BILL NUMBER: AB 467 AMENDED
BILL TEXT
AMENDED IN SENATE SEPTEMBER 6, 2013
AMENDED IN SENATE AUGUST 19, 2013
AMENDED IN SENATE AUGUST 12, 2013
AMENDED IN ASSEMBLY APRIL 11, 2013
AMENDED IN ASSEMBLY MARCH 19, 2013
INTRODUCED BY Assembly Member Stone
(Principal coauthor: Senator Hill)
FEBRUARY 19, 2013
An act to amend Section 150201 of, add
Section 4046 to, and to add Article 11.5 (commencing with Section
4169.5) to, Chapter 9 of Division 2 of, the Business and Professions
Code, and to amend Section 150205 of, and to add
Section 150208 to, the Health and Safety Code, relating to
pharmaceuticals, making an appropriation therefor, and
declaring the urgency thereof, to take effect immediately.
LEGISLATIVE COUNSEL'S DIGEST
AB 467, as amended, Stone. Prescription drugs: collection and
distribution program.
Existing law authorizes a county to establish, by ordinance, a
repository and distribution program under which specified pharmacies
and primary care clinics may distribute surplus unused medications,
as defined, to persons in need of financial assistance to ensure
access to necessary pharmaceutical therapies. Existing law authorizes
specified health and care facilities, pharmacies, drug
manufacturers, and pharmacy wholesalers to donate unused medications
to the program. Existing law requires a county that has established a
program to establish procedures to, among other things, ensure
proper safety and management of any medications collected and
maintained by a participating entity. Existing la w
exempts specified persons and entities, including prescription drug
manufacturers and pharmacists and physicians who accept or
dispense prescription drugs, from criminal and civil liability for
injury caused when donating, accepting, or dispensing prescription
drugs in compliance with these provisions.
This bill would provide that activities relating to the donation
or distribution of medications under the program are not wholesaling
activities, and any person, as defined, that is not otherwise a
wholesaler shall not be deemed a wholesaler or required to be
licensed as a wholesaler when performing those activities.
Existing law, the Pharmacy Law, governs the scope and practice of
pharmacy, including dispensing dangerous drugs and devices. Existing
law establishes in the Department of Consumer Affairs the California
State Board of Pharmacy to exercise licensing, regulatory, and
disciplinary functions with respect to the practice of pharmacy.
Existing law provides that fees collected on behalf of the board are
credited to the Pharmacy Board Contingent Fund, a continuously
appropriated fund. A violation of the Pharmacy Law is a crime.
This bill would require the California State Board of Pharmacy to
license a surplus medication collection and distribution
intermediary, as defined, established for the purpose of facilitating
the connection of eligible and participating entities under the
unused medication repository and distribution program described
above. Among other things, the bill would prohibit that intermediary
from taking possession, custody, or control of dangerous drugs and
devices, but would authorize the intermediary to charge specified
fees for the reasonable costs of the services provided. The bill
would require that a surplus medication collection and distribution
intermediary be licensed by the board, as specified, and would
require the payment of a fee in the amount of $300 to obtain the
license. The bill would provide that the fees collected would be
deposited in the Pharmacy Board Contingent Fund. By providing a new
source of funds for a continuously appropriated fund, the bill would
make an appropriation. Because a violation of the provision governing
licensing would be a crime, the bill would impose a state-mandated
local program. The bill would exempt a surplus medication collection
and distribution intermediary from criminal or civil liability for
injury caused when facilitating the donation of prescription drugs.
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.
This bill would declare that it is to take effect immediately as
an urgency statute.
Vote: 2/3. Appropriation: no yes .
Fiscal committee: no yes .
State-mandated local program: no yes .
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 150201 of the Health and
Safety Code is amended to read:
150201. For purposes of this division:
(a) "Eligible entity" means all of the following:
(1) A licensed pharmacy, as defined in subdivision (a) of Section
4037 of the Business and Professions Code, that is county owned or
that contracts with the county pursuant to this division and is not
on probation with the California State Board of Pharmacy.
(2) A licensed pharmacy, as defined in subdivision (a) of Section
4037 of the Business and Professions Code, that is owned and operated
by a primary care clinic, as defined in Section 1204, that is
licensed by the State Department of Public Health and is not on
probation with the California State Board of Pharmacy.
(3) A primary care clinic, as defined in Section 1204, that is
licensed by the State Department of Public Health and licensed to
administer and dispense drugs pursuant to subparagraph (A) of
paragraph (1) of subdivision (a) of Section 4180 of the Business and
Professions Code and is not on probation with the California State
Board of Pharmacy.
(b) "Medication" or "medications" means a dangerous drug, as
defined in Section 4022 of the Business and Professions Code.
(c) "Participating entity" means an eligible entity that has
received written or electronic documentation from the county health
department pursuant to paragraph (3) of subdivision (a) of Section
150204 and that operates a repository and distribution program
pursuant to this division.
(d) "Person" includes a firm, association, partnership,
corporation, limited liability company, state governmental agency, or
political subdivision.
SECTION 1. Section 4046 is added to the
Business and Professions Code , to read:
4046. "Surplus medication collection and distribution
intermediary" means a firm, association, partnership, corporation,
limited liability company, state governmental agency or political
subdivision that performs the functions specified in Section 4169.5
for the purpose of a program established pursuant to Division 116
(commencing with Section 150200) of the Health and Safety Code.
SEC. 2. Article 11.5 (commencing with Section
4169.5) is added to Chapter 9 of Division 2 of the
Business and Professions Code , to read:
Article 11.5. Surplus Medication Collection and Distribution
Intermediaries
4169.5. (a) A surplus medication collection and distribution
intermediary established for the purpose of facilitating the
connection of eligible and participating entities under a program
established pursuant to Division 116 (commencing with Section 150200)
of the Health and Safety Code shall be licensed by the board. The
board shall enforce the requirements set forth in Section 150208 of
the Health and Safety Code.
(b) An application for licensure as a surplus medication
collection and distribution intermediary 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 an entity other than a natural person,
the application shall state the information as to each person
beneficially interested in that entity.
(c) As used in this section, and subject to subdivision (e), 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.
(d) In any case where the applicant is a charitable organization
described in Section 501 (c) (3) of the Internal Revenue Code, the
applicant shall furnish the board with organizations the articles of
incorporation. The applicant shall also furnish the board with the
names of the controlling members.
(e) In any case where 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's
entity. Upon request by the executive officer of the board, 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.
(f) The application shall contain a statement to the effect that
the applicant or persons beneficially interested have not been
convicted of a felony and have 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.
(g) Upon the approval of the application by the board and payment
of a fee in the amount of three hundred dollars ($300), the executive
officer of the board shall issue a license to operate as a surplus
medication collection and distribution intermediary, if all of the
provisions of this chapter have been complied with. Fees received by
the board pursuant to this section shall be deposited into the
Pharmacy Board Contingent Fund. An applicant for licensure as a
surplus medication collection and distribution intermediary that is a
nonprofit organization pursuant to subdivision (d) is exempt from
the fee requirement.
(h) A surplus medication collection and distribution intermediary
licensed pursuant to this section is exempt from licensure as a
wholesaler.
SEC. 3. Section 150205 of the Health
and Safety Code is amended to read:
150205. (a) The following persons and
entities shall not be subject to criminal or civil liability for
injury caused when donating, accepting, or dispensing prescription
drugs in compliance with this division:
(a)
(1) A prescription drug manufacturer, wholesaler,
governmental entity, or participating entity.
(b)
(2) A pharmacist or physician who accepts or dispenses
prescription drugs.
(c)
(3) A licensed health or care facility, as described in
Section 150202, or a pharmacy, as described in Section 150202.5.
(b) A surplus medication collection and distribution intermediary,
as described in Section 150208, shall not be subject to criminal or
civil liability for injury caused when facilitating the donation of
prescription drugs in compliance with this division.
SEC. 2. SEC. 4. Section 150208 is
added to the Health and Safety Code, to read:
150208. Activities relating to the donation or distribution of
medications, including, but not limited to, facilitating or
negotiating the donation or distribution of medications, pursuant to
this division shall not be deemed wholesaling activities. Any person
that is not otherwise a wholesaler, as defined in Section 4043 of the
Business and Professions Code, shall not be deemed a wholesaler or
required to be licensed as a wholesaler under the Pharmacy Law
(Chapter 9 (commencing with Section 4000) of Division 2 of the
Business and Professions Code) when performing those activities
pursuant to this division.
150208. (a) A surplus medication collection and
distribution intermediary that is licensed pursuant to Section 4169.5
of the Business and Professions Code, established for the purpose of
facilitating the connection of eligible and participating entities
under a program established pursuant to this division is authorized
to operate under this section.
(b) A surplus medication collection and distribution intermediary
shall comply with the following:
(1) It shall not take possession, custody, or control of dangerous
drugs and devices.
(2) It shall ensure that notification is provided to participating
entities that a package has been shipped when the surplus medication
collection and distribution intermediary has knowledge of the
shipment or provided logistical support to facilitate a shipment
directly from an eligible entity to a participating entity.
(3) It shall not select, or direct an eligible entity to select, a
specific participating entity to receive surplus medications.
(c) A surplus medication collection and distribution intermediary
is authorized to do the following:
(1) Contract directly with a county to connect eligible entities
with participating entities and provide general support in a county's
implementation of a program established pursuant to this division.
(2) Charge membership, administrative, or overhead fees sufficient
to cover the reasonable costs of the services provided.
(d) No participating entities shall receive donated medication
directly from the surplus medication collection and distribution
intermediary.
SEC. 5. 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.
SEC. 3. SEC. 6. This act is an
urgency statute necessary for the immediate preservation of the
public peace, health, or safety within the meaning of Article IV of
the Constitution and shall go into immediate effect. The facts
constituting the necessity are:
To ensure that California's medication donation program is allowed
to continue to operate to facilitate the distribution of medications
to the indigent population which would not otherwise have access to
these medications, it is necessary that this act take effect
immediately.