Amended in Senate August 15, 2016

Amended in Senate August 1, 2016

Amended in Senate July 1, 2015

Amended in Assembly May 6, 2015

Amended in Assembly March 26, 2015

California Legislature—2015–16 Regular Session

Assembly Bill No. 1069

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 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. 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 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 authorize a pharmacy that exists solely to operate the repository and distribution program to repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population. The bill would require a pharmacy that repackages medication to have repackaging policies and procedures in place for identifying and recalling begin delete medications. end delete begin insert medications, and to label the repackaged medicine with the earliest expiration date. end insert

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 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.

(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 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. Donated
medication that does not meet the requirements of this division
shall not be sold, dispensed, or otherwise transferred to any other
entity.

(i) (1) Except as provided in paragraph (2), 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.

(2) A pharmacy that exists solely to operate the repository and
distribution program may repackage a reasonable quantity of
donated medicine in anticipation of dispensing the medicine to its
patient population. The pharmacy shall have repackaging policies
and procedures in place for identifying and recalling medications.

begin insert Medication that is repackaged shall be labeled with the earliest
expiration date. end insert

(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.