BILL NUMBER: SB 1329 ENROLLED
BILL TEXT
PASSED THE SENATE AUGUST 30, 2012
PASSED THE ASSEMBLY AUGUST 23, 2012
AMENDED IN ASSEMBLY AUGUST 16, 2012
AMENDED IN ASSEMBLY AUGUST 13, 2012
AMENDED IN ASSEMBLY JUNE 26, 2012
AMENDED IN SENATE MAY 14, 2012
AMENDED IN SENATE MARCH 29, 2012
INTRODUCED BY Senator Simitian
(Coauthor: Assembly Member Galgiani)
FEBRUARY 23, 2012
An act to amend Sections 150200, 150201, 150202, 150204, and
150205 of, and to add Section 150202.5 to, the Health and Safety
Code, relating to pharmaceuticals.
LEGISLATIVE COUNSEL'S DIGEST
SB 1329, Simitian. Prescription drugs: collection and distribution
program.
Existing law authorizes a county to establish, by ordinance, a
repository and distribution program under which a pharmacy that is
owned by or contracts with the county may distribute surplus unused
medications, as defined, to persons in need of financial assistance
to ensure access to necessary pharmaceutical therapies. 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 pharmacy. Existing law authorizes a skilled nursing
facility, specified drug manufacturer, or pharmacy wholesaler to
donate medications to the program. Existing law requires medication
under the program to be dispensed to an eligible patient, destroyed,
or returned to a reverse distributor, as specified. Except in cases
of noncompliance, bad faith, or gross negligence, existing law
prohibits certain people and entities from being subject to criminal
or civil liability for injury caused when donating, accepting, or
dispensing prescription drugs in compliance with the program's
provisions.
This bill would authorize a county to establish the program by
action of the county board of supervisors or by action of a public
health officer of the county, as prescribed. This bill would also
authorize specified primary care clinics and pharmacies to
participate in the program. This bill would require a pharmacy or
clinic seeking to participate in the program to inform the county
health department in writing of its intent and prohibit the pharmacy
or clinic from participating until the county health department has
confirmed that it has received this notice. This bill would require
participating pharmacies and clinics to disclose specified
information to the county health department and require the county
board of supervisors or public health officer to make this
information available upon request to the California State Board of
Pharmacy. This bill would authorize the county board of supervisors,
public health officer, and California State Board of Pharmacy to
prohibit a pharmacy or clinic from participating in the program,
under certain circumstances, and require written notice to be
provided to prohibited pharmacies or clinics. This bill would
authorize certain licensed health and care facilities and certain
pharmacies, as specified, to donate unused medications to the
program, in accordance with prescribed conditions. This bill would
also make other conforming changes to those provisions.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 150200 of the Health and Safety Code is amended
to read:
150200. It is the intent of the Legislature in enacting this
division to authorize the establishment of a voluntary drug
repository and distribution program for the purpose of distributing
surplus medications to persons in need of financial assistance to
ensure access to necessary pharmaceutical therapies. It is also the
intent of the Legislature that the health and safety of Californians
are protected and promoted through this program, while reducing
unnecessary waste at licensed health and care facilities, by allowing
those facilities to donate unused and unexpired medications that
were never in the hands of a patient or resident and for which no
credit or refund to the patient or resident could be received.
SEC. 2. 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.
SEC. 3. Section 150202 of the Health and Safety Code is amended to
read:
150202. (a) Notwithstanding any other provision of law, the
following health and care facilities 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. 4. Section 150202.5 is added to the Health and Safety Code,
to read:
150202.5. Notwithstanding any other law, a pharmacy, licensed in
California and not on probation with the California State Board of
Pharmacy, whose primary or sole type of pharmacy practice type is
limited to a skilled nursing facility, home health care, board and
care, or mail order, may donate unused, unexpired medication that
meets the requirements of subdivisions (c) and (d) of Section 150204,
under a program established pursuant to this division and that meets
either of the following requirements:
(a) The medication was received directly from a manufacturer or
wholesaler.
(b) The medication was returned from a health facility to the
issuing pharmacy, in a manner consistent with state and federal law.
SEC. 5. Section 150204 of the Health and Safety Code is amended to
read:
150204. (a) (1) A county may establish, by an action of the
county board of supervisors or by an action of the public health
officer of the county, as directed by the county board of
supervisors, a repository and distribution program for purposes of
this division. The county shall advise the California State Board of
Pharmacy within 30 days from the date it establishes a repository and
distribution program.
(2) Only an eligible entity, pursuant to subdivision (a) of
Section 150201, may participate in this program to dispense
medication donated to the drug repository and distribution program.
(3) An eligible entity that seeks to participate in the program
shall inform the county health department and the California State
Board of Pharmacy in writing of its intent to participate in the
program. An eligible entity may not participate in the program until
it has received written or electronic documentation from the county
health department confirming that the department has received its
notice of intent.
(4) (A) A participating entity shall disclose to the county health
department on a quarterly basis the name and location of the source
of all donated medication it receives.
(B) A participating primary care clinic, as described in paragraph
(3) of subdivision (a) of Section 150201 shall disclose to the
county health department the name of the licensed physician who shall
be accountable to the California State Board of Pharmacy for the
clinic's program operations pursuant to this division. This physician
shall be the professional director, as defined in subdivision (c) of
Section 4182 of the Business and Professions Code.
(C) The county board of supervisors or public health officer of
the county shall, upon request, make available to the California
State Board of Pharmacy the information in this division.
(5) The county board of supervisors, the public health officer of
the county, and the California State Board of Pharmacy may prohibit
an eligible or participating entity from participating in the program
if the entity does not comply with the provisions of the program,
pursuant to this division. If the county board of supervisors, the
public health officer of the county, or the California State Board of
Pharmacy prohibits an eligible or participating entity from
participating in the program, it shall provide written notice to the
prohibited entity within 15 days of making this determination. The
county board of supervisors, the public health officer of the county,
and the California State Board of Pharmacy shall ensure that this
notice also is provided to one another.
(b) A county that elects to establish a repository and
distribution program pursuant to this division shall establish
written procedures for, at a minimum, all of the following:
(1) Establishing eligibility for medically indigent patients who
may participate in the program.
(2) Ensuring that patients eligible for the program shall not be
charged for any medications provided under the program.
(3) Developing a formulary of medications appropriate for the
repository and distribution program.
(4) Ensuring proper safety and management of any medications
collected by and maintained under the authority of a participating
entity.
(5) Ensuring the privacy of individuals for whom the medication
was originally prescribed.
(c) Any medication donated to the repository and distribution
program shall comply with the requirements specified in this
division. Medication donated to the repository and distribution
program shall meet all of the following criteria:
(1) The medication shall not be a controlled substance.
(2) The medication shall not have been adulterated, misbranded, or
stored under conditions contrary to standards set by the United
States Pharmacopoeia (USP) or the product manufacturer.
(3) The medication shall not have been in the possession of a
patient or any individual member of the public, and in the case of
medications donated by a health or care facility, as described in
Section 150202, shall have been under the control of a staff member
of the health or care facility who is licensed in California as a
health care professional or has completed, at a minimum, the training
requirements specified in Section 1569.69.
(d) Only medication that is donated in unopened, tamper-evident
packaging or modified unit dose containers that meet USP standards is
eligible for donation to the repository and distribution program,
provided lot numbers and expiration dates are affixed. Medication
donated in opened containers shall not be dispensed by the repository
and distribution program and once identified, shall be quarantined
immediately and handled and disposed of in accordance with the
Medical Waste Management Act (Part 14 (commencing with Section
117600) of Division 104).
(e) A pharmacist or physician at a participating entity shall use
his or her professional judgment in determining whether donated
medication meets the standards of this division before accepting or
dispensing any medication under the repository and distribution
program.
(f) A pharmacist or physician shall adhere to standard pharmacy
practices, as required by state and federal law, when dispensing all
medications.
(g) Medication that is donated to the repository and distribution
program shall be handled in the following ways:
(1) Dispensed to an eligible patient.
(2) Destroyed.
(3) Returned to a reverse distributor or licensed waste hauler.
(4) (A) Transferred to another participating entity within the
county to be dispensed to eligible patients pursuant to this
division. Notwithstanding this paragraph, a participating
county-owned pharmacy may transfer eligible donated medication to a
participating county-owned pharmacy within another adjacent county
that has adopted a program pursuant to this division, if the
pharmacies transferring the medication have a written agreement
between the entities that outlines protocols and procedures for safe
and appropriate drug transfer that are consistent with this division.
(B) Medication donated under this division shall not be
transferred by any participating entity more than once, and after it
has been transferred, shall be dispensed to an eligible patient,
destroyed, or returned to a reverse distributor or licensed waste
hauler.
(C) Medication transferred pursuant to this paragraph shall be
transferred with documentation that identifies the drug name,
strength, and quantity of the medication, and the donation facility
from where the medication originated shall be identified on
medication packaging or in accompanying documentation. The document
shall include a statement that the medication may not be transferred
to another participating entity and must be handled pursuant to
subparagraph (B). A copy of this document shall be kept by the
participating entity transferring the medication and the
participating entity receiving the medication.
(h) Medication that is donated to the repository and distribution
program that does not meet the requirements of this division shall
not be distributed or transferred under this program and shall be
either destroyed or returned to a reverse distributor. This
medication shall not be sold, dispensed, or otherwise transferred to
any other entity.
(i) Medication donated to the repository and distribution program
shall be maintained in the donated packaging units until dispensed to
an eligible patient under this program, who presents a valid
prescription. When dispensed to an eligible patient under this
program, the medication shall be in a new and properly labeled
container, specific to the eligible patient and ensuring the privacy
of the individuals for whom the medication was initially dispensed.
Expired medication shall not be dispensed.
(j) Medication donated to the repository and distribution program
shall be segregated from the participating entity's other drug stock
by physical means, for purposes including, but not limited to,
inventory, accounting, and inspection.
(k) A participating entity shall keep complete records of the
acquisition and disposition of medication donated to, and
transferred, dispensed, and destroyed under, the repository and
distribution program. These records shall be kept separate from the
participating entity's other acquisition and disposition records and
shall conform to the Pharmacy Law (Chapter 9 (commencing with Section
4000) of Division 2 of the Business and Professions Code), including
being readily retrievable.
( l ) Local and county protocols established pursuant
to this division shall conform to the Pharmacy Law regarding
packaging, transporting, storing, and dispensing all medications.
(m) County protocols established for packaging, transporting,
storing, and dispensing medications that require refrigeration,
including, but not limited to, any biological product as defined in
Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an
intravenously injected drug, or an infused drug, shall include
specific procedures to ensure that these medications are packaged,
transported, stored, and dispensed at appropriate temperatures and in
accordance with USP standards and the Pharmacy Law.
(n) Notwithstanding any other provision of law, a participating
entity shall follow the same procedural drug pedigree requirements
for donated drugs as it would follow for drugs purchased from a
wholesaler or directly from a drug manufacturer.
SEC. 6. Section 150205 of the Health and Safety Code is amended to
read:
150205. 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) A prescription drug manufacturer, wholesaler, governmental
entity, or participating entity.
(b) A pharmacist or physician who accepts or dispenses
prescription drugs.
(c) A licensed health or care facility, as described in Section
150202, or a pharmacy, as described in Section 150202.5.