SECTIONS 4070-4078 - California Statutes

BUSINESS AND PROFESSIONS CODE

SECTION 4070-4078

4070. (a) Except as provided in Section 4019 and subdivision (b),
an oral or an electronic data transmission prescription as defined in
subdivision (c) of Section 4040 shall as soon as practicable be
reduced to writing by the pharmacist and shall be filled by, or under
the direction of, the pharmacist. The pharmacist need not reduce to
writing the address, telephone number, license classification,
federal registry number of the prescriber or the address of the
patient or patients if the information is readily retrievable in the
pharmacy.
(b) A pharmacy receiving an electronic transmission prescription
shall not be required to reduce that prescription to writing or to
hard copy form if, for three years from the last date of furnishing
pursuant to that prescription or order, the pharmacy is able, upon
request by the board, to immediately produce a hard copy report that
includes for each date of dispensing of a dangerous drug or dangerous
device pursuant to that prescription or order: (1) all of the
information described in subparagraphs (A) to (E), inclusive, of
paragraph (1) of subdivision (a) of Section 4040, and (2) the name or
identifier of the pharmacist who dispensed the dangerous drug or
dangerous device. This subdivision shall not apply to prescriptions
for controlled substances classified in Schedule II, III, IV, or V,
except as permitted pursuant to Section 11164.5 of the Health and
Safety Code.
(c) If only recorded and stored electronically, on magnetic media,
or in any other computerized form, the pharmacy's computer system
shall not permit the received information or the dangerous drug or
dangerous device 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 and once the dangerous drug or dangerous
device has been dispensed. Once a dangerous drug or dangerous device
has been dispensed, if the previously created record is determined to
be incorrect, a correcting addition may be made only by or with the
approval of a pharmacist. After a pharmacist enters the change or
enters his or her approval of the change into the computer, the
resulting record shall include the correcting addition and the date
it was made to the record, the identity of the person or pharmacist
making the correction, and the identity of the pharmacist approving
the correction.
(d) Nothing in this section shall impair the requirement to have
an electronically transmitted prescription transmitted only to the
pharmacy of the patient's choice or to have a written prescription.
This requirement shall not apply to orders for medications to be
administered in an acute care hospital.

4071. Notwithstanding any other provision of law, a prescriber may
authorize his or her agent on his or her behalf to orally or
electronically transmit a prescription to the furnisher. The
furnisher shall make a reasonable effort to determine that the person
who transmits the prescription is authorized to do so and shall
record the name of the authorized agent of the prescriber who
transmits the order.
This section shall not apply to orders for Schedule II controlled
substances.

4071.1. (a) A prescriber, a prescriber's authorized agent, or a
pharmacist may electronically enter a prescription or an order, as
defined in Section 4019, into a pharmacy's or hospital's computer
from any location outside of the pharmacy or hospital with the
permission of the pharmacy or hospital. For purposes of this section,
a "prescriber's authorized agent" is a person licensed or registered
under Division 2 (commencing with Section 500). This subdivision
shall not apply to prescriptions for controlled substances classified
in Schedule II, III, IV, or V, except as permitted pursuant to
Section 11164.5 of the Health and Safety Code.
(b) Nothing in this section shall reduce the existing authority of
other hospital personnel to enter medication orders or prescription
orders into a hospital's computer.
(c) No dangerous drug or dangerous device shall be dispensed
pursuant to a prescription that has been electronically entered into
a pharmacy's computer without the prior approval of a pharmacist.

4072. (a) Notwithstanding any other provision of law, a pharmacist,
registered nurse, licensed vocational nurse, licensed psychiatric
technician, or other healing arts licentiate, if so authorized by
administrative regulation, who is employed by or serves as a
consultant for a licensed skilled nursing, intermediate care, or
other health care facility, may orally or electronically transmit to
the furnisher a prescription lawfully ordered by a person authorized
to prescribe drugs or devices pursuant to Sections 4040 and 4070. The
furnisher shall take appropriate steps to determine that the person
who transmits the prescription is authorized to do so and shall
record the name of the person who transmits the order. This section
shall not apply to orders for Schedule II controlled substances.
(b) In enacting this section, the Legislature recognizes and
affirms the role of the State Department of Public Health in
regulating drug order processing requirements for licensed health
care facilities as set forth in Title 22 of the California Code of
Regulations as they may be amended from time to time.

4073. (a) A pharmacist filling a prescription order for a drug
product prescribed by its trade or brand name may select another drug
product with the same active chemical ingredients of the same
strength, quantity, and dosage form, and of the same generic drug
name as determined by the United States Adopted Names (USAN) and
accepted by the federal Food and Drug Administration (FDA), of those
drug products having the same active chemical ingredients.
(b) In no case shall a selection be made pursuant to this section
if the prescriber personally indicates, either orally or in his or
her own handwriting, "Do not substitute," or words of similar
meaning. Nothing in this subdivision shall prohibit a prescriber from
checking a box on a prescription marked "Do not substitute";
provided that the prescriber personally initials the box or
checkmark. To indicate that a selection shall not be made pursuant to
this section for an electronic data transmission prescription as
defined in subdivision (c) of Section 4040, a prescriber may indicate
"Do not substitute," or words of similar meaning, in the
prescription as transmitted by electronic data, or may check a box
marked on the prescription "Do not substitute." In either instance,
it shall not be required that the prohibition on substitution be
manually initialed by the prescriber.
(c) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (b). The person
who selects the drug product to be dispensed pursuant to this section
shall assume the same responsibility for selecting the dispensed
drug product as would be incurred in filling a prescription for a
drug product prescribed by generic name. There shall be no liability
on the prescriber for an act or omission by a pharmacist in
selecting, preparing, or dispensing a drug product pursuant to this
section. In no case shall the pharmacist select a drug product
pursuant to this section unless the drug product selected costs the
patient less than the prescribed drug product. Cost, as used in this
subdivision, is defined to include any professional fee that may be
charged by the pharmacist.
(d) This section shall apply to all prescriptions, including those
presented by or on behalf of persons receiving assistance from the
federal government or pursuant to the California Medical Assistance
Program set forth in Chapter 7 (commencing with Section 14000) of
Part 3 of Division 9 of the Welfare and Institutions Code.
(e) When a substitution is made pursuant to this section, the use
of the cost-saving drug product dispensed shall be communicated to
the patient and the name of the dispensed drug product shall be
indicated on the prescription label, except where the prescriber
orders otherwise.

4074. (a) A pharmacist shall inform a patient orally or in writing
of the harmful effects of a drug dispensed by prescription if the
drug poses substantial risk to the person consuming the drug when
taken in combination with alcohol or if the drug may impair a person'
s ability to drive a motor vehicle, whichever is applicable, and
provided the drug is determined by the board pursuant to subdivision
(b) to be a drug or drug type for which this warning shall be given.
(b) The board may by regulation require additional information or
labeling.
(c) This section shall not apply to drugs furnished to patients in
conjunction with treatment or emergency services provided in health
facilities or, except as provided in subdivision (d), to drugs
furnished to patients pursuant to subdivision (a) of Section 4056.
(d) A health facility shall establish and implement a written
policy to ensure that each patient shall receive information
regarding each medication given at the time of discharge and each
medication given pursuant to subdivision (a) of Section 4056. This
information shall include the use and storage of each medication, the
precautions and relevant warnings, and the importance of compliance
with directions. This information shall be given by a pharmacist or
registered nurse, unless already provided by a patient's prescriber,
and the written policy shall be developed in collaboration with a
physician, a pharmacist, and a registered nurse. The written policy
shall be approved by the medical staff. Nothing in this subdivision
or any other provision of law shall be construed to require that only
a pharmacist provide this consultation.

4075. No prescription for a controlled substance transmitted by
means of an oral or electronically transmitted order shall be
furnished to any person unknown and unable to properly establish his
or her identity. The board may by regulation establish procedures to
prevent unauthorized persons from receiving prescription drugs
furnished to a patient or a representative of the patient.

4076. (a) A pharmacist shall not dispense any prescription except
in a container that meets the requirements of state and federal law
and is correctly labeled with all of the following:
(1) Except where the prescriber or the certified nurse-midwife who
functions pursuant to a standardized procedure or protocol described
in Section 2746.51, the nurse practitioner who functions pursuant to
a standardized procedure described in Section 2836.1 or protocol,
the physician assistant who functions pursuant to Section 3502.1, the
naturopathic doctor who functions pursuant to a standardized
procedure or protocol described in Section 3640.5, or the pharmacist
who functions pursuant to a policy, procedure, or protocol pursuant
to either Section 4052.1 or 4052.2 orders otherwise, either the
manufacturer's trade name of the drug or the generic name and the
name of the manufacturer. Commonly used abbreviations may be used.
Preparations containing two or more active ingredients may be
identified by the manufacturer's trade name or the commonly used name
or the principal active ingredients.
(2) The directions for the use of the drug.
(3) The name of the patient or patients.
(4) The name of the prescriber or, if applicable, the name of the
certified nurse-midwife who functions pursuant to a standardized
procedure or protocol described in Section 2746.51, the nurse
practitioner who functions pursuant to a standardized procedure
described in Section 2836.1 or protocol, the physician assistant who
functions pursuant to Section 3502.1, the naturopathic doctor who
functions pursuant to a standardized procedure or protocol described
in Section 3640.5, or the pharmacist who functions pursuant to a
policy, procedure, or protocol pursuant to either Section 4052.1 or
4052.2.
(5) The date of issue.
(6) The name and address of the pharmacy, and prescription number
or other means of identifying the prescription.
(7) The strength of the drug or drugs dispensed.
(8) The quantity of the drug or drugs dispensed.
(9) The expiration date of the effectiveness of the drug
dispensed.
(10) The condition or purpose for which the drug was prescribed if
the condition or purpose is indicated on the prescription.
(11) (A) Commencing January 1, 2006, the physical description of
the dispensed medication, including its color, shape, and any
identification code that appears on the tablets or capsules, except
as follows:
(i) Prescriptions dispensed by a veterinarian.
(ii) An exemption from the requirements of this paragraph shall be
granted to a new drug for the first 120 days that the drug is on the
market and for the 90 days during which the national reference file
has no description on file.
(iii) Dispensed medications for which no physical description
exists in any commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
(C) The information required by this paragraph may be printed on
an auxiliary label that is affixed to the prescription container.
(D) This paragraph shall not become operative if the board, prior
to January 1, 2006, adopts regulations that mandate the same labeling
requirements set forth in this paragraph.
(b) If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation, for
a patient in a skilled nursing, intermediate care, or other health
care facility, the requirements of this section will be satisfied if
the unit dose medication system contains the aforementioned
information or the information is otherwise readily available at the
time of drug administration.
(c) If a pharmacist dispenses a dangerous drug or device in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include on individual unit dose
containers for a specific patient, the name of the certified
nurse-midwife who functions pursuant to a standardized procedure or
protocol described in Section 2746.51, the nurse practitioner who
functions pursuant to a standardized procedure described in Section
2836.1 or protocol, the physician assistant who functions pursuant to
Section 3502.1, the naturopathic doctor who functions pursuant to a
standardized procedure or protocol described in Section 3640.5, or
the pharmacist who functions pursuant to a policy, procedure, or
protocol pursuant to either Section 4052.1 or 4052.2.
(d) If a pharmacist dispenses a prescription drug for use in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include the information required in
paragraph (11) of subdivision (a) when the prescription drug is
administered to a patient by a person licensed under the Medical
Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing
Practice Act (Chapter 6 (commencing with Section 2700)), or the
Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section
2840)), who is acting within his or her scope of practice.

4076.5. (a) The board shall promulgate regulations that require, on
or before January 1, 2011, a standardized, patient-centered,
prescription drug label on all prescription medicine dispensed to
patients in California.
(b) To ensure maximum public comment, the board shall hold public
meetings statewide that are separate from its normally scheduled
hearings in order to seek information from groups representing
consumers, seniors, pharmacists or the practice of pharmacy, other
health care professionals, and other interested parties.
(c) When developing the requirements for prescription drug labels,
the board shall consider all of the following factors:
(1) Medical literacy research that points to increased
understandability of labels.
(2) Improved directions for use.
(3) Improved font types and sizes.
(4) Placement of information that is patient-centered.
(5) The needs of patients with limited English proficiency.
(6) The needs of senior citizens.
(7) Technology requirements necessary to implement the standards.
(d) The board may exempt from the requirements of regulations
promulgated pursuant to subdivision (a) prescriptions dispensed to a
patient in a health facility, as defined in Section 1250 of the
Health and Safety Code, if the prescriptions are administered by a
licensed health care professional. Prescriptions dispensed to a
patient in a health facility that will not be administered by a
licensed health care professional or that are provided to the patient
upon discharge from the facility shall be subject to the
requirements of this section and the regulations promulgated pursuant
to subdivision (a). Nothing in this subdivision shall alter or
diminish existing statutory and regulatory informed consent, patients'
rights, or pharmaceutical labeling and storage requirements,
including, but not limited to, the requirements of Section 1418.9 of
the Health and Safety Code or Section 72357, 72527, or 72528 of Title
22 of the California Code of Regulations.
(e) (1) The board may exempt from the requirements of regulations
promulgated pursuant to subdivision (a) a prescription dispensed to a
patient if all of the following apply:
(A) The drugs are dispensed by a JCAHO-accredited home infusion or
specialty pharmacy.
(B) The patient receives health-professional-directed education
prior to the beginning of therapy by a nurse or pharmacist.
(C) The patient receives weekly or more frequent followup contacts
by a nurse or pharmacist.
(D) Care is provided under a formal plan of care based upon a
physician and surgeon's orders.
(2) For purposes of paragraph (1), home infusion and specialty
therapies include parenteral therapy or other forms of administration
that require regular laboratory and patient monitoring.
(f) (1) On or before January 1, 2010, the board shall report to
the Legislature on its progress under this section as of the time of
the report.
(2) On or before January 1, 2013, the board shall report to the
Legislature the status of implementation of the prescription drug
label requirements adopted pursuant to this section.

4077. (a) Except as provided in subdivisions (b) and (c), no person
shall dispense any dangerous drug upon prescription except in a
container correctly labeled with the information required by Section
4076.
(b) Physicians, dentists, podiatrists, and veterinarians may
personally furnish any dangerous drug prescribed by them to the
patient for whom prescribed, provided that the drug is properly
labeled to show all information required in Section 4076 except the
prescription number.
(c) Devices that bear the legend "Caution: federal law restricts
this device to sale by or on the order of a _____," or words of
similar meaning, are exempt from the requirements of Section 4076,
and Section 111480 of the Health and Safety Code, when provided to
patients in skilled nursing facilities or intermediate care
facilities licensed pursuant to Chapter 2 (commencing with Section
1250) of Division 2 of the Health and Safety Code.
(d) The following notification shall be affixed to all quantities
of dimethyl sulfoxide (DMSO) prescribed by a physician, or dispensed
by a pharmacy pursuant to the order of a physician in California:
"Warning: DMSO may be hazardous to your health. Follow the directions
of the physician who prescribed the DMSO for you."
(e) The label of any retail package of DMSO shall include
appropriate precautionary measures for proper handling and first aid
treatment and a warning statement to keep the product out of reach of
children.

4078. (a) (1) No person shall place a false or misleading label on
a prescription.
(2) No prescriber shall direct that a prescription be labeled with
any information that is false or misleading.
(b) Notwithstanding subdivision (a), a person may label a
prescription, or a prescriber may direct that a prescription be
labeled, with information about the drug that is false under either
of the following circumstances:
(1) If the labeling is a necessary part of a clinical or
investigational drug program approved by the federal Food and Drug
Administration or a legitimate investigational drug project involving
a drug previously approved by the federal Food and Drug
Administration.
(2) If, in the medical judgment of the prescriber, the labeling is
appropriate for the proper treatment of the patient.
(c) The furnisher of a prescription labeled pursuant to
subdivision (b) shall make, and retain for three years from the date
of making, a record stating the manner in which the information on
the prescription label varies from the actual drug in the container
and documenting the order of the prescriber to so label the
container. The prescriber shall make, and retain for at least three
years, a record of his or her order to so label the container.