BILL ANALYSIS Ó
SB 431
Page 1
Date of Hearing: June 21, 2011
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
SB 431 (Emmerson) - As Amended: May 10, 2011
SENATE VOTE : 39-0
SUBJECT : Pharmacies: regulation.
SUMMARY : Expands existing reporting requirements to the Board
of Pharmacy (Board) regarding employee theft of drugs, prohibits
a pharmacist whose license has been revoked from dispensing
medication via mail, and prohibits a reverse distributor from
accepting dangerous drugs that have been dispensed to a patient
and later returned to the pharmacy, unless certain conditions
are met. Specifically, this bill :
1)Requires any record pertaining to the return of dangerous
drugs to a wholesaler or provided to a reverse distributor to
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.
2)Requires any record pertaining to the return of dangerous
drugs to a hazardous waste hauler, as specified, to 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 the waste was provided.
3)Changes, to 14 days from the current-law requirement of 30
days, the date by which pharmacies must report specified
information to the Board regarding licensed employees'
chemical, mental, or physical impairment that affects their
ability to practice, and employee theft, diversion or self-use
of dangerous drugs.
4)Requires the report required above to include sufficient
detail to inform the Board of the facts on which the report is
based, including an estimate of the type and quantity of all
dangerous drugs involved, the timeframe over which the losses
are suspected, and the date of the last controlled substances
inventory. Upon request of the Board, the pharmacy must
prepare and submit an audit involving the dangerous drugs
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suspected to be missing.
5)Requires the owner, corporate officer, or manager of an entity
licensed by the Board, when requested by an authorized officer
of the law or by an authorized representative of the Board, to
provide requested records of the acquisition and disposition
of dangerous drugs and devices within three business days of
the time the request is made. The entity may request in
writing an extension for up to 14 calendar days, subject to
Board approval. An extension is deemed approved if the Board
fails to deny the request within two business days.
6)Prohibits a nonresident pharmacy from permitting a pharmacist
whose license has been revoked by the Board 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.
7)Prohibits a reverse distributor from accepting the return of
dangerous drugs that have been dispensed to a patient and
returned to the pharmacy unless the dangerous drugs were
dispensed in a sealed or tamper-evident package and there is
no evidence that the package was opened, damaged or otherwise
tampered with. The pharmacy must keep records of these
returned dangerous drugs.
EXISTING LAW
1)Provides for the licensure and regulation of pharmacies,
pharmacists and wholesalers of dangerous drugs or devices by
the Board within the Department of Consumer Affairs (DCA).
2)Defines the following terms:
a) "Authorized officers of the law" as inspectors of the
Board, inspectors of the Food and Drug Branch of the State
Department of Public Health, and investigators of DCA's
Division of Investigation or peace officers engaged in
official investigations.
b) "Designated representative" as an individual to whom a
license has been granted to provide sufficient and
qualified supervision in a wholesaler or veterinary
food-animal drug retailer. The designated representative
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must protect the public health and safety in the handling,
storage, and shipment of dangerous drugs and dangerous
devices. "Designated representative-in-charge" means a
designated representative or a pharmacist proposed by a
wholesaler or veterinary food-animal drug retailer and
approved by the Board as the supervisor or manager
responsible for ensuring compliance with all state and
federal laws.
c) "Pharmacist-in-charge" as a pharmacist proposed by a
pharmacy and approved by the Board as the supervisor or
manager responsible for ensuring the pharmacy's compliance
with all state and federal laws and regulations pertaining
to the practice of pharmacy.
d) "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.
3)Requires pharmacies to keep records of the 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.
An inventory must be kept by every manufacturer, wholesaler,
pharmacy, veterinary food-animal drug retailer, physician,
dentist, podiatrist, veterinarian, laboratory, clinic,
hospital, institution, or establishment holding a currently
valid and unrevoked certificate, license, permit, or
registration that maintains a stock of dangerous drugs or
devices. The owner, officer, partner and pharmacist-in-charge
or designated representative-in-charge is responsible for
maintaining records and keeping inventory. The
pharmacist-in-charge or designated representative-in-charge is
not criminally responsible for the acts of an owner, officer,
partner or employee if the pharmacist-in-charge or designated
representative-in-charge had no knowledge of the acts.
4)Requires pharmacies to have procedures in place to take action
when a licensed individual employed by or with the pharmacy is
chemically, mentally, or physically impaired to the extent it
affects his or her ability to practice the profession or
occupation he or she is licensed to practice, or when a
licensed individual has engaged in theft, diversion, or
self-use of dangerous drugs. Pharmacies must have written
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policies and procedures for addressing chemical, mental, or
physical impairment, as well as theft, diversion, or self-use
of dangerous drugs among licensed individuals employed by or
with the pharmacy. Pharmacies must report the following to
the Board within 30 days:
a) Any admission by a licensed individual of chemical,
mental, or physical impairment affecting his or her ability
to practice;
b) Any admission by a licensed individual of theft,
diversion, or self-use of dangerous drugs;
c) Any video or documentary evidence demonstrating
chemical, mental, or physical impairment of a licensed
individual to the extent it affects his/her ability to
practice;
d) Any video or documentary evidence demonstrating theft,
diversion, or self-use of dangerous drugs by a licensed
individual;
e) Any termination based on chemical, mental, or physical
impairment of a licensed individual to the extent it
affects his/her ability to practice; and,
f) Any termination of a licensed individual based on theft,
diversion, or self-use of dangerous drugs.
5)Provides that anyone making a report pursuant to 4), above,
has immunity from any civil or criminal liability that might
otherwise arise from making the report. Any participant shall
have the same immunity with respect to participation in any
administrative or judicial proceeding resulting from the
report.
6)Requires all records or other documentation of the acquisition
and disposition of dangerous drugs and dangerous devices by
any entity licensed by the Board to be retained on the
licensed premises in readily retrievable form, as specified.
7)Specifies that a nonresident pharmacy is any pharmacy located
outside of California that ships, mails or delivers controlled
substances, dangerous drugs, or dangerous devices into
California and establishes certain licensing, disclosure and
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record keeping requirements for these entities.
8)Establishes a system to license and oversee medical waste
haulers.
9)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
Board to establish model disposal programs for waste
pharmaceuticals that include requirements for safety,
oversight, diversion prevention, and ease of use for
consumers.
10)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 must include the consideration of
the incidence of diversion of drugs for unlawful sale and use,
if any. The report also must provide recommendations for the
potential implementation of a statewide program and statutory
changes.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author's office, "As a
matter of public protection, it is vital that unused or expired
prescription drugs do not re-enter the drug supply chain nor
reach the hands of unauthorized individuals? SB 431 will
increase consumer protection as well as ensure the proper
disposal of prescription drugs."
Background . Health boards throughout DCA have struggled to meet
enforcement goals and streamline what have become extremely
lengthy disciplinary processes. Boards have been further
hampered by mandatory furloughs, a state hiring freeze which
limits boards' ability to hire staff, and loans to the state's
General Fund.
In response to press criticism and legislative review of public
health and safety impacts of enforcement delays, then-Governor
Schwarzenegger established a goal for all investigation cases to
be completed within 12 to 18 months in 2009. DCA designed a new
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enforcement model for all boards to comply with this timeline.
Compared to other boards, the Board is relatively timely in
processing investigations. However, given a significant growth
in the number of licensees that the board regulates, there is a
related growth in investigations, the number of complaints
received, and initial application investigations.
The Board believes the provisions in this bill will allow for
better enforcement, quicker outcomes in disciplinary cases, and
an enhanced ability to fulfill its regulatory mission.
There are growing concerns about the improper disposal of drugs
and pharmaceutical waste, which leads to contamination of water
systems and improper access by potential abusers. In addition,
prescription drug abuse is the fastest-growing drug problem in
the U.S. Studies show that some individuals who misuse
prescription drugs, particularly teens, believe these substances
are safer than illicit drugs because they are prescribed by a
health care professional and sold behind the counter. Proper
disposal is believed to decrease the availability of expired and
unused prescription drugs to abusers.
Unfortunately, guidelines for proper disposal of prescription
drugs can be confusing, lack uniformity throughout the state and
nation, and are cumbersome for consumers.
Take-back programs for medication disposal have risen in
popularity due to problems surrounding safe, accessible, and
easy disposal options. These programs are seen as an effective
way to remove expired, unwanted, or unused medicines from the
home.
SB 966 (Simitian) Chapter 542, Statutes of 2007, established a
program at DRRR to develop and evaluate home-generated
pharmaceutical waste (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:
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, statutory direction to
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address funding barriers by providing financing through a
private sector approach with government oversight, commonly
referred to as product stewardship.
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. 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. These regulations are currently under development.
Support . The California State Board of Pharmacy states, "
Senate Bill 431 contains provisions of importance to the
California State Board of Pharmacy that will improve the board's
regulation over its licensees and provide for greater consumer
protection."
Opposition . The Bay Area Pollution Prevention Group is
concerned that this bill could conflict with pending federal
regulations and make it more costly for agencies, retailers, and
drug manufacturers to provide programs for the public to
properly dispose of pharmaceuticals.
Related legislation . SB 544 (Price) enacts the Consumer Health
Protection Enforcement Act that includes various provisions
affecting the investigation and enforcement of disciplinary
actions against licensees of healing arts boards. This bill was
held in Senate Business, Professions and Economic Development
Committee.
Previous Legislation . SB 1111 (Negrete McLeod) of 2010 contains
provisions similar to SB 544 (Price) of 2011. This bill was
held in Senate Business, Professions and Economic Development
Committee.
SB 26 (Simitian) of 2009 develops a management and tracking
system within the Medical Waste Act for HGPW that removed HGPW
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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.
SB 966 (Simitian), Chapter 542, Statutes of 2007, requires the
California Integrated Waste Management Board to develop, in
consultation with appropriate state, local, and federal
agencies, model programs for the collection and proper disposal
of pharmaceutical drug waste.
Double referred . This bill is double-referred to Assembly
Health Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
California State Board of Pharmacy (sponsor)
Opposition
Bay Area Pollution Prevention Group
EXP Pharmaceutical Services Corp.
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301