Amended in Senate June 6, 2013

Amended in Assembly April 22, 2013

California Legislature—2013–14 Regular Session

Assembly Bill No. 1045

Introduced by Assembly Member Quirk-Silva

February 22, 2013

An act to amend begin delete Sections 4112 and 4127.2 end delete begin insert Section 4303 end insert 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 begin insert and nonresident end insert 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 begin insert resident or end insert nonresident pharmacy.

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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.

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The

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begin insert This end insert bill would begin delete also end delete 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.

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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.

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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:

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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.

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begin delete SEC. 3. end delete
begin insert SECTION 1. end insert   

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.

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begin insert SEC. end insert begin insert 2. end insert   

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begin insert Section 4303 of the end insert begin insert Business and Professions Code end insert begin insert is
amended to read: end insert

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.

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(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.

end insert

begin delete SEC. 4. end delete
begin insert SEC. 3. end insert   

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.