tag:blogger.com,1999:blog-28450497.post5039159238625307854..comments2008-03-02T09:12:50.250-05:00Adam J. Fein, Ph.D.http://www.blogger.com/profile/12217252282643255442noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-28450497.post-80308495442024615962008-03-01T20:38:00.000-05:002008-03-01T20:38:00.000-05:00Adam, 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.<BR/><BR/>Regards,<BR/>JAHJAHnoreply@blogger.comtag:blogger.com,1999:blog-28450497.post-4317257878551850822008-02-26T14:41:00.000-05:002008-02-26T14:41:00.000-05:00One 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."<BR/><BR/>There seems to be a lot to glean from this section:<BR/><BR/>1. Track and trace and pedigree requirements are synonymous under California law<BR/>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.<BR/>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”<BR/>4. “Used for dangerous drugs” suggests a separate electronic system for this class of drugs. <BR/>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”<BR/>6. For some suppliers, this will be heart-breaking: nonproprietary data format AND architecture<BR/>7. There is no mention of who should record the pedigree transaction: the buyer or the seller or both?<BR/><BR/>Neither bill mentions penalty for noncompliance. How about a penalty we can just tag onto the GP% for California consumers?Jonnoreply@blogger.comtag:blogger.com,1999:blog-28450497.post-20689166305143522412008-02-25T10:44:00.000-05:002008-02-25T10:44:00.000-05:00Dr. Fein,<BR/><BR/>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? <BR/><BR/>BTAnonymousnoreply@blogger.com