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California Business and Professions Code Section 4163.3

Legal Research Home > California Laws > Business and Professions Code > California Business and Professions Code Section 4163.3

(a) It is the intent of the Legislature that participants
in the distribution chain for dangerous drugs, including
manufacturers, wholesalers, or pharmacies furnishing, administering,
or dispensing dangerous drugs, distribute and receive electronic
pedigrees, and verify and validate the delivery and receipt of
dangerous drugs against those pedigrees at the unit level, in a
manner that maintains the integrity of the pedigree system without an
unacceptable increase in the risk of diversion or counterfeiting.
   (b) To meet this goal, and to facilitate efficiency and safety in
the distribution chain, the board shall, by regulation, define the
circumstances under which participants in the distribution chain may
infer the contents of a case, pallet, or other aggregate of
individual units, packages, or containers of dangerous drugs, from a
unique identifier associated with the case, pallet, or other
aggregate, without opening each case, pallet, or other aggregate or
otherwise individually validating each unit.
   (c) Manufacturers, wholesalers, and pharmacies opting to employ
the use of inference as authorized by the board to comply with the
pedigree requirements shall document their processes and procedures
in their standard operating procedures (SOPs) and shall make those
SOPs available for board review.
   (d) SOPs regarding inference shall include a process for
statistically sampling the accuracy of information sent with inbound
product.
   (e) Liability associated with accuracy of product information and
pedigree using inference shall be specified in the board's
regulations.

Last modified: February 13, 2012