In less than one month the Drug Supply Chain Security Act (DSCSA) will require all sales of drugs in the U.S. pharma supply chain to be accompanied by some very specific data (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”). The law requires companies to begin exchanging data on January 1 in either paper or electronic form, but because it would be virtually impossible for the big 3 wholesale distributors to accept even a single piece of paper for even a single shipment, the bulk of the U.S. sales by pharma manufacturers will be documented electronically from day-one. It turns out, the vast majority of that electronic documentation will be passed in the form of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) (see “DQSA: Getting To Electronic Transaction Data Exchange”, “Just Released – The HDMA EDI ASN Guidance For DSCSA”, “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again” and “The HDMA Supply Chain Product Transaction Scenarios For DSCSA”).
But the vast majority of those EDI ASN documents are not likely to Continue reading The Coming Transition To Serialized Data
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
NOTICE: 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 “” and ““), but companies who Continue reading Just Released – The HDMA EDI ASN Guidance For DSCSA