BILL NUMBER: AB 2605 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 23, 2014
AMENDED IN ASSEMBLY MARCH 18, 2014
INTRODUCED BY Assembly Member Bonilla
FEBRUARY 21, 2014
An act to amend Section 4200.3 of the Business and
Professions Code, relating to pharmacy. An act to
amend Sections 4022.5, 4040.5, 4043, 4045, 4053, 4060, 4081, 4101, 4
105, 4120, 4126, 4149, 4160, 4161, 4162, 4162.5, 4164,
4165, 4166, 4167, 4168, 4169, 4201, 4305.5, 4312, 4331, and 4400 of,
and to amend the heading of Article 11 (commencing with Section 4160)
of Chapter 9 of Division 2 of, the Business and Professions Code,
relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
AB 2605, as amended, Bonilla. Pharmacy: sterile drug
products. Pharmacy: third-party logistics providers.
(1) Under the Pharmacy Law, a violation of which is a crime, the
California State Board of Pharmacy licenses and regulates the
practice of pharmacy. Existing law restricts the purchase, trade,
sale, or transfer of dangerous drugs or dangerous devices, as
defined, to licensed wholesalers and other authorized persons. Under
the Pharmacy Law, the board licenses and regulates entities,
including third-party logistics providers, as wholesalers. The
Pharmacy Law defines a "third-party logistics provider" or a "reverse
third-party logistics provider" as an entity licensed as a
wholesaler that contracts with a dangerous drug manufacturer to
provide or coordinate warehousing, distribution, or other similar
services on behalf of a manufacturer, but for which there is no
change of ownership in the dangerous drugs.
This bill would delete from the definition of "third-party
logistics provider" or "reverse third-party logistics provider" the
requirement that the entity be a licensed wholesaler, and would
require a third-party logistics provider of a dangerous drug or
dangerous device to be separately licensed by the board as a
third-party logistics provider.
(2) The Pharmacy Law requires a person located outside this state
that ships, sells, mails, or delivers dangerous drugs or dangerous
devices into this state, or sells, brokers, or distributes dangerous
drugs or devices within this state to be a licensed nonresident
wholesaler.
This bill would, in addition, require a person located outside
this state that performs those actions or that warehouses or
distributes dangerous drugs or dangerous devices into this state, or
warehouses dangerous drugs or devices within this state to be
licensed as either a nonresident wholesaler or a nonresident
third-party logistics provider. The bill would make conforming
changes, and would delete obsolete cross-references and provisions.
(3) Existing law sets the fees for the issuance and renewal of
licenses for wholesalers and designated representatives at specified
amounts and authorizes those fees to be increased to specified higher
amounts.
This bill would instead set the fees at the higher amounts.
(4) Because a violation of the requirements described in
paragraphs (1) and (2) above would be a crime, the bill would 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.
The Pharmacy Law provides for the licensure and regulation of
pharmacists and pharmacy corporations in this state by the California
State Board of Pharmacy. Existing law requires an applicant for
licensure to have, among other things, passed specified national and
state examinations. Existing law requires the examination process to
be regularly reviewed, as specified, and to meet certain national
testing standards. Existing law requires the board to report to the
Joint Committee on Boards, Commissions, and Consumer Protection and
the Department of Consumer Affairs, as part of its next scheduled
review, the pass rates of applicants who sat for the national
examination compared with the pass rates of applicants who sat for
the prior state examination, as specified.
This bill would instead require the board to report the pass rate
information described above to the appropriate policy committees of
the Legislature and the department.
Vote: majority. Appropriation: no. Fiscal committee: no
yes . State-mandated local program: no
yes .
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 4022.5 of the
Business and Professions Code is amended to read:
4022.5. (a) "Designated representative" means an individual to
whom a license has been granted pursuant to Section 4053. A
pharmacist fulfilling the duties of Section 4053 shall not be
required to obtain a license as a designated representative.
(b) "Designated representative-in-charge" means a designated
representative or a pharmacist proposed by a wholesaler
wholesaler, third-party logistics provider, or
veterinary food-animal drug retailer and approved by the board as the
supervisor or manager responsible for ensuring the
wholesaler's compliance of the wholesaler, third-party
logistics provider, or veterinary food-animal drug
retailer's compliance retailer with all state and
federal laws and regulations pertaining to practice in the
applicable license category.
SEC. 2. Section 4040.5 of the Business
and Professions Code is amended to read:
4040.5. "Reverse distributor" means every person who acts as an
agent for pharmacies, drug wholesalers, third-party logistics
providers, manufacturers, and other entities by receiving,
inventorying, warehousing, and managing the disposition of
outdated or nonsalable nonsaleable
dangerous drugs.
SEC. 3. Section 4043 of the Business
and Professions Code is amended to read:
4043. (a) "Wholesaler"
means and includes a person who acts as a wholesale merchant, broker,
jobber, customs broker, reverse distributor, agent, or a nonresident
wholesaler, who sells for resale, or negotiates for distribution, or
takes possession of, any drug or device included in Section 4022.
Unless otherwise authorized by law, a wholesaler may not store,
warehouse, or authorize the storage or warehousing of drugs with any
person or at any location not licensed by the board.
(b) This section shall become operative January 1, 2006.
SEC. 4. Section 4045 of the Business
and Professions Code is amended to read:
4045. "Third-party logistics provider" or "reverse third-party
logistic provider" means an entity
licensed as a wholesaler an entity that
contracts with a dangerous drug manufacturer to provide or coordinate
warehousing, distribution, or other similar services on behalf of a
manufacturer, but for which there is no change of ownership in the
dangerous drugs. For purposes of Sections 4034, 4163,
4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, a third-party logistics
provider shall not be responsible for generating or updating pedigree
documentation, but shall maintain copies of the pedigree.
To be exempt from documentation for pedigrees, a reverse
third-party logistic provider may only accept decommissioned drugs
from pharmacies or wholesalers.
SEC. 5. Section 4053 of the Business
and Professions Code is amended to read:
4053. (a) Notwithstanding Section 4051, the board may issue a
license as a designated representative to provide sufficient and
qualified supervision in a wholesaler
wholesaler, third-party logistics provider, or veterinary
food-animal drug retailer. The designated representative shall
protect the public health and safety in the handling, storage,
warehousing, distribution, and shipment of dangerous drugs and
dangerous devices in the wholesaler
wholesaler, third-party logistics provider, or veterinary
food-animal drug retailer.
(b) An individual who is at least 18 years of age may
apply for a designated representative license. In order to obtain and
maintain that license, the individual shall meet all of the
following requirements:
(1) He or she shall be a high school graduate or possess a general
education development certificate equivalent.
(2) He or she shall have a minimum of one year of paid work
experience in a licensed pharmacy, or with a drug wholesaler,
third-party logistics provider, drug distributor, or drug
manufacturer, in the past three years, related to the distribution or
dispensing of dangerous drugs or dangerous devices or meet all of
the prerequisites to take the examination required for licensure as a
pharmacist by the board.
(3) He or she shall complete a training program approved by the
board that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California law and federal law
relating to the distribution of dangerous drugs and dangerous
devices.
(B) Knowledge and understanding of California law and federal law
relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia
standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology,
abbreviations, dosages, and format.
(4) The board may, by regulation, require training programs to
include additional material.
(5) The board may shall not issue a
license as a designated representative until the applicant provides
proof of completion of the required training to the board.
(c) The wholesaler, third-party logistics provider, or
veterinary food-animal drug retailer or wholesaler
shall not operate without a pharmacist or a designated
representative on its premises.
(d) Only a pharmacist or a designated representative shall prepare
and affix the label to veterinary food-animal drugs.
(e) Section 4051 shall not apply to any laboratory licensed under
Section 351 of Title III of the Public Health Service Act (Public Law
78-410).
SEC. 6. Section 4060 of the Business
and Professions Code is amended to read:
4060. A person shall not possess any controlled substance, except
that furnished to a person upon the prescription of a physician,
dentist, podiatrist, optometrist, veterinarian, or naturopathic
doctor pursuant to Section 3640.7, or furnished pursuant to a drug
order issued by a certified nurse-midwife pursuant to Section
2746.51, a nurse practitioner pursuant to Section 2836.1, a physician
assistant pursuant to Section 3502.1, a naturopathic doctor pursuant
to Section 3640.5, or a pharmacist pursuant to Section 4052.1,
4052.2, or 4052.6. This section does not apply to the possession of
any controlled substance by a manufacturer, wholesaler,
third-party logistics provider, pharmacy, pharmacist,
physician, podiatrist, dentist, optometrist, veterinarian,
naturopathic doctor, certified nurse-midwife, nurse practitioner, or
physician assistant, if in stock in containers correctly labeled with
the name and address of the supplier or producer.
This section does not authorize a certified nurse-midwife, a nurse
practitioner, a physician assistant, or a naturopathic doctor, to
order his or her own stock of dangerous drugs and devices.
SEC. 7. Section 4081 of the Business
and Professions Code is amended to read:
4081. (a) All records of manufacture and of sale, acquisition, or
disposition of dangerous drugs or dangerous devices shall be at all
times during business hours open to inspection by authorized officers
of the law, and shall be preserved for at least three years from the
date of making. A current inventory shall be kept by every
manufacturer, wholesaler, third-party logistics provider,
pharmacy, veterinary food-animal drug retailer, physician, dentist,
podiatrist, veterinarian, laboratory, clinic, hospital, institution,
or establishment holding a currently valid and unrevoked certificate,
license, permit, registration, or exemption under Division 2
(commencing with Section 1200) of the Health and Safety Code or under
Part 4 (commencing with Section 16000) of Division 9 of the Welfare
and Institutions Code who maintains a stock of dangerous drugs or
dangerous devices.
(b) The owner, officer, and partner of a pharmacy, wholesaler,
third-party logistics provider, or veterinary food-animal
drug retailer shall be jointly responsible, with the
pharmacist-in-charge or designated representative-in-charge, for
maintaining the records and inventory described in this section.
(c) The pharmacist-in-charge or designated
representative-in-charge shall not be criminally responsible for acts
of the owner, officer, partner, or employee that violate this
section and of which the pharmacist-in-charge or designated
representative-in-charge had no knowledge, or in which he or she did
not knowingly participate.
SEC. 8. Section 4101 of the Business
and Professions Code is amended to read:
4101. (a) A pharmacist may take charge of and act as the
pharmacist-in-charge of a pharmacy upon application by the pharmacy
and approval by the board. Any pharmacist-in-charge who ceases to act
as the pharmacist-in-charge of the pharmacy shall notify the board
in writing within 30 days of the date of that change in status.
(b) A designated representative or a pharmacist may take charge
of, and act as, the designated representative-in-charge of a
wholesaler wholesaler, third-party logistics
provider, or veterinary food-animal drug retailer upon
application by the wholesaler wholesaler,
third-party logistics provider, or veterinary food-animal drug
retailer and approval by the board. Any designated
representative-in-charge who ceases to act as the designated
representative-in-charge at that entity shall notify the board in
writing within 30 days of the date of that change in status.
SEC. 9. Section 4105 of the Business
and Professions Code is amended to read:
4105. (a) All records or other documentation of the acquisition
and disposition of dangerous drugs and dangerous devices by any
entity licensed by the board shall be retained on the licensed
premises in a readily retrievable form.
(b) The licensee may remove the original records or documentation
from the licensed premises on a temporary basis for license-related
purposes. However, a duplicate set of those records or other
documentation shall be retained on the licensed premises.
(c) The records required by this section shall be retained on the
licensed premises for a period of three years from the date of
making.
(d) Any records that are maintained electronically shall be
maintained so that the pharmacist-in-charge, the pharmacist on duty
if the pharmacist-in-charge is not on duty, or, in the case of a
veterinary food-animal drug retailer or
retailer, wholesaler, third-party logistics provider, or
the designated representative on duty, shall, at all times
during which the licensed premises are open for business, be able to
produce a hardcopy and electronic copy of all records of acquisition
or disposition or other drug or dispensing-related records maintained
electronically.
(e) (1) Notwithstanding subdivisions (a), (b), and (c), the board,
may upon written request, grant to a licensee a waiver of the
requirements that the records described in subdivisions (a), (b), and
(c) be kept on the licensed premises.
(2) A waiver granted pursuant to this subdivision shall not affect
the board's authority under this section or any other provision of
this chapter.
(f) When requested by an authorized officer of the law or by an
authorized representative of the board, the owner, corporate officer,
or manager of an entity licensed by the board shall provide the
board with the requested records within three business days of the
time the request was made. The entity may request in writing an
extension of this timeframe for a period not to exceed 14 calendar
days from the date the records were requested. A request for an
extension of time is subject to the approval of the board. An
extension shall be deemed approved if the board fails to deny the
extension request within two business days of the time the extension
request was made directly to the board.
SEC. 10. Section 4120 of the Business
and Professions Code is amended to read:
4120. (a) A nonresident pharmacy shall not sell or distribute
dangerous drugs or dangerous devices in this state through any person
or media other than a wholesaler or third-party logistics
provider who has obtained a license pursuant to this chapter or
through a selling or distribution outlet that is licensed as a
wholesaler or third-party logistics provider pursuant to
this chapter without registering as a nonresident pharmacy.
(b) Applications for a nonresident pharmacy registration shall be
made on a form furnished by the board. The board may require any
information as the board deems reasonably necessary to carry out the
purposes of this section.
(c) The Legislature, by enacting this section, does not intend a
license issued to any nonresident pharmacy pursuant to this section
to change or affect the tax liability imposed by Chapter 3
(commencing with Section 23501) of Part 11 of Division 2 of the
Revenue and Taxation Code on any nonresident pharmacy.
(d) The Legislature, by enacting this section, does not intend a
license issued to any nonresident pharmacy pursuant to this section
to serve as any evidence that the nonresident pharmacy is doing
business within this state.
SEC. 11. Section 4126 of the Business
and Professions Code is amended to read:
4126. (a) Notwithstanding any other provision of
law, a covered entity may contract with a pharmacy to
provide pharmacy services to patients of the covered entity, as
defined in Section 256b of Title 42 of the United States Code,
including dispensing preferentially priced drugs obtained pursuant to
Section 256b of Title 42 of the United States Code. Contracts
between those covered entities and pharmacies shall comply with
guidelines published by the Health Resources and Services
Administration and shall be available for inspection by board staff
during normal business hours.
(b) Drugs purchased pursuant to Section 256b of Title 42 of the
United States Code and received by a pharmacy shall be segregated
from the pharmacy's other drug stock by either physical or electronic
means. All records of acquisition and disposition of these drugs
shall be readily retrievable in a form separate from the pharmacy's
other records.
(c) Drugs obtained by a pharmacy to be dispensed to patients of a
covered entity pursuant to Section 256b of Title 42 of the United
States Code that cannot be distributed because of a change in
circumstances for the covered entity or the pharmacy shall be
returned to the distributor from which they were obtained. For the
purposes of this section, a change in circumstances includes, but is
not limited to, the termination or expiration of the contract between
the pharmacy and the covered entity, the closure of a pharmacy,
disciplinary action against the pharmacy, or closure of the covered
entity.
(d) A licensee that participates in a contract to dispense
preferentially priced drugs pursuant to this section shall not have
both a pharmacy and a wholesaler license, or both a pharmacy and
a third-party logistics provider license.
(e) Neither a covered entity nor a pharmacy shall be required to
obtain a license as a wholesaler or a third-party logistics
provider based on acts reasonably necessary to fully
participate in the drug purchase program established by Section 256b
of Title 42 of the United States Code.
SEC. 12. Section 4149 of the Business
and Professions Code is amended to read:
4149. (a) A nonresident distributor shall not sell or distribute
hypodermic needles or syringes in this state without obtaining a
license from the board pursuant to Section 4141.
(b) Notwithstanding subdivision (a), no a
license shall be is not required
if the nonresident distributor sells or distributes solely through a
person who is licensed as a wholesaler or third-party logistics
provider pursuant to Section 4160.
(c) The Legislature, by enacting this section, does not intend a
license issued to any nonresident distributor pursuant to this
article to serve as evidence that the entity is doing business within
this state.
SEC. 13. The heading of Article 11 (commencing
with Section 4160) of Chapter 9 of Division 2 of the
Business and Professions Code is amended to read:
Article 11. Wholesalers Wholesalers,
Third-Party Logistics Providers, and Manufacturers
SEC. 14. Section 4160 of the Business
and Professions Code is amended to read:
4160. (a) A person may shall not
act as a wholesaler or third-party logistics provider of
any dangerous drug or dangerous device unless he or she has obtained
a license from the board.
(b) Upon approval by the board and the payment of the required
fee, the board shall issue a license to the applicant.
(c) A separate license shall be required for each place of
business owned or operated by a wholesaler.
wholesaler or third-party logistics provider. Each license
shall be renewed annually and shall not be transferable.
(d) Every wholesaler or third-party logistics provider
shall be supervised or managed by a designated
representative-in-charge. The designated representative-in-charge
shall be responsible for the wholesaler's
compliance of the wholesaler or third-party logistics provider
with state and federal laws governing wholesalers.
wholesalers and third-party logistics providers.
As part of its initial application for a license, and for each
renewal, each wholesaler or third-party logistics provider
shall, on a form designed by the board, provide identifying
information and the California license number for a designated
representative or pharmacist proposed to serve as the designated
representative-in-charge. The proposed designated
representative-in-charge shall be subject to approval by the board.
The board shall not issue or renew a wholesaler or third-party
logistics provider license without identification of an
approved designated representative-in-charge for the
wholesaler. wholesaler or third-party logistics
provider.
(e) Every A wholesaler or
third-party logistics provider shall notify the board in
writing, on a form designed by the board, within 30 days of the date
when a designated representative-in-charge ceases to act as the
designated representative-in-charge, and shall on the same form
propose another designated representative or pharmacist to take over
as the designated representative-in-charge. The proposed replacement
designated representative-in-charge shall be subject to approval by
the board. If disapproved, the wholesaler or third-party
logistics provider shall propose another replacement within 15
days of the date of disapproval, and shall continue to name proposed
replacements until a designated representative-in-charge is approved
by the board.
(f) A drug manufacturer premises licensed by the Food and Drug
Administration or licensed pursuant to Section 111615 of the Health
and Safety Code that only distributes dangerous drugs and dangerous
devices of its own manufacture is exempt from this section and
Section 4161.
(g) 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 required in an amount
established by the board as specified in subdivision (f) of Section
4400. 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.
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. 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) 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. A license shall be renewed annually
and shall not be transferable.
(d) The following information shall be reported, in writing, to
the board at the time of initial application for licensure by a
nonresident wholesaler, 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 transferred 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) The board may shall not issue or
renew a nonresident wholesaler or nonresident third-party
logistics provider license until the nonresident wholesaler
or nonresident third-party logistics provider identifies a
designated representative-in-charge and notifies the board in
writing of the identity and license number of the designated
representative-in-charge.
(j) The designated representative-in-charge shall be responsible
for the compliance of the nonresident wholesaler'
s compliance wholesaler or nonresident third-party
logistics provider with state and federal laws governing
wholesalers. wholesalers and 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 within
30 days of the date that the prior designated
representative-in-charge ceases to be the designated
representative-in-charge.
(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 4162 of the Business
and Professions Code is amended to read:
4162. (a) (1) An applicant, that is not a government
owned and operated wholesaler, applicant for the
issuance or renewal of a wholesaler license
or third-party logistics provider license, which is not government
owned and operated, shall submit a surety bond of one hundred
thousand dollars ($100,000) or other equivalent means of security
acceptable to the board payable to the Pharmacy Board Contingent
Fund. The purpose of the surety bond is to secure payment of any
administrative fine imposed by the board and any cost recovery
ordered pursuant to Section 125.3.
(2) For purposes of paragraph (1), the board may accept a surety
bond less than one hundred thousand dollars ($100,000) if
the annual gross receipts of
the previous tax year for the wholesaler or third-party
logistics provider is ten million dollars ($10,000,000) or
less, in which case the surety bond shall be twenty-five thousand
dollars ($25,000).
(3) A person to whom an approved new drug application has been
issued by the United States Food and Drug Administration who engages
in the wholesale distribution of only the dangerous drug specified in
the new drug application, and is licensed or applies for licensure
as a wholesaler, wholesaler or third-party
logistics provider, shall not be required to post a surety bond
as provided in paragraph (1).
(4) For licensees subject to paragraph (2) or (3), the board may
require a bond up to one hundred thousand dollars ($100,000) for any
licensee who has been disciplined by any state or federal agency or
has been issued an administrative fine pursuant to this chapter.
(b) The board may make a claim against the bond if the licensee
fails to pay a fine within 30 days after the order imposing the fine,
or costs become final.
(c) A single surety bond or other equivalent means of security
acceptable to the board shall satisfy the requirement of subdivision
(a) for all licensed sites under common control as defined in Section
4126.5.
SEC. 17. Section 4162.5 of the Business
and Professions Code is amended to read:
4162.5. (a) (1) An applicant for the issuance or renewal of a
nonresident wholesaler or third-party logistics provider
license shall submit a surety bond of one hundred thousand dollars
($100,000), or other equivalent means of security acceptable to the
board, such as an irrevocable letter of credit, or a deposit in a
trust account or financial institution, payable to the Pharmacy Board
Contingent Fund. The purpose of the surety bond is to secure payment
of any administrative fine imposed by the board and any cost
recovery ordered pursuant to Section 125.3.
(2) For purposes of paragraph (1), the board may accept a surety
bond less than one hundred thousand dollars ($100,000) if the annual
gross receipts of the previous tax year for the nonresident
wholesaler or third-party logistics provider is ten
million dollars ($10,000,000) or less less,
in which case the surety bond shall be twenty-five
thousand dollars ($25,000).
(3) For applicants who satisfy paragraph (2), the board may
require a bond up to one hundred thousand dollars ($100,000) for any
nonresident wholesaler or third-party logistics provider
who has been disciplined by any state or federal agency or has been
issued an administrative fine pursuant to this chapter.
(4) A person to whom an approved new drug application or a
biologics license application has been issued by the United States
Food and Drug Administration who engages in the wholesale
distribution of only the dangerous drug specified in the new drug
application or biologics license application, and is licensed or
applies for licensure as a nonresident wholesaler,
wholesaler or third-party logistics provider, shall not
be required to post a surety bond as provided in this section.
(b) The board may make a claim against the bond if the licensee
fails to pay a fine within 30 days of the issuance of the fine or
when the costs become final.
(c) A single surety bond or other equivalent means of security
acceptable to the board shall satisfy the requirement of subdivision
(a) for all licensed sites under common control as defined in Section
4126.5.
SEC. 18. Section 4164 of the Business
and Professions Code is amended to read:
4164. (a) A wholesaler or third-party logistics provider
licensed by the board that distributes controlled substances,
dangerous drugs, or dangerous devices within or into this state shall
report to the board all sales distributions
of dangerous drugs and controlled substances that are subject
to abuse, as determined by the board.
(b) Each wholesaler shall develop and maintain a system for
tracking individual sales of dangerous drugs at preferential or
contract prices to pharmacies that primarily or solely dispense
prescription drugs to patients of long-term care facilities. The
system shall be capable of identifying purchases of any dangerous
drug at preferential or contract prices by customers that vary
significantly from prior ordering patterns for the same customer,
including by identifying purchases in the preceding 12 calendar
months by that customer or similar customers and identifying current
purchases that exceed prior purchases by either that customer or
similar customers by a factor of 20 percent. Each wholesaler
shall have the tracking system required by this subdivision in place
no later than January 1, 2006.
(c) Upon written, oral, or electronic request by the board, a
wholesaler shall furnish data tracked pursuant to subdivision (b) to
the board in written, hardcopy, or electronic form. The board shall
specify the dangerous drugs, the customers, or both the dangerous
drugs and customers for which data are to be furnished, and the
wholesaler shall have 30 calendar days to comply with the request.
(d) As used in this section, "preferential or contract prices"
means and refers to purchases by contract of dangerous drugs at
prices below the market wholesale price for those drugs.
(e) This section shall become operative on January 1, 2006.
SEC. 19. Section 4165 of the Business
and Professions Code is amended to read:
4165. A wholesaler or third-party logistics provider
licensed by the board who sells or transfers any dangerous drug or
dangerous device into this state or who receives, by sale or
otherwise, any dangerous drug or dangerous device from any person in
this state shall, on request, furnish an authorized officer of the
law with all records or other documentation of that sale or transfer.
SEC. 20. Section 4166 of the Business
and Professions Code is amended to read:
4166. (a) Any wholesaler that uses the services of any
third-party logistics provider or carrier, including, but not
limited to, the United States Postal Service or any common carrier,
shall be liable for the security and integrity of any dangerous drugs
or dangerous devices through that provider or carrier
until the drugs or devices are delivered to the transferee at its
board-licensed premises.
(b) Nothing in this section is intended to affect the liability of
a wholesaler wholesaler, third-party
logistics provider, or other distributor for dangerous drugs or
dangerous devices after their delivery to the transferee.
SEC. 21. Section 4167 of the Business
and Professions Code is amended to read:
4167. A wholesaler or third-party logistics provider
shall not obtain, by purchase or otherwise, any dangerous drugs or
dangerous devices that it cannot maintain, in a secure manner, on the
premises licensed by the board.
SEC. 22. Section 4168 of the Business
and Professions Code is amended to read:
4168. A county or municipality may shall
not issue a business license for any establishment that
requires a wholesaler or third-party logistics provider
license unless the establishment possesses a current wholesaler
or third-party logistics provider license issued by the board.
For purposes of this section, an "establishment" is the licensee's
physical location in California.
SEC. 23. Section 4169 of the Business
and Professions Code is amended to read:
4169. (a) A person or entity may shall
not do any of the following:
(1) Purchase, trade, sell, warehouse, distribute, or
transfer dangerous drugs or dangerous devices at wholesale with a
person or entity that is not licensed with the board as a
wholesaler wholesaler, third-party logistics provider,
or pharmacy.
(2) Purchase, trade, sell, or transfer dangerous drugs that the
person knew or reasonably should have known were adulterated, as set
forth in Article 2 (commencing with Section 111250) of Chapter 6 of
Part 5 of Division 104 of the Health and Safety Code.
(3) Purchase, trade, sell, or transfer dangerous drugs that the
person knew or reasonably should have known were misbranded, as
defined in Section 111335 of the Health and Safety Code.
(4) Purchase, trade, sell, or transfer dangerous drugs or
dangerous devices after the beyond use date on the label.
(5) Fail to maintain records of the acquisition or disposition of
dangerous drugs or dangerous devices for at least three years.
(b) Notwithstanding any other provision of law,
a violation of this section or of subdivision (c) or (d) of
Section 4163 may subject the person or entity that has
committed the violation to a fine not to exceed the amount specified
in Section 125.9 for each occurrence, pursuant to a citation issued
by the board.
(c) Amounts due from any person under this section shall be offset
as provided under Section 12419.5 of the Government Code. Amounts
received by the board under this section shall be deposited into the
Pharmacy Board Contingent Fund.
(d) This section shall not apply to a pharmaceutical manufacturer
licensed by the Food and Drug Administration or by the State
Department of Public Health.
SEC. 24. Section 4201 of the Business
and Professions Code is amended to read:
4201. (a) Each application to conduct a pharmacy, wholesaler,
third-party logistics provider, or veterinary food-animal
drug retailer, shall be made on a form furnished by the board, and
shall state the name, address, usual occupation, and professional
qualifications, if any, of the applicant. If the applicant is other
than a natural person, the application shall state the information as
to each person beneficially interested therein.
(b) As used in this section, and subject to subdivision (c), the
term "person beneficially interested" means and includes:
(1) If the applicant is a partnership or other unincorporated
association, each partner or member.
(2) If the applicant is a corporation, each of its officers,
directors, and stockholders, provided that no natural person shall be
deemed to be beneficially interested in a nonprofit corporation.
(3) If the applicant is a limited liability company, each officer,
manager, or member.
(c) In any case where If the
applicant is a partnership or other unincorporated association,
is a limited liability company, or is
a corporation, and where the number of
partners, members, or stockholders, as the case may be, exceeds five,
the application shall so state, and shall further state the
information required by subdivision (a) as to each of the five
partners, members, or stockholders who own the five largest interests
in the applicant entity. Upon request by the executive officer, the
applicant shall furnish the board with the information required by
subdivision (a) as to partners, members, or stockholders not named in
the application, or shall refer the board to an appropriate source
of that information.
(d) The application shall contain a statement to the effect that
the applicant has not been convicted of a felony and has not violated
any of the provisions of this chapter. If the applicant cannot make
this statement, the application shall contain a statement of the
violation, if any, or reasons which will prevent the applicant from
being able to comply with the requirements with respect to the
statement.
(e) Upon the approval of the application by the board and payment
of the fee required by this chapter for each pharmacy, wholesaler,
third-party logistics provider, or veterinary food-animal
drug retailer, the executive officer of the board shall issue a
license to conduct a pharmacy, wholesaler, third-party logistics
provider, or veterinary food-animal drug retailer, if all of
the provisions of this chapter have been complied with.
(f) Notwithstanding any other provision of law,
the pharmacy license shall authorize the holder to conduct a
pharmacy. The license shall be renewed annually and shall not be
transferable.
(g) Notwithstanding any other provision of law,
the wholesale wholesaler license shall
authorize the holder to wholesale dangerous drugs and dangerous
devices. The license shall be renewed annually and shall not be
transferable.
(h) Notwithstanding any other law, the third-party logistics
provider license shall authorize the holder to provide or coordinate
warehousing, distribution, or other similar services of dangerous
drugs and dangerous devices. The license shall be renewed annually
and shall not be transferable.
(h)
(i) Notwithstanding any other provision of
law, the veterinary food-animal drug retailer license shall
authorize the holder thereof to conduct a
veterinary food-animal drug retailer and to sell and dispense
veterinary food-animal drugs as defined in Section 4042.
(i)
(j) For licenses referred to in subdivisions (f), (g),
(h), and (h), (i), any
change in the proposed beneficial ownership interest shall be
reported to the board within 30 days thereafter upon a form to be
furnished by the board.
(j) This section shall become operative on July 1, 2001.
SEC. 25. Section 4305.5 of the Business
and Professions Code is amended to read:
4305.5. (a) A person who has obtained
that is licensed as a license to conduct a wholesaler
wholesaler, third-party logistics provider, or
veterinary food-animal drug retailer, shall notify the board within
30 days of the termination of employment of the designated
representative-in-charge. Failure to notify the board within the
30-day period shall constitute grounds for disciplinary action.
(b) A person who has obtained that is
licensed as a license to conduct a wholesaler
wholesaler, third-party logistics provider, or
veterinary food-animal drug retailer, who
that willfully fails to notify the board of the termination of
employment of the designated representative-in-charge,
representative-in-charge at its licensed place of
business, and who that continues
to operate the licensee place of business
in the absence of the designated representative-in-charge for
that location, place of business shall
be subject to summary suspension or revocation of his or her
its license to conduct
as a wholesaler wholesaler, third-party
logistics provider, or veterinary food-animal drug
retailer. retailer at that place of business.
(c) A designated representative-in-charge of a wholesaler
wholesaler, third-party logistics provider, or
veterinary food-animal drug retailer, who terminates his or her
employment at the licensee, licensed place of
business, shall notify the board within 30 days of the
termination of employment. Failure to notify the board within the
30-day period shall constitute grounds for disciplinary action.
(d) This section shall become operative on January 1, 2006.
SEC. 26. Section 4312 of the Business
and Professions Code is amended to read:
4312. (a) The board may cancel the license of a wholesaler,
third-party logistics provider, pharmacy, or veterinary
food-animal drug retailer if the licensed premises remain closed, as
defined in subdivision (e), other than by order of the board. For
good cause shown, the board may cancel a license after a shorter
period of closure. To cancel a license pursuant to this subdivision,
the board shall make a diligent, good faith effort to give notice by
personal service on the licensee. If a written objection is not
received within 10 days after personal service is made or a diligent,
good faith effort to give notice by personal service on the licensee
has failed, the board may cancel the license without the necessity
of a hearing. If the licensee files a written objection, the board
shall file an accusation based on the licensee remaining closed.
Proceedings shall be conducted in accordance with Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2 of
the Government Code, and the board shall have all the powers granted
in that chapter.
(b) In If the event that the
license of a wholesaler, third-party logistics
provider, pharmacy, or veterinary food-animal drug retailer is
cancelled canceled pursuant to
subdivision (a) or revoked pursuant to Article 19 (commencing with
Section 4300), or a wholesaler, third-party logistics provider,
pharmacy, or veterinary food-animal drug retailer notifies the
board of its intent to remain closed or to discontinue business, the
licensee shall, within 10 days thereafter, arrange for the transfer
of all dangerous drugs and controlled substances or dangerous devices
to another licensee authorized to possess the dangerous drugs and
controlled substances or dangerous devices. The licensee transferring
the dangerous drugs and controlled substances or dangerous devices
shall immediately confirm in writing to the board that the transfer
has taken place.
(c) If a wholesaler, third-party logistics provider,
pharmacy, or veterinary food-animal drug retailer fails to comply
with subdivision (b), the board may seek and obtain an order from the
superior court in the county in which the wholesaler,
third-party logistics provider, pharmacy, or veterinary
food-animal drug retailer is located, authorizing the board to enter
the wholesaler, third-party logistics provider, pharmacy,
or veterinary food-animal drug retailer and inventory and store,
transfer, sell, or arrange for the sale of, all dangerous drugs and
controlled substances and dangerous devices found in the wholesaler,
third-party logistics provider, pharmacy, or veterinary
food-animal drug retailer.
(d) In If the event that
the board sells or arranges for the sale of any dangerous
drugs, controlled substances, or dangerous devices pursuant to
subdivision (c), the board may retain from the proceeds of the sale
an amount equal to the cost to the board of obtaining and enforcing
an order issued pursuant to subdivision (c), including the cost of
disposing of the dangerous drugs, controlled substances, or dangerous
devices. The remaining proceeds, if any, shall be returned to the
licensee from whose premises the dangerous drugs or controlled
substances or dangerous devices were removed.
(1) The licensee shall be notified of his or her right to the
remaining proceeds by personal service or by certified mail, postage
prepaid.
(2) If a statute or regulation requires the licensee to file with
the board his or her address, and any change of address, the notice
required by this subdivision may be sent by certified mail, postage
prepaid, to the latest address on file with the board and service of
notice in this manner shall be deemed completed on the 10th day after
the mailing.
(3) If the licensee is notified as provided in this subdivision,
and the licensee fails to contact the board for the remaining
proceeds within 30 calendar days after personal service has been made
or service by certified mail, postage prepaid, is deemed completed,
the remaining proceeds shall be deposited by the board into the
Pharmacy Board Contingent Fund. These deposits shall be deemed to
have been received pursuant to Chapter 7 (commencing with Section
1500) of Title 10 of Part 3 of the Code of Civil Procedure and shall
be subject to claim or other disposition as provided in that chapter.
(e) For the purposes of this section, "closed" means not engaged
in the ordinary activity for which a license has been issued for at
least one day each calendar week during any 120-day period.
(f) Nothing in this section shall be construed as requiring a
pharmacy to be open seven days a week.
SEC. 27. Section 4331 of the Business
and Professions Code is amended to read:
4331. (a) A person who is neither a pharmacist nor a designated
representative and who takes charge does
either of a wholesaler or veterinary food-animal drug
retailer or who dispenses a prescription or furnishes dangerous
devices the following, except as otherwise
provided in this chapter chapter, is
guilty of a misdemeanor. misdemeanor:
(1) Takes charge of a wholesaler, third-party logistics provider,
or veterinary food-animal drug retailer.
(2) Coordinates the warehousing or distribution of dangerous
drugs or dangerous devices or dispenses a prescription or furnishes
dangerous devices.
(b) A person who has obtained licensed as
a license to conduct a veterinary
food-animal drug retailer and who that
fails to place in charge of that veterinary food-animal drug retailer
a pharmacist or designated representative, or any person who, by
himself or herself, or by any other person, permits the dispensing of
prescriptions, except by a pharmacist or designated representative,
or as otherwise provided in this chapter, is guilty of a misdemeanor.
(c) A person who has obtained licensed as
a license to conduct a wholesaler
and who or third-party logistics provider that
fails to place in charge of that wholesaler or third-party
logistics provider a pharmacist or designated representative,
or any person who, by himself or herself, or by any other person,
permits the furnishing of dangerous drugs or dangerous devices,
except by a pharmacist or designated representative, or as otherwise
provided in this chapter, is guilty of a misdemeanor.
(d) This section shall become operative on January 1, 2006.
SEC. 28. Section 4400 of the Business
and Professions Code , as added by Section 9 of Chapter
565 of the Statutes of 2013, 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
six hundred dollars ($600), and may be increased to 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 two hundred twenty-five dollars ($225) and may be
increased to three hundred dollars ($300) and may be
decreased to no less than two hundred twenty-five dollars ($225)
. A temporary license fee shall be five hundred fifty
dollars ($550) and may be increased to 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
license as a designated representative pursuant to Section 4053 shall
be two hundred fifty-five dollars ($255) and may be
increased to 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 shall be one hundred fifty dollars ($150) and
may be increased to 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
two hundred fifty-five dollars ($255) and may be increased to
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 fifty dollars ($150) and may be increased to
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'
s wholesaler or third-party logistics provider
license issued pursuant to Section 4161 shall be six hundred
dollars ($600) and may be increased to seven hundred
eighty dollars ($780) and may be decreased to no less than si
x hundred dollars ($600) .
(2) For nonresident wholesalers who or
third-party logistics providers that have 21 or more facilities
operating nationwide the application fees for the first 20 locations
shall be six hundred dollars ($600) and may be increased to
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 two hundred twenty-five dollars
($225) and may be increased to three hundred dollars ($300)
and may be decreased to no less than two hundred
twenty-five dollars ($225) . A temporary license fee shall be
five hundred fifty dollars ($550)
and may be increased to 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's
wholesaler license or third-party
logistics provider license issued pursuant to Section 4161
shall be six hundred dollars ($600) and may be increased to
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) This section shall become operative on July 1, 2014.
SEC. 29. 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.
SECTION 1. Section 4200.3 of the Business and
Professions Code is amended to read:
4200.3. (a) The examination process shall be regularly reviewed
pursuant to Section 139.
(b) The examination process shall meet the standards and
guidelines set forth in the Standards for Educational and
Psychological Testing and the Federal Uniform Guidelines for Employee
Selection Procedures. The board shall work with the Office of
Professional Examination Services of the department or with an
equivalent organization who shall certify at minimum once every five
years that the examination process meets these national testing
standards. If the department determines that the examination process
fails to meet these standards, the board shall terminate its use of
the North American Pharmacy Licensure Examination and shall use only
the written and practical examination developed by the board.
(c) The examination shall meet the mandates of subdivision (a) of
Section 12944 of the Government Code.
(d) The board shall work with the Office of Professional
Examination Services or with an equivalent organization to develop
the state jurisprudence examination to ensure that applicants for
licensure are evaluated on their knowledge of applicable state laws
and regulations.
(e) The board shall annually publish the pass and fail rates for
the pharmacist's licensure examination administered pursuant to
Section 4200, including a comparison of historical pass and fail
rates before utilization of the North American Pharmacist Licensure
Examination.
(f) The board shall report to the appropriate policy committees of
the Legislature and the department, as part of its next scheduled
review, the pass rates of applicants who sat for the national
examination compared with the pass rates of applicants who sat for
the prior state examination. This report shall be a component of the
evaluation of the examination process that is based on
psychometrically sound principles for establishing minimum
qualifications and levels of competency.