BILL NUMBER: SB 734 CHAPTERED
BILL TEXT
CHAPTER 487
FILED WITH SECRETARY OF STATE OCTOBER 4, 2005
APPROVED BY GOVERNOR OCTOBER 4, 2005
PASSED THE SENATE SEPTEMBER 7, 2005
PASSED THE ASSEMBLY SEPTEMBER 6, 2005
AMENDED IN ASSEMBLY AUGUST 25, 2005
AMENDED IN ASSEMBLY AUGUST 15, 2005
AMENDED IN SENATE APRIL 18, 2005
INTRODUCED BY Senator Torlakson
FEBRUARY 22, 2005
An act to amend Sections 11159.2, 11161, 11161.5, 11162.1, 11164,
and 11190 of, and to add and repeal Section 11165.5 of, the Health
and Safety Code, relating to controlled substances, and making an
appropriation therefor.
LEGISLATIVE COUNSEL'S DIGEST
SB 734, Torlakson Controlled substances.
(1) Existing law provides that a prescription for a Schedule II
controlled substance for use by a patient who has a terminal illness
shall meet specified requirements.
This bill would provide that a prescription for a controlled
substance for use by a patient who has a terminal illness may be
written on a form that does not contain certain other features, as
specified.
(2) Existing law provides that when a practitioner is charged with
a felony violation of specified controlled substance offenses, the
court, upon the motion of a law enforcement agency, shall issue an
order requiring the practitioner to surrender any prescription forms
in his or her possession at the time set in the order.
This bill would require the court, in its order, to also prohibit
the practitioner from obtaining, ordering, or using any additional
prescription forms. The bill would impose a state-mandated local
program by requiring the law enforcement agency obtaining the order
to notify the Department of Justice of the order. The bill would make
clarifying and conforming changes to this and related provisions.
(3) Existing law provides that prescription forms for controlled
substance prescriptions shall be obtained from security printers
approved by the Board of Pharmacy; the board may approve security
printer applications after the applicant has provided specified
information and the applicant's fingerprints, in a manner specified
by the board, for the purpose of completing state and federal
criminal background checks.
This bill would revise the latter provision to provide instead
that the prescription forms for controlled substance prescriptions
shall be obtained from security printers approved by the Department
of Justice and that the department shall provide the applicant with
the means and direction to provide fingerprints and related
information, in a manner specified by the department, for the purpose
of completing state, federal, or foreign criminal background checks.
The bill would provide that the applicant shall submit his or her
fingerprint images and related information to the department for the
purpose of the department obtaining information as to the existence
and nature of a record of specified state, federal, or foreign level
convictions and arrests. Requests for federal level criminal offender
record information received by the department shall be forwarded to
the Federal Bureau of Investigation by the department. The bill would
provide that the department shall assess the applicant a fee
sufficient to cover all processing or maintenance costs of the
department associated with providing the background checks, as
specified.
(4) Existing law provides that the Board of Pharmacy or the
Department of Justice may deny a security printer application for
specified reasons, including that the applicant has been convicted of
a crime.
This bill would provide that the Department of Justice, but not
the Board of Pharmacy, may deny the security printer application for
the specified reasons, including if any individual owner, partner,
corporate officer, manager, agent, representative, employee, or
subcontractor for the applicant who has direct access, management, or
control of controlled substance prescription forms has been
convicted of a crime. The bill would also add as a condition for
approval as a security printer that the applicant authorize the
department to make any examination of books and records of the
applicant, or to visit and inspect the applicant during business
hours, to the extent deemed necessary by the board or department to
properly enforce the provisions relating to security printers. An
approved applicant would be required to submit an exemplar of a
controlled substance prescription form, with all security features,
to the department within 30 days of initial production.
(5) Existing law provides that prescription forms shall be printed
with specified features.
This bill would provide that prescription forms shall also include
the feature of an identifying number assigned to the approved
security printer by the Department of Justice. The bill would also
require the forms to set forth specified information, as appropriate,
with respect to multiple prescribers.
(6) Existing law provides that controlled substances in Schedule
III, IV, or V may be dispensed upon an oral or electronically
transmitted prescription.
This bill would require persons who transmit or receive any oral
or electronically transmitted prescription to ensure its integrity
and confidentiality.
(7) Existing law provides for the electronic monitoring of the
prescribing and dispensing of Schedule II controlled substances
pursuant to the Controlled Substance Utilization Review and
Evaluation System (CURES) program.
This bill would provide that the Board of Pharmacy shall,
contingent upon the availability of adequate funds, evaluate the
viability of implementing real time reporting, as defined, and access
to data on controlled substances in the operation of CURES. This
bill would provide that these provisions shall be implemented to the
extent that sufficient nonstate funds are received to cover the costs
to the Board of Pharmacy of providing staff and for the preparation
of the report; and that any nonstate funds donated for that purpose
are appropriated to the board for that purpose.
(8) Existing law generally provides that a violation of the
provisions relating to the prescription of controlled substances is a
misdemeanor, punishable as specified. This bill, to the extent it
revises existing crimes, would impose a state-mandated local program
upon local governments.
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 with regard to certain mandates no
reimbursement is required by this act for a specified reason.
With regard to any other mandates, this bill would provide that,
if the Commission on State Mandates determines that the bill contains
costs so mandated by the state, reimbursement for those costs shall
be made pursuant to the statutory provisions noted above.
Appropriation: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 11159.2 of the Health and Safety Code is
amended to read:
11159.2. (a) Notwithstanding any other provision of law, a
prescription for a controlled substance for use by a patient who has
a terminal illness may be written on a prescription form that does
not meet the requirements of Section 11162.1 if the prescription
meets the following requirements:
(1) Contain the information specified in subdivision (a) of
Section 11164.
(2) Indicate that the prescriber has certified that the patient is
terminally ill by the words "11159.2 exemption."
(b) A pharmacist may fill a prescription pursuant to this section
when there is a technical error in the certification required by
paragraph (2) of subdivision (a), provided that he or she has
personal knowledge of the patient's terminal illness, and
subsequently returns the prescription to the prescriber for
correction within 72 hours.
(c) For purposes of this section, "terminally ill" means a patient
who meets all of the following conditions:
(1) In the reasonable medical judgment of the prescribing
physician, the patient has been determined to be suffering from an
illness that is incurable and irreversible.
(2) In the reasonable medical judgment of the prescribing
physician, the patient's illness will, if the illness takes its
normal course, bring about the death of the patient within a period
of one year.
(3) The patient's treatment by the physician prescribing a
controlled substance pursuant to this section primarily is for the
control of pain, symptom management, or both, rather than for cure of
the illness.
(d) This section shall become operative on July 1, 2004.
SEC. 2. Section 11161 of the Health and Safety Code is amended to
read:
11161. (a) When a practitioner is named in a warrant of arrest or
is charged in an accusatory pleading with a felony violation of
Section 11153, 11154, 11156, 11157, 11170, 11173, 11350, 11351,
11352, 11353, 11353.5, 11377, 11378, 11378.5, 11379, 11379.5, or
11379.6, the court in which the accusatory pleading is filed or the
magistrate who issued the warrant of arrest shall, upon the motion of
a law enforcement agency which is supported by reasonable cause,
issue an order which requires the practitioner to surrender to the
clerk of the court all controlled substance prescription forms in the
practitioner's possession at a time set in the order and which
prohibits the practitioner from obtaining, ordering, or using any
additional prescription forms. The law enforcement agency obtaining
the order shall notify the Department of Justice of this order.
Except as provided in subdivisions (b) and (e) of this section, the
order shall remain in effect until further order of the court. Any
practitioner possessing prescription forms in violation of the order
is guilty of a misdemeanor.
(b) The order provided by subdivision (a) shall be vacated if the
court or magistrate finds that the underlying violation or violations
are not supported by reasonable cause at a hearing held within two
court days after the practitioner files and personally serves upon
the prosecuting attorney and the law enforcement agency that obtained
the order, a notice of motion to vacate the order with any
affidavits on which the practitioner relies. At the hearing, the
burden of proof, by a preponderance of the evidence, is on the
prosecution. Evidence presented at the hearing shall be limited to
the warrant of arrest with supporting affidavits, the motion to
require the defendant to surrender controlled substance prescription
forms and to prohibit the defendant from obtaining, ordering, or
using controlled substance prescription forms, with supporting
affidavits, the sworn complaint together with any documents or
reports incorporated by reference thereto which, if based on
information and belief, state the basis for the information, or any
other documents of similar reliability as well as affidavits and
counter affidavits submitted by the prosecution and defense. Granting
of the motion to vacate the order is no bar to prosecution of the
alleged violation or violations.
(c) The defendant may elect to challenge the order issued under
subdivision (a) at the preliminary examination. At that hearing, the
evidence shall be limited to that set forth in subdivision (b) and
any other evidence otherwise admissible at the preliminary
examination.
(d) If the practitioner has not moved to vacate the order issued
under subdivision (a) by the time of the preliminary examination and
he or she is held to answer on the underlying violation or
violations, the practitioner shall be precluded from afterwards
moving to vacate the order. If the defendant is not held to answer on
the underlying charge or charges at the conclusion of the
preliminary examination, the order issued under subdivision (a) shall
be vacated.
(e) Notwithstanding subdivision (d), any practitioner who is
diverted pursuant to Chapter 2.5 (commencing with Section 1000) of
Title 7 of Part 2 of the Penal Code may file a motion to vacate the
order issued under subdivision (a).
(f) This section shall become operative on November 1, 2004.
SEC. 3. Section 11161.5 of the Health and Safety Code is amended
to read:
11161.5. (a) Prescription forms for controlled substance
prescriptions shall be obtained from security printers approved by
the Department of Justice.
(b) The department may approve security printer applications after
the applicant has provided the following information:
(1) Name, address, and telephone number of the applicant.
(2) Policies and procedures of the applicant for verifying the
identity of the prescriber ordering controlled substance prescription
forms.
(3) Policies and procedures of the applicant for verifying
delivery of controlled substance prescription forms to prescribers.
(4) (A) The location, names, and titles of the applicant's agent
for service of process in this state; all principal corporate
officers, if any; and all managing general partners, if any.
(B) A report containing this information shall be made on an
annual basis and within 30 days after any change of office, principal
corporate officers, or managing general partner.
(5) (A) A signed statement indicating whether the applicant,
principal corporate officers, or managing general partners have ever
been convicted of, or pled no contest to, a violation of any law of a
foreign country, the United States, or any state, or of any local
ordinance.
(B) The department shall provide the applicant with the means and
direction to provide fingerprints and related information, in a
manner specified by the department, for the purpose of completing
state, federal, or foreign criminal background checks.
(C) Any applicant described in subdivision (b) shall submit his or
her fingerprint images and related information to the department,
for the purpose of the department obtaining information as to the
existence and nature of a record of state, federal, or foreign level
convictions and state, federal, or foreign level arrests for which
the department establishes that the applicant was released on bail or
on his or her own recognizance pending trial, as described in
subdivision (l) of Section 11105 of the Penal Code. Requests for
federal level criminal offender record information received by the
department pursuant to this section shall be forwarded to the Federal
Bureau of Investigation by the department.
(D) The department shall assess against each applicant a fee
determined by the department to be sufficient to cover all
processing, maintenance, and investigative costs generated from or
associated with completing state, federal, or foreign background
checks pursuant to this section with respect to that applicant; the
fee shall be paid by the applicant at the time he or she submits
fingerprints and related information to the department.
(E) The department shall retain fingerprint impressions and
related information for subsequent arrest notification pursuant to
Section 11105.2 of the Penal Code for all applicants.
(c) The department may, within 60 calendar days of receipt of the
application from the applicant, deny the security printer
application.
(d) The department may deny a security printer application on any
of the following grounds:
(1) The applicant, any individual owner, partner, corporate
officer, manager, agent, representative, employee, or subcontractor
for the applicant, who has direct access, management, or control of
controlled substance prescription forms, has been convicted of a
crime. A conviction within the meaning of this paragraph means a plea
or verdict of guilty or a conviction following a plea of nolo
contendere. Any action which a board is permitted to take following
the establishment of a conviction may be taken when the time for
appeal has elapsed, the judgment of conviction has been affirmed on
appeal, or when an order granting probation is made suspending the
imposition of sentence, irrespective of a subsequent order under the
provisions of Section 1203.4 of the Penal Code.
(2) The applicant committed any act involving dishonesty, fraud,
or deceit with the intent to substantially benefit himself, herself,
or another, or substantially injure another.
(3) The applicant committed any act that would constitute a
violation of this division.
(4) The applicant knowingly made a false statement of fact
required to be revealed in the application to produce controlled
substance prescription forms.
(5) The department determines that the applicant failed to
demonstrate adequate security procedures relating to the production
and distribution of controlled substance prescription forms.
(6) The department determines that the applicant has submitted an
incomplete application.
(7) As a condition for its approval as a security printer, an
applicant shall authorize the Department of Justice to make any
examination of the books and records of the applicant, or to visit
and inspect the applicant during business hours, to the extent deemed
necessary by the board or department to properly enforce this
section.
(e) An approved applicant shall submit an exemplar of a controlled
substance prescription form, with all security features, to the
Department of Justice within 30 days of initial production.
(f) The department shall maintain a list of approved security
printers and the department shall make this information available to
prescribers and other appropriate government agencies, including the
Board of Pharmacy.
(g) Before printing any controlled substance prescription forms, a
security printer shall verify with the appropriate licensing board
that the prescriber possesses a license and current prescribing
privileges which permits the prescribing of controlled substances.
(h) Controlled substance prescription forms shall be provided
directly to the prescriber either in person, by certified mail, or by
a means that requires a signature signifying receipt of the package
and provision of that signature to the security printer.
(i) Security printers shall retain ordering and delivery records
in a readily retrievable manner for individual prescribers for three
years.
(j) Security printers shall produce ordering and delivery records
upon request by an authorized officer of the law as defined in
Section 4017 of the Business and Professions Code.
(k) (1) The department may revoke its approval of a security
printer for a violation of this division or action that would permit
a denial pursuant to subdivision (d) of this section.
(2) When the department revokes its approval, it shall notify the
appropriate licensing boards and remove the security printer from the
list of approved security printers.
SEC. 4. Section 11162.1 of the Health and Safety Code is amended
to read:
11162.1. (a) The prescription forms for controlled substances
shall be printed with the following features:
(1) A latent, repetitive "void" pattern shall be printed across
the entire front of the prescription blank; if a prescription is
scanned or photocopied, the word "void" shall appear in a pattern
across the entire front of the prescription.
(2) A watermark shall be printed on the backside of the
prescription blank; the watermark shall consist of the words
"California Security Prescription."
(3) A chemical void protection that prevents alteration by
chemical washing.
(4) A feature printed in thermo-chromic ink.
(5) An area of opaque writing so that the writing disappears if
the prescription is lightened.
(6) A description of the security features included on each
prescription form.
(7) (A) Six quantity check off boxes shall be printed on the form
and the following quantities shall appear:
1-24
25-49
50-74
75-100
101-150
151 and over.
(B) In conjunction with the quantity boxes, a space shall be
provided to designate the units referenced in the quantity boxes when
the drug is not in tablet or capsule form.
(8) Prescription blanks shall contain a statement printed on the
bottom of the prescription blank that the "Prescription is void if
the number of drugs prescribed is not noted."
(9) The preprinted name, category of licensure, license number,
federal controlled substance registration number of the prescribing
practitioner.
(10) A check box indicating the prescriber's order not to
substitute.
(11) An identifying number assigned to the approved security
printer by the Department of Justice.
(12) (A) A check box by the name of each prescriber when a
prescription form lists multiple prescribers.
(B) Each prescriber who signs the prescription form shall identify
himself or herself as the prescriber by checking the box by their
name.
(b) Each batch of controlled substance prescription forms shall
have the lot number printed on the form and each form within that
batch shall be numbered sequentially beginning with the numeral one.
(c) (1) A prescriber designated by a licensed health care
facility, a clinic specified in Section 1200, or a clinic specified
in subdivision (a) of Section 1206 that has 25 or more physicians or
surgeons may order controlled substance prescription forms for use by
prescribers when treating patients in that facility without the
information required in paragraph (9) of subdivision (a) or paragraph
(3) of this subdivision.
(2) Forms ordered pursuant to this subdivision shall have the
name, category of licensure, license number, and federal controlled
substance registration number of the designated prescriber and the
name, address, category of licensure, and license number of the
licensed health care facility the clinic specified in Section 1200,
or the clinic specified in subdivision (a) of Section 1206 that has
25 or more physicians or surgeons preprinted on the form.
(3) Forms ordered pursuant to this section shall not be valid
prescriptions without the name, category of licensure, license
number, and federal controlled substance registration number of the
prescriber on the form.
(4) (A) Except as provided in subparagraph (B), the designated
prescriber shall maintain a record of the prescribers to whom the
controlled substance prescription forms are issued, that shall
include the name, category of licensure, license number, federal
controlled substance registration number, and the quantity of
controlled substance prescription forms issued to each prescriber and
be maintained in the health facility for three years.
(B) Forms ordered pursuant to this subdivision that are printed by
a computerized prescription generation system shall not be subject
to the requirements set forth in subparagraph (A) or paragraph (7) of
subdivision (a). Forms printed pursuant to this subdivision that are
printed by a computerized prescription generation system may contain
the prescriber's name, category of professional licensure, license
number, federal controlled substance registration number, and the
date of the prescription.
(d) This section shall become operative on July 1, 2004.
SEC. 5. Section 11164 of the Health and Safety Code is amended to
read:
11164. Except as provided in Section 11167, no person shall
prescribe a controlled substance, nor shall any person fill,
compound, or dispense a prescription for a controlled substance,
unless it complies with the requirements of this section.
(a) Each prescription for a controlled substance classified in
Schedule II, III, IV, or V, except as authorized by subdivision (b),
shall be made on a controlled substance prescription form as
specified in Section 11162.1 and shall meet the following
requirements:
(1) The prescription shall be signed and dated by the prescriber
in ink and shall contain the prescriber's address and telephone
number; the name of the person for whom the controlled substance is
prescribed; and the name, quantity, strength, and directions for use
of the controlled substance prescribed.
(2) The prescription shall also contain the address of the person
for whom the controlled substance is prescribed. If the prescriber
does not specify this address on the prescription, the pharmacist
filling the prescription or an employee acting under the direction of
the pharmacist shall write or type the address on the prescription
or maintain this information in a readily retrievable form in the
pharmacy.
(b) (1) Notwithstanding paragraph (1) of subdivision (a) of
Section 11162.1, any controlled substance classified in Schedule III,
IV, or V may be dispensed upon an oral or electronically transmitted
prescription, which shall be produced in hard copy form and signed
and dated by the pharmacist filling the prescription or by any other
person expressly authorized by provisions of the Business and
Professions Code. Any person who transmits, maintains, or receives
any electronically transmitted prescription shall ensure the
security, integrity, authority, and confidentiality of the
prescription.
(2) The date of issue of the prescription and all the information
required for a written prescription by subdivision (a) shall be
included in the written record of the prescription; the pharmacist
need not include the address, telephone number, license
classification, or federal registry number of the prescriber or the
address of the patient on the hard copy, if that information is
readily retrievable in the pharmacy.
(3) Pursuant to an authorization of the prescriber, any agent of
the prescriber on behalf of the prescriber may orally or
electronically transmit a prescription for a controlled substance
classified in Schedule III, IV, or V, if in these cases the written
record of the prescription required by this subdivision specifies the
name of the agent of the prescriber transmitting the prescription.
(c) The use of commonly used abbreviations shall not invalidate an
otherwise valid prescription.
(d) Notwithstanding any provision of subdivisions (a) and (b),
prescriptions for a controlled substance classified in Schedule V may
be for more than one person in the same family with the same medical
need.
(e) This section shall become operative on January 1, 2005.
SEC. 6. Section 11165.5 is added to the Health and Safety Code, to
read:
11165.5. (a) The Board of Pharmacy shall, contingent upon the
availability of adequate funds, evaluate the viability of the
implementing real time reporting and access to data on prescriptions
for controlled substances in the operation of the Controlled
Substances Utilization Review and Evaluation System (CURES). For the
purposes of this subdivision, "real time reporting" means the ability
to send and access prescription data instantaneously in the
operation of CURES.
(b) The Board of Pharmacy, in consultation with the Medical Board
of California and Department of Justice, shall contract with a vendor
to prepare a feasibility study report in accordance with the State
Administrative Manual (SAM) to analyze the costs, benefits, and
processes necessary to implement real time reporting of controlled
substances in the operation of CURES.
(c) This section shall be implemented to the extent that
sufficient nonstate funds are received to cover the costs to the
Board of Pharmacy of providing staff, and for the preparation of the
report. The costs incurred by the Board of Pharmacy implementing this
section shall be solicited and funded from nongovernmental entities.
It is not the responsibility of the Board of Pharmacy to solicit the
funds for this study. The costs for the feasibility study report and
the staff to support the preparation of the report shall be no more
than two hundred fifty thousand dollars ($250,000). Any nonstate
funds donated for that purpose are appropriated to the Board of
Pharmacy for that purpose.
(d) The board shall submit the feasibility study report to the
Legislature on or before July 1, 2007, or within 18 months of receipt
of sufficient funding, whichever date is later.
(e) This section shall remain in effect until January 1, 2008, and
as of that date is repealed, unless a later enacted statute, that
becomes operative on or before January 1, 2008, deletes or extends
that date.
SEC. 7. Section 11190 of the Health and Safety Code is amended to
read:
11190. (a) Every practitioner, other than a pharmacist, who
prescribes or administers a controlled substance classified in
Schedule II shall make a record that, as to the transaction, shows
all of the following:
(1) The name and address of the patient.
(2) The date.
(3) The character, including the name and strength, and quantity
of controlled substances involved.
(b) The prescriber's record shall show the pathology and purpose
for which the controlled substance was administered or prescribed.
(c) (1) For each prescription for a Schedule II or Schedule III
controlled substance that is dispensed by a prescriber pursuant to
Section 4170 of the Business and Professions Code, the prescriber
shall record and maintain the following information:
(A) Full name, address, gender, and date of birth of the patient.
(B) The prescriber's category of licensure and license number;
federal controlled substance registration number; and the state
medical license number of any prescriber using the federal controlled
substance registration number of a government-exempt facility.
(C) NDC (National Drug Code) number of the controlled substance
dispensed.
(D) Quantity of the controlled substance dispensed.
(E) ICD-9 (diagnosis code), if available.
(F) Date of dispensing of the prescription.
(2) Each prescriber that dispenses controlled substances shall
provide the Department of Justice the information required by this
subdivision on a monthly basis in a format set by the Department of
Justice pursuant to regulation.
(d) This section shall become operative on January 1, 2005.
SEC. 8. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution for
certain costs that may be incurred by a local agency or school
district because, in that regard, 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.
However, if the Commission on State Mandates determines that this
act contains other costs mandated by the state, reimbursement to
local agencies and school districts for those costs shall be made
pursuant to Part 7 (commencing with Section 17500) of Division 4 of
Title 2 of the Government Code.