FDA Guidance on Standardised Identification for Medicinal Products

As the first of numerous further guidelines planned on this topic, the FDA has published a draft that gives information on the standardisation of numerical identification for prescription of medicinal products. This draft goes back to the Food And Drug Administration Act of 2007 (FDAAA), which was signed on 27 September 2007 and requires in Section 505D the development and identification of technical standards for securing the supply chain against counterfeit medicinal products. The text calls for SNIs (standardised numerical identifiers) on the packaging of prescription medicinal products ensuring identification, authentication as well as tracking and tracing.

This SNI should consist of the sNDC (serialised National Drug Code indicating the manufacturer/repackager, 21 CFR Part 207) combined with a unique 8-digit serial number, which is generated by the manufacturer or repackager. In the FDA's view, batch number and expiration date should not be part of the SNI. According to the FDA requirements, these pieces of information have to be included on the label. However, including these data is possible if it is ensured that the resulting code still permits the user to make use of the SNI. For this case, the FDA suggests the use of the GS1 standard.

Consequently, the SNI is meant to indicate the manufacturer/repackager on the one hand and to enable an unambiguous labelling of each package of prescription medicinal product on the other hand. The text does not specify any preferences as to the technology to be used; 2D barcodes and the RFID technology are listed next to each other. However, the SNI should be applied in a way as to be readable by human beings and machines.

The contents of this guidance represent hardly more than a proposal, but the document shows that the topic of tracking and tracing is indeed in motion. The Draft Guidance can be found here.

You get more information on this topic at the international conference Tracking & Tracing in Berlin on 28 and 29 April 2009. Apart from the current developments in the USA and in Europe, the technical prerequisites and the experience gathered from the project in Turkey - the first of its kind in Europe - are presented at this event.

Dr. Robert Eicher
On behalf of the European Compliance Academy (ECA)

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