Tuesday, February 11, 2014

California's E-Pedigree Law Preempted

Updated September 24, 2020

The link in the original post broke.

Here's the full text article from the California State Board of Pharmacy.  Source:  The Script (Spring 2014, page 4) - California State Board of Pharmacy: E-pedigree Pre-empted by National Tracking System Law .

"On November 27, 2013, President Obama signed Public Law
113-54, which contains provisions for a national tracking system
for prescription medication.

Included within this law are provisions that pre-empt
California’s e-pedigree requirements that were enacted originally
in 2004 and were to be in full effect by July 2017. California’s
Business and Professions Code contains provisions that
effectively preempt California’s provisions if federal legislation
in this area is enacted.

The board is required to post a message about the
inactivation of California’s e-pedigree provisions. This notice
is provided below; it also will be published in the California
Regulatory Notice Register and posted on our website. Also, this
year the board will sponsor legislation to repeal the e-pedigree
provisions that are now inactive provisions in California law.

The board thanks the many individuals including
pharmaceutical supply chain companies, computer and
technology firms, policy makers, staff of the California
delegation and the many others who worked with the board over
the last 10 years to develop e-pedigree provisions and implement
a system to strengthen the integrity of the US drug supply.

We especially thank the early adopters and those who
worked on pilot projects to ensure California’s provisions
would be implemented by the coming deadlines. It was a large
endeavor and we trust that what was learned to “get ready for
California” will be transferable to the national system that is now
under development. We are grateful to have played a role in this
important area of public safety and health.

Public Notice:

Pursuant to Business and Professions Code section 4034.1,
which provides in pertinent part that “[u]pon the effective date
of federal legislation . . . addressing pedigree or serialization
measures for dangerous drugs, Sections 4034, 4163(c)
– (g), 4163.1, 4163.2, 4163.4, and 4163.5 shall become
inoperative,” and which requires that within 90 days of the
enactment of such legislation the board publish a notice regarding
the invalidation of these statutes, the California State Board of
Pharmacy is hereby publishing notice that federal legislation
meeting the requirements of section 4034.1 has been enacted, and
that Business and Professions Code sections 4034, 4163, 4163.1,
4163.2, 4163.4, and 4163.5 became inoperative as of November
27, 2013."

- - -  original post follows below  - - -

California Board of Pharmacy - Information on E-Pedigree:

"Public Notice:

Pursuant to Business and Professions Code section 4034.1, which provides in pertinent part that “[u]pon the effective date of federal legislation . . . addressing pedigree or serialization measures for dangerous drugs, Sections 4034, 4163(c) – (g), 4163.1, 4163.2, 4163.4, and 4163.5 shall become inoperative,” and which requires that within 90 days of the enactment of such legislation the board publish a notice regarding the invalidation of these statutes, the California State Board of Pharmacy is hereby publishing notice that federal legislation meeting the requirements of section 4034.1 has been enacted, and that Business and Professions Code sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 became inoperative as of November 27, 2013."

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