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Guideline anticipates final FDA guidance to be issued later this year
Electronic Data Interchange (EDI) is a relatively old method of transmitting transaction information between business organizations, but it is still an essential process for most pharmaceutical product ordering, especially between pharma manufacturers and drug wholesalers. One EDI format in particular, the 856 Advance Ship Notice (a.k.a “ASN”) is a commonly used format for documenting transfers of drugs from sellers to buyers. With that format in place, the Healthcare Distribution Management Assn. (HDMA) has been working energetically since the Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act) was passed last November to adapt ASN to the requirements of DSCSA. Now, it has issued a guideline for how to carry this adaptation out.
The actual document is relevant mostly to IT programmers who would code online purchasing or order-processing systems so that the data can move smoothly from seller to buyer. DSCSA creates a set of definitions, Transaction Information, Transaction History and Transaction Statement; ASN, with the extensions or defined fields that the guidance details, can accommodate some of this information. In effect, it gets the machinery of pharma track-and-trace started; more will happen as FDA develops specific requirements for the Transaction Statement and other elements of DSCSA.
There is no little urgency to all this: by January 2015, manufacutrers, wholesalers and wholesaler customers (mostly pharmacies, either retailers or hospitals) are supposed to be able to receive and transmit verified transaction information among each other. Word on the street is that most major wholesalers will be ready, and most large pharma companies (or the logistics providers that pharma companies employ to handle distribution); but the pharmacy industry—especially hospital-based systems—are going to have a tough time meeting the deadline.
The HDMA document, HDMA Electronic Data Interchange (EDI) Guidelines for the 856 Advance Ship Notice to Support Implementation of DSCSA, is available for purchase at the HDMA store.