Tag Archives: transaction information

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

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 →