BILL NUMBER: AB 1045 AMENDED
BILL TEXT
AMENDED IN SENATE JUNE 19, 2013
AMENDED IN SENATE JUNE 6, 2013
AMENDED IN ASSEMBLY APRIL 22, 2013
INTRODUCED BY Assembly Member Quirk-Silva
FEBRUARY 22, 2013
An act to amend Section 4303 of, and to add Section 4127.9 to, the
Business and Professions Code, relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
AB 1045, as amended, Quirk-Silva. Sterile compounding and
nonresident pharmacies.
Existing law, the Pharmacy Law, provides for the licensure and
regulation of pharmacies in this state by the California State Board
of Pharmacy. A violation of these provisions is a crime.
Existing law provides that a pharmacy located outside this state
that ships, mails, or delivers, in any manner, controlled substances,
dangerous drugs, or dangerous devices into this state shall be
considered a nonresident pharmacy. Existing law prohibits a person
from acting as a nonresident pharmacy unless he or she has obtained a
license from the board, and authorizes the board to register a
nonresident pharmacy that is organized as a limited liability company
in the state in which it is licensed. The law also prohibits a
resident or nonresident pharmacy from compounding injectable sterile
drug products for shipment into this state without a license issued
by the board, and authorizes a license to compound injectable sterile
drug products to be issued only for a location that is licensed as a
resident or nonresident pharmacy.
This bill would require a resident or a nonresident pharmacy that
issues a recall notice regarding a sterile compounded drug to
contact the recipient pharmacy, prescriber, or patient of the
recalled drug and the board as soon as possible within
24 12 hours of the recall notice if use
of or exposure to the recalled drug may cause serious adverse health
consequences or death and if the recalled drug was dispensed or is
intended for use in this state. Because a violation of these
requirements would be a crime, the bill would impose a state-mandated
local program.
The bill would also provide that if the home state pharmacy
license of a nonresident pharmacy is canceled, revoked
, or suspended for any reason, any license issued pursuant
to the provisions governing the licensing and registration of
nonresident pharmacies or authorizing a nonresident pharmacy to
compound injectable sterile drug products shall be immediately
canceled, revoked , or suspended by operation of
law.
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 4127.9 is added to the Business and Professions
Code, to read:
4127.9. (a) A pharmacy licensed pursuant to Section 4127.1 or
4127.2, including a pharmacy that is exempt from licensure pursuant
to subdivision (d) of Section 4127.1 and subdivision (c) of Section
4127.2, that issues a recall notice regarding a sterile compounded
drug shall, in addition to any other duties, contact the recipient
pharmacy, prescriber, or patient of the recalled drug and the board
as soon as possible within 24 12
hours of the recall notice if both of the following apply:
(1) Use of or exposure to the recalled drug may cause serious
adverse health consequences or death.
(2) The recalled drug was dispensed, or is intended for use, in
this state.
(b) A recall notice issued pursuant to subdivision (a) shall be
made as follows:
(1) If the recalled drug was dispensed directly to the patient,
the notice shall be made to the patient.
(2) If the recalled drug was dispensed directly to the prescriber,
the notice shall be made to the prescriber, who shall ensure the
patient is notified.
(3) If the recalled drug was dispensed directly to a pharmacy, the
notice shall be made to the pharmacy, who shall notify the
prescriber or patient, as appropriate. If the pharmacy notifies the
prescriber, the prescriber shall ensure the patient is notified.
SEC. 2. Section 4303 of the Business and Professions Code is
amended to read:
4303. (a) The board may report any violation by a nonresident
pharmacy of the laws and regulations of this state, any other state,
or of the United States, including, but not limited to, any violation
of this chapter or of the regulations established by the board, to
any appropriate state or federal regulatory or licensing agency,
including, but not limited to, the regulatory or licensing agency of
the state in which the nonresident pharmacy is a resident or in which
the pharmacist is licensed.
(b) The board may cancel, deny, revoke, or suspend a
nonresident pharmacy registration, issue a citation or letter of
admonishment to a nonresident pharmacy, or take any other action
against a nonresident pharmacy that the board may take against a
resident pharmacy license, on any of the same grounds upon which such
action might be taken against a resident pharmacy, provided that the
grounds for the action are also grounds for action in the state in
which the nonresident pharmacy is permanently located.
(c) If the home state pharmacy license of a nonresident pharmacy
is canceled, revoked , or suspended for any
reason, any license issued pursuant to Section 4112 or 4127.2 shall
be immediately canceled, revoked , or suspended
by operation of law.
SEC. 3. 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.