11150. No person other than a physician, dentist, podiatrist, or
veterinarian, or naturopathic doctor acting pursuant to Section
3640.7 of the Business and Professions Code, or pharmacist acting
within the scope of a project authorized under Article 1 (commencing
with Section 128125) of Chapter 3 of Part 3 of Division 107 or within
the scope of either Section 4052.1 or 4052.2 of the Business and
Professions Code, a registered nurse acting within the scope of a
project authorized under Article 1 (commencing with Section 128125)
of Chapter 3 of Part 3 of Division 107, a certified nurse-midwife
acting within the scope of Section 2746.51 of the Business and
Professions Code, a nurse practitioner acting within the scope of
Section 2836.1 of the Business and Professions Code, a physician
assistant acting within the scope of a project authorized under
Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of
Division 107 or Section 3502.1 of the Business and Professions Code,
a naturopathic doctor acting within the scope of Section 3640.5 of
the Business and Professions Code, or an optometrist acting within
the scope of Section 3041 of the Business and Professions Code, or an
out-of-state prescriber acting pursuant to Section 4005 of the
Business and Professions Code shall write or issue a prescription.
11150.6. Notwithstanding Section 11150.5 or subdivision (a) of
Section 11054, methaqualone, its salts, isomers, and salts of its
isomers shall be deemed to be classified in Schedule I for the
purposes of this chapter.
11151. A prescription written by an unlicensed person lawfully
practicing medicine pursuant to Section 2065 of the Business and
Professions Code, shall be filled only at a pharmacy maintained in
the hospital which employs such unlicensed person.
11152. No person shall write, issue, fill, compound, or dispense a
prescription that does not conform to this division.
11153. (a) A prescription for a controlled substance shall only be
issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his or her professional practice. The
responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills the
prescription. Except as authorized by this division, the following
are not legal prescriptions: (1) an order purporting to be a
prescription which is issued not in the usual course of professional
treatment or in legitimate and authorized research; or (2) an order
for an addict or habitual user of controlled substances, which is
issued not in the course of professional treatment or as part of an
authorized narcotic treatment program, for the purpose of providing
the user with controlled substances, sufficient to keep him or her
comfortable by maintaining customary use.
(b) Any person who knowingly violates this section shall be
punished by imprisonment in the state prison or in the county jail
not exceeding one year, or by a fine not exceeding twenty thousand
dollars ($20,000), or by both a fine and imprisonment.
(c) No provision of the amendments to this section enacted during
the second year of the 1981-82 Regular Session shall be construed as
expanding the scope of practice of a pharmacist.
11153.5. (a) No wholesaler or manufacturer, or agent or employee of
a wholesaler or manufacturer, shall furnish controlled substances
for other than legitimate medical purposes.
(b) Anyone who violates this section knowing, or having a
conscious disregard for the fact, that the controlled substances are
for other than a legitimate medical purpose shall be punishable by
imprisonment in the state prison, or in the county jail not exceeding
one year, or by a fine not exceeding twenty thousand dollars
($20,000), or by both a fine and imprisonment.
(c) Factors to be considered in determining whether a wholesaler
or manufacturer, or agent or employee of a wholesaler or
manufacturer, furnished controlled substances knowing or having a
conscious disregard for the fact that the controlled substances are
for other than legitimate medical purposes shall include, but not be
limited to, whether the use of controlled substances was for purposes
of increasing athletic ability or performance, the amount of
controlled substances furnished, the previous ordering pattern of the
customer (including size and frequency of orders), the type and size
of the customer, and where and to whom the customer distributes the
product.
11154. (a) Except in the regular practice of his or her profession,
no person shall knowingly prescribe, administer, dispense, or
furnish a controlled substance to or for any person or animal which
is not under his or her treatment for a pathology or condition other
than addiction to a controlled substance, except as provided in this
division.
(b) No person shall knowingly solicit, direct, induce, aid, or
encourage a practitioner authorized to write a prescription to
unlawfully prescribe, administer, dispense, or furnish a controlled
substance.
11155. Any physician, who by court order or order of any state or
governmental agency, or who voluntarily surrenders his controlled
substance privileges, shall not possess, administer, dispense, or
prescribe a controlled substance unless and until such privileges
have been restored, and he has obtained current registration from the
appropriate federal agency as provided by law.
11156. (a) Except as provided in Section 2241 of the Business and
Professions Code, no person shall prescribe for, or administer, or
dispense a controlled substance to, an addict, or to any person
representing himself or herself as such, except as permitted by this
division.
(b) (1) For purposes of this section, "addict" means a person
whose actions are characterized by craving in combination with one or
more of the following:
(A) Impaired control over drug use.
(B) Compulsive use.
(C) Continued use despite harm.
(2) Notwithstanding paragraph (1), a person whose drug-seeking
behavior is primarily due to the inadequate control of pain is not an
addict within the meaning of this section.
11157. No person shall issue a prescription that is false or
fictitious in any respect.
11158. (a) Except as provided in Section 11159 or in subdivision
(b) of this section, no controlled substance classified in Schedule
II shall be dispensed without a prescription meeting the requirements
of this chapter. Except as provided in Section 11159 or when
dispensed directly to an ultimate user by a practitioner, other than
a pharmacist or pharmacy, no controlled substance classified in
Schedule III, IV, or V may be dispensed without a prescription
meeting the requirements of this chapter.
(b) A practitioner specified in Section 11150 may dispense
directly to an ultimate user a controlled substance classified in
Schedule II in an amount not to exceed a 72-hour supply for the
patient in accordance with directions for use given by the dispensing
practitioner only where the patient is not expected to require any
additional amount of the controlled substance beyond the 72 hours.
Practitioners dispensing drugs pursuant to this subdivision shall
meet the requirements of subdivision (f) of Section 11164.
(c) Except as otherwise prohibited or limited by law, a
practitioner specified in Section 11150, may administer controlled
substances in the regular practice of his or her profession.
11159. An order for controlled substances for use by a patient in a
county or licensed hospital shall be exempt from all requirements of
this article, but shall be in writing on the patient's record,
signed by the prescriber, dated, and shall state the name and
quantity of the controlled substance ordered and the quantity
actually administered. The record of such orders shall be maintained
as a hospital record for a minimum of seven years.
11159.1. An order for controlled substances furnished to a patient
in a clinic which has a permit issued pursuant to Article 13
(commencing with Section 4180) of Chapter 9 of Division 2 of the
Business and Professions Code, except an order for a Schedule II
controlled substance, shall be exempt from the prescription
requirements of this article and shall be in writing on the patient's
record, signed by the prescriber, dated, and shall state the name
and quantity of the controlled substance ordered and the quantity
actually furnished. The record of the order shall be maintained as a
clinic record for a minimum of seven years. This section shall apply
only to a clinic that has obtained a permit under the provisions of
Article 13 (commencing with Section 4180) of Chapter 9 of Division 2
of the Business and Professions Code.
Clinics that furnish controlled substances shall be required to
keep a separate record of the furnishing of those drugs which shall
be available for review and inspection by all properly authorized
personnel.
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.
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.
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.
11161.7. (a) When a prescriber's authority to prescribe controlled
substances is restricted by civil, criminal, or administrative
action, or by an order of the court issued pursuant to Section 11161,
the law enforcement agency or licensing board that sought the
restrictions shall provide the name, category of licensure, license
number, and the nature of the restrictions imposed on the prescriber
to security printers, the Department of Justice, and the Board of
Pharmacy.
(b) The Board of Pharmacy shall make available the information
required by subdivision (a) to pharmacies and security printers to
prevent the dispensing of controlled substance prescriptions issued
by the prescriber and the ordering of additional controlled substance
prescription forms by the restricted prescriber.
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 thermochromic 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) Check boxes shall be printed on the form so that the
prescriber may indicate the number of refills ordered.
(11) The date of origin of the prescription.
(12) A check box indicating the prescriber's order not to
substitute.
(13) An identifying number assigned to the approved security
printer by the Department of Justice.
(14) (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 his or
her 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 quantity of controlled
substance prescription forms issued to each prescriber. The record
shall 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 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.
11162.5. (a) Every person who counterfeits a prescription blank
purporting to be an official prescription blank prepared and issued
pursuant to Section 11161.5, or knowingly possesses more than three
counterfeited prescription blanks, shall be punished by imprisonment
in the state prison or by imprisonment in a county jail for not more
than one year.
(b) Every person who knowingly possesses three or fewer
counterfeited prescription blanks purporting to be official
prescription blanks prepared and issued pursuant to Section 11161.5,
shall be guilty of a misdemeanor punishable by imprisonment in a
county jail not exceeding six months, or by a fine not exceeding one
thousand dollars ($1,000), or by both.
11162.6. (a) Every person who counterfeits a controlled substance
prescription form shall be guilty of a misdemeanor punishable by
imprisonment in a county jail for not more than one year, by a fine
not exceeding one thousand dollars ($1,000), or by both that
imprisonment and fine.
(b) Every person who knowingly possesses a counterfeited
controlled substance prescription form shall be guilty of a
misdemeanor punishable by imprisonment in a county jail not exceeding
six months, by a fine not exceeding one thousand dollars ($1,000),
or by both that imprisonment and fine.
(c) Every person who attempts to obtain or obtains a controlled
substance prescription form under false pretenses shall be guilty of
a misdemeanor punishable by imprisonment in a county jail not
exceeding six months, by a fine not exceeding one thousand dollars
($1,000), or by both that imprisonment and fine.
(d) Every person who fraudulently produces controlled substance
prescription forms shall be guilty of a misdemeanor punishable by
imprisonment in a county jail not exceeding six months, by a fine not
exceeding one thousand dollars ($1,000), or by both that
imprisonment and fine.
(e) This section shall become operative on July 1, 2004.
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 ultimate user or research subject, or contact
information as determined by the Secretary of the United States
Department of Health and Human Services; refill information, such as
the number of refills ordered and whether the prescription is a
first-time request or a refill; 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.
11164.1. (a) (1) Notwithstanding any other provision of law, a
prescription for a controlled substance issued by a prescriber in
another state for delivery to a patient in another state may be
dispensed by a California pharmacy, if the prescription conforms with
the requirements for controlled substance prescriptions in the state
in which the controlled substance was prescribed.
(2) All prescriptions for Schedule II and Schedule III controlled
substances dispensed pursuant to this subdivision shall be reported
by the dispensing pharmacy to the Department of Justice in the manner
prescribed by subdivision (d) of Section 11165.
(b) Pharmacies may dispense prescriptions for Schedule III,
Schedule IV, and Schedule V controlled substances from out-of-state
prescribers pursuant to Section 4005 of the Business and Professions
Code and Section 1717 of Title 16 of the California Code of
Regulations.
(c) This section shall become operative on January 1, 2005.
11164.5. (a) Notwithstanding Section 11164, with the approval of
the California State Board of Pharmacy and the Department of Justice,
a pharmacy or hospital may receive electronic data transmission
prescriptions or computer entry prescriptions or orders as specified
in Section 4071.1 of the Business and Professions Code, for
controlled substances in Schedule II, III, IV, or V if authorized by
federal law and in accordance with regulations promulgated by the
Drug Enforcement Administration. The California State Board of
Pharmacy shall maintain a list of all requests and approvals granted
pursuant to this subdivision.
(b) Notwithstanding Section 11164, if approved pursuant to
subdivision (a), a pharmacy or hospital receiving an electronic
transmission prescription or a computer entry prescription or order
for a controlled substance classified in Schedule II, III, IV, or V
shall not be required to reduce that prescription or order to writing
or to hard copy form, if for three years from the last day of
dispensing that prescription, the pharmacy or hospital is able, upon
request of the board or the Department of Justice, to immediately
produce a hard copy report that includes for each date of dispensing
of a controlled substance in Schedules II, III, IV, and V pursuant to
the prescription all of the information described in subparagraphs
(A) to (E), inclusive, of paragraph (1) of subdivision (a) of Section
4040 of the Business and Professions Code and the name or identifier
of the pharmacist who dispensed the controlled substance.
(c) Notwithstanding Section 11164, if only recorded and stored
electronically, on magnetic media, or in any other computerized form,
the pharmacy's or hospital's computer system shall not permit the
received information or the controlled substance dispensing
information required by this section to be changed, obliterated,
destroyed, or disposed of, for the record maintenance period required
by law, once the information has been received by the pharmacy or
the hospital and once the controlled substance has been dispensed,
respectively. Once the controlled substance has been dispensed, if
the previously created record is determined to be incorrect, a
correcting addition may be made only by or with the approval of a
pharmacist. After a pharmacist enters the change or enters his or her
approval of the change into the computer, the resulting record shall
include the correcting addition and the date it was made to the
record, the identity of the person or pharmacist making the
correction, and the identity of the pharmacist approving the
correction.
(d) Nothing in this section shall be construed to exempt any
pharmacy or hospital dispensing Schedule II controlled substances
pursuant to electronic transmission prescriptions from existing
reporting requirements.
11165. (a) To assist law enforcement and regulatory agencies in
their efforts to control the diversion and resultant abuse of
Schedule II, Schedule III, and Schedule IV controlled substances, and
for statistical analysis, education, and research, the Department of
Justice shall, contingent upon the availability of adequate funds
from the Contingent Fund of the Medical Board of California, the
Pharmacy Board Contingent Fund, the State Dentistry Fund, the Board
of Registered Nursing Fund, and the Osteopathic Medical Board of
California Contingent Fund, maintain the Controlled Substance
Utilization Review and Evaluation System (CURES) for the electronic
monitoring of the prescribing and dispensing of Schedule II, Schedule
III, and Schedule IV controlled substances by all practitioners
authorized to prescribe or dispense these controlled substances.
(b) The reporting of Schedule III and Schedule IV controlled
substance prescriptions to CURES shall be contingent upon the
availability of adequate funds from the Department of Justice. The
Department of Justice may seek and use grant funds to pay the costs
incurred from the reporting of controlled substance prescriptions to
CURES. Funds shall not be appropriated from the Contingent Fund of
the Medical Board of California, the Pharmacy Board Contingent Fund,
the State Dentistry Fund, the Board of Registered Nursing Fund, the
Naturopathic Doctor's Fund, or the Osteopathic Medical Board of
California Contingent Fund to pay the costs of reporting Schedule III
and Schedule IV controlled substance prescriptions to CURES.
(c) CURES shall operate under existing provisions of law to
safeguard the privacy and confidentiality of patients. Data obtained
from CURES shall only be provided to appropriate state, local, and
federal persons or public agencies for disciplinary, civil, or
criminal purposes and to other agencies or entities, as determined by
the Department of Justice, for the purpose of educating
practitioners and others in lieu of disciplinary, civil, or criminal
actions. Data may be provided to public or private entities, as
approved by the Department of Justice, for educational, peer review,
statistical, or research purposes, provided that patient information,
including any information that may identify the patient, is not
compromised. Further, data disclosed to any individual or agency as
described in this subdivision shall not be disclosed, sold, or
transferred to any third party.
(d) For each prescription for a Schedule II, Schedule III, or
Schedule IV controlled substance, the dispensing pharmacy or clinic
shall provide the following information to the Department of Justice
on a weekly basis and in a format specified by the Department of
Justice:
(1) Full name, address, and the telephone number of the ultimate
user or research subject, or contact information as determined by the
Secretary of the United States Department of Health and Human
Services, and the gender, and date of birth of the ultimate user.
(2) 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.
(3) Pharmacy prescription number, license number, and federal
controlled substance registration number.
(4) NDC (National Drug Code) number of the controlled substance
dispensed.
(5) Quantity of the controlled substance dispensed.
(6) ICD-9 (diagnosis code), if available.
(7) Number of refills ordered.
(8) Whether the drug was dispensed as a refill of a prescription
or as a first-time request.
(9) Date of origin of the prescription.
(10) Date of dispensing of the prescription.
(e) This section shall become operative on January 1, 2005.
11165.1. (a) (1) A licensed health care practitioner eligible to
prescribe Schedule II, Schedule III, or Schedule IV controlled
substances or a pharmacist may make a written request for, and the
Department of Justice may release to that practitioner or pharmacist,
the history of controlled substances dispensed to an individual
under his or her care based on data contained in CURES.
(2) Any request for, or release of, a controlled substance history
pursuant to this section shall be made in accordance with guidelines
developed by the Department of Justice.
(b) In order to prevent the inappropriate, improper, or illegal
use of Schedule II, Schedule III, or Schedule IV controlled
substances, the Department of Justice may initiate the referral of
the history of controlled substances dispensed to an individual based
on data contained in CURES to licensed health care practitioners,
pharmacists, or both, providing care or services to the individual.
(c) The history of controlled substances dispensed to an
individual based on data contained in CURES that is received by a
practitioner or pharmacist from the Department of Justice pursuant to
this section shall be considered medical information subject to the
provisions of the Confidentiality of Medical Information Act
contained in Part 2.6 (commencing with Section 56) of Division 1 of
the Civil Code.
11166. No person shall fill a prescription for a controlled
substance after six months has elapsed from the date written on the
prescription by the prescriber. No person shall knowingly fill a
mutilated or forged or altered prescription for a controlled
substance except for the addition of the address of the person for
whom the controlled substance is prescribed as provided by paragraph
(3) of subdivision (b) of Section 11164.
11167. Notwithstanding subdivision (a) of Section 11164, in an
emergency where failure to issue a prescription may result in loss of
life or intense suffering, an order for a controlled substance may
be dispensed on an oral order, an electronic data transmission order,
or a written order not made on a controlled substance form as
specified in Section 11162.1, subject to all of the following
requirements:
(a) The order contains all information required by subdivision (a)
of Section 11164.
(b) Any written order is signed and dated by the prescriber in
ink, and the pharmacy reduces any oral or electronic data
transmission order to hard copy form prior to dispensing the
controlled substance.
(c) The prescriber provides a written prescription on a controlled
substance prescription form that meets the requirements of Section
11162.1, by the seventh day following the transmission of the initial
order; a postmark by the seventh day following transmission of the
initial order shall constitute compliance.
(d) If the prescriber fails to comply with subdivision (c), the
pharmacy shall so notify the Bureau of Narcotic Enforcement in
writing within 144 hours of the prescriber's failure to do so and
shall make and retain a hard copy, readily retrievable record of the
prescription, including the date and method of notification of the
Bureau of Narcotic Enforcement.
(e) This section shall become operative on January 1, 2005.
11167.5. (a) An order for a controlled substance classified in
Schedule II for a patient of a licensed skilled nursing facility, a
licensed intermediate care facility, a licensed home health agency,
or a licensed hospice may be dispensed upon an oral or electronically
transmitted prescription. If the prescription is transmitted orally,
the pharmacist shall, prior to filling the prescription, reduce the
prescription to writing in ink in the handwriting of the pharmacist
on a form developed by the pharmacy for this purpose. If the
prescription is transmitted electronically, the pharmacist shall,
prior to filling the prescription, produce, sign, and date a hard
copy prescription. The prescriptions shall contain the date the
prescription was orally or electronically transmitted by the
prescriber, the name of the person for whom the prescription was
authorized, the name and address of the licensed skilled nursing
facility, licensed intermediate care facility, licensed home health
agency, or licensed hospice in which that person is a patient, the
name and quantity of the controlled substance prescribed, the
directions for use, and the name, address, category of professional
licensure, license number, and federal controlled substance
registration number of the prescriber. The original shall be properly
endorsed by the pharmacist with the pharmacy's state license number,
the name and address of the pharmacy, and the signature of the
person who received the controlled substances for the licensed
skilled nursing facility, licensed intermediate care facility,
licensed home health agency, or licensed hospice. A licensed skilled
nursing facility, a licensed intermediate care facility, a licensed
home health agency, or a licensed hospice shall forward to the
dispensing pharmacist a copy of any signed telephone orders, chart
orders, or related documentation substantiating each oral or
electronically transmitted prescription transaction under this
section.
(b) This section shall become operative on July 1, 2004.
11170. No person shall prescribe, administer, or furnish a
controlled substance for himself.
11171. No person shall prescribe, administer, or furnish a
controlled substance except under the conditions and in the manner
provided by this division.
11172. No person shall antedate or postdate a prescription.
11173. (a) No person shall obtain or attempt to obtain controlled
substances, or procure or attempt to procure the administration of or
prescription for controlled substances, (1) by fraud, deceit,
misrepresentation , or subterfuge; or (2) by the concealment of a
material fact.
(b) No person shall make a false statement in any prescription,
order, report, or record, required by this division.
(c) No person shall, for the purpose of obtaining controlled
substances, falsely assume the title of, or represent himself to be,
a manufacturer, wholesaler, pharmacist, physician, dentist,
veterinarian, registered nurse, physician's assistant, or other
authorized person.
(d) No person shall affix any false or forged label to a package
or receptacle containing controlled substances.
11174. No person shall, in connection with the prescribing,
furnishing, administering, or dispensing of a controlled substance,
give a false name or false address.
11175. No person shall obtain or possess a prescription that does
not comply with this division, nor shall any person obtain a
controlled substance by means of a prescription which does not comply
with this division or possess a controlled substance obtained by
such a prescription.
11179. A person who fills a prescription shall keep it on file for
at least three years from the date of filling it.
11180. No person shall obtain or possess a controlled substance
obtained by a prescription that does not comply with this division.
11150. No person other than a physician, dentist, podiatrist, or
veterinarian, or naturopathic doctor acting pursuant to Section
3640.7 of the Business and Professions Code, or pharmacist acting
within the scope of a project authorized under Article 1 (commencing
with Section 128125) of Chapter 3 of Part 3 of Division 107 or within
the scope of either Section 4052.1 or 4052.2 of the Business and
Professions Code, a registered nurse acting within the scope of a
project authorized under Article 1 (commencing with Section 128125)
of Chapter 3 of Part 3 of Division 107, a certified nurse-midwife
acting within the scope of Section 2746.51 of the Business and
Professions Code, a nurse practitioner acting within the scope of
Section 2836.1 of the Business and Professions Code, a physician
assistant acting within the scope of a project authorized under
Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of
Division 107 or Section 3502.1 of the Business and Professions Code,
a naturopathic doctor acting within the scope of Section 3640.5 of
the Business and Professions Code, or an optometrist acting within
the scope of Section 3041 of the Business and Professions Code, or an
out-of-state prescriber acting pursuant to Section 4005 of the
Business and Professions Code shall write or issue a prescription.
11150.6. Notwithstanding Section 11150.5 or subdivision (a) of
Section 11054, methaqualone, its salts, isomers, and salts of its
isomers shall be deemed to be classified in Schedule I for the
purposes of this chapter.
11151. A prescription written by an unlicensed person lawfully
practicing medicine pursuant to Section 2065 of the Business and
Professions Code, shall be filled only at a pharmacy maintained in
the hospital which employs such unlicensed person.
11152. No person shall write, issue, fill, compound, or dispense a
prescription that does not conform to this division.
11153. (a) A prescription for a controlled substance shall only be
issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his or her professional practice. The
responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills the
prescription. Except as authorized by this division, the following
are not legal prescriptions: (1) an order purporting to be a
prescription which is issued not in the usual course of professional
treatment or in legitimate and authorized research; or (2) an order
for an addict or habitual user of controlled substances, which is
issued not in the course of professional treatment or as part of an
authorized narcotic treatment program, for the purpose of providing
the user with controlled substances, sufficient to keep him or her
comfortable by maintaining customary use.
(b) Any person who knowingly violates this section shall be
punished by imprisonment in the state prison or in the county jail
not exceeding one year, or by a fine not exceeding twenty thousand
dollars ($20,000), or by both a fine and imprisonment.
(c) No provision of the amendments to this section enacted during
the second year of the 1981-82 Regular Session shall be construed as
expanding the scope of practice of a pharmacist.
11153.5. (a) No wholesaler or manufacturer, or agent or employee of
a wholesaler or manufacturer, shall furnish controlled substances
for other than legitimate medical purposes.
(b) Anyone who violates this section knowing, or having a
conscious disregard for the fact, that the controlled substances are
for other than a legitimate medical purpose shall be punishable by
imprisonment in the state prison, or in the county jail not exceeding
one year, or by a fine not exceeding twenty thousand dollars
($20,000), or by both a fine and imprisonment.
(c) Factors to be considered in determining whether a wholesaler
or manufacturer, or agent or employee of a wholesaler or
manufacturer, furnished controlled substances knowing or having a
conscious disregard for the fact that the controlled substances are
for other than legitimate medical purposes shall include, but not be
limited to, whether the use of controlled substances was for purposes
of increasing athletic ability or performance, the amount of
controlled substances furnished, the previous ordering pattern of the
customer (including size and frequency of orders), the type and size
of the customer, and where and to whom the customer distributes the
product.
11154. (a) Except in the regular practice of his or her profession,
no person shall knowingly prescribe, administer, dispense, or
furnish a controlled substance to or for any person or animal which
is not under his or her treatment for a pathology or condition other
than addiction to a controlled substance, except as provided in this
division.
(b) No person shall knowingly solicit, direct, induce, aid, or
encourage a practitioner authorized to write a prescription to
unlawfully prescribe, administer, dispense, or furnish a controlled
substance.
11155. Any physician, who by court order or order of any state or
governmental agency, or who voluntarily surrenders his controlled
substance privileges, shall not possess, administer, dispense, or
prescribe a controlled substance unless and until such privileges
have been restored, and he has obtained current registration from the
appropriate federal agency as provided by law.
11156. (a) Except as provided in Section 2241 of the Business and
Professions Code, no person shall prescribe for, or administer, or
dispense a controlled substance to, an addict, or to any person
representing himself or herself as such, except as permitted by this
division.
(b) (1) For purposes of this section, "addict" means a person
whose actions are characterized by craving in combination with one or
more of the following:
(A) Impaired control over drug use.
(B) Compulsive use.
(C) Continued use despite harm.
(2) Notwithstanding paragraph (1), a person whose drug-seeking
behavior is primarily due to the inadequate control of pain is not an
addict within the meaning of this section.
11157. No person shall issue a prescription that is false or
fictitious in any respect.
11158. (a) Except as provided in Section 11159 or in subdivision
(b) of this section, no controlled substance classified in Schedule
II shall be dispensed without a prescription meeting the requirements
of this chapter. Except as provided in Section 11159 or when
dispensed directly to an ultimate user by a practitioner, other than
a pharmacist or pharmacy, no controlled substance classified in
Schedule III, IV, or V may be dispensed without a prescription
meeting the requirements of this chapter.
(b) A practitioner specified in Section 11150 may dispense
directly to an ultimate user a controlled substance classified in
Schedule II in an amount not to exceed a 72-hour supply for the
patient in accordance with directions for use given by the dispensing
practitioner only where the patient is not expected to require any
additional amount of the controlled substance beyond the 72 hours.
Practitioners dispensing drugs pursuant to this subdivision shall
meet the requirements of subdivision (f) of Section 11164.
(c) Except as otherwise prohibited or limited by law, a
practitioner specified in Section 11150, may administer controlled
substances in the regular practice of his or her profession.
11159. An order for controlled substances for use by a patient in a
county or licensed hospital shall be exempt from all requirements of
this article, but shall be in writing on the patient's record,
signed by the prescriber, dated, and shall state the name and
quantity of the controlled substance ordered and the quantity
actually administered. The record of such orders shall be maintained
as a hospital record for a minimum of seven years.
11159.1. An order for controlled substances furnished to a patient
in a clinic which has a permit issued pursuant to Article 13
(commencing with Section 4180) of Chapter 9 of Division 2 of the
Business and Professions Code, except an order for a Schedule II
controlled substance, shall be exempt from the prescription
requirements of this article and shall be in writing on the patient's
record, signed by the prescriber, dated, and shall state the name
and quantity of the controlled substance ordered and the quantity
actually furnished. The record of the order shall be maintained as a
clinic record for a minimum of seven years. This section shall apply
only to a clinic that has obtained a permit under the provisions of
Article 13 (commencing with Section 4180) of Chapter 9 of Division 2
of the Business and Professions Code.
Clinics that furnish controlled substances shall be required to
keep a separate record of the furnishing of those drugs which shall
be available for review and inspection by all properly authorized
personnel.
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.
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.
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.
11161.7. (a) When a prescriber's authority to prescribe controlled
substances is restricted by civil, criminal, or administrative
action, or by an order of the court issued pursuant to Section 11161,
the law enforcement agency or licensing board that sought the
restrictions shall provide the name, category of licensure, license
number, and the nature of the restrictions imposed on the prescriber
to security printers, the Department of Justice, and the Board of
Pharmacy.
(b) The Board of Pharmacy shall make available the information
required by subdivision (a) to pharmacies and security printers to
prevent the dispensing of controlled substance prescriptions issued
by the prescriber and the ordering of additional controlled substance
prescription forms by the restricted prescriber.
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 thermochromic 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) Check boxes shall be printed on the form so that the
prescriber may indicate the number of refills ordered.
(11) The date of origin of the prescription.
(12) A check box indicating the prescriber's order not to
substitute.
(13) An identifying number assigned to the approved security
printer by the Department of Justice.
(14) (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 his or
her 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 quantity of controlled
substance prescription forms issued to each prescriber. The record
shall 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 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.
11162.5. (a) Every person who counterfeits a prescription blank
purporting to be an official prescription blank prepared and issued
pursuant to Section 11161.5, or knowingly possesses more than three
counterfeited prescription blanks, shall be punished by imprisonment
in the state prison or by imprisonment in a county jail for not more
than one year.
(b) Every person who knowingly possesses three or fewer
counterfeited prescription blanks purporting to be official
prescription blanks prepared and issued pursuant to Section 11161.5,
shall be guilty of a misdemeanor punishable by imprisonment in a
county jail not exceeding six months, or by a fine not exceeding one
thousand dollars ($1,000), or by both.
11162.6. (a) Every person who counterfeits a controlled substance
prescription form shall be guilty of a misdemeanor punishable by
imprisonment in a county jail for not more than one year, by a fine
not exceeding one thousand dollars ($1,000), or by both that
imprisonment and fine.
(b) Every person who knowingly possesses a counterfeited
controlled substance prescription form shall be guilty of a
misdemeanor punishable by imprisonment in a county jail not exceeding
six months, by a fine not exceeding one thousand dollars ($1,000),
or by both that imprisonment and fine.
(c) Every person who attempts to obtain or obtains a controlled
substance prescription form under false pretenses shall be guilty of
a misdemeanor punishable by imprisonment in a county jail not
exceeding six months, by a fine not exceeding one thousand dollars
($1,000), or by both that imprisonment and fine.
(d) Every person who fraudulently produces controlled substance
prescription forms shall be guilty of a misdemeanor punishable by
imprisonment in a county jail not exceeding six months, by a fine not
exceeding one thousand dollars ($1,000), or by both that
imprisonment and fine.
(e) This section shall become operative on July 1, 2004.
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 ultimate user or research subject, or contact
information as determined by the Secretary of the United States
Department of Health and Human Services; refill information, such as
the number of refills ordered and whether the prescription is a
first-time request or a refill; 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.
11164.1. (a) (1) Notwithstanding any other provision of law, a
prescription for a controlled substance issued by a prescriber in
another state for delivery to a patient in another state may be
dispensed by a California pharmacy, if the prescription conforms with
the requirements for controlled substance prescriptions in the state
in which the controlled substance was prescribed.
(2) All prescriptions for Schedule II and Schedule III controlled
substances dispensed pursuant to this subdivision shall be reported
by the dispensing pharmacy to the Department of Justice in the manner
prescribed by subdivision (d) of Section 11165.
(b) Pharmacies may dispense prescriptions for Schedule III,
Schedule IV, and Schedule V controlled substances from out-of-state
prescribers pursuant to Section 4005 of the Business and Professions
Code and Section 1717 of Title 16 of the California Code of
Regulations.
(c) This section shall become operative on January 1, 2005.
11164.5. (a) Notwithstanding Section 11164, with the approval of
the California State Board of Pharmacy and the Department of Justice,
a pharmacy or hospital may receive electronic data transmission
prescriptions or computer entry prescriptions or orders as specified
in Section 4071.1 of the Business and Professions Code, for
controlled substances in Schedule II, III, IV, or V if authorized by
federal law and in accordance with regulations promulgated by the
Drug Enforcement Administration. The California State Board of
Pharmacy shall maintain a list of all requests and approvals granted
pursuant to this subdivision.
(b) Notwithstanding Section 11164, if approved pursuant to
subdivision (a), a pharmacy or hospital receiving an electronic
transmission prescription or a computer entry prescription or order
for a controlled substance classified in Schedule II, III, IV, or V
shall not be required to reduce that prescription or order to writing
or to hard copy form, if for three years from the last day of
dispensing that prescription, the pharmacy or hospital is able, upon
request of the board or the Department of Justice, to immediately
produce a hard copy report that includes for each date of dispensing
of a controlled substance in Schedules II, III, IV, and V pursuant to
the prescription all of the information described in subparagraphs
(A) to (E), inclusive, of paragraph (1) of subdivision (a) of Section
4040 of the Business and Professions Code and the name or identifier
of the pharmacist who dispensed the controlled substance.
(c) Notwithstanding Section 11164, if only recorded and stored
electronically, on magnetic media, or in any other computerized form,
the pharmacy's or hospital's computer system shall not permit the
received information or the controlled substance dispensing
information required by this section to be changed, obliterated,
destroyed, or disposed of, for the record maintenance period required
by law, once the information has been received by the pharmacy or
the hospital and once the controlled substance has been dispensed,
respectively. Once the controlled substance has been dispensed, if
the previously created record is determined to be incorrect, a
correcting addition may be made only by or with the approval of a
pharmacist. After a pharmacist enters the change or enters his or her
approval of the change into the computer, the resulting record shall
include the correcting addition and the date it was made to the
record, the identity of the person or pharmacist making the
correction, and the identity of the pharmacist approving the
correction.
(d) Nothing in this section shall be construed to exempt any
pharmacy or hospital dispensing Schedule II controlled substances
pursuant to electronic transmission prescriptions from existing
reporting requirements.
11165. (a) To assist law enforcement and regulatory agencies in
their efforts to control the diversion and resultant abuse of
Schedule II, Schedule III, and Schedule IV controlled substances, and
for statistical analysis, education, and research, the Department of
Justice shall, contingent upon the availability of adequate funds
from the Contingent Fund of the Medical Board of California, the
Pharmacy Board Contingent Fund, the State Dentistry Fund, the Board
of Registered Nursing Fund, and the Osteopathic Medical Board of
California Contingent Fund, maintain the Controlled Substance
Utilization Review and Evaluation System (CURES) for the electronic
monitoring of the prescribing and dispensing of Schedule II, Schedule
III, and Schedule IV controlled substances by all practitioners
authorized to prescribe or dispense these controlled substances.
(b) The reporting of Schedule III and Schedule IV controlled
substance prescriptions to CURES shall be contingent upon the
availability of adequate funds from the Department of Justice. The
Department of Justice may seek and use grant funds to pay the costs
incurred from the reporting of controlled substance prescriptions to
CURES. Funds shall not be appropriated from the Contingent Fund of
the Medical Board of California, the Pharmacy Board Contingent Fund,
the State Dentistry Fund, the Board of Registered Nursing Fund, the
Naturopathic Doctor's Fund, or the Osteopathic Medical Board of
California Contingent Fund to pay the costs of reporting Schedule III
and Schedule IV controlled substance prescriptions to CURES.
(c) CURES shall operate under existing provisions of law to
safeguard the privacy and confidentiality of patients. Data obtained
from CURES shall only be provided to appropriate state, local, and
federal persons or public agencies for disciplinary, civil, or
criminal purposes and to other agencies or entities, as determined by
the Department of Justice, for the purpose of educating
practitioners and others in lieu of disciplinary, civil, or criminal
actions. Data may be provided to public or private entities, as
approved by the Department of Justice, for educational, peer review,
statistical, or research purposes, provided that patient information,
including any information that may identify the patient, is not
compromised. Further, data disclosed to any individual or agency as
described in this subdivision shall not be disclosed, sold, or
transferred to any third party.
(d) For each prescription for a Schedule II, Schedule III, or
Schedule IV controlled substance, the dispensing pharmacy or clinic
shall provide the following information to the Department of Justice
on a weekly basis and in a format specified by the Department of
Justice:
(1) Full name, address, and the telephone number of the ultimate
user or research subject, or contact information as determined by the
Secretary of the United States Department of Health and Human
Services, and the gender, and date of birth of the ultimate user.
(2) 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.
(3) Pharmacy prescription number, license number, and federal
controlled substance registration number.
(4) NDC (National Drug Code) number of the controlled substance
dispensed.
(5) Quantity of the controlled substance dispensed.
(6) ICD-9 (diagnosis code), if available.
(7) Number of refills ordered.
(8) Whether the drug was dispensed as a refill of a prescription
or as a first-time request.
(9) Date of origin of the prescription.
(10) Date of dispensing of the prescription.
(e) This section shall become operative on January 1, 2005.
11165.1. (a) (1) A licensed health care practitioner eligible to
prescribe Schedule II, Schedule III, or Schedule IV controlled
substances or a pharmacist may make a written request for, and the
Department of Justice may release to that practitioner or pharmacist,
the history of controlled substances dispensed to an individual
under his or her care based on data contained in CURES.
(2) Any request for, or release of, a controlled substance history
pursuant to this section shall be made in accordance with guidelines
developed by the Department of Justice.
(b) In order to prevent the inappropriate, improper, or illegal
use of Schedule II, Schedule III, or Schedule IV controlled
substances, the Department of Justice may initiate the referral of
the history of controlled substances dispensed to an individual based
on data contained in CURES to licensed health care practitioners,
pharmacists, or both, providing care or services to the individual.
(c) The history of controlled substances dispensed to an
individual based on data contained in CURES that is received by a
practitioner or pharmacist from the Department of Justice pursuant to
this section shall be considered medical information subject to the
provisions of the Confidentiality of Medical Information Act
contained in Part 2.6 (commencing with Section 56) of Division 1 of
the Civil Code.
11166. No person shall fill a prescription for a controlled
substance after six months has elapsed from the date written on the
prescription by the prescriber. No person shall knowingly fill a
mutilated or forged or altered prescription for a controlled
substance except for the addition of the address of the person for
whom the controlled substance is prescribed as provided by paragraph
(3) of subdivision (b) of Section 11164.
11167. Notwithstanding subdivision (a) of Section 11164, in an
emergency where failure to issue a prescription may result in loss of
life or intense suffering, an order for a controlled substance may
be dispensed on an oral order, an electronic data transmission order,
or a written order not made on a controlled substance form as
specified in Section 11162.1, subject to all of the following
requirements:
(a) The order contains all information required by subdivision (a)
of Section 11164.
(b) Any written order is signed and dated by the prescriber in
ink, and the pharmacy reduces any oral or electronic data
transmission order to hard copy form prior to dispensing the
controlled substance.
(c) The prescriber provides a written prescription on a controlled
substance prescription form that meets the requirements of Section
11162.1, by the seventh day following the transmission of the initial
order; a postmark by the seventh day following transmission of the
initial order shall constitute compliance.
(d) If the prescriber fails to comply with subdivision (c), the
pharmacy shall so notify the Bureau of Narcotic Enforcement in
writing within 144 hours of the prescriber's failure to do so and
shall make and retain a hard copy, readily retrievable record of the
prescription, including the date and method of notification of the
Bureau of Narcotic Enforcement.
(e) This section shall become operative on January 1, 2005.
11167.5. (a) An order for a controlled substance classified in
Schedule II for a patient of a licensed skilled nursing facility, a
licensed intermediate care facility, a licensed home health agency,
or a licensed hospice may be dispensed upon an oral or electronically
transmitted prescription. If the prescription is transmitted orally,
the pharmacist shall, prior to filling the prescription, reduce the
prescription to writing in ink in the handwriting of the pharmacist
on a form developed by the pharmacy for this purpose. If the
prescription is transmitted electronically, the pharmacist shall,
prior to filling the prescription, produce, sign, and date a hard
copy prescription. The prescriptions shall contain the date the
prescription was orally or electronically transmitted by the
prescriber, the name of the person for whom the prescription was
authorized, the name and address of the licensed skilled nursing
facility, licensed intermediate care facility, licensed home health
agency, or licensed hospice in which that person is a patient, the
name and quantity of the controlled substance prescribed, the
directions for use, and the name, address, category of professional
licensure, license number, and federal controlled substance
registration number of the prescriber. The original shall be properly
endorsed by the pharmacist with the pharmacy's state license number,
the name and address of the pharmacy, and the signature of the
person who received the controlled substances for the licensed
skilled nursing facility, licensed intermediate care facility,
licensed home health agency, or licensed hospice. A licensed skilled
nursing facility, a licensed intermediate care facility, a licensed
home health agency, or a licensed hospice shall forward to the
dispensing pharmacist a copy of any signed telephone orders, chart
orders, or related documentation substantiating each oral or
electronically transmitted prescription transaction under this
section.
(b) This section shall become operative on July 1, 2004.
11170. No person shall prescribe, administer, or furnish a
controlled substance for himself.
11171. No person shall prescribe, administer, or furnish a
controlled substance except under the conditions and in the manner
provided by this division.
11172. No person shall antedate or postdate a prescription.
11173. (a) No person shall obtain or attempt to obtain controlled
substances, or procure or attempt to procure the administration of or
prescription for controlled substances, (1) by fraud, deceit,
misrepresentation , or subterfuge; or (2) by the concealment of a
material fact.
(b) No person shall make a false statement in any prescription,
order, report, or record, required by this division.
(c) No person shall, for the purpose of obtaining controlled
substances, falsely assume the title of, or represent himself to be,
a manufacturer, wholesaler, pharmacist, physician, dentist,
veterinarian, registered nurse, physician's assistant, or other
authorized person.
(d) No person shall affix any false or forged label to a package
or receptacle containing controlled substances.
11174. No person shall, in connection with the prescribing,
furnishing, administering, or dispensing of a controlled substance,
give a false name or false address.
11175. No person shall obtain or possess a prescription that does
not comply with this division, nor shall any person obtain a
controlled substance by means of a prescription which does not comply
with this division or possess a controlled substance obtained by
such a prescription.
11179. A person who fills a prescription shall keep it on file for
at least three years from the date of filling it.
11180. No person shall obtain or possess a controlled substance
obtained by a prescription that does not comply with this division.
11150. No person other than a physician, dentist, podiatrist, or
veterinarian, or naturopathic doctor acting pursuant to Section
3640.7 of the Business and Professions Code, or pharmacist acting
within the scope of a project authorized under Article 1 (commencing
with Section 128125) of Chapter 3 of Part 3 of Division 107 or within
the scope of either Section 4052.1 or 4052.2 of the Business and
Professions Code, a registered nurse acting within the scope of a
project authorized under Article 1 (commencing with Section 128125)
of Chapter 3 of Part 3 of Division 107, a certified nurse-midwife
acting within the scope of Section 2746.51 of the Business and
Professions Code, a nurse practitioner acting within the scope of
Section 2836.1 of the Business and Professions Code, a physician
assistant acting within the scope of a project authorized under
Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of
Division 107 or Section 3502.1 of the Business and Professions Code,
a naturopathic doctor acting within the scope of Section 3640.5 of
the Business and Professions Code, or an optometrist acting within
the scope of Section 3041 of the Business and Professions Code, or an
out-of-state prescriber acting pursuant to Section 4005 of the
Business and Professions Code shall write or issue a prescription.
11150.6. Notwithstanding Section 11150.5 or subdivision (a) of
Section 11054, methaqualone, its salts, isomers, and salts of its
isomers shall be deemed to be classified in Schedule I for the
purposes of this chapter.
11151. A prescription written by an unlicensed person lawfully
practicing medicine pursuant to Section 2065 of the Business and
Professions Code, shall be filled only at a pharmacy maintained in
the hospital which employs such unlicensed person.
11152. No person shall write, issue, fill, compound, or dispense a
prescription that does not conform to this division.
11153. (a) A prescription for a controlled substance shall only be
issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his or her professional practice. The
responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills the
prescription. Except as authorized by this division, the following
are not legal prescriptions: (1) an order purporting to be a
prescription which is issued not in the usual course of professional
treatment or in legitimate and authorized research; or (2) an order
for an addict or habitual user of controlled substances, which is
issued not in the course of professional treatment or as part of an
authorized narcotic treatment program, for the purpose of providing
the user with controlled substances, sufficient to keep him or her
comfortable by maintaining customary use.
(b) Any person who knowingly violates this section shall be
punished by imprisonment in the state prison or in the county jail
not exceeding one year, or by a fine not exceeding twenty thousand
dollars ($20,000), or by both a fine and imprisonment.
(c) No provision of the amendments to this section enacted during
the second year of the 1981-82 Regular Session shall be construed as
expanding the scope of practice of a pharmacist.
11153.5. (a) No wholesaler or manufacturer, or agent or employee of
a wholesaler or manufacturer, shall furnish controlled substances
for other than legitimate medical purposes.
(b) Anyone who violates this section knowing, or having a
conscious disregard for the fact, that the controlled substances are
for other than a legitimate medical purpose shall be punishable by
imprisonment in the state prison, or in the county jail not exceeding
one year, or by a fine not exceeding twenty thousand dollars
($20,000), or by both a fine and imprisonment.
(c) Factors to be considered in determining whether a wholesaler
or manufacturer, or agent or employee of a wholesaler or
manufacturer, furnished controlled substances knowing or having a
conscious disregard for the fact that the controlled substances are
for other than legitimate medical purposes shall include, but not be
limited to, whether the use of controlled substances was for purposes
of increasing athletic ability or performance, the amount of
controlled substances furnished, the previous ordering pattern of the
customer (including size and frequency of orders), the type and size
of the customer, and where and to whom the customer distributes the
product.
11154. (a) Except in the regular practice of his or her profession,
no person shall knowingly prescribe, administer, dispense, or
furnish a controlled substance to or for any person or animal which
is not under his or her treatment for a pathology or condition other
than addiction to a controlled substance, except as provided in this
division.
(b) No person shall knowingly solicit, direct, induce, aid, or
encourage a practitioner authorized to write a prescription to
unlawfully prescribe, administer, dispense, or furnish a controlled
substance.
11155. Any physician, who by court order or order of any state or
governmental agency, or who voluntarily surrenders his controlled
substance privileges, shall not possess, administer, dispense, or
prescribe a controlled substance unless and until such privileges
have been restored, and he has obtained current registration from the
appropriate federal agency as provided by law.
11156. (a) Except as provided in Section 2241 of the Business and
Professions Code, no person shall prescribe for, or administer, or
dispense a controlled substance to, an addict, or to any person
representing himself or herself as such, except as permitted by this
division.
(b) (1) For purposes of this section, "addict" means a person
whose actions are characterized by craving in combination with one or
more of the following:
(A) Impaired control over drug use.
(B) Compulsive use.
(C) Continued use despite harm.
(2) Notwithstanding paragraph (1), a person whose drug-seeking
behavior is primarily due to the inadequate control of pain is not an
addict within the meaning of this section.
11157. No person shall issue a prescription that is false or
fictitious in any respect.
11158. (a) Except as provided in Section 11159 or in subdivision
(b) of this section, no controlled substance classified in Schedule
II shall be dispensed without a prescription meeting the requirements
of this chapter. Except as provided in Section 11159 or when
dispensed directly to an ultimate user by a practitioner, other than
a pharmacist or pharmacy, no controlled substance classified in
Schedule III, IV, or V may be dispensed without a prescription
meeting the requirements of this chapter.
(b) A practitioner specified in Section 11150 may dispense
directly to an ultimate user a controlled substance classified in
Schedule II in an amount not to exceed a 72-hour supply for the
patient in accordance with directions for use given by the dispensing
practitioner only where the patient is not expected to require any
additional amount of the controlled substance beyond the 72 hours.
Practitioners dispensing drugs pursuant to this subdivision shall
meet the requirements of subdivision (f) of Section 11164.
(c) Except as otherwise prohibited or limited by law, a
practitioner specified in Section 11150, may administer controlled
substances in the regular practice of his or her profession.
11159. An order for controlled substances for use by a patient in a
county or licensed hospital shall be exempt from all requirements of
this article, but shall be in writing on the patient's record,
signed by the prescriber, dated, and shall state the name and
quantity of the controlled substance ordered and the quantity
actually administered. The record of such orders shall be maintained
as a hospital record for a minimum of seven years.
11159.1. An order for controlled substances furnished to a patient
in a clinic which has a permit issued pursuant to Article 13
(commencing with Section 4180) of Chapter 9 of Division 2 of the
Business and Professions Code, except an order for a Schedule II
controlled substance, shall be exempt from the prescription
requirements of this article and shall be in writing on the patient's
record, signed by the prescriber, dated, and shall state the name
and quantity of the controlled substance ordered and the quantity
actually furnished. The record of the order shall be maintained as a
clinic record for a minimum of seven years. This section shall apply
only to a clinic that has obtained a permit under the provisions of
Article 13 (commencing with Section 4180) of Chapter 9 of Division 2
of the Business and Professions Code.
Clinics that furnish controlled substances shall be required to
keep a separate record of the furnishing of those drugs which shall
be available for review and inspection by all properly authorized
personnel.
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.
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.
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.
11161.7. (a) When a prescriber's authority to prescribe controlled
substances is restricted by civil, criminal, or administrative
action, or by an order of the court issued pursuant to Section 11161,
the law enforcement agency or licensing board that sought the
restrictions shall provide the name, category of licensure, license
number, and the nature of the restrictions imposed on the prescriber
to security printers, the Department of Justice, and the Board of
Pharmacy.
(b) The Board of Pharmacy shall make available the information
required by subdivision (a) to pharmacies and security printers to
prevent the dispensing of controlled substance prescriptions issued
by the prescriber and the ordering of additional controlled substance
prescription forms by the restricted prescriber.
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 thermochromic 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) Check boxes shall be printed on the form so that the
prescriber may indicate the number of refills ordered.
(11) The date of origin of the prescription.
(12) A check box indicating the prescriber's order not to
substitute.
(13) An identifying number assigned to the approved security
printer by the Department of Justice.
(14) (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 his or
her 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 quantity of controlled
substance prescription forms issued to each prescriber. The record
shall 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 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.
11162.5. (a) Every person who counterfeits a prescription blank
purporting to be an official prescription blank prepared and issued
pursuant to Section 11161.5, or knowingly possesses more than three
counterfeited prescription blanks, shall be punished by imprisonment
in the state prison or by imprisonment in a county jail for not more
than one year.
(b) Every person who knowingly possesses three or fewer
counterfeited prescription blanks purporting to be official
prescription blanks prepared and issued pursuant to Section 11161.5,
shall be guilty of a misdemeanor punishable by imprisonment in a
county jail not exceeding six months, or by a fine not exceeding one
thousand dollars ($1,000), or by both.
11162.6. (a) Every person who counterfeits a controlled substance
prescription form shall be guilty of a misdemeanor punishable by
imprisonment in a county jail for not more than one year, by a fine
not exceeding one thousand dollars ($1,000), or by both that
imprisonment and fine.
(b) Every person who knowingly possesses a counterfeited
controlled substance prescription form shall be guilty of a
misdemeanor punishable by imprisonment in a county jail not exceeding
six months, by a fine not exceeding one thousand dollars ($1,000),
or by both that imprisonment and fine.
(c) Every person who attempts to obtain or obtains a controlled
substance prescription form under false pretenses shall be guilty of
a misdemeanor punishable by imprisonment in a county jail not
exceeding six months, by a fine not exceeding one thousand dollars
($1,000), or by both that imprisonment and fine.
(d) Every person who fraudulently produces controlled substance
prescription forms shall be guilty of a misdemeanor punishable by
imprisonment in a county jail not exceeding six months, by a fine not
exceeding one thousand dollars ($1,000), or by both that
imprisonment and fine.
(e) This section shall become operative on July 1, 2004.
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 ultimate user or research subject, or contact
information as determined by the Secretary of the United States
Department of Health and Human Services; refill information, such as
the number of refills ordered and whether the prescription is a
first-time request or a refill; 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.
11164.1. (a) (1) Notwithstanding any other provision of law, a
prescription for a controlled substance issued by a prescriber in
another state for delivery to a patient in another state may be
dispensed by a California pharmacy, if the prescription conforms with
the requirements for controlled substance prescriptions in the state
in which the controlled substance was prescribed.
(2) All prescriptions for Schedule II and Schedule III controlled
substances dispensed pursuant to this subdivision shall be reported
by the dispensing pharmacy to the Department of Justice in the manner
prescribed by subdivision (d) of Section 11165.
(b) Pharmacies may dispense prescriptions for Schedule III,
Schedule IV, and Schedule V controlled substances from out-of-state
prescribers pursuant to Section 4005 of the Business and Professions
Code and Section 1717 of Title 16 of the California Code of
Regulations.
(c) This section shall become operative on January 1, 2005.
11164.5. (a) Notwithstanding Section 11164, with the approval of
the California State Board of Pharmacy and the Department of Justice,
a pharmacy or hospital may receive electronic data transmission
prescriptions or computer entry prescriptions or orders as specified
in Section 4071.1 of the Business and Professions Code, for
controlled substances in Schedule II, III, IV, or V if authorized by
federal law and in accordance with regulations promulgated by the
Drug Enforcement Administration. The California State Board of
Pharmacy shall maintain a list of all requests and approvals granted
pursuant to this subdivision.
(b) Notwithstanding Section 11164, if approved pursuant to
subdivision (a), a pharmacy or hospital receiving an electronic
transmission prescription or a computer entry prescription or order
for a controlled substance classified in Schedule II, III, IV, or V
shall not be required to reduce that prescription or order to writing
or to hard copy form, if for three years from the last day of
dispensing that prescription, the pharmacy or hospital is able, upon
request of the board or the Department of Justice, to immediately
produce a hard copy report that includes for each date of dispensing
of a controlled substance in Schedules II, III, IV, and V pursuant to
the prescription all of the information described in subparagraphs
(A) to (E), inclusive, of paragraph (1) of subdivision (a) of Section
4040 of the Business and Professions Code and the name or identifier
of the pharmacist who dispensed the controlled substance.
(c) Notwithstanding Section 11164, if only recorded and stored
electronically, on magnetic media, or in any other computerized form,
the pharmacy's or hospital's computer system shall not permit the
received information or the controlled substance dispensing
information required by this section to be changed, obliterated,
destroyed, or disposed of, for the record maintenance period required
by law, once the information has been received by the pharmacy or
the hospital and once the controlled substance has been dispensed,
respectively. Once the controlled substance has been dispensed, if
the previously created record is determined to be incorrect, a
correcting addition may be made only by or with the approval of a
pharmacist. After a pharmacist enters the change or enters his or her
approval of the change into the computer, the resulting record shall
include the correcting addition and the date it was made to the
record, the identity of the person or pharmacist making the
correction, and the identity of the pharmacist approving the
correction.
(d) Nothing in this section shall be construed to exempt any
pharmacy or hospital dispensing Schedule II controlled substances
pursuant to electronic transmission prescriptions from existing
reporting requirements.
11165. (a) To assist law enforcement and regulatory agencies in
their efforts to control the diversion and resultant abuse of
Schedule II, Schedule III, and Schedule IV controlled substances, and
for statistical analysis, education, and research, the Department of
Justice shall, contingent upon the availability of adequate funds
from the Contingent Fund of the Medical Board of California, the
Pharmacy Board Contingent Fund, the State Dentistry Fund, the Board
of Registered Nursing Fund, and the Osteopathic Medical Board of
California Contingent Fund, maintain the Controlled Substance
Utilization Review and Evaluation System (CURES) for the electronic
monitoring of the prescribing and dispensing of Schedule II, Schedule
III, and Schedule IV controlled substances by all practitioners
authorized to prescribe or dispense these controlled substances.
(b) The reporting of Schedule III and Schedule IV controlled
substance prescriptions to CURES shall be contingent upon the
availability of adequate funds from the Department of Justice. The
Department of Justice may seek and use grant funds to pay the costs
incurred from the reporting of controlled substance prescriptions to
CURES. Funds shall not be appropriated from the Contingent Fund of
the Medical Board of California, the Pharmacy Board Contingent Fund,
the State Dentistry Fund, the Board of Registered Nursing Fund, the
Naturopathic Doctor's Fund, or the Osteopathic Medical Board of
California Contingent Fund to pay the costs of reporting Schedule III
and Schedule IV controlled substance prescriptions to CURES.
(c) CURES shall operate under existing provisions of law to
safeguard the privacy and confidentiality of patients. Data obtained
from CURES shall only be provided to appropriate state, local, and
federal persons or public agencies for disciplinary, civil, or
criminal purposes and to other agencies or entities, as determined by
the Department of Justice, for the purpose of educating
practitioners and others in lieu of disciplinary, civil, or criminal
actions. Data may be provided to public or private entities, as
approved by the Department of Justice, for educational, peer review,
statistical, or research purposes, provided that patient information,
including any information that may identify the patient, is not
compromised. Further, data disclosed to any individual or agency as
described in this subdivision shall not be disclosed, sold, or
transferred to any third party.
(d) For each prescription for a Schedule II, Schedule III, or
Schedule IV controlled substance, the dispensing pharmacy or clinic
shall provide the following information to the Department of Justice
on a weekly basis and in a format specified by the Department of
Justice:
(1) Full name, address, and the telephone number of the ultimate
user or research subject, or contact information as determined by the
Secretary of the United States Department of Health and Human
Services, and the gender, and date of birth of the ultimate user.
(2) 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.
(3) Pharmacy prescription number, license number, and federal
controlled substance registration number.
(4) NDC (National Drug Code) number of the controlled substance
dispensed.
(5) Quantity of the controlled substance dispensed.
(6) ICD-9 (diagnosis code), if available.
(7) Number of refills ordered.
(8) Whether the drug was dispensed as a refill of a prescription
or as a first-time request.
(9) Date of origin of the prescription.
(10) Date of dispensing of the prescription.
(e) This section shall become operative on January 1, 2005.
11165.1. (a) (1) A licensed health care practitioner eligible to
prescribe Schedule II, Schedule III, or Schedule IV controlled
substances or a pharmacist may make a written request for, and the
Department of Justice may release to that practitioner or pharmacist,
the history of controlled substances dispensed to an individual
under his or her care based on data contained in CURES.
(2) Any request for, or release of, a controlled substance history
pursuant to this section shall be made in accordance with guidelines
developed by the Department of Justice.
(b) In order to prevent the inappropriate, improper, or illegal
use of Schedule II, Schedule III, or Schedule IV controlled
substances, the Department of Justice may initiate the referral of
the history of controlled substances dispensed to an individual based
on data contained in CURES to licensed health care practitioners,
pharmacists, or both, providing care or services to the individual.
(c) The history of controlled substances dispensed to an
individual based on data contained in CURES that is received by a
practitioner or pharmacist from the Department of Justice pursuant to
this section shall be considered medical information subject to the
provisions of the Confidentiality of Medical Information Act
contained in Part 2.6 (commencing with Section 56) of Division 1 of
the Civil Code.
11166. No person shall fill a prescription for a controlled
substance after six months has elapsed from the date written on the
prescription by the prescriber. No person shall knowingly fill a
mutilated or forged or altered prescription for a controlled
substance except for the addition of the address of the person for
whom the controlled substance is prescribed as provided by paragraph
(3) of subdivision (b) of Section 11164.
11167. Notwithstanding subdivision (a) of Section 11164, in an
emergency where failure to issue a prescription may result in loss of
life or intense suffering, an order for a controlled substance may
be dispensed on an oral order, an electronic data transmission order,
or a written order not made on a controlled substance form as
specified in Section 11162.1, subject to all of the following
requirements:
(a) The order contains all information required by subdivision (a)
of Section 11164.
(b) Any written order is signed and dated by the prescriber in
ink, and the pharmacy reduces any oral or electronic data
transmission order to hard copy form prior to dispensing the
controlled substance.
(c) The prescriber provides a written prescription on a controlled
substance prescription form that meets the requirements of Section
11162.1, by the seventh day following the transmission of the initial
order; a postmark by the seventh day following transmission of the
initial order shall constitute compliance.
(d) If the prescriber fails to comply with subdivision (c), the
pharmacy shall so notify the Bureau of Narcotic Enforcement in
writing within 144 hours of the prescriber's failure to do so and
shall make and retain a hard copy, readily retrievable record of the
prescription, including the date and method of notification of the
Bureau of Narcotic Enforcement.
(e) This section shall become operative on January 1, 2005.
11167.5. (a) An order for a controlled substance classified in
Schedule II for a patient of a licensed skilled nursing facility, a
licensed intermediate care facility, a licensed home health agency,
or a licensed hospice may be dispensed upon an oral or electronically
transmitted prescription. If the prescription is transmitted orally,
the pharmacist shall, prior to filling the prescription, reduce the
prescription to writing in ink in the handwriting of the pharmacist
on a form developed by the pharmacy for this purpose. If the
prescription is transmitted electronically, the pharmacist shall,
prior to filling the prescription, produce, sign, and date a hard
copy prescription. The prescriptions shall contain the date the
prescription was orally or electronically transmitted by the
prescriber, the name of the person for whom the prescription was
authorized, the name and address of the licensed skilled nursing
facility, licensed intermediate care facility, licensed home health
agency, or licensed hospice in which that person is a patient, the
name and quantity of the controlled substance prescribed, the
directions for use, and the name, address, category of professional
licensure, license number, and federal controlled substance
registration number of the prescriber. The original shall be properly
endorsed by the pharmacist with the pharmacy's state license number,
the name and address of the pharmacy, and the signature of the
person who received the controlled substances for the licensed
skilled nursing facility, licensed intermediate care facility,
licensed home health agency, or licensed hospice. A licensed skilled
nursing facility, a licensed intermediate care facility, a licensed
home health agency, or a licensed hospice shall forward to the
dispensing pharmacist a copy of any signed telephone orders, chart
orders, or related documentation substantiating each oral or
electronically transmitted prescription transaction under this
section.
(b) This section shall become operative on July 1, 2004.
11170. No person shall prescribe, administer, or furnish a
controlled substance for himself.
11171. No person shall prescribe, administer, or furnish a
controlled substance except under the conditions and in the manner
provided by this division.
11172. No person shall antedate or postdate a prescription.
11173. (a) No person shall obtain or attempt to obtain controlled
substances, or procure or attempt to procure the administration of or
prescription for controlled substances, (1) by fraud, deceit,
misrepresentation , or subterfuge; or (2) by the concealment of a
material fact.
(b) No person shall make a false statement in any prescription,
order, report, or record, required by this division.
(c) No person shall, for the purpose of obtaining controlled
substances, falsely assume the title of, or represent himself to be,
a manufacturer, wholesaler, pharmacist, physician, dentist,
veterinarian, registered nurse, physician's assistant, or other
authorized person.
(d) No person shall affix any false or forged label to a package
or receptacle containing controlled substances.
11174. No person shall, in connection with the prescribing,
furnishing, administering, or dispensing of a controlled substance,
give a false name or false address.
11175. No person shall obtain or possess a prescription that does
not comply with this division, nor shall any person obtain a
controlled substance by means of a prescription which does not comply
with this division or possess a controlled substance obtained by
such a prescription.
11179. A person who fills a prescription shall keep it on file for
at least three years from the date of filling it.
11180. No person shall obtain or possess a controlled substance
obtained by a prescription that does not comply with this division.
