BILL NUMBER: SB 1329 INTRODUCED
BILL TEXT
INTRODUCED BY Senator Simitian
FEBRUARY 23, 2012
An act to amend Sections 150201, 150202, 150204, and 150205 of the
Health and Safety Code, relating to pharmaceuticals.
LEGISLATIVE COUNSEL'S DIGEST
SB 1329, as introduced, 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
authorize a primary care clinic dispensary, as defined, 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 require the county
board of supervisors or public health officer to approve the pharmacy
or clinic. 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
State Board of Pharmacy. This bill would authorize the county board
of supervisors, public health officer, and State Board of Pharmacy to
prohibit a pharmacy or clinic from participating in the program,
under certain circumstances. This bill would authorize licensed
health and care facilities, as specified, to donate unused
medications to the program. This bill would authorize medication
under the program to be transferred to another participating pharmacy
or primary care clinic. This bill would also make other conforming
changes to those provisions.
Vote: majority. Appropriation: no. Fiscal committee: no.
State-mandated local program: no.
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. (a) For purposes of this division,
"medication" or "medications" means a dangerous drug, as defined in
Section 4022 of the Business and Professions Code.
(b) For purposes of this division, "primary care clinic dispensary"
means a licensed primary care clinic, as defined in Section 1204,
that is 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.
SEC. 2. Section 150202 of the Health and Safety Code is amended to
read:
150202. Notwithstanding any other provision of law, a
licensed skilled nursing facility, as defined in Section 1250,
including a skilled nursing facility designated as an institution for
mental disease, the following health and care
facilities may donate unused medications under a program
established pursuant to this division.
division:
(a) A licensed general acute care hospital, as defined in Section
1250.
(b) A licensed acute psychiatric hospital, as defined in Section
1250.
(c) A licensed skilled nursing facility, as defined in Section
1250, including a skilled nursing facility designated as an
institution for mental disease.
(d) A licensed intermediate care facility, as defined in Section
1250.
(e) A licensed intermediate care facility/developmentally
disabled-habilitative facility, as defined in Section 1250.
(f) A licensed intermediate care facility/developmentally
disabled-nursing facility, as defined in Section 1250.
(g) A licensed correctional treatment center, as defined in
Section 1250.
(h) A licensed psychiatric health facility, as defined in Section
1250.2.
(i) A licensed chemical dependency recovery hospital, as defined
in Section 1250.3.
(j) A licensed residential care facility for the elderly, as
defined in Section 1569.2.
(k) A licensed residential care facility for persons with chronic,
life-threatening illness, as defined in Section 1568.01.
SEC. 3. Section 150204 of the Health and Safety Code is amended to
read:
150204. (a) (1) A county may establish, by
ordinance an action of the county board of
supervisors or by an action of the public health officer of the
county, as delegated by the county board of supervisors , a
repository and distribution program for purposes of this division.
Only pharmacies
(2) Only a pharmacy
that are is county-owned or that
contract contracts with the county
pursuant to this division may , or a primary
care clinic dispensary, as defined in subdivision (b) of Section
150201, is eligible to participate in this program
to dispense medication donated to the drug repository and
distribution program.
(3) An eligible pharmacy or primary care clinic dispensary that
seeks to participate in the program shall inform the county health
department in writing of its intent to participate in the program. An
eligible pharmacy or primary care clinic dispensary may not
participate in the program unless it is approved by the county board
of supervisors or the public health officer of the county.
(4) (A) A participating pharmacy or primary care clinic dispensary
shall disclose to the county health department the name and location
of the source of all donated medication it receives.
(B) A participating primary care clinic dispensary shall disclose
to the county health department the licensed physician to be
accountable to the State Board of Pharmacy for the clinic's program
operations pursuant to this division.
(C) The county board of supervisors or public health officer of
the county shall, upon request, make available to the State Board of
Pharmacy the information in this paragraph.
(5) The county board of supervisors, the public health officer of
the county, and the State Board of Pharmacy may prohibit a pharmacy
or primary care clinic dispensary from participating in the program
if the pharmacy or primary care clinic dispensary does not comply
with the provisions of the program, pursuant to this division.
(b) A county that elects to establish a repository and
distribution program pursuant to this division shall establish
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 county-owned or
county-contracted, licensed pharmacy or primary care clinic
dispensary .
(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 skilled nursing facility
health or care facility, as described in Section
150202 , shall have been under the control of staff of
the skilled nursing facility the health or care
facility, as described in Section 150202 .
(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.
(e) A pharmacist or physician 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 any of the following
ways:
(1) Dispensed to an eligible patient.
(2) Destroyed.
(3) Returned to a reverse distributor.
(4) Transferred to another participating pharmacy or primary care
clinic dispensary to be dispensed to eligible patients pursuant to
this division.
(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 pharmacy's or primary
care clinic dispensary's other drug stock by physical means,
for purposes including, but not limited to, inventory, accounting,
and inspection.
(k) The pharmacy or primary care clinic dispensary
shall keep complete records of the acquisition and disposition of
medication donated to to, transferred,
and dispensed under the repository and distribution program. These
records shall be kept separate from the pharmacy's or primary
care clinic dispensary'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 and 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 their
appropriate temperatures and in accordance with USP
standards and the Pharmacy Law.
(n) Notwithstanding any other provision of law, a participating
county-owned or county-contracted pharmacy or primary care
clinic dispensary 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. 4. 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, county-owned or county-contracted licensed pharmacy, or
skilled nursing facility primary care clinic
dispensary .
(b) A pharmacist or health care professional who accepts or
dispenses prescription drugs.
(c) A health or care facility, as described in Section 150202.