Pages

Friday, September 30, 2016


FDA warns against the use of homeopathic teething tablets and gels
The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.

Notable Pattern Reporting: Imprimis Pharmaceuticals Inc on Focus ...

Chester News-3 hours ago
The Firm operates through the business of developing drug therapies and providing such therapies through sterile and non-sterile pharmaceutical compounding ...

Pharmakon Pharmaceuticals to lay off 195 by the end of the week

currentnoblesville.com/pharmakon-pharmaceuticals-to-lay-off-195-by-the-end-of-the...
1 day ago - Weeks later, Pharmakon held another nationwide, voluntary recall of “drug compoundedproducts” (the combining two or more drugs) that were intended to be ...

Virginia's lethal injection costs set to skyrocket as secret drug vendor ...

Roanoke Times-12 hours ago
The price covers three doses of the compounded drug (a primary dose and two backups) and enough vials to allow the drug to be tested every month until its

Meningitis outbreak victims to be awarded compensation

Baltimore Sun (blog)-15 hours ago
The outbreak stemmed from contaminated drugs manufactured by the New EnglandCompounding Center in Framingham, Mass., federal officials said.

NECC victims can now apply for help from federal fund

WCVB Boston-14 hours ago
BOSTON —Four years after contaminated steroids from a Framinghamcompounding pharmacy sickened 778 and killed at least 76, a $40 million special victims ...
Empower Pharmacy opens $4.7M compounding facility
Houston Chronicle - 15 hours ago
A Houston compounding pharmacy has relocated to a $4.7 million facility built to meet higher standards of ...

Thursday, September 29, 2016

Veterinary-drugs peddler eludes justice Sean Gerson remains in business despite years of pursuit September 19, 2016 By: Edie Lau For The VIN News Service

Pharmacy Exec Wants Civil Docs In Meningitis Murder Trial - LexisNexis

https://www.lexisnexis.com/.../pharmacy-exec-wants-civil-docs-in-meningi...
LexisNexis
23 hours ago - A former executive of the now-defunct Massachusetts compounding pharmacy linked to a fatal 2012 meningitis outbreak urged a federal court Wednesday to let ...

New Indictment Charges West L.A. Pharmacy and its Owners with Drug Trafficking and Using Stolen Identities to Conceal the Offense

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

FOR IMMEDIATE RELEASE
Wednesday, September 28, 2016

New Indictment Charges West L.A. Pharmacy and its Owners with Drug Trafficking and Using Stolen Identities to Conceal the Offense

            LOS ANGELES – A federal grand jury has issued a superseding indictment that charges a West Los Angeles pharmacy and its owners with operating a years-long narcotic drug trafficking, money laundering, and tax fraud conspiracy.
            Under the new indictment, Brentwood residents Berry Kabov, 45, and his brother Dalibor Kabov (also known as “Dabo”), 33, are charged with operating Global Compounding Pharmacy for the purpose “of concealing and growing” their conspiracy to profit from black market sales of narcotics including oxycodone (best known by the brand name OxyContin), hydromorphone (also known as Dilaudid), and hydrocodone (commonly known as Vicodin or Norco). 
            The prior indictment, as further detailed in a search warrant unsealed on October 1, 2015, charged the Kabov brothers with using Los Angeles as a base to sell bulk shipments of prescription drugs – including oxycodone, which is commonly sold under the brand name OxyContin – to black market customers across the country.  Investigators seized parcels containing thousands of hidden oxycodone pills that the Kabov brothers attempted to ship to black market customers in and around Columbus, Ohio, according to the search warrant affidavit, which states that the customers in turn made cash deposits into Kabov-controlled bank accounts or simply shipped bulk cash to the brothers in Southern California.
            The new indictment charges that, to conceal those black market drug sales, the Kabovs would use the pharmacy to “generate records” falsely showing that prescriptions “had been filled in the names of identity theft victims, that is, persons who did not in fact receive or fill” the prescriptions.  Similarly, the new indictment charges that, from June 2012 through December 2014, the pharmacy ordered nearly 100,000 pills of oxycodone, yet its reported prescription records only account for half of those pills, resulting in a shortfall of more than 45,000 pills of unaccounted oxycodone, along with parallel disparities for the pharmacy’s orders of other narcotic drugs.
            “These defendants are charged with using their pharmacy to vastly increase the volume of their drug dealing and multiple bank accounts to hide their illicit proceeds from federal authorities,” said United States Attorney Eileen M. Decker. “Prescription drug abuse is an epidemic in this country that causes harm and in some cases death, and these defendants’ use of their pharmacy in the scheme increased significantly the amount of these types of drugs on the street, posing a serious danger to the community.”
            The indictment also charges the Kabovs with laundering more than $1 million in unlawful cash proceeds, which the Kabov brothers attempted to conceal in structured cash deposits into multiple bank accounts that they controlled. New tax counts added to the indictment also charge that the Kabovs falsely underreported this income to the IRS in tax years 2012 through 2014.
            “Law enforcement agencies throughout the country are seizing record amounts of heroin and other opioids and first responders are witnessing the devastating effects of these substances in numbing proportions,” said DEA Special Agent in Charge John S. Comer.  “DEA will continue to target the illicit trafficking organizations responsible for these detriments, but we’re also committed to educating the public about the dangers of drug misuse and reducing demand – awareness is a crucial element in combatting this epidemic.”
            In addition to the charges related to oxycodone and other narcotic drugs, the indictment alleges that the brothers illegally imported anabolic steroids purchased from a wholesale drug distributor located in Hubei, China.  The indictment details how the brothers used the pharmacy to illegally order bulk quantities of testosterone, oxandrolone, and nandrolone.
            If convicted of the charges in the indictment, Berry Kabov faces a 479-year maximum prison term and Dalibor Kabov faces a 485-year maximum prison term.
            An indictment contains allegations that a defendant has committed a crime. Every defendant is presumed to be innocent until and unless proven guilty in court.
            The investigation into the Kabov brothers and Global Compounding is being conducted by the Drug Enforcement Administration, the Internal Revenue Service – Criminal Investigation, the United States Postal Inspection Service, the Los Angeles Police Department, and the California Board of Pharmacy.
            The case is being prosecuted by Assistant United States Attorneys Benjamin Barron and Ryan Weinstein of the Organized Crime Drug Enforcement Task Force.

Informational Webinar on FSMA Draft Guidances for Current Good Manufacturing Practices Requirements for Food for Animals and the Human Food By-Products for Use as Animal Food September 29, 2016

Informational Webinar on FSMA Draft Guidances for Current Good Manufacturing Practices Requirements for Food for Animals and the Human Food By-Products for Use as Animal Food
September 29, 2016
On October 14, the FDA Foods and Veterinary Program will hold a webinar to discuss FDA’s recent announcement of the FSMA draft guidances for current good manufacturing practices requirements for food for animals and thehuman food by-products for use as animal food, which became available for public comment on August 25, 2016. These draft guidances are meant to assist domestic and foreign companies in complying with Current Good Manufacturing Practice (cGMP) requirements and with human food by-product requirements under the FSMA Preventive Controls for Animal Food Rule.
Additional Information

In the Passmore opinion, the court held that Texas' requirement regarding expert reports in healthcare claims pursuant to Section 74.351 of the Texas Civil Practice & Remedies Code was procedural and thus not applicable in federal court.

ß
Strasburger & Price, L.L.P.
In the Passmore opinion, the court held that Texas' requirement regarding expert reports in healthcare claims pursuant to Section 74.351 of the Texas Civil Practice & Remedies Code was procedural in nature...
ß
Jones Day
With this proposal, FDA intends to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
ß
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
After a merits trial, a jury found Defendants liable for violating the Sherman Act and Plaintiffs were awarded $147 million in damages plus injunctive relief.

Teva builds injectables plant in Russia with Nanolek

Mylan could face big Medicaid bill after underpaying EpiPen rebates, CMS says

U.S. payer pressures force Novo Nordisk to cut loose 1,000 staffers

Creating a Safe Workplace Despite Hazardous Drug Risk

Anesthesiology News-9 hours ago
Pharmacy and nursing staff involved in drug mixing are at the highest risk,” she ... all areas where hazardous drugs are compounded, prepared or administered, 

Essential Read!! Compounding Is Not a Safe Solution to Rising Drug Prices

Compounding Is Not a Safe Solution to Rising Drug Prices

www.pewtrusts.org/.../compounding-is-not-a-safe-solution-t...
The Pew Charitable Trusts
18 hours ago - Pharmacists often make drugs for patients whose clinical needs cannot be met by a commercially available product, a practice known as compounding.

Congress says HHS has to step up efforts to secure nation's medical records


Privacy and security gurus praised the GAO for taking an unflinching look at the dual role HHS plays as both a promoter of health information technology use and the primary enforcer of HIPAA, the federal privacy, security and breach notification law.  READ MORE

Feds recovered $2.4 billion in healthcare fraud last year

Feds recovered $2.4 billion in healthcare fraud last year
Officials told a House subcommittee Wednesday that government agencies and contractors are trying to prevent fraud through better use of data analytics.  READ MORE

September 28, 2016 Ninth Circuit Confounds Practice of Medicine and Off-Label Use Issues By Anne K. Walsh & Andrew J. Hull –

Wednesday, September 28, 2016

Did Mylan misclassify its EpiPen to game Medicaid?

STLtoday.com-9 hours ago
In this July 8, 2016, file photo, a pharmacist holds a package of EpiPens epinephrine auto-injector, a Mylan product, in Sacramento, Calif. (AP Photo/Rich .

Furor over drug prices puts patient advocacy groups in bind

Pharmacy Today, American Pharmacists Association, pharmacist.com-10 hours ago
As outrage over exorbitant drug prices plays out on the public and political stages, patient advocacy groups have largely watched the debate from the sidelines.

California governor signs bill targeting 'doctor shopping' for opioids

Pharmacy Today, American Pharmacists Association, pharmacist.com-10 hours ago
Gov. Jerry Brown of California signed on Tuesday legislation that requires all doctors in the state to check a database for a patient's prescription history before ...

No State Action in Fired Pharmacist's Claim

Virginia Lawyers Weekly-7 hours ago
pharmacist who alleges his discharge by defendant 

The global scourge of counterfeit medicines

PMLiVE-30 minutes ago
The Alliance for Safe Online Pharmacy in the EU (ASOP EU) warns that 130 million people in Europe are risking their health by ordering from the 30,000 illegal 

Limit pharmacy sales, allow GP dispensing: RACGP

Australian Journal of Pharmacy (registration) (blog)-18 hours ago
This is one of 11 recommendations about pharmacy made by the Royal Australian College of General Practitioners in its submission to the King pharmacy ...

Insurance, pharmacy companies raking customers

The Bozeman Daily Chronicle-17 hours ago
I applaud the Chronicle editorial board for drawing attention to Montana's private health insurers, who are raking consumers with exorbitant and outrageous ...

Customer alleges pharmacy's negligence led to fall

West Virginia Record-9 hours ago
CHARLESTON — A Michigan woman is suing a West Virginia pharmacy, alleging ... The plaintiff alleges Fruth Pharmacy Inc. failed to examine its premises for ...

You thought your prescription drugs were overpriced? Check this out: the State of Missouri has paid over $125,000 cash to a private, anonymous pharmacy

Pharmacy Making Big Bucks Selling Execution Drugs To The State ...

The Ring of Fire Network-5 hours ago
You thought your prescription drugs were overpriced? Check this out: the State of Missouri has paid over $125,000 cash to a private, anonymous pharmacy for ...

Rx for Medicare Transparency, Ending Retroactive Pharmacy ...

Morning Consult-14 hours ago
The most frustrating current tactic utilized by PBM corporations are direct and indirect remuneration (DIR) fees levied on pharmacy providers in the Medicare Part ...

Witless Pharmacy Claims It Has Constitutional Right to Sell ...

Slate Magazine (blog)-9 hours ago
Missouri has spent months waging a legal battle against the subpoena, so far unsuccessfully. Now the pharmacy that produces the lethal chemicals has joined ..

FDA’s Clinical Investigator Training Helps Support the Drug Development Process

FDA’s Clinical Investigator Training Helps Support the Drug Development Process

McCann Health looks to break the pharma consulting mold with new unit

Must Watch!! New Report Finds Serious Health Risks From Taking Dietary Supplements

New Report Finds Serious Health Risks From Taking Dietary Supplements: A new investigation finds serious health risks from supplements including vitamins, probiotics, and weight loss pills. WBZ-TV's Dr. Mallika Marshall has more.

Consumers can help fight distribution of dangerous dietary supplements

Consumers can help fight distribution of dangerous dietary supplements

www.rightinginjustice.com/.../consumers-can-help-fight-distribution-of-dangerous-di...
2 hours ago - Dietary supplements are used by more than 180 million Americans each day, and it is up to the Food and Drug Administration (FDA) to ensure they do not caus.

Puerto Rico reconsiders dietary supplement Administrative Order 346 ...

www.drugstorenews.com/.../puerto-rico-reconsiders-ds-industry-bane-administrative-...
5 days ago - Both the Council for Responsible Nutrition and the Natural Products Association have been lobbying on behalf of the dietary supplement industry to combat ...

FDA to Dietary Supplement Marketers: Marketers of dietary supplements who outsource their manufacturing to a third party should have a close relationship with their supplier, an FDA official advised

FDA to Dietary Supplement Marketers: Enter 'Close Relationship' with ...

www.naturalproductsinsider.com/.../fda-to-dietary-supplement-marketers-enter-close-...
2 days ago - Marketers of dietary supplements who outsource their manufacturing to a third party should have a close relationship with their supplier, an FDA official advised ...