12/9/2020.

Fruitvale Avenue Pharmacy, PHY 53737, Administrative Case AC 6243
Oakland, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 12/9/2020.

Hawthorne Professional Pharmacy, PHY 38184, Administrative Case AC 6700
Hawthorne, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered. The effective date shall be stayed until April 8, 2021.
Decision effective 12/9/2020.

Horton & Converse Pharmacy, PHY 19454, Administrative Case AC 6609
Santa Monica, CA   
Through a disciplinary action of the Board, the license is voluntarily surrendered. 
Decision effective 10/8/2020.

Lockeford Drug, PHY 39960, Administrative Case AC 6781
Lockeford, CA
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 11/4/2020.

Molino Pharmacy, PHY 54954, Administrative Case AC 6667
Long Beach, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered.
Decision effective 12/23/2020.

Omnicare of Northern California, PHY 54230, Administrative Case AC 6753
Lodi, CA
Through a disciplinary action of the Board, the license is revoked, the revocation stayed, and the license is placed on probation for three years subject to the terms and conditions in the decision.
Decision effective 12/9/2020.

Payless Pharmacy, PHY 50705, Administrative Case AC 7000
Rosemead, CA
Through a disciplinary action of the Board, the license is revoked and the right to practice or operate has ended.
Decision effective 12/9/2020.

Pharmerica, PHY 55902, Administrative Case AC 6791
Union City, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 12/9/2020.

Pharmerica, PHY 55912, Administrative Case AC 6791
Sacramento, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 12/9/2020.

Pharmco Drugs, PHY 51829, Administrative Case AC 6872
Norco, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 11/25/2020.

Raley’s Pharmacy #336, PHY 53518, Administrative Case AC 6615
Brentwood, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 11/25/2020.

San Ysidro Pharmacy, Inc., PHY 46711, Administrative Case AC 5737
Santa Barbara, CA
Through a disciplinary action of the Board, the license is voluntarily surrendered. The effective date shall be stayed until April 8, 2021, at which time the pharmacy shall be sold or closed.    
Decision effective 12/9/2020.

Star Pharmacy, PHY 57459, Administrative Case AC 6555
Van Nuys, CA
Through a disciplinary action of the Board, the license is publicly reproved and subject to the terms and conditions in the decision.
Decision effective 11/4/2020.

Tustin Community Pharmacy, PHY 30023, Administrative Case AC 6160
Tustin, CA   
Through a disciplinary action of the Board, the license is voluntarily surrendered. 
Decision effective 10/8/2020.

West Marin Pharmacy Inc, PHY 48531, Administrative Case AC 6801
Point Reyes Station, CA
Through a disciplinary action of the Board, the license is revoked, the revocation stayed, and the license is placed on probation for three years subject to the terms and conditions in the decision.
Decision effective 12/9/2020.

 Facility Licenses

Alixarx, PHY 51693, Administrative Case AC 6995
Fresno, CA
Accusation Filed 11/4/2020; Case pending.

Alixarx, LSC 99953 51693, Administrative Case AC 6995
Fresno, CA
Accusation Filed 11/4/2020; Case pending.

Edge Pharma LLC, NSF 132, Administrative Case AC 7047
Colchester, CA
Accusation Filed 11/12/2020; Case pending.

McKesson Drug Company, WLS 3076, Administrative Case AC 6850
Santa Fe Springs, CA
First Amended Accusation Filed 11/16/2020; Case pending.

OC Wellness and Specialty Pharmacy, PHY 55826, Administrative Case AC 6979
Orange, CA
Accusation Filed 11/23/2020; Case pending.

Omega Care Pharmacy, PHY 53936, Administrative Case AC 7004
Sherman Oaks, CA
Accusation Filed 11/23/2020; Case pending.

Santa Monica Medical Plaza Pharmacy, PHY 51669, Administrative Case AC 6865
Santa Monica, CA
Accusation Filed 11/23/2020; Case pending.

Skilled Nursing Pharmacy, PHY 49974, Administrative Case AC 6975
Hayward, CA
Accusation Filed 11/23/2020; Case pending.

Skilled Nursing Pharmacy, LSC 99561, Administrative Case AC 6975
Hayward, CA
Accusation Filed 11/23/2020; Case pending.

Tower Pharmacy, PHY 53607, Administrative Case AC 7035
Burbank, CA
Accusation Filed 11/16/2020; Case pending.

University of California Irvine Medical Center, HPE 49819, Administrative Case AC 6997         
Orange, CA
Accusation Filed 11/16/2020; Case pending.

University of California Irvine Medical Center, LSE 100230, Administrative Case AC 6997         
Orange, CA
Accusation Filed 11/16/2020; Case pending.

 

Application for Veterinarian Authority to Dispense Drugs

2 days ago — Nevada State Board of Pharmacy. 985 Damonte Ranch Parkway, Suite 206. Reno, NV 89521. If your dispensing address changes or you add additional 

Streamlining animal biotech rules unlikely as FDA rejects USDA proposal to take over regulation, citing ‘potential health repercussions’

Streamlining animal biotech rules unlikely as FDA rejects USDA proposal to take over regulation, citing ‘potential health repercussions’
Department of Justice
Office of Public Affairs

FOR IMMEDIATE RELEASE
Friday, January 15, 2021

Federal Court Restrains Toledo Pharmacy and Two Pharmacists From Dispensing Opioids or Other Controlled Substances

A federal court in Ohio issued a temporary restraining order enjoining a Toledo, Ohio, pharmacy and two of its pharmacists from dispensing opioids and other controlled substances, the Department of Justice announced today.

In a civil complaint filed Jan. 6, 2021, and unsealed Jan. 14, 2021, in the Northern District of Ohio, the United States alleges that Shaffer Pharmacy, its pharmacist owner Thomas Tadsen, and pharmacist Wilson Bunton repeatedly dispensed opioids and other controlled substances in violation of the Controlled Substances Act. The complaint alleges that over a period of several years, the defendants dispensed highly addictive and highly abused prescription opioids while ignoring “red flags” — that is, obvious indications of drug diversion and drug-seeking behavior. U.S. District Judge Jack Zouhary granted the government’s request for a temporary restraining order, which was filed along with the complaint.

“Federal law requires pharmacists to ensure that the controlled substance prescriptions they fill are medically legitimate,” said Acting Assistant Attorney General Jennifer B. Dickey of the Justice Department's Civil Division. “The Department of Justice will continue to work with DEA and our law enforcement partners to combat the opioid crisis by holding accountable pharmacies that abandon their obligations.”

“The illegal prescribing or dispensing of narcotics by medical personnel only serves to further worsen the opioid epidemic in northern Ohio and increase the number of overdose deaths in our community,” said Acting U.S. Attorney Bridget M. Brennan for the Northern District of Ohio. “Allegations of prescription misuse continue to be a priority for this office, and offenders should expect significant consequences.”

“Dispensing controlled substances is a privilege that requires abiding by the law,” said Drug Enforcement Administration (DEA) Special Agent in Charge Keith Martin. “DEA is committed to ensuring that those who have pledged to follow our nation’s drug laws are living up to that responsibility.”

“We continue to face an uphill battle against drug abuse and addiction, and it is unthinkable that a licensed provider would contribute to this growing epidemic,” said Special Agent in Charge Eric B. Smith of the FBI, Cleveland Division. “Restraining the ability of these defendants to continue filling prescriptions without medical necessity is a significant step. The FBI will continue efforts to identify and hold accountable any medical professional that violates their legal obligation to do no harm when they engage in criminal misconduct."

The complaint alleges that the defendants failed to take steps required to resolve red flags and ensure the legitimacy of prescriptions before filling them. According to court documents, the prescriptions dispensed by the defendants often involved highly abused opioid painkillers such as oxycodone, hydrocodone, oxymorphone, buprenorphine, and fentanyl, often in dangerous combination with other prescription drugs such as benzodiazepines (i.e., sedatives indicated for the treatment of anxiety, such as Xanax), and muscle relaxants (e.g., carisoprodol, also known by its brand name, Soma). The complaint seeks civil penalties as well as a permanent injunction against the defendants.   

The claims made in the complaint are merely allegations that the United States must prove if the case proceeds to trial.

The United States is represented by Assistant U.S. Attorneys Patricia Fitzgerald and Angelita Cruz Bridges for the Northern District of Ohio, and Trial Attorneys Scott Dahlquist and Maryann McGuire of the Justice Department’s Consumer Protection Branch. This investigation is being conducted by the DEA, FBI, U.S. Department of Health and Human Services Office of Inspector General, the State of Ohio Board of Pharmacy, the Ohio Bureau of Workers’ Compensation, and the Ohio Attorney General’s Medicaid Fraud Control Unit.

Topic(s): 
Consumer Protection
Opioids
Component(s): 
Press Release Number: 
21-60

Industry 4.0; Strengthening US Public Health Infrastructure The FDA moves to leverage Industry 4.0 to help strengthen the nation’s public health infrastructure Laura V. Garcia |Jan 17

https://www.manufacturingglobal.com/smart-manufacturing/industry-40-strengthening-us-public-health-infrastructure 

Shark Tank's Mark Cuban Dives into Generic Drug Market Published: Jan 14, 2021 By Alex Keown

https://www.biospace.com/article/billionaire-entrepreneur-mark-cuban-offers-low-cost-generic-drugs-with-new-generics-startup/ 

Utah pharmacy owner admits illegally receiving hydroxychloroquine shipment from China By Dennis Romboy, Deseret News | Posted - Jan. 16, 2021 at 11:12 a.m.

https://www.ksl.com/article/50088867/utah-pharmacy-owner-admits-illegally-receiving-hydroxychloroquine-shipment-from-china 

 

20 CSR 2220 - Missouri Secretary of State: Code of State ...

10 hours ago — compounded in a pharmacy or other estab- lishments holding ... no prescription will be compounded, dis- pensed or ... dispensing, compounding or admixture of.

Wade Ashley Walters, 54, of Hattiesburg, a co-owner of numerous compounding pharmacies and pharmaceutical distributors, was sentenced today on his guilty plea to one count of conspiracy to commit health care fraud and one count of conspiracy to commit money laundering. U.S. District Judge Keith Starrett of the Southern District of Mississippi ordered Walters to serve a total of 18 years in prison and to pay $287,659,569 in restitution. Walters was remanded into custody following the sentencing hearing. Walters was further ordered to forfeit $56,565,963, representing the proceeds he personally derived from the fraud scheme.

 Department of Justice

Office of Public Affairs

FOR IMMEDIATE RELEASE
Friday, January 15, 2021

Compounding Pharmacy Mogul Sentenced for Multimillion-Dollar Health Care Fraud Scheme

A Mississippi businessman was sentenced today for his role in a multimillion-dollar scheme to defraud TRICARE, the health care benefit program serving U.S. military, veterans, and their respective family members, as well as private health care benefit programs.

Wade Ashley Walters, 54, of Hattiesburg, a co-owner of numerous compounding pharmacies and pharmaceutical distributors, was sentenced today on his guilty plea to one count of conspiracy to commit health care fraud and one count of conspiracy to commit money laundering. U.S. District Judge Keith Starrett of the Southern District of Mississippi ordered Walters to serve a total of 18 years in prison and to pay $287,659,569 in restitution. Walters was remanded into custody following the sentencing hearing. Walters was further ordered to forfeit $56,565,963, representing the proceeds he personally derived from the fraud scheme.

“The fraud committed by Walters and others in this investigation wasted hundreds of millions of taxpayer dollars and deprived individuals of needed medical care,” said David P. Burns, Acting Assistant Attorney General of the Justice Department’s Criminal Division. “Today’s significant sentence signifies that we will continue to stand with our agency partners to root out health care fraud schemes and see their perpetrators brought to justice.”

Between 2012 and 2016, Walters orchestrated a scheme to defraud TRICARE and other health care benefit programs by distributing compounded medications that were not medically necessary. As part of the scheme, Walters and his co-conspirators, among other things, adjusted prescription formulas to ensure the highest reimbursement without regard to efficacy; solicited recruiters to procure prescriptions for high-margin compounded medications and paid those recruiters commissions based on the percentage of the reimbursements paid by pharmacy benefit managers and health care benefit programs, including commissions on claims reimbursed by TRICARE; solicited (and at times paying kickbacks to) practitioners to authorize prescriptions for high-margin compounded medications; routinely and systematically waived and/or reduced copayments to be paid by beneficiaries and members, including utilizing a purported copayment assistance program to falsely make it appear as if the pharmacies were collecting copayments.

“Today’s sentencing is another mile marker on the long road to justice for victims, our veterans, our military, and all American taxpayers, as the mastermind of the largest healthcare fraud scheme in Mississippi history has been held to answer for his crimes,” said Mike Hurst, U.S. Attorney for the Southern District of Mississippi. “I want to commend our prosecutors, Justice Department trial attorneys, and every member of this incredible team of federal, state, and local law enforcement agencies for discovering this scheme and bringing all of these criminals to justice. While there is more work to do, the public can rest assured that we will continue to hold evildoers to account and that justice will always be done in the Southern District of Mississippi.”

“This scheme to defraud TRICARE out of hundreds of millions of dollars not only diverted taxpayer money from essential services and medical care but victimized the brave men and women who selflessly serve or have served our country,” said Michelle Sutphin, Special Agent in Charge of the FBI’s Jackson Field Office. “The investigation into this specific scheme, which now spans across multiple states and FBI field offices, began in the FBI’s Jackson Field Office. I am incredibly proud of the relentless efforts made by our Special Agents, Intelligence Analysts and professional support staff, but also the assistance from our partner agencies which make cases like this successful. The FBI and our law enforcement partners are committed to seeking those that intend to steal from others for their own financial gain.”

“IRS Criminal Investigation provides financial investigative expertise in our work with our law enforcement partners, said James E. Dorsey, Special Agent in Charge of IRS Criminal Investigation (CI), Atlanta Field Office. “Pooling the skills of each agency makes a formidable team as we investigate allegations of wrong-doing. Today's sentencing demonstrates our collective efforts to successfully enforce the law and ensure public trust.”

“The Defense Health Agency (DHA) works to set the standard in care for our military, families and veterans,” said Cyndy Bruce, Special Agent in Charge with the Defense Criminal Investigative Service (DCIS), Southeast Field Office. “With full knowledge, Mr. Walters aggressively exploited DHA for personal enrichment. I want thank the U.S. Department of Justice and our investigative team for their tireless work to bring these crimes to light. There is no victimless crime, these significant funds were stolen from each and every tax payer and I am pleased that today, this defendant is being held accountable for his actions.”

“The sentencing of Walters highlights continued cooperation among law enforcement agencies at the local, state, and federal levels to ensure public safety throughout Mississippi,” said Colonel Steven Maxwell, Director of the Mississippi Bureau of Narcotics (MBN). “Protecting the public from individuals like Walters is a priority for MBN and is a mainstay in accomplishing our agency’s mission.”

Walters and his numerous co-conspirators effectuated a scheme to defraud health care benefit programs, including the TRICARE program, in an amount exceeding $287 million. Walters further conspired with others to launder the proceeds of his fraud scheme by engaging in monetary  transactions in amounts of over $10,000 in proceeds from the fraud scheme, including transactions relating to his participation in a sham intellectual property scheme.

The FBI’s Jackson Field Office investigated the case with assistance from the IRS-CI, DCIS, and MBN. Principal Assistant Deputy Chief Dustin M. Davis, Assistant Deputy Chief Katherine E. Payerle, and Trial Attorney Sara E. Porter of the Criminal Division’s Fraud Section, Trial Attorneys Emily Cohen and Steven Brantley of the Criminal Division’s Money Laundering and Asset Recovery Section, and Assistant U.S. Attorney Kathlyn R. Van Buskirk of the Southern District of Mississippi are prosecuting the case.

The Fraud Section leads the Health Care Fraud Strike Force. Since its inception in March 2007, the Health Care Fraud Strike Force, which maintains 15 strike forces operating in 24 districts, has charged more than 4,200 defendants who have collectively billed the Medicare program for approximately $19 billion. In addition, the Health and Human Services (HHS) Centers for Medicare & Medicaid Services, working in conjunction with the HHS-Office of Inspector General, are taking steps to increase accountability and decrease the presence of fraudulent providers.

 

Wednesday, January 13, 2021

 

2 days ago — Compounded Drugs. Gail Bormel from the Office of Compliance in FDA's Center for Drug Evaluation and Research joins Dr. Shah for a discussion on drug ..

 

State of Ohio Board of Pharmacy Adopts Resolution ...

5 days ago — Distributors of dangerous drugs business types including, but not limited to, ... action against the distributor of dangerous drugs and/or the responsible person. ... Distributor's License In Order to Compound Or Possess Compounded Drugs *

 

2 days ago — chemist shop, drug store, druggist and drugs, ... compounded in a pharmacy or other estab- lishments holding a ... compound or dispense a medication or for.

 

Pandemic Response, Pandemic Preparation

Over the past year, we’ve seen first-hand the devastation and turmoil wreaked by the COVID-19 pandemic; the unparalleled economic and personal tragedies inflicted on families and communities across the nation. We’ve also had the opportunity to be part of the extraordinary governmental response to this unparalleled public health emergency. 

Working closely with other government agencies, industry, the health care community, researchers, and others, the U.S. Food and Drug Administration has helped foster the knowledge and understanding of the SARS-CoV-2 virus necessary to bring it and the disease it causes under control. 

We are extremely proud of the role the FDA has played on many different fronts in this effort. That work has included expediting access to COVID-19 medical countermeasures for the detection, protection against, and treatment of COVID-19, supporting the stability and quality of medical product and food supply chains, and ensuring that the agency’s decisions are guided firmly by science using an open and transparent process to ensure continued public confidence. 

To build on these efforts, in April 2020, we began the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative, with a formal launch in August 2020. The goal was to strengthen our on-going COVID-19 response and resiliency for future emergencies. To this end, we engaged an external third party for an independent and objective review of the agency’s response, to assess actions, and identify forward-looking opportunities for the agency’s consideration.

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