BILL ANALYSIS Ó
SB 431
Page 1
Date of Hearing: July 5, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 431 (Emmerson) - As Amended: May 10, 2011
SENATE VOTE : 39-0
SUBJECT : Pharmacies: regulation.
SUMMARY : Modifies 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a pharmacist whose license has been revoked from dispensing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)Decreases, from 30 days to 14 days, the length of time by
which pharmacies are required to report specified information
to the Board regarding a licensed employees' chemical, mental,
or physical impairment that affects his or her ability to
practice; and, employee theft, diversion, or self-use of
dangerous drugs.
4)Requires the report required in 3) 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. Requires the pharmacy, upon request of the Board,
to prepare and submit an audit involving the dangerous drugs
suspected to be missing.
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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. Permits the entity to request
in writing an extension for up to 14 calendar days, subject to
Board approval and deems the extension 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. Requires the pharmacy to 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)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.
Requires 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.
3)Requires pharmacies to have procedures in place to take action
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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. Requires pharmacies to have
written 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. Requires pharmacies to
report specified information to the Board (within 30 days)
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 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.
5)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 record keeping requirements for these entities.
6)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.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill will
improve the Board's consumer protection focus and provide it
with the tools needed to prosecute errant licensees more
quickly. The author states that this bill will also
strengthen consumer protection by preventing a pharmacist
whose California license has been revoked from dispensing
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medication to Californians via mail. The author states that
if California prohibits a pharmacist from practicing in
California, it undermines the Board's public protection
efforts if that pharmacist can still dispense medication to
Californians from outside of the state. Further, the author
contends that 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. The author states that this bill clarifies the
law to enable reverse distributors to accept prescription
drugs that have been dispensed to patients and returned to the
pharmacy for destruction in specific circumstances.
2)ENFORCEMENT . DCA is the umbrella agency that oversees 19
healing arts boards, which regulate a variety of professions
from doctors and nurses to physical therapists and
optometrists. The Board is one of these self-funded boards.
In January 2010, DCA launched the Consumer Protection
Enforcement Initiative (CPEI) to overhaul the enforcement
process at the healing arts boards with a goal to reduce the
average enforcement prosecution timeline from 36 months to
between 12 and 18 months. The CPEI was also meant to address
administrative improvements, increased enforcement resources,
and the pursuit of legislation to help boards better protect
consumers in areas where their enforcement authorities have
not kept up with legal trends. The CPEI legislative proposals
were introduced as SB 1111 (Negrete McLeod) in 2010 and SB 544
(Price) this year.
In 2011, the Board states it has sponsored the provisions in
this bill with a goal of shaving time off its investigation
processes. The Board believes the enforcement provisions in
this bill will allow for better enforcement, quicker outcomes
in disciplinary cases, and an enhanced ability to fulfill its
regulatory mission of consumer protection. This bill will
specify shorter timelines for submitting records or reporting
drug losses to the Board, require specific information
regarding drug losses, and prohibit a pharmacist whose license
is revoked in California to dispense drugs to patients in
California from a nonresident pharmacy.
3)REVERSE DISTRIBUTORS . The Board licenses the pharmacies and
drug wholesalers (among other license categories) that
distribute prescription drugs throughout California. Reverse
distributors are one type of drug wholesalers whose role is to
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remove nonsalable drugs from pharmacies (for example, outdated
drugs or drugs damaged by heat). This bill requires certain
conditions to be met in order for reverse distributors remove
drugs that have not been dispensed to patients from
pharmacies, in effect prohibiting their participation in
home-generated pharmaceutical waste (HGPW) take-back programs.
4)TAKE-BACK PROGRAMS . SB 966 (Simitian), Chapter 542, Statutes
of 2007, establishes a program to develop and evaluate HGPW
take-back programs. In March of this year, the Department of
Resources Recycling and Recovery (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: a) 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, b) statutory direction to address funding
barriers by providing financing through a private sector
approach with government oversight, commonly referred to as
product stewardship.
5)ENVIRONMENTAL PROTECTION AGENCY REGULATIONS . The federal
Environmental Protection Agency is in the process of
developing regulations that will add hazardous pharmaceutical
wastes to the universal waste system. According to the
federal Office of Management and Budget summary of the
proposed rule, it will streamline the current regulations
governing these wastes, ensuring that hazardous pharmaceutical
and consumer product wastes are properly managed. Expansion
of the universal waste system to include hazardous
pharmaceutical wastes will allow all pharmaceuticals,
waste-like or product-like, to be sent to reverse distribution
centers, which have expertise in making hazardous waste
determinations and in managing hazardous waste. In addition,
the inclusion of hazardous pharmaceutical wastes in the
universal waste rule will also encourage health care
facilities to manage all their pharmaceutical wastes as
universal wastes, particularly wastes that are not regulated
as hazardous but which nonetheless pose hazards.
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6)SUPPORT . According to the Board, who is the sponsor, this
bill contains provisions of importance to Board that will
improve the Board's regulation over its licensees and provide
for greater consumer protection. The Board further states
that this bill's modest provisions are important to improving
the Board's regulatory provisions.
7)OPPOSE UNLESS AMENDED . EXP Pharmaceutical Services Corp.
(EXP) is opposed to Section five of this bill, which relates
to reverse distributors. EXP states that adoption these
provisions would preclude reverse distributors, the most
qualified industry at the handling and proper disposal of
waste pharmaceuticals, from assisting pharmaceutical take back
programs. EXP writes that they cannot conceive of a single
reason that California would want to preclude reverse
distributors from assisting pharmaceutical take back programs
in the handling and disposing of HGPW. EXP further asserts
that allowing pharmacies participating in take back programs
to transport HGPW to reverse distributors would: decrease the
amount of pharmaceuticals entering our water ways by providing
homeowners a viable alternative to flushing; decrease the
volume of pharmaceuticals available for diversion; and
leverage the skills, experience and licensure of reverse
distributors to properly dispose of waste pharmaceuticals.
8)Related legislation . SB 544 (Price) would have enacted the
Consumer Health Protection Enforcement Act that includes
various provisions affecting the investigation and enforcement
of disciplinary actions against licensees of healing arts
boards. SB 544 was held in Senate Business, Professions and
Economic Development Committee.
9)Previous Legislation . SB 1111 (Negrete McLeod) of 2010
contained provisions similar to SB 544. SB 1111 was held in
the Senate Business, Professions and Economic Development
Committee. SB 26 (Simitian) of 2009 would have required 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. SB 26 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.
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10)Double referred . This bill has been double referred. It was
heard by the Assembly Business, Professions and Consumer
Protection Committee on June 21, 2011 and passed by a vote of
9-0.
REGISTERED SUPPORT / OPPOSITION :
Support
Board of Pharmacy (sponsor)
Opposition
None on file.
Analysis Prepared by : Melanie Moreno / HEALTH / (916)
319-2097