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.

In addition to these improvements, the updated guidance (July) also greatly improves the HDMA’s proposed text for the Transaction Statement (see “DSCSA: Transaction Statement”).  The earlier guidance proposed the very terse text, “DSCSA Compliant”, to replace the full text given in the DSCSA itself.  Abbreviation is needed, but that one went a little too far and a number of manufacturers complained that it would not pass their legal departments.  This new updated guidance proposes the much more reasonable text,

“Seller has complied with each applicable subsection of FDCA Sec. 581(27)(A)–(G).

Here the abbreviation, “FDCA” means the “Food, Drug and Cosmetics Act” (also sometimes abbreviate as “FD&C”), which is appropriate since “DSCSA” refers only to the act that was passed by Congress last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  The DSCSA contained directions for modifying the FDCA—the fully consolidated regulation—so it would reflect the desires of Congress.  HDMA is right that “FDCA” is the correct reference here.

Keep in mind, we still won’t know if the FDA will accept even this improved statement until they publish their data exchange guidance before November 27 of this year.

In addition to the updated guidance, HDMA has also updated the examples to reflect the new guidance.

If you are planning to accept or supply ASNs as official DSCSA TI, TH and TS, then you must get a copy of this newly updated (July) version of the HDMA ASN guidance.  It’s free from the HDMA.  Get it here.

Dirk.