Tag Archives: transaction data

The Differences Between The DSCSA, FDA Rules and Guidance

???????????From reading the responses to the FDA docket requesting public feedback on standards for interoperable information exchange, I think it is time to review the difference between laws, FDA Rules and FDA guidance, like those stemming from the Drug Supply Chain Security Act (DSCSA).  It appears that some people might be confusing these a little.

Dr. Connie Jung, RPh, PhD, Acting Associate Director of Policy and Communications, in the Office of Drug Security, Integrity and Recalls, in the Office of Compliance within the U.S. FDA Center for Drug Evaluation and Research, helped put it all into perspective for me.  During one of the breaks at the recent FDA DSCSA Workshop (see “The 2014 FDA DSCSA Workshop“)  I asked Dr. Jung what the odds are Continue reading The Differences Between The DSCSA, FDA Rules and Guidance

DSCSA: Transaction History

TH.iStock_000000755934SmallerThis is the second in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January.  Last week’s essay was about DSCSA Transaction Information (TI).  On the surface, Transaction History (TH) looks simple.  The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines TH this way:

“(25) TRANSACTION HISTORY.—

The term ‘transaction history’ means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.”

According to this simple definition, Continue reading DSCSA: Transaction History

DQSA: Dancing Around The Returns Problem

Dancing.iStock.612379There is an interesting dialog going on in the Food and Drug Serialization Professionals group in LinkedIn that was kicked off by a recent RxTrace essayClick here to see the conversation.  It got real interesting when Marc Rosenblatt, Director of Sales at Veracity Network, related an experience his company had in a recent pilot.  He said:

“…An unsettling example occurred during one of our distributor pilot programs. Our system detected a number of counterfeit products (9% of the total sample to be exact) that were sent back as returns. This means that the molecular structure or product signature didn’t match up with the legitimate product standard. Upon further examination, it was discovered that the sealed bottles contained counterfeit replacements for the valid product. What makes this even a more difficult pill to swallow (pun intended) is the fact that these products would in most cases be restocked and sold again. The returns areas are the most overlooked link in the supply chain and from reading the DSCSA text, it continues to be (at least for the next 4 years).”

Marc’s reading of the Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA), gives him some comfort Continue reading DQSA: Dancing Around The Returns Problem