FDA refined its draft guidance on a serialized numerical identifier (SNI) for prescription drug packaging with the issuance of final guidance March 26. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm.
The agency said the final guidance should be viewed as recommendations and its current thinking on the topic. Though offered as recommendations—and without naming dates for implementation--the guidance will provide companies with confidence their serialization efforts will comply with any future federal regulations.
The guidance does not depart radically from the draft guidance published in January 2009, says Dirk Rodgers, in his blog www.RxTrace.com.
“In my view, the only really important difference is how the serial number portion of the sNDC is defined. The obvious difference is an increase in length from 8 to 20 characters, but more subtle and significant changes are that the serial number has changed from a proposed fixed-length to a variable-length field, and from a numeric-only to optionally alphanumeric,” Rodgers says.
The changes bring FDA’s sNDC into full alignment with the GS1 definition of a product serial number using Application Identifier 21 and an SGTIN in RFID tags, Rodgers says.
‘This change also technically results in a mis-alignment in the name “Serialized Numeric Identifier” since the serial number doesn’t have to be numeric anymore, but I’ll forgive the authors for not changing the name,” Rodgers writes.
In supporting the presentation of the sNDC in the SGTIN, the guidance satisfies the law’s requirement that the SNI be harmonized with internationally recognized standards to the extent practical.
“By combining the serial number of up to 20 characters with the NDC, the sNDC should be sufficiently robust to support billions of units of marked products without duplication of an SNI,” the agency said.
The guidance states that the “SNI generally should be applied to each package in both human–readable and machine-readable form,” and maintains the data-carrier-neutral position of the draft guidance.
“At this time, FDA is not specifying the means of incorporating the SNI onto the package,” the agency says, noting that the SNI described is compatible with encoding into a variety of machine readable forms of data carriers, including 2D bar codes and RFID.
In establishing unique identification at the salable level of packaging with the guidance, FDA is favoring a user-driven process by not being overly prescriptive on the technology and symbology, an approach supported in comments to the draft guidance.