Bill Text: CA SB1329 | 2011-2012 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Prescription drugs: collection and distribution program.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Passed) 2012-09-28 - Chaptered by Secretary of State. Chapter 709, Statutes of 2012. [SB1329 Detail]

Download: California-2011-SB1329-Amended.html

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BILL NUMBER: SB 1329	AMENDED
	BILL TEXT

	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 150201, 150202, 150204, and 150205 of the
Health and Safety Code, relating to pharmaceuticals.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1329, as amended, 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. This bill would authorize licensed
health and care facilities, as specified, to donate unused
medications to the program. 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.  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.
   (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 licensed primary care clinic, as defined in Section 1204.
   (3) 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.
   (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. 2.  Section 150202 of the Health and Safety Code is amended to
read:
   150202.  Notwithstanding any other provision of law, the following
health and care facilities may donate unused medications under a
program established pursuant to this 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.
   (l) An approved mental health rehabilitation center, as described
in Section 5675 of the Welfare and Institutions Code.
  SEC. 3.  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  delegated   directed
 by the county board of supervisors, a repository and
distribution program for purposes of this division.
   (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 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 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 licensed physician who shall be
accountable to the California 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 California
State Board of Pharmacy the information in this paragraph.
   (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.
   (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 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 staff of 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 the following ways:
   (1) Dispensed to an eligible patient.
   (2) Destroyed.
   (3) Returned to a reverse distributor.
   (4) Transferred to another participating entity 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 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, 
transferred,   and transferred  and dispensed
 under   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. 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, or participating entity.
   (b) A pharmacist or health care professional who accepts or
dispenses prescription drugs.
   (c) A health or care facility, as described in Section 150202.