SB 294, as amended, Emmerson. Sterile drug products.
(1) 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, commencing July 1, 2014, 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, commencing July 1, 2014, would specify requirements for the board for the issuance or renewal of a license, and requirements for the pharmacy as a licensee. The bill would require the board to adopt regulations to implement these provisions, as specified. 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.
(2) Existing law specifies the fee for issuance or renewal of a nongovernmental license to compound sterile drug products.
This bill, commencing July 1, 2014, would establish the fee for the issuance or renewal of a nonresident sterile compounding pharmacy license in the amount of $780 and would require the applicant to deposit a reasonable amount, as determined by the board, necessary to cover the board’s estimated cost of performing an inspection of the nonresident pharmacy location, as specified.
(3) 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:
The heading of Article 7.5 (commencing with
2Section 4127) of Chapter 9 of Division 2 of the Business and
3Professions Code is amended to read:
4
Section 4127 of the Business and Professions Code is
8amended to read:
(a) The board shall adopt regulations establishing
10standards for compounding injectable sterile drug products in a
11pharmacy.
12(b) The board shall adopt emergency regulations in accordance
13with the Administrative Procedure Act (Chapter 3.5 (commencing
14with Section 11340) of Part 1 of Division 3 of Title 2 of the
15Government Code) to establish policies, guidelines, and procedures
P3 1to initially implement the provisions of this article that become
2operative on July 1, 2014, including, but not limited to, building
3standards adopted pursuant to Part 2.5 (commencing with Section
418901) of Division 13 of the Health and Safety Code. The initial
5
adoption, amendment, or repeal of a regulation authorized by this
6section is deemed to address an emergency for purposes of Sections
711346.1 and 11346.6 of the Government Code, and the board is
8hereby exempted for that purpose from the requirements of
9subdivision (b) of Section 11346.1 of the Government Code. After
10the initial adoption, amendment, or repeal of an emergency
11regulation pursuant to this section, the boardbegin delete shall notend deletebegin insert mayend insert request
12approval from the Office of Administrative Law to readopt the
13regulation as an emergency regulation pursuant to Section 11346.1
14of the Government Code.
15(c) This section shall become inoperative on July 1,
2014, and,
16as of January 1, 2015, is repealed, unless a later enacted statute,
17that becomes operative on or before January 1, 2015, deletes or
18extends the dates on which it becomes inoperative and is repealed.
Section 4127 is added to the Business and Professions
20Code, to read:
(a) A pharmacy that compounds sterile drug products
22for injection, administration into the eye, or inhalation shall possess
23a sterile compounding pharmacy license as provided in this article.
24(b) The board shall adopt regulations in accordance with the
25Administrative Procedure Act (Chapter 3.5 (commencing with
26Section 11340) of Part 1 of Division 3 of Title 2 of the Government
27Code) to establish policies, guidelines, and procedures to
28implement this article, including, but not limited to, building
29standards adopted pursuant to Part 2.5 (commencing with Section
3018901) of Division 13 of the Health and Safety Code.
31(c) This section shall become operative on July 1, 2014.
Section 4127.1 of the Business and Professions Code
33 is amended to read:
(a) A pharmacy shall not compound injectable sterile
35drug products in this state unless the pharmacy has obtained a
36license from the board pursuant to this section. The license shall
37be renewed annually and is not transferable.
38(b) A license to compound injectable sterile drug products may
39only be issued for a location that is licensed as a pharmacy.
40Furthermore, the license to compound injectable sterile drug
P4 1products may only be issued to the owner of the pharmacy license
2at that location. A license to compound injectable sterile drug
3products may not be issued until the location is inspected by the
4board and found in compliance with this article and regulations
5adopted by the
board.
6(c) A license to compound injectable sterile drug products may
7not be renewed until the location has been inspected by the board
8and found to be in compliance with this article and regulations
9adopted by the board.
10(d) Pharmacies operated by entities that are licensed by either
11the board or the State Department of Public Health and that have
12current accreditation from the Joint Commission on Accreditation
13of Healthcare Organizations, or other private accreditation agencies
14approved by the board, are exempt from the requirement to obtain
15a license pursuant to this section.
16(e) The reconstitution of a sterile powder shall not require a
17license pursuant to this section if both of the following are met:
18(1) The sterile powder was obtained from a manufacturer.
19(2) The drug is reconstituted for administration to patients by
20a health care professional licensed to administer drugs by injection
21pursuant to this division.
22(f) This section shall become inoperative on July 1, 2014, and,
23as of January 1, 2015, is repealed, unless a later enacted statute,
24that becomes operative on or before January 1, 2015, deletes or
25extends the dates on which it becomes inoperative and is repealed.
Section 4127.1 is added to the Business and Professions
27Code, to read:
(a) A pharmacy shall not compound sterile drug
29products unless the pharmacy has obtained a sterile compounding
30pharmacy license from the board pursuant to this section. The
31license shall be renewed annually and is not transferable.
32(b) A license to compound sterile drug products shall be issued
33only to a location that is licensed as a pharmacy and shall be issued
34only to the owner of the pharmacy licensed at that location.
35(c) A license to compound sterile drug products shall not be
36issued or renewed until the location is inspected by the board and
37found in compliance with this article and regulations adopted by
38
the board.
39(d) A license to compound sterile drug products shall not be
40issued or renewed until the board does all of the following:
P5 1(1) Reviews a current copy of the pharmacy’s policies and
2procedures for sterile compounding.
3(2) Reviews the pharmacy’s completed self-assessment form
4required by Section 1735.2 of Title 16 of the California Code of
5Regulations.
6(3) Is provided with copies of all inspection reports conducted
7of the pharmacy’s premises, and any reports from a private
8accrediting agency, conducted in the prior 12 months documenting
9the pharmacy’s operations.
10(4) Receives a
list of all sterile medications compounded by the
11pharmacy since the last license renewal.
12(e) A pharmacy licensed pursuant to this section shall do all of
13the following:
14(1) Provide to the board a copy of any disciplinary or other
15action taken by another state within 10 days of the action.
16(2) Notify the board within 10 days of the suspension of any
17accreditation held by the pharmacy.
18(3) Provide to the board, within 12 hours, any recall notice
19issued by the pharmacy for sterile drug products it has
20compounded.
21(f) Adverse effects reported or potentially attributable to a
22pharmacy’s sterile
drug product shall be immediately reported to
23the board and the MedWatch program of the federal Food and
24Drug Administration.
25(g) The reconstitution of a sterile powder shall not require a
26license pursuant to this section if both of the following
27requirements are met:
28(1) The sterile powder was obtained from a manufacturer.
29(2) The drug is reconstituted for administration to patients by
30a health care professional licensed to administer drugs by injection
31pursuant to this division.
32(h) This section shall become operative on July 1, 2014.
Section 4127.2 of the Business and Professions Code
34 is amended to read:
(a) A nonresident pharmacy shall not compound
36injectable sterile drug products for shipment into the State of
37California without a license issued by the board pursuant to this
38section. The license shall be renewed annually and shall not be
39transferable.
P6 1(b) A license to compound injectable sterile drug products may
2only be issued for a location that is licensed as a nonresident
3pharmacy. Furthermore, the license to compound injectable sterile
4drug products may only be issued to the owner of the nonresident
5pharmacy license at that location. A license to compound injectable
6sterile drug products may not be issued or renewed until the board
7receives
the following from the nonresident pharmacy:
8(1) A copy of an inspection report issued by the pharmacy’s
9licensing agency, or a report from a private accrediting agency
10approved by the board, in the prior 12 months documenting the
11pharmacy’s compliance with board regulations regarding the
12compounding of injectable sterile drug products.
13(2) A copy of the nonresident pharmacy’s proposed policies
14and procedures for sterile compounding.
15(c) Nonresident pharmacies operated by entities that are licensed
16as a hospital, home health agency, or a skilled nursing facility and
17have current accreditation from the Joint Commission on
18Accreditation of Healthcare Organizations, or other private
19accreditation agencies approved by the
board, are exempt from
20the requirement to obtain a license pursuant to this section.
21(d) This section shall become inoperative on July 1, 2014, and,
22as of January 1, 2015, is repealed, unless a later enacted statute,
23that becomes operative on or before January 1, 2015, deletes or
24extends the dates on which it becomes inoperative and is repealed.
Section 4127.2 is added to the Business and Professions
26Code, to read:
(a) A nonresident pharmacy shall not compound sterile
28drug products for shipment into this state without a sterile
29compounding pharmacy license issued by the board pursuant to
30this section. The license shall be renewed annually and shall not
31be transferable.
32(b) A license to compound sterile drug products shall be issued
33only to a location that is licensed as a nonresident pharmacy and
34shall be issued only to the owner of the nonresident pharmacy
35licensed at that location.
36(c) A license to compound sterile drug products shall not be
37issued or renewed until the location is inspected by the board and
38found
in compliance with this article and any regulations adopted
39by the board. The nonresident pharmacy shall reimburse the board
40for all actual and necessary costs incurred by the board in
P7 1conducting an inspection of the pharmacy at least once annually
2pursuant to subdivision (v) of Section 4400.
3(d) A license to compound sterile drug products shall not be
4issued or renewed until the board does all of the following:
5(1) Reviews a current copy of the nonresident pharmacy’s
6policies and procedures for sterile compounding.
7(2) Reviews the pharmacy’s completed self-assessment form
8required by Section 1735.2 of Title 16 of the California Code of
9Regulations.
10(3) Is
provided with copies of all inspection reports conducted
11of the nonresident pharmacy’s premises, and any reports from a
12private accrediting agency, conducted in the prior 12 months
13documenting the nonresident pharmacy’s operations.
14(4) Receives a list of all sterile drug products compounded by
15the pharmacy within the prior 12 months.
16(e) A pharmacy licensed pursuant to this section shall do all of
17the following:
18(1) Provide to the board a copy of any disciplinary or other
19action taken by its state of residence or another state within 10
20days of the action.
21(2) Notify the board within 10 days of the suspension of any
22accreditation held by the pharmacy.
23(3) Provide to the board, within 12 hours, any recall notice
24issued by the pharmacy for sterile drug products it has compounded
25that have been shipped into, or dispensed in, California.
26(4) Advise the board of any complaint it receives from a
27provider, pharmacy, or patient in California.
28(f) Adverse effects reported or potentially attributable to a
29nonresident pharmacy’s sterile compounded drug product shall be
30immediately reported to the board and the MedWatch program of
31the federal Food and Drug Administration.
32(g) This section shall become operative on July 1, 2014.
Section 4400 of the Business and Professions Code is
34amended to read:
The amount of fees and penalties prescribed by this
36chapter, except as otherwise provided, is that fixed by the board
37according to the following schedule:
38(a) The fee for a nongovernmental pharmacy license shall be
39four hundred dollars ($400) and may be increased to five hundred
40twenty dollars ($520). The fee for the issuance of a temporary
P8 1nongovernmental pharmacy permit shall be two hundred fifty
2dollars ($250) and may be increased to three hundred twenty-five
3dollars ($325).
4(b) The fee for a nongovernmental pharmacy license annual
5renewal shall be two hundred fifty dollars ($250) and may be
6increased to three hundred twenty-five dollars
($325).
7(c) The fee for the pharmacist application and examination shall
8be two hundred dollars ($200) and may be increased to two
9hundred sixty dollars ($260).
10(d) The fee for regrading an examination shall be ninety dollars
11($90) and may be increased to one hundred fifteen dollars ($115).
12If an error in grading is found and the applicant passes the
13examination, the regrading fee shall be refunded.
14(e) The fee for a pharmacist license and biennial renewal shall
15be one hundred fifty dollars ($150) and may be increased to one
16hundred ninety-five dollars ($195).
17(f) The fee for a nongovernmental wholesaler license and annual
18renewal shall be six hundred dollars
($600), and may be increased
19to seven hundred eighty dollars ($780). The application fee for
20any additional location after licensure of the first 20 locations shall
21be two hundred twenty-five dollars ($225) and may be increased
22to three hundred dollars ($300). A temporary license fee shall be
23five hundred fifty dollars ($550) and may be increased to seven
24hundred fifteen dollars ($715).
25(g) The fee for a hypodermic license and renewal shall be one
26hundred twenty-five dollars ($125) and may be increased to one
27hundred sixty-five dollars ($165).
28(h) (1) The fee for application, investigation, and issuance of
29license as a designated representative pursuant to Section 4053
30shall be two hundred fifty-five dollars ($255) and may be increased
31to three hundred
thirty dollars ($330).
32(2) The fee for the annual renewal of a license as a designated
33representative shall be one hundred fifty dollars ($150) and may
34be increased to one hundred ninety-five dollars ($195).
35(i) (1) The fee for the application, investigation, and issuance
36of a license as a designated representative for a veterinary
37food-animal drug retailer pursuant to Section 4053 shall be two
38hundred fifty-five dollars ($255) and may be increased to three
39hundred thirty dollars ($330).
P9 1(2) The fee for the annual renewal of a license as a designated
2representative for a veterinary food-animal drug retailer shall be
3one hundred fifty dollars ($150) and may be increased to one
4hundred ninety-five
dollars ($195).
5(j) (1) The application fee for a nonresident wholesaler’s license
6issued pursuant to Section 4161 shall be six hundred dollars ($600)
7and may be increased to seven hundred eighty dollars ($780).
8(2) For nonresident wholesalers who have 21 or more facilities
9operating nationwide the application fees for the first 20 locations
10shall be six hundred dollars ($600) and may be increased to seven
11hundred eighty dollars ($780). The application fee for any
12additional location after licensure of the first 20 locations shall be
13two hundred twenty-five dollars ($225) and may be increased to
14three hundred dollars ($300). A temporary license fee shall be five
15hundred fifty dollars ($550) and may be increased to seven hundred
16fifteen dollars ($715).
17(3) The annual renewal fee for a nonresident wholesaler’s license
18issued pursuant to Section 4161 shall be six hundred dollars ($600)
19and may be increased to seven hundred eighty dollars ($780).
20(k) The fee for evaluation of continuing education courses for
21accreditation shall be set by the board at an amount not to exceed
22forty dollars ($40) per course hour.
23(l) The fee for an intern pharmacist license shall be ninety dollars
24($90) and may be increased to one hundred fifteen dollars ($115).
25The fee for transfer of intern hours or verification of licensure to
26another state shall be twenty-five dollars ($25) and may be
27increased to thirty dollars ($30).
28(m) The
board may waive or refund the additional fee for the
29issuance of a license where the license is issued less than 45 days
30before the next regular renewal date.
31(n) The fee for the reissuance of any license, or renewal thereof,
32that has been lost or destroyed or reissued due to a name change
33shall be thirty-five dollars ($35) and may be increased to forty-five
34dollars ($45).
35(o) The fee for the reissuance of any license, or renewal thereof,
36
that must be reissued because of a change in the information, shall
37be one hundred dollars ($100) and may be increased to one hundred
38thirty dollars ($130).
39(p) It is the intent of the Legislature that, in setting fees pursuant
40to this section, the board shall seek to maintain a reserve in the
P10 1Pharmacy Board Contingent Fund equal to approximately one
2year’s operating expenditures.
3(q) The fee for any applicant for a nongovernmental clinic
4license shall be four hundred dollars ($400) and may be increased
5to five hundred twenty dollars ($520) for each license. The annual
6fee for renewal of the license shall be two hundred fifty dollars
7($250) and may be increased to three hundred twenty-five dollars
8($325) for each license.
9(r) The fee for the issuance of a pharmacy technician license
10shall be eighty dollars ($80) and may be increased to one hundred
11five dollars ($105). The fee for renewal of a pharmacy technician
12license shall be one hundred dollars ($100) and may be increased
13to one hundred thirty dollars ($130).
14(s) The fee for a veterinary food-animal drug retailer license
15shall be four hundred five dollars ($405) and may be increased to
16four hundred twenty-five dollars ($425). The annual renewal fee
17for a veterinary food-animal drug retailer license shall be two
18hundred fifty dollars ($250) and may be increased to three hundred
19twenty-five dollars ($325).
20(t) The fee for issuance of a retired license pursuant to Section
214200.5 shall be thirty-five dollars ($35) and may be increased to
22forty-five
dollars ($45).
23(u) The fee for issuance or renewal of a nongovernmental license
24to compound sterile drug products shall be six hundred dollars
25($600) and may be increased to seven hundred eighty dollars
26($780). The fee for a temporary license shall be five hundred fifty
27dollars ($550) and may be increased to seven hundred fifteen
28dollars ($715).
29(v) This section shall become inoperative on July 1, 2014, and,
30as of January 1, 2015, is repealed, unless a later enacted statute,
31that becomes operative on or before January 1, 2015, deletes or
32extends the dates on which it becomes inoperative and is repealed.
Section 4400 is added to the Business and Professions
34Code, to read:
The amount of fees and penalties prescribed by this
36chapter, except as otherwise provided, is that fixed by the board
37according to the following schedule:
38(a) The fee for a nongovernmental pharmacy license shall be
39four hundred dollars ($400) and may be increased to five hundred
40twenty dollars ($520). The fee for the issuance of a temporary
P11 1nongovernmental pharmacy permit shall be two hundred fifty
2dollars ($250) and may be increased to three hundred twenty-five
3dollars ($325).
4(b) The fee for a nongovernmental pharmacy license annual
5renewal shall be two hundred fifty dollars ($250) and may be
6increased to three hundred
twenty-five dollars ($325).
7(c) The fee for the pharmacist application and examination shall
8be two hundred dollars ($200) and may be increased to two
9hundred sixty dollars ($260).
10(d) The fee for regrading an examination shall be ninety dollars
11($90) and may be increased to one hundred fifteen dollars ($115).
12If an error in grading is found and the applicant passes the
13examination, the regrading fee shall be refunded.
14(e) The fee for a pharmacist license and biennial renewal shall
15be one hundred fifty dollars ($150) and may be increased to one
16hundred ninety-five dollars ($195).
17(f) The fee for a nongovernmental wholesaler license and annual
18renewal shall be
six hundred dollars ($600), and may be increased
19to seven hundred eighty dollars ($780). The application fee for
20any additional location after licensure of the first 20 locations shall
21be two hundred twenty-five dollars ($225) and may be increased
22to three hundred dollars ($300). A temporary license fee shall be
23five hundred fifty dollars ($550) and may be increased to seven
24hundred fifteen dollars ($715).
25(g) The fee for a hypodermic license and renewal shall be one
26hundred twenty-five dollars ($125) and may be increased to one
27hundred sixty-five dollars ($165).
28(h) (1) The fee for application, investigation, and issuance of
29license as a designated representative pursuant to Section 4053
30shall be two hundred fifty-five dollars ($255) and may be increased
31to
three hundred thirty dollars ($330).
32(2) The fee for the annual renewal of a license as a designated
33representative shall be one hundred fifty dollars ($150) and may
34be increased to one hundred ninety-five dollars ($195).
35(i) (1) The fee for the application, investigation, and issuance
36of a license as a designated representative for a veterinary
37food-animal drug retailer pursuant to Section 4053 shall be two
38hundred fifty-five dollars ($255) and may be increased to three
39hundred thirty dollars ($330).
P12 1(2) The fee for the annual renewal of a license as a designated
2representative for a veterinary food-animal drug retailer shall be
3one hundred fifty dollars ($150) and may be increased to one
4hundred
ninety-five dollars ($195).
5(j) (1) The application fee for a nonresident wholesaler’s license
6issued pursuant to Section 4161 shall be six hundred dollars ($600)
7and may be increased to seven hundred eighty dollars ($780).
8(2) For nonresident wholesalers who have 21 or more facilities
9operating nationwide the application fees for the first 20 locations
10shall be six hundred dollars ($600) and may be increased to seven
11hundred eighty dollars ($780). The application fee for any
12additional location after licensure of the first 20 locations shall be
13two hundred twenty-five dollars ($225) and may be increased to
14three hundred dollars ($300). A temporary license fee shall be five
15hundred fifty dollars ($550) and may be increased to seven hundred
16fifteen dollars ($715).
17(3) The annual renewal fee for a nonresident wholesaler’s license
18issued pursuant to Section 4161 shall be six hundred dollars ($600)
19and may be increased to seven hundred eighty dollars ($780).
20(k) The fee for evaluation of continuing education courses for
21accreditation shall be set by the board at an amount not to exceed
22forty dollars ($40) per course hour.
23(l) The fee for an intern pharmacist license shall be ninety dollars
24($90) and may be increased to one hundred fifteen dollars ($115).
25The fee for transfer of intern hours or verification of licensure to
26another state shall be twenty-five dollars ($25) and may be
27increased to thirty dollars ($30).
28(m) The
board may waive or refund the additional fee for the
29issuance of a license where the license is issued less than 45 days
30before the next regular renewal date.
31(n) The fee for the reissuance of any license, or renewal thereof,
32that has been lost or destroyed or reissued due to a name change
33shall be thirty-five dollars ($35) and may be increased to forty-five
34dollars ($45).
35(o) The fee for the reissuance of any license, or renewal thereof,
36that must be reissued because of a change in the information, shall
37be one hundred dollars ($100) and may be increased to one hundred
38thirty dollars ($130).
39(p) It is the intent of the Legislature that, in setting fees pursuant
40to this section, the board shall seek to maintain a
reserve in the
P13 1Pharmacy Board Contingent Fund equal to approximately one
2year’s operating expenditures.
3(q) The fee for any applicant for a nongovernmental clinic
4license shall be four hundred dollars ($400) and may be increased
5to five hundred twenty dollars ($520) for each license. The annual
6fee for renewal of the license shall be two hundred fifty dollars
7($250) and may be increased to three hundred twenty-five dollars
8($325) for each license.
9(r) The fee for the issuance of a pharmacy technician license
10shall be eighty dollars ($80) and may be increased to one hundred
11five dollars ($105). The fee for renewal of a pharmacy technician
12license shall be one hundred dollars ($100) and may be increased
13to one hundred thirty dollars ($130).
14(s) The fee for a veterinary food-animal drug retailer license
15shall be four hundred five dollars ($405) and may be increased to
16four hundred twenty-five dollars ($425). The annual renewal fee
17for a veterinary food-animal drug retailer license shall be two
18hundred fifty dollars ($250) and may be increased to three hundred
19twenty-five dollars ($325).
20(t) The fee for issuance of a retired license pursuant to Section
214200.5 shall be thirty-five dollars ($35) and may be increased to
22forty-five dollars ($45).
23(u) The fee for issuance or renewal of a nongovernmental sterile
24compounding pharmacy license shall be six hundred dollars ($600)
25and may be increased to seven hundred eighty dollars ($780). The
26fee for a temporary license shall be five hundred fifty dollars ($550)
27and
may be increased to seven hundred fifteen dollars ($715).
28(v) The fee for the issuance or renewal of a nonresident sterile
29compounding pharmacy license shall be seven hundred eighty
30dollars ($780). In addition to paying
that application fee, the
31nonresident sterile compounding pharmacy shall deposit, when
32submitting the application, a reasonable amount, as determined by
33the board, necessary to cover the board’s estimated cost of
34performing the inspection required by Section 4127.2. If the
35required deposit is not submitted with the application, the
36application shall be deemed to be incomplete. If the actual cost of
37the inspection exceeds the amount deposited, the board shall
38provide to the applicant a written invoice for the remaining amount
39and shall not take action on the application until the full amount
40has been paid to the board. If the amount deposited exceeds the
P14 1amount of actual and necessary costs incurred, the board shall
2remit the difference to the applicant.
3(w) This section shall become operative on July 1, 2014.
No reimbursement is required by this act pursuant to
5Section 6 of Article XIII B of the California Constitution because
6the only costs that may be incurred by a local agency or school
7district will be incurred because this act creates a new crime or
8infraction, eliminates a crime or infraction, or changes the penalty
9for a crime or infraction, within the meaning of Section 17556 of
10the Government Code, or changes the definition of a crime within
11the meaning of Section 6 of Article XIII B of the California
12Constitution.
O
96