BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 1193|
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UNFINISHED BUSINESS
Bill No: SB 1193
Author: Hill (D), et al.
Amended: 8/18/16
Vote: 21
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 4/18/16
AYES: Hill, Bates, Berryhill, Block, Galgiani, Hernandez,
Jackson, Mendoza, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/27/16
AYES: Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen
SENATE FLOOR: 39-0, 6/1/16
AYES: Allen, Anderson, Bates, Beall, Berryhill, Block,
Cannella, De León, Fuller, Gaines, Galgiani, Glazer, Hall,
Hancock, Hernandez, Hertzberg, Hill, Hueso, Huff, Jackson,
Lara, Leno, Leyva, Liu, McGuire, Mendoza, Mitchell, Monning,
Moorlach, Morrell, Nguyen, Nielsen, Pan, Pavley, Roth, Stone,
Vidak, Wieckowski, Wolk
NO VOTE RECORDED: Runner
ASSEMBLY FLOOR: 76-1, 8/23/16 - See last page for vote
SUBJECT: Healing arts
SOURCE: Author
DIGEST: This bill extends the operation of the Board of
Pharmacy (BOP) and Pharmacy Law until 2021 and makes various
changes to the Pharmacy Law intended to improve BOP oversight of
licensees involved in the acquisition, storage, distribution and
dispensing of dangerous drugs and dangerous devices, including:
oversight by the BOP for outsourcing facilities; registration
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Page 2
with the BOP for use of an automated delivery device by a
pharmacy; timeline requirements for the Board to approve clinic
licenses; and technical changes. The bill also makes various
changes that are intended to improve the effectiveness of the
Veterinary Medical Board (VMB) and extends the VMB's sunset
dates. The bill extends the operation of the Board of
Psychology (Psychology Board) and Psychology Licensing Law to
2021, authorizes the issuance of a retired license and makes
technical amends.
Assembly Amendments add provisions related to the Psychology
Board, adjust the fees for outsourcing facilities and make
technical and conforming changes, including removing chaptering
conflicts.
ANALYSIS:
Existing law:
1)Establishes the Psychology Board to enforce and administer the
Psychology Licensing Law. (Business and Professions Code
(BPC) § 2900 et seq.)
2)Under the Pharmacy Law, provides for the licensure and
regulation of pharmacies, pharmacists and wholesalers of
dangerous drugs or devices by the Board within the Department
of Consumer Affairs (DCA) until January 1, 2017. (BPC § 4000
et seq.)
3)Establishes the California Veterinary Medicine Practice Act
(VM Act) until January 1, 2017, and requires the VMB within
the DCA to, among other things, license and regulate
veterinarians, registered veterinary technicians (RVTs), RVT
schools and programs, and veterinary premises. (BPC § 4800 et
seq.)
This bill:
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1)Extends the operation of the Psychology Board and Psychology
Licensing Law to 2021 and makes a number of changes intended
to improve the Psychology Board's functions.
2)Extends the operation of the BOP and Pharmacy Law until 2021
and makes various changes to the Pharmacy Law intended to
improve Board oversight of licensees involved in the
acquisition, storage, distribution and dispensing of dangerous
drugs and dangerous devices,
3)Extends the operation of VMB until 2021 and makes various
changes to the VM Act intended to improve the effectiveness
VMB.
Background
Beginning in 2015, the Senate Business and Professions Committee
and the Assembly Business and Professions Committee (Committees)
conducted joint oversight hearings to review 12 regulatory
entities: DCA, Acupuncture Board, Board of Behavioral Sciences,
California Massage Therapy Association, Court Reporters Board,
BOP, Physician Assistant Board, Board of Podiatric Medicine,
Bureau for Private Postsecondary Education, Psychology Board,
Bureau of Real Estate, Bureau of Real Estate Appraisers and VMB.
The Committees conducted two hearings in March and joined with
the Senate Committee on Education and Assembly Committee on
Higher Education to review the Bureau for Private Postsecondary
Education. This bill is intended to implement legislative
changes as recommended by staff of the Committees and which are
reflected in the Background Papers prepared by Committee staff.
BOP is responsible for enforcing federal and state laws
pertaining to the acquisition, storage, distribution and
dispensing of dangerous drugs (including controlled substances)
and dangerous devices. The BOP has over 140,000 licensees in 23
license categories that include both personal and business
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licenses. As an agency that regulates the individuals and
businesses that dispense, compound, provide, store and
distribute prescription drugs and devices and pharmaceutical
services to the public, or to other health care practitioners in
compliance with state and federal law, the licensing of
pharmacists, pharmacies, and pharmacy technicians is the primary
focus of BOP activity, with consumer protection at the core of
the BOP's operations. The BOP's regulatory authority, as
described in the Pharmacy Law, extends over individuals and
firms located both within and outside California, if they
provide services in California. The BOP notes that it also
ensures the safety of drug products dispensed to patients and
regulates those who handle, store, and ship products from the
manufacturer through the supply chain to the pharmacy and
ultimately to the patient.
The mission of VMB is to protect consumers and animals through
development and maintenance of professional standards, licensing
of veterinarians, RVTs, and premises, and diligent enforcement
of the California Veterinary Medicine Practice Act. The VMB is
composed of eight members: four veterinarians, one RVT, and
three public members. The VMB licenses 12,086 Veterinarians and
6,424 RVTs. The licensee population has increased steadily over
the past five years. The VMB also requires registration of all
premises where veterinary medicine, veterinary dentistry,
veterinary surgery, and the various branches thereof, is being
practiced. The VMB currently registers 3,636 veterinary
premises.
The Psychology Board regulates licensed psychologists,
registered physician assistants and registered psychologists.
Psychology as a profession was recognized with the Certification
Act of 1958, which provided only title protection. In 1967, the
Legislature statutorily defined the practice of psychology and
required licensure to practice. During these early days, the
Board was an examining committee under the jurisdiction of the
Division of Allied Health Professions of The Board of Medical
Quality Assurance (BMQA). The Psychology Examining Committee
gradually became more independent in the 1970s, taking
responsibility for its own operations, including the authority
to adopt regulations and administrative disciplinary actions
without the endorsement of BMQA. The Psychology Examining
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Committee officially became the Psychology Board in 1990.
In response to issues stemming from the Pharmacy Law's lack of
formal recognition for outsourcing facilities and in order to
ensure that the state's hospitals and practitioners have access
to high quality, carefully compounded sterile medication, this
bill establishes a regulatory framework in California for
outsourcing facilities operating under provisions of the federal
Drug Quality and Security Act which created a voluntary
compliance regime in which large-scale compounding pharmacies
may voluntarily register as "outsourcing facilities" and be
subject to oversight by the federal Food and Drug Administration
(FDA) in much of the same way that traditional pharmaceutical
manufacturers are monitored.
In response to concerns that the BOP is not currently able to
track how many automated delivery devices are in use, where they
are in use, or which pharmacy is responsible for specific
delivery devices, this bill establishes a registration process
to enable the Board to identify which pharmacies operate these
delivery devices and where each is located.
In response to concerns about backlogs at BOP, this bill
clarifies current law related to processing timelines for
applications filed by clinics opening a new location, reporting
a change to an existing location or updating certain information
like changes to corporate officers to ensure a streamlined
process for commonly-owned clinics to use just one application
which in turn will speed up processing timelines. This bill also
requires license renewals to be consolidated for commonly owned
clinics.
In response to concerns that BOP does not currently have the
authority to issue a cease and desist order to businesses
involved in unlicensed activity and the fact that simply citing
and fining an unlicensed business is often an insufficient
consequence to stop unlicensed activity, as frequently the
business will continue to do the very action which violates the
law, this bill authorizes the Board to issue a cease and desist
to an entity practicing activities without a license if those
activities would require licensure by the Board.
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During the sunset review of the VMB, several concerns were
raised: drug compounding is a common and essential practice of
veterinary medicine, however, there is a lack of state authority
for veterinarians to compound drugs within their practice; the
Committees were also concerned that the licensure exemption for
veterinarians practicing solely within a University setting
creates a consumer protection issue, as the VMB is unable to
pursue disciplinary action against these individuals. The
proposed solutions to these concerns require legislative action
and are therefore included in this bill.
In response to concerns that California is the only state that
allows students from unaccredited schools to sit for psychology
licensing examinations and that licensed California
psychologists are not able to be full members of the national
professional association, in addition to facing barriers to
practice in other states through reciprocity, this bill requires
that an applicant for psychologist licensure graduate from a
college or institution of higher education that is accredited by
a regional accrediting agency recognized by the United States
Department of Education. The bill contains a grandfather clause
for current students to ensure they are not impacted by the
change.
The bill also makes changes conforming to the Psychology Board's
recognition of professional development and updates the
Psychology Law to authorize a retired license and increases
public transparency by authorizing the Psychology Board to post
information on the status of its licensees relating to
disciplinary and enforcement actions, academic credentials, a
licensee's website, and other information.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: Yes
According to analyses by the Assembly Committee on
Appropriations, provisions related to the Psychology Board will
result in approximately $5 million per year to continue its
operation for an additional four years, the costs for which are
paid for by licensing fees as well as minor and absorbable costs
to implement changes to the Psychology Board and likely minor
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ongoing revenue loss and reduced administrative workload to the
extent some individuals apply for a retired license proposed in
the bill. The Committee noted that provisions related to the
BOP will result in costs of $20.1 million per year for the
continued operation of the BOP, which are paid for by licensing
fees and also one-time costs of $335,000 and ongoing costs of
$320,000 per year for licensing and inspection activities
relating to outsourcing facilities and $288,000 in revenue from
an outsourcing facilities fee authorized by this bill in the
first year and $244,000 annually in the second year. The
analysis noted other provisions in the bill related to the BOP
are expected to be minor and absorbable. The bill will result
in ongoing costs of about $5.0 million per year for the
continued operation of the VMB, paid for by licensing fees as
well as minor and absorbable cost to implement changes to VMB
operations proposed in the bill.
SUPPORT: (Verified8/23/16)
California Pharmacists Association
California Psychological Association
California Veterinary Medical Association
Community Action Fund of Planned Parenthood of Orange and San
Bernardino Counties
Planned Parenthood Affiliates of California
Planned Parenthood Action Fund of the Pacific Southwest
Planned Parenthood Action Fund of Santa Barbara
Planned Parenthood Advocacy Project Los Angeles County
Planned Parenthood Mar Monte
Planned Parenthood Northern California Action Fund
Planned Parenthood Advocates Pasadena and San Gabriel Valley
OPPOSITION: (Verified8/23/16)
None received
ASSEMBLY FLOOR: 76-1, 8/23/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker,
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Page 8
Bigelow, Bloom, Bonilla, Bonta, Brown, Burke, Calderon,
Campos, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh,
Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher,
Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez,
Gonzalez, Gordon, Gray, Grove, Hadley, Roger Hernández,
Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine,
Linder, Lopez, Low, Maienschein, Mathis, McCarty, Medina,
Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen,
Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago,
Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber,
Wilk, Williams, Wood, Rendon
NOES: Harper
NO VOTE RECORDED: Brough, Chang, Mayes
Prepared by:Sarah Mason / B., P. & E.D. / (916) 651-4104
8/23/16 19:54:35
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