FDA seeks comment on SNI developments

The US Food and Drug Administration (FDA) is seeking comment from pharmaceutical manufacturers and other interested stakeholders on draft guidance relating to the provisions set out in Section 505D of the Federal Food, Drug, and Cosmetic Act regarding the development of standardised numerical identifiers (SNIs) for prescription drug packages.

The FDA has already asked for public comment on specific questions related to the development of an SNI and received 59 comments from a range of stakeholders and the guidance is based on these comments.

The FDA says the SNI for most prescription drug packages should be a serialised National Drug Code (sNDC). For prescription drugs, such as blood and blood components, that do not use NDC numbers, the FDA is considering the use of ISBT 128 or Codabar as the SNI.

The FDA chose the sNDC because "it 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 prescription drugs.

Because the sNDC 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".

At this time, the FDA is not specifying a particular means of incorporating the SNI onto the package, or its positioning on the package.