Bill Text: CA AB2605 | 2013-2014 | Regular Session | Chaptered
Bill Title: Pharmacy: third-party logistics providers.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2014-09-20 - Chaptered by Secretary of State - Chapter 507, Statutes of 2014. [AB2605 Detail]
Download: California-2013-AB2605-Chaptered.html
BILL NUMBER: AB 2605 CHAPTERED
BILL TEXT
CHAPTER 507
FILED WITH SECRETARY OF STATE SEPTEMBER 20, 2014
APPROVED BY GOVERNOR SEPTEMBER 20, 2014
PASSED THE SENATE AUGUST 26, 2014
PASSED THE ASSEMBLY AUGUST 27, 2014
AMENDED IN SENATE AUGUST 22, 2014
AMENDED IN SENATE AUGUST 6, 2014
AMENDED IN SENATE JUNE 17, 2014
AMENDED IN ASSEMBLY MAY 5, 2014
AMENDED IN ASSEMBLY APRIL 23, 2014
AMENDED IN ASSEMBLY MARCH 18, 2014
INTRODUCED BY Assembly Member Bonilla
FEBRUARY 21, 2014
An act to amend Sections 208, 4040.5, 4043, 4060, 4081, 4101,
4105, 4120, 4149, 4160, 4161, 4162, 4162.5, 4164, 4165, 4166, 4167,
4168, 4169, 4201, 4305.5, 4312, 4331, and 4400 of, to amend the
heading of Article 11 (commencing with Section 4160) of Chapter 9 of
Division 2 of, to add Sections 4022.7, 4044.5, 4053.1, 4107.5, and
4161.5 to, and to repeal and add Section 4045 of, the Business and
Professions Code, relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
AB 2605, Bonilla. 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. Existing law requires a
wholesaler to have a pharmacist or designated representative on its
premises and to be supervised or managed by a designated
representative-in-charge. Existing law requires a separate license
for each place of business owned or operated by a wholesaler.
Existing law also requires a wholesaler to submit a surety bond of
$100,000 payable to a specified fund of the board to secure payment
of any administrative fine imposed by the board. Existing law, the
federal Drug Supply Chain Security Act, prohibits a third-party
logistics provider, as defined, from conducting any activities in a
state unless each facility of the provider is licensed by the state
from which drugs are distributed by the provider in accordance with
regulations to be promulgated by the Secretary of the United States
Department of Health and Human Services.
This bill would revise the definition of the terms "third-party
logistics provider" and "reverse third-party logistics provider" to
conform to federal law, as specified, 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.
The bill would require a third-party logistics provider to be
supervised and managed by a responsible manager who would need to be
licensed by the board as a designated representative-3PL. Under the
bill, a designated representative-3PL and a responsible manager would
be subject to similar requirements as those imposed on a designated
representative and a designated representative-in-charge,
respectively. The bill would limit a place of business to a single
board-issued license, except for entities under common ownership that
meet specified requirements, and would require that at least one
designated representative, in the case of a wholesaler, or designated
representative-3PL, in the case of a third-party logistics provider,
be present during business hours for each licensed place of
business. The bill would require a third-party logistics provider to
submit a surety bond of $90,000 payable to a specified fund of the
board to secure payment of any administrative fine imposed by the
board. The bill would enact parallel requirements with respect to
nonresident third-party logistics providers and would make related
conforming changes and delete obsolete provisions. After specified
federal regulations under the federal Drug Supply Chain Security Act
are promulgated, the bill would require the board to act to identify
any California laws governing interstate commerce in conflict with
those regulations and act to remove the conflict.
Existing law makes a wholesaler that uses the services of a
carrier liable for the security and integrity of any dangerous drug
or devices through that carrier until the drugs or devices are
delivered to the transferee.
This bill would extend that liability when the wholesaler uses the
services of a third-party logistics provider and would require a
third-party logistics provider that uses the services of a carrier to
have in place and comply with specified written policies and
procedures.
(2) Existing law requires that all records of manufacture and of
sale, acquisition, or disposition of dangerous drugs or dangerous
devices be open to inspection by authorized officers of the law
during business hours and be preserved for at least 3 years.
This bill would make those requirements also applicable to records
of receipt and shipment of dangerous drugs and dangerous devices.
The bill would also require a manufacturer, wholesaler, third-party
logistics provider, or pharmacy that has reasonable cause to believe
that a dangerous drug or device that is or was in its possession, and
has been sold or distributed in or through California, is
counterfeit or the subject of a fraudulent transaction to notify the
board within 72 hours of obtaining that knowledge.
(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 PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 208 of the Business and Professions Code is
amended to read:
208. (a) Beginning April 1, 2014, a CURES fee of six dollars ($6)
shall be assessed annually on each of the licensees specified in
subdivision (b) to pay the reasonable costs associated with operating
and maintaining CURES for the purpose of regulating those licensees.
The fee assessed pursuant to this subdivision shall be billed and
collected by the regulating agency of each licensee at the time of
the licensee's license renewal. If the reasonable regulatory cost of
operating and maintaining CURES is less than six dollars ($6) per
licensee, the Department of Consumer Affairs may, by regulation,
reduce the fee established by this section to the reasonable
regulatory cost.
(b) (1) Licensees authorized pursuant to Section 11150 of the
Health and Safety Code to prescribe, order, administer, furnish, or
dispense Schedule II, Schedule III, or Schedule IV controlled
substances or pharmacists licensed pursuant to Chapter 9 (commencing
with Section 4000) of Division 2.
(2) Wholesalers, third-party logistics providers, nonresident
wholesalers, and nonresident third-party logistics providers of
dangerous drugs licensed pursuant to Article 11 (commencing with
Section 4160) of Chapter 9 of Division 2.
(3) Nongovernmental clinics licensed pursuant to Article 13
(commencing with Section 4180) and Article 14 (commencing with
Section 4190) of Chapter 9 of Division 2.
(4) Nongovernmental pharmacies licensed pursuant to Article 7
(commencing with Section 4110) of Chapter 9 of Division 2.
(c) The funds collected pursuant to subdivision (a) shall be
deposited in the CURES Fund, which is hereby created within the State
Treasury. Moneys in the CURES Fund shall, upon appropriation by the
Legislature, be available to the Department of Consumer Affairs to
reimburse the Department of Justice for costs to operate and maintain
CURES for the purposes of regulating the licensees specified in
subdivision (b).
(d) The Department of Consumer Affairs shall contract with the
Department of Justice on behalf of the Medical Board of California,
the Dental Board of California, the California State Board of
Pharmacy, the Veterinary Medical Board, the Board of Registered
Nursing, the Physician Assistant Board of the Medical Board of
California, the Osteopathic Medical Board of California, the
Naturopathic Medicine Committee of the Osteopathic Medical Board, the
State Board of Optometry, and the California Board of Podiatric
Medicine to operate and maintain CURES for the purposes of regulating
the licensees specified in subdivision (b).
SEC. 2. Section 4022.7 is added to the Business and Professions
Code, to read:
4022.7. (a) "Designated representative-3PL" means an individual
to whom a license has been granted pursuant to Section 4053.1.
(b) "Responsible manager" means a designated representative-3PL
selected by a third-party logistics provider and approved by the
board as responsible for ensuring compliance of the licensed place of
business with state and federal laws with respect to dangerous drugs
and dangerous devices received by, stored in, or shipped from the
licensed place of business of the third-party logistics provider.
SEC. 3. 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 nonsaleable dangerous drugs.
SEC. 4. Section 4043 of the Business and Professions Code is
amended to read:
4043. "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.
SEC. 5. Section 4044.5 is added to the Business and Professions
Code, to read:
4044.5. "Reverse third-party logistics provider" means an entity
that processes or manages the disposition of an outdated or
nonsaleable dangerous drug or dangerous device on behalf of a
manufacturer, wholesaler, or dispenser of the dangerous drug or
dangerous device, but does not take ownership of the dangerous drug
or dangerous device nor have the responsibility to direct its sale or
disposition. Unless otherwise specified in this chapter, every
provision of this chapter that applies to a third-party logistics
provider shall also apply to a reverse third-party logistics
provider.
SEC. 6. Section 4045 of the Business and Professions Code is
repealed.
SEC. 7. Section 4045 is added to the Business and Professions
Code, to read:
4045. "Third-party logistics provider" means an entity that
provides or coordinates warehousing or other logistics services for a
dangerous drug or dangerous device in intrastate or interstate
commerce on behalf of a manufacturer, wholesaler, or dispenser of the
dangerous drug or dangerous device, but does not take ownership of
the dangerous drug or dangerous device, nor have responsibility to
direct its sale or disposition.
SEC. 8. Section 4053.1 is added to the Business and Professions
Code, to read:
4053.1. (a) Notwithstanding Section 4051, the board may issue a
license to a qualified individual as a designated representative-3PL
to provide sufficient and qualified supervision of a third-party
logistics provider's place of business. The designated
representative-3PL shall protect the public health and safety in the
handling, storage, warehousing, distribution, and shipment of
dangerous drugs and dangerous devices in the third-party logistics
provider's place of business.
(b) An individual who is at least 18 years of age may apply for a
designated representative-3PL 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 meet one of the following requirements:
(A) Have a minimum of one year of paid work experience in the past
three years with a third-party logistics provider.
(B) Have a minimum of one year of paid work experience in the past
three years in a licensed pharmacy, or with a drug wholesaler, drug
distributor, or drug manufacturer, performing duties related to the
distribution or dispensing of dangerous drugs or dangerous devices.
(C) Meet all of the prerequisites to take the examination required
for licensure as a pharmacist by the board.
(3) (A) He or she shall complete a training program approved by
the board that, at a minimum, addresses each of the following
subjects:
(i) Knowledge and understanding of California law and federal law
relating to the distribution of dangerous drugs and dangerous
devices.
(ii) Knowledge and understanding of California law and federal law
relating to the distribution of controlled substances.
(iii) Knowledge and understanding of quality control systems.
(iv) Knowledge and understanding of the United States
Pharmacopoeia or federal Food and Drug Administration standards
relating to the safe storage, handling, and transport of dangerous
drugs and dangerous devices.
(B) The board may, by regulation, require the training program
required under this paragraph to include additional material.
(C) The board shall not issue a license as a designated
representative-3PL until the applicant provides proof of completion
of the training required by this paragraph to the board.
(c) A third-party logistics provider shall not operate without at
least one designated representative-3PL present at each of its
licensed places of business as required under Section 4160.
SEC. 9. 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. 10. Section 4081 of the Business and Professions Code is
amended to read:
4081. (a) All records of manufacture and of sale, acquisition,
receipt, shipment, or disposition of dangerous drugs or dangerous
devices shall be at all times during business hours open to
inspection by authorized officers of the law, and shall be preserved
for at least three years from the date of making. A current inventory
shall be kept by every manufacturer, wholesaler, third-party
logistics provider, pharmacy, veterinary food-animal drug retailer,
physician, dentist, podiatrist, veterinarian, laboratory, clinic,
hospital, institution, or establishment holding a currently valid and
unrevoked certificate, license, permit, registration, or exemption
under Division 2 (commencing with Section 1200) of the Health and
Safety Code or under Part 4 (commencing with Section 16000) of
Division 9 of the Welfare and Institutions Code who maintains a stock
of dangerous drugs or dangerous devices.
(b) The owner, officer, and partner of a pharmacy, wholesaler,
third-party logistics provider, or veterinary food-animal drug
retailer shall be jointly responsible, with the pharmacist-in-charge,
responsible manager, or designated representative-in-charge, for
maintaining the records and inventory described in this section.
(c) The pharmacist-in-charge, responsible manager, or designated
representative-in-charge shall not be criminally responsible for acts
of the owner, officer, partner, or employee that violate this
section and of which the pharmacist-in-charge, responsible manager,
or designated representative-in-charge had no knowledge, or in which
he or she did not knowingly participate.
SEC. 11. 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. A 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 or veterinary food-animal drug retailer upon application
by the wholesaler or veterinary food-animal drug retailer and
approval by the board. A 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.
(c) A designated representative-3PL may take charge of, and act
as, the responsible manager of a third-party logistics provider upon
application by the third-party logistics provider and approval by the
board. A responsible manager who ceases to act as the responsible
manager at that entity shall notify the board in writing within 30
days of the date of that change in status.
SEC. 12. 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) (1) Any records that are maintained electronically shall be
maintained so that the pharmacist-in-charge, or the pharmacist on
duty if the pharmacist-in-charge is not 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.
(2) In the case of a veterinary food-animal drug retailer,
wholesaler, or third-party logistics provider, any records that are
maintained electronically shall be maintained so that the designated
representative-in-charge or the responsible manager, or the
designated representative on duty or the designated
representative-3PL on duty if the designated representative-in-charge
or responsible manager is not on duty, shall, at all times during
which the licensed place of business is 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. 13. Section 4107.5 is added to the Business and Professions
Code, to read:
4107.5. If a manufacturer, wholesaler, third-party logistics
provider, or pharmacy has reasonable cause to believe that a
dangerous drug or dangerous device in, or having been in, its
possession is counterfeit or the subject of a fraudulent transaction,
the manufacturer, wholesaler, third-party logistics provider, or
pharmacy shall notify the board within 72 hours of obtaining that
knowledge. This section shall apply to any dangerous drug or
dangerous device that has been sold or distributed in or through this
state.
SEC. 14. 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. 15. 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), a license 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. 16. 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, Third-Party Logistics Providers, and
Manufacturers
SEC. 17. Section 4160 of the Business and Professions Code is
amended to read:
4160. (a) A person 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) (1) A separate license shall be required for each place of
business owned or operated by a wholesaler or third-party logistics
provider. Each place of business may only be issued a single license
by the board, except as provided in paragraph (2). Each license shall
be renewed annually and shall not be transferable. At all times
during which a place of business is open for business, at least one
designated representative, in the case of a wholesaler, or designated
representative-3PL in the case of a third-party logistics provider,
shall be present.
(2) A wholesaler and a 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) Every wholesaler shall be supervised or managed by a
designated representative-in-charge. The designated
representative-in-charge shall be responsible for the wholesaler's
compliance with state and federal laws governing wholesalers. As part
of its initial application for a license, and for each renewal, each
wholesaler 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 license without
identification of an approved designated representative-in-charge for
the wholesaler. The designated representative-in-charge shall
maintain an active license as a designated representative with the
board at all times during which he or she is designated as the
designated representative-in-charge.
(e) Each place of business of a third-party logistics provider
shall be supervised and managed by a responsible manager. The
responsible manager shall be responsible for the compliance of the
place of business with state and federal laws governing third-party
logistics providers and with the third-party logistics provider's
customer specifications, except where the customer's specifications
conflict with state or federal laws. As part of its initial
application for a license, and for each renewal, each third-party
logistics provider shall, on a form designated by the board, provide
identifying information and the California license number for a
designated representative-3PL proposed to serve as the responsible
manager. The proposed responsible manager shall be subject to
approval by the board. The board shall not issue or renew a
third-party logistics provider license without identification of an
approved responsible manager for the third-party logistics provider.
The responsible manager shall maintain an active license as a
designated representative-3PL with the board at all times during
which he or she is designated as the responsible manager.
(f) A wholesaler 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 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.
(g) A 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 responsible manager ceases to act as the responsible manager,
and shall on the same form propose another designated
representative-3PL to take over as the responsible manager. The
proposed replacement responsible manager shall be subject to approval
by the board. If disapproved, the 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
responsible manager is approved by the board.
(h) 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.
(i) 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. 18. 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. 19. Section 4161.5 is added to the Business and Professions
Code, to read:
4161.5. At such time as federal regulations are promulgated to
implement Section 584 of the federal Food, Drug, and Cosmetic Act (21
U.S.C. Sec. 360eee-3), the board shall immediately identify any
standard, requirement, or regulation in California law governing
interstate commerce that is in conflict with the federal regulations
and act to remove the conflict in the manner permitted by law.
SEC. 20. Section 4162 of the Business and Professions Code is
amended to read:
4162. (a) (1) An applicant for the issuance or renewal of a
wholesaler 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) An applicant for the issuance or renewal of a third-party
logistics provider license, which is not government owned and
operated, shall submit a surety bond of ninety thousand dollars
($90,000) 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.
(3) For purposes of paragraphs (1) and (2), the board may accept a
surety bond less than the amount required under paragraph (1) or (2)
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).
(4) 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 or third-party logistics provider, shall not be
required to post a surety bond as provided in paragraph (1) or (2).
(5) For licensees subject to paragraph (3) or (4), 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. 21. 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 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) An applicant for the issuance or renewal of a nonresident
third-party logistics provider license shall submit a surety bond of
ninety thousand dollars ($90,000), 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.
(3) For purposes of paragraphs (1) and (2), the board may accept a
surety bond less than the amount required under paragraph (1) or (2)
if the annual gross receipts of the previous tax year for the
nonresident wholesaler or the nonresident 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).
(4) For applicants who satisfy paragraph (3), the board may
require a bond up to one hundred thousand dollars ($100,000) for any
nonresident wholesaler or nonresident 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.
(5) 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 or a nonresident
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. 22. 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 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.
(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.
SEC. 23. 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. 24. Section 4166 of the Business and Professions Code is
amended to read:
4166. (a) A wholesaler that uses the services of a third-party
logistics provider or carrier, including, but not limited to, the
United States Postal Service or a 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) A third-party logistics provider that uses the services of a
carrier, including, but not limited to, the United States Postal
Service or a common carrier, shall have in place and comply with
written policies and procedures that provide for both of the
following:
(1) Verification that the third-party logistics provider, or the
owner of the dangerous drugs or dangerous devices stored at the
third-party logistics provider, has imposed obligations on the
carrier that provide for the security and integrity of any dangerous
drugs or dangerous devices transported by the carrier until the drugs
or devices are delivered to the transferee at its premises.
(2) Confirmation, prior to shipping a dangerous drug or dangerous
device, that the intended recipient is legally authorized to receive
the dangerous drug or dangerous device.
(c) Nothing in this section is intended to affect the liability of
a wholesaler, third-party logistics provider, or other distributor
for dangerous drugs or dangerous devices after their delivery to the
transferee.
SEC. 25. 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, at the place of
business licensed by the board.
SEC. 26. Section 4168 of the Business and Professions Code is
amended to read:
4168. A county or municipality 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. 27. Section 4169 of the Business and Professions Code is
amended to read:
4169. (a) A person or entity 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,
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 law, a violation of this section 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. 28. 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) If the applicant is a partnership or other unincorporated
association, a limited liability company, or a corporation, and the
number of partners, members, or stockholders, as the case may be,
exceeds five, the application shall so state, and shall further state
the information required by subdivision (a) as to each of the five
partners, members, or stockholders who own the five largest interests
in the applicant entity. Upon request by the executive officer, the
applicant shall furnish the board with the information required by
subdivision (a) as to partners, members, or stockholders not named in
the application, or shall refer the board to an appropriate source
of that information.
(d) The application shall contain a statement to the effect that
the applicant has not been convicted of a felony and has not violated
any of the provisions of this chapter. If the applicant cannot make
this statement, the application shall contain a statement of the
violation, if any, or reasons which will prevent the applicant from
being able to comply with the requirements with respect to the
statement.
(e) Upon the approval of the application by the board and payment
of the fee required by this chapter for each pharmacy, wholesaler,
third-party logistics provider, or veterinary food-animal drug
retailer, the executive officer of the board shall issue a license to
conduct a pharmacy, wholesaler, third-party logistics provider, or
veterinary food-animal drug retailer, if all of the provisions of
this chapter have been complied with.
(f) Notwithstanding any other law, the pharmacy license shall
authorize the holder to conduct a pharmacy. The license shall be
renewed annually and shall not be transferable.
(g) Notwithstanding any other law, the wholesaler license shall
authorize the holder to wholesale dangerous drugs and dangerous
devices. The license shall be renewed annually and shall not be
transferable.
(h) Notwithstanding any other law, the third-party logistics
provider license shall authorize the holder to provide or coordinate
warehousing, distribution, or other similar services of dangerous
drugs and dangerous devices. The license shall be renewed annually
and shall not be transferable.
(i) Notwithstanding any other law, the veterinary food-animal drug
retailer license shall authorize the holder to conduct a veterinary
food-animal drug retailer and to sell and dispense veterinary
food-animal drugs as defined in Section 4042.
(j) For licenses referred to in subdivisions (f), (g), (h), and
(i), any change in the proposed beneficial ownership interest shall
be reported to the board within 30 days thereafter upon a form to be
furnished by the board.
SEC. 29. Section 4305.5 of the Business and Professions Code is
amended to read:
4305.5. (a) A person that is licensed as a 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 or responsible
manager. Failure to notify the board within the 30-day period shall
constitute grounds for disciplinary action.
(b) A person that is licensed as a wholesaler, third-party
logistics provider, or veterinary food-animal drug retailer, that
willfully fails to notify the board of the termination of employment
of the designated representative-in-charge or responsible manager at
its licensed place of business, and that continues to operate the
place of business in the absence of the designated
representative-in-charge or responsible manager for that place of
business shall be subject to summary suspension or revocation of its
license as a wholesaler, third-party logistics provider, or
veterinary food-animal drug retailer at that place of business.
(c) A designated representative-in-charge of a wholesaler or
veterinary food-animal drug retailer, or a responsible manager of a
third-party logistics provider, who terminates his or her employment
at the 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.
SEC. 30. 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) If the license of a wholesaler, third-party logistics
provider, pharmacy, or veterinary food-animal drug retailer is
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) If the board sells or arranges for the sale of any dangerous
drugs, controlled substances, or dangerous devices pursuant to
subdivision (c), the board may retain from the proceeds of the sale
an amount equal to the cost to the board of obtaining and enforcing
an order issued pursuant to subdivision (c), including the cost of
disposing of the dangerous drugs, controlled substances, or dangerous
devices. The remaining proceeds, if any, shall be returned to the
licensee from whose premises the dangerous drugs or controlled
substances or dangerous devices were removed.
(1) The licensee shall be notified of his or her right to the
remaining proceeds by personal service or by certified mail, postage
prepaid.
(2) If a statute or regulation requires the licensee to file with
the board his or her address, and any change of address, the notice
required by this subdivision may be sent by certified mail, postage
prepaid, to the latest
address on file with the board and service of notice in this manner
shall be deemed completed on the 10th day after the mailing.
(3) If the licensee is notified as provided in this subdivision,
and the licensee fails to contact the board for the remaining
proceeds within 30 calendar days after personal service has been made
or service by certified mail, postage prepaid, is deemed completed,
the remaining proceeds shall be deposited by the board into the
Pharmacy Board Contingent Fund. These deposits shall be deemed to
have been received pursuant to Chapter 7 (commencing with Section
1500) of Title 10 of Part 3 of the Code of Civil Procedure and shall
be subject to claim or other disposition as provided in that chapter.
(e) For the purposes of this section, "closed" means not engaged
in the ordinary activity for which a license has been issued for at
least one day each calendar week during any 120-day period.
(f) Nothing in this section shall be construed as requiring a
pharmacy to be open seven days a week.
SEC. 31. Section 4331 of the Business and Professions Code is
amended to read:
4331. (a) A person who is not a pharmacist, a designated
representative-in-charge, or a designated representative and who
takes charge of a wholesaler or veterinary food-animal drug retailer
or who dispenses a prescription or furnishes dangerous devices,
except as otherwise provided in this chapter, is guilty of a
misdemeanor.
(b) A person who is not a responsible manager or a designated
representative-3PL who takes charge of a third-party logistics
provider or coordinates the warehousing or distribution of dangerous
drugs or dangerous devices within a third-party logistics provider,
except as otherwise provided in this chapter, is guilty of a
misdemeanor.
(c) A person licensed as a veterinary food-animal drug retailer
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.
(d) A person licensed as a wholesaler that fails to place in
charge of that wholesaler 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.
(e) A person licensed as a third-party logistics provider that
fails to place in charge of a licensed place of business of the
third-party logistics provider a responsible manager, 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
facility manager, or as otherwise provided in this chapter, is guilty
of a misdemeanor.
SEC. 32. 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 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) This section shall become operative on July 1, 2014.
SEC. 33. 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.
