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 provisionsbegin insert, and, on and after July 1, 2014, to review formal revisions to specified national standards relating to the compounding of sterile preparations to determine whether amendments to those regulations are necessaryend insert, 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.
begin insert(3) The bill would also require the board to report to the Legislature, on or before January 1, 2018, regarding the regulation of nonresident pharmacies, including, among other things, a detailed description of board activities related to the inspection and licensure of nonresident pharmacies.
end insert(3)
end deletebegin insert (4)end insert 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
16to initially implement the provisions of this article that become
17operative on July 1, 2014. The initial adoption, amendment, or
18repeal of a regulation authorized by this section is deemed to
19address an emergency for purposes of Sections 11346.1 and
2011346.6 of the
Government Code, and the board is hereby
21exempted for that purpose from the requirements of subdivision
22(b) of Section 11346.1 of the Government Code. After the initial
23adoption, amendment, or repeal of an emergency regulation
24pursuant to this section, the board may request approval from the
25Office of Administrative Law to readopt the regulation as an
26emergency regulation pursuant to Section 11346.1 of the
27Government Code.
28(c) This section shall become inoperative on July 1, 2014, and,
29as of January 1, 2015, is repealed, unless a later enacted statute,
30that becomes operative on or before January 1, 2015, deletes or
31extends the dates on which it becomes inoperative and is repealed.
Section 4127 is added to the Business and Professions
33Code, to read:
(a) A pharmacy that compounds sterile drug products
35for injection, administration into the eye, or inhalation shall possess
36a sterile compounding pharmacy license as provided in this article.
37(b) The board shall adopt regulations in accordance with the
38Administrative Procedure Act (Chapter 3.5 (commencing with
P4 1Section 11340) of Part 1 of Division 3 of Title 2 of the Government
2Code) to establish policies, guidelines, and procedures to
3implement this article.
4(c) The board shall review any formal revision to General
5Chapter 797 of the United States
Pharmacopeia and The National
6Formulary (USP-NF), relating to the compounding of sterile
7preparations, not later than 90 days after the revision becomes
8official, to determine whether amendments are necessary for the
9regulations adopted by the board pursuant to subdivision (b).
10(c)
end delete11begin insert(d)end insert This section shall become operative on July 1, 2014.
Section 4127.1 of the Business and Professions Code
13 is amended to read:
(a) A pharmacy shall not compound injectable sterile
15drug products in this state unless the pharmacy has obtained a
16license from the board pursuant to this section. The license shall
17be renewed annually and is not transferable.
18(b) A license to compound injectable sterile drug products may
19only be issued for a location that is licensed as a pharmacy.
20Furthermore, the license to compound injectable sterile drug
21products may only be issued to the owner of the pharmacy license
22at that location. A license to compound injectable sterile drug
23products may not be issued until the location is inspected by the
24board and found in compliance with this article and regulations
25adopted by the
board.
26(c) A license to compound injectable sterile drug products may
27not be renewed until the location has been inspected by the board
28and found to be in compliance with this article and regulations
29adopted by the board.
30(d) Pharmacies operated by entities that are licensed by either
31the board or the State Department of Public Health and that have
32current accreditation from the Joint Commission on Accreditation
33of Healthcare Organizations, or other private accreditation agencies
34approved by the board, are exempt from the requirement to obtain
35a license pursuant to this section.
36(e) The reconstitution of a sterile powder shall not require a
37license pursuant to this section if both of the following
38requirements are
met:
39(1) The sterile powder was obtained from a manufacturer.
P5 1(2) The drug is reconstituted for administration to patients by
2a health care professional licensed to administer drugs by injection
3pursuant to this division.
4(f) This section shall become inoperative on July 1, 2014, and,
5as of January 1, 2015, is repealed, unless a later enacted statute,
6that becomes operative on or before January 1, 2015, deletes or
7extends the dates on which it becomes inoperative and is repealed.
Section 4127.1 is added to the Business and Professions
9Code, to read:
(a) A pharmacy shall not compound sterile drug
11products unless the pharmacy has obtained a sterile compounding
12pharmacy license from the board pursuant to this section. The
13license shall be renewed annually and is not transferable.
14(b) A license to compound sterile drug products shall be issued
15only to a location that is licensed as a pharmacy and shall be issued
16only to the owner of the pharmacy licensed at that location.
17(c) A license to compound sterile drug products shall not be
18issued or renewed until the location is inspected by the board and
19found in compliance with this article and regulations adopted by
20
the board.
21(d) A license to compound sterile drug products shall not be
22issued or renewed until the board does all of the following:
23(1) Reviews a current copy of the pharmacy’s policies and
24procedures for sterile compounding.
25(2) Reviews the pharmacy’s completed self-assessment form
26required by Section 1735.2 of Title 16 of the California Code of
27Regulations.
28(3) Is provided with copies of all inspection reports conducted
29of the pharmacy’s premises, and any reports from a private
30accrediting agency, conducted in the prior 12 months documenting
31the pharmacy’s operations.
32(4) Receives a list of all sterile medications compounded by the
33pharmacy since the last license renewal.
34(e) A pharmacy licensed pursuant to this section shall do all of
35the following:
36(1) Provide to the board a copy of any disciplinary or other
37action taken by another state within 10 days of the action.
38(2) Notify the board within 10 days of the suspension of any
39accreditation held by the pharmacy.
P6 1(3) Provide to the board, within 12 hours, any recall notice
2issued by the pharmacy for sterile drug products it has
3compounded.
4(f) Adverse effects reported or potentially attributable to a
5pharmacy’s
sterile drug product shall be reported to the board
6withinbegin delete 24end deletebegin insert 12end insert hours and immediately reported to the MedWatch
7program of the federal Food and Drug Administration.
8(g) The reconstitution of a sterile powder shall not require a
9license pursuant to this section if both of the following
10requirements are met:
11(1) The sterile powder was obtained from a manufacturer.
12(2) The drug is reconstituted for administration to patients by
13a health care professional licensed to administer drugs by injection
14pursuant to this division.
15(h) This section shall become operative on July 1, 2014.
Section 4127.2 of the Business and Professions Code
17 is amended to read:
(a) A nonresident pharmacy shall not compound
19injectable sterile drug products for shipment into the State of
20California without a license issued by the board pursuant to this
21section. The license shall be renewed annually and shall not be
22transferable.
23(b) A license to compound injectable sterile drug products may
24only be issued for a location that is licensed as a nonresident
25pharmacy. Furthermore, the license to compound injectable sterile
26drug products may only be issued to the owner of the nonresident
27pharmacy license at that location. A license to compound injectable
28sterile drug products may not be issued or renewed until the board
29receives
the following from the nonresident pharmacy:
30(1) A copy of an inspection report issued by the pharmacy’s
31licensing agency, or a report from a private accrediting agency
32approved by the board, in the prior 12 months documenting the
33pharmacy’s compliance with board regulations regarding the
34compounding of injectable sterile drug products.
35(2) A copy of the nonresident pharmacy’s proposed policies
36and procedures for sterile compounding.
37(c) Nonresident pharmacies operated by entities that are licensed
38as a hospital, home health agency, or a skilled nursing facility and
39have current accreditation from the Joint Commission on
40Accreditation of Healthcare Organizations, or other private
P7 1accreditation agencies approved by the
board, are exempt from
2the requirement to obtain a license pursuant to this section.
3(d) On or before January 1, 2018, the board shall provide a
4report to the Legislature regarding the regulation of nonresident
5pharmacies. The report shall be submitted to the Legislature in
6the manner required pursuant to Section 9795 of the Government
7Code. At a minimum, the report shall address all of the following:
8(1) A detailed description of board activities related to the
9inspection and licensure of nonresident pharmacies.
10(2) The status of proposed changes to federal law that are under
11serious consideration and that would govern compounding
12pharmacies, including legislation pending before the United States
13Congress, administrative rules, regulations, or orders under
14consideration by the federal Food and Drug Administration or
15other appropriate federal agency, and cases pending before the
16courts.
17(3) If applicable, recommended modifications to the board’s
18statutory duties related to nonresident pharmacies as a result of
19changes to federal law or any additional modifications necessary
20to protect the health and safety of the public.
21(d)
end delete
22begin insert(e)end insert 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 4127.2 is added to the Business and Professions
27Code, to read:
(a) A nonresident pharmacy shall not compound sterile
29drug products for shipment into this state without a sterile
30compounding pharmacy license issued by the board pursuant to
31this section. The license shall be renewed annually and shall not
32be transferable.
33(b) A license to compound sterile drug products shall be issued
34only to a location that is licensed as a nonresident pharmacy and
35shall be issued only to the owner of the nonresident pharmacy
36licensed at that location.
37(c) A license to compound sterile drug products shall not be
38issued or renewed until the location is inspected by the board and
39found
in compliance with this article and any regulations adopted
40by the board. The nonresident pharmacy shall reimburse the board
P8 1for all actual and necessary costs incurred by the board in
2conducting an inspection of the pharmacy at least once annually
3pursuant to subdivision (v) of Section 4400.
4(d) A license to compound sterile drug products shall not be
5issued or renewed until the board does all of the following:
6(1) Reviews a current copy of the nonresident pharmacy’s
7policies and procedures for sterile compounding.
8(2) Reviews the pharmacy’s completed self-assessment form
9required by Section 1735.2 of Title 16 of the California Code of
10Regulations.
11(3) Is
provided with copies of all inspection reports conducted
12of the nonresident pharmacy’s premises, and any reports from a
13private accrediting agency, conducted in the prior 12 months
14documenting the nonresident pharmacy’s operations.
15(4) Receives a list of all sterile drug products compounded by
16the pharmacy within the prior 12 months.
17(e) A pharmacy licensed pursuant to this section shall do all of
18the following:
19(1) Provide to the board a copy of any disciplinary or other
20action taken by its state of residence or another state within 10
21days of the action.
22(2) Notify the board within 10 days of the suspension of any
23accreditation held by the pharmacy.
24(3) Provide to the board, within 12 hours, any recall notice
25issued by the pharmacy for sterile drug products it has compounded
26that have been shipped into, or dispensed in, California.
27(4) Advise the board of any complaint it receives from a
28provider, pharmacy, or patient in California.
29(f) Adverse effects reported or potentially attributable to a
30nonresident pharmacy’s sterile compounded drug product shall be
31reported to the board withinbegin delete 24end deletebegin insert 12end insert hours and immediately reported
32to the MedWatch program of the federal Food and Drug
33Administration.
34(g) On or before January 1, 2018, the board shall provide a
35report to the Legislature regarding the regulation of nonresident
36pharmacies. The report shall be submitted to the Legislature in
37the manner required pursuant to Section 9795 of the Government
38Code. At a minimum, the report shall address all of the following:
39(1) A detailed description of board activities related to the
40inspection and licensure of nonresident pharmacies.
P9 1(2) Whether fee revenue collected pursuant to subdivision (v)
2of Section 4400 and travel cost reimbursements collected pursuant
3to subdivision (c) of this section provide revenue in an amount
4sufficient to support the board’s activities related to the inspection
5and licensure of nonresident pharmacies.
6(3) The status of proposed
changes to federal law that are under
7serious consideration and that would govern compounding
8pharmacies, including legislation pending before the United States
9Congress, administrative rules, regulations, or orders under
10consideration by the federal Food and Drug Administration or
11other appropriate federal agency, and cases pending before the
12courts.
13(4) If applicable, recommended modifications to the board’s
14statutory duties related to nonresident pharmacies as a result of
15changes to federal law or any additional modifications necessary
16to protect the health and safety of the public.
17(h) The requirement for submitting a report imposed under
18subdivision (g) is inoperative on January 1, 2022, pursuant to
19Section 10231.5 of the Government Code.
20(g)
end delete21begin insert(i)end insert This section shall become operative on July 1, 2014.
Section 4400 of the Business and Professions Code is
23amended to read:
The amount of fees and penalties prescribed by this
25chapter, except as otherwise provided, is that fixed by the board
26according to the following schedule:
27(a) The fee for a nongovernmental pharmacy license shall be
28four hundred dollars ($400) and may be increased to five hundred
29twenty dollars ($520). The fee for the issuance of a temporary
30nongovernmental pharmacy permit shall be two hundred fifty
31dollars ($250) and may be increased to three hundred twenty-five
32dollars ($325).
33(b) The fee for a nongovernmental pharmacy license annual
34renewal shall be two hundred fifty dollars ($250) and may be
35increased to three hundred twenty-five dollars
($325).
36(c) The fee for the pharmacist application and examination shall
37be two hundred dollars ($200) and may be increased to two
38hundred sixty dollars ($260).
39(d) The fee for regrading an examination shall be ninety dollars
40($90) and may be increased to one hundred fifteen dollars ($115).
P10 1If an error in grading is found and the applicant passes the
2examination, the regrading fee shall be refunded.
3(e) The fee for a pharmacist license and biennial renewal shall
4be one hundred fifty dollars ($150) and may be increased to one
5hundred ninety-five dollars ($195).
6(f) The fee for a nongovernmental wholesaler license and annual
7renewal shall be six hundred dollars
($600), and may be increased
8to seven hundred eighty dollars ($780). The application fee for
9any additional location after licensure of the first 20 locations shall
10be two hundred twenty-five dollars ($225) and may be increased
11to three hundred dollars ($300). A temporary license fee shall be
12five hundred fifty dollars ($550) and may be increased to seven
13hundred fifteen dollars ($715).
14(g) The fee for a hypodermic license and renewal shall be one
15hundred twenty-five dollars ($125) and may be increased to one
16hundred sixty-five dollars ($165).
17(h) (1) The fee for application, investigation, and issuance of
18license as a designated representative pursuant to Section 4053
19shall be two hundred fifty-five dollars ($255) and may be increased
20to three hundred
thirty dollars ($330).
21(2) The fee for the annual renewal of a license as a designated
22representative shall be one hundred fifty dollars ($150) and may
23be increased to one hundred ninety-five dollars ($195).
24(i) (1) The fee for the application, investigation, and issuance
25of a license as a designated representative for a veterinary
26food-animal drug retailer pursuant to Section 4053 shall be two
27hundred fifty-five dollars ($255) and may be increased to three
28hundred thirty dollars ($330).
29(2) The fee for the annual renewal of a license as a designated
30representative for a veterinary food-animal drug retailer shall be
31one hundred fifty dollars ($150) and may be increased to one
32hundred ninety-five
dollars ($195).
33(j) (1) The application fee for a nonresident wholesaler’s license
34issued pursuant to Section 4161 shall be six hundred dollars ($600)
35and may be increased to seven hundred eighty dollars ($780).
36(2) For nonresident wholesalers who have 21 or more facilities
37operating nationwide the application fees for the first 20 locations
38shall be six hundred dollars ($600) and may be increased to seven
39hundred eighty dollars ($780). The application fee for any
40additional location after licensure of the first 20 locations shall be
P11 1two hundred twenty-five dollars ($225) and may be increased to
2three hundred dollars ($300). A temporary license fee shall be five
3hundred fifty dollars ($550) and may be increased to seven hundred
4fifteen dollars ($715).
5(3) The annual renewal 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(k) The fee for evaluation of continuing education courses for
9accreditation shall be set by the board at an amount not to exceed
10forty dollars ($40) per course hour.
11(l) The fee for an intern pharmacist license shall be ninety dollars
12($90) and may be increased to one hundred fifteen dollars ($115).
13The fee for transfer of intern hours or verification of licensure to
14another state shall be twenty-five dollars ($25) and may be
15increased to thirty dollars ($30).
16(m) The
board may waive or refund the additional fee for the
17issuance of a license where the license is issued less than 45 days
18before the next regular renewal date.
19(n) The fee for the reissuance of any license, or renewal thereof,
20that has been lost or destroyed or reissued due to a name change
21shall be thirty-five dollars ($35) and may be increased to forty-five
22dollars ($45).
23(o) The fee for the reissuance of any license, or renewal thereof,
24that must be reissued because of a change in the information, shall
25be one hundred dollars ($100) and may be increased to one hundred
26thirty dollars ($130).
27(p) It is the intent of the Legislature that, in setting fees pursuant
28to this section, the board shall seek to maintain a
reserve in the
29Pharmacy Board Contingent Fund equal to approximately one
30year’s operating expenditures.
31(q) The fee for any applicant for a nongovernmental clinic
32license shall be four hundred dollars ($400) and may be increased
33to five hundred twenty dollars ($520) for each license. The annual
34fee for renewal of the license shall be two hundred fifty dollars
35($250) and may be increased to three hundred twenty-five dollars
36($325) for each license.
37(r) The fee for the issuance of a pharmacy technician license
38shall be eighty dollars ($80) and may be increased to one hundred
39five dollars ($105). The fee for renewal of a pharmacy technician
P12 1license shall be one hundred dollars ($100) and may be increased
2to one hundred thirty dollars ($130).
3(s) The fee for a veterinary food-animal drug retailer license
4shall be four hundred five dollars ($405) and may be increased to
5four hundred twenty-five dollars ($425). The annual renewal fee
6for a veterinary food-animal drug retailer license shall be two
7hundred fifty dollars ($250) and may be increased to three hundred
8twenty-five dollars ($325).
9(t) The fee for issuance of a retired license pursuant to Section
104200.5 shall be thirty-five dollars ($35) and may be increased to
11forty-five dollars ($45).
12(u) The fee for issuance or renewal of a nongovernmental license
13to compound sterile drug products shall be six hundred dollars
14($600) and may be increased to seven hundred eighty dollars
15($780). The fee for a temporary license shall be five hundred fifty
16dollars
($550) and may be increased to seven hundred fifteen
17dollars ($715).
18(v) This section shall become inoperative on July 1, 2014, and,
19as of January 1, 2015, is repealed, unless a later enacted statute,
20that becomes operative on or before January 1, 2015, deletes or
21extends the dates on which it becomes inoperative and is repealed.
Section 4400 is added to the Business and Professions
23Code, to read:
The amount of fees and penalties prescribed by this
25chapter, except as otherwise provided, is that fixed by the board
26according to the following schedule:
27(a) The fee for a nongovernmental pharmacy license shall be
28four hundred dollars ($400) and may be increased to five hundred
29twenty dollars ($520). The fee for the issuance of a temporary
30nongovernmental pharmacy permit shall be two hundred fifty
31dollars ($250) and may be increased to three hundred twenty-five
32dollars ($325).
33(b) The fee for a nongovernmental pharmacy license annual
34renewal shall be two hundred fifty dollars ($250) and may be
35increased to three hundred
twenty-five dollars ($325).
36(c) The fee for the pharmacist application and examination shall
37be two hundred dollars ($200) and may be increased to two
38hundred sixty dollars ($260).
39(d) The fee for regrading an examination shall be ninety dollars
40($90) and may be increased to one hundred fifteen dollars ($115).
P13 1If an error in grading is found and the applicant passes the
2examination, the regrading fee shall be refunded.
3(e) The fee for a pharmacist license and biennial renewal shall
4be one hundred fifty dollars ($150) and may be increased to one
5hundred ninety-five dollars ($195).
6(f) The fee for a nongovernmental wholesaler license and annual
7renewal shall be
six hundred dollars ($600), and may be increased
8to seven hundred eighty dollars ($780). The application fee for
9any additional location after licensure of the first 20 locations shall
10be two hundred twenty-five dollars ($225) and may be increased
11to three hundred dollars ($300). A temporary license fee shall be
12five hundred fifty dollars ($550) and may be increased to seven
13hundred fifteen dollars ($715).
14(g) The fee for a hypodermic license and renewal shall be one
15hundred twenty-five dollars ($125) and may be increased to one
16hundred sixty-five dollars ($165).
17(h) (1) The fee for application, investigation, and issuance of
18license as a designated representative pursuant to Section 4053
19shall be two hundred fifty-five dollars ($255) and may be increased
20to
three hundred thirty dollars ($330).
21(2) The fee for the annual renewal of a license as a designated
22representative shall be one hundred fifty dollars ($150) and may
23be increased to one hundred ninety-five dollars ($195).
24(i) (1) The fee for the application, investigation, and issuance
25of a license as a designated representative for a veterinary
26food-animal drug retailer pursuant to Section 4053 shall be two
27hundred fifty-five dollars ($255) and may be increased to three
28hundred thirty dollars ($330).
29(2) The fee for the annual renewal of a license as a designated
30representative for a veterinary food-animal drug retailer shall be
31one hundred fifty dollars ($150) and may be increased to one
32hundred
ninety-five dollars ($195).
33(j) (1) The application fee for a nonresident wholesaler’s license
34issued pursuant to Section 4161 shall be six hundred dollars ($600)
35and may be increased to seven hundred eighty dollars ($780).
36(2) For nonresident wholesalers who have 21 or more facilities
37operating nationwide the application fees for the first 20 locations
38shall be six hundred dollars ($600) and may be increased to seven
39hundred eighty dollars ($780). The application fee for any
40additional location after licensure of the first 20 locations shall be
P14 1two hundred twenty-five dollars ($225) and may be increased to
2three hundred dollars ($300). A temporary license fee shall be five
3hundred fifty dollars ($550) and may be increased to seven hundred
4fifteen dollars ($715).
5(3) The annual renewal 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(k) The fee for evaluation of continuing education courses for
9accreditation shall be set by the board at an amount not to exceed
10forty dollars ($40) per course hour.
11(l) The fee for an intern pharmacist license shall be ninety dollars
12($90) and may be increased to one hundred fifteen dollars ($115).
13The fee for transfer of intern hours or verification of licensure to
14another state shall be twenty-five dollars ($25) and may be
15increased to thirty dollars ($30).
16(m) The
board may waive or refund the additional fee for the
17issuance of a license where the license is issued less than 45 days
18before the next regular renewal date.
19(n) The fee for the reissuance of any license, or renewal thereof,
20that has been lost or destroyed or reissued due to a name change
21shall be thirty-five dollars ($35) and may be increased to forty-five
22dollars ($45).
23(o) The fee for the reissuance of any license, or renewal thereof,
24that must be reissued because of a change in the information, shall
25be one hundred dollars ($100) and may be increased to one hundred
26thirty dollars ($130).
27(p) It is the intent of the Legislature that, in setting fees pursuant
28to this section, the board shall seek to maintain a
reserve in the
29Pharmacy Board Contingent Fund equal to approximately one
30year’s operating expenditures.
31(q) The fee for any applicant for a nongovernmental clinic
32license shall be four hundred dollars ($400) and may be increased
33to five hundred twenty dollars ($520) for each license. The annual
34fee for renewal of the license shall be two hundred fifty dollars
35($250) and may be increased to three hundred twenty-five dollars
36($325) for each license.
37(r) The fee for the issuance of a pharmacy technician license
38shall be eighty dollars ($80) and may be increased to one hundred
39five dollars ($105). The fee for renewal of a pharmacy technician
P15 1license shall be one hundred dollars ($100) and may be increased
2to one hundred thirty dollars ($130).
3(s) The fee for a veterinary food-animal drug retailer license
4shall be four hundred five dollars ($405) and may be increased to
5four hundred twenty-five dollars ($425). The annual renewal fee
6for a veterinary food-animal drug retailer license shall be two
7hundred fifty dollars ($250) and may be increased to three hundred
8twenty-five dollars ($325).
9(t) The fee for issuance of a retired license pursuant to Section
104200.5 shall be thirty-five dollars ($35) and may be increased to
11forty-five dollars ($45).
12(u) The fee for issuance or renewal of a nongovernmental sterile
13compounding pharmacy license shall be six hundred dollars ($600)
14and may be increased to seven hundred eighty dollars ($780). The
15fee for a temporary license shall be five hundred fifty dollars ($550)
16and
may be increased to seven hundred fifteen dollars ($715).
17(v) The fee for the issuance or renewal of a nonresident sterile
18compounding pharmacy license shall be seven hundred eighty
19dollars ($780). In addition to paying that application fee, the
20nonresident sterile compounding pharmacy shall deposit, when
21submitting the application, a reasonable amount, as determined by
22the board, necessary to cover the board’s estimated cost of
23performing the inspection required by Section 4127.2. If the
24required deposit is not submitted with the application, the
25application shall be deemed to be incomplete. If the actual cost of
26the inspection exceeds the amount deposited, the board shall
27provide to the applicant a written invoice for the remaining amount
28and shall not take action on the application until the full amount
29has been paid to the board. If
the amount deposited exceeds the
30amount of actual and necessary costs incurred, the board shall
31remit the difference to the applicant.
32(w) This section shall become operative on July 1, 2014.
No reimbursement is required by this act pursuant to
34Section 6 of Article XIII B of the California Constitution because
35the only costs that may be incurred by a local agency or school
36district will be incurred because this act creates a new crime or
37infraction, eliminates a crime or infraction, or changes the penalty
38for a crime or infraction, within the meaning of Section 17556 of
39the Government Code, or changes the definition of a crime within
P16 1the meaning of Section 6 of Article XIII B of the California
2Constitution.
O
93