BILL ANALYSIS �
SB 600
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Date of Hearing: August 6, 2014
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Mike Gatto, Chair
SB 600 (Lieu) - As Amended: June 30, 2014
Policy Committee: Business and
Professions Vote: 12-0
Urgency: No State Mandated Local Program:
Yes Reimbursable: No
SUMMARY
This bill repeals provisions that require tracing of
pharmaceuticals throughout the supply chain to conform to
federal law, defines drugs obtained outside of the licensed
supply chain as misbranded, and authorizes higher fines and
penalties for violations related to misbranded drugs.
FISCAL EFFECT
1)Negligible costs to Board of Pharmacy. Current law invalidates
California's E-pedigree requirements if superseded by a
federal requirement. This bill simply updates statute and
should not result in additional costs.
2)Unknown, potentially higher penalty revenue for misbranded
drugs, depending on enforcement.
COMMENTS
1)Purpose . This bill is intended to conform California's
statute to recent changes in federal law, as well as reduce
circumvention of approved purchasing channels by punishing the
purchase of drugs that are not regulated by the state or
federal government. This bill is author-sponsored.
2)Background . E-pedigree is a California statutory program
intended to prevent counterfeit medicine from entering the
legitimate supply chain. E-pedigree was created by SB 1307
(Figueroa), Chapter 857, Statutes of 2004, and began
implementation the following year, with full operability
anticipated by 2015. The term "pedigree" describes a custody
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record containing data about each transaction that results in
a change of ownership of a prescription drug. The goal of the
program was to show the lineage of the drug through the entire
drug distribution channel.
The federal Drug Quality and Security Act, which became law in
fall 2013, was prompted by a 2012 fungal meningitis outbreak
linked to unsanitary conditions at a Massachusetts compounding
pharmacy as well as concerns regarding increases in
counterfeit, falsified, substandard and dangerous prescription
medications. DQSA contained two parts - the Compounding
Quality Act, which authorized FDA regulation of compounding
pharmacies, and the Drug Supply Chain Security Act.
The Drug Supply Chain Security Act creates a national
electronic track and trace system for prescription drugs, and
explicitly preempts any state's requirements for tracing
products through the distribution system that are inconsistent
with, more stringent than, or in addition to any of the
requirements under the Act. Thus, California's e-pedigree
system is currently invalid by operation of law. This law
repeals those invalid sections.
3)Related Legislation . AB 2605 (Bonilla) requires third party
logistic providers who provide pharmaceutical storage,
handling, or distribution services to be licensed by the
California Board of Pharmacy. AB 2605 is pending in the
Senate Appropriations Committee.
4)Previous Legislation . SB 1307 (Figueroa), Chapter 857,
Statutes of 2004, created California's e-Pedigree program,
which made comprehensive changes to the drug distribution
system to protect the integrity of the pharmaceutical supply
chain.
SB1476 (Figueroa), Chapter 658, Statutes of 2006, delayed the
implementation date for the E-pedigree component to January 1,
2009 and granted the Board the authority to extend the
deadline an additional two years to allow the industry
additional time to implement technologies necessary for
electronic pedigrees.
Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081
SB 600
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