FDA Issues Packaging Guidance to Increase Drug Supply-Chain Protection

In an attempt to strengthen safeguards against counterfeit, diverted, subpotent, misbranded, adulterated, or expired drugs, the US Food and Drug Administration on Mar. 26, 2010 issued a new final guidance for industry, Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages.

The guidance, meant to ease the adoption of a uniform electronic track-and-trace system for prescription drugs, is part of FDA’s effort to implement Section 913 of the 2007 Food and Drug Administration Amendments Act. That section requires the US Department of Health and Human Services to develop standards and identify and validate technologies for securing the pharmaceutical drug chain.

Standardized numerical identifiers (SNIs) are the main focus of the guidance, which does not mandate a specific way of incorporating an SNIs onto a package or a location where it must be placed.

“FDA believes that an SNI generally should be applied to each package in both human-readable and machine-readable forms. However, at this time, FDA is not specifying the means of incorporating the SNI onto the package,” says the guidance. “The SNIs described in this guidance are compatible with, and flexible for, encoding into a variety of machine-readable forms of data carriers such as 2-dimensional bar codes and radio-frequency identification, leaving options open as technologies for securing the supply chain continue to be identified, and standards making use of SNI are developed.”

For most prescription drug packages, the SNI is a serialized National Drug Code (sNDC). “By combining a serial number of up to 20 characters with the NDC, the sNDC should be sufficiently robust to support billions of units of marketed products without duplication of an SNI,” the guidance says. “This approach will allow manufacturers and repackagers to assign serial numbers to combine with the NDC for unique identification of individual packages.”

The final guidance finalizes the draft version of the same name issued in January 2009.