CA E-Pedigree Timeline in Flux

I hope you are still paying attention to the California pedigree situation.

Yes, we all know that the CA Board of Pharmacy extended the e-pedigree implementation deadline to January 1, 2011. But SB1307, which was introduced by CA State Senator Ridley-Thomas in February, proposes the following new e-pedigree implementation timelines:

• Wholesalers: January 1, 2011
• Pharmacies: January 1, 2012
• Manufacturers: January 1, 2011 to January 1, 2013

The manufacturers have a phased in serialization schedule under SB1307 because “the process of implementing serialized electronic pedigree for all prescription drugs in the entire chain of distribution is a complicated technological and logistical undertaking for manufacturers, wholesalers, pharmacies, and other supply chain participants. The Legislature seeks to ensure continued availability of prescription drugs in California while drug manufacturers implement these requirements.” (according to page 10 of the bill’s text.)

Here is the proposed schedule by which a manufacturer must (1) designate the particular drugs that will be serialized, and (2) actually comply with the serialized electronic pedigree requirements:

• Designated by January 1, 2010; Compliance by January 1, 2011: 20 percent of drugs
• Designated by January 1, 2011; Compliance by January 1, 2012: 30 percent of drugs (Total = 50 percent)
• Designated by January 1, 2012; Compliance by January 1, 2013: 50 percent of drugs (Total = 100 percent)

I’m encouraged that California will be incorporating more realistic timelines for serialization, especially given the unknown prospects for national standards. However, it's harder than ever to predict the precise future deadlines.

Where's Doc Brown when you need him?

READER OF THE WEEK

The Texas Startup Blog recently interviewed Jon Cameron, founder and President of Pop Technology. According to the article: “When Jon isn’t inventing cool gadgets for the retail industry he can be found reading Drug Channels…”

Gosh, your friendly neighborhood blogger is now someone’s hobby!

Thanks for the shout-out, Jon.

COMMENTS, WE GOT COMMENTS

There are many interesting comments on yesterday's analysis of the latest AMP study. Read them below the original post. Perhaps you'll even add you own $0.02?