BILL ANALYSIS Ó
------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 431|
|Office of Senate Floor Analyses | |
|1020 N Street, Suite 524 | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
------------------------------------------------------------
UNFINISHED BUSINESS
Bill No: SB 431
Author: Emmerson (R)
Amended: 8/31/11
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, 5/4/11
AYES: Simitian, Strickland, Blakeslee, Hancock, Kehoe,
Lowenthal, Pavley
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SENATE FLOOR : 39-0, 5/31/11
AYES: Alquist, Anderson, Blakeslee, Calderon, Cannella,
Corbett, Correa, De León, DeSaulnier, Dutton, Emmerson,
Evans, Fuller, Gaines, Hancock, Harman, Hernandez, Huff,
Kehoe, La Malfa, Leno, Lieu, Liu, Lowenthal, Negrete
McLeod, Padilla, Pavley, Price, Rubio, Runner, Simitian,
Steinberg, Strickland, Vargas, Walters, Wolk, Wright,
Wyland, Yee
NO VOTE RECORDED: Berryhill
ASSEMBLY FLOOR : Not available
SUBJECT : Pharmacies: regulation
SOURCE : Board of Pharmacy
CONTINUED
SB 431
Page
2
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prohibits a pharmacist whose California license has been
revoked from dispensing medication to Californians via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.
Assembly Amendments delete the provisions of the bill which
dealt with records pertaining to the return of dangerous
drugs to a wholesaler, reverse distributor, or hazardous
waste hauler, and delete the provision of the bill which
prohibited a revere distributor from accepting dangerous
drugs returned to a pharmacy unless the dangerous drugs
were dispensed in a sealed or tamper-evident package and
there was no evidence that the package was opened, damaged
or otherwise tampered with.
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.
CONTINUED
SB 431
Page
3
"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.
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,
CONTINUED
SB 431
Page
4
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.
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. 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.Requires a pharmacy, within 14 days, report certain
information and evidence about licensees related to
chemical, mental, or physical impairment to the extent it
CONTINUED
SB 431
Page
5
affects his or her ability to practice and theft,
diversion or self-use of dangerous drugs to the Board.
2.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.
3.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.
4.Clarifies that a nonresident pharmacy shall not permit 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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
SUPPORT : (Verified 9/6/11)
Board of Pharmacy (source)
JJA:do 9/8/11 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
**** END ****
CONTINUED
SB 431
Page
6
CONTINUED