Monday, February 25, 2008

*NEW* CA Pedigree Legislation

Today’s lesson: If at first you don’t succeed, change the rules!

Two bills were introduced last week that would modify California’s pedigree legislation.

Just to be crystal clear: Don’t stop planning for January 1, 2009. Obviously, there can be no guarantee that either the proposed legislation will pass or that the Board of Pharmacy will vote for a delay to 2011. Nevertheless, the likelihood of a delay or phased implementation just went up again.

I'M JUST A BILL

You can read the text of the proposed bills at these links:

SB 1307 (introduced by CA State Senator Ridley-Thomas)

SB 1270 (introduced by CA State Senator Cedillo)

SB1270 is more interesting of the two because it potentially changes the January 1, 2009, implementation date. The text looks like a placeholder to me:

“This bill would instead impose the pedigree requirement and the prohibition against selling, trading, transferring, or acquiring a dangerous drug without a pedigree on an unspecified date, authorize the board to extend the compliance date to an unspecified date in those specified circumstances, and make conforming changes.” (emphasis added)

Right now, the CA Board of Pharmacy only has the ability to delay implementation of e-pedigree requirements until 2011 if the board determines that “manufacturers or wholesalers require additional time to implement electronic technology to track the distribution of drugs within the state.” (See CA Pedigree: Going to '11?) Unfortunately, the Board’s decision making process regarding the 2009 deadline seems dysfunctional and unnecessarily opaque, as I describe in Pedigree and Obscenity.

I’ve been told that additional legislation may be on the way, especially with regard to phased implementation such as a risk-based approach to serialization. You can read more about California’s legislative process here.

AND SPEAKING OF SERIALIZATION...

I will be attending SecurePharma2008 on Tuesday morning. If you'll be there, please stop by and see me at the Secure Symbology booth at 10:30 AM on Tuesday. I’m always looking for good story ideas and tips for Drug Channels.

I'll be at the booth with other members of Secure Symbology’s Advisory Board of Directors. But please don’t call us booth babes!

3 comments:

  1. Dr. Fein,

    This is amazing information -- thanks for getting it out so fast. I did not know about these bills. Do you know who lobbied for them?

    BT

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  2. One section in both bills jumped off the page: (i) "Interoperable electronic system" as used in this chapter means an electronic track and trace system for dangerous drugs that uses a unique identification number, established at the point of manufacture, contained within a standardized nonproprietary data format and architecture, that is uniformly used by manufacturers, wholesalers, and pharmacies for the pedigree of a dangerous drug."

    There seems to be a lot to glean from this section:

    1. Track and trace and pedigree requirements are synonymous under California law
    2. No comment on who owns or operates the “electronic system,” but “interoperable” suggests multiple systems or providers is allowable. It does make it clear the state won’t be paying for the system.
    3. “Unique identification number” does not say serialized. Diet Coke 12 oz has a unique identification number “that is uniformly used by manufacturers, wholesalers, and pharmacies”
    4. “Used for dangerous drugs” suggests a separate electronic system for this class of drugs.
    5. “Established at the point of manufacturer” will put new logistical demands on our current system of packaging and repackaging. According to (5)d this would be at the “at the smallest package or immediate container distributed by the manufacturer”
    6. For some suppliers, this will be heart-breaking: nonproprietary data format AND architecture
    7. There is no mention of who should record the pedigree transaction: the buyer or the seller or both?

    Neither bill mentions penalty for noncompliance. How about a penalty we can just tag onto the GP% for California consumers?

    ReplyDelete
  3. Adam, it was a pleasure to meet you at SecurePharma 2008! My guess is that Cedillo's bill is just a spot bill...something that we will not see amended for at least 30 days. It will be interesting to see what gets dropped in from there.

    Regards,
    JAH

    ReplyDelete

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