BILL NUMBER: SB 1270	INTRODUCED
	BILL TEXT


INTRODUCED BY   Senator Cedillo

                        FEBRUARY 19, 2008

   An act to amend Sections 4034, 4163, and 4163.5 of the Business
and Professions Code, relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1270, as introduced, Cedillo. Pharmacy: dangerous drug and
device pedigrees.
   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. On and after January 1, 2009,
existing law requires a pedigree, as defined, to accompany each
distribution of a dangerous drug, and prohibits a wholesaler or
pharmacy from selling, trading, transferring, or acquiring a
dangerous drug without a pedigree. Existing law authorizes the board
to extend the compliance date for these pedigree requirements to
January 1, 2011, in specified circumstances. Existing law provides
exceptions from the pedigree requirements for certain transactions.
   This bill would instead impose the pedigree requirement and the
prohibition against selling, trading, transferring, or acquiring a
dangerous drug without a pedigree on an unspecified date, authorize
the board to extend the compliance date to an unspecified date in
those specified circumstances, and make conforming changes.
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.


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.
   (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.  Section 4163 of the Business and Professions Code is
amended to read:
   4163.  (a) A manufacturer or wholesaler may not furnish a
dangerous drug or dangerous device to an unauthorized person.
   (b) Dangerous drugs or dangerous devices shall be acquired from a
person authorized by law to possess or furnish dangerous drugs or
dangerous devices. When the person acquiring the dangerous drugs or
dangerous devices is a wholesaler, the obligation of the wholesaler
shall be limited to obtaining confirmation of licensure of those
sources from whom it has not previously acquired dangerous drugs or
dangerous devices.
   (c) Except as otherwise provided in Section 4163.5, commencing on
January 1,  2009   ____  , a wholesaler or
pharmacy may not sell, trade, or transfer a dangerous drug at
wholesale without providing a pedigree.
   (d) Except as otherwise provided in Section 4163.5, commencing on
January 1,  2009   ____  , a wholesaler or
pharmacy may not acquire a dangerous drug without receiving a
pedigree.
  SEC. 3.  Section 4163.5 of the Business and Professions Code is
amended to read:
   4163.5.  The board may extend the date for compliance with the
requirement for a pedigree set forth in Sections 4034 and 4163 until
January 1,  2011   ____  , if it determines
that manufacturers or wholesalers require additional time to
implement electronic technologies to track the distribution of
dangerous drugs within the state. A determination by the board to
extend the deadline for providing pedigrees shall not be subject to
the requirements of Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code.