BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 1069|
|Office of Senate Floor Analyses | |
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THIRD READING
Bill No: AB 1069
Author: Gordon (D), et al.
Amended: 8/15/16 in Senate
Vote: 21
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 7-0, 7/6/15
AYES: Hill, Bates, Berryhill, Block, Galgiani, Jackson,
Mendoza
NO VOTE RECORDED: Hernandez, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 80-0, 6/1/15 - See last page for vote
SUBJECT: Prescription drugs: collection and distribution
program
SOURCE: Supporting Initiatives to Redistribute Unused
Medicine
DIGEST: This bill authorizes a pharmacy that operates solely
within a voluntary, county-operated prescription drug collection
and distribution program to repackage a reasonable quantity of
donated medicine in anticipation of dispensing the medicine to
its patient population and requires that pharmacy to have
repackaging policies and procedures in place for identifying and
recalling medications.
Senate Floor Amendments of 8/15/16 add language to require
medication that is repackaged to be labeled with the earliest
expiration date.
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ANALYSIS:
Existing law:
1)Establishes a voluntary unused medication repository and
distribution program (Program) for the purpose of distributing
surplus medications to persons in need of financial assistance
to ensure access to necessary pharmaceutical therapies.
(Health and Safety Code (HSC) § 150200-150207)
2)Authorizes a county to establish a Program, 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. Requires the county to notify the Board of
Pharmacy (Board) within 30 days from the date it establishes a
Program. (HSC § 150204)
3)Establishes requirements for medication donated to the
Program, including that a pharmacist or physician shall adhere
to standard pharmacy practices, as required by state and
federal law, when dispensing all medications and medication
that is donated to the Program shall either be dispensed to an
eligible patient, destroyed, returned to a reverse distributor
or licensed waste hauler or transferred to another
participating entity within the county to be dispensed to
eligible patients. Requires medication donated to the Program
to be maintained in the donated packaging units until
dispensed to an eligible patient who presents a valid
prescription.
4)Defines "repackager" as a person or entity that is registered
with the federal FDA as a repackager and operates an
establishment that packages finished drugs from bulk or that
repackages dangerous drugs into different containers,
excluding shipping containers. (Business and Professions Code
(BPC) § 4044)
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5)Establishes a licensure category under the authority of the
Board for a "surplus medication collection and distribution
intermediary" (Intermediary) operating for the purpose of
facilitating the donation of medications to, or transfer of
medications between, participating entities under a county's
Program. (BPC § 4169.5)
This bill authorizes a pharmacy that operates solely within a
Program to repackage a reasonable quantity of donated medicine
in anticipation of dispensing the medicine to its patient
population, labeled with the earliest expiration date, and
requires that pharmacy to have repackaging policies and
procedures in place for identifying and recalling medications.
Background
California's efforts to donate unused medication. SB 798
(Simitian, Chapter 444, Statutes of 2005) took effect in 2006,
authorizing California counties to establish a "surplus
prescription drug collection and distribution program" (Program)
for the distribution of unused, unexpired medication to
medically indigent patients. Under the Program, counties could
adopt an ordinance to establish such a Program, under which
skilled nursing facilities (SNFs), and SNFs that are
institutions for mental disease, drug wholesalers, and drug
manufacturers could donate unused medications to county-owned
pharmacies, or pharmacies that contract with the county for
dispensing to medically indigent patients free of charge. Prior
to the enactment of SB 798, SNFs were required to either destroy
the drugs in the presence of a pharmacist or nurse, or return
the drugs to the issuing pharmacy (if unopened and in a sealed
container) for disposition. SB 1329 (Simitian, Chapter 709,
Statutes of 2012) made a number of changes to the way a Program
could be authorized and the entities eligible to donate
medications under a Program, authorizing a county public health
officer, as delegated by a county board of supervisors, to
implement a Program and adding several categories of licensed
health care facilities that may donate medications. AB 467
(Stone, Chapter 10, Statutes of 2014) established a licensure
category in the Pharmacy Law for a surplus medication collection
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and distribution Intermediary.
Two counties in California (Santa Clara and San Mateo) have
established a Program through ordinance, although the Santa
Clara Program is the only current operational program. As a
result of changes in SB 1329, medication can be donated from a
number of organizations, facilities and entities throughout the
state, but the only recipients of donated medications must be
located within Santa Clara County.
Need for program changes. This bill is sponsored by Supporting
Initiatives to Redistribute Unused Medicine (SIRUM), an
organization in the author's district that coordinates Program
efforts in Santa Clara County. Specifically, under the current
law, participating entities must repackage medications in a new
container prior to dispensing to a patient, but cannot do this
in advance. The author states that repackaging donated medicine
is very time-consuming because most medicine comes in unit-dose
packaging, which means each pill needs to be individually popped
out and placed in a new container. The author is concerned that
this currently must be done while the patient waits and that
allowing participating entities to repackage the medications in
advance alleviates the time pressure on the pharmacist and
prevents the patient from a needlessly long wait.
The author intends for the changes in this bill, which only
impact a pharmacy operating solely under a Program, to increase
efficiency by allowing for a reasonable quantity of donated
medicine to be packaged in anticipation of dispensing the
medicine to its patient population.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:NoLocal: No
SUPPORT: (Verified8/16/16)
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Supporting Initiatives to Redistribute Unused Medicine (source)
Board of Pharmacy
OPPOSITION: (Verified8/16/16)
None received
ARGUMENTS IN SUPPORT: SIRUM believes that AB 1069 will
increase access to necessary, and in many cases lifesustaining,
prescription drugs to medically indigent Californians while at
the same time reduce the environmental impact of pharmaceutical
waste.
ASSEMBLY FLOOR: 80-0, 6/1/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,
Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang,
Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle,
Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina
Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez,
Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden,
Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder,
Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina,
Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen,
Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez,
Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting,
Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins
Prepared by:Sarah Mason / B., P. & E.D. / (916) 651-4104
8/16/16 17:38:50
**** END ****
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