BILL NUMBER: AB 1045	AMENDED
	BILL TEXT

	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  Sections 4112 and 4127.2  
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 provide that if the home state pharmacy license
of a nonresident pharmacy is revoked or suspended for any reason, any
license issued pursuant to provisions governing the licensing and
registration of nonresident pharmacies and authorizing a nonresident
pharmacy to compound injectable sterile drug products shall be
immediately revoked or suspended by operation of law. 

   The 
    This  bill would  also  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
within 24 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 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 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 4112 of the Business and
Professions Code is amended to read:
   4112.  (a) Any 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.
   (b) A person may not act as a nonresident pharmacy unless he or
she has obtained a license from the board. The board may register a
nonresident pharmacy that is organized as a limited liability company
in the state in which it is licensed.
   (c) A nonresident pharmacy shall disclose to the board the
location, names, and titles of (1) its agent for service of process
in this state, (2) all principal corporate officers, if any, (3) all
general partners, if any, and (4) all pharmacists who are dispensing
controlled substances, dangerous drugs, or dangerous devices to
residents of this state. A report containing this information shall
be made on an annual basis and within 30 days after any change of
office, corporate officer, partner, or pharmacist.
   (d) All nonresident pharmacies shall comply with all lawful
directions and requests for information from the regulatory or
licensing agency of the state in which it is licensed as well as with
all requests for information made by the board pursuant to this
section. The nonresident pharmacy shall maintain, at all times, a
valid unexpired license, permit, or registration to conduct the
pharmacy in compliance with the laws of the state in which it is a
resident. As a prerequisite to registering with the board, the
nonresident pharmacy shall submit a copy of the most recent
inspection report resulting from an inspection conducted by the
regulatory or licensing agency of the state in which it is located.
If the home state pharmacy license of a nonresident pharmacy is
revoked or suspended for any reason, any license issued pursuant to
this section shall be immediately revoked or suspended by operation
of law.
   (e) All nonresident pharmacies shall maintain records of
controlled substances, dangerous drugs, or dangerous devices
dispensed to patients in this state so that the records are readily
retrievable from the records of other drugs dispensed.
   (f) Any pharmacy subject to this section shall, during its regular
hours of operation, but not less than six days per week, and for a
minimum of 40 hours per week, provide a toll-free telephone service
to facilitate communication between patients in this state and a
pharmacist at the pharmacy who has access to the patient's records.
This toll-free telephone number shall be disclosed on a label affixed
to each container of drugs dispensed to patients in this state.
   (g) A nonresident pharmacy shall not permit a pharmacist whose
license has been revoked by the board to manufacture, compound,
furnish, sell, dispense, or initiate the prescription of a dangerous
drug or dangerous device, or to provide any pharmacy-related service,
to a person residing in California.
   (h) The board shall adopt regulations that apply the same
requirements or standards for oral consultation to a nonresident
pharmacy that operates pursuant to this section and ships, mails, or
delivers any controlled substances, dangerous drugs, or dangerous
devices to residents of this state, as are applied to an in-state
pharmacy that operates pursuant to Section 4037 when the pharmacy
ships, mails, or delivers any controlled substances, dangerous drugs,
or dangerous devices to residents of this state. The board shall not
adopt any regulations that require face-to-face consultation for a
prescription that is shipped, mailed, or delivered to the patient.
The regulations adopted pursuant to this subdivision shall not result
in any unnecessary delay in patients receiving their medication.
   (i) The registration fee shall be the fee specified in subdivision
(a) of Section 4400.
   (j) The registration requirements of this section shall apply only
to a nonresident pharmacy that ships, mails, or delivers controlled
substances, dangerous drugs, and dangerous devices into this state
pursuant to a prescription.
   (k) Nothing in this section shall be construed to authorize the
dispensing of contact lenses by nonresident pharmacists except as
provided by Section 4124.  
  SEC. 2.    Section 4127.2 of the Business and
Professions Code is amended to read:
   4127.2.  (a) A nonresident pharmacy may not compound injectable
sterile drug products for shipment into the State of California
without a license issued by the board pursuant to this section. The
license shall be renewed annually and shall not be transferable.
   (b) A license to compound injectable sterile drug products may
only be issued for a location that is licensed as a nonresident
pharmacy. Furthermore, the license to compound injectable sterile
drug products may only be issued to the owner of the nonresident
pharmacy license at that location. If the home state pharmacy license
of a nonresident pharmacy is revoked or suspended for any reason,
any license issued pursuant to Section 4112 or this section shall be
immediately revoked or suspended by operation of law. A license to
compound injectable sterile drug products may not be issued or
renewed until the board receives the following from the nonresident
pharmacy:
   (1) A copy of an inspection report issued by the pharmacy's
licensing agency, or a report from a private accrediting agency
approved by the board, in the prior 12 months documenting the
pharmacy's compliance with board regulations regarding the
compounding of injectable sterile drug products.
   (2) A copy of the nonresident pharmacy's proposed policies and
procedures for sterile compounding.
   (c) Nonresident pharmacies operated by entities that are licensed
as a hospital, home health agency, or a skilled nursing facility and
have current accreditation from the Joint Commission on Accreditation
of Healthcare Organizations, or other private accreditation agencies
approved by the board, are exempt from the requirement to obtain a
license pursuant to this section.
   (d) This section shall become effective on the earlier of July 1,
2003, or the effective date of regulations adopted by the board
pursuant to Section 4127. 
   SEC. 3.   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
within 24 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 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 revoked or suspended for any reason, any license issued pursuant
to Section 4112 or 4127.2 shall be immediately revoked or suspended
by operation of law. 
   SEC. 4.   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.