2022 LAWBOOK FOR PHARMACY - page 15

 

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2022 LAWBOOK FOR PHARMACY - page 15

 

 

person not known to the furnisher, the manufacturer,
wholesaler, or third-party logistics provider shall contact the
board or, if the person is licensed or registered by another
government entity, that entity, to confirm the recipient is an
authorized person.
(b) “Authorized person” means a person to whom the board has
issued a permit which enables the permit holder to purchase
dangerous drugs or devices for use within the scope of its permit.
“Authorized person” also means any person in this state or in
another jurisdiction within the United States to the extent such
furnishing is authorized by the law of this state, any applicable
federal law, and the law of the jurisdiction in which that person is
located. The manufacturer, wholesaler, or third-party logistics
provider furnishing to such person shall, prior to furnishing the
dangerous drugs and devices, establish the intended recipient is
legally authorized to receive the dangerous drugs or devices.
(c) Dangerous drugs or devices furnished by a manufacturer,
wholesaler, or third-party logistics provider shall be delivered
only to the premises listed on the permit; provided that a
manufacturer, wholesaler, or third-party logistics provider may
furnish drugs to an authorized person or an agent of that person
at the premises of the manufacturer, wholesaler, or and third-
party logistics provider if (1) the identity and authorization of the
recipient is properly established and (2) this method of receipt is
employed only to meet the immediate needs of a particular
patient of the authorized person. Dangerous drugs or devices
may be furnished to a hospital pharmacy receiving area provided
that a pharmacist or authorized receiving personnel signs, at the
time of delivery, a receipt showing the type and quantity of the
dangerous drugs or devices so received. Any discrepancy
between the receipt and the type and quantity of dangerous
drugs and devices actually received shall be reported to the
delivering manufacturer, wholesaler, or third-party logistics
provider by the next business day after the delivery to the
pharmacy receiving area.
560
(d) A manufacturer, wholesaler, or third-party logistics provider
shall not accept payment for or allow the use of an entity's credit
to establish an account for the purchase of dangerous drugs or
devices from any person other than: (1) the owner(s) of record,
chief executive officer, or chief financial officer listed on the
permit for the authorized person; and (2) on an account bearing
the name of the permittee.
(e) All records of dangerous drugs or devices furnished by a
manufacturer, wholesaler, or third-party logistics provider to an
authorized person shall be preserved by the authorized person
for at least three years from the date of making and shall, at all
times during business hours, be open to inspection by authorized
officers of the law at the licensed premises. The manufacturer,
wholesaler, or third-party logistics provider shall also maintain all
records of dangerous drugs or devices furnished pursuant to this
section for at least three years from the date of making and shall,
at all times during business hours, keep them open to inspection
by authorized officers of the law at the premises from which the
dangerous drugs or devices were furnished.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4025, 4043, 4059, 4059.5, 4080, 4081, 4105,
4120, 4160, 4161, 4163, 4165 and 4304, Business and Professions
Code; and Section 11209, Health and Safety Code.
1784. Self-Assessment of a Wholesaler by the Designated
Representative-in-Charge.
(a) The designated representative-in-charge of each wholesaler
as defined under section 4160 of the Business and Professions
Code shall complete a self-assessment of the wholesaler’s
compliance with federal and state pharmacy law. The assessment
shall be performed before July 1 of every odd-numbered year.
The primary purpose of the self-assessment is to promote
compliance through self-examination and education.
561
(b) In addition to the self-assessment required in subdivision (a)
of this section, the designated representative-in-charge shall
complete a self-assessment within 30 days whenever:
(1) A new wholesaler permit is issued, or
(2) There is a change in the designated representative-in-charge.
The new designated representative-in-charge of a wholesaler is
responsible for compliance with this subdivision.
(3) There is a change in the licensed location of a wholesaler to a
new address.
(c) The components of this assessment shall be on Form 17M-26
(Rev. 10/14) entitled “Wholesaler Dangerous Drugs & Dangerous
Devices Self-Assessment” which is hereby incorporated by
reference to evaluate compliance with federal and state laws and
regulations.
(d) Each self-assessment shall be kept on file in the licensed
wholesale premises for three years after it is completed.
(e) The wholesaler is jointly responsible with the designated
representative-in-charge for compliance with this section.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4022.5,4043, 4053, 4059, 4120, 4160, 4161,
4201, 4301 and 4305.5, Business and Professions Code.
Article 10.1. Home Dialysis Drugs and Devices
1787. Authorization to Distribute Dialysis Drugs and Devices.
(a) Only the following dangerous drugs and devices may be
distributed directly to home dialysis patients in case or full shelf
package lots:
(1) Dialysate
(2) Heparin 1000u/cc
(3) Sterile Sodium Chloride 0.9% for injection
(4) Needles
(5) Syringes
(6) Dialyzers, delivery systems and their accessory equipment
necessary for chronic hemodialysis.
562
(b) The drugs and devices specified in 1787(a) may be
distributed on the basis of a written or oral order received from a
licensed prescriber. The prescriber or his or her authorized
employee may transmit oral orders directly to a pharmacist or
designated representative.
(c) Orders are refillable during a six-month interval as ordered
by the prescriber. Records of such refills shall be retained by the
supplier for three years.
Authority cited: Sections 4005 and 4059, Business and
Professions Code. Reference: Sections 4059, 4081 and 4332,
Business and Profession Code.
1790. Assembling and Packaging.
A record of shipment or expanded invoice shall be included in
the patient's shipment, and shall include the name(s) of the drugs
or devices, quantities, manufacturer's name and lot number,
date of shipment, and the name of the pharmacist or designated
representative who supervised and was responsible for the
distribution. Copies of the record shall also be distributed to the
prescribing physician and retained by the supplier for three
years.
Authority cited: Sections 4005 and 4059, Business and Profession
Code. Reference: Sections 4059, 4081 and 4332, Business and
Professions Code.
1791. Labeling.
In addition to the manufacturer's label, each case or full shelf
package furnished to a home hemodialysis patient shall have
affixed in a conspicuous place the name of that patient. In
addition the shipment must include the following information:
the patient's name and address, the name, strength, dosage size
and quantity of the dangerous drugs or devices contained
therein, the name of the prescriber, the name and address of the
supplier, the date of assembly, and appropriate directions for
use.
563
Authority cited: Sections 4005 and 4059, Business and
Professions Code. Reference: Sections 4059, 4081 and 4332,
Business and Professions Code.
1792. Receipt for Shipment.
Upon delivery of such drugs and devices, the supplier or his or
her agent shall obtain the signature of the patient or his or her
agent on the invoice with notations of any discrepancies,
corrections or damage.
Authority cited: Sections 4005 and 4059, Business and
Professions Code. Reference: Sections 4059, 4081 and 4332,
Business and Professions Code.
Article 11. Ancillary Personnel
1793. Definitions.
“Pharmacy technician” means an individual who, under the
direct supervision and control of a pharmacist, performs
packaging, manipulative, repetitive, or other nondiscretionary
tasks related to the processing of a prescription in a pharmacy,
but who does not perform duties restricted to a pharmacist
under section 1793.1.
Authority cited: Sections 4005, 4007, 4038, 4115 and 4202,
Business and Professions Code. Reference: Sections 4005, 4007,
4038, 4115 and 4202, Business and Professions Code.
1793.1. Duties of a Pharmacist.
Only a pharmacist, or an intern pharmacist acting under the
supervision of a pharmacist, may:
(a) Receive a new prescription order orally from a prescriber or
other person authorized by law.
(b) Consult with a patient or his or her agent regarding a
prescription, either prior to or after dispensing, or regarding any
medical information contained in a patient medication record
system or patient chart.
564
(c) Identify, evaluate and interpret a prescription.
(d) Interpret the clinical data in a patient medication record
system or patient chart.
(e) Consult with any prescriber, nurse or other health care
professional or authorized agent thereof.
(f) Supervise the packaging of drugs and check the packaging
procedure and product upon completion.
(g) Perform all functions which require professional judgment.
Authority cited: Sections 4005, 4007, 4038, 4115 and 4202,
Business and Professions Code. Reference: Sections 4005, 4007,
4038, 4115 and 4202, Business and Professions Code.
1793.2. Duties of a Pharmacy Technician.
“Nondiscretionary tasks” as used in Business and Professions
Code section 4115, include:
(a) removing the drug or drugs from stock;
(b) counting, pouring, or mixing pharmaceuticals;
(c) placing the product into a container;
(d) affixing the label or labels to the container;
(e) packaging and repackaging.
Authority cited: Sections 4005, 4007, 4038, 4115 and 4202,
Business and Professions Code. Reference: Sections 4005, 4007,
4038, 4115 and 4202, Business and Professions Code.
1793.3. Other Non-Licensed Pharmacy Personnel.
(a) In addition to employing a pharmacy technician to perform
the tasks specified in section 1793.2, a pharmacy may employ a
non-licensed person to type a prescription label or otherwise
enter prescription information into a computer record system,
but the responsibility for the accuracy of the prescription
information and the prescription as dispensed lies with the
registered pharmacist who initials the prescription or
prescription record. At the direction of the registered pharmacist,
a non-licensed person may also request and receive refill
authorization.
565
(b) A pharmacist may supervise the number of non-licensed
personnel performing the duties specified in subdivision (a) that
the pharmacist determines, in the exercise of his or her
professional judgment, does not interfere with the effective
performance of the pharmacist's responsibilities under the
Pharmacy Law.
(c) A pharmacist who, exercising his or her professional
judgment pursuant to subdivision (b), refuses to supervise the
number of non-licensed personnel scheduled by the pharmacy,
shall notify the pharmacist-in-charge in writing of his or her
determination, specifying the circumstances of concern with
respect to the pharmacy or the non-licensed personnel that have
led to the determination, within a reasonable period, but not to
exceed 24 hours, after the posting of the relevant schedule.
(d) No entity employing a pharmacist may discharge, discipline,
or otherwise discriminate against any pharmacist in the terms
and conditions of employment for exercising or attempting to
exercise in good faith the right established pursuant to this
section.
Authority cited: Sections 4005 and 4007, Business and
Professions Code. Reference: Sections 4005 and 4007, Business
and Professions Code.
1793.5. Pharmacy Technician Application.
The “Pharmacy Technician Application” (Form 17A-5 (Rev.
7/2020)), incorporated by reference herein, required by this
section is available from the Board of Pharmacy upon request.
(a) Each application for a pharmacy technician license shall
include:
(1) Information sufficient to identify the applicant.
(2) A description of the applicant's qualifications and supporting
documentation for those qualifications.
(3) A criminal background check that will require submission of
fingerprints in a manner specified by the board and the fee
authorized in Penal Code section 11105(e).
566
(4) A sealed, original Self-Query from the National Practitioner
Data Bank (NPDB) dated no earlier than 60 days of the date an
application is submitted to the board.
(b) The applicant shall sign the application under penalty of
perjury and shall submit it to the Board of Pharmacy.
(c) The board shall notify the applicant within 30 days if an
application is deficient; and what is needed to correct the
deficiency. Once the application is complete, and upon
completion of any investigation conducted pursuant to section
4207 of the Business and Professions Code, the board will notify
the applicant within 60 days of a license decision.
(d) Before expiration of a pharmacy technician license, a
pharmacy technician must renew that license by payment of the
fee specified in subdivision (r) of section 4400 of the Business and
Professions Code.
Note: Authority cited: Sections 163.5, 4005, 4007, 4038, 4115,
4202, 4207 and 4400, Business and Professions Code. Reference:
Sections 163.5, 4005, 4007, 4038, 4115, 4202, 4207, 4402 and
4400, Business and Professions Code; and Section 11105, Penal
Code.
1793.6. Training Courses Specified by the Board.
A course of training that meets the requirements of Business
and Professions Code section 4202 (a)(2) is:
(a) Any pharmacy technician training program accredited by the
American Society of Health--System Pharmacists,
(b) Any pharmacy technician training program provided by a
branch of the federal armed services for which the applicant
possesses a certificate of completion, or
(c) Any other course that provides a training period of at least
240 hours of instruction covering at least the following:
(1) Knowledge and understanding of different pharmacy
practice settings.
(2) Knowledge and understanding of the duties and
responsibilities of a pharmacy technician in relationship to other
567
pharmacy personnel and knowledge of standards and ethics,
laws and regulations governing the practice of pharmacy.
(3) Knowledge and ability to identify and employ
pharmaceutical and medical terms, abbreviations and symbols
commonly used in prescribing, dispensing and record keeping of
medications.
(4) Knowledge of and the ability to carry out calculations
required for common dosage determination, employing both the
metric and apothecary systems.
(5) Knowledge and understanding of the identification of drugs,
drug dosages, routes of administration, dosage forms and
storage requirements.
(6) Knowledge of and ability to perform the manipulative and
record-keeping functions involved in and related to dispensing
prescriptions.
(7) Knowledge of and ability to perform procedures and
techniques relating to manufacturing, packaging, and labeling of
drug products.
Authority cited: Sections 4005, 4007, 4038, 4115 and 4202,
Business and Professions Code. Reference: Sections 4005, 4007,
4038, 4115 and 4202, Business and Professions Code.
1793.7. Requirements for Pharmacies Employing Pharmacy
Technicians.
(a) Except as otherwise provided in section 1793.8, any function
performed by a pharmacy technician in connection with the
dispensing of a prescription, including repackaging from bulk and
storage of pharmaceuticals, must be verified and documented in
writing by a pharmacist. Except for the preparation of
prescriptions for an inpatient of a hospital and for an inmate of a
correctional facility, the pharmacist shall indicate verification of
the prescription by initialing the prescription label before the
medication is provided to the patient.
(b) Pharmacy technicians must work under the direct
supervision of a pharmacist and in such a relationship that the
568
supervising pharmacist is fully aware of all activities involved in
the preparation and dispensing of medications, including the
maintenance of appropriate records.
(c) A pharmacy technician must wear identification clearly
identifying him or her as a pharmacy technician.
(d) Any pharmacy employing or using a pharmacy technician
shall develop a job description and written policies and
procedures adequate to ensure compliance with the provisions
of Article 11 of this Chapter, and shall maintain, for at least three
years from the time of making, records adequate to establish
compliance with these sections and written policies and
procedures.
(e) A pharmacist shall be responsible for all activities of
pharmacy technicians to ensure that all such activities are
performed completely, safely and without risk of harm to
patients.
(f) For the preparation of a prescription for an inpatient of a
licensed health facility and for a patient of a licensed home
health agency, the ratio shall not be less than one pharmacist on
duty for a total of two pharmacy technicians on duty. Pursuant to
Business and Professions Code section 4115(g)(1), this ratio shall
not apply to the preparation of a prescription for an inmate of a
correctional facility of the Department of the Youth Authority or
the Department of Corrections, or for a person receiving
treatment in a facility operated by the State Department of
Mental Health, the State Department of Developmental Services,
or the Department of Veterans Affairs.
Authority cited: Sections 4005, 4007, 4038, 4115 and 4202,
Business and Professions Code. Reference: Sections 4005, 4007,
4038, 4115 and 4202, Business and Professions Code.
569
1793.8. Technicians in Hospitals with Clinical Pharmacy
Programs.
(a) A general acute care hospital, as defined in Health and Safety
Code 1250 (a), that has an ongoing clinical pharmacy program
may allow pharmacy technicians to check the work of other
pharmacy technicians in connection with the filling of floor and
ward stock and unit dose distribution systems for patients
admitted to the hospital whose orders have previously been
reviewed and approved by a licensed pharmacist. Only inpatient
hospital pharmacies as defined in 4029(a) that maintain a clinical
pharmacy services program as described in 4052.1 may have a
technician checking technician program as described. The
pharmacy shall have on file a description of the clinical pharmacy
program prior to initiating a technician checking technician
program.
(1) This section shall only apply to acute care inpatient hospital
pharmacy settings.
(2) Hospital pharmacies that have a technician checking
technician program shall deploy pharmacists to the inpatient care
setting to provide clinical services.
(b) Compounded or repackaged products must have been
previously checked by a pharmacist and then may be used by the
technician to fill unit dose distribution systems, and floor and
ward stock.
(c) To ensure quality patient care and reduce medication errors,
programs that use pharmacy technicians to check the work of
other pharmacy technicians pursuant to this section must include
the following components:
(1) The overall operation of the program shall be the
responsibility of the pharmacist-in-charge.
(2) The program shall be under the direct supervision of a
pharmacist and the parameters for the direct supervision shall be
specified in the facility’s policies and procedures
570
(3) The pharmacy technician who performs the checking
function has received specialized and advanced training as
prescribed in the policies and procedures of the facility.
(4) To ensure quality there shall be ongoing evaluation of
programs that use pharmacy technicians to check the work of
other pharmacy technicians.
Authority cited: Section 4005 and 4115, Business and Professions
Code. Reference: Section 4005, 4052.1 and 4115 Business and
Professions Code.
571
HEALTH & SAFETY CODE
DIVISION 2. LICENSING PROVISIONS
Section
1211.
Clinics Sharing Office Space
1261.5.
Emergency Supplies; Doses Stored in Emergency
Supplies Container
1261.6.
Automated Drug Delivery Systems
1342.74
Health Care Service Plans Coverage of HIV
Preexposure and Postexposure Prophylaxis
DIVISION 10. UNIFORM CONTROLLED
SUBSTANCES ACT
CHAPTER 1. GENERAL PROVISIONS AND DEFINITIONS
Section
11000.
Designation
11001.
Definitions Govern Construction
11002.
Administer Defined
11003.
Agent Defined
11004.
Attorney General Defined
11005.
Board of Pharmacy Defined
11006.5.
Concentrated Cannabis Defined
11007.
Controlled Substance Defined
11008.
Customs Broker Defined
11009.
Deliver or Delivery Defined
11010.
Dispense Defined
11011.
Dispenser Defined
11012.
Distribute Defined
11013.
Distributor Defined
11014.
Drug Defined
572
11014.5.
Drug Paraphernalia Defined
11015.
Federal Bureau Defined
11016.
Furnish Defined
11017.
Manufacturer Defined
11018.
Marijuana Defined
11019.
Narcotic Drug Defined
11020.
Opiate Defined
11021.
Opium Poppy Defined
11022.
Person Defined
11023.
Pharmacy Defined
11024.
Physician, Dentist, Podiatrist, Pharmacist, and
Veterinarian Defined
11025.
Poppy Straw Defined
11026.
Practitioner Defined
11027.
Prescription Defined
11029.
Production Defined
11029.5
Security Printer Defined
11030.
Ultimate User Defined
11031.
Wholesaler Defined
11032.
References to Narcotics, Restricted Dangerous
Drugs, Marijuana as Schedule I, II, III and IV
Controlled Substances
11033.
Isomer Defined
CHAPTER 2. STANDARDS AND SCHEDULES
Section
11053.
Substances Included by Whatever Name Used
11054.
Schedule I Controlled Substances
11055.
Schedule II Controlled Substances
11056.
Schedule III Controlled Substances
11057.
Schedule IV Controlled Substances
11058.
Schedule V Controlled Substances
11059.
Schedule Exceptions
573
CHAPTER 3. REGULATION AND CONTROL
Article 1. Reporting
Section
11100.
Report of Certain Chemical: Chemicals Included;
Exclusions; Penalties
11100.05.
Drug Cleanup Fine
11100.1.
Report of Chemicals Received from Outside State;
Penalties
11101.
Reporting Form Contents
11102.
Adoption of Necessary Regulations
11103.
Report of Theft, Loss, or Shipping Discrepancy
11104.
Providing Chemical for Illicit Manufacturing;
Evasion of Reporting Requirements; Penalties
11104.5.
Illegal Possession of Certain Glassware or Lab
Apparatus
11105.
False Statement in Report
11106.
Permit for Providing Chemicals; Process;
Discipline; Renewal and Fees
11106.5.
Order Suspending or Imposing Permit Restrictions
11106.7.
System for DOJ Citations to Permittees; Order of
Abatement or Order to Pay Fine; System
Requirements
11107.
Sale of Laboratory Items: Required Procedures and
Records; Penalties for Violation
11107.1.
Requirements When Selling Specified Chemicals;
Violation as Misdemeanor
11110.
Sale of Dextromethorphan Prohibited to Those
Under 18 Years of Age without Prescription
11111.
Use of Cash Register with Age-Verification Feature
for OTC Sale of Dextromethorphan
574
CHAPTER 4. PRESCRIPTIONS
Article 1. Requirements of Prescriptions
Section
11150.
Persons Authorized to Write or Issue a
Prescription
11150.6.
Methaqualone as Schedule I Controlled Substance
11151.
Limitation on Filling Prescriptions From Medical
Students
11152.
Nonconforming Prescriptions Prohibited
11153.
Responsibility for Legitimacy of Prescription;
Corresponding Responsibility of Pharmacist;
Knowing Violation
11153.5.
Wholesaler or Manufacturer Furnishing Controlled
Substance Other Than for Legitimate Medical
Purpose; Knowing Violation; Factors in Assessing
Legitimacy
11154.
Prescription, etc. Must Be for Treatment; Knowing
Solicitation of Unlawful Prescription, etc.
11155.
Prohibition on Physician Prescribing, etc., Where
Controlled Substance Privileges Surrendered
11156.
Prescribing, etc. Controlled Substances to Addict
Only as Authorized
11157.
No False or Fictitious Prescriptions
11158.
Prescription Required for Schedule II, III, IV, or V
Controlled Substance; Exception for Limited
Dispensing, Administration
11158.1.
Prescribing Controlled Substance Containing an
Opioid to a Minor
11159.
Chart Order Exemption for Patient in County or
Licensed Hospital; Maintaining Record for Seven
Years
11159.1.
Chart Order Exemption for Clinic Patient;
Maintaining Record for Seven Years
575
11159.2.
Exception to Controlled Substance Prescription
Requirement; Terminally Ill Patient
11159.3
Filling Controlled Substance Prescription during
Declared Emergency
11161.
Controlled Substance Prescription Blanks; Issuance
by Department; Unlawful Possession; Restriction
in Criminal Proceeding
11161.5.
Prescription Forms for Controlled Substance
Prescriptions; Requirements
11161.7.
Prescriber Authority to Prescribe Restricted;
Information to Board; Board Notification to
Security Printers
11162.1.
Prescription Forms for Controlled Substances;
Requirements
11162.5.
Counterfeiting or Possession of Counterfeit
Controlled Substance Prescription Blank; Penalty
11162.6.
Controlled Substance Prescription Form;
Counterfeiting, Possession of, Attempt to Obtain
or Obtain Under False Pretenses; Penalty
11164.
Prescribing, Filling, Compounding or Dispensing
Prescription for Controlled Substance;
Requirements
11164.1.
Controlled Substance Prescription Issued in
Another State for Delivery to Patient in Another
State; Dispensing by California Pharmacy
11164.5.
Electronic Prescriptions or Orders to Pharmacies
and Hospitals
11165.
Controlled Substance Utilization Review and
Evaluation System: Establishment; Operation;
Funding; Reporting to Department of Justice
11165.1.
History of Controlled Substances Dispensed to an
Individual/PDMP
11165.2.
CURES Violation: Citations; Request for Hearing;
Fines
11165.3.
Report Theft/Loss of Security Forms
576
11165.4.
CURES: Prescribers’ Duty Required to Consult
CURES
11165.5.
CURES Funding; Definitions
11165.6
Prescriber Access for List of Prescriber’s Patients
11166.
Time Limit for Filling Schedule II Prescription;
Knowingly Filling Mutilated, Forged, or Altered
Prescription Prohibited
11167.
Emergency Dispensing of Controlled Substance:
Circumstances and Requirements
11167.5.
Oral or Electronic Prescriptions for Schedule II
Controlled Substance for Specified Inpatients,
Residents, and Home Hospice Patients;
Requirements
11170.
Prohibition on Prescribing, etc. Controlled
Substance for Self
11171.
Prescribing, etc. Controlled Substance Only as
Authorized
11172.
Antedating or Postdating Prescription Prohibited
11173.
Fraud, Deceit, Misrepresentation or False
Statement; False Representation; False Label
11174.
Prohibition on Providing False Name or Address in
Connection with Prescription, etc.
11175.
Prohibition on Obtaining or Possessing
Nonconforming Prescription; Prohibition on
Obtaining Controlled Substance by Nonconforming
Prescription
11179.
Retention of Controlled Substance Prescription
11180.
Prohibition of Controlled Substance Obtained or
Possessed by Nonconforming Prescription
Article 2. Prescriber’s Record
Section
11190.
Prescriber’s Record for Schedule II, III or IV
Controlled Substances; Prescription Requirements
11191.
Retention Period; Violation
577
11192.
Prima Facie Evidence of Violation of Section 11190
Article 3. Copies of Prescriptions
Section
11195.
Providing Receipt for Prescription Removed by
Peace Officer, Board Inspector, etc.
Article 4. Refilling Prescriptions
Section
11200.
Restrictions on Dispensing or Refilling; Refill of
Schedule II Prescription Prohibited
11201.
Emergency Refill of Schedule III, IV, or V
Prescription; Circumstances; Requirements
Article 5. Pharmacists’ Records
Section
11205.
Maintenance and Retention of Records in
Separate File
11206.
Required Information on Prescription
11207.
Only Pharmacist or Intern Authorized to Fill
Prescription
11208.
Prima Facie Evidence of Violation of Controlled
Substance Act
11209.
Delivery and Receiving Requirements for Schedule
II, III, and IV Substances; Violation
CHAPTER 5. USE OF CONTROLLED SUBSTANCES
Article 1. Lawful Medical Use Other Than Treatment
of Addicts
Section
11210.
Issuing Prescription: By Whom; For What Purpose;
Quantity to Be Prescribed
578
11211.
Purchases of Controlled Substances by Hospital
Without a Pharmacist for Emergencies; Conditions
on Providing to Patients
11212.
Obtaining and Using Controlled Substance for
Research, Instruction, or Analysis; Conditions
11213.
Research Approval by Research Advisory Panel
Article 2. Treatment of Addicts for Addiction
Section
11215.
Administration of Narcotics By or Under Direction
of Physician, etc.; Who Physician May Direct to
Administer
11217.
Authorized Place of Treatment
11217.5.
Administration in Office or Medical Facility of Non-
Narcotic Drugs
11218.
Limitation on Narcotics in First 15 Days of
Treatment
11219.
Limitation on Narcotics after First 15 Days of
Treatment
11220.
Required Discontinuance of Controlled
Substances, Except Methadone or LAAM, After 30
Days
11222.
Persons in Custody: Treatment for Withdrawal
Symptoms; Continued Participation in Narcotic
Treatment Programs
Article 3. Veterinarians
Section
11240.
Prohibition on Prescribing, etc. Controlled
Substance for Human Being
11241.
Prescription Contents
579
Article 4. Sale Without Prescription
Section
11250.
Authorized Retail Sale by Pharmacists to
Physicians, etc.; Required Order Form
11251.
Authorized Wholesale Sale by Pharmacists
11252.
Preservation of Federally Required Forms
11253.
Duration of Retention
11255.
Actions Constituting Sale
11256.
Required Report of Order by or Sale to Out-of-
State Wholesaler or Manufacturer
11364
Possession of Illegal Drug Paraphernalia
11364.1
Unlawful Possession of Drug Paraphernalia in
Effect until January 1, 2015 Unless Another Law is
Enacted Before That Date
CHAPTER 13.5. DISEASE PREVENTION
DEMONSTRATION PROJECT
Section
121281.
Board Web Site: Testing for HIV and Viral
Hepatitis; Disposal of Sharps Waste; How to
Access Drug Treatment
CHAPTER 18. CLEAN NEEDLE AND SYRINGE
EXCHANGE PROGRAM
Section
121349.
Legislative Findings and Declaration
121349.1.
Needle and Syringe Exchange Project;
Requirements
121349.2.
Local, Health and Law Enforcement Comment
Biennually; Public Input
121349.2.
Local, Health and Law Enforcement Comment
Annually; Public Input
121349.3.
Biennial Report of Health Officer of Participating
Jurisdiction
580
121349.3.
Annual Report of Health Officer of Participating
Jurisdiction
124960.
Treatment of Severe Chronic Intractable Pain
124961.
Pain Patient’s Bill of Rights
DIVISION 106.
Part 5. HEREDITARY DISEASES/
CONGENITAL DEFECTS
CHAPTER 2. GENETIC DISEASE SERVICES
Article 5. Standards of Service
For Providers of Blood Clotting Products
For Home Use Act
Section
125286.10. Standards of Service for Providers of Blood
Clotting Products for Home Use Act
125286.15. Legislative Declarations
125186.20. Definitions
125286.26. Requirements for Providers of Blood Clotting
Products for Home Use
125286.30. Administration and Enforcement
126286.35. Exemptions
581
DIVISION 114. PRESCRIPTION DRUG DISCOUNT
PROHIBITION
Section
132000.
Prescription Drug Discount Prohibition - Food and
Drug Administration’s “Approved Drug Products
with Therapeutic Equivalence Evaluations”
132002.
Prescription Drug Discount Prohibition - Active
Ingredients Regulated by Food and Drug
Administration, Available at Lower Cost and
Otherwise Not Contraindicated
132004.
Prescription Drug Discount Prohibition -
Exceptions
132006.
Prescription Drug Discount Prohibition - Exception
if Product is Free for Patient and Insurer, Health
Care Service Plan or Other Health Coverage
132008.
Pharmacist’s Ability to Substitute Prescription
Drug; Assistance by Independent Charity Patient
Assistance Program; Assistance by Pharmaceutical
Manufacturer
DIVISION 116. SURPLUS MEDICATION COLLECTION
AND DISTRIBUTION
CHAPTER 12. HEALTH FACILITIES
Section
150200.
Legislative Intent to Establish Voluntary Drug
Repository and Distribution Program
150201.
Medication or Medications Defined
150202.
Skilled Nursing Facilities May Donate Unused
Medications
150203.
Drug Wholesalers and Manufacturers May Donate
Unused Medications
150204.
County May Establish Repository and Distribution
Program for Dispensing Donated Drugs
582
150205.
Liability
150206.
No Immunity for Noncompliance or Negligence
150207.
Disciplinary Actions
DIVISION 117. CANCER MEDICATION RECYCLING ACT
Section
150400.
Name of Act
150401.
Definitions
150403.
Requirements for Participating Practitioner
150404.
Division Repeal Date
HEALTH & SAFETY CODE
Division 2. Licensing Provisions
1211. Clinics Sharing Office Space
(a) Notwithstanding any other law, a clinic licensed pursuant to
Section 1204 may operate in shared clinic space with a clinic
exempt from licensure pursuant to subdivision (b) of Section
1206 under the following conditions:
(1) Each clinic uses signage that clearly identifies which clinic is
operating during the hours of operation.
(2) The licensed clinic reports the operating hours of both
clinics.
(3) Each clinic maintains separate medical records.
(4) Each clinic maintains separate drug storage.
(5) Both clinics are licensed by the California State Board of
Pharmacy pursuant to Section 4180.5 of the Business and
Professions Code.
(b) The department may enter and inspect the shared space at
any time pursuant to Section 1227 of the Health and Safety Code,
including accessing records. The exempt clinic shall allow the
department to access and inspect its records.
583
(c) The licensed clinic shall be responsible for any statutory or
regulatory violations occurring on the premises.
(d) Notwithstanding the rulemaking provisions of the
Administrative Procedure Act (Chapter 3.5 (commencing with
Section 11340) of Part 1 of Division 3 of Title 2 of the
Government Code), the department may implement, interpret,
or make specific this section by means of all-facility letters, or
similar instructions, without taking regulatory action.
(e) This section shall become inoperative on January 1, 2021,
and as of that date is repealed.
1261.5. Emergency Supplies; Doses Stored in Emergency
Supplies Container
(a) The number of oral dosage form or suppository form drugs
provided by a pharmacy to a health facility licensed pursuant to
subdivision (c) or (d), or both (c) and (d), of Section 1250 for
storage in a secured emergency supplies container, pursuant to
Section 4119 of the Business and
Professions Code, shall be limited to 48. The State Department of
Public Health may limit the number of doses of each drug
available to not more than 16 doses of any separate drug dosage
form in each emergency supply.
(b) Not more than four of the 48 oral form or suppository form
drugs secured for storage in the emergency supplies container
shall be psychotherapeutic drugs, except that the department
may grant a program flexibility request to the facility to increase
the number of psychotherapeutic drugs in the emergency
supplies container to not more than 10 if the facility can
demonstrate the necessity for an increased number of drugs
based on the needs of the patient population at the facility. In
addition, the four oral form or suppository form
psychotherapeutic drug limit shall not apply to a special
treatment program service unit distinct part, as defined in
Section 1276.9. The department shall limit the number of doses
of psychotherapeutic drugs available to not more than four doses
584
in each emergency supply. Nothing in this section shall alter or
diminish informed consent requirements, including, but not
limited to, the requirements of Section 1418.9.
(c) Any limitations established pursuant to subdivisions (a) and
(b) on the number and quantity of oral dosage or suppository
form drugs provided by a pharmacy to a health facility licensed
pursuant to subdivision (c), (d), or both (c) and (d), of Section
1250 for storage in a secured emergency supplies container shall
not apply to an automated drug delivery system, as defined in
Section 1261.6, when a pharmacist controls access to the drugs.
1261.6. Automated Drug Delivery Systems
(a) (1) For purposes of this section and Section 1261.5, an
“automated drug delivery system” means a mechanical system
that performs operations or activities, other than compounding
or administration, relative to the storage, dispensing, or
distribution of drugs. An automated drug delivery system shall
collect, control, and maintain all transaction information to
accurately track the movement of drugs into and out of the
system for security, accuracy, and accountability.
(2) For purposes of this section, “facility” means a health facility
licensed pursuant to subdivision (c), (d), or (k) of Section 1250
that has an automated drug delivery system provided by a
pharmacy.
(3) For purposes of this section, “pharmacy services” means the
provision of both routine and emergency drugs and biologicals to
meet the needs of the patient, as prescribed by a physician.
(b) Transaction information shall be made readily available in a
written format for review and inspection by individuals
authorized by law. These records shall be maintained in the
facility for a minimum of three years.
(c) Individualized and specific access to automated drug delivery
systems shall be limited to facility and contract personnel
authorized by law to administer drugs.
585
(d) (1) The facility and the pharmacy shall develop and implement
written policies and procedures to ensure safety, accuracy,
accountability, security, patient confidentiality, and maintenance
of the quality, potency, and purity of stored drugs. Policies and
procedures shall define access to the automated drug delivery
system and limits to access to equipment and drugs.
(2) All policies and procedures shall be maintained at the
pharmacy operating the automated drug delivery system and the
location where the automated drug delivery system is being
used.
(e) When used as an emergency pharmaceutical supplies
container, drugs removed from the automated drug delivery
system shall be limited to the following:
(1) A new drug order given by a prescriber for a patient of the
facility for administration prior to the next scheduled delivery
from the pharmacy, or 72 hours, whichever is less. The drugs
shall be retrieved only upon authorization by a pharmacist and
after the pharmacist has reviewed the prescriber’s order and the
patient’s profile for potential contraindications and adverse drug
reactions.
(2) Drugs that a prescriber has ordered for a patient on an as-
needed basis, if the utilization and retrieval of those drugs are
subject to ongoing review by a pharmacist.
(3) Drugs designed by the patient care policy committee or
pharmaceutical service committee of the facility as emergency
drugs or acute onset drugs. These drugs may be retrieved from
an automated drug delivery system pursuant to the order of a
prescriber for emergency or immediate administration to a
patient of the facility. Within 48 hours after retrieval under this
paragraph, the case shall be reviewed by a pharmacist.
(f) When used to provide pharmacy services pursuant to Section
4017.3 of, and Article 25 (commencing with Section 4427) of
Chapter 9 of Division 2 of, the Business and Professions Code, the
automated drug delivery system shall be subject to all of the
following requirements:
586
(1) Drugs removed from the automated drug delivery system for
administration to a patient shall be in properly labeled units of
administration containers or packages.
(2) A pharmacist shall review and approve all orders prior to a
drug being removed from the automated drug delivery system
for administration to a patient. The pharmacist shall review the
prescriber’s order and the patient’s profile for potential
contraindications and adverse drug reactions.
(3) The pharmacy providing services to the facility pursuant to
Article 25 (commencing with Section 4427) of Chapter 9 of
Division 2 of the Business and Professions Code shall control
access to the drugs stored in the automated drug delivery
system.
(4) Access to the automated drug delivery system shall be
controlled and tracked using an identification or password
system or biosensor.
(5) The automated drug delivery system shall make a complete
and accurate record of all transactions that will include all users
accessing the system and all drugs added to, or removed from,
the system.
(6) After the pharmacist reviews the prescriber’s order, access by
licensed personnel to the automated drug delivery system shall
be limited only to drugs ordered by the prescriber and reviewed
by the pharmacist and that are specific to the patient. When the
prescriber’s order requires a dosage variation of the same drug,
licensed personnel shall have access to the drug ordered for that
scheduled time of administration.
(7) (A) Systems that allow licensed personnel to have access to
multiple drugs and are not patient specific in their design, shall
be allowed under this subdivision if those systems have
electronic and mechanical safeguards in place to ensure that the
drugs delivered to the patient are specific to that patient. Each
facility using such an automated drug delivery system shall notify
the department in writing prior to the utilization of the system.
The notification submitted to the department pursuant to this
587
paragraph shall include, but is not limited to, information
regarding system design, personnel with system access, and
policies and procedures covering staff training, storage, and
security, and the facility’s administration of these types of
systems.
(B) As part of its routine oversight of these facilities, the
department shall review a facility’s medication training, storage,
and security, and its administration procedures related to its use
of an automated drug delivery system to ensure that adequate
staff training and safeguards are in place to make sure that the
drugs delivered are appropriate for the patient. If the
department determines that a facility is not in compliance with
this section, the department may revoke its authorization to use
automated drug delivery systems granted under subparagraph
(A).
(g) The stocking of an automated drug delivery system shall be
performed by a pharmacist. If the automated drug delivery
system utilizes removable pockets, cards, drawers, similar
technology, or unit of use or single dose containers as defined by
the United States Pharmacopoeia, the stocking system may be
done outside of the facility and be delivered to the facility if all of
the following conditions are met:
(1) The task of placing drugs into the removable pockets, cards,
drawers, or unit of use or single dose containers is performed by
a pharmacist, or by an intern pharmacist or a pharmacy
technician working under the direct supervision of a pharmacist.
(2) The removable pockets, cards, drawers, or unit of use or
single dose containers are transported between the pharmacy
and the facility in a secure tamper-evident container.
(3) The facility, in conjunction with the pharmacy, has developed
policies and procedures to ensure that the removable pockets,
cards, drawers, or unit of use or single dose containers are
properly placed into the automated drug delivery system.
(h) Review of the drugs contained within, and the operation and
maintenance of, the automated drug delivery system shall be
588
done in accordance with law and shall be the responsibility of the
pharmacy. The review shall be conducted on a monthly basis by a
pharmacist and shall include a physical inspection of the drugs in
the automated drug delivery system, an inspection of the
automated drug delivery system machine for cleanliness, and a
review of all transaction records in order to verify the security
and accountability of the system.
(i) Drugs dispensed from an automated drug delivery system that
meets the requirements of this section shall not be subject to the
labeling requirements of Section 4076 of the Business and
Professions Code or Section 111480 of this code if the drugs to be
placed into the automated drug delivery system are in unit dose
packaging or unit of use and if the information required by
Section 4076 of the Business and Professions Code and Section
111480 of this code is readily available at the time of drug
administration. For purposes of this section, unit dose packaging
includes blister pack cards.
(j) This section shall become operative on July 1, 2019.
1342.74. Health Care Service Plans Coverage of HIV
Preexposure and Postexposure Prophylaxis
(a) (1) Notwithstanding Section 1342.71, a health care service
plan shall not subject antiretroviral drugs that are medically
necessary for the prevention of AIDS/HIV, including preexposure
prophylaxis or postexposure prophylaxis, to prior authorization
or step therapy, except as provided in paragraph (2).
(2) If the United States Food and Drug Administration has
approved one or more therapeutic equivalents of a drug, device,
or product for the prevention of AIDS/HIV, this section does not
require a health care service plan to cover all of the
therapeutically equivalent versions without prior authorization or
step therapy, if at least one therapeutically equivalent version is
covered without prior authorization or step therapy.
(b) Notwithstanding any other law, a health care service plan
shall not prohibit, or permit a delegated pharmacy benefit
589
manager to prohibit, a pharmacy provider from dispensing
preexposure prophylaxis or postexposure prophylaxis.
(c) A health care service plan shall not cover preexposure
prophylaxis that has been furnished by a pharmacist, as
authorized in Section 4052.02 of the Business and Professions
Code, in excess of a 60-day supply to a single patient once every
two years, unless the pharmacist has been directed otherwise by
a prescriber.
(d) This section does not require a health care service plan to
cover preexposure prophylaxis or postexposure prophylaxis by a
pharmacist at an out-of-network pharmacy, unless the health
care service plan has an out-of-network pharmacy benefit.
DIVISION 10. UNIFORM CONTROLLED
SUBSTANCE ACT
CHAPTER 1. GENERAL PROVISIONS AND DEFINITIONS
11000. Designation
This division shall be known as the "California Uniform
Controlled Substances Act."
11001. Definitions Govern Construction
Unless the context otherwise requires, the definitions in this
chapter govern the construction of this division.
11002. Administer Defined
"Administer" means the direct application of a controlled
substance, whether by injection, inhalation, ingestion, or any
other means, to the body of a patient for his immediate needs or
to the body of a research subject by any of the following:
(a) A practitioner or, in his presence, by his authorized agent.
(b) The patient or research subject at the direction and in the
presence of the practitioner.
590
11003. Agent Defined
"Agent" means an authorized person who acts on behalf of or at
the direction of a manufacturer, distributor, or dispenser. It does
not include a common or contract carrier, public warehouseman,
or employee of the carrier or warehouseman.
11004. Attorney General Defined
"Attorney General" means the Attorney General of the State of
California.
11005. Board of Pharmacy Defined
"Board of Pharmacy" means the California State Board of
Pharmacy.
11006.5. Concentrated Cannabis Defined
"Concentrated cannabis" means the separated resin, whether
crude or purified, obtained from marijuana.
11007. Controlled Substance Defined
"Controlled substance," unless otherwise specified, means a
drug, substance, or immediate precursor which is listed in any
schedule in Section 11054, 11055, 11056, 11057, or 11058.
11008. Customs Broker Defined
"Customs broker" means a person in this state who is
authorized to act as a broker for any of the following:
(a) A person in this state who is licensed to sell, distribute, or
otherwise possess any controlled substance.
(b) A person in any other state who ships any controlled
substance into this state.
(c) A person in this state or any other state who ships or
transfers any controlled substance through this state.
591
11010. Dispense Defined
"Dispense" means to deliver a controlled substance to an
ultimate user or research subject by or pursuant to the lawful
order of a practitioner, including the prescribing, furnishing,
packaging, labeling, or compounding necessary to prepare the
substance for that delivery.
11011. Dispenser Defined
"Dispenser" means a practitioner who dispenses.
11012. Distribute Defined
"Distribute" means to deliver other than by administering or
dispensing a controlled substance.
11013. Distributor Defined
"Distributor" means a person who distributes. The term
distributor also includes warehousemen handling or storing
controlled substances and customs brokers.
11014. Drug Defined
"Drug" means (a) substances recognized as drugs in the official
United States Pharmacopoeia, official Homeopathic
Pharmacopoeia of the United States, or official National
Formulary, or any supplement to any of them; (b) substances
intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or animals; (c) substances (other
than food) intended to affect the structure or any function of the
body of man or animals; and (d) substances intended for use as a
component of any article specified in subdivision (a), (b), or (c) of
this section. It does not include devices or their components,
parts, or accessories.
11014.5. Drug Paraphernalia Defined
(a) "Drug paraphernalia" means all equipment, products and
materials of any kind which are designed for use or marketed for
592
use, in planting, propagating, cultivating, growing, harvesting,
manufacturing, compounding, converting, producing, processing,
preparing, testing, analyzing, packaging, repackaging, storing,
containing, concealing, injecting, ingesting, inhaling, or otherwise
introducing into the human body a controlled substance in
violation of this division. It includes, but is not limited to:
(1) Kits designed for use or marketed for use in planting,
propagating, cultivating, growing, or harvesting of any species of
plant which is a controlled substance or from which a controlled
substance can be derived.
(2) Kits designed for use or marketed for use in manufacturing,
compounding, converting, producing, processing, or preparing
controlled substances.
(3) Isomerization devices designed for use or marketed for use
in increasing the potency of any species of plant which is a
controlled substance.
(4) Testing equipment designed for use or marketed for use in
identifying, or in analyzing the strength, effectiveness, or purity
of controlled substances.
(5) Scales and balances designed for use or marketed for use in
weighing or measuring controlled substances.
(6) Containers and other objects designed for use or marketed
for use in storing or concealing controlled substances.
(7) Hypodermic syringes, needles, and other objects designed
for use or marketed for use in parenterally injecting controlled
substances into the human body.
(8) Objects designed for use or marketed for use in ingesting,
inhaling, or otherwise introducing marijuana, cocaine, hashish, or
hashish oil into the human body, such as:
(A) Carburetion tubes and devices.
(B) Smoking and carburetion masks.
(C) Roach clips, meaning objects used to hold burning material,
such as a marijuana cigarette, that has become too small or too
short to be held in the hand.
(D) Miniature cocaine spoons, and cocaine vials.
593
(E) Chamber pipes.
(F) Carburetor pipes.
(G) Electric pipes.
(H) Air-driven pipes.
(I) Chillums.
(J) Bongs.
(K) Ice pipes or chillers.
(b) For the purposes of this section, the phrase "marketed for
use" means advertising, distributing, offering for sale, displaying
for sale, or selling in a manner which promotes the use of
equipment, products, or materials with controlled substances.
(c) In determining whether an object is drug paraphernalia, a
court or other authority may consider, in addition to all other
logically relevant factors, the following:
(1) Statements by an owner or by anyone in control of the
object concerning its use.
(2) Instructions, oral or written, provided with the object
concerning its use for ingesting, inhaling, or otherwise
introducing a controlled substance into the human body.
(3) Descriptive materials accompanying the object which explain
or depict its use.
(4) National and local advertising concerning its use.
(5) The manner in which the object is displayed for sale.
(6) Whether the owner, or anyone in control of the object, is a
legitimate supplier of like or related items to the community,
such as a licensed distributor or dealer of tobacco products.
(7) Expert testimony concerning its use.
(d) If any provision of this section or the application thereof to
any person or circumstance is held invalid, it is the intent of the
Legislature that the invalidity shall not affect other provisions or
applications of the section which can be given effect without the
invalid provision or application and to this end the provisions of
this section are severable.
594
11015. Federal Bureau Defined
"Federal bureau" means the Drug Enforcement Administration
of the United States Department of Justice, or its successor
agency.
11016. Furnish Defined
"Furnish" has the same meaning as provided in Section 4048.5
of the Business and Professions Code.
11017. Manufacturer Defined
"Manufacturer" has the same meaning as provided in Section
4034 of the Business and Professions Code.
11018. Marijuana Defined
"Marijuana" means all parts of the plant Cannabis sativa L.,
whether growing or not; the seeds thereof; the resin extracted
from any part of the plant; and every compound, manufacture,
salt, derivative, mixture, or preparation of the plant, its seeds or
resin. It does not include the mature stalks of the plant, fiber
produced from the stalks, oil or cake made from the seeds of the
plant, any other compound, manufacture, salt, derivative,
mixture, or preparation of the mature stalks (except the resin
extracted therefrom), fiber, oil, or cake, or the sterilized seed of
the plant which is incapable of germination.
(Added by Stats. 1972, Ch. 1407. Superseded on operative date of
amendment by Stats. 2013, Ch. 398.)
11018. Marijuana Defined
“Marijuana” means all parts of the plant Cannabis sativa L.,
whether growing or not; the seeds of that plant; the resin
extracted from any part of the plant; and every compound,
manufacture, salt, derivative, mixture, or preparation of the
plant, its seeds or resin. It does not include industrial hemp, as
defined in Section 11018.5, except where the plant is cultivated
or processed for purposes not expressly allowed for by Division
595
24 (commencing with Section 81000) of the Food and Agricultural
Code.
(Amended by Stats. 2013, Ch. 398, Sec. 5. Effective January 1, 2014.
Conditionally operative as prescribed by Sec. 8 of Ch. 398.)
11018.5. Industrial Hemp Defined
“Industrial hemp” means a crop that is limited to
nonpsychoactive types of the plant Cannabis sativa L. and the
seed produced therefrom, having no more than three-tenths of 1
percent tetrahydrocannabinol (THC) contained in the dried
flowering tops, and that is cultivated and processed exclusively
for the purpose of producing the mature stalks of the plant, fiber
produced from the stalks, oil or cake made from the seeds of the
plant, or any other compound, manufacture, salt, derivative,
mixture, or preparation of the mature stalks, except the resin or
flowering tops extracted therefrom, fiber, oil, or cake, or the
sterilized seed, or any component of the seed, of the plant that is
incapable of germination.
(Added by Stats. 2013, Ch. 398, Sec. 6. Effective January 1, 2014.
Conditionally operative as prescribed by Sec. 8 of Ch. 398.)
11019. Narcotic Drug Defined
"Narcotic drug" means any of the following, whether produced
directly or indirectly by extraction from substances of vegetable
origin, or independently by means of chemical synthesis, or by a
combination of extraction and chemical synthesis:
(a) Opium and opiate, and any salt, compound, derivative, or
preparation of opium or opiate.
(b) Any salt, compound, isomer, or derivative, whether natural
or synthetic, of the substances referred to in subdivision (a), but
not including the isoquinoline alkaloids of opium.
(c) Opium poppy and poppy straw.
(d) Coca leaves and any salt, compound, derivative, or
preparation of coca leaves, but not including decocainized coca
596
leaves or extractions of coca leaves which do not contain cocaine
or ecgonine.
(e) Cocaine, whether natural or synthetic, or any salt, isomer,
derivative, or preparation thereof.
(f) Ecgonine, whether natural or synthetic, or any salt, isomer,
derivative, or preparation thereof.
(g) Acetylfentanyl, the thiophene analog thereof, derivatives of
either, and any salt, compound, isomer, or preparation of
acetylfentanyl or the thiophene analog thereof.
11020. Opiate Defined
"Opiate" means any substance having an addiction-forming or
addiction-sustaining liability similar to morphine or being capable
of conversion into a drug having addiction-forming or addiction-
sustaining liability. It does not include, unless specifically
designated as controlled under Chapter 2 (commencing with
Section 11053) of this division, the dextrorotatory isomer of 3-
methoxy-n-methylmorphinan and its salts (dextromethorphan). It
does include its racemic and levorotatory forms.
11021. Opium Poppy Defined
"Opium poppy" means the plant of the species Papaver
somniferum L., except its seeds.
11022. Person Defined
"Person" means individual, corporation, government or
governmental subdivision or agency, business trust, estate, trust,
partnership, limited liability company, or association, or any
other legal entity.
11023. Pharmacy Defined
"Pharmacy" has the same meaning as provided in Section 4035
of the Business and Professions Code.
597
11024. Physician, Dentist, Podiatrist, Pharmacist, and
Veterinarian Defined
"Physician," "dentist," "podiatrist," "pharmacist," "veterinarian,"
and "optometrist" means persons who are licensed to practice
their respective professions in this state.
11025. Poppy Straw Defined
"Poppy straw" means all parts, except the seeds, of the opium
poppy, after mowing.
11026. Practitioner Defined
"Practitioner" means any of the following:
(a) A physician, dentist, veterinarian, podiatrist, 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, 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, or 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, or an optometrist acting within
the scope of Section 3041 of the Business and Professions Code.
(b) A pharmacy, hospital, or other institution licensed,
registered, or otherwise permitted to distribute, dispense,
conduct research with respect to, or to administer, a controlled
substance in the course of professional practice or research in
this state.
(c) A scientific investigator, or other person licensed, registered,
or otherwise permitted, to distribute, dispense, conduct research
with respect to, or administer, a controlled substance in the
course of professional practice or research in this state.
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11027. Prescription Defined
(a) "Prescription" means an oral order or electronic transmission
prescription for a controlled substance given individually for the
person(s) for whom prescribed, directly from the prescriber to
the furnisher or indirectly by means of a written order of the
prescriber.
(b) "Electronic transmission prescription" includes both image
and data prescriptions. "Electronic image transmission
prescription" is any prescription order for which a facsimile of the
order is received by a pharmacy from a licensed prescriber.
"Electronic data transmission prescription" is any prescription
order, other than an electronic image transmission prescription,
which is electronically transmitted from a licensed prescriber to a
pharmacy.
11029. Production Defined
"Production" includes the manufacture, planting, cultivation,
growing, or harvesting of a controlled substance.
11029.5. Security Printer Defined
"Security printer" means a person approved to produce
controlled substance prescription forms pursuant to Section
11161.5.
11030. Ultimate User Defined
"Ultimate user" means a person who lawfully possesses a
controlled substance for his own use or for the use of a member
of his household or for administering to an animal owned by him
or by a member of his household.
11031. Wholesaler Defined
"Wholesaler" has the same meaning as provided in Section 4038
of the Business and Professions Code.
599

 

 

 

 

 

 

 

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