BILL ANALYSIS Ó
SB 1193
Page 1
SENATE THIRD READING
SB
1193 (Hill)
As Amended August 1, 2016
Majority vote
SENATE VOTE: 39-0
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|Committee |Votes|Ayes |Noes |
| | | | |
| | | | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Business & |13-0 |Salas, Bloom, Campos, | |
|Professions | |Chávez, Dahle, Dodd, | |
| | |Eggman, Gatto, Gomez, | |
| | |Holden, Mullin, Ting, | |
| | |Wood | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Appropriations |15-0 |Gonzalez, Bloom, | |
| | |Bonilla, Bonta, | |
| | |Calderon, Daly, | |
| | |Eggman, Eduardo | |
| | |Garcia, Holden, | |
| | |Obernolte, Quirk, | |
| | |Santiago, Weber, | |
| | |Wood, McCarty | |
| | | | |
| | | | |
SB 1193
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SUMMARY: Extends the operation of the Board of Pharmacy (BOP)
and Pharmacy Law until January 1, 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. This 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, until January 1, 2021. Specifically,
this bill:
1)Extends the operation of the BOP and its Executive Officer
(EO) until January 1, 2021.
2)Requires, beginning July 1, 2017, each pharmacist, intern
pharmacist, pharmacy technician, designated
representative-Third Party Logistics (3PL) licensed in this
state to join the BOP's email notification list within 60 days
of obtaining a license or at the time of license renewal;
requires him or her to update his or her email address with
the BOP's email notification list within 30 days of a change
in the licensee's email address; exempts this email address
from being posted on the board's online license verification
system; and requires the BOP, with each renewal application,
to remind licensees of this obligation.
3)Requires the BOP to take action against any holder of a
license who is guilty of unprofessional conduct, including
among others, actions that lead to 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, and specifies that the administrative
action taken in this state is coterminous with action taken by
another state, except as specified.
4)Defines "outsourcing facility" as a facility that is located
within the United States (U.S.) at one address that is engaged
SB 1193
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in the compounding of sterile and nonsterile drugs; has
registered with the Food and Drug Administration (FDA); is
doing business within or into California; and, is licensed
with the BOP.
5)Requires a pharmacy using an automated drug delivery system
(ADD) to register use of the ADD with the BOP within 30 days
of installation of the device, and annually thereafter,
including the address at which the ADD is being used; and,
requires a pharmacy to advise the BOP within 30 days if the
pharmacy discontinues the use of an ADD.
6)Allows a pharmacy to use an ADD only if the pharmacy uses the
ADD consistent with legal requirements; the pharmacy's
policies and procedures related to the ADD include appropriate
security and monitoring measures; the pharmacy reports drug
losses as required by law; and, the pharmacy license is
unexpired and not subject to disciplinary action. Exempts
from registration with the BOP an ADD operated by a licensed
hospital pharmacy for doses administered in a facility
operated under a consolidated license.
7)Authorizes the BOP to prohibit a pharmacy from using an ADD if
specified conditions are not met; requires the BOP to give the
pharmacy written notice explaining the basis for the
determination; and allows the pharmacy to appeal the decision
within 30 days.
8)Requires a pharmacy that issues a recall notice regarding a
nonsterile compounded drug product to contact the recipient
pharmacy, prescriber, or patient (as applicable) and the BOP
within 12 hours of the recall notice if both the use or
exposure to the recalled drug may cause serious adverse health
consequence or death, and if the recalled drug was dispensed
or intended for use in this state.
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9)Requires a pharmacy to report to MedWatch within 72 hours if
the pharmacy has been advised that a patient has been harmed
by using a nonsterile compounded product potentially
attributable to the pharmacy.
10)Requires outsourcing facilities, as defined under federal
law, to be licensed by the BOP; prohibits an outsourcing
facility to be simultaneously licensed with the BOP as a
sterile compounding pharmacy at the same location; prohibits a
licensed outsourcing facility from filling patient specific
prescriptions; requires an outsourcing facility to notify the
BOP of any disciplinary or other action taken by another state
or the FDA or of any recall notices or any adverse events
potentially attributable to an outsourcing facility's
products; requires the BOP to inspect the location of a
nonresident outsourcing facility to ensure that the facility
is in compliance with all laws and regulations before issuing
or renewing a nonresident outsourcing facility's license; and,
authorizes the BOP to issue a cease and desist order to an
outsourcing facility if the BOP has reasonable belief that the
products produced by the facility poses an immediate threat to
the public health or safety.
11)Establishes a fee for the issuance of an in-state outsourcing
facility license fee of $2,270 that may be increased to up to
$3,180 by the BOP; establishes a renewal fee of $1,325 that
may be increased to up to $1,855 by the BOP.
12)Establishes a fee for the issuance of a nonresident
outsourcing facility license of $2,380 that may be increased
to up to $3,335 by the BOP; establishes the fee for the
renewal of a nonresident outsourcing facility license of
$2,270 that may be increased to up to $3,180 by the BOP, as
specified.
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13)Includes pharmacists in the list of licensed professionals
authorized to establish a professional corporation.
14)Extends the sunset date for the VMB and its executive officer
until January 1, 2021.
15)Authorizes a veterinarian and Registered Veterinary
Technician (RVT), who is under the director supervision of a
veterinarian with a current and active license, to compound a
drug for anesthesia, the prevention, cure, or relief of a
wound, fracture, bodily injury, or disease of an animal in a
premises currently and actively registered with the VMB, as
specified, and would authorize the BOP and the VMB to ensure
compliance with these requirements.
16)Requires veterinarians engaged in the practice of veterinary
medicine and employed by the University of California or by
Western University of Health Sciences, while engaged in the
performance of specific duties, to be licensed as a
veterinarians in the state or hold a university license issued
by the VMB, and that the applicant for a university license to
meet certain requirements, including that the applicant passes
a specified exam.
17)Provides that a veterinary premise registration may be
canceled after five years of delinquency, unless the VMB finds
circumstances or conditions that would justify a new premise
registration to be issued.
18)Makes technical changes to the Business and Professions Code
regarding the BOP and the VMB.
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FISCAL EFFECT: According Assembly Committee on Appropriations
this bill will result in:
BOP provisions (All costs are fee-supported - Pharmacy Board
Contingent Fund):
1)Ongoing costs of $20.1 million per year for the continued
operation of the BOP.
2)One-time costs of $335,000 and ongoing costs of $320,000 per
year, for licensing and inspection activities relating to
outsourcing facilities. The BOP also estimates $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. Costs related to other provisions, including
information technology costs, are expected to be minor and
absorbable.
VMB provisions (All costs are fee-supported-Veterinary Medical
Board Contingent Fund):
1)Ongoing costs of about $5.0 million per year for the continued
operation of the VMB. All costs to operate the VMB are funded
with licensing fees.
2)Costs related to VMB-related provisions are anticipated to be
minor and absorbable.
COMMENTS:
Purpose. This bill is sponsored by the author, and is one of
five "sunset bills" the author is sponsoring this year.
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According to the author, "this bill is necessary to make changes
to the Pharmacy Law and Veterinary Practice Act in order to
strengthen the laws to improve [BOP] and VMB oversight of
licensees."
Background. Joint Oversight Hearings and Sunset Review of the
DCA Licensing Boards. In March of 2016, the Assembly Committee
on Business and Professions and the Senate Committee on
Business, Professions and Economic Development (Committees)
conducted multiple joint oversight hearings to review 11
regulatory boards within the DCA and one regulatory entity
outside of the DCA. The sunset bills are intended to implement
legislative changes recommended in the respective background
reports drafted by the Committee staff for the agencies reviewed
this year.
Background on the BOP. The 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 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.
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Pharmacists also convey information related to drug therapy
management and are the health care provider most educated on
pharmaceutical care and management. The BOP has a highly
diverse and detailed licensing program for the individuals and
facilities the BOP regulates, reflecting the careful and
deliberative manner in which the U.S. regulates the
manufacturing, distributing, and dispensing of prescription
drugs and devices.
The BOP's enforcement activities are the core of its program,
with the majority of its staff and resources dedicated to
enforcement functions. The BOP employs investigators who work
from home offices throughout the state and perform random,
unannounced inspections to detect violations, investigate
complaints, monitor licensees on probation, educate licensees
about Pharmacy Law requirements, serve as expert witnesses in
disciplinary hearings and identify violations and issues that
non-pharmacists may not be able to identify.
Background on the VMB. The mission of the 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 VMB conducts regular practice analyses to validate the
licensing examinations for both veterinarians and RVTs.
Additional eligibility pathways have also been approved for
licensure of internationally trained veterinary graduates and
certification of RVTs to allow qualified applicants from other
states in the U.S. and countries around the world to come to
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California and to improve the provision of veterinary health
care for consumers and their animals. The VMB's goals, as
stated in its Strategic Plan, include decreased enforcement
cycle times, enhanced quality and training of hospital
inspectors, inspecting existing hospitals within one year of
registration, and working with DCA to reduce the amount of
unlicensed activity occurring in the marketplace.
Analysis Prepared by:
Gabby Nepomuceno / B. & P. / (916) 319-3301 FN:
0004099