BILL NUMBER: SB 1193 AMENDED
BILL TEXT
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 4001, 4003, 4107, 4110,
4119.1, 4127, 4127.3, 4127.7, 4127.8, 4127.9, 4128.6, 4161,
4180, 4400, and 4400 4406 of, to
add Sections 4034, 4126.9, 4203.5, and 4316 to, and to add
Article 7.7 (commencing with Section 4129) to Chapter 9 of Division
2 of, the Business and Professions Code, and 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, and making an appropriation therefor.
LEGISLATIVE COUNSEL'S DIGEST
SB 1193, as amended, Hill. Pharmacy: outsourcing
facilities. Law.
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. That
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 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.
The 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. That law also
provides for
This bill would require a pharmacy to register use of an automated
drug delivery system with the board, including the address and
location of use.
Existing 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.
This bill would make these provisions operative by repealing the
provision that made them inoperative on January 1, 2012.
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. Existing law makes a violation of any provision
of the Pharmacy Law punishable as an infraction if no other penalty
is provided.
This bill would extend the operation of the board and the
board's authorization to appoint an executive officer until January
1, 2021. The bill would require a pharmacy to register use of an
automated drug delivery system with the board, including the address
and location of use. The 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. By placing new requirements on a pharmacy, this
bill would expand an existing crime and would, therefore, impose a
state-mandated local program.
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. Existing law provides that fees
collected on behalf of the board are credited to the Pharmacy Board
Contingent Fund, which continuously appropriates fees in the fund.
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 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.
The 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
This bill would require the board to license an
outsourcing facility, as defined, and would prohibit an outsourcing
facility to be concurrently licensed with the board as a sterile
compounding pharmacy at the same location. The bill would require an
outsourcing facility to be licensed with the board before doing
business within or into the state and 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 within 10 days of the action. The bill would require
the board to, among other things, inspect the location of an
outsourcing facility to ensure that the outsourcing facility is in
compliance with all laws and regulations before issuing or renewing
an outsourcing facility's license. 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, 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
Existing 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. Existing 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 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 also authorize the
board to collect a fee of $780 for the issuance and renewal of an
outsourcing license and a fee of $715 for a temporary license, as
specified. By increasing the amount of money deposited into
a continuously appropriated fund, the bill would make an
appropriation. This bill would provide that the
Pharmacy Board Contingent Fund is available for expenditure only upon
an appropriation by the Legislature.
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.
By placing new requirements on a pharmacy, this bill would expand
an existing crime and would, therefore, impose a state-mandated local
program.
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.
Vote: majority. Appropriation: yes no
. Fiscal committee: yes. State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. 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. 2. 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. 3. 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. 4. Section 4107 of the Business
and Professions Code is amended to read:
4107. (a) The board may 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 injectable
drugs to a pharmacy pursuant to Section 4127.1.
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. 5. 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, when the ownership of a pharmacy is transferred from one
person to another, 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. 4. SEC. 6. 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) The pharmacy shall register use of an automated drug delivery
system with the board, including the address and location of use.
(f) 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. 7. 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) In cases where patient harm has occurred resulting from use of
the compounded product, the event shall be reported to MedWatch
within 72 hours of the pharmacy being advised.
SEC. 8. Section 4127 of the Business
and Professions Code is amended to read:
4127. (a) A pharmacy that compounds sterile drug products
for injection, administration into the eye, or inhalation
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).
(d) This section shall become operative on July 1, 2014.
SEC. 9. 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 injectable
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
injectable 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. 10. Section 4127.7 of the Business
and Professions Code is amended to read:
4127.7. On and after July 1, 2005, a A
pharmacy shall compound sterile injectable
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. 11. 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 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,
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. 12. 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, including a pharmacy that is exempt from licensure
pursuant to subdivision (d) of Section 4127.1 and subdivision (c) of
Section 4127.2, 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. 13. 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 injectable compounding.
SEC. 5. SEC. 14. 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.
4129.6. For purposes of this article, "sterile compounded
products" means compounded preparations for injection, administration
into the eye, or inhalation.
4129.8. The board, at its discretion, may issue a temporary
license to an outsourcing facility when the ownership of the
outsourcing facility is transferred from one person to another, 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. 15. 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 injectable
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. 16. 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. 6. SEC. 17. 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. 7. SEC. 18. 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. 8. SEC. 19. 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 or renewal of an outsourcing facility
license shall be seven hundred eighty dollars ($780). The fee for a
temporary outsourcing facility license shall be seven hundred fifteen
dollars ($715).
(x) The fee for the issuance or renewal of a nonresident
outsourcing facility license shall be seven hundred eighty dollars
($780). 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. 20. 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 State 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 and out of it
and not otherwise shall be paid all expenses of the board.
SEC. 9. SEC. 21. 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. 22. 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).
(C) This paragraph shall remain in effect only until January 1,
2012, unless a later enacted statute is enacted on or before January
1, 2012, deletes or extends that date.
(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, or similar technology,
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,
or drawers 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, or drawers 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 pockets, cards, or drawers
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. 23. Section 11164.5 of the Health
and Safety Code is amended to read:
11164.5. (a) Notwithstanding Section 11164, with the approval of
the California State Board of Pharmacy and the Department of
Justice, a pharmacy or hospital may receive electronic data
transmission prescriptions or computer entry prescriptions or orders
as specified in Section 4071.1 of the Business and Professions Code,
for controlled substances in Schedule II, III, IV, or V if authorized
by federal law and in accordance with regulations promulgated by the
Drug Enforcement Administration. The California State Board of
Pharmacy shall maintain a list of all requests and approvals granted
pursuant to this subdivision.
(b) Notwithstanding Section 11164, if approved pursuant to
subdivision (a), a pharmacy or hospital receiving an electronic
transmission prescription or a computer entry prescription or order
for a controlled substance classified in Schedule II, III, IV, or V
shall not be required to reduce that prescription or order to writing
or to hard copy form, if for three years from the last day of
dispensing that prescription, the pharmacy or hospital is able, upon
request of the board or the Department of Justice, to immediately
produce a hard copy report that includes for each date of dispensing
of a controlled substance in Schedules II, III, IV, and V pursuant to
the prescription all of the information described in subparagraphs
(A) to (E), inclusive, of paragraph (1) of subdivision (a) of Section
4040 of the Business and Professions Code and the name or identifier
of the pharmacist who dispensed the controlled substance.
(c)
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.
(d)
(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. 10. SEC. 24. 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.