Tag Archives: Record-keeping

DSCSA

DSCSA: Historic Change To Commerce

Back in 2010 I posted an RxTrace essay called “California Pedigree Law:  Historic Change To Commerce” that pointed out the significant change that was then scheduled to occur once the California law was to go into full effect in 2016.  Of course, that state law was preempted by the Drug Supply Chain Security Act (DSCSA) back in 2013 so we never actually experience that change.  But what about the DSCSA?  Will it change the way commerce happens in a historic way?  Let’s take a look.

Continue reading DSCSA: Historic Change To Commerce →
Record-keeping

Again, A Closer Look At The Six-Year Record-Keeping Requirement

I sat on my back porch gazing at this amazing sky all afternoon Sunday.
I sat on my back porch gazing at this amazing sky all afternoon Sunday.

It was a very beautiful weekend here in the Chicago area, and consequently I could not bring myself to spend any part of it sitting in front of a computer hammering out a new essay, so for the second week in a row (sorry), here is a re-run of a popular essay from July 14, 2014.  I promise to return next week with a brand new essay.

??????????The Drug Supply Chain Security Act (DSCSA) contains record-keeping requirements for drug manufacturers, wholesale distributors, repackagers and dispensers that begin on January 1st, 2015,  All companies must keep a copy of the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) they receive and those they send for at least six years.  In addition, manufacturers and repackagers must also retain Continue reading Again, A Closer Look At The Six-Year Record-Keeping Requirement →

DSCSA Web Portals

A Closer Look At Web Portals for DSCSA Transaction Data Exchange

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???????????????These are the last few days of 2014.  During the rush up to Christmas, the FDA gave the industry a gift by announcing that they will not enforce the transaction data exchange requirements of the Drug Supply Chain Security Act (DSCSA) until May 1, 2015—a four month delay (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1” for details).  So things are likely to be quieter this week than they otherwise might have been.  And if you are one of those who are working this week, why not fill out the 2015 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz?  It will be closed soon so make sure you click here to fill it out now.

One of the approaches that the FDA mentioned in their data exchange guidance, published on November 26, is the use of secure web portals (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”).  Some companies are Continue reading A Closer Look At Web Portals for DSCSA Transaction Data Exchange →

Record-keeping

DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement

??????????The Drug Supply Chain Security Act (DSCSA) contains record-keeping requirements for drug manufacturers, wholesale distributors, repackagers and dispensers that begin on January 1st.  All companies must keep a copy of the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) they receive and those they send for at least six years.  In addition, manufacturers and repackagers must also retain knowledge about the “product identifier” on each unit they sell into the supply chain for a period of six years after the date it was sold.  Companies who perform investigations into suspect product must also keep records of their process and the outcome for six years.

There are a few implications of these record-keeping requirements.  Let’s take a look at some of them.  Continue reading DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement →