The proposal is that all packages should be marked with an SNI made up of a National Drug Code (NDC), as set out in the US Food and Drug Administration’s (FDA) 21 CFR part 207, and a unique, 8-digit serial number generated by the manufacturer or re-packager.
The FDA said that approach “serves the needs of the drug supply chain as a means of identifying individual prescription drug packages. That identification can in turn facilitate authentication and tracking and tracing of the prescription drugs.”
The agency added that: “the NDC incorporates an 8-digit numerical serial number with the NDC, it should provide appropriate robustness to support billions of units of marketed products without duplication of an SNI.”
Another feature on the guidance is its compatibility with the serialised Global Trade Item Number (sGTIN) model set up by the international standards organisation GS1. The FDA has been a key collaborator on the sGTIN system which, to date, has been adopted by 65 countries as a way of tracking pharmaceuticals.
This aspect of the scheme fits very well with the supply chain monitoring scheme that was launched by the FDA last week and will doubtless be welcomed by those who have questioned how the agency will police non-US firms making drugs for the US market.
January has been a busy month for the agency, both in terms of the guidance on supply and import security and efforts to increase its presence on the ground in countries like India and China that are major suppliers to the US market.
While the appointment of Frank Torti as acting FDA head suggests that President Obama’s selection of a full time replacement for Andrew von Eschenbach is still a way off, those jockeying for the top spot will be keen to maintain the momentum the agency has built up in the last few weeks.