Category Archives: DSCSA

DSCSA

DSCSA: Transaction Statement

2 Comments

TS.iStock_000008261949SmallerThis is the third in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January.  The previous essays in this series include DSCSA Transaction Information (TI) and DSCSA Transaction History (TH).   The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines Transaction Statement (TS) this way:

“(27) TRANSACTION STATEMENT.—

The ‘transaction statement’ is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—

(A) is Continue reading DSCSA: Transaction Statement →

DSCSA

DSCSA: Transaction History

1 Comment

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 →

DSCSA

DSCSA: Transaction Information

1 Comment

TI.iStock_000020581807SmallerIn the new U.S. Drug Supply Chain Security Act (DSCSA) enacted last November as part of the Drug Quality and Security Act (DQSA), “Transaction Information” (TI) is one of three primary sets of data that supply chain sellers of drugs must provide to the buyers beginning January 1 of next year.  I will discuss “Transaction History” (TH) and “Transaction Statements” (TS) in future essays.

On first look, TI can seem pretty simple.  Here is how the DSCSA defines it:

“(26) TRANSACTION INFORMATION.—

The term ‘transaction information’ means—

“(A) the proprietary or established name or names of the product;
“(B) the strength and dosage form of the product;
“(C) the National Drug Code (NDC) number of the product;
“(D) the container size;
“(E) the number of containers;
“(F) the lot number of the product;
“(G) the date of the transaction;
“(H) the date of the shipment, if more than 24 hours after the date of the transaction;
“(I) the business name and address of the person from whom ownership is being transferred; and
“(J) the business name and address of the person to whom ownership is being transferred.”

Sounds kind of like a delivery manifest or packing list. Continue reading DSCSA: Transaction Information →

DSCSA

The Drug Supply Chain Security Act Explained

OLYMPUS DIGITAL CAMERAEven before the Drug Quality and Security Act (DQSA) was passed last November I began to study Title II, the Drug Supply Chain Security Act (DSCSA).  But as soon as it was passed, I began to devote all of my spare time to that study.  The DSCSA text is much more complicated than any previous U.S. drug pedigree law and so, to really understand it, I’ve read it through many times, concentrating on different parts at different times.  I wanted to understand the law as well as I had come to understand the California pedigree law, the one that previously was the most complex.

It has taken this long, but I can now say that I have cracked it.  Continue reading The Drug Supply Chain Security Act Explained →

DSCSA, FDA

Decoding The FDA’s DSCSA Timeline

2 Comments

FDA DSCSA Implementation Plan.shrunkMany RxTrace readers probably saw the FDA press release last week that included the timeline chart called “Summary of Planned Implementation Timeframes for the Drug Supply Chain Security Act”.  If you did not see it, here is the link.  I found the text to be too small so I reproduced the chart using a larger font size.  See that version below.  Click on it to enlarge the image.  You might find this version better for inclusion in Powerpoint slides.

This is the FDA’s interpretation of their obligations under the Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA) that was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  There really are not any surprises in their interpretation, but there are a few interesting things to notice in this timeline and the associated table of target dates that accompanied it.  I have also reproduced the FDA’s deliverable table, but my version is sorted by the estimated target date column to make it easier to see what they plan to do in time sequence.

The first thing to notice about the timeline is Continue reading Decoding The FDA’s DSCSA Timeline →