Tag Archives: EDI

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 →

Data Exchange

Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?

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SteadyState.2015.to.2023The use of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) in the U.S. pharmaceutical supply chain has expanded over the last year, due entirely to its recognition by the FDA as a valid method for passing the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) as required by the Drug Supply Chain Security Act (DSCSA).  The Healthcare Distribution Management Association (HDMA) has encouraged that expansion by publishing a “how-to” guide for meeting the requirements of the DSCSA using an ASN (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).

Although not everything has worked out Continue reading Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday? →

Transaction Data Exchange

Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?

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??????????????We are now more than six weeks past the date that the DSCSA originally mandated drug manufacturers, repackagers and wholesale distributors to pass Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) to their customers in the U.S. and save a copy for six years (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”).  Of course, just before Christmas, the FDA pushed out that part of the requirement until May 1, 2015 to ensure that the requirement did not induce or exacerbate drug shortages (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).

Despite the delay, many companies are already passing the required data to their trading partners through Electronic Data Interchange (EDI) Advance Shipment Notices (ASNs) (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).  In fact, the vast majority of companies have Continue reading Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data? →

Exception Handling

DSCSA Exception Handling: A Preview of Your Next Surprise Headache

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HDMA ASN Exception GuidelinesCompanies that participate in the U.S. pharma supply chain and are subject to the U.S. Drug Supply Chain Security Act (DSCSA) are preparing to meet the FDA’s 2015 deadlines for exchanging Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for every shipment.  Those preparations include integrating the generation, transmission, confirmation, storage and retrieval (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”) of these documents into their existing supply chain and regulatory compliance processes.  It is a big deal and it affects a large number of companies. Continue reading DSCSA Exception Handling: A Preview of Your Next Surprise Headache →

GS1 Healthcare US

The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1

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GS1 US logoA few weeks ago, GS1 Healthcare US published version 1.1 of their guidance for using the GS1 Electronic Product Code Information Services (EPCIS) standard to meet the U.S. Drug Supply Chain Security Act (DSCSA).  See “GS1 Healthcare US Publishes Updated Guidance For DSCSA”.  I was too busy at that time to review the document properly, but it is an important addition to the spectrum of information that companies can use to help them understand how to best meet the requirements of the DSCSA so I wanted to get back to it when I had time.  That time is now.

As long term readers of RxTrace know, I did not believe EPCIS would ever be usable to meet the now obsolete California Pedigree law (see “The California Pedigree Law Is Now Officially Inoperative”), or any other State pedigree laws, and I do not believe it will be widely used to meet the Federal DSCSA before maybe 2021 or 2022, but I do believe it will take center-stage for meeting the long-term requirements of the DSCSA.

In 2023 the DSCSA transitions into Continue reading The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1 →

EPCIS

Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange?

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????????????????????????????????????????I am confident that GS1’s Electronic Product Code Information Services (EPCIS) standard will take center stage in 2023 when the U.S. Drug Supply Chain Security Act (DSCSA) transitions into what that law calls the “Enhanced Drug Distribution System”, or EDDS.  That’s when the DSCSA mandates that supply chain changes of ownership of prescription drugs must be documented in an interoperable electronic system based on their unique serial numbers.

Each of the steps that must be implemented by the industry between now and Continue reading Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange? →

DSCSA, HDMA

HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again

The Healthcare Distribution Management Association (HDMA) had just published another update to their guidance for meeting the U.S. Drug Supply Chain Security Act (DSCSA) using Electronic Data Interchange (EDI) 856 Advance Ship Notice (ASN).  In case you thought they already did that a few months ago, you are right.  This is an update (July) to the earlier update, and this one is important, so make sure you replace your old copy with this one.

The previous guidance document (see “Just Released – The HDMA EDI ASN Guidance For DSCSA”) was pulled together very quickly to meet the demands of everyone in the supply chain.  However, it missed a few critical characteristics, like how to document:

  • the identity of the buyer and seller when either differs from the ship-to or ship-from locations;
  • when the drugs were originally purchased directly from the manufacturer or exclusive distributor;
  • when the seller received a direct purchase statement from their supplier.

Continue reading HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again →

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 →