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.
You 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.
The 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?→
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.