A NUMBERS DRIVEN PERSPECTIVE ON SUPPLY CHAIN SECURITY

Any law, no matter how well-intentioned or deftly crafted, will ultimately miss its mark without the requisite resources in place to ensure compliance. This is best described by the oft-used speeding analogy. Legislators can require the posting of speed limit signs at...

APOLLO CREED’S SOLUTION TO SUPPLY CHAIN SECURITY

In one of the first criminal convictions of its type, two companies pled guilty for failing to provide pedigrees. Can you guess the year? No, it wasn’t 1988, the year President Reagan signed the PDMA into law. Not even 1998, a decade later. If you guessed 2004, a...

THE PROBLEM WITH ILLEGITIMATE PRODUCT DETERMINATIONS UNDER THE DSCSA

The requirement for wholesaler distributors, dispensers, and repackagers to coordinate illegitimate product determinations with manufacturers is a relatively minor aspect of the Drug Supply Chain Security Act, but one that has the potential to cause some serious...

MASSIVE $400 MILLION PRESCRIPTION DRUG DIVERSION SCHEME ANNOUNCED

A massive prescription drug diversion scheme spanning 2007 through April 2014 and totaling nearly $400 million in total sales was the subject of recent U.S. Department of Justice press release, dated May 7, 2015. David Miller, his Eagan, Minnesota based wholesale...

STILL WAITING FOR FDA’S NATIONAL DATABASE OF WHOLESALE DISTRIBUTORS

FDA is keeping us waiting. It’s long-anticipated (at least by me) national database of authorized wholesale distributors, mandated under the Drug Supply Chain Security Act to be established by January 1, 2015, has yet to make an appearance on the public stage. Maybe...

COMING SOON- FDA’S DATABASE OF WHOLESALE DISTRIBUTORS

FDA’s long-overdue database of licensed wholesale distributors should be unveiled soon. Although the Drug Supply Chain Security Act required FDA to establish this database by January 1, 2015, the agency’s web site indicates it will be coming in the future. Most...

WEST VIRGINIA PHARMACY OWNER PLEADS GUILTY IN HEALTHCARE FRAUD CASE

Another federal prosecution involving a corrupt pharmacist is once again adding to concerns that rogue pharmacists and pharmacy owners are thriving amidst an under-regulated and vulnerable pharmaceutical supply chain. Unfortunately, as history has shown, patients will...

FORMER PHARMACY CEO PLEADS GUILTY IN MASSIVE DRUG DIVERSION SCHEME

The former CEO of a Michigan pharmacy is facing up to 10 years in prison after pleading guilty for his role in a massive prescription drug diversion scheme totaling 18 defendants, including 6 licensed pharmacists, and more than $80 million in insurance payments for...

TAINTED DIETARY SUPPLEMENTS-A CONTINUING PUBLIC HEALTH MENACE

Fraudulent products marketed as dietary supplements are a continuing public health menace. These products, predominantly sold for sexual enhancement, bodybuilding and weight loss are likely to be the cause of our next public health catastrophe, possibly exceeding the...

THE ALARMING DECREASE IN FDA REGISTERED OUTSOURCING FACILITIES

In a July 2014 post, I commented on what appeared to be a very low number of outsourcing facilities that had registered with FDA under section 503B of the FD&C Act. At the time of that post, the number was 48. Since then, it has fallen to 37, an alarming decrease...

FATHER AND SON PHARMACISTS SENTENCED TO PRISON

A father and son duo of pharmacists has been sentenced to prison for their roles in operating separate drug diversion schemes from a Boston, Georgia pharmacy. This criminal case is yet another alarming reminder that suboptimal pharmacy oversight is critically...

THE DSCSA AND DUE DILIGENCE-BUELLER? BUELLER? BUELLER?

When I think of due diligence and the Drug Supply Chain Security Act, I’m reminded of that memorable scene from Ferris Bueller’s Day Off.   Ben Stein, who played Bueller’s economics teacher, repeatedly calls his name when taking attendance, even though he’s not...

THE DSCSA AND SALEABLE RETURNS-A KEY SUPPLY CHAIN VULNERABILITY

It’s probably safe to say that many new laws, however well-intended, are not perfect.  The bad guys are highly motivated, often undeterred, and eventually find ways around them. You build a fence, they build a bigger ladder. Such is the case with the Drug Supply Chain...

PERSPECTIVES ON DRUG COMPOUNDING AND THE COMPOUNDING QUALITY ACT

In November 2013, President Obama signed the Drug Quality Safety Act into law.  Title I of this law, designated as the Compounding Quality Act, added a new Section 503B to the Federal Food, Drug and Cosmetic Act and placed the drug compounding activities of certain...

THE DSCSA AND SUPPLY CHAIN SECURITY-SIX PREDICTIONS

There is a lot of uncertainty surrounding the implementation of the Drug Supply Chain Security Act (DSCSA) and how it will impact our supply chain, but I’m willing to go out on a limb here and make a few predictions.  1. Although the DSCSA includes a provision for...

SUSPECT PRODUCT INCIDENTS AND THE DSCSA

The next 10 years under the Drug Supply Chain Security Act (DSCSA) are going to be quite busy.  Almost every year will bring about some type of requirement or other key milestone.  Only years 3, 8 and 9 appear to be left out of the mix, but don’t hold me to that...

PHARMACIST’S WIFE SENTENCED IN PA PHARMACY RX DRUG SMUGGLING CASE

A Pennsylvania pharmacist’s wife has been sentenced to probation and turned over $600,000 to the government following her conviction on federal prescription drug smuggling-related charges. According to the U.S. Department of Justice press release, Robin W. Simon...

MARYLAND PHARMACY OWNER INDICTED IN ILLEGAL FOREIGN-SOURCED DRUG CASE

A Maryland pharmacy owner is facing federal charges related to a contraband cigarette trafficking conspiracy, money laundering, oxycodone distribution and prescription drug sample sales.  Salim Yusufov, owner of Healthway Pharmacy in Pikesville, and 10 other...

PA PHARMACIST PLEADS GUILTY IN RX DRUG SMUGGLING CASE

Illegal foreign-sourced drugs have snared yet another health care professional. This time it’s a pharmacist.  Following the counterfeit Avastin and Altuzan incidents of early 2012, FDA issued hundreds of letters informing medical practices throughout the country about...