Bill Text: CA AB1069 | 2015-2016 | 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 6-0)

Status: (Passed) 2016-09-13 - Chaptered by Secretary of State - Chapter 316, Statutes of 2016. [AB1069 Detail]

Download: California-2015-AB1069-Amended.html

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BILL NUMBER: AB 1069	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  MAY 6, 2015
	AMENDED IN ASSEMBLY  MARCH 26, 2015

INTRODUCED BY   Assembly Member Gordon
   (Coauthors: Assembly Members Chu, Low, and Mark Stone)
   (Coauthors: Senators Beall and Wieckowski)

                        FEBRUARY 26, 2015

   An act to amend  Sections 150201 and  
Section  150204 of the Health and Safety Code, relating to
pharmaceuticals.



	LEGISLATIVE COUNSEL'S DIGEST


   AB 1069, as amended, Gordon. Prescription drugs: collection and
distribution program.
   Existing law authorizes a county to establish a repository and
distribution program under which a pharmacy, including 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 establishes a
depository and redistribution program to develop written procedures
for, among other things, establishing eligibility for medically
indigent patients who may participate in the program, and ensuring
that patients eligible for the program are not charged for any
medications provided under the program. Existing law also prohibits
the donation of controlled substances to the repository and
distribution program. Under existing law, only medication that is
donated in unopened, tamper-evident packaging or modified unit dose
containers that meet the United States Pharmacopoeia standards, and
that includes lot numbers and expiration dates, is eligible for
donation to the program. Existing law authorizes a county-owned
pharmacy participating in the program to transfer eligible donated
medication to a county-owned pharmacy participating in the program
within another adjacent county, as specified. Existing law prohibits
medication that does not meet the requirements for donation and
distribution from being sold, dispensed, or otherwise transferred to
any other entity. Existing law requires medication donated to the
repository and distribution program to be maintained in the donated
packaging units.
   This  bill would define "tamper-evident packaging" for
purposes of the program. The bill would require a county that
establishes a medication repository and donation program to develop
written procedures ensuring that manufacturer recalls are handled
appropriately for medications with and without lot numbers. The bill
would delete the requirement that a donated medication container have
a lot number. The  bill would authorize a county-owned
pharmacy participating in the medication repository and distribution
program to transfer eligible donated medication to a participating
county-owned pharmacy in any other county, as specified. The bill
would authorize medication donated to a medication repository and
distribution program to be maintained in new, properly labeled
containers.  The bill would prohibit donated medication from
being repackaged more than 2 times.  This bill would also make a
technical, nonsubstantive change to these 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) "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.
   (e) "Tamper-evident packaging" means an immediate, outer, or
secondary container that is sealed by an organization eligible to
donate medication pursuant to this division and that has a seal that
must be broken in order to gain access to the container's medication.

   SEC. 2.   SECTION 1.   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 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 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. 
   (6) Ensuring manufacturer recalls are handled appropriately for
medications with and without lot numbers. 
   (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) (1) 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).
   (2) (A) A medication that is the subject of a United States Food
and Drug Administration managed risk evaluation and mitigation
strategy pursuant to Section 355-1 of Title 21 of the United States
Code shall not be donated if this inventory transfer is prohibited by
that strategy, or if the inventory transfer requires prior
authorization from the manufacturer of the medication.
   (B) A medication that is the subject of a United States Food and
Drug Administration managed risk evaluation and mitigation strategy
pursuant to Section 355-1 of Title 21 of the United States Code, the
donation of which is not prohibited pursuant to subparagraph (A),
shall be managed and dispensed according to the requirements of that
strategy.
   (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 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. Donated
medication that does not meet the requirements of this division 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 or new, properly
labeled containers 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. 
Donated medication shall not be repackaged more than two times.
Nothing in this section requires donated medication to be repackaged
two times. 
   (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.