BILL NUMBER: SB 294 INTRODUCED
BILL TEXT
INTRODUCED BY Senator Emmerson
FEBRUARY 15, 2013
An act to amend Sections 4127.1, 4127.2, and 4400 of, to amend the
heading of Article 7.5 (commencing with Section 4127) of Chapter 9
of Division 2 of, and to repeal and add Section 4127 of, the Business
and Professions Code, relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
SB 294, as introduced, Emmerson. Sterile drug products.
The Pharmacy Law provides for the licensure and regulation of
pharmacists and pharmacy corporations in this state by the California
State Board of Pharmacy. Existing law requires the board to adopt
regulations establishing standards for compounding injectable sterile
drug products in a pharmacy. Existing law requires pharmacies to
obtain a license from the board, subject to annual renewal, in order
to compound injectable sterile drug products. A similar licensing
requirement applies to nonresident pharmacies compounding injectable
sterile drug products for shipment into California. A violation of
the Pharmacy Law is a crime.
This bill would expand these provisions to prohibit a pharmacy
from compounding or dispensing, and a nonresident pharmacy from
compounding for shipment into this state, sterile drug products for
injection, administration into the eye, or inhalation, unless the
pharmacy has obtained a sterile compounding pharmacy license from the
board. The bill would specify requirements for the board for
issuance or renewal of a license, and requirements for the pharmacy
as a licensee. By adding additional requirements to the Pharmacy Law
concerning sterile drug products, the violation of which is a crime,
the bill would impose a state-mandated local program.
Existing law specifies the fee for issuance or renewal of a
nongovernmental license to compound sterile drug products.
This bill would provide that the fee for a nonresident sterile
compounding pharmacy license shall also require payment of the travel
expenses incurred by the board in inspecting the pharmacy at least
once annually.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The heading of Article 7.5 (commencing with Section
4127) of Chapter 9 of Division 2 of the Business and Professions Code
is amended to read:
Article 7.5. Injectable Sterile Drug
Products
SEC. 2. Section 4127 of the Business and Professions Code is
repealed.
4127. The board shall adopt regulations establishing standards
for compounding injectable sterile drug products in a pharmacy.
SEC. 3. Section 4127 is added to the Business and Professions
Code, to read:
4127. A pharmacy that compounds sterile drug products for
injection, administration into the eye, or inhalation shall possess a
sterile compounding pharmacy license as provided in this article
before dispensing the compounded medication.
SEC. 4. Section 4127.1 of the Business and Professions Code is
amended to read:
4127.1. (a) A pharmacy shall not compound injectable
sterile drug products in this state
unless the pharmacy has obtained a sterile compounding pharmacy
license from the board pursuant to this section. The license
shall be renewed annually and is not transferable.
(b) A license to compound injectable sterile
drug products may only shall be issued
for only to a location that is licensed
as a pharmacy. Furthermore, the license to compound
injectable sterile drug products may only
shall be issued only to the owner of
the pharmacy license licensed at that
location. A license to compound injectable sterile
drug products may shall not be issued
until the location is inspected by the board and found in compliance
with this article and regulations adopted by the board.
(c) A license to compound injectable sterile
drug products may shall not be
issued or renewed until the location has been
inspected by the board and found to be in compliance with this
article and regulations adopted by the board. board
does all of the following:
(d) Pharmacies operated by entities that are licensed by either
the board or the State Department of Public Health and that have
current accreditation from the Joint Commission on Accreditation of
Healthcare Organizations, or other private accreditation agencies
approved by the board, are exempt from the requirement to obtain a
license pursuant to this section.
(1) Performs an onsite inspection of the premises, and any
deficiencies noted are corrected.
(2) Reviews a current copy of the pharmacy's policies and
procedures for sterile compounding.
(3) Reviews the pharmacy's completed self-assessment form required
by Section 1735.2 of Title 16 of the California Code of Regulations.
(4) Is provided with copies of all inspection reports conducted of
the pharmacy's premises, and any reports from a private accrediting
agency, conducted in the prior 12 months documenting the pharmacy's
operations.
(5) Receives a list of all sterile medications compounded by the
pharmacy since the last license renewal.
(d) A pharmacy licensed pursuant to this section shall do all of
the following:
(1) Provide to the board a copy of any disciplinary or other
action taken by another state within 10 days of the action.
(2) Notify the board within 10 days of the suspension of any
accreditation held by the pharmacy.
(3) Provide to the board, within 24 hours, any recall notice
issued by the pharmacy for sterile drug products it has compounded.
(e) Adverse effects reported or potentially attributable to a
pharmacy's sterile drug product shall be immediately reported to the
board and the MedWatch program of the federal Food and Drug
Administration.
(e)
(f) The reconstitution of a sterile powder shall not
require a license pursuant to this section if both of the following
are met:
(1) The sterile powder was obtained from a manufacturer.
(2) The drug is reconstituted for administration to patients by a
health care professional licensed to administer drugs by injection
pursuant to this division.
SEC. 5. Section 4127.2 of the Business and Professions Code is
amended to read:
4127.2. (a) A nonresident pharmacy may
shall not compound injectable sterile drug
products for shipment into the State of California
this state without a sterile compounding pharmacy
license issued by the board pursuant to this section. The
license shall be renewed annually and shall not be transferable.
(b) A license to compound injectable sterile
drug products may only shall be issued
for only to a location that is licensed
as a nonresident pharmacy. Furthermore, the license to compound
injectable sterile drug products may only
shall be issued only to the owner of
the nonresident pharmacy license licensed
at that location. A license to compound injectable
sterile drug products may shall
not be issued or renewed until the board receives the
following from the nonresident pharmacy: until the
location is inspected by the board and found in compliance with this
article and any regulations adopted by the board.
(1) A copy of an inspection report issued by the pharmacy's
licensing agency, or a report from a private accrediting agency
approved by the board, in the prior 12 months documenting the
pharmacy's compliance with board regulations regarding the
compounding of injectable sterile drug products.
(2) A copy of the nonresident pharmacy's proposed policies and
procedures for sterile compounding.
(c) Nonresident pharmacies operated by entities that are licensed
as a hospital, home health agency, or a skilled nursing facility and
have current accreditation from the Joint Commission on Accreditation
of Healthcare Organizations, or other private accreditation agencies
approved by the board, are exempt from the requirement to obtain a
license pursuant to this section.
(d) This section shall become effective on the earlier of July 1,
2003, or the effective date of regulations adopted by the board
pursuant to Section 4127.
(c) A license to compound sterile drug products shall not be
issued or renewed until the board does all of the following:
(1) Performs an onsite inspection of the premises, and any
deficiencies noted are corrected. The nonresident pharmacy shall be
responsible for payment of reasonable travel expenses incurred by the
board in connection with inspecting the pharmacy at least once
annually pursuant to subdivision (v) of Section 4400.
(2) Reviews a current copy of the nonresident pharmacy's policies
and procedures for sterile compounding.
(3) Reviews the pharmacy's completed self-assessment form required
by Section 1735.2 of Title 16 of the California Code of Regulations.
(4) Is provided with copies of all inspection reports conducted of
the nonresident pharmacy's premises, and any reports from a private
accrediting agency, conducted in the prior 12 months documenting the
nonresident pharmacy's operations.
(5) Receives a list of all sterile drug products compounded by the
pharmacy within the prior 12 months.
(d) A pharmacy licensed pursuant to this section shall do all of
the following:
(1) Provide to the board a copy of any disciplinary or other
action taken by its state of residence or another state within 10
days of the action.
(2) Notify the board within 10 days of the suspension of any
accreditation held by the pharmacy.
(3) Provide to the board, within 24 hours, any recall notice
issued by the pharmacy for sterile drug products it has compounded
that have been shipped into, or dispensed in, California.
(4) Advise the board of any complaint it receives from a provider,
pharmacy, or patient in California.
(e) Adverse effects reported or potentially attributable to a
nonresident pharmacy's sterile compounded drug products shall be
immediately reported to the board and the MedWatch program of the
federal Food and Drug Administration.
SEC. 6. Section 4400 of the Business and Professions Code is
amended to read:
4400. The amount of fees and penalties prescribed by this
chapter, except as otherwise provided, is that fixed by the board
according to the following schedule:
(a) The fee for a nongovernmental pharmacy license shall be four
hundred dollars ($400) and may be increased to five hundred twenty
dollars ($520). The fee for the issuance of a temporary
nongovernmental pharmacy permit shall be two hundred fifty dollars
($250) and may be increased to three hundred twenty-five dollars
($325).
(b) The fee for a nongovernmental pharmacy license annual renewal
shall be two hundred fifty dollars ($250) and may be increased to
three hundred twenty-five dollars ($325).
(c) The fee for the pharmacist application and examination shall
be two hundred dollars ($200) and may be increased to two hundred
sixty dollars ($260).
(d) The fee for regrading an examination shall be ninety dollars
($90) and may be increased to one hundred fifteen dollars ($115). If
an error in grading is found and the applicant passes the
examination, the regrading fee shall be refunded.
(e) The fee for a pharmacist license and biennial renewal shall be
one hundred fifty dollars ($150) and may be increased to one hundred
ninety-five dollars ($195).
(f) The fee for a nongovernmental wholesaler license and annual
renewal shall be six hundred dollars ($600), and may be increased to
seven hundred eighty dollars ($780). The application fee for any
additional location after licensure of the first 20 locations shall
be two hundred twenty-five dollars ($225) and may be increased to
three hundred dollars ($300). A temporary license fee shall be five
hundred fifty dollars ($550) and may be increased to seven hundred
fifteen dollars ($715).
(g) The fee for a hypodermic license and renewal shall be one
hundred twenty-five dollars ($125) and may be increased to one
hundred sixty-five dollars ($165).
(h) (1) The fee for application, investigation, and issuance of
license as a designated representative pursuant to Section 4053 shall
be two hundred fifty-five dollars ($255) and may be increased to
three hundred thirty dollars ($330).
(2) The fee for the annual renewal of a license as a designated
representative shall be one hundred fifty dollars ($150) and may be
increased to one hundred ninety-five dollars ($195).
(i) (1) The fee for the application, investigation, and issuance
of a license as a designated representative for a veterinary
food-animal drug retailer pursuant to Section 4053 shall be two
hundred fifty-five dollars ($255) and may be increased to three
hundred thirty dollars ($330).
(2) The fee for the annual renewal of a license as a designated
representative for a veterinary food-animal drug retailer shall be
one hundred fifty dollars ($150) and may be increased to one hundred
ninety-five dollars ($195).
(j) (1) The application fee for a nonresident wholesaler's license
issued pursuant to Section 4161 shall be six hundred dollars ($600)
and may be increased to seven hundred eighty dollars ($780).
(2) For nonresident wholesalers who have 21 or more facilities
operating nationwide the application fees for the first 20 locations
shall be six hundred dollars ($600) and may be increased to seven
hundred eighty dollars ($780). The application fee for any additional
location after licensure of the first 20 locations shall be two
hundred twenty-five dollars ($225) and may be increased to three
hundred dollars ($300). A temporary license fee shall be five hundred
fifty dollars ($550) and may be increased to seven hundred fifteen
dollars ($715).
(3) The annual renewal fee for a nonresident wholesaler's license
issued pursuant to Section 4161 shall be six hundred dollars ($600)
and may be increased to seven hundred eighty dollars ($780).
(k) The fee for evaluation of continuing education courses for
accreditation shall be set by the board at an amount not to exceed
forty dollars ($40) per course hour.
(l) The fee for an intern pharmacist license shall be ninety
dollars ($90) and may be increased to one hundred fifteen dollars
($115). The fee for transfer of intern hours or verification of
licensure to another state shall be twenty-five dollars ($25) and may
be increased to thirty dollars ($30).
(m) The board may waive or refund the additional fee for the
issuance of a license where the license is issued less than 45 days
before the next regular renewal date.
(n) The fee for the reissuance of any license, or renewal thereof,
that has been lost or destroyed or reissued due to a name change
shall be thirty-five dollars ($35) and may be increased to forty-five
dollars ($45).
(o) The fee for the reissuance of any license, or renewal thereof,
that must be reissued because of a change in the information, shall
be one hundred dollars ($100) and may be increased to one hundred
thirty dollars ($130).
(p) It is the intent of the Legislature that, in setting fees
pursuant to this section, the board shall seek to maintain a reserve
in the Pharmacy Board Contingent Fund equal to approximately one year'
s operating expenditures.
(q) The fee for any applicant for a nongovernmental clinic license
shall be four hundred dollars ($400) and may be increased to five
hundred twenty dollars ($520) for each license. The annual fee for
renewal of the license shall be two hundred fifty dollars ($250) and
may be increased to three hundred twenty-five dollars ($325) for each
license.
(r) The fee for the issuance of a pharmacy technician license
shall be eighty dollars ($80) and may be increased to one hundred
five dollars ($105). The fee for renewal of a pharmacy technician
license shall be one hundred dollars ($100) and may be increased to
one hundred thirty dollars ($130).
(s) The fee for a veterinary food-animal drug retailer license
shall be four hundred five dollars ($405) and may be increased to
four hundred twenty-five dollars ($425). The annual renewal fee for a
veterinary food-animal drug retailer license shall be two hundred
fifty dollars ($250) and may be increased to three hundred
twenty-five dollars ($325).
(t) The fee for issuance of a retired license pursuant to Section
4200.5 shall be thirty-five dollars ($35) and may be increased to
forty-five dollars ($45).
(u) The fee for issuance or renewal of a nongovernmental
sterile compounding pharmacy license to compound
sterile drug products shall be six hundred dollars ($600)
and may be increased to seven hundred eighty dollars ($780). The fee
for a temporary license shall be five hundred fifty dollars ($550)
and may be increased to seven hundred fifteen dollars ($715).
(v) The fee for a nonresident sterile compounding pharmacy license
shall also require payment of the travel expenses incurred by the
board in inspecting the pharmacy at least once annually. Failure to
pay this fee within 30 days shall result in the suspension of the
nonresident sterile compounding pharmacy license.
SEC. 7. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.