BILL ANALYSIS �
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|SENATE RULES COMMITTEE | SB 431|
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THIRD READING
Bill No: SB 431
Author: Emmerson (R)
Amended: 5/10/11
Vote: 21
SENATE BUS., PROF. & ECON. DEVEL. COMMITTEE : 9-0, 4/25/11
AYES: Price, Emmerson, Corbett, Correa, Hernandez, Negrete
McLeod, Vargas, Walters, Wyland
SENATE ENVIRONMENTAL QUALITY COMMITTEE : 7-0, 05/04/11
AYES: Simitian, Strickland, Blakeslee, Hancock, Kehoe,
Lowenthal, Pavley
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SUBJECT : Pharmacies: regulation
SOURCE : Board of Pharmacy
DIGEST : This bill expands existing reporting
requirements to the Board of Pharmacy when a pharmacy
discovers that an employee has been stealing drugs,
prohibits a pharmacist whose California license has been
revoked from dispensing medication to Californians via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 the drugs were
dispensed in a sealed or tampered-evident pack and there is
no evidence that the package was opened, damaged or
otherwise tampered with.
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ANALYSIS :
Existing law :
1. Provides for the licensure and regulation of pharmacies,
pharmacists and wholesalers of dangerous drugs or
devices by the Board of Pharmacy (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. Specifies that the designated
representative shall 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,
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inventorying, and managing the disposition of
outdated or nonsalable dangerous drugs.
3. 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. Requires that an inventory 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, registration
who maintains a stock of dangerous drugs or devices.
Makes the owner, officer, partner and
pharmacist-in-charge or designated
representative-in-charge responsible for maintaining
records and keeping inventory. Clarifies that the
pharmacist-in-charge or designated
representative-in-charge are 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 the 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. States that anyone
making a report has immunity from any civil or criminal
liability that might otherwise arise from making of the
report. Requires pharmacies to 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.
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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.
F. Any termination of a licensed individual based
on theft, diversion, or self-use of dangerous
drugs.
5. 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.
6. 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.
This bill:
1.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. Specifies that a reverse
distributor must not accept the return of dangerous drugs
that have been dispensed to a patient and later returned
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by a patient or patient's agent.
2.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. 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 by a patient or patient's agent.
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.
3.Requires a pharmacy, within 14 days, report 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 Board.
4.Requires the report required above 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 a
pharmacy, upon request of the Board, prepare and submit
an audit involving the suspected missing dangerous drugs.
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 the requested
records within three business days of the time the
request was made. Specifies that the entity may request
an extension in writing for up to 14 calendar days,
subject to Board approval. Deems an extension approved
if the Board fails to deny the request within two
business days of the time the extension request was made
directly to the Board.
6.Clarifies that a nonresident pharmacy shall not permit a
pharmacist whose license has been revoked by the Board to
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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 dangerous
drugs that have been dispensed to a patient and later
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 keep
records of returned dangerous drugs.
Background
There are growing concerns about the impact of drugs and
pharmaceutical waste based on improper disposal, which in
turn leads to contamination of water systems and improper
access by potential abusers. The U.S. Geological Survey
conducted a study in 2002, sampling 139 streams across 30
states and found that 80 percent had measurable
concentrations of prescription and nonprescription drugs,
steroids, and reproductive hormones. Exposure, even to low
levels of pharmaceuticals, has been shown to have negative
effects on fish and other aquatic species and may have
negative effects on human health. Proper disposal is
believed to decrease the threat of these substances to the
environment and waterways.
According to recent studies, and data collected by the
federal government, prescription drug abuse is the
fastest-growing drug problem in the U.S. As prescription
drugs are legal, they are easily accessible, often from a
home medicine cabinet. 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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
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SUPPORT : (Verified 5/23/11)
Board of Pharmacy (source)
OPPOSITION : (Verified 5/23/11)
Bay Area Pollution Prevention Group
EXP Pharmaceutical Services Corp.
ARGUMENTS IN SUPPORT : According to the author's office,
this bill will increase consumer protection as well as
better ensure the proper disposal of prescription drugs.
The author's office believes that this bill contains
consumer protection measures that provide the Board with
information it needs to quickly discipline errant licensees
by requiring additional reporting on drug loss.
Additionally, the author's office 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 Board's public
protection efforts.
ARGUMENTS IN OPPOSITION : The Bay Area Pollution
Prevention Group represents 43 wastewater treatment
facilities around 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
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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.
JJA:do 5/23/11 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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