FDA DSCSA Deadline Passes Quietly

Last Friday was the deadline for the FDA to publish four new guidance documents under the Drug Supply Chain Security Act (DSCSA) (see “Decoding The FDA’s DSCSA Timeline”).  The deadline was established by the U.S. Congress when they enacted the legislation and it was signed by President Obama on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  But time spent by the FDA to meet their obligations under the DSCSA is “unfunded”.  That is, Congress did not provide any specific additional money to pay for the FDA’s new obligations under the DSCSA.  It is an unfunded mandate.

Fortunately the FDA is Continue reading FDA DSCSA Deadline Passes Quietly

Insufficient Transitional Measures Doom The FMD-EUDA

EU Member States
EU Member States. Source

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 Directive (FMD) and the Delegated Act (EUDA) is going to be difficult (see “Breaking News: The EC Has Published The Delegated Act“).  It represents a huge change to the way drugs are packaged and how they are handled by each entity in the supply chain.  It is vital that the transition Continue reading Insufficient Transitional Measures Doom The FMD-EUDA

The Future of RxTrace Has Arrived

RXTRACE_LOGO_Trans_300x113You may recall my essay back in April I called “The Future Of RxTrace”.  Here is an update.  I am still an independent consultant, and I have decided to continue writing RxTrace, no matter what else I end up doing—whether I stay as a consultant, or get a job somewhere.  It has to allow me to continue to publish RxTrace.

But I have also decided that I can no longer Continue reading The Future of RxTrace Has Arrived

The Next Markets To Impose Pharma Serialization and Tracing?

Digital WorldThe pharmaceutical markets that currently have a serialization and/or tracing regulation on the books include the United States, the European Union, China, Brazil, India, Italy, Turkey, South Korea, Argentina, Saudi Arabia and Jordan.  Not all are fully operational yet, but they are official.  This list may be about to grow by two. Continue reading The Next Markets To Impose Pharma Serialization and Tracing?

Pay No Attention To The Enforcement Delay Unless You Are A Dispenser

iStock_000037865140_smallerAs I reported last Thursday, the FDA published new revised guidance that extends their enforcement delay of the Drug Supply Chain Security Act (DSCSA) data exchange requirements for dispensers by an additional 4 months (see “FDA Extends Dispenser Delay in DSCSA Enforcement“).  What does this mean for drug manufacturers, wholesale distributors and repackagers? Continue reading Pay No Attention To The Enforcement Delay Unless You Are A Dispenser