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(6) The originating pharmacy is responsible for compliance with
the requirements set forth in Section 1707.1, 1707.2 and 1707.3
of the California Code of Regulations.
(b) Nothing in this section shall be construed as barring a
pharmacy from also filling new prescriptions presented by a
patient or a patient's agent or transmitted to it by a prescriber.
Authority cited: Section 4005, Business & Professions Code.
Reference: Sections 4063, 4076, 4081 and 4333, Business &
Professions Code.
1707.5. Patient-Centered Labels for Prescription Drug
Containers; Requirements
(a) Labels on drug containers dispensed to patients in California
shall conform to the following format:
(1) Each of the following items, and only these four items, shall
be clustered into one area of the label that comprises at least 50
percent of the label. Each item shall be printed in at least a 12-
point sans serif typeface, and listed in the following order:
(A) Name of the patient
(B) Name of the drug and strength of the drug. For the purposes
of this section, “name of the drug” means either the
manufacturer's trade name of the drug, or the generic name and
the statement “generic for _____” where the brand name is
inserted, and the name of the manufacturer. In the professional
judgment of the pharmacist,
(i) If the brand name is no longer widely used, the label may list
only the generic name of the drug, and
(ii) The manufacturer’s name may be listed outside of the
patient-centered area.
(C) The directions for the use of the drug.
(D) The condition or purpose for which the drug was prescribed
if the condition or purpose is indicated on the prescription.
(2) For added emphasis, the label shall also highlight in bold
typeface or color, or use blank space to set off the items listed in
subdivision (a)(1).
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(3) The remaining required elements for the label specified in
section 4076 of the Business and Professions Code, as well as any
other items of information appearing on the label or the
container, shall be printed so as not to interfere with the
legibility or emphasis of the primary elements specified in
paragraph (1) of subdivision (a). These additional elements may
appear in any style, font, and size typeface.
(4) When applicable, directions for use shall use one of the
following phrases:
(A) Take 1 [insert appropriate dosage form] at bedtime
(B) Take 2 [insert appropriate dosage form] at bedtime
(C) Take 3 [insert appropriate dosage form] at bedtime
(D) Take 1 [insert appropriate dosage form] in the morning
(E) Take 2 [insert appropriate dosage form] in the morning
(F) Take 3 [insert appropriate dosage form] in the morning
(G) Take 1 [insert appropriate dosage form] in the morning, and
Take 1 [insert appropriate dosage form] at bedtime
(H) Take 2 [insert appropriate dosage form] in the morning, and
Take 2 [insert appropriate dosage form] at bedtime
(I) Take 3 [insert appropriate dosage form] in the morning, and
Take 3 [insert appropriate dosage form] at bedtime
(J) Take 1 [insert appropriate dosage form] in the morning, 1
[insert appropriate dosage form] at noon, and l [insert
appropriate dosage form] in the evening
(K) Take 2 [insert appropriate dosage form] in the morning, 2
[insert appropriate dosage form] at noon, and 2 [insert
appropriate dosage form] in the evening
(L) Take 3 [insert appropriate dosage form] in the morning, 3
[insert appropriate dosage form] at noon, and 3 [insert
appropriate dosage form] in the evening
(M) Take 1 [insert appropriate dosage form] in the morning, 1
[insert appropriate dosage form] at noon, 1 [insert appropriate
dosage form] in the evening, and 1 [insert appropriate dosage
form] at bedtime
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(N) Take 2 [insert appropriate dosage form] in the morning, 2
[insert appropriate dosage form] at noon, 2 [insert appropriate
dosage form] in the evening, and 2 [insert appropriate dosage
form] at bedtime
(O) Take 3 [insert appropriate dosage form] in the morning, 3
[insert appropriate dosage form] at noon, 3 [insert appropriate
dosage form] in the evening, and 3 [insert appropriate dosage
form] at bedtime
(P) If you have pain, take __ [insert appropriate dosage form] at
a time. Wait at least __ hours before taking again. Do not take
more than __ [appropriate dosage form] in one day
(b) By October 2011, and updated as necessary, the board shall
publish on its Web site translation of the directions for use listed
in subdivision (a)(4) into at least five languages other than
English, to facilitate the use thereof by California pharmacies.
(c) The board shall collect and publish on its Web site examples
of labels conforming to these requirements, to aid pharmacies in
label design and compliance.
(d) The pharmacy shall have policies and procedures in place to
help patients with limited or no English proficiency understand
the information on the label as specified in subdivision (a) in the
patient's language. The pharmacy's policies and procedures shall
be specified in writing and shall include, at minimum, the
selected means to identify the patient's language and to provide
interpretive services and translation services in the patient's
language. The pharmacy shall, at minimum, provide interpretive
services in the patient's language, if interpretive services in such
language are available, during all hours that the pharmacy is
open, either in person by pharmacy staff or by use of a third-
party interpretive service available by telephone at or adjacent to
the pharmacy counter.
(e) As used in this section, “appropriate dosage form” includes
pill, caplet, capsule or tablet.
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Authority cited: Sections 4005 and 4076.5, Business and
Professions Code. Reference: Sections 4005, 4076, and 4076.5,
Business and Professions Code.
1707.6. Notice to Consumers
(a) In every pharmacy there shall be prominently posted, in a
place conspicuous to and readable by a prescription drug
consumer, a notice containing the text in subdivision (b). Each
pharmacy shall use the standardized poster-sized notice provided
or made available by the board, unless the pharmacy has
received prior approval of another format or display
methodology from the board. The board may delegate authority
to a committee or to the Executive Officer to give the approval.
As an alternative to a printed notice, the pharmacy may also or
instead display the notice on a video screen located in a place
conspicuous to and readable by prescription drug consumers, so
long as: (1) The video screen is at least 24 inches, measured
diagonally; (2) The pharmacy utilizes the video image notice
provided by the board; (3) The text of the notice remains on the
screen for a minimum of 60 seconds; and (4) No more than five
minutes elapses between displays of any notice on the screen, as
measured between the time that a one-screen notice or the final
screen of a multi-screen notice ceases to display and the time
that the first or only page of that notice re-displays. The
pharmacy may seek approval of another format or display
methodology from the board. The board may delegate authority
to a committee or to the Executive Officer to give the approval.
(b) The notice shall contain the following text:
NOTICE TO CONSUMERS
California law requires a pharmacist to speak with you every
time you get a new prescription.
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You have the right to ask for and receive from any pharmacy
prescription drug labels in 12-point font.
Interpreter services are available to you upon request at no
cost.
Before taking your medicine, be sure you know: the name of
the medicine and what it does; how and when to take it, for
how long, and what to do if you miss a dose; possible side
effects and what you should do if they occur; whether the
new medicine will work safely with other medicines or
supplements; and what foods, drinks, or activities should be
avoided while taking the medicine. Ask the pharmacist if you
have any questions.
This pharmacy must provide any medicine or device legally
prescribed for you, unless it is not covered by your insurance;
you are unable to pay the cost of a copayment; or the
pharmacist determines doing so would be against the law or
potentially harmful to health. If a medicine or device is not
immediately available, the pharmacy will work with you to
help you get your medicine or device in a timely manner.
You may ask this pharmacy for information on drug pricing
and use of generic drugs.
(c) Every pharmacy, in a place conspicuous to and readable
by a prescription drug consumer, at or adjacent to each
counter in the pharmacy where dangerous drugs are
dispensed or furnished, shall post or provide a notice
containing the following text:
Point to your language. Interpreter services will be provided
to you upon request at no cost.
This text shall be repeated in at least the following languages:
Arabic, Armenian, Cambodian, Cantonese, Farsi, Hmong, Korean,
Mandarin, Russian, Spanish, Tagalog, and Vietnamese.
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Each pharmacy shall use the standardized notice provided or
made available by the board, unless the pharmacy has received
prior approval of another format or display methodology from
the board. The board may delegate authority to a committee or
to the Executive Officer to give the approval.
The pharmacy may post this notice in paper form or on a video
screen if the posted notice or video screen is positioned so that a
consumer can easily point to and touch the statement identifying
the language in which he or she requests assistance. Otherwise,
the notice shall be made available on a flyer or handout clearly
visible from and kept within easy reach of each counter in the
pharmacy where dangerous drugs are dispensed or furnished,
available at all hours that the pharmacy is open. The flyer or
handout shall be at least 8 1/2 inches by 11 inches.
Note: Authority cited: Sections 4005 and 4122, Business and
Professions Code. Reference: Sections 733, 4005, 4076.5 and
4122, Business and Professions Code.
1708.2. Discontinuance of Business.
Any permit holder shall contact the board prior to transferring
or selling any dangerous drugs, devices or hypodermics inventory
as a result of termination of business or bankruptcy proceedings
and shall follow official instructions given by the board applicable
to the transaction.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4080, 4081, 4322 and 4333, Business and
Professions Code; and 11205, Health and Safety Code.
1708.3. Radioactive Drugs.
A radioactive drug is any substance defined as a drug in Section
201(g)(1) of the Federal Food, Drug and Cosmetic Act or a
radioactive biological product as defined in 21 CFR 600.3(ee)
which exhibits spontaneous disintegration of unstable nuclei with
the emission of nuclear particles or photons and includes any
such drug or biological product which is intended to be made
405
radioactive. This definition includes non-radioactive reagent kits
and nuclide generators which are intended to be used in the
preparation of any such substance but does not include drugs
such as carbon-containing compounds, potassium-containing
compounds or potassium-containing salts which contain trace
quantities of naturally occurring radionuclides.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4025, Business and Professions Code.
1708.4. Pharmacist Handling Radioactive Drugs.
A pharmacist handling radioactive drugs must be competent in
the preparation, handling, storage, receiving, dispensing,
disposition and pharmacology of radioactive drugs. He must have
completed a nuclear pharmacy course and/or acquired
experience in programs approved by the Board. Education and
experience in non-approved programs may be granted partial or
equivalent credit, if, in the opinion of the Board, such programs
provide the level of competence as approved programs or the
Nuclear Pharmacy Competency Statement adopted by the Board.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4021, 4022, 4025, 4036 and 4037, Business
and Professions Code
1708.5. Pharmacy Furnishing Radioactive Drugs.
A pharmacy furnishing radioactive drugs is any area, place or
premises described in a permit issued by the board where
radioactive drugs are stored, processed, compounded,
repackaged, or dispensed. A pharmacy exclusively furnishing
radioactive drugs shall be exempt from the patient consultation
area requirements of Title 16 Cal. Code of Regulations Section
1714(a) unless the Board finds that the public health and safety
require their application.
A pharmacist qualified under Section 1708.4 to furnish
radioactive drugs shall be in the pharmacy whenever the
furnishing of radioactive drugs occurs. All personnel involved in
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the furnishing of radioactive drugs shall be under the immediate
and direct supervision of such a qualified pharmacist.
Authority cited: Sections 4005, 4008 and 4008.2, Business and
Professions Code. Reference: Sections 4005, 4008 and 4008.2,
Business and Professions Code.
1709. Names of Owners and Pharmacist in Charge.
(a) Each permit to operate a pharmacy shall show the name and
address of the pharmacy, the form of ownership (individual,
partnership or corporation) and the pharmacist-in-charge. Each
pharmacy shall, in its initial application on the annual renewal
form, report the name of the pharmacist-in-charge, the names of
all owners and the names of the corporate officers (if a
corporation). Any changes in the pharmacist-in-charge, or the
owners, or corporate officers shall be reported to the Board
within 30 days.
(b) Any transfer, in a single transaction or in a series of
transactions, of 10 percent or more of the beneficial interest in a
business entity licensed by the board to a person or entity who
did not hold a beneficial interest at the time the original permit
was issued, shall require written notification to the board within
30 days.
(c) The following shall constitute a transfer of permit and
require application for a change of ownership: any transfer of a
beneficial interest in a business entity licensed by the board, in a
single transaction or in a series of transactions, to any person or
entity, which transfer results in the transferee's holding 50% or
more of the beneficial interest in that license.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4058, 4101, 4111, 4112, 4113, 4120, 4124,
4130, 4133, 4141, 4149, 4160, 4161, 4196, 4201, 4304, 4305 and
4330, Business and Professions Code
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1709.1. Designation of Pharmacist in Charge.
(a) The pharmacist-in-charge of a pharmacy shall be employed
at that location and shall have responsibility for the daily
operation of the pharmacy.
(b) The pharmacy owner shall vest the pharmacist-in-charge
with adequate authority to assure compliance with the laws
governing the operation of a pharmacy.
(c) No pharmacist shall be the pharmacist-in-charge of more
than two pharmacies. If a pharmacist serves as pharmacist-in-
charge at two pharmacies, those pharmacies shall not be
separated by a driving distance of more than 50 miles.
(d) No pharmacist shall be the pharmacist-in-charge of a
pharmacy while concurrently serving as the designated
representative-in-charge for a wholesaler or a veterinary food-
animal drug retailer.
(e) Notwithstanding subdivision (a), a pharmacy may designate
any pharmacist who is an employee, officer or administrator of
the pharmacy or the entity which owns the pharmacy and who is
actively involved in the management of the pharmacy on a daily
basis as the pharmacist-in-charge for a period not to exceed 120
days. The pharmacy, or the entity which owns the pharmacy,
shall be prepared during normal business hours to provide a
representative of the board with documentation of the
involvement of a pharmacist-in-charge designated pursuant to
this subdivision with the pharmacy and efforts to obtain and
designate a permanent pharmacist-in-charge.
(f) A pharmacist may refuse to act as a pharmacist-in-charge at a
second pharmacy if the pharmacist determines, in the exercise of
his or her professional judgment, that assuming responsibility for
a second pharmacy would interfere with the effective
performance of the pharmacist's responsibilities under the
Pharmacy Law. A pharmacist who refuses to become pharmacist-
in-charge at a second pharmacy shall notify the pharmacy owner
in writing of his or her determination, specifying the
circumstances of concern that have led to that determination.
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(g) A person employing a pharmacist may not 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: Section 4005, Business and Professions Code.
Reference: Sections 4081, 4113, 4305 and 4330, Business and
Professions Code.
1710. Hospital Pharmacy.
(a) A hospital pharmacy which predominantly furnishes drugs to
inpatients of that hospital may furnish drugs to outpatients or
employees of that hospital or to walk-in customers, provided that
sales to walk-in customers do not exceed one (1) percent of all
the pharmacy's prescriptions.
(b) A hospital pharmacy may process an order for filling patient
cassettes by another pharmacy within this state, provided:
(1) The pharmacy that is to fill the cassettes either has a
contract with the ordering hospital pharmacy or has the same
owner as the ordering inpatient hospital pharmacy,
(2) The filled cassette is delivered directly from the filling
pharmacy to the ordering hospital pharmacy,
(3) Each cassette or container meets the requirements of
Business and Professions Code section 4076,
(4) Both pharmacies are responsible for ensuring that the order
has been properly filled.
(5) Both pharmacies shall maintain complete and accurate
records of each cassette fill transaction, including the name of
the pharmacist checking the cassettes at each pharmacy.
(6) Prescription information shall be electronically transferred
between the two pharmacies.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4005, 4029, 4076 and 4380, Business and
Professions Code.
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1711. Quality Assurance Programs.
(a) Each pharmacy shall establish or participate in an established
quality assurance program that documents and assesses
medication errors to determine cause and an appropriate
response as part of a mission to improve the quality of pharmacy
service and prevent errors.
(b) For purposes of this section, “medication error” means any
variation from a prescription or drug order not authorized by the
prescriber, as described in Section 1716. Medication error, as
defined in the section, does not include any variation that is
corrected prior to furnishing the drug to the patient or patient's
agent or any variation allowed by law.
(c) (1) Each quality assurance program shall be managed in
accordance with written policies and procedures maintained in
the pharmacy in an immediately retrievable form.
(2) When a pharmacist determines that a medication error has
occurred, a pharmacist shall as soon as possible:
(A) Communicate to the patient or the patient’s agent the fact
that a medication error has occurred and the steps required to
avoid injury or mitigate the error.
(B) Communicate to the prescriber the fact that a medication
error has occurred.
(3) The communication requirement in paragraph (2) of this
subdivision shall only apply to medication errors if the drug was
administered to or by the patient, or if the medication error
resulted in a clinically significant delay in therapy.
(4) If a pharmacist is notified of a prescription error by the
patient, the patient’s agent, or a prescriber, the pharmacist is not
required to communicate with that individual as required in
paragraph (2) of this subdivision.
(d) Each pharmacy shall use the findings of its quality assurance
program to develop pharmacy systems and workflow processes
designed to prevent medication errors. An investigation of each
medication error shall commence as soon as is reasonably
possible, but no later than 2 business days from the date the
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medication error is discovered. All medication errors discovered
shall be subject to a quality assurance review.
(e) The primary purpose of the quality assurance review shall be
to advance error prevention by analyzing, individually and
collectively, investigative and other pertinent data collected in
response to a medication error to assess the cause and any
contributing factors such as system or process failures. A record
of the quality assurance review shall be immediately retrievable
in the pharmacy. The record shall contain at least the following:
(1) The date, location, and participants in the quality assurance
review;
(2) The pertinent data and other information relating to the
medication error(s) reviewed and documentation of any patient
contact required by subdivision (c);
(3) The findings and determinations generated by the quality
assurance review; and,
(4) Recommend changes to pharmacy policy, procedure,
systems, or processes, if any.
The pharmacy shall inform pharmacy personnel of changes to
pharmacy policy, procedure, systems, or processes made as a
result of recommendations generated in the quality assurance
program.
(f) The record of the quality assurance review, as provided in
subdivision (e) shall be immediately retrievable in the pharmacy
for at least one year from the date the record was created. Any
quality assurance record related to the use of a licensed
automated drug delivery system must also be submitted to the
board within 30 days of completion of the quality assurance
review and any facility with an unlicensed automated drug
delivery system must report the quality assurance review to the
Board at the time of annual renewal of the facility license.
(g) The pharmacy's compliance with this section will be
considered by the board as a mitigating factor in the
investigation and evaluation of a medication error.
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(h) Nothing in this section shall be construed to prevent a
pharmacy from contracting or otherwise arranging for the
provision of personnel or other resources, by a third party or
administrative offices, with such skill or expertise as the
pharmacy believes to be necessary to satisfy the requirements of
this section.
Authority cited: Section 4005, Business and Professions Code;
and Section 2 of Chapter 677, Statutes of 2000. Reference:
Sections 4125 and 4427.7, Business and Professions Code.
1712. Use of Pharmacist Identifiers.
(a) Any requirement in this division for a pharmacist to initial or
sign a prescription record or prescription label can be satisfied by
recording the identity of the reviewing pharmacist in a computer
system by a secure means. The computer used to record the
reviewing pharmacist’s identity shall not permit such a record to
be altered after it is made.
(b) The record of the reviewing pharmacist’s identity made in a
computer system pursuant to subdivision (a) of this section shall
be immediately retrievable in the pharmacy.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4005 and 4115, Business and Professions
Code.
1713. Receipt and Delivery of Prescriptions and Prescription
Medications Must be To or From Licensed Pharmacy Must be To
or From Licensed Pharmacy
(a) Except as otherwise provided in this Division, no licensee
shall participate in any arrangement or agreement, whereby
prescriptions, or prescription medications, may be left at, picked
up from, accepted by, or delivered to any place not licensed as a
retail pharmacy.
(b) A licensee may pick up prescriptions at the office or home of
the prescriber or pick up or deliver prescriptions or prescription
medications at the office of or a residence designated by the
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patient or at the hospital, institution, medical office or clinic at
which the patient receives health care services. In addition, the
Board may, in its sole discretion, waive application of subdivision
(a) for good cause shown.
(c) A patient or the patient’s agent may deposit a prescription in
a secure container that is at the same address as the licensed
pharmacy premises. The pharmacy shall be responsible for the
security and confidentiality of the prescriptions deposited in the
container.
(d) A pharmacy may use an automated patient dispensing
system (APDS) to deliver prescription medications to patients
provided:
(1) A pharmacist has determined that each patient using the
APDS meets inclusion criteria for use of the APDS established by
the pharmacy prior to delivery of prescription medication to that
patient.
(2) The APDS has a means to identify each patient and only
release that patient’s prescription medications to the patient or
patient’s agent.
(3) The pharmacy provides an immediate consultation with a
pharmacist, either in-person or via telephone, upon the request
of a patient.
(4) Any incident involving the APDS where a complaint, delivery
error, or omission has occurred shall be reviewed as part of the
pharmacy's quality assurance program mandated by Business
and Professions Code section 4125.
(e) Any pharmacy making use of an APDS shall maintain, and on
an annual basis review, written policies and procedures providing
for:
(1) Maintaining the security of the APDS and the dangerous
drugs within the APDS.
(2) Determining and applying inclusion criteria regarding which
medications are appropriate for placement in the APDS and for
which patients, including when consultation is needed.
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(3) Ensuring that patients are aware that consultation with a
pharmacist is available for any prescription medication, including
for those delivered via the APDS.
(4) Describing the assignment of responsibilities to, and training
of, pharmacy personnel regarding the maintenance and filing
procedures for the APDS.
(5) Orienting participating patients on use of the APDS, notifying
patients when expected prescription medications are not
available in the APDS, and ensuring that patient use of the APDS
does not interfere with delivery of prescription medications.
(6) Ensuring the delivery of medications to patients in the event
the APDS is disabled or malfunctions.
(f) Written policies and procedures shall be maintained at least
three years beyond the last use of an APDS.
Authority cited: Sections 4005, 4075, and 4114, Business and
Professions Code. Reference: Sections 4005, 4017.3, 4052, 4116,
4117, 4427, 4427.1, 4427.2, 4427.3, 4427.4, 4427.5, 4427.6,
4427.7, and 4427.8, Business and Professions Code.
1714. Operational Standards and Security.
(a) All pharmacies (except hospital inpatient pharmacies as
defined by Business and Professions Code section 4029 which
solely or predominantly furnish drugs to inpatients of the
hospital) shall contain an area which is suitable for confidential
patient counseling.
(b) Each pharmacy licensed by the board shall maintain its
facilities, space, fixtures, and equipment so that drugs are safely
and properly prepared, maintained, secured and distributed. The
pharmacy shall be of sufficient size and unobstructed area to
accommodate the safe practice of pharmacy.
(c) The pharmacy and fixtures and equipment shall be
maintained in a clean and orderly condition. The pharmacy shall
be dry, well-ventilated, free from rodents and insects, and
properly lighted. The pharmacy shall be equipped with a sink
with hot and cold running water for pharmaceutical purposes.
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(d) Each pharmacist while on duty shall be responsible for the
security of the prescription department, including provisions for
effective control against theft or diversion of dangerous drugs
and devices, and records for such drugs and devices. Possession
of a key to the pharmacy where dangerous drugs and controlled
substances are stored shall be restricted to a pharmacist.
(e) The pharmacy owner, the building owner or manager, or a
family member of a pharmacist owner (but not more than one of
the aforementioned) may possess a key to the pharmacy that is
maintained in a tamper evident container for the purpose of 1)
delivering the key to a pharmacist or 2) providing access in case
of emergency. An emergency would include fire, flood or
earthquake. The signature of the pharmacist-in-charge shall be
present in such a way that the pharmacist may readily determine
whether the key has been removed from the container.
(f) The board shall require an applicant for a licensed premise or
for renewal of that license to certify that it meets the
requirements of this section at the time of licensure or renewal.
(g) A pharmacy shall maintain a readily accessible restroom. The
restroom shall contain a toilet and washbasin supplied with
running water.
Authority cited: Sections 4005 and 4116, Business and
Professions Code. Reference: Sections 4116 and 4117, Business
and Professions Code.
1714.1. Pharmacy Operations during the Temporary Absence of
a Pharmacist.
This section is to ensure that pharmacists are able to have duty
free breaks and meal periods to which they are entitled under
Section 512 of the Labor Code and the orders of the Industrial
Welfare Commission, without unreasonably impairing the ability
of a pharmacy to remain open.
(a) In any pharmacy that is staffed by a single pharmacist, the
pharmacist may leave the pharmacy temporarily for breaks and
meal periods pursuant to Section 512 of the Labor Code and the
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orders of the Industrial Welfare Commission without closing the
pharmacy and removing ancillary staff from the pharmacy if the
pharmacist reasonably believes that the security of the
dangerous drugs and devices will be maintained in his or her
absence.
If in the professional judgment of the pharmacist, the
pharmacist determines that the pharmacy should close during his
or her absence, then the pharmacist shall close the pharmacy
and remove all ancillary staff from the pharmacy during his or her
absence.
(b) During the pharmacist's temporary absence, no prescription
medication may be provided to a patient or to a patient's agent
unless the prescription medication is a refill medication that the
pharmacist has checked, released for furnishing to the patient
and was determined not to require the consultation of a
pharmacist.
(c) During such times that the pharmacist is temporarily absent
from the pharmacy, the ancillary staff may continue to perform
the non-discretionary duties authorized to them by pharmacy
law. However, any duty performed by any member of the
ancillary staff shall be reviewed by a pharmacist upon his or her
return to the pharmacy.
(d) During the temporary absence of a pharmacist as authorized
by this section, an intern pharmacist may not perform any
discretionary duties nor otherwise act as a pharmacist.
(e) The temporary absence authorized by this section shall be
limited to the minimum period authorized for pharmacists by
section 512 of Labor Code or orders of the Industrial Welfare
Commission, and any meal shall be limited to 30 minutes. The
pharmacist who is on break shall not be required to remain in the
pharmacy area during the break period.
(f) The pharmacy shall have written policies and procedures
regarding the operations of the pharmacy during the temporary
absence of the pharmacist for breaks and meal periods. The
policies and procedures shall include the authorized duties of
416
ancillary staff, the pharmacist's responsibilities for checking all
work performed by ancillary staff and the pharmacist's
responsibility for maintaining the security of the pharmacy. The
policies and procedures shall be open to inspection by the board
or its designee at all times during business hours.
(g) For the purposes of this section, ancillary staff includes: an
intern pharmacist, a pharmacy technician, non-licensed
personnel as defined in Section 1793.3 of Title 16 of the
California Code of Regulations and a pharmacy technician trainee
as defined in Section 4115.5(a) of the Business and Professions
Code.
Authority cited: Sections 4005, 4115 and 4116, Business and
Professions Code. Reference: Sections 4009, 4115, 4115.5 and
4116, Business and Professions Code; and Sections 512 and 1186,
Labor Code.
1714.3. Community Pharmacy Staffing
This section applies to a community pharmacy that is required
to comply with Business and Professions Code section 4113.5.
(a) When a pharmacy is open to the public and a pharmacist is
working without another pharmacy employee currently working,
the pharmacy shall make another person who is an employee of
the establishment within which the pharmacy is located available
to assist the pharmacist. The pharmacy shall:
(1) Designate the name(s) of one or more persons who will be
available to assist the pharmacist;
(2) Ensure that each designated person is able, at a minimum,
to perform the duties of nonlicensed pharmacy personnel as
specified in section 1793.3;
(3) Ensure that each designated person qualifies to have access
to controlled substances by conducting a background check on
each person that is consistent with federal requirements for
pharmacy employees with such access;
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(4) Ensure that a designated person responds and is able to
assist the pharmacist within five minutes after the pharmacist’s
request.
(b) A pharmacy shall have and maintain policies and procedures
that address the following:
(1) How a pharmacist on duty will be able to identify the
person(s) designated as available to assist them, and the required
criteria and training for those designated person(s), which shall
be consistent with subdivision (a).
(2) The process for the pharmacist to request assistance and to
document the response time between the request and arrival of
the designated person at the pharmacy.
(c) All impacted pharmacy employees and designated persons
must read and sign a copy of the policies and procedures
required by this section. For purposes of this section, “impacted
pharmacy employees” means any employee of the pharmacy,
whether the person works within or for the pharmacy owner,
who has any duties to prepare for or to execute how or when a
pharmacist may seek or obtain assistance pursuant to Business
and Professions Code section 4113.5, including any pharmacist,
any person who creates or approves pharmacy employees’ work
schedules, or who designates persons who may assist the
pharmacist pursuant to this section.
(d) The pharmacy must maintain the policies and procedures in
the pharmacy premises in a readily retrievable format.
Note: Authority cited: Section 4005, Business and Professions
Code. Reference: Section 4113.5, Business and Professions Code.
1714.5. Dangerous Drugs and Devices Exempt from the
Provisions of Chapter 9, Division 2 of the Business and
Professions Code.
As provided in Section 4057 of the Business and Professions
Code, the listing below shall be exempt from the provisions of
Chapter 9, Division 2 of the Business and Professions Code where
the sale or furnishing is made to a clinic, hospital, institution, or
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establishment holding a currently valid and unrevoked license or
permit under division 2 (commencing with Section 1200) of the
Health and Safety Code, or Chapter 2 (commencing with Section
3300) of Division 3 of, or Part 2 (commencing with Section 6250)
of Division 6, of the Welfare and Institutions Code:
(a) dangerous devices,
(b) hypodermic needles and syringes,
(c) sterilized sutures,
(d) parenteral solutions of 50 cubic centimeters or over,
(1) sterile water for injection,
(2) dextrose solutions of 10% or less,
(3) ready-made parenteral nutritional solutions,
(4) pre-diluted ready-to-use electrolyte containing solutions,
(5) colloidal and low molecular weight plasma expanders,
(6) Mannitol,
(7) sodium chloride solutions of 5% or less,
(8) alcohol (ethanol) solutions of 10% or less in dextrose
infusions,
(e) sterile water U.S.P.,
(f) sterile normal saline solution,
(g) medicinal gases,
(h) inhalation anesthetics,
(i) laboratory chemicals,
(j) non-controlled topical anesthetics,
(k) injectable local anesthetics when in sealed, pre-packaged
kits,
(l) topical stains and dyes,
(m) diagnostic agents and contrast medium for X-ray
examination,
(n) medicated dressings,
(o) irrigation solutions, and
(p) ophthalmic irrigation solutions.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4005 and 4057, Business and Professions
Code.
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1715. Self-Assessment of a Pharmacy by the Pharmacist-in-
Charge.
(a) The pharmacist-in-charge of each pharmacy as defined under
section 4029 or section 4037 of the Business and Professions
Code shall complete a self-assessment of the pharmacy'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.
(b) In addition to the self-assessment required in subdivision (a)
of this section, the pharmacist-in-charge shall complete a self-
assessment within 30 days whenever:
(1) A new pharmacy permit has been issued, or
(2) There is a change in the pharmacist-in-charge, and he or she
becomes the new pharmacist-in-charge of a pharmacy.
(3) There is a change in the licensed location of a pharmacy to a
new address.
(c) The components of this assessment shall be on Form 17M-13
(Rev. 10/14) entitled “Community Pharmacy Self-Assessment
Hospital Outpatient Pharmacy Self-Assessment and on Form
17M-14 (Rev. 10/14) entitled “Hospital Pharmacy Self-
Assessment” which are 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 pharmacy
for three years after it is performed.
Authority cited: Sections 4005 and 4127, Business and
Professions Code. Reference: Sections 4021, 4022, 4029, 4030,
4037, 4038, 4040, 4050, 4052, 4070, 4081, 4101, 4105, 4113,
4115, 4119, 4127, 4305, 4330, 4332 and 4333, Business and
Professions Code, and Sections 1735.2 and 1751. of Title 16 of
the California Code of Regulations..
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1715.1. Self-Assessment of an Automated Drug Delivery System
by the Pharmacist-in-Charge.
(a) The pharmacist-in-charge of each automated drug delivery
system as defined under section 4119.11, 4187.5 or section
4427.3 of the Business and Professions Code shall complete a
self-assessment of the pharmacy's compliance with federal and
state pharmacy law. The assessment shall be performed annually
before July 1 of every year. The primary purpose of the self-
assessment is to promote compliance through self-examination
and education.
(b) In addition to the self-assessment required in subdivision
(a) of this section, the pharmacist-in-charge shall complete a self-
assessment within 30 days whenever:
(1) A new automated drug delivery system license has been
issued.
(2) There is a change in the pharmacist-in-charge, and he or
she becomes the new pharmacist-in-charge of an automated
drug delivery system.
(3) There is a change in the licensed location of an automated
drug delivery system to a new address.
(c) A pharmacist-in-charge of an automated drug delivery
system shall assess the system’s compliance with current laws
and regulations by using the components of Form 17M-112 (Rev
12/18) entitled “Automated Drug Delivery System Self
Assessment”. Form 17M-112 shall be used for all automated drug
delivery systems and is hereby incorporated by reference.
(1) The pharmacist-in-charge shall provide identifying
information about the underlying operating pharmacy including:
(A) Name and any license number(s) of the underlying
pharmacy and their expiration date(s);
(B) Address, phone number, and website address, if
applicable, of the underlying pharmacy;
(C) DEA registration number, expiration date, and date of most
recent DEA inventory;
(D) Hours of operation of the pharmacy; and
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(E) ADDS license number, address, and hours of operation.
(2) The pharmacist-in-charge shall respond “yes”, “no”, or “not
applicable” (N/A) about whether the automated drug delivery
system is, at the time of the self-assessment, in compliance with
laws and regulations that apply to that pharmacy setting.
(3) For each “no” response, the pharmacist-in-charge shall
provide a written corrective action or action plan to come into
compliance with the law.
(4) The pharmacist-in-charge shall initial each page of the self-
assessment with original handwritten initials in ink or digitally
signed in compliance with Civil Code Section 1633.2(h) on the
self-assessment form.
(5) The pharmacist-in-charge shall certify on the last page of
the self-assessment that he or she has completed the self-
assessment of the automated drug delivery system of which he
or she is the pharmacist-in-charge. The pharmacist-in-charge
shall also certify a timeframe within which any deficiency
identified within the self-assessment will be corrected and
acknowledge that all responses are subject to verification by the
Board of Pharmacy. The certification shall be made under penalty
of perjury of the laws of the State of California that the
information provided in the self-assessment form is true and
correct with an original handwritten signature in ink or digitally
signed in compliance with Civil Code Section 1633.2(h) on the
self-assessment form.
(6) The automated drug delivery system owner shall certify on
the final page of the self-assessment that he or she has read and
reviewed the completed self-assessment and acknowledges that
failure to correct any deficiency identified in the self-assessment
could result in the revocation of the automated dispensing
system’s license issued by the board. This certification shall be
made under penalty of perjury of the laws of the State of
California with an original handwritten signature in ink or digitally
signed in compliance Civil Code Section 1633.2(h) on the self-
assessment form.
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(d) Each self-assessment shall be completed in its entirety and
kept on file in the underlying pharmacy for three years after it is
performed. The completed, initialed, and signed original must be
readily available for review during any inspection by the board.
(e) Any identified areas of noncompliance shall be corrected as
specified in the assessment.
Note: Authority cited: Sections 4119.11 and 4427.7, Business and
Professions Code. Reference: Sections 4001.1, 4008, 4017.3,
4021, 4022, 4036, 4037, 4038, 4040, 4050, 4051, 4052, 4059,
4070, 4076, 4081, 4101, 4105, 4107, 4113, 4119.11, 4125, 4126,
4180, 4186, 4305, 4330, 4332, 4333, 4400, 4427, 4427.1, 4427.2,
4427.3, 4427.4, and 4427.5, Business and Professions Code and
16.5, Government Code.
1715.5. Implementation of Electronic Monitoring of Schedule II
Prescriptions.
The collection of information authorized by Health and Safety
Code section 11165 shall be provided as follows:
(a) For each prescription for a Schedule II controlled substance,
the dispensing pharmacy shall provide the following information:
the full name and address of the patient; the gender and date of
birth of the patient; the DEA (Drug Enforcement Administration)
number of the prescriber; the triplicate prescription number; the
pharmacy prescription number; the pharmacy license number;
the NDC (National Drug Code) number and the quantity of the
controlled substance; the ICD-9 (diagnosis code), if available; the
date of issue of the prescription, the date of dispensing of the
prescription, and the state medical license number of any
prescriber using the DEA number of a government exempt
facility.
(b) The above information shall be provided in the following
format:
(1) For each pharmacy with the capacity to do so, by on-line
transmission at least every 30 days and no later than the 18th
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calendar day of the month following the month in which the
prescription is dispensed.
(2) For each pharmacy which does not have the capacity to
transmit the information on-line, on a three and one-half inch
diskette in a ASCII format or one-half inch nine track magnetic
1600 BPI tape or any other medium approved by the Board of
Pharmacy, which diskette, tape or medium shall be mailed or
delivered to a location specified by The Board of Pharmacy, at
least every 30 days and no later than the 18th calendar day of
the month following the month in which the prescription is
dispensed.
(3) For each pharmacy without the capacity to comply with
either subsection (b)(1) or (2), the original triplicate shall be
transmitted to the Department of Justice by the end of the
month in which the prescription was filled.
For each pharmacy which submits hard copy pursuant to this
subdivision and which pharmacy averages more than 25 triplicate
prescriptions per month in any six months, the Board of
Pharmacy or its designee may thereafter require that pharmacy
to comply with subsections (b)(1) and (2).
(4) As to a prescription which is partially filled or dispensed, the
period for compliance with subsections (1), (2), or (3) shall be
measured from the earlier of the following dates and times: the
prescription is either (1) completely dispensed or (2) can no
longer be dispensed.
(c) Every pharmacy which has made a submission as required by
this section by July 18, 1998, shall receive a reduction of $75 on
its next renewal fee for licensure of the pharmacy by the board.
Every pharmacy shall be in compliance with this section and
Health and Safety Code section 11165 by September 18, 1998.
Authority cited: Sections 4005, Business and Professions Code.
Reference: Sections 11164 and 11165, Health and Safety Code.
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1715.6. Reporting Drug Loss.
The owner shall report to the Board within thirty (30) days of
discovery of any loss of the controlled substances, including their
amounts and strengths.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4081 and 4332, Business and Professions
Code.
1715.65. Inventory Reconciliation Report of Controlled
Substances
(a) Every pharmacy, and every clinic licensed under sections
4180 or 4190 of the Business and Professions Code, shall perform
periodic inventory and inventory reconciliation functions to
detect and prevent the loss of controlled substances.
(b) The pharmacist-in-charge of a pharmacy or consultant
pharmacist for a clinic shall review all inventory and inventory
reconciliation reports taken, and establish and maintain secure
methods to prevent losses of controlled drugs. Written policies
and procedures shall be developed for performing the inventory
reconciliation reports required by this section.
(c) A pharmacy or clinic shall compile an inventory reconciliation
report of all federal Schedule II controlled substances at least
every three months. This compilation shall require:
(1) A physical count, not an estimate, of all quantities of federal
Schedule II controlled substances. The biennial inventory of
controlled substances required by federal law may serve as one
of the mandated inventories under this section in the year where
the federal biennial inventory is performed, provided the biennial
inventory was taken no more than three months from the last
inventory required by this section;
(2) A review of all acquisitions and dispositions of federal
Schedule II controlled substances since the last inventory
reconciliation report;
(3) A comparison of (1) and (2) to determine if there are any
variances;
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(4) All records used to compile each inventory reconciliation
report shall be maintained in the pharmacy or clinic for at least
three years in a readily retrievable form; and
(5) Possible causes of overages shall be identified in writing and
incorporated into the inventory reconciliation report.
(d) A pharmacy or clinic shall report in writing identified losses
and known causes to the board within 30 days of discovery
unless the cause of the loss is theft, diversion, or self-use in
which case the report shall be made within 14 days of discovery.
If the pharmacy or clinic is unable to identify the cause of the
loss, further investigation shall be undertaken to identify the
cause and actions necessary to prevent additional losses of
controlled substances.
(e) The inventory reconciliation report shall be dated and signed
by the individual(s) performing the inventory, and countersigned
by the pharmacist-in-charge or professional director (if a clinic)
and be readily retrievable in the pharmacy or clinic for three
years. A countersignature is not required if the pharmacist-in-
charge or professional director personally completed the
inventory reconciliation report.
(f) A new pharmacist-in-charge of a pharmacy shall complete an
inventory reconciliation report as identified in subdivision (c)
within 30 days of becoming pharmacist-in-charge. Whenever
possible an outgoing pharmacist-in-charge should also complete
an inventory reconciliation report as required in subdivision (c).
(g) For inpatient hospital pharmacies, a separate quarterly
inventory reconciliation report shall be required for federal
Schedule II controlled substances stored within the pharmacy
and for each pharmacy satellite location.
(h) The pharmacist-in-charge of an inpatient hospital pharmacy
or of a pharmacy servicing onsite or offsite automated drug
delivery systems shall ensure that:
(1) All controlled substances added to an automated drug
delivery system are accounted for;
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(2) Access to automated drug delivery systems is limited to
authorized facility personnel;
(3) An ongoing evaluation of discrepancies or unusual access
associated with controlled substances is performed; and
(4) Confirmed losses of controlled substances are reported to
the board.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4008, 4037, 4080, 4081, 4101, 4104, 4105,
4105.5, 4110, 4113, 4119.1, 4180, 4181, 4182, 4186, 4190, 4191,
4192, and 4332, Business and Professions Code and 1261.6,
Health and Safety Code.
1716. Variation from Prescriptions.
Pharmacists shall not deviate from the requirements of a
prescription except upon the prior consent of the prescriber or to
select the drug product in accordance with Section 4073 of the
Business and Professions Code. Nothing in this regulation is
intended to prohibit a pharmacist from exercising commonly-
accepted pharmaceutical practice in the compounding or
dispensing of a prescription.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4040, Business and Professions Code.
1717. Pharmacy Practice.
(a) No medication shall be dispensed on prescription except in a
new container which conforms with standards established in the
official compendia. Notwithstanding the above, a pharmacist
may dispense and refill a prescription for non-liquid oral products
in a clean multiple-drug patient medication package (patient med
pak), provided:
(1) a patient med pak is reused only for the same patient;
(2) no more than a one-month supply is dispensed at one time;
and
(3) each patient med pak bears an auxiliary label which reads,
“store in a cool, dry place.”
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(b) In addition to the requirements of Business and Professions
Code Section 4040, the following information shall be maintained
for each prescription on file and shall be readily retrievable:
(1) The date dispensed, and the name or initials of the
dispensing pharmacist. All prescriptions filled or refilled by an
intern pharmacist must also be initialed by the supervising
pharmacist before they are dispensed.
(2) The brand name of the drug or device; or if a generic drug or
device is dispensed, the distributor's name which appears on the
commercial package label; and
(3) If a prescription for a drug or device is refilled, a record of
each refill, quantity dispensed, if different, and the initials or
name of the dispensing pharmacist.
(4) A new prescription must be created if there is a change in
the drug, strength, prescriber or directions for use, unless a
complete record of all such changes is otherwise maintained.
(c) Promptly upon receipt of an orally transmitted prescription,
the pharmacist shall reduce it to writing, and initial it, and
identify it as an orally transmitted prescription. If the prescription
is then dispensed by another pharmacist, the dispensing
pharmacist shall also initial the prescription to identify him or
herself. All orally transmitted prescriptions shall be received and
transcribed by a pharmacist prior to compounding, filling,
dispensing, or furnishing. Chart orders as defined in Section 4019
of the Business and Professions Code are not subject to the
provisions of this subsection.
(d) A pharmacist may furnish a drug or device pursuant to a
written or oral order from a prescriber licensed in a State other
than California in accordance with Business and Professions Code
Section 4005.
(e) A pharmacist may transfer a prescription for Schedule III, IV
or V controlled substances to another pharmacy for refill
purposes in accordance with Title 21, Code of Federal
Regulations, 1306.25. Prescriptions for other dangerous drugs
which are not controlled substances may also be transferred by
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direct communication between pharmacists or by the receiving
pharmacist's access to prescriptions or electronic files that have
been created or verified by a pharmacist at the transferring
pharmacy. The receiving pharmacist shall create a written
prescription; identifying it as a transferred prescription; and
record the date of transfer and the original prescription number.
When a prescription transfer is accomplished via direct access by
the receiving pharmacist, the receiving pharmacist shall notify
the transferring pharmacy of the transfer. A pharmacist at the
transferring pharmacy shall then assure that there is a record of
the prescription as having been transferred, and the date of
transfer. Each pharmacy shall maintain inventory accountability
and pharmacist accountability and dispense in accordance with
the provisions of Section 1716. Information maintained by each
pharmacy shall at least include:
(1) Identification of pharmacist(s) transferring information;
(2) Name and identification code or address of the pharmacy
from which the prescription was received or to which the
prescription was transferred, as appropriate;
(3) Original date and last dispensing date;
(4) Number of refills and date originally authorized;
(5) Number of refills remaining but not dispensed;
(6) Number of refills transferred.
(f) The pharmacy must have written procedures that identify
each individual pharmacist responsible for the filling of a
prescription and a corresponding entry of information into an
automated data processing system, or a manual record system,
and the pharmacist shall create in his/her handwriting or through
hand-initializing a record of such filling, not later than the
beginning of the pharmacy's next operating day. Such record
shall be maintained for at least three years.
Authority cited: Sections 4005, 4075 and 4114, Business and
Professions Code. Reference: Sections 4005, 4019, 4027, 4050,
4051, 4052, 4075, 4114, 4116, 4117 and 4342, Business and
Professions Code.
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1717.1. Common Electronic Files.
(a) For dangerous drugs other than controlled substances: Two
or more pharmacies may establish and use a common electronic
file to maintain required dispensing information. Pharmacies
using such a common file are not required to transfer
prescriptions or information for dispensing purposes between or
among pharmacies participating in the same common
prescription file.
(b) For controlled substances: To the extent permitted by
Federal law, two or more pharmacies may establish and use a
common electronic file of prescriptions and dispensing
information.
(c) All common electronic files must contain complete and
accurate records of each prescription and refill dispensed.
(d) Common electronic files as authorized by this section shall
not permit disclosure of confidential medical information except
as authorized by the Confidentiality of Medical Information Act
(Civil Code 56 et seq.).
(e) Pharmacies maintaining a common electronic file authorized
by this section shall develop and implement written policies and
procedures designed to prevent the unauthorized disclosure of
confidential medical information.
Authority cited: Sections 4005, 4075 and 4114, Business and
Professions Code. Reference: Sections 4005, 4019, 4027, 4050,
4051, 4052, 4075, 4114, 4116 and 4117, Business and Professions
Code and Sections 56.10 and 56.11 of the Civil Code.
1717.3. Preprinted Multiple Checkoff Prescription Blanks.
(a) No person shall dispense a controlled substance pursuant to
a preprinted multiple check-off prescription blank.
(b) A person may dispense a dangerous drug, that is not a
controlled substance, pursuant to a preprinted multiple checkoff
prescription blank and may dispense more than one dangerous
drug, that is not a controlled substance, pursuant to such a blank
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if the prescriber has indicated on the blank the number of
dangerous drugs he or she has prescribed.
(c) “Preprinted multiple checkoff prescription blank,” as used in
this section means any form listing more than one dangerous
drug where the intent is that a mark next to the name of a drug
i.e., a “checkoff,” indicates a prescription order for that drug.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4040, Business and Professions Code; and
Section 11164, Health and Safety Code.
1717.4. Electronic Transmission of Prescriptions.
(a) Except as otherwise prohibited by law, prescriptions may be
transmitted by electronic means from the prescriber to the
pharmacy.
(b) An electronically transmitted prescription which meets the
requirements of this regulation shall be deemed to be a
prescription within the meaning of Business and Professions
Code section 4040.
(c) An electronically transmitted prescription order shall include
the name and address of the prescriber, a telephone number for
oral confirmation, date of transmission and the identity of the
recipient, as well as any other information required by federal or
state law or regulations. The prescriber's address, license
classification and federal registry number may be omitted if they
are on file and readily retrievable in the receiving pharmacy.
(d) An “interim storage device” means as electronic file into
which a prescription is entered for later retrieval by an
authorized individual. Any interim storage device shall, in
addition to the above information, record and maintain the date
of entry and/or receipt of the prescription order, date of
transmission from the interim storage device and identity of the
recipient of such transmission. The interim storage device shall
be maintained so as to ensure against unauthorized access and
use of prescription information, including dispensing information.
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(e) A pharmacy receiving an electronic image transmission
prescription shall either receive the prescription in hard copy
form or have the capacity to retrieve a hard copy facsimile of the
prescription from the pharmacy's computer memory. Any hard
copy of a prescription shall be maintained on paper of
permanent quality.
(f) An electronically transmitted prescription shall be
transmitted only to the pharmacy of the patient's choice. This
requirement shall not apply to orders for medications to be
administered in an acute care hospital.
(g) Electronic equipment for transmitting prescriptions (or
electronic transmittal technology) shall not be supplied or used
so as to violate or circumvent Business and Professions Code
section 4000 et seq., Health and Safety Code section 11150 et
seq., or any regulations of the board.
(h) Any person who transmits, maintains or receives any
prescription or prescription refill, orally, in writing or
electronically, shall ensure the security, integrity, authenticity,
and confidentiality of the prescription and any information
contained therein.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4019, 4040, 4071, 4072 and 4075, Business
and Professions Code; and Section 11150, et seq., Health and
Safety Code.
1718. Current Inventory Defined.
“Current Inventory” as used in Sections 4081 and 4332 of the
Business and Professions Code shall be considered to include
complete accountability for all dangerous drugs handled by every
licensee enumerated in Sections 4081 and 4332. The controlled
substances inventories required by Title 21, CFR, Section 1304
shall be available for inspection upon request for at least 3 years
after the date of the inventory.
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Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4080, 4081 and 4332, Business and
Professions Code.
1718.1. Manufacturer's Expiration Date.
All prescription drugs not bearing a manufacturer's expiration
date pursuant to Title 21, Code of Federal Regulations, section
211.137 are deemed to have expired and may not be
manufactured, distributed, held for sale, or dispensed by any
manufacturer, distributor, pharmacist, pharmacy or other
persons authorized to dispense such drugs in California.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4005 and 4342, Business and Professions
Code.
Article 3. Pharmacist Candidates
1719. Recognized Schools of Pharmacy.
As used in this division, “recognized school of pharmacy” means
a school of pharmacy accredited, or granted candidate status, by
the Accreditation Council for Pharmacy Education or otherwise
recognized by the board.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4200 of the Business and Professions Code.
1720. Application for Pharmacist Examination and Licensure.
(a) An application for examination shall be submitted on the
form provided by the board, and filed with the board at its office
in Sacramento.
(b) The fee required by subdivision (d) of section 1749 of this
Division shall be paid for each application for initial examination
and for any application to retake the examination described in
section 4200.2 of the Business and Professions Code. The fee is
nonrefundable.
(c) Each applicant shall be solely responsible for applying to and
complying with the requirements imposed by the administrators
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of the North American Pharmacist Licensure Examination and the
Multi-State Pharmacy Jurisprudence Examination for California
for the administration of those examinations.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4200 and 4200.2, Business and Professions
Code.
1720.1. Graduates of Foreign Pharmacy Schools.
Graduates of foreign pharmacy schools who have been certified
by the Foreign Pharmacy Graduate Equivalency Committee shall
be deemed by the board to have satisfied the requirements of
paragraphs (3) and (4) of Business and Professions Code Section
4200(a). Candidates who have been certified by the Foreign
Pharmacy Graduate Equivalency Committee before January 1,
1998, must also provide the board with a score on the Test of
Spoken English of least 50. For candidates who took the Test of
Spoken English before June 30, 1995, a score of at least 220 must
be achieved.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 851 and 4200, Business and Professions
Code.
1721. Dishonest Conduct during Examination.
An applicant for examination as a pharmacist who engages in
dishonest conduct during the examination shall not have that
examination graded, shall not be approved to take the
examination for three years from the date of the incident, and
shall surrender his or her intern license until eligible to take the
examination. The applicant may not be issued a pharmacy
technician license until the applicant is again eligible to take the
examination.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 123, 496 and 4200, Business and Professions
Code.
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1723.1. Confidentiality of Examination Questions
Examination questions are confidential. Any applicant for any
license issued by the board who removes all or part of any
qualifying examination from the examination room or area, or
who conveys or exposes all or part of any qualifying examination
to any other person may be disqualified as a candidate for a
license. The applicant shall not be approved to take the
examination for three years from the date of the incident and
shall surrender his or her intern license until again eligible to take
the examination. The applicant may not be issued a pharmacy
technician license until the applicant is again eligible to take the
examination.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 123 and 496, business and Professions Code.
1724. Passing Grade in Pharmacist Examination.
In order to pass the examination, an applicant shall be required
to obtain a passing score as determined by a criterion-referenced
method of establishing the passing point on each part of the
examination. The board may scale the passing score to 75 for the
purpose of releasing scores to examinees.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4200, Business and Professions Code.
1725. Acceptable Pharmacy Coursework for Examination
Candidates with Four Failed Attempts.
(a) Coursework that meets the requirements of section 4200.1
of the Business and Professions Code is any pharmacy
coursework offered by a recognized school of pharmacy.
(b) A final examination must be a part of the course of study.
(c) When a candidate applies for reexamination after four failed
attempts, he or she shall furnish evidence of successful
completion of at least 16 semester units or the equivalent of
pharmacy coursework. Evidence of successful completion must
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be posted on a transcript from the pharmacy school sent directly
to the board.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4200.1, Business and Professions Code.
1726. Supervision of Intern Pharmacists.
(a) The pharmacist supervising an intern pharmacist shall be
responsible for all professional activities performed by the intern
under his or her supervision.
(b) The pharmacist supervising an intern pharmacist shall
provide the experience necessary for the intern pharmacist to
become proficient in the practice of pharmacy.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4030, 4114 and 4200, Business and
Professions Code.
1727.1 Intern Pharmacist Address.
The board shall not make an intern pharmacist’s address
publicly available on the “Internet,” as defined by Business and
Professions Code section 17538.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4005, 4030, 4100 and 4208, Business and
Professions Code.
1727.2. Requirements for Pharmacist Intern.
Every applicant for a pharmacist intern license shall submit as
part of the application process, a sealed, original Self Query
Report from the National Practitioner Data Bank-Healthcare
Integrity and Protection Data Bank (NPDB-HIPDB), dated no
earlier than 60 days before the date an application is submitted
to the board.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4207 and 4208, Business and Professions
Code.
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1728. Requirements for Examination.
(a) Prior to receiving authorization from the board to take the
pharmacist licensure examinations required by section 4200 of
the Business and Professions Code, applicants shall submit to the
board the following:
(1) Proof of 1500 hours of pharmacy practice experience that
meets the following requirements:
(A) A minimum of 900 hours of pharmacy practice experience
obtained in a pharmacy.
(B) A maximum of 600 hours of pharmacy practice experience
may be granted at the discretion of the board for other
experience substantially related to the practice of pharmacy.
(C) Experience in both community pharmacy and institutional
pharmacy practice settings.
(D) Pharmacy practice experience that satisfies the
requirements for both introductory and advanced pharmacy
practice experiences established by the Accreditation Council for
Pharmacy Education.
(2) Satisfactory proof that the applicant graduated from a
recognized school of pharmacy.
(3) Fingerprints to obtain criminal history information from both
the Department of Justice and the United States Federal Bureau
of Investigation pursuant to Business and Professions Code
section 144.
(4) A signed copy of the examination security acknowledgment.
(b) Applicants who hold or held a pharmacist license in another
state shall provide a current license verification from each state
in which the applicant holds or held a pharmacist license prior to
being authorized by the boar to take the examinations.
(c) Applicants who graduated from a foreign school of pharmacy
shall provide the board with satisfactory proof of certification by
the Foreign Pharmacy Graduate Examination Committee prior to
being authorized by the board to take the examinations.
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Authority cited: Sections 851, and 4005, Business and Professions
Code. Reference: Sections 144, 851, and 4200, Business and
Professions Code.
Article 3.5. Advanced Practice Pharmacist
1730. Acceptable Certification Programs
The board recognizes the pharmacy patient care certification
programs that are accredited by the National Commission for
Certifying Agencies for purposes of satisfying the requirements in
Business and Professions Code section 4210, subdivision
(a)(2)(A).
Authority cited: Sections 4005 and 4210, Business and
Professions Code. Reference: Section 4210, Business and
Professions Code.
1730.1. Application Requirements for Advanced Practice
Pharmacist Licensure
(a) For purposes of Business and Professions Code section 4210,
an applicant for advanced practice pharmacist licensure must
satisfy two of the following subsections.
(1) Demonstrate possession of a current certification as
specified in Business and Professions Code section 4210,
subdivision (a)(2)(A), by providing either:
(A) A copy of the certification award that includes the name of
the applicant pharmacist, the area of specialty and date of
completion, or
(B) A letter from the certification program confirming the award
of the certification that includes the name of the applicant
pharmacist, the area of specialty and the date of completion.
(2) Demonstrate completion of a postgraduate residency earned
in the United States through an accredited postgraduate
institution as specified in Business and Professions Code section
4210, subdivision (a)(2)(B), by providing either:
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(A) A copy of the residency certificate awarded by the
postgraduate institution that includes the name of the applicant
pharmacist, the area of specialty, and dates of participation and
completion, or
(B) A letter of completion of a postgraduate residency, signed by
the dean or residency program director of the postgraduate
institution and sent directly to the board from the postgraduate
institution, that lists the name of the applicant pharmacist, the
area of specialty, and the dates of participation and completion.
For an applicant who cannot satisfy this documentation
requirement, the board may, for good cause shown, grant a
waiver for this subsection.
(3) Demonstrate that experience earned under a collaborative
practice agreement or protocol, as required by Business and
Professions Code section 4210, subdivision (a)(2)(C), has been
earned within 10 years of the time of application for advanced
practice pharmacist licensure. Additionally, the one year of
experience must include no fewer than 1,500 hours of experience
providing clinical services to patients. The experience earned
under a collaborative practice agreement or protocol must
include initiating, adjusting, modifying or discontinuing drug
therapy of patients as authorized by law. An applicant shall
demonstrate possession of experience by providing both of the
following:
(A) A written statement from the applicant attesting under
penalty of perjury that he or she has:
(i) Earned the clinical experience within the required time
frame; and
(ii) Completed the required number of hours of experience
providing clinical services to patients, as specified in subsection
(a)(3).
(I)The applicant shall provide a copy of the collaborative
practice agreement or protocol.
(II)If a copy of the collaborative practice agreement or protocol
is not available, the applicant shall provide a description of the
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