Bill Text: CA AB1045 | 2013-2014 | Regular Session | Chaptered

California Assembly Bill 1045 (Prior Session Legislation)

Bill Title: Sterile compounding and nonresident pharmacies.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2013-09-09 - Chaptered by Secretary of State - Chapter 302, Statutes of 2013. [AB1045 Detail]

Download: California-2013-AB1045-Chaptered.html

BILL NUMBER: AB 1045	CHAPTERED
	BILL TEXT

	CHAPTER  302
	FILED WITH SECRETARY OF STATE  SEPTEMBER 9, 2013
	APPROVED BY GOVERNOR  SEPTEMBER 9, 2013
	PASSED THE SENATE  AUGUST 19, 2013
	PASSED THE ASSEMBLY  AUGUST 22, 2013
	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, 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 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.


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 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.