Final FDA guidance for placing standardized numerical identifiers on individual prescription drug packages recommends the use of the National Drug Code plus an alphanumeric serial number containing as many as 20 digits.

The combination of the serial number and NDC, which corresponds to the specific drug product (including the particular package configuration), would constitute a serialized NDC that would enable each end-use container of drugs to be tracked to ensure it is not counterfeit.

By adding up to 20 characters to the NDC, the sNDC should be "sufficiently robust to support billions of units of marketed products without duplication" of a standardized numerical identifier, FDA points out.

The agency proposed an eight-digit numerical serial number, plus the NDC, in 2009 draft guidance, but in comments on the document, the Pharmaceutical Research and Manufacturers of America pointed out the inadequacy of the eight-number add-on for high-production manufacturers.

No matter how many digits it recommends, the impact of the guidance remains uncertain as it is just that - guidance. As FDA Deputy Principal Commissioner Joshua Sharfstein recently told a House subcommittee, the agency lacks authority to enforce a system to track and trace pharmaceuticals (Also see "FDA To Unveil Drug Identifier System Soon, Short On Enforcement Authority" - Pink Sheet, 15 March, 2010.). The FDA Amendments Act of 2007 nevertheless calls on the agency to set standards and systems to identify, validate, authenticate, track and trace prescription drugs.

And the basic process of serializing individual product packages has been a struggle for industry, prompting the California State Board of Pharmacy to twice delay its rules for companies to produce an electronic document to track ownership of drug products through the supply chain ([A#0070013009]).

FDA sees the standardized numerical identifier as "a first step to facilitate the development of other standards and systems for securing the drug supply chain. Many aspects of the implementation of package-level identification will take shape in the future, as the standards that make use of SNI are developed."

The guidance applies to the development of standardized numerical identifiers for drug packages only, not to case- or pallet-level packaging. A prescription drug package is the smallest unit placed into interstate commerce by the manufacturer or repackager and is intended for individual sale, the guidance says.

Where On the Package Should The SNI Go?

A product meant for individual sale is accompanied by labeling that permits its individual distribution, the guidance continues. As an example, FDA notes that if the manufacturer's smallest unit-of-sale package holds six drug-filled syringes, that package would be accompanied by a standardized numerical identifier.

If the syringes subsequently are repackaged for individual sale, the repackager must ensure that appropriate labeling accompanies each syringe and place a new and unique SNI on each repackaged syringe(s).

Repackager SNIs are to be linked to the manufacturer's SNI. It remains for industry to determine how to do that.

Biologic products approved under the Public Health Service Act already have unique identification numbers on each package, in accordance with recognized identification and labeling standards, and these numbers can serve as the SNI, FDA says.

The agency recommends that the SNI be applied to packages in both human-readable and machine-readable forms. The former "would provide the ability to identify the package when electronic means are unavailable (e.g., in the event of hardware/software failure)."

The SNIs recommended in the guidance are compatible with or flexible enough to be used with a variety of machine-readable forms of data carriers, such as two-dimensional bar codes and radio-frequency identification, FDA suggests.

While not specifying a location on the package for the SNI, FDA points out it must not obstruct required labeling information and should be scannable without impairing package integrity.

The sNDC is compatible with the global trade item number, which is a worldwide standard for item and object identification, established by GS1, a consensus-based, not-for profit, international standards organization, FDA maintains.

-Cathy Dombrowski (c.dombrowski@elsevier.com )

FDA Takes First Step Towards "Track And Trace" As Final Guidance Lengthens Identifiers For Drug Packaging

More from Archive

More from Pink Sheet