BILL NUMBER: AB 467 AMENDED
BILL TEXT
AMENDED IN SENATE MARCH 11, 2014
AMENDED IN SENATE JANUARY 7, 2014
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 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 Sections 150201, 150202, and 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 law 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.
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 donation of medications to or transfer of medications between
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
support and services provided. The bill would also require a surplus
medication collection and distribution intermediary to keep and
maintain for 3 years complete records for which the intermediary
facilitated the donation of medications to or transfer of medications
between participating entities. The bill would require that a
surplus medication collection and distribution intermediary
be licensed by the board, as specified, would require that the
license be renewed annually, and would require the payment
of a fee in the amount of $300 to obtain or renew 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 provisions governing
licensing and record-keeping recordkeeping
would be crimes, 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 medications to or transfer
of medications in compliance with these provisions.
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: yes. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
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 donation
of medications to or transfer of medications between 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. The
license shall be renewed annually.
(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) If the applicant is a charitable organization described in
Section 501(c)(3) of the Internal Revenue Code, the applicant shall
furnish the board with the organization's articles of incorporation.
The applicant shall also furnish the board with the names of the
controlling members.
(e) If the applicant is a partnership or other unincorporated
association, a limited liability company, or a corporation, and if
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)
(b) 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) (b) 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 or renew 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 government owned or 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.
(i) A surplus medication collection and distribution intermediary
licensed pursuant to this section shall keep and maintain for three
years complete records for which the intermediary facilitated the
donation of medications to or transfer of medications between
participating entities.
SEC. 3. Section 150201 of the Health and Safety Code is amended to
read:
150201. For purposes of this division:
(a) "Donor organization" means an entity described in subdivision
(a) of Section 150202.
(b) "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.
(c) "Medication" or "medications" means a dangerous drug, as
defined in Section 4022 of the Business and Professions Code.
(d) "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.
SEC. 4. Section 150202 of the Health and Safety Code is amended to
read:
150202. (a) Notwithstanding any other law, a donor organization
is defined, for purposes of this division, to refer to one of the
following health and care facilities that may donate centrally stored
unused medications under a program established pursuant to this
division:
(1) A licensed general acute care hospital, as defined in Section
1250.
(2) A licensed acute psychiatric hospital, as defined in Section
1250.
(3) A licensed skilled nursing facility, as defined in Section
1250, including a skilled nursing facility designated as an
institution for mental disease.
(4) A licensed intermediate care facility, as defined in Section
1250.
(5) A licensed intermediate care facility/developmentally
disabled-habilitative facility, as defined in Section 1250.
(6) A licensed intermediate care facility/developmentally
disabled-nursing facility, as defined in Section 1250.
(7) A licensed correctional treatment center, as defined in
Section 1250.
(8) A licensed psychiatric health facility, as defined in Section
1250.2.
(9) A licensed chemical dependency recovery hospital, as defined
in Section 1250.3.
(10) A licensed residential care facility for the elderly, as
defined in Section 1569.2, with 16 or more residents.
(11) An approved mental health rehabilitation center, as described
in Section 5675 of the Welfare and Institutions Code.
(b) Medication donated by health and care facilities pursuant to
subdivision (a) shall meet the requirements of subdivisions (c) and
(d) of Section 150204 and shall be unexpired medication that would
have otherwise been destroyed by the facility or another appropriate
entity.
(c) Medication eligible for donation by the health and care
facilities pursuant to subdivision (a) shall be directly delivered
from the dispensing pharmacy, wholesaler or manufacturer, to the
health or care facility and subsequently centrally stored. Centrally
stored medication that originated from a patient or resident is not
eligible for donation under this division.
SEC. 5. 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:
(1) A prescription drug manufacturer, wholesaler, governmental
entity, or participating entity.
(2) A pharmacist or physician who accepts or dispenses
prescription drugs.
(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
medications to or transfer of medications in compliance with this
division.
SEC. 6. Section 150208 is added to the Health and Safety Code, to
read:
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 donation of medications to or transfer of
medications between 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 and provided logistical support to facilitate a shipment
directly from a donor organization, as defined in subdivision (a) of
Section 150202, to a participating entity.
(3) It shall not select, or direct a donor organization, as
defined in subdivision (a) of Section 150202, 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) Charge membership, administrative, or overhead fees sufficient
to cover the reasonable costs of the support and services provided.
(2) Contract directly with a county to facilitate the donation of
medications to or transfer of medications between participating
entities and provide general support in a county's implementation of
a program established pursuant to this division.
(d) No participating entities shall receive donated medication
directly from the surplus medication collection and distribution
intermediary.
SEC. 7. 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. 8. 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.