Category Archives: DSCSA

DSCSA, HDMA

Just Released – The HDMA EDI ASN Guidance For DSCSA

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HDMA ASN for DSCSA coverNOTICE:  The HDMA has updated this guideline again only a few months after this essay was published.  Please see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again” for additional information.  — Dirk.

The Healthcare Distribution Management Association (HDMA) has just published their much anticipated new guidance on applying the Electronic Data Interchange (EDI) 856 Advance Ship Notice (ASN) transaction set toward compliance with the new U.S. Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA).  HDMA members and non-members can download a copy of the new document here.  Make sure you look for “HDMA Electronic Data Interchange (EDI) Guidelines for the 856 Advance Ship Notice to Support Implementation of DSCSA“.  (See the image to the right.)

The new guidance is voluntary, like all HDMA guidance (see “GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance” and “Updated HDMA Bar Code Guidance: A Must Read“), but companies who Continue reading Just Released – The HDMA EDI ASN Guidance For DSCSA →

DSCSA, FDA

DSCSA: Many Questions, Few Answers

Jung_ConnieConnie T. Jung, RPh, PhD, Acting Associate Director of Policy and Communications, Office of Drug Security, Integrity and Recalls, in the Office of Compliance within the U.S. FDA Center for Drug Evaluation and Research (CDER) delivered an overview of the new Drug Supply Chain Security Act (DSCSA) during a webinar last Monday.  The title of the webinar was “FDA Perspectives on Implementation of the Drug Supply Chain Security Act”.  The webinar is one of a series that the Healthcare Distribution Management Association (HDMA) plans to offer on related topics through the remainder of the year.  If you missed it, don’t worry, they will post the recording and the slides on the HDMA event web page.

I have to give credit to Dr. Jung and the FDA in general for being willing to make presentations like this at this time.  The material they cover is a good overview of the new law at a high level.  The tough part for the speaker comes at the end when the floor is opened up for Q&A.  There were a number of very good questions asked by participants on this one, but most were answered with simple reference to future guidance.  Here is Dr. Jung’s answer to Continue reading DSCSA: Many Questions, Few Answers →

DSCSA, exemptions

Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?

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Exempt signEver since the Drug Quality and Security Act (DQSA) was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), more and more people are asking the question, “Does my drug have to follow the DQSA?”.  Recently I was on a monthly industry call put on by one of the Big 3 wholesale distributors to discuss the Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA.

I was surprised how many people asked the wholesaler if their specific product was covered or exempt.  Of course, asking a wholesale distributor if your own product must follow a particular Federal law is not likely to get a usable response and that was true in this case, but it did not stop the next person from asking the same kind of question.

In fact, no one can answer that question for you.  Even the FDA can’t answer that question for you.  I can’t answer that question for you.  Only YOU can answer that question based on your knowledge of your product’s characteristics and a careful reading of certain provisions of the DSCSA.  I can help you with that part.  Continue reading Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? →

DSCSA

DSCSA: Transaction Statement

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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

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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

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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

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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 →