BILL NUMBER: SB 1307	INTRODUCED
	BILL TEXT


INTRODUCED BY   Senator Ridley-Thomas

                        FEBRUARY 20, 2008

   An act to amend Section 4034 of the Business and Professions Code,
relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1307, as introduced, Ridley-Thomas. Pharmacy: pedigree.
   Existing law, the Pharmacy Law, provides for the licensure and
regulation of the practice of pharmacy and the sale of dangerous
drugs or dangerous devices by the California State Board of Pharmacy,
in the Department of Consumer Affairs. Under existing law, on and
after January 1, 2009, pedigree means an electronic record containing
information regarding each transaction resulting in a change of
ownership of a given dangerous drug, from sale by a manufacturer,
through acquisition and sale by one or more wholesalers,
manufacturers, or pharmacies, until final sale to a pharmacy or other
person furnishing, administering, or dispensing the dangerous drug.
On and after January 1, 2009, existing law prohibits a wholesaler or
pharmacy from selling, trading, or transferring a dangerous drug
without a pedigree and prohibits a wholesaler or pharmacy from
acquiring a dangerous drug without receiving a pedigree. Existing
law, on and after January 1, 2009, requires that a pedigree include
certain information, including, but not limited to, the source of the
dangerous drug and the trade or generic name of the drug. Existing
law authorizes the board to extend the January 1, 2009 compliance
date to January 1, 2011, in specified circumstances. Existing law
makes it a crime to knowingly violate the Pharmacy Law.
   This bill would require a pedigree to also include a specified
unique identification number. By changing the definition of a crime,
the bill would impose a state-mandated local program.
   The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
   This bill would provide that no reimbursement is required by this
act for a specified reason.
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  Section 4034 of the Business and Professions Code is
amended to read:
   4034.  (a) "Pedigree" means a record, in electronic form,
containing information regarding each transaction resulting in a
change of ownership of a given dangerous drug, from sale by a
manufacturer, through acquisition and sale by one or more
wholesalers, manufacturers, or pharmacies, until final sale to a
pharmacy or other person furnishing, administering, or dispensing the
dangerous drug. The pedigree shall be created and maintained in an
interoperable electronic system, ensuring compatibility throughout
all stages of distribution.
   (b) A pedigree shall include all of the following information:
   (1) The source of the dangerous drug, including the name, the
federal manufacturer's registration number or a state license number
as determined by the board, and principal address of the source.
   (2) The trade or generic name of the drug, the quantity of the
dangerous drug, its dosage form and strength, the date of the
transaction, the sales invoice number, the container size, the number
of containers, the expiration dates, and the lot numbers.
   (3) The business name, address, and the federal manufacturer's
registration number or a state license number as determined by the
board, of each owner of the dangerous drug, and the dangerous drug
shipping information, including the name and address of each person
certifying delivery or receipt of the dangerous drug.
   (4) A certification under penalty of perjury from a responsible
party of the source of the dangerous drug that the information
contained in the pedigree is true and accurate. 
   (5) The unique identification number described in subdivision (i).

   (c) A single pedigree shall include every change of ownership of a
given dangerous drug from its initial manufacture through to its
final transaction to a pharmacy or other person for furnishing,
administering, or dispensing the drug, regardless of repackaging or
assignment of another National Drug Code (NDC) Directory number.
   (d) A pedigree shall track each dangerous drug at the smallest
package or immediate container distributed by the manufacturer,
received and distributed by the wholesaler, and received by the
pharmacy or another person furnishing, administering, or dispensing
the dangerous drug.
   (e) Any return of a dangerous drug to a wholesaler or manufacturer
shall be documented on the same pedigree as the transaction that
resulted in the receipt of the drug by the party returning it.
   (f) If a licensed health care service plan, hospital organization,
and one or more physician organizations have exclusive contractual
relationships to provide health care services, drugs distributed
between these persons shall be deemed not to have changed ownership.
   (g) The following transactions are not required to be recorded on
a pedigree:
   (1) The provision of samples of dangerous drugs by a manufacturer'
s employee to an authorized prescriber, provided the samples are
dispensed to a patient of the prescriber without charge.
   (2) An injectable dangerous drug that is delivered by the
manufacturer directly to an authorized prescriber or other entity
directly responsible for administration of the injectable dangerous
drug, only for an injectable dangerous drug that by law may only be
administered under the professional supervision of the prescriber or
other entity directly responsible for administration of the drug.
Injectable dangerous drugs exempted from the pedigree requirement by
this paragraph may not be dispensed to a patient or a patient's agent
for self-administration, and shall only be administered to the
patient, as defined in Section 4016, by the prescriber or other
authorized entity that received the drug directly from the
manufacturer.
   (3) The exemption in paragraph (2) shall expire and be inoperative
on January 1, 2010, unless prior to that date the board receives, at
a public hearing, evidence that entities involved in the
distribution of the injectable dangerous drugs subject to that
paragraph are not able to provide a pedigree in compliance with all
of the provisions of California law, and the board votes to extend
the expiration date for the exemption until January 1, 2011. The
decision as to whether to extend the expiration date shall be within
the sole discretion of the board, and shall not be subject to the
requirements of Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of the Government Code.
   (h) If a manufacturer, wholesaler, or pharmacy has reasonable
cause to believe that a dangerous drug in, or having been in, its
possession is counterfeit or the subject of a fraudulent transaction,
the manufacturer, wholesaler, or pharmacy shall notify the board
within 72 hours of obtaining that knowledge. This subdivision shall
apply to any dangerous drug that has been sold or distributed in or
through this state.
   (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.
   (j) The application of the pedigree requirement in pharmacies
shall be subject to review during the board's sunset review to be
conducted as described in subdivision (f) of Section 4001.
   (k) This section shall become operative on January 1, 2009.
However, the board may extend the date for compliance with this
section and Section 4163 until January 1, 2011, in accordance with
Section 4163.5.
  SEC. 2.  No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.