Many thanks to Alec Gaffney of Regulatory Focus for pointing out that the FDA just published their annual list of draft guidances that they anticipate will be published before the end of 2013. Of course, no guarantees come with it. In fact, they included the anticipation of Track & Trace guidance in last year’s list as well but nothing was published (See “FDA To Publish Track & Trace Standard By Year End“). That’s why it’s not surprising that it’s on the list again this year.
The FDA list seems to come out earlier each year. Considering that the Track & Trace guidance was included on last year’s list, perhaps it will be published in the near future. I’m not holding my breath, but it sure would be an interesting addition to the current situation in California where companies are trying to figure out exactly how to exchange the ePedigree data that the law mandates but doesn’t explain how (For example, see “‘The Shadows Of Things That MAY BE, Only’ : EPCIS and California Compliance“).
As I predicted last year, the California Board of Pharmacy has now adopted the FDA’s non-binding Standardized Numeric Identifier (SNI) guidance as the “unique identifier” to be used for compliance with their pedigree law. Another theory I wrote about last year was that, like SNI, once the FDA publishes final guidance on Track & Trace, California just might adopt it as their preferred way of exchanging ePedigree data (see my theory in “What Happens If RxTEC Isn’t Adopted?”). We’ll be able to see if that would even be possible once we get a glimpse of the FDA draft sometime this year. Let’s hope it doesn’t slip into 2014.