PERSPECTIVES ON FDA’S MOST RECENT DSCSA GUIDANCE

FDA just issued another DSCSA compliance extension. This time it was offered to wholesale distributors who were facing a November 27th deadline for verifying saleable returns.  They now have an extra year to establish compliance with this provision of the law.  I find...

FBI DRUG DIVERSION CASE HIGHLIGHTS FATAL DSCSA FLAW

Those who claim our nation’s drug distribution system is safer under the Drug Supply Chain Security Act (DSCSA) may have to change their tune.  A recent FBI prescription drug diversion case suggests it’s just as vulnerable today as it was for 25 years...

FDA’S OCTOBER 2018 DRAFT GUIDANCE ON DSCSA VERIFICATION SYSTEMS IS MIA

Where have you gone, draft DSCSA guidance? FDA’s position on DSCSA verification systems was announced last October but went MIA from the agency’s dedicated web page a few months ago.  A web site overhaul in April is the likely culprit, but the powerful influence of...

FDA AND CBP TO INCREASE JOINT INTERNATIONAL MAIL FACILITY EFFORTS

FDA and CBP are teaming up to increase inspection and detention efforts at our nation’s International Mail Facilities (IMFs) and Ports of Entry.  In its press release announcing the collaboration, FDA stated that “Thousands of illicit and dangerous products come from...

FDA’S LONG OVERDUE NATIONAL WHOLESALE DISTRIBUTOR LICENSING STANDARDS

FDA’s proposed national wholesale distributor licensing standards are almost three-and-a-half-years overdue and it’s becoming apparent the agency has no intention of issuing them any time soon.  According to CDER’s 2019 guidance agenda, these standards are not on the...

THE OPIOID ABUSE EPIDEMIC AND FDA’S LAW ENFORCEMENT MISSION CREEP

FDA’s wide-ranging public health and safety responsibilities make it an unlikely candidate for mission creep.  Nonetheless, that specter may very well apply to the agency’s ongoing International Mail Facility (IMF) surge involving its small but invaluable cadre of...

FDA LEADERSHIP IS THE ANTIDOTE TO SHORTAGE DRUG DIVERSION SCHEMES

It’s been more than six years since Congress first exposed the despicable gray market shortage drug distribution practices of certain pharmacies and distributors.  In its July 2012 report, Congress concluded, “gray market companies that operate outside of authorized...

A POTENTIAL SHIFT IN FDA’S APPROACH TO TAINTED DIETARY SUPPLEMENTS

FDA’s latest tainted dietary supplement alert seems to signal a shift in the agency’s approach to this problem. FDA alerts on these products have not typically referenced OCI investigations in this fashion. Perhaps the agency is beginning to grasp the need...

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...