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(e) Administrative fines collected pursuant to this section shall
be deposited in the General Fund.
(f) The sanctions authorized under this section shall be separate
from, and in addition to, any other administrative, civil, or
criminal remedies; however, a criminal action may not be
initiated for a specific offense if a citation has been issued
pursuant to this section for that offense, and a citation may not
be issued pursuant to this section for a specific offense if a
criminal action for that offense has been filed.
(g) Nothing in this section shall be deemed to prevent the
department from serving and prosecuting an accusation to
suspend or revoke a permit if grounds for that suspension or
revocation exist.
11107. Sale of Laboratory Items: Required Procedures and
Records; Penalties for Violation
(a) Any manufacturer, wholesaler, retailer, or other person or
entity in this state that sells to any person or entity in this state
or any other state, any laboratory glassware or apparatus, any
chemical reagent or solvent, or any combination thereof, where
the value of the goods sold in the transaction exceeds one
hundred dollars ($100) shall do the following:
(1) Notwithstanding any other law, in any face-to-face or will-
call sale, the seller shall prepare a bill of sale which identifies the
date of sale, cost of product, method of payment, specific items
and quantities purchased, and the proper purchaser
identification information, all of which shall be entered onto the
bill of sale or a legible copy of the bill of sale, and shall also affix
on the bill of sale his or her signature as witness to the purchase
and identification of the purchaser.
(A) For the purposes of this section, “proper purchaser
identification” includes a valid motor vehicle operator’s license or
other official and valid state-issued identification of the
purchaser that contains a photograph of the purchaser, and
includes the residential or mailing address of the purchaser,
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other than a post office box number, the motor vehicle license
number of the motor vehicle used by the purchaser at the time
of purchase, a description of how the substance is to be used,
and the signature of the purchaser.
(B) The seller shall retain the original bill of sale containing the
purchaser identification information for five years in a readily
presentable manner, and present the bill of sale containing the
purchaser identification information upon demand by any law
enforcement officer or authorized representative of the Attorney
General. Copies of these bills of sale obtained by representatives
of the Attorney General shall be maintained by the Department
of Justice for a period of not less than five years.
(2) (A) Notwithstanding any other law, in all sales other than
face-to-face or will-call sales the seller shall maintain for a period
of five years the following sales information: the name and
address of the purchaser, date of sale, product description, cost
of product, method of payment, method of delivery, delivery
address, and valid identifying information.
(B) For the purposes of this paragraph, “valid identifying
information” includes two or more of the following: federal tax
identification number; resale tax identification number; city or
county business license number; license issued by the State
Department of Public Health; registration number issued by the
federal Drug Enforcement Administration; precursor business
permit number issued by the Department of Justice; motor
vehicle operator’s license; or other identification issued by a
state.
(C) The seller shall, upon the request of any law enforcement
officer or any authorized representative of the Attorney General,
produce a report or record of sale containing the information in a
readily presentable manner.
(D) If a common carrier is used, the seller shall maintain a
manifest regarding the delivery in a readily presentable manner
and for a period of five years.
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(b) This section shall not apply to any wholesaler who is licensed
by the California State Board of Pharmacy and registered with
the federal Drug Enforcement Administration of the United
States Department of Justice and who sells laboratory glassware
or apparatus, any chemical reagent or solvent, or any
combination thereof, to a licensed pharmacy, physician, dentist,
podiatrist, or veterinarian.
(c) A violation of this section is a misdemeanor.
(d) For the purposes of this section, the following terms have
the following meanings:
(1) “Laboratory glassware” includes, but is not limited to,
condensers, flasks, separatory funnels, and beakers.
(2) “Apparatus” includes, but is not limited to, heating mantles,
ring stands, and rheostats.
(3) “Chemical reagent” means a chemical that reacts chemically
with one or more precursors, but does not become part of the
finished product.
(4) “Chemical solvent” means a chemical that does not react
chemically with a precursor or reagent and does not become part
of the finished product. A “chemical solvent” helps other
chemicals mix, cools chemical reactions, and cleans the finished
product.
11107.1. Requirements When Selling Specified Chemicals;
Violation as Misdemeanor
(a) Any manufacturer, wholesaler, retailer, or other person or
entity in this state that sells to any person or entity in this state
or any other state any quantity of sodium cyanide, potassium
cyanide, cyclohexanone, bromobenzene, magnesium turnings,
mercuric chloride, sodium metal, lead acetate, palladium black,
hydrogen chloride gas, trichlorofluoromethane
(fluorotrichloromethane), dichlorodifluoromethane, 1,1,2-
trichloro-1,2,2-trifluoroethane (trichlorotrifluoroethane), sodium
acetate, or acetic anhydride shall do the following:
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(1) (A) Notwithstanding any other provision of law, in any face-
to-face or will-call sale, the seller shall prepare a bill of sale which
identifies the date of sale, cost of sale, method of payment, the
specific items and quantities purchased and the proper purchaser
identification information, all of which shall be entered onto the
bill of sale or a legible copy of the bill of sale, and shall also affix
on the bill of sale his or her signature as witness to the purchase
and identification of the purchaser.
(B) For the purposes of this paragraph, “proper purchaser
identification” includes a valid driver’s license or other official
and valid state-issued identification of the purchaser that
contains a photograph of the purchaser, and includes the
residential or mailing address of the purchaser, other than a post
office box number, the motor vehicle license number of the
motor vehicle used by the purchaser at the time of purchase, a
description of how the substance is to be used, the
Environmental Protection Agency certification number or resale
tax identification number assigned to the individual or business
entity for which the individual is purchasing any
chlorofluorocarbon product, and the signature of the purchaser.
(C) The seller shall retain the original bill of sale containing the
purchaser identification information for five years in a readily
presentable manner, and present the bill of sale containing the
purchaser identification information upon demand by any law
enforcement officer or authorized representative of the Attorney
General. Copies of these bills of sale obtained by representatives
of the Attorney General shall be maintained by the Department
of Justice for a period of not less than five years.
(2) (A) Notwithstanding any other law, in all sales other than
face-to-face or will-call sales the seller shall maintain for a period
of five years the following sales information: the name and
address of the purchaser, date of sale, product description, cost
of product, method of payment, method of delivery, delivery
address, and valid identifying information.
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(B) For the purposes of this paragraph, “valid identifying
information” includes two or more of the following: federal tax
identification number; resale tax identification number; city or
county business license number; license issued by the State
Department of Public Health; registration number issued by the
federal Drug Enforcement Administration; precursor business
permit number issued by the Department of Justice; driver’s
license; or other identification issued by a state.
(C) The seller shall, upon the request of any law enforcement
officer or any authorized representative of the Attorney General,
produce a report or record of sale containing the information in a
readily presentable manner.
(D) If a common carrier is used, the seller shall maintain a
manifest regarding the delivery in a readily presentable manner
for a period of five years.
(b) Any manufacturer, wholesaler, retailer, or other person or
entity in this state that purchases any item listed in subdivision
(a) of Section 11107.1 shall do the following:
(1) Provide on the record of purchase information on the source
of the items purchased, the date of purchase, a description of the
specific items, the quantities of each item purchased, and the
cost of the items purchased.
(2) Retain the record of purchase for three years in a readily
presentable manner and present the record of purchase upon
demand to any law enforcement officer or authorized
representative of the Attorney General.
(c) (1) A first violation of this section is a misdemeanor.
(2) Any person who has previously been convicted of a violation
of this section shall, upon a subsequent conviction thereof, be
punished by imprisonment in a county jail not exceeding one
year, by a fine not exceeding one hundred thousand dollars
($100,000), or both the fine and imprisonment.
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11110. Sale of Dextromethorphan Prohibited to Those Under
18 Years of Age without Prescription
(a) It shall be an infraction, punishable by a fine not exceeding
two hundred fifty dollars ($250), for any person, corporation, or
retail distributor to willfully and knowingly supply, deliver, or give
possession of a drug, material, compound, mixture, preparation,
or substance containing any quantity of dextromethorphan (the
dextrorotatory isomer of 3-methoxy-N-methylmorphinan,
including its salts, but not including its racemic or levorotatory
forms) to a person under 18 years of age in an over-the-counter
sale without a prescription.
(b) It shall be prima facie evidence of a violation of this section if
the person, corporation, or retail distributor making the sale does
not require and obtain bona fide evidence of majority and
identity from the purchaser, unless from the purchaser’s outward
appearance the person making the sale would reasonably
presume the purchaser to be 25 years of age or older.
(c) Proof that a person, corporation, or retail distributor, or his
or her agent or employee, demanded, was shown, and acted in
reasonable reliance upon, bona fide evidence of majority and
identity shall be a defense to any criminal prosecution under this
section. As used in this section, “bona fide evidence of majority
and identity” means a document issued by a federal, state,
county, or municipal government, or subdivision or agency
thereof, including, but not limited to, a motor vehicle operator’s
license, California state identification card, identification card
issued to a member of the Armed Forces, or other form of
identification that bears the name, date of birth, description, and
picture of the person.
(d) (1) Notwithstanding any other provision of this section, a
retail clerk who fails to require and obtain proof of age from the
purchaser shall not be guilty of an infraction pursuant to
subdivision (a) or subject to any civil penalties.
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(2) This subdivision shall not apply to a retail clerk who is a
willful participant in an ongoing criminal conspiracy to violate this
section.
11111. Use of Cash Register with Age-Verification Feature for
OTC Sale of Dextromethorphan
A person, corporation, or retail distributor that sells or makes
available products containing dextromethorphan, as defined in
subdivision (a) of Section 11110, in an over-the-counter sale
without a prescription shall, if feasible, use a cash register that is
equipped with an age-verification feature to monitor age-
restricted items. The cash register shall be programmed to direct
the retail clerk making the sale to request bona fide evidence of
majority and identity, as described in subdivision (c) of Section
11110, before a product containing dextromethorphan may be
purchased.
CHAPTER 4. PRESCRIPTIONS
Article 1 - Requirements of Prescriptions
11150. Persons Authorized to Write or Issue a Prescription
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 Section 4052.1, 4052.2, or
4052.6 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
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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.
11150.2 Cannabidiol - Impact of Federal Action on State Law
(a) Notwithstanding any other law, if cannabinoids are excluded
from Schedule I of the federal Controlled Substances Act and
placed on a schedule of the act other than Schedule I, or if a
product composed of cannabinoids is approved by the federal
Food and Drug Administration and either placed on a schedule of
the act other than Schedule I, or exempted from one or more
provisions of the act, so as to permit a physician, pharmacist, or
other authorized healing arts licensee acting within their scope of
practice, to prescribe, furnish, or dispense that product, the
physician, pharmacist, or other authorized healing arts licensee
who prescribes, furnishes, or dispenses that product in
accordance with federal law shall be deemed to be in compliance
with state law governing those acts.
(b) For purposes of this chapter, upon the effective date of one of
the changes in federal law described in subdivision (a),
notwithstanding any other state law, a product composed of
cannabinoids may be prescribed, furnished, dispensed,
transferred, transported, possessed, or used in accordance with
federal law and is authorized pursuant to state law.
(c) This section does not apply to any product containing
cannabinoids that is made or derived from industrial hemp, as
defined in Section 11018.5 and regulated pursuant to that
section.
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11150.6. Methaqualone as Schedule I Controlled Substance
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. Limitations on Filling Prescriptions From Medical
Students
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. Nonconforming Prescriptions Prohibited
No person shall write, issue, fill, compound, or dispense a
prescription that does not conform to this division.
11153. Responsibility for Legitimacy of Prescription;
Corresponding Responsibility of Pharmacist; Knowing Violation
(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.
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(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. Wholesaler or Manufacturer Furnishing Controlled
Substance Other Than for Legitimate Medical Purpose; Knowing
Violation; Factors in Assessing Legitimacy
(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.
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11154. Prescription, etc. Must Be for Treatment; Knowing
Solicitation of Unlawful Prescription, etc.
(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. Prohibition on Physician Prescribing, etc. Where
Controlled Substance Privileges Surrendered
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 Prescribing, etc., Controlled Substances to Addict Only as
Authorized
(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.
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(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 False or Fictitious Prescriptions
No person shall issue a prescription that is false or fictitious in
any respect.
11158. Prescription Required for Schedule II, III, IV, or V
Controlled Substance; Exception for Limited Dispensing,
Administration
(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.
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11158.1. Prescribing Controlled Substance Containing an Opioid
to a Minor
(a) Except when a patient is being treated as set forth in
Sections 11159, 11159.2, and 11167.5, and Article 2
(commencing with Section 11215) of Chapter 5, pertaining to the
treatment of addicts, or for a diagnosis of chronic intractable
pain as used in Section 124960 of this code and Section 2241.5 of
the Business and Professions Code, a prescriber shall discuss all
of the following with the minor, the minor’s parent or guardian,
or another adult authorized to consent to the minor’s medical
treatment before directly dispensing or issuing for a minor the
first prescription in a single course of treatment for a controlled
substance containing an opioid:
(1) The risks of addiction and overdose associated with the use
of opioids.
(2) The increased risk of addiction to an opioid to an individual
who is suffering from both mental and substance abuse
disorders.
(3) The danger of taking an opioid with a benzodiazepine,
alcohol, or another central nervous system depressant.
(4) Any other information required by law.
(b) This section does not apply in any of the following
circumstances:
(1) If the minor’s treatment includes emergency services and
care as defined in Section 1317.1.
(2) If the minor’s treatment is associated with or incident to an
emergency surgery, regardless of whether the surgery is
performed on an inpatient or outpatient basis.
(3) If, in the prescriber’s professional judgment, fulfilling the
requirements of subdivision (a) would be detrimental to the
minor’s health or safety, or in violation of the minor’s legal rights
regarding confidentiality.
(c) Notwithstanding any other law, including Section 11374,
failure to comply with this section shall not constitute a criminal
offense.
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11159. Chart Order Exemption for Patient in County or Licensed
Hospital; Maintaining Record for Seven Years
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. Chart Order Exemption for Clinic Patient; Maintaining
Record for Seven Years
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. Exception to Controlled Substance Prescription
Requirement; Terminally Ill Patient
(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
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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.
11159.3 Filling Controlled Substance Prescription during
Declared Emergency
(a) Notwithstanding any other law, during a declared local,
state, or federal emergency, if the California State Board of
Pharmacy issues a notice that the board is waiving the
application of the provisions of, or regulations adopted pursuant
to, the Pharmacy Law, as specified in subdivision (b) of Section
4062 of the Business and Professions Code, a pharmacist may fill
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a prescription for a controlled substance for use by a patient who
cannot access medications as a result of the declared local, state,
or federal emergency, regardless of whether the prescription
form meets the requirements of Section 11162.1, if the
prescription meets the following requirements:
(1) Contains the information specified in subdivision (a) of
Section 11164.
(2) Indicates that the patient is affected by a declared
emergency with the words “11159.3 exemption” or a similar
statement.
(3) Is written and dispensed within the first two weeks of the
notice issued by the board. (b) A pharmacist filling a prescription
pursuant to this section shall do all of the following:
(1) Exercise appropriate professional judgment, including
reviewing the patient’s activity report from the CURES
Prescription Drug Monitoring Program before dispensing the
medication.
(2) If the prescription is for a Schedule II controlled substance,
dispense no greater than the amount needed for a seven-day
supply.
(3) Require the patient to first demonstrate, to the satisfaction
of the pharmacist, their inability to access medications. This
demonstration may include, but is not limited to, verification of
residency within an evacuation area.
(c) A pharmacist shall not refill a prescription that has been
dispensed pursuant to this section.
11161. Controlled Substance Prescription Blanks; Issuance by
Department; Unlawful Possession; Restriction in Criminal
Proceeding
(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
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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.
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(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. Prescription Forms for Controlled Substance
Prescriptions; Requirements
(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; all managing general partners, if any; and any individual
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owner, partner, corporate officer, manager, agent,
representative, employee, or subcontractor of the applicant who
has direct access to, or management or control of, controlled
substance prescription forms.
(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, managing general partner, or of any
person described in subparagraph (A).
(5) (A) A signed statement indicating whether the applicant, any
principal corporate officer, any managing general partner, or any
individual owner, partner, corporate officer, manager, agent,
representative, employee, or subcontractor of the applicant who
has direct access to, or management or control of, controlled
substance prescription forms, has 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 and any
individual owner, partner, corporate officer, manager, agent,
representative, employee, or subcontractor of the applicant who
has direct access to, or management or control of, controlled
substance prescription forms, 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
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section shall be forwarded to the Federal Bureau of Investigation
by the department.
(D) The department shall assess against each security printer
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 and inspections of security printers
pursuant to this section with respect to that applicant; the fee
shall be paid by the applicant at the time he or she submits the
security printer application, 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.
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(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
with the federal Drug Enforcement Administration (DEA).
(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.
Controlled substance prescription forms provided in person shall
be restricted to established customers. Security printers shall
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obtain a photo identification from the customer and maintain a
log of this information. Controlled substance prescription forms
shall be shipped only to the prescriber’s address on file and
verified with the federal Drug Enforcement Administration or the
Medical Board of California.
(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) Security printers shall report any theft or loss of controlled
substance prescription forms to the Department of Justice via fax
or email within 24 hours of the theft or loss.
(l) (1) The department shall impose restrictions, sanctions, or
penalties, subject to subdivisions (m) and (n), against security
printers who are not in compliance with this division pursuant to
regulations implemented pursuant to this division and shall
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.
(m) The following violations by security printers shall be
punishable pursuant to subdivision (n):
(1) Failure to comply with the Security Printer Guidelines
established by the Security Printer Program as a condition of
approval.
(2) Failure to take reasonable precautions to prevent any
dishonest act or illegal activity related to the access and control
of security prescription forms.
(3) Theft or fraudulent use of a prescriber’s identity in order to
obtain security prescription forms.
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(n) A security printer approved pursuant to subdivision (b) shall
be subject to the following penalties for actions leading to the
denial of a security printer application specified in subdivision (d)
or for a violation specified in subdivision (m):
(1) For a first violation, a fine not to exceed one thousand
dollars ($1,000).
(2) For a second or subsequent violation, a fine not to exceed
two thousand five hundred dollars ($2,500) for each violation.
(3) For a third or subsequent violation, a filing of an
administrative disciplinary action seeking to suspend or revoke
security printer approval.
(o) In order to facilitate the standardization of all prescription
forms and the serialization of prescription forms with unique
identifiers, the Department of Justice may cease issuing new
approvals of security printers to the extent necessary to achieve
these purposes. The department may, pursuant to regulation,
reduce the number of currently approved security printers to no
fewer than three vendors. The department shall ensure that any
reduction or limitation of approved security printers does not
impact the ability of vendors to meet demand for prescription
forms.
11161.7. Prescriber Authority to Prescribe Restricted;
Information to Board; Board Notification to Security Printers
(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
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issued by the prescriber and the ordering of additional controlled
substance prescription forms by the restricted prescriber.
11162.1. Prescription Forms for Controlled Substances;
Requirements
(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
so that the prescriber may indicate the quantity by checking the
applicable box where 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.
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(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, and address 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.
(15) A uniquely serialized number, in a manner prescribed by
the Department of Justice.
(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
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license number of the licensed health care facility the clinic
specified in Section 1200, or the clinic specified in Section 1206
that has 25 or more physicians or surgeons preprinted on the
form. Licensed health care facilities or clinics exempt under
Section 1206 are not required to preprint the category of
licensure and license number of their facility or clinic.
(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) Within the next working day following delivery, a security
printer shall submit via Web-based application, as specified by
the Department of Justice, all of the following information for all
prescription forms delivered:
(1) Serial numbers of all prescription forms delivered.
(2) All prescriber names and Drug Enforcement Administration
Controlled Substance Registration Certificate numbers displayed
on the prescription forms.
(3) The delivery shipment recipient names.
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(4) The date of delivery.
11162.5. Counterfeiting or Possession of Counterfeit Controlled
Substance Prescription Blank; Penalty
(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 pursuant to subdivision (h) of Section 1170 of
the Penal Code 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 that
fine and imprisonment.
11162.6. Controlled Substance Prescription Form;
Counterfeiting, Possession of, Attempt to Obtain or Obtain
Under False Pretenses; Penalty
(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
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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. Prescribing, Filling, Compounding or Dispensing
Prescription for Controlled Substance; Requirements
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
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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.
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11164.1. Controlled Substance Prescription Issued in Another
State for Delivery to Patient in Another State; Dispensing by
California Pharmacy
(a) (1) Notwithstanding any other 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) A prescription for a Schedule II, Schedule III, Schedule IV, or
Schedule V controlled substance 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) A pharmacy may dispense a prescription for a Schedule III,
Schedule IV, or Schedule V controlled substance from an out-of-
state prescriber 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, 2021.
11164.5. Electronic Prescriptions or Orders to Pharmacies and
Hospitals
(a) 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
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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.
(b) 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. Controlled Substance Utilization Review and Evaluation
System: Establishment; Operation; Funding; Reporting to
Department of Justice
(a) To assist health care practitioners in their efforts to ensure
appropriate prescribing, ordering, administering, furnishing, and
dispensing of controlled substances, law enforcement and
regulatory agencies in their efforts to control the diversion and
resultant abuse of Schedule II, Schedule III, Schedule IV, and
Schedule V controlled substances, and for statistical analysis,
education, and research, the Department of Justice shall,
contingent upon the availability of adequate funds in the CURES
Fund, maintain the Controlled Substance Utilization Review and
Evaluation System (CURES) for the electronic monitoring of, and
internet access to information regarding, the prescribing and
dispensing of Schedule II, Schedule III, Schedule IV, and Schedule
V controlled substances by all practitioners authorized to
prescribe, order, administer, furnish, or dispense these controlled
substances.
(b) The department may seek and use grant funds to pay the
costs incurred by the operation and maintenance of CURES. The
department shall annually report to the Legislature and make
available to the public the amount and source of funds it receives
for support of CURES.
(c) (1) The operation of CURES shall comply with all applicable
federal and state privacy and security laws and regulations.
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(2) (A) 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 public agencies for disciplinary, civil, or criminal
purposes and to other agencies or entities, as determined by the
department, 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, for educational, peer review, statistical, or research
purposes, if patient information, including information that may
identify the patient, is not compromised. The University of
California shall be provided access to identifiable data for
research purposes if the requirements of subdivision (t) of
Section 1798.24 of the Civil Code are satisfied. Further, data
disclosed to an individual or agency as described in this
subdivision shall not be disclosed, sold, or transferred to a third
party, unless authorized by, or pursuant to, state and federal
privacy and security laws and regulations. The department shall
establish policies, procedures, and regulations regarding the use,
access, evaluation, management, implementation, operation,
storage, disclosure, and security of the information within CURES,
consistent with this subdivision.
(B) Notwithstanding subparagraph (A), a regulatory board
whose licensees do not prescribe, order, administer, furnish, or
dispense controlled substances shall not be provided data
obtained from CURES.
(3) The department shall, no later than January 1, 2021, adopt
regulations regarding the access and use of the information
within CURES. The department shall consult with all stakeholders
identified by the department during the rulemaking process. The
regulations shall, at a minimum, address all of the following in a
manner consistent with this chapter:
(A) The process for approving, denying, and disapproving
individuals or entities seeking access to information in CURES.
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(B) The purposes for which a health care practitioner may access
information in CURES.
(C) The conditions under which a warrant, subpoena, or court
order is required for a law enforcement agency to obtain
information from CURES as part of a criminal investigation.
(D) The process by which information in CURES may be provided
for educational, peer review, statistical, or research purposes.
(4) In accordance with federal and state privacy laws and
regulations, a health care practitioner may provide a patient with
a copy of the patient’s CURES patient activity report as long as no
additional CURES data are provided and the health care
practitioner keeps a copy of the report in the patient’s medical
record in compliance with subdivision (d) of Section 11165.1.
(d) For each prescription for a Schedule II, Schedule III, Schedule
IV, or Schedule V controlled substance, as defined in the
controlled substances schedules in federal law and regulations,
specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15,
respectively, of Title 21 of the Code of Federal Regulations, the
dispensing pharmacy, clinic, or other dispenser shall report the
following information to the department or contracted
prescription data processing vendor as soon as reasonably
possible, but not more than one working day after the date a
controlled substance is released to the patient or patient’s
representative, in a format specified by the department:
(1) Full name, address, and, if available, 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, license number,
national provider identifier (NPI) number, if applicable, the
federal controlled substance registration number, and the state
medical license number of a prescriber using the federal
controlled substance registration number of a government-
exempt facility.
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(3) Pharmacy prescription number, license number, NPI number,
and federal controlled substance registration number.
(4) National Drug Code (NDC) number of the controlled
substance dispensed.
(5) Quantity of the controlled substance dispensed.
(6) The International Statistical Classification of Diseases (ICD)
Code contained in the most current ICD revision, or any revision
deemed sufficient by the State Board of Pharmacy, 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) Prescribing date of the prescription.
(10) Date of dispensing of the prescription.
(11) The serial number for the corresponding prescription form,
if applicable.
(e) The department may invite stakeholders to assist, advise,
and make recommendations on the establishment of rules and
regulations necessary to ensure the proper administration and
enforcement of the CURES database. A prescriber or dispenser
invitee shall be licensed by one of the boards or committees
identified in subdivision (d) of Section 208 of the Business and
Professions Code, in active practice in California, and a regular
user of CURES.
(f) The department shall, prior to upgrading CURES, consult with
prescribers licensed by one of the boards or committees
identified in subdivision (d) of Section 208 of the Business and
Professions Code, one or more of the boards or committees
identified in subdivision (d) of Section 208 of the Business and
Professions Code, and any other stakeholder identified by the
department, for the purpose of identifying desirable capabilities
and upgrades to the CURES Prescription Drug Monitoring
Program (PDMP).
(g) The department may establish a process to educate
authorized subscribers of the CURES PDMP on how to access and
use the CURES PDMP.
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(h) (1) The department may enter into an agreement with an
entity operating an interstate data sharing hub, or an agency
operating a prescription drug monitoring program in another
state, for purposes of interstate data sharing of prescription drug
monitoring program information.
(2) Data obtained from CURES may be provided to authorized
users of another state’s prescription drug monitoring program, as
determined by the department pursuant to subdivision (c), if the
entity operating the interstate data sharing hub, and the
prescription drug monitoring program of that state, as applicable,
have entered into an agreement with the department for
interstate data sharing of prescription drug monitoring program
information.
(3) An agreement entered into by the department for purposes
of interstate data sharing of prescription drug monitoring
program information shall ensure that all access to data obtained
from CURES and the handling of data contained within CURES
comply with California law, including regulations, and meet the
same patient privacy, audit, and data security standards
employed and required for direct access to CURES.
(4) For purposes of interstate data sharing of CURES information
pursuant to this subdivision, an authorized user of another
state’s prescription drug monitoring program shall not be
required to register with CURES, if the authorized user is
registered and in good standing with that state’s prescription
drug monitoring program.
(5) The department shall not enter into an agreement pursuant
to this subdivision until the department has issued final
regulations regarding the access and use of the information
within CURES as required by paragraph (3) of subdivision (c).
(i) Notwithstanding subdivision (d), a veterinarian shall report
the information required by that subdivision to the department
as soon as reasonably possible, but not more than seven days
after the date a controlled substance is dispensed.
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(j) If the dispensing pharmacy, clinic, or other dispenser
experiences a temporary technological or electrical failure, it
shall, without undue delay, seek to correct any cause of the
temporary technological or electrical failure that is reasonably
within its control. The deadline for transmitting prescription
information to the department or contracted prescription data
processing vendor pursuant to subdivision (d) shall be extended
until the failure is corrected. If the dispensing pharmacy, clinic, or
other dispenser experiences technological limitations that are
not reasonably within its control, or is impacted by a natural or
manmade disaster, the deadline for transmitting prescription
information to the department or contracted prescription data
processing vendor shall be extended until normal operations
have resumed.
11165.1. History of Controlled Substances Dispensed to an
Individual/PDMP
(a) (1) (A) (i) A health care practitioner authorized to prescribe,
order, administer, furnish, or dispense Schedule II, Schedule III,
Schedule IV, or Schedule V controlled substances pursuant to
Section 11150 shall, upon receipt of a federal Drug Enforcement
Administration (DEA) registration, submit an application
developed by the department to obtain approval to electronically
access information regarding the controlled substance history of
a patient that is maintained by the department. Upon approval,
the department shall release to the practitioner or their delegate
the electronic history of controlled substances dispensed to an
individual under the practitioner’s care based on data contained
in the CURES Prescription Drug Monitoring Program (PDMP).
(ii) A pharmacist shall, upon licensure, submit an application
developed by the department to obtain approval to electronically
access information regarding the controlled substance history of
a patient that is maintained by the department. Upon approval,
the department shall release to the pharmacist or their delegate
the electronic history of controlled substances dispensed to an
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individual under the pharmacist’s care based on data contained
in the CURES PDMP.
(iii) A licensed physician and surgeon who does not hold a DEA
registration may submit an application developed by the
department to obtain approval to electronically access
information regarding the controlled substance history of the
patient that is maintained by the department. Upon approval,
the department shall release to the physician and surgeon or
their delegate the electronic history of controlled substances
dispensed to a patient under their care based on data contained
in the CURES PDMP.
(B) The department may deny an application or suspend a
subscriber, for reasons that include, but are not limited to, the
following:
(i) Materially falsifying an application to access information
contained in the CURES database. (ii) Failing to maintain effective
controls for access to the patient activity report.
(iii) Having their federal DEA registration suspended or revoked.
(iv) Violating a law governing controlled substances or another
law for which the possession or use of a controlled substance is
an element of the crime.
(v) Accessing information for a reason other than to diagnose or
treat a patient, or to document compliance with the law.
(C) An authorized subscriber shall notify the department within
30 days of a change to the subscriber account.
(D) An approved health care practitioner, pharmacist, or a
person acting on behalf of a health care practitioner or
pharmacist pursuant to subdivision (b) of Section 209 of the
Business and Professions Code may use the department’s online
portal or a health information technology system that meets the
criteria required in subparagraph (E) to access information in the
CURES database pursuant to this section. A subscriber who uses a
health information technology system that meets the criteria
required in subparagraph (E) to access the CURES database may
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submit automated queries to the CURES database that are
triggered by predetermined criteria.
(E) An approved health care practitioner or pharmacist may
submit queries to the CURES database through a health
information technology system if the entity that operates the
health information technology system certifies all of the
following:
(i) The entity will not use or disclose data received from the
CURES database for a purpose other than delivering the data to
an approved health care practitioner or pharmacist or
performing data processing activities that may be necessary to
enable the delivery unless authorized by, and pursuant to, state
and federal privacy and security laws and regulations.
(ii) The health information technology system will authenticate
the identity of an authorized health care practitioner or
pharmacist initiating queries to the CURES database and, at the
time of the query to the CURES database, the health information
technology system submits the following data regarding the
query to CURES:
(I) The date of the query.
(II) The time of the query.
(III) The first and last name of the patient queried. (IV) The date
of birth of the patient queried.
(V) The identification of the CURES user for whom the system is
making the query.
(iii) The health information technology system meets applicable
patient privacy and information security requirements of state
and federal law.
(iv) The entity has entered into a memorandum of
understanding with the department that solely addresses the
technical specifications of the health information technology
system to ensure the security of the data in the CURES database
and the secure transfer of data from the CURES database. The
technical specifications shall be universal for all health
information technology systems that establish a method of
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system integration to retrieve information from the CURES
database. The memorandum of understanding shall not govern,
or in any way impact or restrict, the use of data received from
the CURES database or impose any additional burdens on
covered entities in compliance with the regulations promulgated
pursuant to the federal Health Insurance Portability and
Accountability Act of 1996 found in Parts 160 and 164 of Title 45
of the Code of Federal Regulations.
(F) No later than October 1, 2018, the department shall develop
a programming interface or other method of system integration
to allow health information technology systems that meet the
requirements in subparagraph (E) to retrieve information in the
CURES database on behalf of an authorized health care
practitioner or pharmacist.
(G) The department shall not access patient-identifiable
information in an entity’s health information technology system.
(H) An entity that operates a health information technology
system that is requesting to establish an integration with the
CURES database shall pay a reasonable fee to cover the cost of
establishing and maintaining integration with the CURES
database.
(I) The department may prohibit integration or terminate a
health information technology system’s ability to retrieve
information in the CURES database if the health information
technology system fails to meet the requirements of
subparagraph (E), or the entity operating the health information
technology system does not fulfill its obligation under
subparagraph (H).
(2) A health care practitioner authorized to prescribe, order,
administer, furnish, or dispense Schedule II, Schedule III,
Schedule IV, or Schedule V controlled substances pursuant to
Section 11150 or a pharmacist shall be deemed to have complied
with paragraph (1) if the licensed health care practitioner or
pharmacist has been approved to access the CURES database
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through the process developed pursuant to subdivision (a) of
Section 209 of the Business and Professions Code.
(b) A request for, or release of, a controlled substance history
pursuant to this section shall be made in accordance with
guidelines developed by the department.
(c) In order to prevent the inappropriate, improper, or illegal use
of Schedule II, Schedule III, Schedule IV, or Schedule V controlled
substances, the department 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.
(d) 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 pursuant to this
section is 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.
(e) Information concerning a patient’s controlled substance
history provided to a practitioner or pharmacist pursuant to this
section shall include prescriptions for controlled substances listed
in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of
the Code of Federal Regulations.
(f) A health care practitioner, pharmacist, or a person acting on
behalf of a health care practitioner or pharmacist, when acting
with reasonable care and in good faith, is not subject to civil or
administrative liability arising from false, incomplete, inaccurate,
or misattributed information submitted to, reported by, or relied
upon in the CURES database or for a resulting failure of the
CURES database to accurately or timely report that information.
(g) For purposes of this section, the following terms have the
following meanings:
(1) “Automated basis” means using predefined criteria to trigger
an automated query to the CURES database, which can be
attributed to a specific health care practitioner or pharmacist.
(2) “Department” means the Department of Justice.
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