Bill Text: CA SB1106 | 2009-2010 | Regular Session | Amended

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Bill Title: Prescribers: dispensing of samples.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Engrossed - Dead) 2010-08-09 - Read second time. To third reading. Re-referred to Com. on HEALTH. [SB1106 Detail]

Download: California-2009-SB1106-Amended.html

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BILL NUMBER: SB 1106	AMENDED
	BILL TEXT

	AMENDED IN SENATE  APRIL 5, 2010

INTRODUCED BY   Senator Yee

                        FEBRUARY 17, 2010

   An act to amend Section 4171 of the Business and Professions Code,
relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1106, as amended, Yee. Prescribers: dispensing of samples.
   Existing law, the Pharmacy Law,  the knowing violation of
which is a crime,  regulates prescribers, as defined, and
the dispensing of drugs. Existing law prohibits a prescriber from
dispensing drugs or dangerous devices to patients in his or her
office unless certain requirements are met. Existing law also
authorizes prescribers to furnish a limited quantity of samples if
(1) the samples are dispensed in the manufacturer's package, (2)
there is no charge to the patient, and (3) an appropriate record is
entered in the patient's chart.  A knowing violation of the
Pharmacy Law is a crime. 
   This bill would  prohibit   require  a
prescriber  from  dispensing a drug sample or a
starter kit  unless the appropriate manufacturer's warning
pamphlet is physically attached to the package   to
either (1) provide the patient with a copy of the FDA-approved
package insert for the drug sample or starter kit  or 
the   (2) ensure that the  manufacturer's warnings
are affixed to the package containing the drug sample or starter kit.

   Because this bill would impose a new requirement under the
Pharmacy Law, the knowing violation of which would be a crime, it
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 4171 of the Business and Professions Code is
amended to read:
   4171.  (a) Section 4170 shall not prohibit the furnishing of a
limited quantity of samples by a prescriber, if the prescriber
dispenses the samples to the patient in the package provided by the
manufacturer, no charge is made to the patient therefor, and an
appropriate record is entered in the patient's chart.
   (b) Section 4170 shall not apply to clinics, as defined in
subdivision (a) of Section 1204 or subdivision (b) or (c) of Section
1206 of the Health and Safety Code, to programs licensed pursuant to
Sections 11876, 11877, and 11877.5 of the Health and Safety Code, or
to a prescriber dispensing parenteral chemotherapeutic agents,
biologicals, or delivery systems used in the treatment of cancer.

   (c) No prescriber dispensing drugs pursuant to Section 4170 shall
dispense a drug sample or a starter kit unless the appropriate
manufacturer's warning pamphlet is physically attached to the package
containing the drug sample or starter kit or the 
    (c)     A prescriber dispensing a drug
sample or starter kit pursuant to subdivision (a) or Section 4170
shall either (1) provide the patient with a copy of the FDA-approved
package insert for the drug sample or starter kit or (2) ensure that
the  manufacturer's warnings are affixed to the package
containing the drug sample or starter kit.
  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.