Due to the FDA Amendments Act of 2007, the FDA is obliged to define measures for securing the supply chain of medicinal products. It is among these measures that the development of standards and identification of technologies effective against counterfeit medicinal products fall. This guidance, which had only existed in the form of a draft (we reported) and which counts as the first in a series of guidance documents, has now been finalised.
The document, which has now been published in its final version, defines the SNI, i.e. the standardized numerical identifier, which is meant to facilitate tracking & tracing solutions on the packaging of prescription medicinal products in the future. Here, the manufacturer shall assign the SNI to his smallest packaging unit. In case this unit is further broken down, e.g. by a trader, the latter has to assign new SNIs that can be traced back to the original SNI. How this should be done exactly is a question unanswered by the document. Standards for track & trace systems for product authentication are not mentioned either.
The text sets out that the SNI is to consist of the sNDC (serialised National Drug Code), a combination of the already existing NDC and a unique serial number. In this context, the greatest change between the former draft and the final guidance can be found. While the draft document determined that the serial number should be 8 digits long, the final version defines a length of up to 20 digits. The reason for this lies in objections by the industry stating that, with an additional randomisation of the serial numbers, 8 digits would not provide enough possibilities.
The SNI shall be applied to the packaging in a way that can be read both by machines and by human beings. The method for this is not laid down in the guidance. From the FDA's point of view, batch numbers and expiration dates should not be coded in the SNI. According to the CFR requirements, these data are already present on the labelling, but can be entered in data bases linked to the serial number in question.
The FDA document on standardised numerical identification can be found here.
Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)