BILL NUMBER: SB 431 AMENDED
BILL TEXT
AMENDED IN SENATE MAY 10, 2011
AMENDED IN SENATE APRIL 11, 2011
INTRODUCED BY Senator Emmerson
FEBRUARY 16, 2011
An act to amend Sections 4081, 4104, 4105, 4112, and
4126.5 and 4112 of, and to add Section 4126.7 to,
the Business and Professions Code, relating to pharmacies.
LEGISLATIVE COUNSEL'S DIGEST
SB 431, as amended, 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. Under existing law, a reverse distributor is any person
who acts as an agent for a pharmacy, drug wholesaler, manufacturer,
or other entity by receiving, inventorying, and managing the
disposition of outdated or nonsalable dangerous drugs. A knowing
violation of the Pharmacy Law is a crime. Existing law
provides for the registration of hazardous waste haulers, as defined.
This bill would , except as specified, prohibit a
reverse distributor from accepting the return of dangerous drugs that
have been dispensed to a patient that are later returned by the
patient or patient's agent to a pharmacy, as specified , and
would authorize only hazardous waste haulers to handle or dispose of
those drugs .
Existing 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 every
pharmacy report to the board within 30 days of the receipt or
development of certain information affecting the ability of those
individuals to practice the profession or occupation authorized by
their license, as specified. Existing law requires an entity licensed
by the board to retain records of the acquisition and disposition of
dangerous drugs and devices in a specified manner. Existing
federal law requires registrants distributing specified controlled
substances to conduct an inventory of controlled substances every 2
years.
This bill would instead require a pharmacy to report and provide
to the board, within 14 days of the receipt or development thereof,
the information described above regarding the ability of licensed
individuals employed by or with the pharmacy to practice the
profession or occupation authorized by their license. The 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 copy of the audit and its results. the report
to include specified detailed information, including the date of the
last controlled substances inventory, and would require the pharmacy
to prepare and submit an audit relating to the report upon the
request of the board. The bill would also require an entity
licensed by the board to provide records to designated persons within
72 hours 3 business days of the time
of the request, unless that timeframe is extended by the board ,
as specified . The bill would prohibit a pharmacist whose
license was revoked by the board to perform pharmacy duties, as
specified, for a nonresident pharmacy.
Existing law requires all records of manufacture and of sale,
acquisition, or disposition of dangerous drugs or dangerous devices
to be at all times during business hours open to inspection by
authorized officers of the law and preserved at least 3 years from
the date of making. Existing law requires every person or entity who
maintains a stock of dangerous drugs or dangerous devices to keep a
current inventory.
This bill would require that any record pertaining to the return
of dangerous drugs to a wholesaler, reverse distributor, or hazardous
waste hauler include specified information, including the quantity
or weight of the drugs returned.
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 4081 of the Business and Professions Code is
amended to read:
4081. (a) All records of manufacture and of sale, acquisition, or
disposition of dangerous drugs or dangerous devices shall be at all
times during business hours open to inspection by authorized officers
of the law, and shall be preserved for at least three years from the
date of making. A current inventory shall be kept by every
manufacturer, wholesaler, pharmacy, veterinary food-animal drug
retailer, physician, dentist, podiatrist, veterinarian, laboratory,
clinic, hospital, institution, or establishment holding a currently
valid and unrevoked certificate, license, permit, registration, or
exemption under Division 2 (commencing with Section 1200) of the
Health and Safety Code or under Part 4 (commencing with Section
16000) of Division 9 of the Welfare and Institutions Code who
maintains a stock of dangerous drugs or dangerous devices.
(b) The owner, officer, and partner of a pharmacy, wholesaler, or
veterinary food-animal drug retailer shall be jointly responsible,
with the pharmacist-in-charge or designated representative-in-charge,
for maintaining the records and inventory described in this section.
(c) The pharmacist-in-charge or designated
representative-in-charge shall not be criminally responsible for acts
of the owner, officer, partner, or employee that violate this
section and of which the pharmacist-in-charge or designated
representative-in-charge had no knowledge, or in which he or she did
not knowingly participate.
(d) Any record pertaining to the return of dangerous drugs to a
wholesaler or provided to a reverse distributor shall document the
quantity or weight of the drugs returned, the date the drugs were
returned, and the name of the reverse distributor or wholesaler to
whom the drugs were provided.
(e) Any record pertaining to the return of dangerous drugs to a
hazardous waste hauler, as described in Section 117660 of the Health
and Safety Code, shall list the volume in weight or measurement of
the pharmaceutical waste returned, the date the waste was returned,
and the name of the hazardous waste hauler to whom the waste was
provided.
SEC. 2. 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
14 days of the receipt or development thereof, 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 copy of the audit within 30 days of the initial
report to the board regarding the evidence described in subdivision
(c).
(d) The report required in subdivision (c) shall include
sufficient detail to inform the board of the facts upon which the
report is based, including an estimate of the type and quantity of
all dangerous drugs involved, the timeframe over which the losses are
suspected, and the date of the last controlled substances inventory.
Upon request of the board, the pharmacy shall prepare and submit an
audit involving the dangerous drugs suspected to be missing.
(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. 3. 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) 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
three business days 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 calendar days from the date the
records were requested. A request for an extension of time is subject
to the approval of the board. An extension shall be deemed
approved if the board fails to deny the extension request within two
business days of the time the extension request was made directly to
the board.
SEC. 4. 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.
(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. 5. Section 4126.5 of the Business and
Professions Code is amended to read:
4126.5. (a) A pharmacy may furnish dangerous drugs only to the
following:
(1) A wholesaler owned or under common control by the wholesaler
from whom the dangerous drug was acquired.
(2) The pharmaceutical manufacturer from whom the dangerous drug
was acquired.
(3) A licensed wholesaler acting as a reverse distributor.
(4) Another pharmacy or wholesaler to alleviate a temporary
shortage of a dangerous drug that could result in the denial of
health care. A pharmacy furnishing dangerous drugs pursuant to this
paragraph may only furnish a quantity sufficient to alleviate the
temporary shortage.
(5) A patient or to another pharmacy pursuant to a prescription or
as otherwise authorized by law.
(6) A health care provider that is not a pharmacy but that is
authorized to purchase dangerous drugs.
(7) To another pharmacy under common control.
(8) A hazardous waste hauler, as described in Section 117660 of
the Health and Safety Code, for the sole purpose of waste disposal of
pharmaceutical waste returned to the pharmacy by a patient or
patient's agent.
(b) Notwithstanding any other provision of law, a violation of
this section may subject the person or persons who committed the
violation to a fine not to exceed the amount specified in Section
125.9 for each occurrence pursuant to a citation issued by the board.
(c) Amounts due from any person under this section on or after
January 1, 2005, shall be offset as provided under Section 12419.5 of
the Government Code. Amounts received by the board under this
section shall be deposited into the Pharmacy Board Contingent Fund.
(d) For purposes of this section, "common control" means the power
to direct or cause the direction of the management and policies of
another person whether by ownership, by voting rights, by contract,
or by other means.
SEC. 6. SEC. 5. Section 4126.7 is
added to the Business and Professions Code, to read:
4126.7. (a) A reverse distributor shall not accept the return of
dangerous drugs that have been dispensed to a patient that
are later returned by the patient or the patient's agent to the
pharmacy or another licensed entity. and returned to
the pharmacy unless the dangerous drugs were dispensed in a sealed or
tamper-evident package and there is no evidence that the package was
opened, damaged, or otherwise tampered with prior to its
return to the pharmacy. Records of these returned dangerous drugs
shall be kept by the pharmacy.
(b) Dangerous drugs returned by a patient or a patient's agent to
a pharmacy, if accepted by the pharmacy, may be picked up or handled
only by a hazardous waste hauler, as described in Section 117660 of
the Health and Safety Code.
(c)
(b) For purposes of this section, "dispensed" means
that the dangerous drugs have been provided to the patient or patient'
s agent and taken from a pharmacy.
SEC. 7. SEC. 6. 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.