BILL ANALYSIS Ó
SB 431
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator S. Joseph Simitian, Chairman
2011-2012 Regular Session
BILL NO: SB 431
AUTHOR: Emmerson
AMENDED: April 11, 2011
FISCAL: Yes HEARING DATE: May 4, 2011
URGENCY: No CONSULTANT: Caroll
Mortensen
SUBJECT : PHARMACY REGULATION
SUMMARY :
Existing law :
1)Generally under the Business and Professions Code, provides
for the licensure and regulation of pharmacies, pharmacists,
and wholesalers of dangerous drugs or devices by the Board
of Pharmacy (BOP) within the Department of Consumer Affairs.
2)Defines "reverse distributor" as every person who acts as an
agent for pharmacies, drug wholesalers, manufacturers, and
other entities by receiving, inventorying, and managing the
disposition of outdated or nonsalable dangerous drugs
(Business and Professions Code §4040.5).
3)Defines "dangerous drug" or "dangerous device" as any drug
or device unsafe for self-use in humans or animals, and
includes the following:
a) Any drug that bears the legend: "Caution: federal law
prohibits dispensing without prescription," "Rx only," or
words of similar import.
b) Any device that bears the statement: "Caution: federal
law restricts this device to sale by or on the order of a
____," "Rx only," or words of similar import, the blank
to be filled in with the designation of the practitioner
licensed to use or order use of the device.
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c) Any other drug or device that by federal or state law
can be lawfully dispensed only on prescription or
furnished as described (§4022).
4)Requires pharmacies to keep records of manufacture, sale,
acquisition or disposition of dangerous drugs or dangerous
devices for three years, and requires these records to be
available for inspection by authorized officers of the law
(§4081).
5)Requires all records or other documentation of the
acquisition and disposition of dangerous drugs and dangerous
devices by any entity licensed by the BOP to be retained on
the licensed premises in readily retrievable form (§4105).
6)Establishes a system to license and oversee medical waste
haulers (Health and Safety Code §118000 et seq.).
7)Requires the Department of Resources Recycling and Recovery
(DRRR), by July 1, 2008, to consult with local, state, and
federal agencies including the Department of Toxic
Substances Control, the State Water Resources Control Board,
and the BOP to establish model disposal programs for waste
pharmaceuticals that include requirements for safety,
oversight, diversion prevention, and ease of use for
consumers (Public Resources Code §47122).
8)Requires DRRR, by December 1, 2010, to submit a report to
the Legislature that includes an evaluation of the model
programs for efficacy, safety, statewide accessibility, and
cost effectiveness. The report shall include the
consideration of the incidence of diversion of drugs for
unlawful sale and use, if any. The report also shall
provide recommendations for the potential implementation of
a statewide program and statutory changes (§47123).
This bill :
1) Specifies that a pharmacy may furnish dangerous drugs to a
hazardous waste hauler for the sole purpose of waste
disposal of pharmaceutical waste returned to the pharmacy
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by a patient or patient's agent.
2) Prohibits a reverse distributor from accepting dangerous
drugs that have been dispensed to a patient and later
returned by a patient or patient's agent.
3) Specifies that only a hazardous waste hauler can pick up or
handle dangerous drugs returned by a patient or patient's
agent to a pharmacy.
4) Contains other provisions not related to the jurisdiction
of the Environmental Quality Committee including:
a) Clarifies that any record pertaining to the return of
dangerous drugs to a wholesaler, or provided to a
reverse distributor, must document the quantity or
weight of the drugs returned, the date the drugs were
returned, and the name of the reverse distributor or
wholesaler to whom the drugs were provided.
b) Clarifies that any record pertaining to the return of
dangerous drugs to a hazardous waste hauler must list
the volume in weight or measurement of the
pharmaceutical waste returned, the date the waste was
returned, and the name of the hazardous waste hauler to
whom waste was provided.
c) Requires that, in addition to reporting certain
information and evidence about licensees related to
chemical, mental, or physical impairment, to the extent
it affects his or her ability to practice, and theft,
diversion or self-use of dangerous drugs to the BOP
within 30 days, a pharmacy must also provide the
information and evidence to the BOP within 30 days.
d) In the event of information or evidence pertaining to
chemical, mental, or physical impairment of a licensee
(to the extent it affects his or her ability to
practice) or theft, diversion or self-use of dangerous
drugs, requires a pharmacy to conduct an audit to
determine the quantity and type of dangerous drugs
stolen, diverted, or used by a licensed individual
employed by or with the pharmacy and submit a copy of
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the audit to the BOP within 30 days.
e) Requires the owner, corporate officer, or manager of
an entity licensed by the BOP, when requested by an
authorized officer of the law or by an authorized
representative of the BOP, to provide the requested
records within 72 hours of the time the request was
made. Specifies that the entity may request an extension
in writing for up to 14 days.
f) Clarifies that a nonresident pharmacy shall not
permit a pharmacist whose license has been revoked by
the BOP to manufacture, compound, furnish, sell,
dispense, or initiate the prescription of a dangerous
drug or dangerous device, or to provide any
pharmacy-related service, to a person residing in
California.
COMMENTS :
1) Purpose of Bill . According to the author, SB 431 will
increase consumer protection as well as better ensure the
proper disposal of prescription drugs. Without a safe and
effective method for disposal, prescription drugs may be
left in medicine cabinets where they pose a threat of
potential drug misuse or abuse. The author asserts that
this bill will also make certain that when drugs are
received by a pharmacy that has established a take-back
program, they are properly disposed of, and not
re-introduced into the pharmaceutical supply. The author
believes that this bill also contains consumer protection
measures that provide the BOP with information it needs to
quickly discipline errant licensees by requiring additional
reporting on drug loss. Additionally, the author notes
that ensuring that an individual whose pharmacist license
has been revoked in California is not able to dispense
medication to Californians via mail supports the BOP public
protection efforts.
As it pertains to the jurisdiction of the Environmental
Quality Committee, this bill would limit the entities that
can transport home-generated pharmaceutical waste (HGPW) to
only hazardous waste haulers. It would preclude reverse
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distributors and those entities that have obtained a
limited-quantity hauling exemption from managing HGPW.
2) Drug Waste Management and Disposal . SB 966 (Simitian)
Chapter 542, Statutes of 2007, established a program at
DRRR to develop and evaluate HGPW take-back programs. In
March of this year, DRRR released the report required
pursuant to that law. Based on the analysis described in
detail in the report, DRRR recommends that the Legislature
adopt a combination of two options related to
pharmaceutical waste collection programs: 1) statutory
changes to establish clear state roles and
responsibilities, provide direction to resolve several
implementation challenges, and direct that the Criteria and
Procedures for Model Home-Generated Pharmaceutical Waste
Collection and Disposal Programs developed by DRRR be
refined and converted into regulations; and 2) statutory
direction to address funding barriers by providing
financing through a private sector approach with government
oversight, commonly referred to as product stewardship.
Manufacturers or drug brand owners would design, manage,
and finance a statewide program, while state government
would oversee program implementation and enforcement.
3) Federal efforts . In 2010, Congress passed legislation
giving the Attorney General authority to promulgate new
regulations, within the framework of the Controlled
Substances Act that will allow patients to deliver unused
pharmaceutical controlled substances to appropriate
entities for disposal in a safe and effective manner
consistent with effective controls against diversion. The
goal of this Act is to encourage the Attorney General to
set controlled substance diversion prevention parameters
that will allow public and private entities to develop a
variety of methods of collection and disposal of controlled
substances, including some pharmaceuticals, in a secure,
convenient, and responsible manner. This will also serve
to reduce instances of diversion and introduction of some
potentially harmful substances into the environment. The
regulations are currently under development.
4) Opposition Arguments . The Bay Area Pollution Prevention
Group represents 43 wastewater treatment facilities around
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the San Francisco Bay and beyond, that work to prevent
pollution in San Francisco Bay. They raise several
concerns with the bill. They state that the bill could be
in conflict with the pending federal regulation and could
make it even more difficult and costly for agencies,
retailers, and drug manufacturers in California to provide
programs for the public to properly dispose of
pharmaceuticals. They point to reverse distributors, as
well as common carriers, as options that the DEA is looking
at as pick-up and transportation services. They claim that
reverse distribution is possibly one of the best and most
cost-effective tools for residential disposal programs.
Reverse distributors already work in pharmacies to dispose
of medication that was not sold either due to overstocking,
recalls, or expiration. A pharmacy-based residential
collection program could utilize their reverse distribution
network to remove unwanted residential medication at the
same time as these unsold drugs. Also, they point to
another option that many public agencies, hospitals, and
long-term care facilities would like to consider for
disposal of residential unwanted medication; the use of
common carriers to transport pharmaceutical waste to an
incineration facility. Currently, United States Postal
Service, FedEx, and United Parcel Service deliver
medication to end users. They claim that leftover
medication could safely be sent by common carrier to a
regulated facility for incineration at a significantly
lower cost than medical or hazardous waste hauling.
5) Previous Legislation . SB 26 (Simitian) of 2009 developed a
management and tracking system within the Medical Waste Act
for HGPW that removed HGPW from the definition of medical
waste and developed a manifest system to ensure proper
management and disposal. This bill was amended to address
another subject matter.
6) Previous Committee . SB 431 was approved by the Business,
Professions and Economic Development Committee on April 11,
2011 (9-0).
7) Amendments Needed . The Medical Waste Act establishes the
process for managing medical waste, including
pharmaceutical waste. Also, many local jurisdictions and
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state agencies are working on the on-going efforts at the
federal level to develop regulations to assist with safe,
efficient collection of pharmaceutical waste, including
controlled substances. Further, the Legislature is in
receipt of the mandated report that contains
recommendations regarding the statutory changes necessary
to implement HGPW take-back programs. This bill should be
amended to remove the provisions in Section 5 and Section 6
of the bill dealing with hazardous waste haulers and HGPW.
SOURCE : California Board of Pharmacy
SUPPORT : None on file
OPPOSITION : Bay Area Pollution Prevention Group