FDA ALERTS THE PUBLIC TO WESTMINSTER PHARMACEUTICALS, LLC DRUG RECALL

FDA recently alerted the public that Westminster Pharmaceuticals, LLC was recalling Levothyroxine and Liothyronine products in various strengths that were manufactured using active pharmaceutical ingredients from a deficient Chinese manufacturer.  According to the...

SENTENCING ANNOUNCED IN ILLEGAL FOREIGN-SOURCED DRUG CAPER

Three Canadians and their company, Quantum Solutions, SRL, have been sentenced in a pharma supply chain caper involving the sale of illegal foreign-sourced prescription drugs to three retail pharmacies in western Pennsylvania.  The individuals in this case were...

STOLEN OCTAGAM COULD SIGNAL A NEW TREND FOR PHARMA CARGO THIEVES

Pharmaceutical cargo thefts have become a relatively infrequent occurrence, but 10 years ago it was a much different story. The problem seemed to be spiraling out of control.  Thankfully, the number of such incidents has slowed to a trickle over recent years. The...

FDA’S INTERNATIONAL MAIL FACILITY STRATEGY UNDERWHELMS

FDA is increasing its regulatory presence at our nation’s international mail facilities (IMFs) and will be implementing a portable screening device to “more quickly identify and assess suspect products entering through IMFs,” according to an article by FDA...

FDA’S OCTOBER 2017 COUNTERFEIT HARVONI NOTICE UNCOVERED

In October 2017, FDA quietly issued a suspected counterfeit Harvoni notice to pharmacies in the Philadelphia area, but apparently decided against warning the broader public by posting it to the agency’s web site.  In fact, the notice is non-existent on the FDA web...

FDA’S OFFICE OF CRIMINAL INVESTIGATIONS FACING AN UNCERTAIN FUTURE

FDA’s Office of Criminal Investigations (OCI) continues to face an uncertain future.  A recently-issued press release following the sentencing of former NECC supervisory pharmacist Glenn Chin contains an easy to overlook, but nonetheless very telling, omission. OCI...

FDA DRUG SHORTAGE STATEMENT TARGETS HOARDING BY HEALTHCARE PROVIDERS

In an unfortunate twist, FDA is admonishing healthcare providers for hoarding behavior in the aftermath of Hurricanes Maria and Irma that devastated Puerto Rico and have contributed to ongoing drug shortages.  According to a recent statement from FDA Commissioner...

PHARMACY VP CHARGED IN PA DRUG RECYCLING DIVERSION SCHEME

Supply chain criminals who infiltrate pharmacies in order to perpetrate non-controlled prescription drug diversion schemes have had the upper hand for years.  The primary culprit behind this sobering reality is the historical lack of oversight from resource-strapped...

OUR AILING SUPPLY CHAIN NEEDS A PANGEA-STYLE FDA OPERATION OF ITS OWN

Operation Pangea X has received a lot of attention in the media, and rightly so.  Not only does this collaborative effort demonstrate a global resolve to protect patients everywhere from the insidious flow of counterfeit drugs and other illegal medical products...

PERFECT STRANGERS-DUE DILIGENCE AND THE DSCSA

Due diligence is an indispensable component of supply chain security, but it is largely non-existent in the Drug Supply Chain Security Act.  Its perceived presence in the law is widely misunderstood too, I believe.  Take, for instance, a just-released and quite...

NEW GLOBAL SUPPLY CHAIN SECURITY INITIATIVE ANNOUNCED BY FDA

Strengthening the global supply chain for medical products is a lofty goal and FDA is striving to make that a reality.  Yesterday, the agency trumpeted its leading role in partnering with Asia Pacific Economic Cooperation (APEC) economies to create a supply chain...

THREE PA PHARMACISTS TIED TO ILLEGAL FOREIGN-SOURCED DRUG CASE

Three pharmacists from Western Pennsylvania allegedly purchased wholesale quantities of illegal foreign-sourced drugs from an illegitimate Canadian supplier, and while we don’t yet know which pharmacies or drugs are involved, you can be certain more criminal charges...

RAMBO AND THE PUSH FOR DRUG IMPORTATION

Adding to the slew of recent articles on the drug importation issue, a just-released California Healthcare piece discusses a new proposal that would allow “not only individuals but drug wholesalers and pharmacies to buy from Canada.”  Undoubtedly, this is music...

FDA’S COUNTERFEIT DETECTOR (CD-3) AWARDED A PATENT

FDA’s groundbreaking handheld counterfeit detection device (CD-3) has been awarded a patent, according to a just-issued report by Securing Industry.  The question I have is why this process took so long.  This amazing device is relatively inexpensive and highly...

FDA ANNOUNCES SEVERAL DSCSA-RELATED GUIDANCE DOCUMENTS SLATED FOR 2017

FDA expects to issue nine DSCSA-related guidance documents this year, according to the agency’s just-released Guidance Agenda for 2017.  While most of these are holdovers from 2016, a few are new additions.  Specifically, all but the last three items below were...

FLORIDA ONCOLOGIST CONVICTED IN ILLEGAL FOREIGN-SOURCED DRUG CASE

A corrupt Florida oncologist who victimized vulnerable cancer patients under her care by exposing them to illegal, foreign-sourced medications is facing serious prison time.  D. Anda Norbergs was convicted by a federal jury yesterday on multiple misbranding,...

COLORADO NURSE ARRESTED IN CONTROLLED SUBSTANCE TAMPERING INCIDENT

A former nurse at the University of Colorado Hospital has been arrested for allegedly tampering with vials of pain medications intended for six patients, according to a recent report by The Denver Post.   Court documents referenced in the report stated Kacye Unruh...

NEW YORK PHARMACIST SENTENCED TO PRISON IN MASSIVE DIVERSION CASE

A New York pharmacist is headed to prison for his role in selling diverted HIV drugs worth over $274 million dollars (that’s not a mistake folks-a quarter of a billion dollars!). Ira Gross was sentenced earlier this week to 8 to 24 years in state prison,...

BLACK MARKET DIVERTER OF HIV DRUGS ARRESTED

If the Drug Supply Chain Security Act was intended to deter the exponential growth of prescription drug diversion and counterfeiting crimes over the last decade, someone forgot to tell Robin Deleonrosa, who was recently arrested for his role in a $1.9 million black...

THE TIME HAS COME FOR FDA TO ADOPT A MORE COMPREHENSIVE CD-3 STRATEGY

It’s been almost three years since FDA announced plans to deploy its ground-breaking handheld counterfeit detection device (CD-3) in Ghana to aid in combating the insidious counterfeit and substandard malaria medicine problem in that region (see my previous posts on...