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  MARCH 29, 2012

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 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  a primary care clinic dispensary, as
defined,   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,
  intent and prohibit the pharmacy or clinic from
participating   until   and require 
the county  board of supervisors or public health officer to
approve the pharmacy or clinic   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
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" 

   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. 
   (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.  
   (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 by the county board of
supervisors, a repository and distribution program for purposes of
this division.
   (2) Only  a pharmacy that is county-owned or that
contracts with the county pursuant to this division, or a primary
care clinic dispensary, as defined in subdivision (b) of Section
150201, is   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  pharmacy or primary care clinic
dispensary   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 
pharmacy or primary care clinic dispensary   entity
 may not participate in the program  unless it is
approved by the county board of supervisors or the public health
officer of the county   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  pharmacy or primary care clinic
dispensary   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 dispensary
  primary care clinic, as described in paragraph (3) of
subdivision (a) of Section 150201  shall disclose to the county
health department the licensed physician  to  
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  a pharmacy or primary care clinic dispensary
  an eligible or participating entity  from
participating in the program if  the pharmacy or primary care
clinic dispensary   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 
county-owned or county-contracted, licensed pharmacy or primary care
clinic dispensary   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  pharmacy or
primary care clinic dispensary   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  pharmacy's or primary care
clinic dispensary's   participating entity'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
  A participating entity  shall keep complete
records of the acquisition and disposition of medication donated 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  
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  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
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   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,  county-owned or county-contracted licensed pharmacy,
 or  primary care clinic dispensary  
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.