FDA Still Receives Requests For Exemptions From 2006 Barcode Rule

FDALogoThis morning the FDA is due to publish an announcement for an opportunity to comment on their proposed collection of certain information as part of ongoing requests for exemptions from the linear “barcode rule” that has been in effect since April 26, 2006.   The FDA is soliciting comments on the barcode label requirements for drugs and biologics.  Apparently federal agencies are required by the Paperwork Reduction Act of 1995 to publish such a notice and ask for public input on their intent to collect certain information, including extensions like this one.

There is not really anything new in this notice, except that I was surprised that the agency continues to receive requests for exemptions to the barcode rule under certain, limited circumstances.  Based on their experience over the last 10 years, they anticipate receiving just two exemption requests per year.  But those requests are just for the current linear barcode requirement, not the 2D barcode requirement that will go into effect on November 27, 2017 as part of the Drug Supply Chain Security Act.

Because the FDA is apparently also asking for general comments on the barcode label requirements in general, you might want to give them your thoughts on how it will impact your business when it is necessary to have both a linear AND a 2D barcode on every package in less than two years.  Your comments may not result in an immediate response, but the FDA needs a better understanding of the impact of that situation so they will begin educating dispensers and other stakeholders on the importance of moving to the 2D barcode as soon as possible.

I have written about this issue several times over the years (see “Will The FDA Eliminate The Linear Barcode On Drugs?“, and “Why NOW Is The Time To Move Away From Linear Barcodes“).

The FDA announcement will be published on this page at some time today.  If it is not present yet, follow the FDA’s link to the pre-publication PDF version.

[UPDATE 12-22-2015:  FDA has issued a correction to the docket number that was referenced in the original announcement.  See the correction here if you plan to respond.]

We are still waiting for the FDA to publish up to four overdue guidance documents related to the DSCSA.  Stay tuned.  I’m watching for them.

Also, don’t forget to anonymously fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz.  Read about it here.  And fill it out here.