BILL NUMBER: SB 431 INTRODUCED
BILL TEXT
INTRODUCED BY Senator Emmerson
FEBRUARY 16, 2011
An act to amend Sections 4104, 4105, and 4112 of the Business and
Professions Code, relating to pharmacies.
LEGISLATIVE COUNSEL'S DIGEST
SB 431, as introduced, Emmerson. Pharmacies: regulation.
Existing law, the Pharmacy Law, creates the California State Board
of Pharmacy and makes it responsible for administering and enforcing
the provisions of that law, including the licensure of pharmacies,
as defined, and nonresident pharmacies that ship, mail, or deliver
controlled substances or dangerous drugs or devices, as defined, into
this state. The law requires that each pharmacy establish procedures
for addressing the theft, diversion, or self-use of dangerous drugs
by a licensed individual employed by or with the pharmacy, and that
an entity licensed by the board retain records of the acquisition and
disposition of dangerous drugs and devices in a specified manner.
The law makes a knowing violation of its provisions a misdemeanor.
This bill would require a pharmacy to conduct an audit of the
theft, diversion, or self-use of dangerous drugs by a licensed
individual employed by or with the pharmacy and provide, as
specified, the board with a certified copy of the audit and its
results. The bill would also require an entity licensed by the board
to provide records to designated persons within 72 hours of the time
of the request, unless that timeframe is extended by the board. The
bill would prohibit a pharmacist whose license was revoked by the
board to perform pharmacy duties, as specified, for a nonresident
pharmacy.
Because this bill would specify additional requirements under the
Pharmacy Law, a violation of which is a crime, it would impose a
state-mandated local program by creating additional crimes.
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 4104 of the Business and Professions Code is
amended to read:
4104. (a) Every pharmacy shall have in place procedures for
taking action to protect the public when a licensed individual
employed by or with the pharmacy is discovered or known to be
chemically, mentally, or physically impaired to the extent it affects
his or her ability to practice the profession or occupation
authorized by his or her license, or is discovered or known to have
engaged in the theft, diversion, or self-use of dangerous drugs.
(b) Every pharmacy shall have written policies and procedures for
addressing chemical, mental, or physical impairment, as well as
theft, diversion, or self-use of dangerous drugs, among licensed
individuals employed by or with the pharmacy.
(c) Every pharmacy shall report and provide to the
board, within 30 days of the receipt or development of the following
information with regard to any licensed individual employed by or
with the pharmacy:
(1) Any admission by a licensed individual of chemical, mental, or
physical impairment affecting his or her ability to practice.
(2) Any admission by a licensed individual of theft, diversion, or
self-use of dangerous drugs.
(3) Any video or documentary evidence demonstrating chemical,
mental, or physical impairment of a licensed individual to the extent
it affects his or her ability to practice.
(4) Any video or documentary evidence demonstrating theft,
diversion, or self-use of dangerous drugs by a licensed individual.
(5) Any termination based on chemical, mental, or physical
impairment of a licensed individual to the extent it affects his or
her ability to practice.
(6) Any termination of a licensed individual based on theft,
diversion, or self-use of dangerous drugs.
(d) The pharmacy shall conduct an audit to determine the quantity
and type of dangerous drugs stolen, diverted, or used by a licensed
individual employed by or with the pharmacy. The pharmacy shall
submit to the board a certified copy of the audit within 30 days of
the receipt or development of information described in paragraph (4)
of subdivision (c).
(d)
(e) Anyone making a report authorized or required by
this section shall have immunity from any liability, civil or
criminal, that might otherwise arise from the making of the report.
Any participant shall have the same immunity with respect to
participation in any administrative or judicial proceeding resulting
from the report.
SEC. 2. Section 4105 of the Business and Professions Code is
amended to read:
4105. (a) All records or other documentation of the acquisition
and disposition of dangerous drugs and dangerous devices by any
entity licensed by the board shall be retained on the licensed
premises in a readily retrievable form.
(b) The licensee may remove the original records or documentation
from the licensed premises on a temporary basis for license-related
purposes. However, a duplicate set of those records or other
documentation shall be retained on the licensed premises.
(c) The records required by this section shall be retained on the
licensed premises for a period of three years from the date of
making.
(d) Any records that are maintained electronically shall be
maintained so that the pharmacist-in-charge, the pharmacist on duty
if the pharmacist-in-charge is not on duty, or, in the case of a
veterinary food-animal drug retailer or wholesaler, the designated
representative on duty, shall, at all times during which the licensed
premises are open for business, be able to produce a hard copy and
electronic copy of all records of acquisition or disposition or other
drug or dispensing-related records maintained electronically.
(e) (1) Notwithstanding subdivisions (a), (b), and (c), the board,
may upon written request, grant to a licensee a waiver of the
requirements that the records described in subdivisions (a), (b), and
(c) be kept on the licensed premises.
(2) A waiver granted pursuant to this subdivision shall not affect
the board's authority under this section or any other provision of
this chapter.
(f) This section shall become operative on January 1, 2006.
(f) When requested by an authorized officer of the law or by an
authorized representative of the board, the owner, corporate officer,
or manager of an entity licensed by the board shall provide the
board with the requested records within 72 hours of the time the
request was made. The entity may request in writing an extension of
this timeframe for a period not to exceed 14 days from the date the
records were requested. A request for an extension of time is subject
to the approval of the board.
SEC. 3. 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.
(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.
(g)
(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.
(h)
(i) The registration fee shall be the fee specified in
subdivision (a) of Section 4400.
(i)
(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.
(j)
(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. 4. 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.