buy cialis

Standardized Numerical Identifiers for Drugs: File Comments by Tax Day

January 15, 2009 – 7:54 am

FDA is suggesting the voluntary use of a standardized numerical identifier (SNI) on prescription drug packages. You now have 90 days (from the Federal Register publication date) to comment on “Guidance for Industry: Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages.”

The draft guidance recommends that the “SNI for most prescription drug packages should be a serialized National Drug Code (sNDC). The sNDC is composed of the National Drug Code (NDC) that reflects each corresponding manufacturer or repackager, combined with a unique 8-digit numerical serial number generated by the manufacturer or repackager for each individual package.” Expiration dates or lot codes are not suggested for inclusion in the code.

By using sNDCs, FDA believes that such identification can “facilitate authentication and tracking and tracing of prescription drugs.”

FDA also believes its suggested SNI is compatible with 2-D bar coding and RFID. Redundant human-readable SNI is encouraged.

FDA has started the year off with a mission focused on securing the supply chain. Earlier this week FDA announced its collaborative work with other government agencies in promoting import safety. Part of that effort entails its own draft guidance on Good Importer Practices. In all of these proposals, FDA speaks of securing the supply chain and utilizing track-and-trace technologies.

More guidances are coming, too. FDA announced a meeting on unique medical device identification, taking a lot-based approach. Expect more to come on systems for identification, authentication, and tracking and tracing. Case- and pallet-level standards are also a possibility.

You have been delayed and waiting for FDA. Not anymore, though!

What do you think? Did you expect the sNDC?

Daphne Allen

  1. 2 Responses to “Standardized Numerical Identifiers for Drugs: File Comments by Tax Day”

  2. Great summary, Daphne.
    I’d echo the last suggestion in the guidance itself–that companies consider adopting a full GS1 sGTIN. It’s a superset of what may be required in the final act, but the guidance does take the time to encourage it in the closing section. sGTINs provide an added level of expressiveness and international compatibility that we have found to be valuable in today’s far flung supply chains.

    By John Beans on Jan 15, 2009

  1. 1 Trackback(s)

  2. Apr 5, 2010: numerical errors

Post a Comment