Bill Text: CA SB1193 | 2015-2016 | Regular Session | Chaptered
Bill Title: Healing arts.
Spectrum: Partisan Bill (Democrat 2-0)
Status: (Passed) 2016-09-22 - Chaptered by Secretary of State. Chapter 484, Statutes of 2016. [SB1193 Detail]
Download: California-2015-SB1193-Chaptered.html
BILL NUMBER: SB 1193 CHAPTERED
BILL TEXT
CHAPTER 484
FILED WITH SECRETARY OF STATE SEPTEMBER 22, 2016
APPROVED BY GOVERNOR SEPTEMBER 22, 2016
PASSED THE SENATE AUGUST 25, 2016
PASSED THE ASSEMBLY AUGUST 23, 2016
AMENDED IN ASSEMBLY AUGUST 18, 2016
AMENDED IN ASSEMBLY AUGUST 1, 2016
AMENDED IN ASSEMBLY JUNE 21, 2016
AMENDED IN SENATE MAY 31, 2016
AMENDED IN SENATE APRIL 13, 2016
INTRODUCED BY Senator Hill
(Principal coauthor: Assembly Member Salas)
FEBRUARY 18, 2016
An act to amend Sections 2909.5, 2913, 2914, 2914.1, 2914.2, 2915,
2920, 2933, 4001, 4003, 4013, 4035, 4081, 4107, 4110, 4119.1, 4127,
4127.3, 4127.7, 4127.8, 4127.9, 4128.6, 4161, 4180, 4201, 4301, 4302,
4307, 4308, 4312, 4400, 4406, 4800, 4804.5, 4830, 4846.5, 4904, and
4905 of, to add Sections 2934.1, 2988.5, 4034, 4105.5, 4126.9,
4203.5, 4301.1, 4303.1, 4316, 4826.5, 4848.1, and 4853.7 to, and to
add Article 7.7 (commencing with Section 4129) to Chapter 9 of
Division 2 of, and to repeal Section 2947 of, the Business and
Professions Code, to amend Section 13401.5 of the Corporations Code,
and to amend Sections 1261.6 and 11164.5 of the Health and Safety
Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
SB 1193, Hill. Healing arts.
(1) The Psychology Licensing Law establishes the Board of
Psychology to license and regulate the practice of psychology, and
authorizes the board to employ all personnel necessary to carry out
that law and to employ an executive officer, as specified. These
provisions are in effect only until January 1, 2017.
This bill would extend the existence of the board and the board's
authorization to employ an executive officer to January 1, 2021.
The Psychology Licensing Law defines the practice of psychology as
rendering or offering to render, for a fee, psychological services
involving the application of psychological principles and methods,
including the diagnosis, prevention, and treatment of psychological
problems and emotional and mental disorders. That law prohibits
unlicensed persons from practicing psychology, but authorizes
unlicensed persons, including psychological assistants who meet
certain requirements and do not provide psychological services to the
public, except as an employee of a licensed psychologist, licensed
physician, contract clinic, psychological corporation, or medical
corporation, to perform limited psychological functions. That law
also prohibits its provisions from being construed as restricting or
preventing specified nonprofit community agency employees from
carrying out activities of a psychological nature or using their
official employment title, as specified, provided the employees do
not render or offer to render psychological services. That law
provides that a violation of any of its provisions is a misdemeanor.
This bill would recast these provisions to authorize an unlicensed
person preparing for licensure as a psychologist to perform
psychological functions under certain conditions, including
registration with the board as a psychological assistant and
immediate supervision by a licensed psychologist or physician and
surgeon who is board certified in psychiatry, as specified. The bill
would prohibit a psychological assistant from providing psychological
services to the public except as a supervisee. The bill would expand
the prohibition on construing the Psychology Licensing Law's
provisions as restricting or preventing specified activities of
nonprofit community agency employees by making this prohibition
contingent on the employees not rendering or offering to render
psychological services to the public. By changing the definition of a
crime, this bill would create a state-mandated local program.
The Psychology Licensing Law conditions the issuance of a
psychology license upon an applicant having received any of certain
kinds of doctorate degrees from an accredited educational
institution. That law requires, with certain exceptions, the board to
issue renewal licenses for psychology only to those applicants who
have completed 36 hours of approved continuing education in the
preceding two years. Existing law prescribes a biennial license
renewal fee of not more than $500. Existing law also requires a
person applying for relicensure or for reinstatement to an active
license to certify under penalty of perjury that he or she is in
compliance with the continuing education requirements. Existing law
requires continuing education instruction to be completed within the
state or be approved for credit by the American Psychological
Association or its equivalent.
This bill would revise and recast the doctorate degree
requirements for licensure to include, until January 1, 2020, a
doctorate degree from an unaccredited institution that is approved
for operation by a specified entity. The bill would replace the term
"continuing education" with "continuing professional development,"
define "continuing professional development," require a person
applying for renewal or reinstatement to certify compliance with
these requirements under penalty of perjury, require continuing
professional courses to be approved by organizations approved by the
board, as specified, and authorize the board to grant exemptions
from, or extensions for compliance with, these requirements.
This bill would authorize the board to issue a retired license to
a licensed psychologist if the psychologist has applied to the board
for a retired license and pays a fee of not more than $75. The bill
would also prohibit the holder of a retired license from engaging in
the practice of psychology in the same manner as an active licensee.
Because a violation of this prohibition would be a crime, the bill
would impose a state-mandated local program.
Existing law authorizes the board to appoint qualified persons to
give the whole or any portion of any examination provided for in the
law, to be designated as commissioners on examination.
This bill would repeal this authorization.
This bill would authorize the board to post on its Internet Web
site the prescribed information regarding all current and former
licensees.
(2) The Pharmacy Law provides for the licensure and regulation of
the practice of pharmacy by the California State Board of Pharmacy,
which is within the Department of Consumer Affairs, and authorizes
the board to appoint, with the approval of the Director of Consumer
Affairs, an executive officer, as specified. That law repeals the
provisions establishing the board and authorizing the board to
appoint an executive officer as of January 1, 2017. Under existing
law, the board is subject to evaluation by the Joint Sunset Review
Committee upon its repeal.
This bill would extend the operation of the board and the board's
authorization to appoint an executive officer until January 1, 2021.
The Pharmacy Law requires each application to conduct a pharmacy,
wholesaler, 3rd-party logistics provider, or veterinary food-animal
drug retailer to be made on a form furnished by the board and to
state specified information. That law requires the executive officer
to issue a license to conduct a pharmacy, wholesaler, 3rd-party
logistics provider, or veterinary food-animal drug retailer, if
specified conditions are met. That law authorizes the board to cancel
a license if the licensed premises remains closed, as defined, other
than by order of the board. That law requires a licensee whose
license is canceled or who notifies the board of its intent to remain
closed or to discontinue business to arrange for the transfer of all
dangerous drugs and controlled substances or dangerous devices to
another licensee within 10 days. That law authorizes the board to
seek and obtain a specified court order authorizing the board to
enter the premises, and inventory and store, transfer, sell, or
arrange for the sale of, all dangerous drugs and controlled
substances and dangerous devices found in the premises if the
licensee does not comply with the requirement to do so.
This bill would require an outsourcing facility, as defined, to be
licensed with the board before doing business within or into the
state. The bill would require each application to conduct an
outsourcing facility to be made on a form furnished by the board and
to state specified information. The bill would require the executive
officer to issue a license if specified conditions are met. The bill
would prohibit an outsourcing facility from being concurrently
licensed with the board as a sterile compounding pharmacy at the same
location. The bill would require an outsourcing facility to, among
other things, notify the board of any disciplinary or other action
taken by another state or the federal Food and Drug Administration
(FDA) within 10 days of the action. The bill would prohibit the
issuance or renewal of an outsourcing facility license until the
board inspects the location of an outsourcing facility to ensure that
the outsourcing facility is in compliance with all laws and
regulations. The bill would make a violation of any of these
provisions or regulations adopted thereto punishable by a fine of up
to $5,000 per occurrence. The bill would immediately cancel, revoke,
or suspend by operation of law the license of any nonresident
outsourcing facility whose registration is canceled, revoked, or
suspended by the FDA. The bill would authorize the board to cancel an
outsourcing facility license if the outsourcing facility remains
closed, as defined, other than by order of the board. The bill would
require an outsourcing facility licensee whose license is canceled or
who notifies the board of its intent to remain closed or to
discontinue business to arrange for the transfer of all dangerous
drugs and controlled substances or dangerous devices to another
licensee within 10 days. The bill would authorize the board to seek
and obtain a specified court order authorizing the board to enter the
outsourcing facility, and inventory and store, transfer, sell, or
arrange for the sale of, all dangerous drugs and controlled
substances and dangerous devices found in the outsourcing facility if
the licensee does not comply with the requirement to do so. The bill
would, on or after January 1, 2018, require the board to provide a
report, as specified, to the Legislature regarding the regulation of
nonresident outsourcing facilities.
The Pharmacy Law requires a facility licensed by the board to join
the board's email notification list within 60 days of obtaining a
license or at the time of license renewal and requires a facility to
update its email address within 30 days of a change in the facility's
email address.
This bill would require each pharmacist, intern pharmacist,
pharmacy technician, designated representative, and designated
representative of a 3rd-party logistics provider licensed in this
state to join the board's email notification list within 60 days of
obtaining a license or at the time of license renewal and to update
the licensee's email address within 30 days of a change in the
licensee's email address. The bill would prohibit the board from
posting those email addresses on the board's license verification
system. The bill would make these provisions operative on July 1,
2017.
The Pharmacy Law requires the board to take action against any
licensee who is guilty of unprofessional conduct or whose license has
been procured by fraud or misrepresentation or by mistake and
includes, among others, gross immorality as unprofessional conduct.
That law also includes the revocation, suspension, or other
discipline by another state of a license to practice pharmacy,
operate a pharmacy, or do any other act for which a license is
required under the Pharmacy Law as grounds for unprofessional
conduct.
This bill would delete gross immorality as unprofessional conduct
and instead provide that procurement of a license by fraud or
misrepresentation is unprofessional conduct. This bill would require
that revocation, suspension, or other discipline by another state as
the basis for similar action under the Pharmacy Law be grounds for
revocation, suspension, or other discipline under the Pharmacy Law
and requires the board to take action coterminously with action taken
by another state. The bill would authorize the board to exceed the
term of discipline of another state consistent with the board's
enforcement guidelines and provide that evidence of discipline by
another state is conclusive proof of unprofessional conduct. The bill
would also require the board, to ensure that its resources are
maximized for the protection of the public health and safety, to
prioritize its investigative and prosecutorial resources to ensure
that pharmacists representing the greatest threat of patient harm are
identified and disciplined expeditiously.
The Pharmacy Law defines "person" as including a firm,
association, partnership, corporation, limited liability company,
state governmental agency, or political subdivision. That law
authorizes the board to deny or revoke any license of a corporation,
as specified. That law prohibits a person who has, among other
things, been denied a license or whose license has been revoked from
serving as a manager, administrator, owner, member, officer,
director, associate, or partner of a licensee, as specified, and
requires the board to notify in writing each licensee for whom a
person is prohibited from serving as a manager, administrator, owner,
member, officer, director, associate, or partner of a licensee of
the prohibition.
This bill would also define "person" to include, but not be
limited to, a trust and would make conforming changes.
The Pharmacy Law requires that fees collected on behalf of the
board be credited to the Pharmacy Board Contingent Fund. Existing law
continuously appropriates fees in the fund.
This bill would authorize the board to collect a fee of $2,270 for
the issuance of an outsourcing facility license, which may be
increased to up to $3,180 by the board, a fee of $1,325 for the
renewal of that license, which may be increased to up to $1,855 by
the board, and a fee of $715 for a temporary outsourcing facility
license, as specified. The bill would authorize the board to collect
a fee of $2,380 for the issuance of a nonresident outsourcing
facility license, which may be increased to up to $3,335 by the
board, and a fee of $2,270 for the renewal of that license, which may
be increased to up to $3,180 by the board, as specified. The bill
would provide that the Pharmacy Board Contingent Fund is available
for expenditure only upon an appropriation by the Legislature.
The Pharmacy Law requires all records of manufacture, and of sale,
acquisition, receipt, shipment, or disposition of dangerous drugs or
dangerous devices to be at all times, during business hours, open to
inspection by authorized officers of the law, and to be preserved
for at least 3 years from the date of making. That law requires
specified entities and individuals to keep a current inventory of
these records.
This bill would require an outsourcing facility to keep a current
inventory of these records.
The Pharmacy Law authorizes the board to issue a temporary permit
to own or operate a pharmacy when the ownership of a pharmacy is
transferred from one person to another, as specified.
This bill would authorize the board to issue a temporary permit,
as specified, regardless of whether the ownership of a pharmacy is
transferred from one person to another.
The Pharmacy Law authorizes a pharmacy to provide pharmacy
services to specified licensed health facilities through the use of
an automated drug delivery system.
This bill would require a pharmacy that owns or provides dangerous
drugs dispensed through an automated drug delivery system to
register the system by providing the board in writing with the
location of each automated drug delivery system within 30 days of
installation and on an annual basis as part of the license renewal.
The bill would also require the pharmacy to advise the board in
writing within 30 days if the pharmacy discontinues operating an
automated drug delivery system. The bill would exempt from these
requirements an automated drug delivery system operated by a licensed
hospital pharmacy for doses administered in a facility operated
under a consolidated license. The bill would authorize a pharmacy to
use an automated drug delivery system only if certain conditions are
satisfied, including, among other conditions, that the pharmacy
report to the board drug losses from the system. The bill would
authorize the board to prohibit a pharmacy from using an automated
drug delivery system if the board determines that those conditions
are not satisfied. The bill would require the board to provide the
pharmacy with written notice, as specified, if the board determines
those conditions are not satisfied. The bill would authorize the
pharmacy, within 30 days of receipt of the written notice, to request
an office conference to appeal the board's decision. The bill would
authorize the executive officer or designee to affirm or overturn the
prohibition as a result of the office conference.
The Pharmacy Law, until January 1, 2012, permitted access by
licensed personnel to multiple drugs that are not patient specific
only if an automated drug delivery system had both electronic and
mechanical safeguards in place to ensure that the only drugs
delivered to the patient were specific to that patient. Existing law,
until January 1, 2012, required each facility using an automated
drug delivery system to notify the State Department of Health Care
Services in writing prior to utilization of the system, as provided.
Existing law, until January 1, 2012, required the department, as part
of its oversight of those facilities, to review a facility's
medication training, storage, and security and its administration
procedures related to its use of an automated drug delivery system.
Existing law authorizes the stocking of an automated drug delivery
system to be done outside the facility if the automated drug delivery
system utilizes removable pockets, cards, drawers, or similar
technology and if certain conditions are met, including that the
removable pockets, cards, or drawers are transported in a secured
tamper-evident container.
This bill would make these provisions operative by repealing the
provision that made them inoperative on January 1, 2012. The bill
would additionally authorize the stocking of an automated drug
delivery system to be done outside the facility if the system
utilizes unit of use or single dose containers, as specified.
The Pharmacy Law requires the board to issue a license, after an
investigation to determine whether the applicant and the premises
qualify for a license, that authorizes specified clinics to purchase
drugs at wholesale for administration or dispensing, under the
direction of a physician and surgeon, to patients registered for care
at the clinic.
This bill would require the board, when a clinic applicant submits
specified types of applications, to issue a license or incorporate
changes to an existing license within 30 days of receipt of a
completed application and payment of fees. The bill would require
that this provision not be construed to limit the board's authority
to investigate to determine whether the applicant and the premises
qualify for a license.
The Pharmacy Law prohibits a pharmacy from compounding sterile
drug products unless the pharmacy has obtained a sterile compounding
pharmacy license from the board and prohibits the board from issuing
or renewing that license until the board has, among other things,
reviewed a current copy of the pharmacy's procedures and policies for
sterile compounding. That law prohibits the board from issuing more
than one site license to a single premises with specified exceptions,
including issuing a license to compound sterile injectable drugs to
a resident pharmacy.
This bill would expand the exception under which the board may
issue more than one site license to a single premises to include
issuing a license to compound sterile drugs to a pharmacy, regardless
of whether those drugs are injectable and regardless of whether the
pharmacy is a nonresident pharmacy.
The Pharmacy Law requires a pharmacy that compounds sterile drug
products for injection, administration into the eye, or inhalation to
possess a sterile compounding pharmacy license.
This bill would require a pharmacy that compounds any sterile drug
products to possess a sterile compounding pharmacy license.
The Pharmacy Law authorizes the executive officer of the board,
based on a reasonable belief obtained during an investigation or
pharmacy inspection by the board, to issue a cease and desist order
to a pharmacy requiring the pharmacy to refrain from compounding
injectable sterile drug products if that activity poses an immediate
threat to the public health or safety.
This bill would expand the authorization of the executive officer
of the board to issue a cease and desist order to include requiring
the pharmacy to refrain from compounding any sterile drug products if
that activity poses an immediate threat to public health or safety.
The Pharmacy Law requires a pharmacy to compound injectable
sterile products from one or more nonsterile ingredients in a
specified environment.
This bill would require a pharmacy to compound any sterile
products from one or more nonsterile ingredients in a specified
environment.
The Pharmacy Law authorizes the board to issue a temporary license
to compound injectable sterile drug products when the ownership of a
pharmacy that is licensed to compound injectable sterile drug
products is transferred from one person to another, as specified.
This bill would authorize the board to issue a temporary permit to
compound sterile drug products, as specified, regardless of whether
the drug product is injectable and regardless of whether the
ownership of the pharmacy is transferred from one person to another.
The Pharmacy Law requires a resident or a nonresident pharmacy
that issues a recall notice regarding a sterile compounded drug to
contact, as specified, the recipient pharmacy, prescriber, or patient
of the recalled drug and the board as soon as possible within 12
hours of the recall notice, if use of or exposure to the recalled
drug may cause serious adverse health consequences or death and if
the recalled drug was dispensed or is intended for use in this state.
This bill would make a technical correction to this provision and
would require a pharmacy that issues a recall notice regarding a
nonsterile compounded drug to contact the recipient pharmacy,
prescriber, or patient of the recalled drug and the board within 12
hours of the recall notice, if use of or exposure to the recalled
drug may cause serious adverse health consequences or death and if
the recalled drug was dispensed or is intended for use in this state.
The bill would also require a pharmacy that has been advised that a
patient has been harmed by using a nonsterile compounded product
potentially attributable to the pharmacy to report the event to the
MedWatch program of the federal Food and Drug Administration within
72 hours.
The Pharmacy Law authorizes specified clinics to purchase drugs at
wholesale for administration or dispensing, under the direction of a
physician and surgeon, to the clinic's patients. That law requires
each clinic location to have a separate license.
This bill would require the board to synchronize license renewal
dates and aggregate fees for multiple clinics under common nonprofit
ownership at the request of the parent organization.
Existing law authorizes specified healing arts licensees to be
shareholders, officers, directors, or professional employees of a
designated professional corporation, subject to certain limitations
relating to ownership of shares.
This bill would additionally authorize licensed pharmacists to be
shareholders, officers, directors, or professional employees of a
designated professional corporation, subject to certain limitations
relating to ownership of shares.
Existing law authorizes, with the approval of the board and the
Department of Justice, a pharmacy or hospital to receive electronic
data transmission prescriptions and computer entry prescriptions or
orders for controlled substances in Schedule II, III, IV, or V, if
authorized by federal law and in accordance with regulations
promulgated by the federal Drug Enforcement Administration. Existing
law requires the board to maintain a list of all requests and
approvals granted. Existing law prohibits an approved pharmacy or
hospital receiving an electronic transmission prescription or a
computer entry prescription or order for a controlled substance in
Schedule II, III, IV, or V from being required to reduce that
prescription or order to writing or to hard copy form as long as the
pharmacy or hospital is able to immediately produce a specified hard
copy upon request.
This bill would remove these provisions.
The Pharmacy Law makes a violation of any of its provisions
punishable as a misdemeanor or an infraction, as specified.
By placing new requirements on a pharmacy, this bill would expand
an existing crime and would, therefore, impose a state-mandated local
program.
(3) The Veterinary Medicine Practice Act provides for the
licensure and registration of veterinarians and registered veterinary
technicians and the regulation of the practice of veterinary
medicine by the Veterinary Medical Board, which is within the
Department of Consumer Affairs, and authorizes the board to appoint
an executive officer, as specified.
Existing law repeals the provisions establishing the board and
authorizing the board to appoint an executive officer as of January
1, 2017.
This bill would extend the operation of the board and the
authorization of the board to appoint an executive officer until
January 1, 2021. The bill would authorize a veterinarian or
registered veterinary technician who is under the direct supervision
of a licensed veterinarian to compound a drug for animal use pursuant
to federal law and regulations promulgated by the board and would
require those regulations to, at a minimum, address the storage of
drugs, the level and type of supervision required for compounding
drugs by a registered veterinary technician, and the equipment
necessary for safe compounding of drugs.
The Veterinary Medicine Practice Act exempts certain persons from
the requirements of the act, including a veterinarian employed by
the University of California or the Western University of Health
Sciences while engaged in the performance of specified duties. That
act requires all premises where veterinary medicine, dentistry, and
surgery is being practiced to register with the board. The Veterinary
Medicine Practice Act makes a violation of any of its provisions
punishable as a misdemeanor.
This bill would instead require a veterinarian engaged in the
practice of veterinary medicine employed by the University of
California or by the Western University of Health Sciences and
engaged in the performance of specified duties to be licensed as a
veterinarian in the state or be issued a university license, as
specified. The bill would authorize an individual to apply for and be
issued a university license if he or she meets certain requirements,
including paying an application and license fee. The bill would
require a university license, among other things, to automatically
cease to be valid upon termination or cessation of employment by the
University of California or the Western University of Health
Sciences. The bill would also prohibit a premise registration that is
not renewed within 5 years after its expiration from being renewed,
restored, reissued, or reinstated; however, the bill would authorize
a new premise registration to be issued to an applicant if no fact,
circumstance, or condition exists that would justify the revocation
or suspension of the
registration if the registration was issued and if specified fees are
paid. By requiring additional persons to be licensed under the act
that were previously exempt, the bill would expand the definition of
an existing crime and, therefore, would result in a state-mandated
local program.
The Veterinary Medicine Practice Act requires all fees collected
on behalf of the board to be deposited into the Veterinary Medical
Board Contingent Fund, which continuously appropriates fees deposited
into the fund.
This bill would provide that the Veterinary Medical Board
Contingent Fund is available for expenditure only upon an
appropriation by the Legislature.
(4) This bill would incorporate additional changes in Section 4400
of the Business and Professions Code proposed by SB 1039 that would
become operative only if SB 1039 and this bill are both chaptered and
become effective on or before January 1, 2017, and this bill is
chaptered last.
(5) This bill would incorporate additional changes in Section 4830
of the Business and Professions Code proposed by SB 1039 that would
become operative only if SB 1039 and this bill are both chaptered and
become effective on or before January 1, 2017, and this bill is
chaptered last.
(6) The California Constitution requires the state to reimburse
local agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 2909.5 of the Business and Professions Code is
amended to read:
2909.5. This chapter shall not be construed as restricting or
preventing activities of a psychological nature or the use of the
official title of the position for which persons were employed on the
part of persons who meet the educational requirements of subdivision
(b) of Section 2914 and who have one year or more of the supervised
professional experience referenced in subdivision (c) of Section
2914, if they are employed by nonprofit community agencies that
receive a minimum of 25 percent of their financial support from any
federal, state, county, or municipal governmental organizations for
the purpose of training and providing services, provided those
persons are performing those activities as part of the duties for
which they were employed, are performing those activities solely
within the confines of or under the jurisdiction of the organization
in which they are employed and do not render or offer to render
psychological services to the public, as defined in Section 2903.
Those persons shall be registered by the agency with the board at the
time of employment and shall be identified in the setting as a
"registered psychologist." Those persons shall be exempt from this
chapter for a maximum period of 30 months from the date of
registration.
SEC. 2. Section 2913 of the Business and Professions Code is
amended to read:
2913. A person other than a licensed psychologist may perform
psychological functions in preparation for licensure as a
psychologist only if all of the following conditions are met:
(a) The person shall register himself or herself with the board as
a "psychological assistant." This registration shall be renewed
annually in accordance with regulations adopted by the board.
(b) The person (1) has completed a master's degree in psychology
or education with the field of specialization in psychology or
counseling psychology, or (2) has been admitted to candidacy for a
doctoral degree in psychology or education with the field of
specialization in psychology or counseling psychology, after having
satisfactorily completed three or more years of postgraduate
education in psychology and having passed preliminary doctoral
examinations, or (3) has completed a doctoral degree that qualifies
for licensure under Section 2914.
(c) (1) The psychological assistant is at all times under the
immediate supervision, as defined in regulations adopted by the
board, of a licensed psychologist, or a licensed physician and
surgeon who is certified in psychiatry by the American Board of
Psychiatry and Neurology or the American College of Osteopathic Board
of Neurology and Psychiatry, who shall be responsible for insuring
that the extent, kind, and quality of the psychological services that
the psychological assistant performs are consistent with his or her
training and experience and be responsible for the psychological
assistant's compliance with this chapter and regulations.
(2) A licensed psychologist or board certified psychiatrist shall
not supervise more than three psychological assistants at any given
time. No psychological assistant may provide psychological services
to the public except as a supervisee pursuant to this section.
(d) The psychological assistant shall comply with regulations that
the board may, from time to time, duly adopt relating to the
fulfillment of requirements in continuing education.
SEC. 3. Section 2914 of the Business and Professions Code is
amended to read:
2914. Each applicant for licensure shall comply with all of the
following requirements:
(a) Is not subject to denial of licensure under Division 1.5
(commencing with Section 475).
(b) Possess an earned doctorate degree (1) in psychology, (2) in
educational psychology, or (3) in education with the field of
specialization in counseling psychology or educational psychology.
Except as provided in subdivision (h), this degree or training shall
be obtained from an accredited university, college, or professional
school. The board shall make the final determination as to whether a
degree meets the requirements of this section.
(c) (1) On or after January 1, 2020, possess an earned doctorate
degree in psychology, in educational psychology, or in education with
the field of specialization in counseling psychology or educational
psychology from a college or institution of higher education that is
accredited by a regional accrediting agency recognized by the United
States Department of Education. Until January 1, 2020, the board may
accept an applicant who possesses a doctorate degree in psychology,
educational psychology, or in education with the field of
specialization in counseling psychology or educational psychology
from an institution that is not accredited by an accrediting agency
recognized by the United States Department of Education, but is
approved to operate in this state by the Bureau for Private
Postsecondary Education.
(2) Paragraph (1) does not apply to any student who was enrolled
in a doctoral program in psychology, educational psychology, or in
education with the field of specialization in counseling psychology
or educational psychology at a nationally accredited or approved
institution as of December 31, 2016.
(3) No educational institution shall be denied recognition as an
accredited academic institution solely because its program is not
accredited by any professional organization of psychologists, and
nothing in this chapter or in the administration of this chapter
shall require the registration with the board by educational
institutions of their departments of psychology or their doctoral
programs in psychology.
(4) An applicant for licensure trained in an educational
institution outside the United States or Canada shall demonstrate to
the satisfaction of the board that he or she possesses a doctorate
degree in psychology that is equivalent to a degree earned from a
regionally accredited university in the United States or Canada.
These applicants shall provide the board with a comprehensive
evaluation of the degree performed by a foreign credential evaluation
service that is a member of the National Association of Credential
Evaluation Services (NACES), and any other documentation the board
deems necessary.
(d) (1) Have engaged for at least two years in supervised
professional experience under the direction of a licensed
psychologist, the specific requirements of which shall be defined by
the board in its regulations, or under suitable alternative
supervision as determined by the board in regulations duly adopted
under this chapter, at least one year of which shall be after being
awarded the doctorate in psychology. The supervisor shall submit
verification of the experience required by this subdivision to the
trainee in a manner prescribed by the board. If the supervising
licensed psychologist fails to provide verification to the trainee in
a timely manner, the board may establish alternative procedures for
obtaining the necessary documentation. Absent good cause, the failure
of a supervising licensed psychologist to provide the verification
to the board upon request shall constitute unprofessional conduct.
(2) The board shall establish qualifications by regulation for
supervising psychologists.
(e) Take and pass the examination required by Section 2941 unless
otherwise exempted by the board under this chapter.
(f) Show by evidence satisfactory to the board that he or she has
completed training in the detection and treatment of alcohol and
other chemical substance dependency. This requirement applies only to
applicants who matriculate on or after September 1, 1985.
(g) (1) Show by evidence satisfactory to the board that he or she
has completed coursework in spousal or partner abuse assessment,
detection, and intervention. This requirement applies to applicants
who began graduate training during the period commencing on January
1, 1995, and ending on December 31, 2003.
(2) An applicant who began graduate training on or after January
1, 2004, shall show by evidence satisfactory to the board that he or
she has completed a minimum of 15 contact hours of coursework in
spousal or partner abuse assessment, detection, and intervention
strategies, including knowledge of community resources, cultural
factors, and same gender abuse dynamics. An applicant may request an
exemption from this requirement if he or she intends to practice in
an area that does not include the direct provision of mental health
services.
(3) Coursework required under this subdivision may be satisfactory
if taken either in fulfillment of other educational requirements for
licensure or in a separate course. This requirement for coursework
shall be satisfied by, and the board shall accept in satisfaction of
the requirement, a certification from the chief academic officer of
the educational institution from which the applicant graduated that
the required coursework is included within the institution's required
curriculum for graduation.
(h) Until January 1, 2020, an applicant holding a doctoral degree
in psychology from an approved institution is deemed to meet the
requirements of this section if both of the following are true:
(1) The approved institution offered a doctoral degree in
psychology designed to prepare students for a license to practice
psychology and was approved by the former Bureau for Private
Postsecondary and Vocational Education on or before July 1, 1999.
(2) The approved institution has not, since July 1, 1999, had a
new location, as described in Section 94823.5 of the Education Code.
SEC. 4. Section 2914.1 of the Business and Professions Code is
amended to read:
2914.1. The board shall encourage every licensed psychologist to
take continuing professional development in geriatric pharmacology.
SEC. 5. Section 2914.2 of the Business and Professions Code is
amended to read:
2914.2. The board shall encourage licensed psychologists to take
continuing professional development in psychopharmacology and
biological basis of behavior.
SEC. 6. Section 2915 of the Business and Professions Code is
amended to read:
2915. (a) Except as provided in this section, the board shall
issue a renewal license only to an applicant who has completed 36
hours of approved continuing professional development in the
preceding two years.
(b) Each person who applies to renew or reinstate his or her
license issued pursuant to this chapter shall certify under penalty
of perjury that he or she is in compliance with this section and
shall retain proof of this compliance for submission to the board
upon request. False statements submitted pursuant to this section
shall be a violation of Section 2970.
(c) Continuing professional development means certain continuing
education learning activities approved in four different categories:
(1) Professional.
(2) Academic.
(3) Sponsored continuing education coursework.
(4) Board certification from the American Board of Professional
Psychology.
The board may develop regulations further defining acceptable
continuing professional development activities.
(d) (1) The board shall require a licensed psychologist who began
graduate study prior to January 1, 2004, to take a continuing
education course during his or her first renewal period after the
operative date of this section in spousal or partner abuse
assessment, detection, and intervention strategies, including
community resources, cultural factors, and same gender abuse
dynamics. Equivalent courses in spousal or partner abuse assessment,
detection, and intervention strategies taken prior to the operative
date of this section or proof of equivalent teaching or practice
experience may be submitted to the board and at its discretion, may
be accepted in satisfaction of this requirement.
(2) Continuing education courses taken pursuant to this
subdivision shall be applied to the 36 hours of approved continuing
professional development required under subdivision (a).
(e) Continuing education courses approved to meet the requirements
of this section shall be approved by organizations approved by the
board. An organization previously approved by the board to provide or
approve continuing education is deemed approved under this section.
(f) The board may accept continuing education courses approved by
an entity that has demonstrated to the board in writing that it has,
at a minimum, a 10-year history of providing educational programming
for psychologists and has documented procedures for maintaining a
continuing education approval program. The board shall adopt
regulations necessary for implementing this section.
(g) The board may grant an exemption, or an extension of the time
for compliance with, from the continuing professional development
requirement of this section.
(h) The administration of this section may be funded through
professional license fees and continuing education provider and
course approval fees, or both. The fees related to the administration
of this section shall not exceed the costs of administering the
corresponding provisions of this section.
SEC. 7. Section 2920 of the Business and Professions Code is
amended to read:
2920. (a) The Board of Psychology shall enforce and administer
this chapter. The board shall consist of nine members, four of whom
shall be public members.
(b) This section shall remain in effect only until January 1,
2021, and as of that date is repealed.
(c) Notwithstanding any other law, the repeal of this section
renders the board subject to review by the appropriate policy
committees of the Legislature.
SEC. 8. Section 2933 of the Business and Professions Code is
amended to read:
2933. (a) Except as provided by Section 159.5, the board shall
employ and shall make available to the board within the limits of the
funds received by the board all personnel necessary to carry out
this chapter. The board may employ, exempt from the State Civil
Service Act, an executive officer to the Board of Psychology. The
board shall make all expenditures to carry out this chapter. The
board may accept contributions to effectuate the purposes of this
chapter.
(b) This section shall remain in effect only until January 1,
2021, and as of that date is repealed.
SEC. 9. Section 2934.1 is added to the Business and Professions
Code, to read:
2934.1. (a) The board may post on its Internet Web site the
following information on the current status of the license for all
current and former licensees:
(1) Whether or not the licensee has a record of a disciplinary
action.
(2) Any of the following enforcement actions or proceedings
against the licensee:
(A) Temporary restraining orders.
(B) Interim suspension orders.
(C) Revocations, suspensions, probations, or limitations on
practice ordered by the board or by a court with jurisdiction in the
state, including those made part of a probationary order, cease
practice order, or stipulated agreement.
(D) Accusations filed by the board, including those accusations
that are on appeal, excluding ones that have been dismissed or
withdrawn where the action is no longer pending.
(E) Citations issued by the board. Unless withdrawn, citations
shall be posted for five years from the date of issuance.
(b) The board may also post on its Internet Web site all of the
following historical information in its possession, custody, or
control regarding all current and former licensees:
(1) Institutions that awarded the qualifying educational degree
and type of degree awarded.
(2) A link to the licensee's professional Internet Web site. Any
link that provides access to a licensee's professional Internet Web
site, once clicked, shall be accompanied by a notification that
informs the Internet Web site viewer that they are no longer on the
board's Internet Web site.
(c) The board may also post other information designated by the
board in regulation.
SEC. 10. Section 2947 of the Business and Professions Code is
repealed.
SEC. 11. Section 2988.5 is added to the Business and Professions
Code, to read:
2988.5. (a) The board may issue, upon an application prescribed
by the board and payment of a fee not to exceed seventy-five dollars
($75), a retired license to a psychologist who holds a current
license issued by the board, or one capable of being renewed, and
whose license is not suspended, revoked, or otherwise restricted by
the board or subject to discipline under this chapter.
(b) The holder of a retired license issued pursuant to this
section shall not engage in any activity for which an active license
is required. A psychologist holding a retired license shall be
permitted to use the title "psychologist, retired" or "retired
psychologist." The designation of retired shall not be abbreviated in
any way.
(c) A retired license shall not be subject to renewal.
(d) The holder of a retired license may apply to obtain an active
status license as follows:
(1) If that retired license was issued less than three years prior
to the application date, the applicant shall meet all of the
following requirements:
(A) Has not committed an act or crime constituting grounds for
denial or discipline of a license.
(B) Pays the renewal fee required by this chapter.
(C) Completes the continuing professional development required for
the renewal of a license within two years of the date of application
for restoration.
(D) Complies with the fingerprint submission requirements
established by the board.
(2) Where the applicant has held a retired license for three or
more years, the applicant shall do all of the following:
(A) Submit a complete application for a new license.
(B) Take and pass the California Psychology Law and Ethics
Examination.
(C) Pay all fees required to obtain a new license.
(D) Comply with the fingerprint submission requirements
established by the board.
(E) Be deemed to have met the educational and experience
requirements of subdivisions (b) and (c) of Section 2914.
(F) Establish that he or she has not been subject to denial or
discipline of a license.
SEC. 12. Section 4001 of the Business and Professions Code is
amended to read:
4001. (a) There is in the Department of Consumer Affairs a
California State Board of Pharmacy in which the administration and
enforcement of this chapter is vested. The board consists of 13
members.
(b) The Governor shall appoint seven competent pharmacists who
reside in different parts of the state to serve as members of the
board. The Governor shall appoint four public members, and the Senate
Committee on Rules and the Speaker of the Assembly shall each
appoint a public member who shall not be a licensee of the board, any
other board under this division, or any board referred to in Section
1000 or 3600.
(c) At least five of the seven pharmacist appointees to the board
shall be pharmacists who are actively engaged in the practice of
pharmacy. Additionally, the membership of the board shall include at
least one pharmacist representative from each of the following
practice settings: an acute care hospital, an independent community
pharmacy, a chain community pharmacy, and a long-term health care or
skilled nursing facility. The pharmacist appointees shall also
include a pharmacist who is a member of a labor union that represents
pharmacists. For the purposes of this subdivision, a "chain
community pharmacy" means a chain of 75 or more stores in California
under the same ownership, and an "independent community pharmacy"
means a pharmacy owned by a person or entity who owns no more than
four pharmacies in California.
(d) Members of the board shall be appointed for a term of four
years. No person shall serve as a member of the board for more than
two consecutive terms. Each member shall hold office until the
appointment and qualification of his or her successor or until one
year shall have elapsed since the expiration of the term for which
the member was appointed, whichever first occurs. Vacancies occurring
shall be filled by appointment for the unexpired term.
(e) Each member of the board shall receive a per diem and expenses
as provided in Section 103.
(f) This section shall remain in effect only until January 1,
2021, and as of that date is repealed. Notwithstanding any other law,
the repeal of this section renders the board subject to review by
the appropriate policy committees of the Legislature.
SEC. 13. Section 4003 of the Business and Professions Code is
amended to read:
4003. (a) The board, with the approval of the director, may
appoint a person exempt from civil service who shall be designated as
an executive officer and who shall exercise the powers and perform
the duties delegated by the board and vested in him or her by this
chapter. The executive officer may or may not be a member of the
board as the board may determine.
(b) The executive officer shall receive the compensation as
established by the board with the approval of the Director of
Finance. The executive officer shall also be entitled to travel and
other expenses necessary in the performance of his or her duties.
(c) The executive officer shall maintain and update in a timely
fashion records containing the names, titles, qualifications, and
places of business of all persons subject to this chapter.
(d) The executive officer shall give receipts for all money
received by him or her and pay it to the department, taking its
receipt therefor. Besides the duties required by this chapter, the
executive officer shall perform other duties pertaining to the office
as may be required of him or her by the board.
(e) This section shall remain in effect only until January 1,
2021, and as of that date is repealed.
SEC. 14. Section 4013 of the Business and Professions Code is
amended to read:
4013. (a) Any facility licensed by the board shall join the board'
s email notification list within 60 days of obtaining a license or at
the time of license renewal.
(b) Any facility licensed by the board shall update its email
address with the board's email notification list within 30 days of a
change in the facility's email address.
(c) An owner of two or more facilities licensed by the board may
comply with subdivisions (a) and (b) by subscribing a single email
address to the board's email notification list, where the owner
maintains an electronic notice system within all of its licensed
facilities that, upon receipt of an email notification from the
board, immediately transmits electronic notice of the same
notification to all of its licensed facilities. If an owner chooses
to comply with this section by using such an electronic notice
system, the owner shall register the electronic notice system with
the board by July 1, 2011, or within 60 days of initial licensure,
whichever is later, informing the board of the single email address
to be utilized by the owner, describing the electronic notice system,
and listing all facilities to which immediate notice will be
provided. The owner shall update its email address with the board's
email notification list within 30 days of any change in the owner's
email address.
(d) (1) Each pharmacist, intern pharmacist, pharmacy technician,
designated representative-3PL licensed in this state shall join the
board's email notification list within 60 days of obtaining a license
or at the time of license renewal.
(2) Each pharmacist, intern pharmacist, pharmacy technician,
designated representative, and designated representative-3PL licensed
in this state shall update his or her email address with the board's
email notification list within 30 days of a change in the licensee's
email address.
(3) The email address provided by a licensee shall not be posted
on the board's online license verification system.
(4) The board shall, with each renewal application, remind
licensees of their obligation to report and keep current their email
address with the board's email notification list.
(5) This subdivision shall become operative on July 1, 2017.
SEC. 15. Section 4034 is added to the Business and Professions
Code, to read:
4034. "Outsourcing facility" means a facility that meets all of
the following:
(a) Is located within the United States of America at one address
that is engaged in the compounding of sterile drugs and nonsterile
drugs.
(b) Has registered as an outsourcing facility with the federal
Food and Drug Administration under Section 503B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. Sec. 353b).
(c) Is doing business within or into California.
(d) Is licensed with the board as an outsourcing facility pursuant
to Article 7.7 (commencing with Section 4129).
SEC. 16. Section 4035 of the Business and Professions Code is
amended to read:
4035. "Person" includes, but is not limited to, firm,
association, partnership, corporation, limited liability company,
state governmental agency, trust, or political subdivision.
SEC. 17. Section 4081 of the Business and Professions Code is
amended to read:
4081. (a) All records of manufacture and of sale, acquisition,
receipt, shipment, or disposition of dangerous drugs or dangerous
devices shall be at all times during business hours open to
inspection by authorized officers of the law, and shall be preserved
for at least three years from the date of making. A current inventory
shall be kept by every manufacturer, wholesaler, third-party
logistics provider, pharmacy, veterinary food-animal drug retailer,
outsourcing facility, physician, dentist, podiatrist, veterinarian,
laboratory, clinic, hospital, institution, or establishment holding a
currently valid and unrevoked certificate, license, permit,
registration, or exemption under Division 2 (commencing with Section
1200) of the Health and Safety Code or under Part 4 (commencing with
Section 16000) of Division 9 of the Welfare and Institutions Code who
maintains a stock of dangerous drugs or dangerous devices.
(b) The owner, officer, and partner of a pharmacy, wholesaler,
third-party logistics provider, or veterinary food-animal drug
retailer shall be jointly responsible, with the pharmacist-in-charge,
responsible manager, or designated representative-in-charge, for
maintaining the records and inventory described in this section.
(c) The pharmacist-in-charge, responsible manager, or designated
representative-in-charge shall not be criminally responsible for acts
of the owner, officer, partner, or employee that violate this
section and of which the pharmacist-in-charge, responsible manager,
or designated representative-in-charge had no knowledge, or in which
he or she did not
knowingly participate.
SEC. 18. Section 4105.5 is added to the Business and Professions
Code, to read:
4105.5. (a) For purposes of this section, an "automated drug
delivery system" has the same meaning as that term is defined in
paragraph (1) of subdivision (a) of Section 1261.6 of the Health and
Safety Code.
(b) Except as provided by subdivision (e), a pharmacy that owns or
provides dangerous drugs dispensed through an automated drug
delivery system shall register the automated drug delivery system by
providing the board in writing with the location of each device
within 30 days of installation of the device, and on an annual basis
as part of the license renewal pursuant to subdivision (a) of Section
4110. The pharmacy shall also advise the board in writing within 30
days if the pharmacy discontinues operating an automated drug
delivery system.
(c) A pharmacy may only use an automated drug delivery system if
all of the following conditions are satisfied:
(1) Use of the automated drug delivery system is consistent with
legal requirements.
(2) The pharmacy's policies and procedures related to the
automated drug delivery system to include appropriate security
measures and monitoring of the inventory to prevent theft and
diversion.
(3) The pharmacy reports drug losses from the automated drug
delivery system to the board as required by law.
(4) The pharmacy license is unexpired and not subject to
disciplinary conditions.
(d) The board may prohibit a pharmacy from using an automated drug
delivery system if the board determines that the conditions provided
in subdivision (c) are not satisfied. If such a determination is
made, the board shall provide the pharmacy with written notice
including the basis for the determination. The pharmacy may request
an office conference to appeal the board's decision within 30 days of
receipt of the written notice. The executive officer or designee may
affirm or overturn the prohibition as a result of the office
conference.
(e) An automated drug delivery system operated by a licensed
hospital pharmacy as defined in Section 4029 for doses administered
in a facility operated under a consolidated license under Section
1250.8 of the Health and Safety Code shall be exempt from the
requirements of subdivision (b).
SEC. 19. Section 4107 of the Business and Professions Code is
amended to read:
4107. (a) The board shall not issue more than one site license to
a single premises except as follows:
(1) To issue a veterinary food-animal drug retailer license to a
wholesaler pursuant to Section 4196.
(2) To issue a license to compound sterile drugs to a pharmacy
pursuant to Section 4127.1 or 4127.2.
(3) To issue a centralized hospital packaging license pursuant to
Section 4128.
(b) For the purposes of this subdivision, "premises" means a
location with its own address and an independent means of ingress and
egress.
SEC. 20. Section 4110 of the Business and Professions Code is
amended to read:
4110. (a) No person shall conduct a pharmacy in the State of
California unless he or she has obtained a license from the board. A
license shall be required for each pharmacy owned or operated by a
specific person. A separate license shall be required for each of the
premises of any person operating a pharmacy in more than one
location. The license shall be renewed annually. The board may, by
regulation, determine the circumstances under which a license may be
transferred.
(b) The board may, at its discretion, issue a temporary permit
upon the conditions and for any periods of time as the board
determines to be in the public interest. A temporary permit fee shall
be required in an amount established by the board as specified in
subdivision (a) of Section 4400. When needed to protect public
safety, a temporary permit may be issued for a period not to exceed
180 days, and may be issued subject to terms and conditions the board
deems necessary. If the board determines a temporary permit was
issued by mistake or denies the application for a permanent license
or registration, the temporary license or registration shall
terminate upon either personal service of the notice of termination
upon the permitholder or service by certified mail, return receipt
requested, at the permitholder's address of record with the board,
whichever comes first. Neither for purposes of retaining a temporary
permit nor for purposes of any disciplinary or license denial
proceeding before the board shall the temporary permitholder be
deemed to have a vested property right or interest in the permit.
(c) The board may allow the temporary use of a mobile pharmacy
when a pharmacy is destroyed or damaged, the mobile pharmacy is
necessary to protect the health and safety of the public, and the
following conditions are met:
(1) The mobile pharmacy shall provide services only on or
immediately contiguous to the site of the damaged or destroyed
pharmacy.
(2) The mobile pharmacy is under the control and management of the
pharmacist-in-charge of the pharmacy that was destroyed or damaged.
(3) A licensed pharmacist is on the premises while drugs are being
dispensed.
(4) Reasonable security measures are taken to safeguard the drug
supply maintained in the mobile pharmacy.
(5) The pharmacy operating the mobile pharmacy provides the board
with records of the destruction of, or damage to, the pharmacy and an
expected restoration date.
(6) Within three calendar days of restoration of the pharmacy
services, the board is provided with notice of the restoration of the
permanent pharmacy.
(7) The mobile pharmacy is not operated for more than 48 hours
following the restoration of the permanent pharmacy.
SEC. 21. Section 4119.1 of the Business and Professions Code is
amended to read:
4119.1. (a) A pharmacy may provide pharmacy services to a health
facility licensed pursuant to subdivision (c), (d), or both, of
Section 1250 of the Health and Safety Code, through the use of an
automated drug delivery system that need not be located at the same
location as the pharmacy.
(b) Drugs stored in an automated drug delivery system shall be
part of the inventory of the pharmacy providing pharmacy services to
that facility, and drugs dispensed from the pharmacy system shall be
considered to have been dispensed by that pharmacy.
(c) (1) The pharmacy shall maintain records of the acquisition and
disposition of dangerous drugs and dangerous devices stored in the
automated drug delivery system separate from other pharmacy records.
(2) The pharmacy shall own and operate the automated drug delivery
system.
(3) The pharmacy shall provide training regarding the operation
and use of the automated drug delivery system to both pharmacy and
health facility personnel using the system.
(4) The pharmacy shall operate the automated drug delivery system
in compliance with Section 1261.6 of the Health and Safety Code.
(d) The operation of the automated drug delivery system shall be
under the supervision of a licensed pharmacist. To qualify as a
supervisor for an automated drug delivery system, the pharmacist need
not be physically present at the site of the automated drug delivery
system and may supervise the system electronically.
(e) This section shall not be construed to revise or limit the use
of automated drug delivery systems as permitted by the board in any
licensed health facility other than a facility defined in subdivision
(c) or (d), or both, of Section 1250 of the Health and Safety Code.
SEC. 22. Section 4126.9 is added to the Business and Professions
Code, to read:
4126.9. (a) A pharmacy that issues a recall notice regarding a
nonsterile compounded drug product shall, in addition to any other
duties, contact the recipient pharmacy, prescriber, or patient of the
recalled drug and the board within 12 hours of the recall notice if
both of the following apply:
(1) Use of or exposure to the recalled drug may cause serious
adverse health consequences or death.
(2) The recalled drug was dispensed, or is intended for use, in
this state.
(b) A recall notice issued pursuant to subdivision (a) shall be
made as follows:
(1) If the recalled drug was dispensed directly to the patient,
the notice shall be made to the patient.
(2) If the recalled drug was dispensed directly to the prescriber,
the notice shall be made to the prescriber, who shall ensure the
patient is notified.
(3) If the recalled drug was dispensed directly to a pharmacy, the
notice shall be made to the pharmacy, which shall notify the
prescriber or patient, as appropriate. If the pharmacy notifies the
prescriber, the prescriber shall ensure the patient is notified.
(c) A pharmacy that has been advised that a patient has been
harmed by using a nonsterile compounded product potentially
attributable to the pharmacy shall report the event to MedWatch
within 72 hours of the pharmacy being advised.
SEC. 23. Section 4127 of the Business and Professions Code is
amended to read:
4127. (a) A pharmacy that compounds sterile drug products shall
possess a sterile compounding pharmacy license as provided in this
article.
(b) The board shall adopt regulations in accordance with the
Administrative Procedure Act (Chapter 3.5 (commencing with Section
11340) of Part 1 of Division 3 of Title 2 of the Government Code) to
establish policies, guidelines, and procedures to implement this
article.
(c) The board shall review any formal revision to General Chapter
797 of the United States Pharmacopeia and The National Formulary
(USP-NF), relating to the compounding of sterile preparations, not
later than 90 days after the revision becomes official, to determine
whether amendments are necessary for the regulations adopted by the
board pursuant to subdivision (b).
SEC. 24. Section 4127.3 of the Business and Professions Code is
amended to read:
4127.3. (a) Whenever the board has a reasonable belief, based on
information obtained during an inspection or investigation by the
board, that a pharmacy compounding sterile drug products poses an
immediate threat to the public health or safety, the executive
officer of the board may issue an order to the pharmacy to
immediately cease and desist from compounding sterile drug products.
The cease and desist order shall remain in effect for no more than 30
days or the date of a hearing seeking an interim suspension order,
whichever is earlier.
(b) Whenever the board issues a cease and desist order pursuant to
subdivision (a), the board shall immediately issue the owner a
notice setting forth the acts or omissions with which the owner is
charged, specifying the pertinent code section or sections.
(c) The order shall provide that the owner, within 15 days of
receipt of the notice, may request a hearing before the president of
the board to contest the cease and desist order. Consideration of the
owner's contest of the cease and desist order shall comply with the
requirements of Section 11425.10 of the Government Code. The hearing
shall be held no later than five days from the date the request of
the owner is received by the board. The president shall render a
written decision within five days of the hearing. In the absence of
the president of the board, the vice president of the board may
conduct the hearing permitted by this subdivision. Review of the
decision of the president of the board may be sought by the owner or
person in possession or control of the pharmacy pursuant to Section
1094.5 of the Code of Civil Procedure.
(d) Failure to comply with a cease and desist order issued
pursuant to this section shall be unprofessional conduct.
SEC. 25. Section 4127.7 of the Business and Professions Code is
amended to read:
4127.7. A pharmacy shall compound sterile products from one or
more nonsterile ingredients in one of the following environments:
(a) An ISO class 5 laminar airflow hood within an ISO class 7
cleanroom. The cleanroom must have a positive air pressure
differential relative to adjacent areas.
(b) An ISO class 5 cleanroom.
(c) A barrier isolator that provides an ISO class 5 environment
for compounding.
SEC. 26. Section 4127.8 of the Business and Professions Code is
amended to read:
4127.8. The board may, at its discretion, issue a temporary
license to compound sterile drug products upon the conditions and for
any periods of time as the board determines to be in the public
interest. A temporary license fee shall be required in an amount
established by the board as specified in subdivision (u) of Section
4400. When needed to protect public safety, a temporary license may
be issued for a period not to exceed 180 days, and may be issued
subject to terms and conditions the board deems necessary. If the
board determines a temporary license was issued by mistake or denies
the application for a permanent license, the temporary license shall
terminate upon either personal service of the notice of termination
upon the licenseholder or service by certified mail, return receipt
requested at the licenseholder's address of record with the board,
whichever comes first. Neither for purposes of retaining a temporary
license nor for purposes of any disciplinary or license denial
proceeding before the board shall the temporary licenseholder be
deemed to have a vested property right or interest in the license.
SEC. 27. Section 4127.9 of the Business and Professions Code is
amended to read:
4127.9. (a) A pharmacy licensed pursuant to Section 4127.1 or
4127.2 that issues a recall notice regarding a sterile compounded
drug shall, in addition to any other duties, contact the recipient
pharmacy, prescriber, or patient of the recalled drug and the board
as soon as possible within 12 hours of the recall notice if both of
the following apply:
(1) Use of or exposure to the recalled drug may cause serious
adverse health consequences or death.
(2) The recalled drug was dispensed, or is intended for use, in
this state.
(b) A recall notice issued pursuant to subdivision (a) shall be
made as follows:
(1) If the recalled drug was dispensed directly to the patient,
the notice shall be made to the patient.
(2) If the recalled drug was dispensed directly to the prescriber,
the notice shall be made to the prescriber, who shall ensure the
patient is notified.
(3) If the recalled drug was dispensed directly to a pharmacy, the
notice shall be made to the pharmacy, who shall notify the
prescriber or patient, as appropriate. If the pharmacy notifies the
prescriber, the prescriber shall ensure the patient is notified.
SEC. 28. Section 4128.6 of the Business and Professions Code is
amended to read:
4128.6. All compounding and packaging functions specified in
Section 4128 shall be performed only in the licensed centralized
hospital packaging pharmacy and that pharmacy shall comply with all
applicable federal and state statutes and regulations, including, but
not limited to, regulations regarding compounding and, when
appropriate, sterile compounding.
SEC. 29. Article 7.7 (commencing with Section 4129) is added to
Chapter 9 of Division 2 of the Business and Professions Code, to
read:
Article 7.7. Outsourcing Facilities
4129. (a) A facility licensed as an outsourcing facility with the
federal Food and Drug Administration (FDA) shall be concurrently
licensed with the board as an outsourcing facility if it compounds
sterile medication or nonsterile medication for nonpatient-specific
distribution within or into California.
(b) A facility premises licensed with the board as a sterile
compounding pharmacy shall not be concurrently licensed with the
board as an outsourcing facility at the same location.
(c) The board may adopt regulations in accordance with the
Administrative Procedure Act (Chapter 3.5 (commencing with Section
11340) of Part 1 of Division 3 of Title 2 of the Government Code) to
establish policies, guidelines, and procedures to implement this
article.
(d) The board shall review any formal requirements or guidance
documents developed by the FDA regarding outsourcing facilities
within 90 days after their release in order to determine whether
revisions are necessary for any regulations promulgated by the board.
(e) An outsourcing facility licensed by the board shall not
perform the duties of a pharmacy, such as filling individual
prescriptions for individual patients.
4129.1. (a) An outsourcing facility that is licensed with the
federal Food and Drug Administration (FDA) and with an address in
this state shall also be licensed by the board as an outsourcing
facility before doing business within this state. The license shall
be renewed annually and is not transferable.
(b) An outsourcing facility shall compound all sterile products
and nonsterile products in compliance with regulations issued by the
board and with federal current good manufacturing practices
applicable to outsourcing facilities.
(c) An outsourcing facility license shall not be issued or renewed
until the location is inspected by the board and found in compliance
with this article and regulations adopted by the board.
(d) An outsourcing facility license shall not be issued or renewed
until the board does all of the following:
(1) Prior to inspection, reviews a current copy of the outsourcing
facility's policies and procedures for sterile compounding and
nonsterile compounding.
(2) Is provided with copies of all federal and state regulatory
agency inspection reports, as well as accreditation reports, and
certification reports of facilities or equipment of the outsourcing
facility's premises conducted in the prior 12 months.
(3) Prior to inspection, receives a list of all sterile drugs and
nonsterile drugs compounded by the outsourcing facility as reported
to the FDA in the last 12 months.
(e) An outsourcing facility licensed pursuant to this section
shall provide the board with all of the following:
(1) A copy of any disciplinary or other action taken by another
state or the FDA within 10 days of the action.
(2) Notice within 24 hours of any recall notice issued by the
outsourcing facility.
(3) A copy of any clinically related complaint it receives
involving an outsourcing facility's compounded products from or
involving any provider, pharmacy, or patient in California within 72
hours of receipt.
(4) Notice within 24 hours after learning of adverse effects
reported or potentially attributable to the outsourcing facility's
products.
4129.2. (a) An outsourcing facility that is licensed with the
federal Food and Drug Administration (FDA) as an outsourcing facility
and has an address outside of this state but in the United States of
America is a nonresident outsourcing facility. A nonresident
outsourcing facility shall not compound sterile drug products or
nonsterile drug products for distribution or use into this state
without an outsourcing license issued by the board pursuant to this
section. The license shall be renewed annually and shall not be
transferable.
(b) A nonresident outsourcing facility shall compound all sterile
products and nonsterile products to be distributed or used in this
state in compliance with regulations of the board and with federal
current good manufacturing practices applicable to outsourcing
facilities.
(c) A license for a nonresident outsourcing facility shall not be
issued or renewed until the location is inspected by the board and
found in compliance with this article and any regulations adopted by
the board. The nonresident outsourcing facility shall reimburse the
board for all actual and necessary costs incurred by the board in
conducting an inspection of the nonresident outsourcing facility at
least once annually pursuant to subdivision (x) of Section 4400.
(d) A license for a nonresident outsourcing facility shall not be
issued or renewed until the board:
(1) Prior to inspection, reviews a current copy of the nonresident
outsourcing facility's policies and procedures for sterile
compounding and nonsterile compounding.
(2) (A) Is provided with copies of all federal and state
regulatory agency inspection reports, as well as accreditation
reports, and certification reports of facilities or equipment of the
nonresident outsourcing facility's premises conducted in the prior 12
months.
(B) For purposes of this paragraph, "state" refers to the state in
which the nonresident outsourcing facility resides.
(3) Prior to inspection, receives a list of all sterile drug
products and nonsterile drug products compounded by the pharmacy as
reported to the FDA within the prior 12 months.
(e) A nonresident outsourcing facility licensed pursuant to this
section shall provide the board with all of the following:
(1) A copy of any disciplinary or other action taken by another
state or the FDA within 10 days of the action.
(2) Notice within 24 hours of any recall notice issued by the
nonresident outsourcing facility.
(3) A copy of any complaint it receives involving an outsourcing
facility's compounded products from or involving any provider,
pharmacy, or patient in California within 72 hours of receipt.
(4) Notice within 24 hours after learning of adverse effects
reported or potentially attributable to a nonresident outsourcing
facility's products.
4129.3. (a) On or before January 1, 2018, the board shall provide
a report to the Legislature regarding the regulation of nonresident
outsourcing facilities. The report shall be submitted to the
Legislature in the manner required pursuant to Section 9795 of the
Government Code. At a minimum, the report shall address all of the
following:
(1) A detailed description of board activities related to the
inspection and licensure of nonresident outsourcing facilities.
(2) Whether fee revenue collected pursuant to subdivision (x) of
Section 4400 and travel cost reimbursements collected pursuant to
subdivision (c) of Section 4129.2 provide revenue in an amount
sufficient to support the board's activities related to the
inspection and licensure of nonresident outsourcing facilities.
(3) The status of proposed changes to federal law that are under
serious consideration and that would govern outsourcing facilities
and compounding pharmacies, including, but not limited to,
legislation pending before Congress, administrative rules,
regulations or orders under consideration by the FDA or other
appropriate federal agency, and cases pending before the courts.
(4) If applicable, recommended modifications to the board's
statutory duties related to nonresident outsourcing facilities as a
result of changes to federal law or any additional modifications
necessary to protect the health and safety of the public.
(b) The requirement for submitting a report imposed under
subdivision (a) is inoperative on January 1, 2022, pursuant to
Section 10231.5 of the Government Code.
4129.4. (a) Whenever the board has a reasonable belief, based on
information obtained during an inspection or investigation by the
board, that an outsourcing facility compounding sterile drug products
or nonsterile drug products poses an immediate threat to the public
health or safety, the executive officer of the board may issue an
order to the outsourcing facility to immediately cease and desist
compounding sterile drug products or nonsterile drug products. The
cease and desist order shall remain in effect for no more than 30
days or the date of a hearing seeking an interim suspension order,
whichever is earlier.
(b) Whenever the board issues a cease and desist order pursuant to
subdivision (a), the board shall immediately issue a notice to the
owner setting forth the acts or omissions with which the owner is
charged, specifying the pertinent code section or sections and any
regulations.
(c) The cease and desist order shall state that the owner, within
15 days of receipt of the notice, may request a hearing before the
president of the board to contest the cease and desist order.
Consideration of the owner's contest of the cease and desist order
shall comply with the requirements of Section 11425.10 of the
Government Code. The hearing shall be held no later than five days
after the date the request of the owner is received by the board. The
president shall render a written decision within five days after the
hearing. In the absence of the president of the board, the vice
president of the board may conduct the hearing permitted by this
subdivision. Review of the decision may be sought by the owner or
person in possession or control of the outsourcing facility pursuant
to Section 1094.5 of the Code of Civil Procedure.
(d) Failure to comply with a cease and desist order issued
pursuant to this section shall be unprofessional conduct.
4129.5. Notwithstanding any other law, a violation of this
article, or regulation adopted pursuant thereto, may subject the
person or entity that committed the violation to a fine of up to five
thousand dollars ($5,000) per occurrence pursuant to a citation
issued by the board.
4129.8. The board, at its discretion, may issue a temporary
license to an outsourcing facility upon the conditions and for any
periods of time as the board determines to be in the public interest.
A temporary license fee shall be required as specified in
subdivision (w) of Section 4400. When needed to protect public
safety, a temporary license may be issued for a period not to exceed
180 days, and may be issued subject to terms and conditions the board
deems necessary. If the board determines a temporary license was
issued by mistake or denies the application for a permanent license,
the temporary license shall terminate upon the earlier of personal
service of the notice of termination upon the licenseholder or
service by certified mail with return receipt requested at the
licenseholder's address of record with the board. The temporary
licenseholder shall not be deemed to have a vested property right or
interest in the license for purposes of retaining a temporary license
or for purposes of any disciplinary or license denial proceeding
before the board.
4129.9. (a) An outsourcing facility licensed pursuant to Section
4129.1 or 4129.2 that issues a recall notice for a sterile drug or
nonsterile drug compounded by the outsourcing facility, in addition
to any other duties, shall contact the recipient pharmacy,
prescriber, or patient of the recalled drug and the board as soon as
possible within 24 hours of the recall notice if both of the
following apply:
(1) Use of or exposure to the recalled drug may cause serious
adverse health consequences or death.
(2) The recalled drug was dispensed, or is intended for use, in
this state.
(b) A recall notice issued pursuant to subdivision (a) shall be
made as follows:
(1) If the recalled drug was dispensed directly to the prescriber,
the notice shall be made to the prescriber and the prescriber shall
ensure the patient is notified.
(2) If the recalled drug was dispensed directly to a pharmacy, the
notice shall be made to the pharmacy and that pharmacy shall notify
the prescriber or patient, as appropriate. If the pharmacy notifies
the prescriber, the prescriber shall ensure the patient is notified.
SEC. 30. Section 4161 of the Business and Professions Code is
amended to read:
4161. (a) A person located outside this state that (1) ships,
sells, mails, warehouses, distributes, or delivers dangerous drugs or
dangerous devices into this state or (2) sells, brokers, warehouses,
or distributes dangerous drugs or devices within this state shall be
considered a nonresident wholesaler or a nonresident third-party
logistics provider.
(b) A nonresident wholesaler or nonresident third-party logistics
provider shall be licensed by the board prior to shipping, selling,
mailing, warehousing, distributing, or delivering dangerous drugs or
dangerous devices to a site located in this state or selling,
brokering, warehousing, or distributing dangerous drugs or devices
within this state.
(c) (1) A separate license shall be required for each place of
business owned or operated by a nonresident wholesaler or nonresident
third-party logistics provider from or through which dangerous drugs
or dangerous devices are shipped, sold, mailed, warehoused,
distributed, or delivered to a site located in this state or sold,
brokered, warehoused, or distributed within this state. Each place of
business may only be issued a single license by the board, except as
provided in paragraph (2). A license shall be renewed annually and
shall not be transferable.
(2) A nonresident wholesaler and a nonresident third-party
logistics provider under common ownership may be licensed at the same
place of business provided that all of the following requirements
are satisfied:
(A) The wholesaler and the third-party logistics provider each
separately maintain the records required under Section 4081.
(B) Dangerous drugs and dangerous devices owned by the wholesaler
are not commingled with the dangerous drugs and dangerous devices
handled by the third-party logistics provider.
(C) Any individual acting as a designated representative for the
wholesaler is not concurrently acting as a designated
representative-3PL on behalf of the third-party logistics provider.
Nothing in this subparagraph shall be construed to prohibit an
individual from concurrently holding a license to act as a designated
representative and to act as a designated representative-3PL.
(D) The wholesaler has its own designated representative-in-charge
responsible for the operations of the wholesaler and the third-party
logistics provider has its own responsible manager responsible for
the operations of the third-party logistics provider. The same
individual shall not concurrently serve as the responsible manager
and the designated representative-in-charge for a wholesaler and a
third-party logistics provider licensed at the same place of
business.
(E) The third-party logistics provider does not handle the
prescription drugs or prescription devices owned by a prescriber.
(F) The third-party logistics provider is not a reverse
third-party logistics provider.
(G) The wholesaler is not acting as a reverse distributor.
(d) The following information shall be reported, in writing, to
the board at the time of initial application for licensure by a
nonresident wholesaler or a nonresident third-party logistics
provider, on renewal of a nonresident wholesaler or nonresident
third-party logistics provider license, or within 30 days of a change
in that information:
(1) Its agent for service of process in this state.
(2) Its principal corporate officers, as specified by the board,
if any.
(3) Its general partners, as specified by the board, if any.
(4) Its owners if the applicant is not a corporation or
partnership.
(e) A report containing the information in subdivision (d) shall
be made within 30 days of any change of ownership, office, corporate
officer, or partner.
(f) A nonresident wholesaler or nonresident third-party logistics
provider shall comply with all directions and requests for
information from the regulatory or licensing agency of the state in
which it is licensed, as well as with all requests for information
made by the board.
(g) A nonresident wholesaler or nonresident third-party logistics
provider shall maintain records of dangerous drugs and dangerous
devices sold, traded, transferred, warehoused, or distributed to
persons in this state or within this state, so that the records are
in a readily retrievable form.
(h) A nonresident wholesaler or nonresident third-party logistics
provider shall at all times maintain a valid, unexpired license,
permit, or registration to conduct the business of the wholesaler or
nonresident third-party logistics provider in compliance with the
laws of the state in which it is a resident. An application for a
nonresident wholesaler or nonresident third-party logistics provider
license in this state shall include a license verification from the
licensing authority in the applicant's state of residence.
(i) (1) The board shall not issue or renew a nonresident
wholesaler license until the nonresident wholesaler identifies a
designated representative-in-charge and notifies the board in writing
of the identity and license number of the designated
representative-in-charge.
(2) The board shall not issue or renew a nonresident third-party
logistics provider license until the nonresident third-party
logistics provider identifies a responsible manager and notifies the
board in writing of the identity and license number of the designated
representative-3PL who will be the responsible manager.
(j) The designated representative-in-charge shall be responsible
for the compliance of the nonresident wholesaler with state and
federal laws governing wholesalers. The responsible manager shall be
responsible for the compliance of the nonresident third-party
logistics provider's place of business with state and federal laws
governing third-party logistics providers. A nonresident wholesaler
or nonresident third-party logistics provider shall identify and
notify the board of a new designated representative-in-charge or
responsible manager within 30 days of the date that the prior
designated representative-in-charge or responsible manager ceases to
be the designated representative-in-charge or responsible manager.
(k) The board may issue a temporary license, upon conditions and
for periods of time as the board determines to be in the public
interest. A temporary license fee shall be five hundred fifty dollars
($550) or another amount established by the board not to exceed the
annual fee for renewal of a license to compound sterile drug
products. When needed to protect public safety, a temporary license
may be issued for a period not to exceed 180 days, subject to terms
and conditions that the board deems necessary. If the board
determines that a temporary license was issued by mistake or denies
the application for a permanent license, the temporary license shall
terminate upon either personal service of the notice of termination
upon the licenseholder or service by certified mail, return receipt
requested, at the licenseholder's address of record with the board,
whichever occurs first. Neither for purposes of retaining a temporary
license, nor for purposes of any disciplinary or license denial
proceeding before the board, shall the temporary licenseholder be
deemed to have a vested property right or interest in the license.
( l ) The registration fee shall be the fee specified
in subdivision (f) of Section 4400.
SEC. 31. Section 4180 of the Business and Professions Code is
amended to read:
4180. (a) (1) Notwithstanding any provision of this chapter, any
of the following clinics may purchase drugs at wholesale for
administration or dispensing, under the direction of a physician and
surgeon, to patients registered for care at the clinic:
(A) A licensed nonprofit community clinic or free clinic as
defined in paragraph (1) of subdivision (a) of Section 1204 of the
Health and Safety Code.
(B) A primary care clinic owned or operated by a county as
referred to in subdivision (b) of Section 1206 of the Health and
Safety Code.
(C) A clinic operated by a federally recognized Indian tribe or
tribal organization as referred to in subdivision (c) of Section 1206
of the Health and Safety Code.
(D) A clinic operated by a primary care community or free clinic,
operated on separate premises from a licensed clinic, and that is
open no more than 20 hours per week as referred to in subdivision (h)
of Section 1206 of the Health and Safety Code.
(E) A student health center clinic operated by a public
institution of higher education as referred to in subdivision (j) of
Section 1206 of the Health and Safety Code.
(F) A nonprofit multispecialty clinic as referred to in
subdivision ( l ) of Section 1206 of the Health and Safety
Code.
(2) The clinic shall keep records of the kind and amounts of drugs
purchased, administered, and dispensed, and the records shall be
available and maintained for a minimum of three years for inspection
by all properly authorized personnel.
(b) No clinic shall be entitled to the benefits of this section
until it has obtained a license from the board. A separate license
shall be required for each clinic location. A clinic shall notify the
board of any change in the clinic's address on a form furnished by
the board.
(c) The board shall synchronize license renewal dates and
aggregate fees for multiple clinics under common nonprofit ownership
at the request of the parent organization.
SEC. 32. Section 4201 of the Business and Professions Code is
amended to read:
4201. (a) Each application to conduct a pharmacy, wholesaler,
third-party logistics provider, veterinary food-animal drug retailer,
or outsourcing facility shall be made on a form furnished by the
board and shall state the name, address, usual occupation, and
professional qualifications, if any, of the applicant. If the
applicant is other than a natural person, the application shall state
the information as to each person beneficially interested therein or
any person with management or control over the license.
(b) As used in this section, and subject to subdivision (c), the
term "person beneficially interested" means and includes:
(1) If the applicant is a partnership or other unincorporated
association, each partner or member.
(2) If the applicant is a corporation, each of its officers,
directors, and stockholders, provided that a natural person shall not
be deemed to be beneficially interested in a nonprofit corporation.
(3) If the applicant is a limited liability company, each officer,
manager, or member.
(c) If the applicant is a partnership or other unincorporated
association, a limited liability company, or a corporation, and the
number of partners, members, or stockholders, as the case may be,
exceeds five, the application shall so state, and shall further state
the information required by subdivision (a) as to each of the five
partners, members, or stockholders who own the five largest interests
in the applicant entity. Upon request by the executive officer, the
applicant shall furnish the board with the information required by
subdivision (a) as to partners, members, or stockholders not named in
the application, or shall refer the board to an appropriate source
of that information.
(d) The application shall contain a statement to the effect that
the applicant has not been convicted of a felony and has not violated
any of the provisions of this chapter. If the applicant cannot make
this statement, the application shall contain a statement of the
violation, if any, or reasons which will prevent the applicant from
being able to comply with the requirements with respect to the
statement.
(e) Upon the approval of the application by the board and payment
of the fee required by this chapter for each pharmacy, wholesaler,
third-party logistics provider, or veterinary food-animal drug
retailer, the executive officer of the board shall issue a license to
conduct a pharmacy, wholesaler, third-party logistics provider,
veterinary food-animal drug retailer, or outsourcing facility if all
of the provisions of this chapter have been complied with.
(f) Notwithstanding any other law, the pharmacy license shall
authorize the holder to conduct a pharmacy. The license shall be
renewed annually and shall not be transferable.
(g) Notwithstanding any other law, the wholesaler license shall
authorize the holder to wholesale dangerous drugs and dangerous
devices. The license shall be renewed annually and shall not be
transferable.
(h) Notwithstanding any other law, the third-party logistics
provider license shall authorize the holder to provide or coordinate
warehousing, distribution, or other similar services of dangerous
drugs and dangerous devices. The license shall be renewed annually
and shall not be transferable.
(i) Notwithstanding any other law, the veterinary food-animal drug
retailer license shall authorize the holder to conduct a veterinary
food-animal drug retailer and to sell and dispense veterinary
food-animal drugs as defined in Section 4042.
(j) For licenses referred to in subdivisions (f), (g), (h), and
(i), any change in the proposed beneficial ownership interest shall
be reported to the board within 30 days thereafter upon a form to be
furnished by the board.
SEC. 33. Section 4203.5 is added to the Business and Professions
Code, to read:
4203.5. (a) Notwithstanding any other law, when a clinic
applicant submits either type of application described in subdivision
(b), the board shall issue a license or incorporate the reported
changes, as appropriate, within 30 days of receipt of a completed
application and payment of any prescribed fees.
(b) This section applies to the following types of applications:
(1) A new clinic license application filed under Section 4180.
(2) Applications to report changes to an existing site licensed
under Section 4180, including, but not limited to, changes in
professional director, clinic administrator, corporate officers,
change of location, or change of address.
(c) This section shall not be construed to limit the board's
authority to conduct an investigation to determine whether applicants
and the premises for which an application is made qualify for a
license.
SEC. 34. Section 4301 of the Business and Professions Code is
amended to read:
4301. The board shall take action against any holder of a license
who is guilty of unprofessional conduct or whose license has been
issued by mistake. Unprofessional conduct shall include, but is not
limited to, any of the following:
(a) Procurement of a license by fraud or misrepresentation.
(b) Incompetence.
(c) Gross negligence.
(d) The clearly excessive furnishing of controlled substances in
violation of subdivision (a) of Section 11153 of the Health and
Safety Code.
(e) The clearly excessive furnishing of controlled substances in
violation of subdivision (a) of Section 11153.5 of the Health and
Safety Code. Factors to be considered in determining whether the
furnishing of controlled substances is clearly excessive shall
include, but not be limited to, the amount of controlled substances
furnished, the previous ordering pattern of the customer (including
size and frequency of orders), the type and size of the customer, and
where and to whom the customer distributes its product.
(f) The commission of any act involving moral turpitude,
dishonesty, fraud, deceit, or corruption, whether the act is
committed in the course of relations as a licensee or otherwise, and
whether the act is a felony or misdemeanor or not.
(g) Knowingly making or signing any certificate or other document
that falsely represents the existence or nonexistence of a state of
facts.
(h) The administering to oneself, of any controlled substance, or
the use of any dangerous drug or of alcoholic beverages to the extent
or in a manner as to be dangerous or injurious to oneself, to a
person holding a license under this chapter, or to any other person
or to the public, or to the extent that the use impairs the ability
of the person to conduct with safety to the public the practice
authorized by the license.
(i) Except as otherwise authorized by law, knowingly selling,
furnishing, giving away, or administering, or offering to sell,
furnish, give away, or administer, any controlled substance to an
addict.
(j) The violation of any of the statutes of this state, of any
other state, or of the United States regulating controlled substances
and dangerous drugs.
(k) The conviction of more than one misdemeanor or any felony
involving the use, consumption, or self-administration of any
dangerous drug or alcoholic beverage, or any combination of those
substances.
(l) The conviction of a crime substantially related to the
qualifications, functions, and duties of a licensee under this
chapter. The record of conviction of a violation of Chapter 13
(commencing with Section 801) of Title 21 of the United States Code
regulating controlled substances or of a violation of the statutes of
this state regulating controlled substances or dangerous drugs shall
be conclusive evidence of unprofessional conduct. In all other
cases, the record of conviction shall be conclusive evidence only of
the fact that the conviction occurred. The board may inquire into the
circumstances surrounding the commission of the crime, in order to
fix the degree of discipline or, in the case of a conviction not
involving controlled substances or dangerous drugs, to determine if
the conviction is of an offense substantially related to the
qualifications, functions, and duties of a licensee under this
chapter. A plea or verdict of guilty or a conviction following a plea
of nolo contendere is deemed to be a conviction within the meaning
of this provision. The board may take action when the time for appeal
has elapsed, or the judgment of conviction has been affirmed on
appeal or when an order granting probation is made suspending the
imposition of sentence, irrespective of a subsequent order under
Section 1203.4 of the Penal Code allowing the person to withdraw his
or her plea of guilty and to enter a plea of not guilty, or setting
aside the verdict of guilty, or dismissing the accusation,
information, or indictment.
(m) The cash compromise of a charge of violation of Chapter 13
(commencing with Section 801) of Title 21 of the United States Code
regulating controlled substances or of Chapter 7 (commencing with
Section 14000) of Part 3 of Division 9 of the Welfare and
Institutions Code relating to the Medi-Cal program.
(n) The revocation, suspension, or other discipline by another
state of a license to practice pharmacy, operate a pharmacy, or do
any other act for which a license is required by this chapter that
would be grounds for revocation, suspension, or other discipline
under this chapter. Any disciplinary action taken by the board
pursuant to this section shall be coterminous with action taken by
another state, except that the term of any discipline taken by the
board may exceed that of another state, consistent with the board's
enforcement guidelines. The evidence of discipline by another state
is conclusive proof of unprofessional conduct.
(o) Violating or attempting to violate, directly or indirectly, or
assisting in or abetting the violation of or conspiring to violate
any provision or term of this chapter or of the applicable federal
and state laws and regulations governing pharmacy, including
regulations established by the board or by any other state or federal
regulatory agency.
(p) Actions or conduct that would have warranted denial of a
license.
(q) Engaging in any conduct that subverts or attempts to subvert
an investigation of the board.
(r) The selling, trading, transferring, or furnishing of drugs
obtained pursuant to Section 256b of Title 42 of the United States
Code to any person a licensee knows or reasonably should have known,
not to be a patient of a covered entity, as defined in paragraph (4)
of subsection (a) of Section 256b of Title 42 of the United States
Code.
(s) The clearly excessive furnishing of dangerous drugs by a
wholesaler to a pharmacy that primarily or solely dispenses
prescription drugs to patients of long-term care facilities. Factors
to be considered in determining whether the furnishing of dangerous
drugs is clearly excessive shall include, but not be limited to, the
amount of dangerous drugs furnished to a pharmacy that primarily or
solely dispenses prescription drugs to patients of long-term care
facilities, the previous ordering pattern of the pharmacy, and the
general patient population to whom the pharmacy distributes the
dangerous drugs. That a wholesaler has established, and employs, a
tracking system that complies with the requirements of subdivision
(b) of Section 4164 shall be considered in determining whether there
has been a violation of this subdivision. This provision shall not be
interpreted to require a wholesaler to obtain personal medical
information or be authorized to permit a wholesaler to have access to
personal medical information except as otherwise authorized by
Section 56 and following of the Civil Code. For purposes of this
section, "long-term care facility" shall have the same meaning given
the term in Section 1418 of the Health and Safety Code.
SEC. 35. Section 4301.1 is added to the Business and Professions
Code, to read:
4301.1. In order to ensure that the board's resources are
maximized for the protection of the public health and safety, the
board shall prioritize its investigative and prosecutorial resources
to ensure that pharmacists representing the greatest threat of
patient harm are identified and disciplined expeditiously.
SEC. 36. Section 4302 of the Business and Professions Code is
amended to read:
4302. The board may deny, suspend, or revoke any license where
conditions exist in relation to any person holding 10 percent or more
of the ownership interest or where conditions exist in relation to
any officer, director, or other person with management or control of
the license that would constitute grounds for disciplinary action
against a licensee.
SEC. 37. Section 4303.1 is added to the Business and Professions
Code, to read:
4303.1. If the federal Food and Drug Administration (FDA)
cancels, revokes, or suspends an outsourcing facility's registration
for any reason, any license issued pursuant to Section 4129.2 shall
be immediately canceled, revoked, or suspended by operation of law.
SEC. 38. Section 4307 of the Business and Professions Code is
amended to read:
4307. (a) Any person who has been denied a license or whose
license has been revoked or is under suspension, or who has failed to
renew his or her license while it was under suspension, or who has
been a manager, administrator, owner, member, officer, director,
associate, partner, or any other person with management or control of
any partnership, corporation, trust, firm, or association whose
application for a license has been denied or revoked, is under
suspension or has been placed on probation, and while acting as the
manager, administrator, owner, member, officer, director, associate,
partner, or any other person with management or control had knowledge
of or knowingly participated in any conduct for which the license
was denied, revoked, suspended, or placed on probation, shall be
prohibited from serving as a manager, administrator, owner, member,
officer, director, associate, partner, or in any other position with
management or control of a licensee as follows:
(1) Where a probationary license is issued or where an existing
license is placed on probation, this prohibition shall remain in
effect for a period not to exceed five years.
(2) Where the license is denied or revoked, the prohibition shall
continue until the license is issued or reinstated.
(b) "Manager, administrator, owner, member, officer, director,
associate, partner, or any other person with management or control of
a license" as used in this section and Section 4308, may refer to a
pharmacist or to any other person who serves in such capacity in or
for a licensee.
(c) The provisions of subdivision (a) may be alleged in any
pleading filed pursuant to Chapter 5 (commencing with Section 11500)
of Part 1 of Division 3 of the Government Code. However, no order may
be issued in that case except as to a person who is named in the
caption, as to whom the pleading alleges the applicability of this
section, and where the person has been given notice of the proceeding
as required by Chapter 5 (commencing with Section 11500) of Part 1
of Division 3 of the Government Code. The authority to proceed as
provided by this subdivision shall be in addition to the board's
authority to proceed under Section 4339 or any other provision of
law.
SEC. 39. Section 4308 of the Business and Professions Code is
amended to read:
4308. Whenever a person is prohibited from serving as a manager,
administrator, owner, member, officer, director, associate, partner,
or in any other position with management or control of a licensee as
provided by Section 4307, the board shall, in each case where it has
that information, notify in writing each licensee for whom the person
is a manager, administrator, owner, member, officer, director,
associate, partner, or in any other position with management or
control of the prohibition. The board shall send the notification to
the licensee's address of record. The licensee shall have 30 days
from the date that the notice is sent to remove and replace the
prohibited person and, where appropriate, file a change of permit to
reflect that change.
SEC. 40. Section 4312 of the Business and Professions Code is
amended to read:
4312. (a) The board may cancel the license of a wholesaler,
third-party logistics provider, pharmacy, veterinary food-animal drug
retailer, or outsourcing facility if the licensed premises remain
closed, as defined in subdivision (e), other than by order of the
board. For good cause shown, the board may cancel a license after a
shorter period of closure. To cancel a license pursuant to this
subdivision, the board
shall make a diligent, good faith effort to give notice by personal
service on the licensee. If a written objection is not received
within 10 days after personal service is made or a diligent, good
faith effort to give notice by personal service on the licensee has
failed, the board may cancel the license without the necessity of a
hearing. If the licensee files a written objection, the board shall
file an accusation based on the licensee remaining closed.
Proceedings shall be conducted in accordance with Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2 of
the Government Code, and the board shall have all the powers granted
in that chapter.
(b) If the license of a wholesaler, third-party logistics
provider, pharmacy, veterinary food-animal drug retailer, or
outsourcing facility is canceled pursuant to subdivision (a) or
revoked pursuant to Article 19 (commencing with Section 4300), or a
wholesaler, third-party logistics provider, pharmacy, veterinary
food-animal drug retailer, or outsourcing facility notifies the board
of its intent to remain closed or to discontinue business, the
licensee shall, within 10 days thereafter, arrange for the transfer
of all dangerous drugs and controlled substances or dangerous devices
to another licensee authorized to possess the dangerous drugs and
controlled substances or dangerous devices. The licensee transferring
the dangerous drugs and controlled substances or dangerous devices
shall immediately confirm in writing to the board that the transfer
has taken place.
(c) If a wholesaler, third-party logistics provider, pharmacy,
veterinary food-animal drug retailer, or outsourcing facility fails
to comply with subdivision (b), the board may seek and obtain an
order from the superior court in the county in which the wholesaler,
third-party logistics provider, pharmacy, veterinary food-animal drug
retailer, or outsourcing facility is located, authorizing the board
to enter the wholesaler, third-party logistics provider, pharmacy,
veterinary food-animal drug retailer, or outsourcing facility and
inventory and store, transfer, sell, or arrange for the sale of, all
dangerous drugs and controlled substances and dangerous devices found
in the wholesaler, third-party logistics provider, pharmacy,
veterinary food-animal drug retailer, or outsourcing facility.
(d) If the board sells or arranges for the sale of any dangerous
drugs, controlled substances, or dangerous devices pursuant to
subdivision (c), the board may retain from the proceeds of the sale
an amount equal to the cost to the board of obtaining and enforcing
an order issued pursuant to subdivision (c), including the cost of
disposing of the dangerous drugs, controlled substances, or dangerous
devices. The remaining proceeds, if any, shall be returned to the
licensee from whose premises the dangerous drugs or controlled
substances or dangerous devices were removed.
(1) The licensee shall be notified of his or her right to the
remaining proceeds by personal service or by certified mail, postage
prepaid.
(2) If a statute or regulation requires the licensee to file with
the board his or her address, and any change of address, the notice
required by this subdivision may be sent by certified mail, postage
prepaid, to the latest address on file with the board and service of
notice in this manner shall be deemed completed on the 10th day after
the mailing.
(3) If the licensee is notified as provided in this subdivision,
and the licensee fails to contact the board for the remaining
proceeds within 30 calendar days after personal service has been made
or service by certified mail, postage prepaid, is deemed completed,
the remaining proceeds shall be deposited by the board into the
Pharmacy Board Contingent Fund. These deposits shall be deemed to
have been received pursuant to Chapter 7 (commencing with Section
1500) of Title 10 of Part 3 of the Code of Civil Procedure and shall
be subject to claim or other disposition as provided in that chapter.
(e) For the purposes of this section, "closed" means not engaged
in the ordinary activity for which a license has been issued for at
least one day each calendar week during any 120-day period.
(f) Nothing in this section shall be construed as requiring a
pharmacy to be open seven days a week.
SEC. 41. Section 4316 is added to the Business and Professions
Code, to read:
4316. (a) The board is authorized to issue a cease and desist
order for operating any facility under this chapter that requires
licensure or for practicing any activity under this chapter that
requires licensure.
(b) Whenever the board issues a cease and desist order pursuant to
subdivision (a), the board shall immediately issue the facility a
notice setting forth the acts or omissions with which it is charged,
specifying the pertinent code section or sections and any
regulations.
(c) The order shall provide that the facility, within 15 days of
receipt of the notice, may request a hearing before the president of
the board to contest the cease and desist order. Consideration of the
facility's contest of the cease and desist order shall comply with
the requirements of Section 11425.10 of the Government Code. The
hearing shall be held no later than five days from the date the
request of the owner is received by the board. The president shall
render a written decision within five days of the hearing. In the
absence of the president of the board, the vice president of the
board may conduct the hearing permitted by this subdivision. Review
of the decision of the president of the board may be sought by the
owner or person in possession or control of the pharmacy pursuant to
Section 1094.5 of the Code of Civil Procedure.
SEC. 42. Section 4400 of the Business and Professions Code is
amended to read:
4400. The amount of fees and penalties prescribed by this
chapter, except as otherwise provided, is that fixed by the board
according to the following schedule:
(a) The fee for a nongovernmental pharmacy license shall be four
hundred dollars ($400) and may be increased to five hundred twenty
dollars ($520). The fee for the issuance of a temporary
nongovernmental pharmacy permit shall be two hundred fifty dollars
($250) and may be increased to three hundred twenty-five dollars
($325).
(b) The fee for a nongovernmental pharmacy license annual renewal
shall be two hundred fifty dollars ($250) and may be increased to
three hundred twenty-five dollars ($325).
(c) The fee for the pharmacist application and examination shall
be two hundred dollars ($200) and may be increased to two hundred
sixty dollars ($260).
(d) The fee for regrading an examination shall be ninety dollars
($90) and may be increased to one hundred fifteen dollars ($115). If
an error in grading is found and the applicant passes the
examination, the regrading fee shall be refunded.
(e) The fee for a pharmacist license and biennial renewal shall be
one hundred fifty dollars ($150) and may be increased to one hundred
ninety-five dollars ($195).
(f) The fee for a nongovernmental wholesaler or third-party
logistics provider license and annual renewal shall be seven hundred
eighty dollars ($780) and may be decreased to no less than six
hundred dollars ($600). The application fee for any additional
location after licensure of the first 20 locations shall be three
hundred dollars ($300) and may be decreased to no less than two
hundred twenty-five dollars ($225). A temporary license fee shall be
seven hundred fifteen dollars ($715) and may be decreased to no less
than five hundred fifty dollars ($550).
(g) The fee for a hypodermic license and renewal shall be one
hundred twenty-five dollars ($125) and may be increased to one
hundred sixty-five dollars ($165).
(h) (1) The fee for application, investigation, and issuance of a
license as a designated representative pursuant to Section 4053, or
as a designated representative-3PL pursuant to Section 4053.1, shall
be three hundred thirty dollars ($330) and may be decreased to no
less than two hundred fifty-five dollars ($255).
(2) The fee for the annual renewal of a license as a designated
representative or designated representative-3PL shall be one hundred
ninety-five dollars ($195) and may be decreased to no less than one
hundred fifty dollars ($150).
(i) (1) The fee for the application, investigation, and issuance
of a license as a designated representative for a veterinary
food-animal drug retailer pursuant to Section 4053 shall be three
hundred thirty dollars ($330) and may be decreased to no less than
two hundred fifty-five dollars ($255).
(2) The fee for the annual renewal of a license as a designated
representative for a veterinary food-animal drug retailer shall be
one hundred ninety-five dollars ($195) and may be decreased to no
less than one hundred fifty dollars ($150).
(j) (1) The application fee for a nonresident wholesaler or
third-party logistics provider license issued pursuant to Section
4161 shall be seven hundred eighty dollars ($780) and may be
decreased to no less than six hundred dollars ($600).
(2) For nonresident wholesalers or third-party logistics providers
that have 21 or more facilities operating nationwide the application
fees for the first 20 locations shall be seven hundred eighty
dollars ($780) and may be decreased to no less than six hundred
dollars ($600). The application fee for any additional location after
licensure of the first 20 locations shall be three hundred dollars
($300) and may be decreased to no less than two hundred twenty-five
dollars ($225). A temporary license fee shall be seven hundred
fifteen dollars ($715) and may be decreased to no less than five
hundred fifty dollars ($550).
(3) The annual renewal fee for a nonresident wholesaler license or
third-party logistics provider license issued pursuant to Section
4161 shall be seven hundred eighty dollars ($780) and may be
decreased to no less than six hundred dollars ($600).
(k) The fee for evaluation of continuing education courses for
accreditation shall be set by the board at an amount not to exceed
forty dollars ($40) per course hour.
( l ) The fee for an intern pharmacist license shall be
ninety dollars ($90) and may be increased to one hundred fifteen
dollars ($115). The fee for transfer of intern hours or verification
of licensure to another state shall be twenty-five dollars ($25) and
may be increased to thirty dollars ($30).
(m) The board may waive or refund the additional fee for the
issuance of a license where the license is issued less than 45 days
before the next regular renewal date.
(n) The fee for the reissuance of any license, or renewal thereof,
that has been lost or destroyed or reissued due to a name change
shall be thirty-five dollars ($35) and may be increased to forty-five
dollars ($45).
(o) The fee for the reissuance of any license, or renewal thereof,
that must be reissued because of a change in the information, shall
be one hundred dollars ($100) and may be increased to one hundred
thirty dollars ($130).
(p) It is the intent of the Legislature that, in setting fees
pursuant to this section, the board shall seek to maintain a reserve
in the Pharmacy Board Contingent Fund equal to approximately one year'
s operating expenditures.
(q) The fee for any applicant for a nongovernmental clinic license
shall be four hundred dollars ($400) and may be increased to five
hundred twenty dollars ($520) for each license. The annual fee for
renewal of the license shall be two hundred fifty dollars ($250) and
may be increased to three hundred twenty-five dollars ($325) for each
license.
(r) The fee for the issuance of a pharmacy technician license
shall be eighty dollars ($80) and may be increased to one hundred
five dollars ($105). The fee for renewal of a pharmacy technician
license shall be one hundred dollars ($100) and may be increased to
one hundred thirty dollars ($130).
(s) The fee for a veterinary food-animal drug retailer license
shall be four hundred five dollars ($405) and may be increased to
four hundred twenty-five dollars ($425). The annual renewal fee for a
veterinary food-animal drug retailer license shall be two hundred
fifty dollars ($250) and may be increased to three hundred
twenty-five dollars ($325).
(t) The fee for issuance of a retired license pursuant to Section
4200.5 shall be thirty-five dollars ($35) and may be increased to
forty-five dollars ($45).
(u) The fee for issuance or renewal of a nongovernmental sterile
compounding pharmacy license shall be six hundred dollars ($600) and
may be increased to seven hundred eighty dollars ($780). The fee for
a temporary license shall be five hundred fifty dollars ($550) and
may be increased to seven hundred fifteen dollars ($715).
(v) The fee for the issuance or renewal of a nonresident sterile
compounding pharmacy license shall be seven hundred eighty dollars
($780). In addition to paying that application fee, the nonresident
sterile compounding pharmacy shall deposit, when submitting the
application, a reasonable amount, as determined by the board,
necessary to cover the board's estimated cost of performing the
inspection required by Section 4127.2. If the required deposit is not
submitted with the application, the application shall be deemed to
be incomplete. If the actual cost of the inspection exceeds the
amount deposited, the board shall provide to the applicant a written
invoice for the remaining amount and shall not take action on the
application until the full amount has been paid to the board. If the
amount deposited exceeds the amount of actual and necessary costs
incurred, the board shall remit the difference to the applicant.
(w) The fee for the issuance of an outsourcing facility license
shall be two thousand two hundred seventy dollars ($2,270) and may be
increased to up to three thousand one hundred eighty dollars
($3,180) by the board. The fee for the renewal of an outsourcing
facility license shall be one thousand three hundred twenty-five
dollars ($1,325) and may be increased to up to one thousand eight
hundred fifty-five dollars ($1,855) by the board. The fee for a
temporary outsourcing facility license shall be seven hundred fifteen
dollars ($715).
(x) The fee for the issuance of a nonresident outsourcing facility
license shall be two thousand three hundred eighty dollars ($2,380)
and may be increased to up to three thousand three hundred
thirty-five dollars ($3,335) by the board. The fee for the renewal of
a nonresident outsourcing facility license shall be two thousand two
hundred seventy dollars ($2,270) and may be increased to up to three
thousand one hundred eighty dollars ($3,180) by the board. In
addition to paying that application fee, the nonresident outsourcing
facility shall deposit, when submitting the application, a reasonable
amount, as determined by the board, necessary to cover the board's
estimated cost of performing the inspection required by Section
4129.2. If the required deposit is not submitted with the
application, the application shall be deemed to be incomplete. If the
actual cost of the inspection exceeds the amount deposited, the
board shall provide to the applicant a written invoice for the
remaining amount and shall not take action on the application until
the full amount has been paid to the board. If the amount deposited
exceeds the amount of actual and necessary costs incurred, the board
shall remit the difference to the applicant.
SEC. 42.5. Section 4400 of the Business and Professions Code is
amended to read:
4400. The amount of fees and penalties prescribed by this
chapter, except as otherwise provided, is that fixed by the board
according to the following schedule:
(a) The fee for a nongovernmental pharmacy license shall be four
hundred dollars ($400) and may be increased to five hundred twenty
dollars ($520). The fee for the issuance of a temporary
nongovernmental pharmacy permit shall be two hundred fifty dollars
($250) and may be increased to three hundred twenty-five dollars
($325).
(b) The fee for a nongovernmental pharmacy license annual renewal
shall be two hundred fifty dollars ($250) and may be increased to
three hundred twenty-five dollars ($325).
(c) The fee for the pharmacist application and examination shall
be two hundred dollars ($200) and may be increased to two hundred
sixty dollars ($260).
(d) The fee for regrading an examination shall be ninety dollars
($90) and may be increased to one hundred fifteen dollars ($115). If
an error in grading is found and the applicant passes the
examination, the regrading fee shall be refunded.
(e) The fee for a pharmacist license and biennial renewal shall be
one hundred fifty dollars ($150) and may be increased to one hundred
ninety-five dollars ($195).
(f) The fee for a nongovernmental wholesaler or third-party
logistics provider license and annual renewal shall be seven hundred
eighty dollars ($780) and may be decreased to no less than six
hundred dollars ($600). The application fee for any additional
location after licensure of the first 20 locations shall be three
hundred dollars ($300) and may be decreased to no less than two
hundred twenty-five dollars ($225). A temporary license fee shall be
seven hundred fifteen dollars ($715) and may be decreased to no less
than five hundred fifty dollars ($550).
(g) The fee for a hypodermic license and renewal shall be one
hundred twenty-five dollars ($125) and may be increased to one
hundred sixty-five dollars ($165).
(h) (1) The fee for application, investigation, and issuance of a
license as a designated representative pursuant to Section 4053, or
as a designated representative-3PL pursuant to Section 4053.1, shall
be three hundred thirty dollars ($330) and may be decreased to no
less than two hundred fifty-five dollars ($255).
(2) The fee for the annual renewal of a license as a designated
representative or designated representative-3PL shall be one hundred
ninety-five dollars ($195) and may be decreased to no less than one
hundred fifty dollars ($150).
(i) (1) The fee for the application, investigation, and issuance
of a license as a designated representative for a veterinary
food-animal drug retailer pursuant to Section 4053 shall be three
hundred thirty dollars ($330) and may be decreased to no less than
two hundred fifty-five dollars ($255).
(2) The fee for the annual renewal of a license as a designated
representative for a veterinary food-animal drug retailer shall be
one hundred ninety-five dollars ($195) and may be decreased to no
less than one hundred fifty dollars ($150).
(j) (1) The application fee for a nonresident wholesaler or
third-party logistics provider license issued pursuant to Section
4161 shall be seven hundred eighty dollars ($780) and may be
decreased to no less than six hundred dollars ($600).
(2) For nonresident wholesalers or third-party logistics providers
that have 21 or more facilities operating nationwide the application
fees for the first 20 locations shall be seven hundred eighty
dollars ($780) and may be decreased to no less than six hundred
dollars ($600). The application fee for any additional location after
licensure of the first 20 locations shall be three hundred dollars
($300) and may be decreased to no less than two hundred twenty-five
dollars ($225). A temporary license fee shall be seven hundred
fifteen dollars ($715) and may be decreased to no less than five
hundred fifty dollars ($550).
(3) The annual renewal fee for a nonresident wholesaler license or
third-party logistics provider license issued pursuant to Section
4161 shall be seven hundred eighty dollars ($780) and may be
decreased to no less than six hundred dollars ($600).
(k) The fee for evaluation of continuing education courses for
accreditation shall be set by the board at an amount not to exceed
forty dollars ($40) per course hour.
( l ) The fee for an intern pharmacist license shall be
ninety dollars ($90) and may be increased to one hundred fifteen
dollars ($115). The fee for transfer of intern hours or verification
of licensure to another state shall be twenty-five dollars ($25) and
may be increased to thirty dollars ($30).
(m) The board may waive or refund the additional fee for the
issuance of a license where the license is issued less than 45 days
before the next regular renewal date.
(n) The fee for the reissuance of any license, or renewal thereof,
that has been lost or destroyed or reissued due to a name change
shall be thirty-five dollars ($35) and may be increased to forty-five
dollars ($45).
(o) The fee for the reissuance of any license, or renewal thereof,
that must be reissued because of a change in the information, shall
be one hundred dollars ($100) and may be increased to one hundred
thirty dollars ($130).
(p) It is the intent of the Legislature that, in setting fees
pursuant to this section, the board shall seek to maintain a reserve
in the Pharmacy Board Contingent Fund equal to approximately one year'
s operating expenditures.
(q) The fee for any applicant for a nongovernmental clinic license
shall be four hundred dollars ($400) and may be increased to five
hundred twenty dollars ($520) for each license. The annual fee for
renewal of the license shall be two hundred fifty dollars ($250) and
may be increased to three hundred twenty-five dollars ($325) for each
license.
(r) The fee for the issuance of a pharmacy technician license
shall be eighty dollars ($80) and may be increased to one hundred
five dollars ($105). The fee for renewal of a pharmacy technician
license shall be one hundred dollars ($100) and may be increased to
one hundred thirty dollars ($130).
(s) The fee for a veterinary food-animal drug retailer license
shall be four hundred five dollars ($405) and may be increased to
four hundred twenty-five dollars ($425). The annual renewal fee for a
veterinary food-animal drug retailer license shall be two hundred
fifty dollars ($250) and may be increased to three hundred
twenty-five dollars ($325).
(t) The fee for issuance of a retired license pursuant to Section
4200.5 shall be thirty-five dollars ($35) and may be increased to
forty-five dollars ($45).
(u) The fee for issuance or renewal of a nongovernmental sterile
compounding pharmacy license shall be six hundred dollars ($600) and
may be increased to seven hundred eighty dollars ($780). The fee for
a temporary license shall be five hundred fifty dollars ($550) and
may be increased to seven hundred fifteen dollars ($715).
(v) The fee for the issuance or renewal of a nonresident sterile
compounding pharmacy license shall be seven hundred eighty dollars
($780). In addition to paying that application fee, the nonresident
sterile compounding pharmacy shall deposit, when submitting the
application, a reasonable amount, as determined by the board,
necessary to cover the board's estimated cost of performing the
inspection required by Section 4127.2. If the required deposit is not
submitted with the application, the application shall be deemed to
be incomplete. If the actual cost of the inspection exceeds the
amount deposited, the board shall provide to the applicant a written
invoice for the remaining amount and shall not take action on the
application until the full amount has been paid to the board. If the
amount deposited exceeds the amount of actual and necessary costs
incurred, the board shall remit the difference to the applicant.
(w) The fee for the issuance of an outsourcing facility license
shall be two thousand two hundred seventy dollars ($2,270) and may be
increased to up to three thousand one hundred eighty dollars
($3,180) by the board. The fee for the renewal of an outsourcing
facility license shall be one thousand three hundred twenty-five
dollars ($1,325) and may be increased to up to one thousand eight
hundred fifty-five dollars ($1,855) by the board. The fee for a
temporary outsourcing facility license shall be seven hundred fifteen
dollars ($715).
(x) The fee for the issuance of a nonresident outsourcing facility
license shall be two thousand three hundred eighty dollars ($2,380)
and may be increased to up to three thousand three hundred
thirty-five dollars ($3,335) by the board. The fee for the renewal of
a nonresident outsourcing facility license shall be two thousand two
hundred seventy dollars ($2,270) and may be increased to up to three
thousand one hundred eighty dollars ($3,180) by the board. In
addition to paying that application fee, the nonresident outsourcing
facility shall deposit, when submitting the application, a reasonable
amount, as determined by the board, necessary to cover the board's
estimated cost of performing the inspection required by Section
4129.2. If the required deposit is not submitted with the
application, the application shall be deemed to be incomplete. If the
actual cost of the inspection exceeds the amount deposited, the
board shall provide to the applicant a written invoice for the
remaining amount and shall not take action on the application until
the full amount has been paid to the board. If the amount deposited
exceeds the amount of actual and necessary costs incurred, the board
shall remit the difference to the applicant.
(y) This section shall become inoperative on July 1, 2017, and as
of January 1, 2018, is repealed.
SEC. 43. Section 4406 of the Business and Professions Code is
amended to read:
4406. All fees collected on behalf of the board and all receipts
of every kind and nature shall be reported each month for the month
preceding to the Controller and at the same time the entire amount
shall be paid into the State Treasury and shall be credited to the
Pharmacy Board Contingent Fund which is hereby created. This
contingent fund shall be available, upon appropriation of the
Legislature, for the use of the board.
SEC. 44. Section 4800 of the Business and Professions Code is
amended to read:
4800. (a) There is in the Department of Consumer Affairs a
Veterinary Medical Board in which the administration of this chapter
is vested. The board consists of the following members:
(1) Four licensed veterinarians.
(2) One registered veterinary technician.
(3) Three public members.
(b) This section shall remain in effect only until January 1,
2021, and as of that date is repealed.
(c) Notwithstanding any other law, the repeal of this section
renders the board subject to review by the appropriate policy
committees of the Legislature. However, the review of the board shall
be limited to those issues identified by the appropriate policy
committees of the Legislature and shall not involve the preparation
or submission of a sunset review document or evaluative
questionnaire.
SEC.
45. Section 4804.5 of the Business and Professions Code is amended
to read:
4804.5. The board may appoint a person exempt from civil service
who shall be designated as an executive officer and who shall
exercise the powers and perform the duties delegated by the board and
vested in him or her by this chapter.
This section shall remain in effect only until January 1, 2021,
and as of that date is repealed.
SEC. 46. Section 4826.5 is added to the Business and Professions
Code, to read:
4826.5. Notwithstanding any other law, a licensed veterinarian or
a registered veterinary technician under the supervision of a
licensed veterinarian may compound drugs for animal use pursuant to
Section 530 of Title 21 of the Code of Federal Regulations and in
accordance with regulations promulgated by the board. The regulations
promulgated by the board shall, at a minimum, address the storage of
drugs, the level and type of supervision required for compounding
drugs by a registered veterinary technician, and the equipment
necessary for the safe compounding of drugs. Any violation of the
regulations adopted by the board pursuant to this section shall
constitute grounds for an enforcement or disciplinary action.
SEC. 47. Section 4830 of the Business and Professions Code is
amended to read:
4830. (a) This chapter does not apply to:
(1) Veterinarians while serving in any armed branch of the
military service of the United States or the United States Department
of Agriculture while actually engaged and employed in their official
capacity.
(2) Regularly licensed veterinarians in actual consultation from
other states.
(3) Regularly licensed veterinarians actually called from other
states to attend cases in this state, but who do not open an office
or appoint a place to do business within this state.
(4) Students in the School of Veterinary Medicine of the
University of California or the College of Veterinary Medicine of the
Western University of Health Sciences who participate in diagnosis
and treatment as part of their educational experience, including
those in off-campus educational programs under the direct supervision
of a licensed veterinarian in good standing, as defined in paragraph
(1) of subdivision (b) of Section 4848, appointed by the University
of California, Davis, or the Western University of Health Sciences.
(5) A veterinarian who is employed by the Meat and Poultry
Inspection Branch of the California Department of Food and
Agriculture while actually engaged and employed in his or her
official capacity. A person exempt under this paragraph shall not
otherwise engage in the practice of veterinary medicine unless he or
she is issued a license by the board.
(6) Unlicensed personnel employed by the Department of Food and
Agriculture or the United States Department of Agriculture when in
the course of their duties they are directed by a veterinarian
supervisor to conduct an examination, obtain biological specimens,
apply biological tests, or administer medications or biological
products as part of government disease or condition monitoring,
investigation, control, or eradication activities.
(b) (1) For purposes of paragraph (3) of subdivision (a), a
regularly licensed veterinarian in good standing who is called from
another state by a law enforcement agency or animal control agency,
as defined in Section 31606 of the Food and Agricultural Code, to
attend to cases that are a part of an investigation of an alleged
violation of federal or state animal fighting or animal cruelty laws
within a single geographic location shall be exempt from the
licensing requirements of this chapter if the law enforcement agency
or animal control agency determines that it is necessary to call the
veterinarian in order for the agency or officer to conduct the
investigation in a timely, efficient, and effective manner. In
determining whether it is necessary to call a veterinarian from
another state, consideration shall be given to the availability of
veterinarians in this state to attend to these cases. An agency,
department, or officer that calls a veterinarian pursuant to this
subdivision shall notify the board of the investigation.
(2) Notwithstanding any other provision of this chapter, a
regularly licensed veterinarian in good standing who is called from
another state to attend to cases that are a part of an investigation
described in paragraph (1) may provide veterinary medical care for
animals that are affected by the investigation with a temporary
shelter facility, and the temporary shelter facility shall be exempt
from the registration requirement of Section 4853 if all of the
following conditions are met:
(A) The temporary shelter facility is established only for the
purpose of the investigation.
(B) The temporary shelter facility provides veterinary medical
care, shelter, food, and water only to animals that are affected by
the investigation.
(C) The temporary shelter facility complies with Section 4854.
(D) The temporary shelter facility exists for not more than 60
days, unless the law enforcement agency or animal control agency
determines that a longer period of time is necessary to complete the
investigation.
(E) Within 30 calendar days upon completion of the provision of
veterinary health care services at a temporary shelter facility
established pursuant to this section, the veterinarian called from
another state by a law enforcement agency or animal control agency to
attend to a case shall file a report with the board. The report
shall contain the date, place, type, and general description of the
care provided, along with a listing of the veterinary health care
practitioners who participated in providing that care.
(c) For purposes of paragraph (3) of subdivision (a), the board
may inspect temporary facilities established pursuant to this
section.
SEC. 47.5. Section 4830 of the Business and Professions Code is
amended to read:
4830. (a) This chapter does not apply to:
(1) Veterinarians while serving in any armed branch of the
military service of the United States or the United States Department
of Agriculture while actually engaged and employed in their official
capacity.
(2) Veterinarians holding a current, valid license in good
standing in another state or country who provide assistance to a
California licensed veterinarian and attend on a specific case. The
California licensed veterinarian shall maintain a valid
veterinarian-client-patient relationship. The veterinarian providing
the assistance shall not establish a veterinarian-client-patient
relationship with the client by attending the case or at a future
time and shall not practice veterinary medicine, open an office,
appoint a place to meet patients, communicate with clients who reside
within the limits of this state, give orders, or have ultimate
authority over the care or primary diagnosis of a patient that is
located within this state.
(3) Veterinarians called into the state by a law enforcement
agency or animal control agency pursuant to subdivision (b).
(4) Students in the School of Veterinary Medicine of the
University of California or the College of Veterinary Medicine of the
Western University of Health Sciences who participate in diagnosis
and treatment as part of their educational experience, including
those in off-campus educational programs under the direct supervision
of a licensed veterinarian in good standing, as defined in paragraph
(1) of subdivision (b) of Section 4848, appointed by the University
of California, Davis, or the Western University of Health Sciences.
(5) A veterinarian who is employed by the Meat and Poultry
Inspection Branch of the California Department of Food and
Agriculture while actually engaged and employed in his or her
official capacity. A person exempt under this paragraph shall not
otherwise engage in the practice of veterinary medicine unless he or
she is issued a license by the board.
(6) Unlicensed personnel employed by the Department of Food and
Agriculture or the United States Department of Agriculture when in
the course of their duties they are directed by a veterinarian
supervisor to conduct an examination, obtain biological specimens,
apply biological tests, or administer medications or biological
products as part of government disease or condition monitoring,
investigation, control, or eradication activities.
(b) (1) For purposes of paragraph (3) of subdivision (a), a
regularly licensed veterinarian in good standing who is called from
another state by a law enforcement agency or animal control agency,
as defined in Section 31606 of the Food and Agricultural Code, to
attend to cases that are a part of an investigation of an alleged
violation of federal or state animal fighting or animal cruelty laws
within a single geographic location shall be exempt from the
licensing requirements of this chapter if the law enforcement agency
or animal control agency determines that it is necessary to call the
veterinarian in order for the agency or officer to conduct the
investigation in a timely, efficient, and effective manner. In
determining whether it is necessary to call a veterinarian from
another state, consideration shall be given to the availability of
veterinarians in this state to attend to these cases. An agency,
department, or officer that calls a veterinarian pursuant to this
subdivision shall notify the board of the investigation.
(2) Notwithstanding any other provision of this chapter, a
regularly licensed veterinarian in good standing who is called from
another state to attend to cases that are a part of an investigation
described in paragraph (1) may provide veterinary medical care for
animals that are affected by the investigation with a temporary
shelter facility, and the temporary shelter facility shall be exempt
from the registration requirement of Section 4853 if all of the
following conditions are met:
(A) The temporary shelter facility is established only for the
purpose of the investigation.
(B) The temporary shelter facility provides veterinary medical
care, shelter, food, and water only to animals that are affected by
the investigation.
(C) The temporary shelter facility complies with Section 4854.
(D) The temporary shelter facility exists for not more than 60
days, unless the law enforcement agency or animal control agency
determines that a longer period of time is necessary to complete the
investigation.
(E) Within 30 calendar days upon completion of the provision of
veterinary health care services at a temporary shelter facility
established pursuant to this section, the veterinarian called from
another state by a law enforcement agency or animal control agency to
attend to a case shall file a report with the board. The report
shall contain the date, place, type, and general description of the
care provided, along with a listing of the veterinary health care
practitioners who participated in providing that care.
(c) For purposes of paragraph (3) of subdivision (a), the board
may inspect temporary facilities established pursuant to this
section.
SEC. 48. Section 4846.5 of the Business and Professions Code is
amended to read:
4846.5. (a) Except as provided in this section, the board shall
issue renewal licenses only to those applicants that have completed a
minimum of 36 hours of continuing education in the preceding two
years.
(b) (1) Notwithstanding any other law, continuing education hours
shall be earned by attending courses relevant to veterinary medicine
and sponsored or cosponsored by any of the following:
(A) American Veterinary Medical Association (AVMA) accredited
veterinary medical colleges.
(B) Accredited colleges or universities offering programs relevant
to veterinary medicine.
(C) The American Veterinary Medical Association.
(D) American Veterinary Medical Association recognized specialty
or affiliated allied groups.
(E) American Veterinary Medical Association's affiliated state
veterinary medical associations.
(F) Nonprofit annual conferences established in conjunction with
state veterinary medical associations.
(G) Educational organizations affiliated with the American
Veterinary Medical Association or its state affiliated veterinary
medical associations.
(H) Local veterinary medical associations affiliated with the
California Veterinary Medical Association.
(I) Federal, state, or local government agencies.
(J) Providers accredited by the Accreditation Council for
Continuing Medical Education (ACCME) or approved by the American
Medical Association (AMA), providers recognized by the American
Dental Association Continuing Education Recognition Program (ADA
CERP), and AMA or ADA affiliated state, local, and specialty
organizations.
(2) Continuing education credits shall be granted to those
veterinarians taking self-study courses, which may include, but are
not limited to, reading journals, viewing video recordings, or
listening to audio recordings. The taking of these courses shall be
limited to no more than six hours biennially.
(3) The board may approve other continuing veterinary medical
education providers not specified in paragraph (1).
(A) The board has the authority to recognize national continuing
education approval bodies for the purpose of approving continuing
education providers not specified in paragraph (1).
(B) Applicants seeking continuing education provider approval
shall have the option of applying to the board or to a
board-recognized national approval body.
(4) For good cause, the board may adopt an order specifying, on a
prospective basis, that a provider of continuing veterinary medical
education authorized pursuant to paragraph (1) or (3) is no longer an
acceptable provider.
(5) Continuing education hours earned by attending courses
sponsored or cosponsored by those entities listed in paragraph (1)
between January 1, 2000, and January 1, 2001, shall be credited
toward a veterinarian's continuing education requirement under this
section.
(c) Every person renewing his or her license issued pursuant to
Section 4846.4, or any person applying for relicensure or for
reinstatement of his or her license to active status, shall submit
proof of compliance with this section to the board certifying that he
or she is in compliance with this section. Any false statement
submitted pursuant to this section shall be a violation subject to
Section 4831.
(d) This section shall not apply to a veterinarian's first license
renewal. This section shall apply only to second and subsequent
license renewals granted on or after January 1, 2002.
(e) The board shall have the right to audit the records of all
applicants to verify the completion of the continuing education
requirement. Applicants shall maintain records of completion of
required continuing education coursework for a period of four years
and shall make these records available to the board for auditing
purposes upon request. If the board, during this audit, questions
whether any course reported by the veterinarian satisfies the
continuing education requirement, the veterinarian shall provide
information to the board concerning the content of the course; the
name of its sponsor and cosponsor, if any; and specify the specific
curricula that was of benefit to the veterinarian.
(f) A veterinarian desiring an inactive license or to restore an
inactive license under Section 701 shall submit an application on a
form provided by the board. In order to restore an inactive license
to active status, the veterinarian shall have completed a minimum of
36 hours of continuing education within the last two years preceding
application. The inactive license status of a veterinarian shall not
deprive the board of its authority to institute or continue a
disciplinary action against a licensee.
(g) Knowing misrepresentation of compliance with this article by a
veterinarian constitutes unprofessional conduct and grounds for
disciplinary action or for the issuance of a citation and the
imposition of a civil penalty pursuant to Section 4883.
(h) The board, in its discretion, may exempt from the continuing
education requirement any veterinarian who for reasons of health,
military service, or undue hardship cannot meet those requirements.
Applications for waivers shall be submitted on a form provided by the
board.
(i) The administration of this section may be funded through
professional license and continuing education provider fees. The fees
related to the administration of this section shall not exceed the
costs of administering the corresponding provisions of this section.
(j) For those continuing education providers not listed in
paragraph (1) of subdivision (b), the board or its recognized
national approval agent shall establish criteria by which a provider
of continuing education shall be approved. The board shall initially
review and approve these criteria and may review the criteria as
needed. The board or its recognized agent shall monitor, maintain,
and manage related records and data. The board may impose an
application fee, not to exceed two hundred dollars ($200) biennially,
for continuing education providers not listed in paragraph (1) of
subdivision (b).
(k) (1) Beginning January 1, 2018, a licensed veterinarian who
renews his or her license shall complete a minimum of one credit hour
of continuing education on the judicious use of medically important
antimicrobial drugs every four years as part of his or her continuing
education requirements.
(2) For purposes of this subdivision, "medically important
antimicrobial drug" means an antimicrobial drug listed in Appendix A
of the federal Food and Drug Administration's Guidance for Industry
#152, including critically important, highly important, and important
antimicrobial drugs, as that appendix may be amended.
SEC. 49. Section 4848.1 is added to the Business and Professions
Code, to read:
4848.1. (a) A veterinarian engaged in the practice of veterinary
medicine, as defined in Section 4826, employed by the University of
California and engaged in the performance of duties in connection
with the School of Veterinary Medicine or employed by the Western
University of Health Sciences and engaged in the performance of
duties in connection with the College of Veterinary Medicine shall be
issued a university license pursuant to this section or hold a
license to practice veterinary medicine in this state.
(b) An individual may apply for and be issued a university license
if all of the following are satisfied:
(1) He or she is currently employed by the University of
California or Western University of Health Sciences, as defined in
subdivision (a).
(2) He or she passes an examination concerning the statutes and
regulations of the Veterinary Medicine Practice Act, administered by
the board, pursuant to subparagraph (C) of paragraph (2) of
subdivision (a) of Section 4848.
(3) He or she successfully completes the approved educational
curriculum described in paragraph (5) of subdivision (b) of Section
4848 on regionally specific and important diseases and conditions.
(4) He or she completes and submits the application specified by
the board and pays the application fee, pursuant to subdivision (g)
of Section 4905, and the initial license fee, pursuant to subdivision
(h) of Section 4905.
(c) A university license:
(1) Shall be numbered as described in Section 4847.
(2) Shall automatically cease to be valid upon termination or
cessation of employment by the University of California or by the
Western University of Health Sciences.
(3) Shall be subject to the license renewal provisions in Section
4846.4 and the payment of the renewal fee pursuant to subdivision (i)
of Section 4905.
(4) Shall be subject to denial, revocation, or suspension pursuant
to Sections 480, 4875, and 4883.
(5) Authorizes the holder to practice veterinary medicine only at
an educational institution described in subdivision (a) and any
locations formally affiliated with those institutions.
(d) An individual who holds a university license is exempt from
satisfying the license renewal requirements of Section 4846.5.
SEC. 50. Section 4853.7 is added to the Business and Professions
Code, to read:
4853.7. A premise registration that is not renewed within five
years after its expiration may not be renewed and shall not be
restored, reissued, or reinstated thereafter. However, an application
for a new premise registration may be submitted and obtained if both
of the following conditions are met:
(a) No fact, circumstance, or condition exists that, if the
premise registration was issued, would justify its revocation or
suspension.
(b) All of the fees that would be required for the initial premise
registration are paid at the time of application.
SEC. 51. Section 4904 of the Business and Professions Code is
amended to read:
4904. All fees collected on behalf of the board and all receipts
of every kind and nature shall be reported each month for the month
preceding to the Controller and at the same time the entire amount
shall be paid into the State Treasury and shall be credited to the
Veterinary Medical Board Contingent Fund. This contingent fund shall
be available, upon appropriation by the Legislature, for the use of
the Veterinary Medical Board.
SEC. 52. Section 4905 of the Business and Professions Code is
amended to read:
4905. The following fees shall be collected by the board and
shall be credited to the Veterinary Medical Board Contingent Fund:
(a) The fee for filing an application for examination shall be set
by the board in an amount it determines is reasonably necessary to
provide sufficient funds to carry out the purpose of this chapter,
not to exceed three hundred fifty dollars ($350).
(b) The fee for the California state board examination shall be
set by the board in an amount it determines is reasonably necessary
to provide sufficient funds to carry out the purpose of this chapter,
not to exceed three hundred fifty dollars ($350).
(c) The fee for the Veterinary Medicine Practice Act examination
shall be set by the board in an amount it determines reasonably
necessary to provide sufficient funds to carry out the purpose of
this chapter, not to exceed one hundred dollars ($100).
(d) The initial license fee shall be set by the board not to
exceed five hundred dollars ($500) except that, if the license is
issued less than one year before the date on which it will expire,
then the fee shall be set by the board not to exceed two hundred
fifty dollars ($250). The board may, by appropriate regulation,
provide for the waiver or refund of the initial license fee where the
license is issued less than 45 days before the date on which it will
expire.
(e) The renewal fee shall be set by the board for each biennial
renewal period in an amount it determines is reasonably necessary to
provide sufficient funds to carry out the purpose of this chapter,
not to exceed five hundred dollars ($500).
(f) The temporary license fee shall be set by the board in an
amount it determines is reasonably necessary to provide sufficient
funds to carry out the purpose of this chapter, not to exceed two
hundred fifty dollars ($250).
(g) The fee for filing an application for a university license
shall be one hundred twenty-five dollars ($125), which may be revised
by the board in regulation but shall not exceed three hundred fifty
dollars ($350).
(h) The initial license fee for a university license shall be two
hundred ninety dollars ($290), which may be revised by the board in
regulation but shall not exceed five hundred dollars ($500).
(i) The biennial renewal fee for a university license shall be two
hundred ninety dollars ($290), which may be revised by the board in
regulation but shall not exceed five hundred dollars ($500).
(j) The delinquency fee shall be set by the board, not to exceed
fifty dollars ($50).
(k) The fee for issuance of a duplicate license is twenty-five
dollars ($25).
(l) Any charge made for duplication or other services shall be set
at the cost of rendering the service, except as specified in
subdivision (k).
(m) The fee for failure to report a change in the mailing address
is twenty-five dollars ($25).
(n) The initial and annual renewal fees for registration of
veterinary premises shall be set by the board in an amount not to
exceed four hundred dollars ($400) annually.
(o) If the money transferred from the Veterinary Medical Board
Contingent Fund to the General Fund pursuant to the Budget Act of
1991 is redeposited into the Veterinary Medical Board Contingent
Fund, the fees assessed by the board shall be reduced
correspondingly. However, the reduction shall not be so great as to
cause the Veterinary Medical Board Contingent Fund to have a reserve
of less than three months of annual authorized board expenditures.
The fees set by the board shall not result in a Veterinary Medical
Board Contingent Fund reserve of more than 10 months of annual
authorized board expenditures.
SEC. 53. Section 13401.5 of the Corporations Code is amended to
read:
13401.5. Notwithstanding subdivision (d) of Section 13401 and any
other provision of law, the following licensed persons may be
shareholders, officers, directors, or professional employees of the
professional corporations designated in this section so long as the
sum of all shares owned by those licensed persons does not exceed 49
percent of the total number of shares of the professional corporation
so designated herein, and so long as the number of those licensed
persons owning shares in the professional corporation so designated
herein does not exceed the number of persons licensed by the
governmental agency regulating the designated professional
corporation. This section does not limit employment by a professional
corporation designated in this section to only those licensed
professionals listed under each subdivision. Any person duly licensed
under Division 2 (commencing with Section 500) of the Business and
Professions Code, the Chiropractic Act, or the Osteopathic Act may be
employed to render professional services by a professional
corporation designated in this section.
(a) Medical corporation.
(1) Licensed doctors of podiatric medicine.
(2) Licensed psychologists.
(3) Registered nurses.
(4) Licensed optometrists.
(5) Licensed marriage and family therapists.
(6) Licensed clinical social workers.
(7) Licensed physician assistants.
(8) Licensed chiropractors.
(9) Licensed acupuncturists.
(10) Naturopathic doctors.
(11) Licensed professional clinical counselors.
(12) Licensed physical therapists.
(13) Licensed pharmacists.
(b) Podiatric medical corporation.
(1) Licensed physicians and surgeons.
(2) Licensed psychologists.
(3) Registered nurses.
(4) Licensed optometrists.
(5) Licensed chiropractors.
(6) Licensed acupuncturists.
(7) Naturopathic doctors.
(8) Licensed physical therapists.
(c) Psychological corporation.
(1) Licensed physicians and surgeons.
(2) Licensed doctors of podiatric medicine.
(3) Registered nurses.
(4) Licensed optometrists.
(5) Licensed marriage and family therapists.
(6) Licensed clinical social workers.
(7) Licensed chiropractors.
(8) Licensed acupuncturists.
(9) Naturopathic doctors.
(10) Licensed professional clinical counselors.
(d) Speech-language pathology corporation.
(1) Licensed audiologists.
(e) Audiology corporation.
(1) Licensed speech-language pathologists.
(f) Nursing corporation.
(1) Licensed physicians and surgeons.
(2) Licensed doctors of podiatric medicine.
(3) Licensed psychologists.
(4) Licensed optometrists.
(5) Licensed marriage and family therapists.
(6) Licensed clinical social workers.
(7) Licensed physician assistants.
(8) Licensed chiropractors.
(9) Licensed acupuncturists.
(10) Naturopathic doctors.
(11) Licensed professional clinical counselors.
(g) Marriage and family therapist corporation.
(1) Licensed physicians and surgeons.
(2) Licensed psychologists.
(3) Licensed clinical social workers.
(4) Registered nurses.
(5) Licensed chiropractors.
(6) Licensed acupuncturists.
(7) Naturopathic doctors.
(8) Licensed professional clinical counselors.
(h) Licensed clinical social worker corporation.
(1) Licensed physicians and surgeons.
(2) Licensed psychologists.
(3) Licensed marriage and family therapists.
(4) Registered nurses.
(5) Licensed chiropractors.
(6) Licensed acupuncturists.
(7) Naturopathic doctors.
(8) Licensed professional clinical counselors.
(i) Physician assistants corporation.
(1) Licensed physicians and surgeons.
(2) Registered nurses.
(3) Licensed acupuncturists.
(4) Naturopathic doctors.
(j) Optometric corporation.
(1) Licensed physicians and surgeons.
(2) Licensed doctors of podiatric medicine.
(3) Licensed psychologists.
(4) Registered nurses.
(5) Licensed chiropractors.
(6) Licensed acupuncturists.
(7) Naturopathic doctors.
(k) Chiropractic corporation.
(1) Licensed physicians and surgeons.
(2) Licensed doctors of podiatric medicine.
(3) Licensed psychologists.
(4) Registered nurses.
(5) Licensed optometrists.
(6) Licensed marriage and family therapists.
(7) Licensed clinical social workers.
(8) Licensed acupuncturists.
(9) Naturopathic doctors.
(10) Licensed professional clinical counselors.
( l ) Acupuncture corporation.
(1) Licensed physicians and surgeons.
(2) Licensed doctors of podiatric medicine.
(3) Licensed psychologists.
(4) Registered nurses.
(5) Licensed optometrists.
(6) Licensed marriage and family therapists.
(7) Licensed clinical social workers.
(8) Licensed physician assistants.
(9) Licensed chiropractors.
(10) Naturopathic doctors.
(11) Licensed professional clinical counselors.
(m) Naturopathic doctor corporation.
(1) Licensed physicians and surgeons.
(2) Licensed psychologists.
(3) Registered nurses.
(4) Licensed physician assistants.
(5) Licensed chiropractors.
(6) Licensed acupuncturists.
(7) Licensed physical therapists.
(8) Licensed doctors of podiatric medicine.
(9) Licensed marriage and family therapists.
(10) Licensed clinical social workers.
(11) Licensed optometrists.
(12) Licensed professional clinical counselors.
(n) Dental corporation.
(1) Licensed physicians and surgeons.
(2) Dental assistants.
(3) Registered dental assistants.
(4) Registered dental assistants in extended functions.
(5) Registered dental hygienists.
(6) Registered dental hygienists in extended functions.
(7) Registered dental hygienists in alternative practice.
(o) Professional clinical counselor corporation.
(1) Licensed physicians and surgeons.
(2) Licensed psychologists.
(3) Licensed clinical social workers.
(4) Licensed marriage and family therapists.
(5) Registered nurses.
(6) Licensed chiropractors.
(7) Licensed acupuncturists.
(8) Naturopathic doctors.
(p) Physical therapy corporation.
(1) Licensed physicians and surgeons.
(2) Licensed doctors of podiatric medicine.
(3) Licensed acupuncturists.
(4) Naturopathic doctors.
(5) Licensed occupational therapists.
(6) Licensed speech-language therapists.
(7) Licensed audiologists.
(8) Registered nurses.
(9) Licensed psychologists.
(10) Licensed physician assistants.
(q) Registered dental hygienist in alternative practice
corporation.
(1) Registered dental assistants.
(2) Licensed dentists.
(3) Registered dental hygienists.
(4) Registered dental hygienists in extended functions.
SEC. 54. Section 1261.6 of the Health and Safety Code is amended
to read:
1261.6. (a) (1) For purposes of this section and Section 1261.5,
an "automated drug delivery system" means a mechanical system that
performs operations or activities, other than compounding or
administration, relative to the storage, dispensing, or distribution
of drugs. An automated drug delivery system shall collect, control,
and maintain all transaction information to accurately track the
movement of drugs into and out of the system for security, accuracy,
and accountability.
(2) For purposes of this section, "facility" means a health
facility licensed pursuant to subdivision (c), (d), or (k), of
Section 1250 that has an automated drug delivery system provided by a
pharmacy.
(3) For purposes of this section, "pharmacy services" means the
provision of both routine and emergency drugs and biologicals to meet
the needs of the patient, as prescribed by a physician.
(b) Transaction information shall be made readily available in a
written format for review and inspection by individuals authorized by
law. These records shall be maintained in the facility for a minimum
of three years.
(c) Individualized and specific access to automated drug delivery
systems shall be limited to facility and contract personnel
authorized by law to administer drugs.
(d) (1) The facility and the pharmacy shall develop and implement
written policies and procedures to ensure safety, accuracy,
accountability, security, patient confidentiality, and maintenance of
the quality, potency, and purity of stored drugs. Policies and
procedures shall define access to the automated drug delivery system
and limits to access to equipment and drugs.
(2) All policies and procedures shall be maintained at the
pharmacy operating the automated drug delivery system and the
location where the automated drug delivery system is being used.
(e) When used as an emergency pharmaceutical supplies container,
drugs removed from the automated drug delivery system shall be
limited to the following:
(1) A new drug order given by a prescriber for a patient of the
facility for administration prior to the next scheduled delivery from
the pharmacy, or 72 hours, whichever is less. The drugs shall be
retrieved only upon authorization by a pharmacist and after the
pharmacist has reviewed the prescriber's order and the patient's
profile for potential contraindications and adverse drug reactions.
(2) Drugs that a prescriber has ordered for a patient on an
as-needed basis, if the utilization and retrieval of those drugs are
subject to ongoing review by a pharmacist.
(3) Drugs designed by the patient care policy committee or
pharmaceutical service committee of the facility as emergency drugs
or acute onset drugs. These drugs may be retrieved from an automated
drug delivery system pursuant to the order of a prescriber for
emergency or immediate administration to a patient of the facility.
Within 48 hours after retrieval under this paragraph, the case shall
be reviewed by a pharmacist.
(f) When used to provide pharmacy services pursuant to Section
4119.1 of the Business and Professions Code, the automated drug
delivery system shall be subject to all of the following
requirements:
(1) Drugs removed from the automated drug delivery system for
administration to a patient shall be in properly labeled units of
administration containers or packages.
(2) A pharmacist shall review and approve all orders prior to a
drug being removed from the automated drug delivery system for
administration to a patient. The pharmacist shall review the
prescriber's order and the patient's profile for potential
contraindications and adverse drug reactions.
(3) The pharmacy providing services to the facility pursuant to
Section 4119.1 of the Business and Professions Code shall control
access to the drugs stored in the automated drug delivery system.
(4) Access to the automated drug delivery system shall be
controlled and tracked using an identification or password system or
biosensor.
(5) The automated drug delivery system shall make a complete and
accurate record of all transactions that will include all users
accessing the system and all drugs added to, or removed from, the
system.
(6) After the pharmacist reviews the prescriber's order, access by
licensed personnel to the automated drug delivery system shall be
limited only to drugs ordered by the prescriber and reviewed by the
pharmacist and that are specific to the patient. When the prescriber'
s order requires a dosage variation of the same drug, licensed
personnel shall have access to the drug ordered for that scheduled
time of administration.
(7) (A) Systems that allow licensed personnel to have access to
multiple drugs and are not patient specific in their design, shall be
allowed under this subdivision if those systems have electronic and
mechanical safeguards in place to ensure that the drugs delivered to
the patient are specific to that patient. Each facility using such an
automated drug system shall notify the department in writing prior
to the utilization of the system. The notification submitted to the
department pursuant to this paragraph shall include, but is not
limited to, information regarding system design, personnel with
system access, and policies and procedures covering staff training,
storage, and security, and the facility's administration of these
types of systems.
(B) As part of its routine oversight of these facilities, the
department shall review a facility's medication training, storage,
and security, and its administration procedures related to its use of
an automated drug delivery system to ensure that adequate staff
training and safeguards are in place to make sure that the drugs
delivered are appropriate for the patient. If the department
determines that a facility is not in compliance with this section,
the department may revoke its authorization to use automated drug
delivery systems granted under subparagraph (A).
(g) The stocking of an automated drug delivery system shall be
performed by a pharmacist. If the automated drug delivery system
utilizes removable pockets, cards, drawers, similar technology, or
unit of use or single dose containers as defined by the United States
Pharmacopoeia, the stocking system may be done outside of the
facility and be delivered to the facility if all of the following
conditions are met:
(1) The task of placing drugs into the removable pockets, cards,
drawers, or unit of use or single dose containers is performed by a
pharmacist, or by an intern pharmacist or a pharmacy technician
working under the direct supervision of a pharmacist.
(2) The removable pockets, cards, drawers, or unit of use or
single dose containers are transported between the pharmacy and the
facility in a secure tamper-evident container.
(3) The facility, in conjunction with the pharmacy, has developed
policies and procedures to ensure that the removable pockets, cards,
drawers, or unit of use or single dose containers are properly placed
into the automated drug delivery system.
(h) Review of the drugs contained within, and the operation and
maintenance of, the automated drug delivery system shall be done in
accordance with law and shall be the responsibility of the pharmacy.
The review shall be conducted on a monthly basis by a pharmacist and
shall include a physical inspection of the drugs in the automated
drug delivery system, an inspection of the automated drug delivery
system machine for cleanliness, and a review of all transaction
records in order to verify the security and accountability of the
system.
(i) Drugs dispensed from an automated drug delivery system that
meets the requirements of this section shall not be subject to the
labeling requirements of Section 4076 of the Business and Professions
Code or Section 111480 of this code if the drugs to be placed into
the automated drug delivery system are in unit dose packaging or unit
of use and if the information required by Section 4076 of the
Business and Professions Code and Section 111480 of this code is
readily available at the time of drug administration. For purposes of
this section, unit dose packaging includes blister pack cards.
SEC. 55. Section 11164.5 of the Health and Safety Code is amended
to read:
11164.5. (a) Notwithstanding Section 11164, if only recorded and
stored electronically, on magnetic media, or in any other
computerized form, the pharmacy's or hospital's computer system shall
not permit the received information or the controlled substance
dispensing information required by this section to be changed,
obliterated, destroyed, or disposed of, for the record maintenance
period required by law, once the information has been received by the
pharmacy or the hospital and once the controlled substance has been
dispensed, respectively. Once the controlled substance has been
dispensed, if the previously created record is determined to be
incorrect, a correcting addition may be made only by or with the
approval of a pharmacist. After a pharmacist enters the change or
enters his or her approval of the change into the computer, the
resulting record shall include the correcting addition and the date
it was made to the record, the identity of the person or pharmacist
making the correction, and the identity of the pharmacist approving
the correction.
(b) Nothing in this section shall be construed to exempt any
pharmacy or hospital dispensing Schedule II controlled substances
pursuant to electronic transmission prescriptions from existing
reporting requirements.
SEC. 56. Section 42.5 of this bill incorporates amendments to
Section 4400 of the Business and Professions Code proposed by both
this bill and Senate Bill 1039. It shall only become operative if (1)
both bills are enacted and become effective on or before January 1,
2017, (2) each bill amends Section 4400 of the Business and
Professions Code, and (3) this bill is enacted after Senate Bill
1039, in which case Section 42 of this bill shall not become
operative.
SEC. 57. Section 47.5 of this bill incorporates amendments to
Section 4830 of the Business and Professions Code proposed by both
this bill and Senate Bill 1039. It shall only become operative if (1)
both bills are enacted and become effective on or before January 1,
2017, (2) each bill amends Section 4830 of the Business and
Professions Code, and (3) this bill is enacted after Senate Bill
1039, in which case Section 47 of this bill shall not become
operative.
SEC. 58. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.
