Insufficient Transitional Measures Doom The FMD-EUDA

The pharmaceutical supply chain in most markets is complex, but in my view, the one in the European Union easily takes the prize for being the most complex of any other.  The addition of unit-level serialization and verification of authenticity to that supply chain over the next few years as required by the Falsified Medicines … Continue reading Insufficient Transitional Measures Doom The FMD-EUDA

Aggregation –> Chargeback Accuracy –> ROI

Last week I attended my favorite annual conference on pharma serialization and tracing in the U.S.:  The Healthcare Distribution Management Association’s (HDMA) Traceability Seminar.  They call it a “seminar” because the subject of the sessions are generally the same every year, but it is better than any other third-party conference, primarily because the right people … Continue reading Aggregation –> Chargeback Accuracy –> ROI

DSCSA: Congress Should Have Mandated Randomization

Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain.  Let me explain. The text of the Drug Supply Chain Security Act (DSCSA) was developed last year … Continue reading DSCSA: Congress Should Have Mandated Randomization

Product Identifier Authentication (PIA)

In my last essay I touched on the use of Product Identifier Authentication, or PIA, as an alternative to the collection and distribution of aggregation data to allow wholesale distributors and repackagers to meet the verification requirements of the Drug Supply Chain Security Act (DSCSA).  Starting in November of 2018 for repackagers and in November … Continue reading Product Identifier Authentication (PIA)

The Aggregation Hoax and PIA

Pharmaceutical manufacturers should be aware that there is a lot of uninformed misinformation going around out there lately about the need for them to supply aggregation data to their trading partners to meet the Drug Supply Chain Security Act (DSCSA) (for more on aggregation, see “Pharma Aggregation: How Companies Are Achieving Perfection Today”, “DQSA: Will … Continue reading The Aggregation Hoax and PIA

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1

The supply chain provisions contained within the Drug Quality and Security Act (DQSA)—themselves known as the Drug Supply Chain Security Act (DSCSA)—mark a significant achievement by Congress and the industry to protect the U.S. pharmaceutical supply chain from criminals.  It is the first completed attempt since 1987 when the Prescription Drug Marketing Act (PDMA) was … Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1

DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?

I attended the Healthcare Distribution Management Association (HDMA) Track and Trace Seminar held in Crystal City, VA on November 11-13, 2013.  I was particularly interested in the session called “Distributor Case Studies and Updates”, as were a lot of other people.  The speakers were: Chris J. Anderson, Director, Quality Systems, Cardinal Health, Inc. Steve Tadevich, … Continue reading DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?

The Federal Lot-Based Pedigree Before Congress

The current drafts of the nationwide pharmaceutical track and trace (Pedigree) bills on the floors of the U.S. Senate and House of Representatives both include an initial lot-based pedigree requirement that may be based on paper or electronic documentation (see “The Politics Of Federal Track & Trace Legislation”).  What is a lot-based pedigree and how is … Continue reading The Federal Lot-Based Pedigree Before Congress