SB 294, as amended, Emmerson. Sterile drug products.
The
end deletebegin insert(1)end insertbegin insert end insertbegin insertTheend insert 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 forbegin insert theend insert 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
end deletebegin insert(2)end insertbegin insert end insertbegin insertExistingend insert law specifies the fee for issuance or renewal of a nongovernmental license to compound sterile drug products.
This bill wouldbegin delete 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 annuallyend deletebegin insert
require the board to establish, by regulation, the fee for the issuance or renewal of a nonresident sterile compounding pharmacy license, in an amount not to exceed the reasonable regulatory costs of issuing and renewing the license, or $2,800, whichever is less. The bill would also require the nonresident sterile compounding pharmacy to reimburse the board for all costs incurred by the board in conducting an inspection of the pharmacy at least once annually, including, but not limited to, travel expenses, meals, lodging, and other actual and necessary costs incurred by the board in connection with the inspection. The failure to reimburse the board for these costs within 30 days of the inspection would result in the suspension of the nonresident sterile compounding pharmacy licenseend insert.
(3) The provisions of the bill would become operative on July 1, 2014.
end insertThe
end deletebegin insert (4)end insertbegin insert end insertbegin insertTheend insert 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:
Section 4127 of the Business and Professions Code is
4repealed.
begin insertSection 4127 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
6amended to read:end insert
begin insert(a)end insertbegin insert end insert The board shall adopt regulations establishing
8standards for compounding injectable sterile drug products in a
9pharmacy.
10(b) This section shall become inoperative on July 1, 2014, and,
11as of January 1, 2015, is repealed, unless a later enacted statute,
12that becomes operative on or before January 1, 2015, deletes or
13extends the dates on which it becomes inoperative and is repealed.
Section 4127 is added to the Business and Professions
15Code, to read:
begin insert(a)end insertbegin insert end insert A pharmacy that compounds sterile drug products
17for injection, administration into the eye, or inhalation shall possess
18a sterile compounding pharmacy license as provided in this article
19before dispensing the compounded medication.
20(b) This section shall become operative on July 1, 2014.
end insertSection 4127.1 of the Business and Professions Code
22 is amended to read:
(a) A pharmacy shall not compound sterile drug
24products unless the pharmacy has obtained a sterile compounding
25pharmacy license from the board pursuant to this section. The
26license shall be renewed annually and is not transferable.
27(b) A license to compound sterile drug products
shall be issued
28only to a location that is licensed as a pharmacy. Furthermore, the
29license to compound sterile drug products shall be issued only to
30the owner of the pharmacy licensed at that location. A license to
31compound sterile drug products shall not be issued until the
32location is inspected by the board and found in compliance with
33this article and regulations adopted by the board.
34(c) A license to compound sterile drug products shall not be
35issued or renewed until the board does all of the following:
36(1) Performs an onsite inspection of the premises, and any
37deficiencies noted are corrected.
38(2) Reviews a current copy of the pharmacy’s policies and
39procedures for sterile compounding.
P4 1(3) Reviews the pharmacy’s completed self-assessment form
2required by Section 1735.2 of Title 16 of the California Code of
3Regulations.
4(4) Is provided with copies of all inspection reports conducted
5of the pharmacy’s premises, and any reports from a private
6accrediting agency, conducted in the prior 12 months documenting
7the pharmacy’s operations.
8(5) Receives a list of all sterile medications compounded by the
9pharmacy since the last license renewal.
10(d) A pharmacy licensed pursuant to this section shall do all of
11the following:
12(1) Provide to the board a copy of any disciplinary or other
13action
taken by another state within 10 days of the action.
14(2) Notify the board within 10 days of the suspension of any
15accreditation held by the pharmacy.
16(3) Provide to the board, within 24 hours, any recall notice
17issued by the pharmacy for sterile drug products it has
18compounded.
19(e) Adverse effects reported or potentially attributable to a
20pharmacy’s sterile drug product shall be immediately reported to
21the board and the MedWatch program of the federal Food and
22Drug Administration.
23(f) The reconstitution of a sterile powder shall not require a
24license pursuant to this section if both of the following are met:
25(1) The sterile powder was obtained from a manufacturer.
26(2) The drug is reconstituted for administration to patients by
27a health care professional licensed to administer drugs by injection
28pursuant to this division.
Section 4127.2 of the Business and Professions Code
30 is amended to read:
(a) A nonresident pharmacy shall not compound sterile
32drug products for shipment into this state without a sterile
33compounding pharmacy license issued by the board pursuant to
34this section. The license shall be renewed annually and shall not
35be transferable.
36(b) A license to compound sterile drug products shall be issued
37only to a location that is licensed as a nonresident pharmacy.
38Furthermore, the license to compound sterile drug products shall
39be issued only to the owner of the nonresident pharmacy licensed
40at that location. A license to compound sterile drug products shall
P5 1not be issued until the location is inspected by
the board and found
2in compliance with this article and any regulations adopted by the
3board.
4(c) A license to compound sterile drug products shall not be
5issued or renewed until the board does all of the following:
6(1) Performs an onsite inspection of the premises, and any
7deficiencies noted are corrected. The nonresident pharmacy shall
8be responsible for payment of reasonable travel expenses incurred
9by the board in connection with inspecting the pharmacy at least
10once annually pursuant to subdivision (v) of Section 4400.
11(2) Reviews a current copy of the nonresident pharmacy’s
12policies and procedures for sterile compounding.
13(3) Reviews the pharmacy’s completed
self-assessment form
14required by Section 1735.2 of Title 16 of the California Code of
15Regulations.
16(4) Is provided with copies of all inspection reports conducted
17of the nonresident pharmacy’s premises, and any reports from a
18private accrediting agency, conducted in the prior 12 months
19documenting the nonresident pharmacy’s operations.
20(5) Receives a list of all sterile drug products compounded by
21the pharmacy within the prior 12 months.
22(d) A pharmacy licensed pursuant to this section shall do all of
23the following:
24(1) Provide to the board a copy of any disciplinary or other
25action taken by its state of residence or another state within 10
26days of
the action.
27(2) Notify the board within 10 days of the suspension of any
28accreditation held by the pharmacy.
29(3) Provide to the board, within 24 hours, any recall notice
30issued by the pharmacy for sterile drug products it has compounded
31that have been shipped into, or dispensed in, California.
32(4) Advise the board of any complaint it receives from a
33provider, pharmacy, or patient in California.
34(e) Adverse effects reported or potentially attributable to a
35nonresident pharmacy’s sterile compounded drug products shall
36be immediately reported to the board and the MedWatch program
37of the federal Food and Drug Administration.
Section 4400 of the Business and Professions Code is
39amended to read:
The amount of fees and penalties prescribed by this
2chapter, except as otherwise provided, is that fixed by the board
3according to the following schedule:
4(a) The fee for a nongovernmental pharmacy license shall be
5four hundred dollars ($400) and may be increased to five hundred
6twenty dollars ($520). The fee for the issuance of a temporary
7nongovernmental pharmacy permit shall be two hundred fifty
8dollars ($250) and may be increased to three hundred twenty-five
9dollars ($325).
10(b) The fee for a nongovernmental pharmacy license annual
11renewal shall be two hundred fifty dollars ($250) and may be
12increased to three hundred twenty-five dollars
($325).
13(c) The fee for the pharmacist application and examination shall
14be two hundred dollars ($200) and may be increased to two
15hundred sixty dollars ($260).
16(d) The fee for regrading an examination shall be ninety dollars
17($90) and may be increased to one hundred fifteen dollars ($115).
18If an error in grading is found and the applicant passes the
19examination, the regrading fee shall be refunded.
20(e) The fee for a pharmacist license and biennial renewal shall
21be one hundred fifty dollars ($150) and may be increased to one
22hundred ninety-five dollars ($195).
23(f) The fee for a nongovernmental wholesaler license and annual
24renewal shall be six hundred dollars
($600), and may be increased
25to seven hundred eighty dollars ($780). The application fee for
26any additional location after licensure of the first 20 locations shall
27be two hundred twenty-five dollars ($225) and may be increased
28to three hundred dollars ($300). A temporary license fee shall be
29five hundred fifty dollars ($550) and may be increased to seven
30hundred fifteen dollars ($715).
31(g) The fee for a hypodermic license and renewal shall be one
32hundred twenty-five dollars ($125) and may be increased to one
33hundred sixty-five dollars ($165).
34(h) (1) The fee for application, investigation, and issuance of
35license as a designated representative pursuant to Section 4053
36shall be two hundred fifty-five dollars ($255) and may be increased
37to three hundred
thirty dollars ($330).
38(2) The fee for the annual renewal of a license as a designated
39representative shall be one hundred fifty dollars ($150) and may
40be increased to one hundred ninety-five dollars ($195).
P7 1(i) (1) The fee for the application, investigation, and issuance
2of a license as a designated representative for a veterinary
3food-animal drug retailer pursuant to Section 4053 shall be two
4hundred fifty-five dollars ($255) and may be increased to three
5hundred thirty dollars ($330).
6(2) The fee for the annual renewal of a license as a designated
7representative for a veterinary food-animal drug retailer shall be
8one hundred fifty dollars ($150) and may be increased to one
9hundred ninety-five dollars
($195).
10(j) (1) The application fee for a nonresident wholesaler’s license
11issued pursuant to Section 4161 shall be six hundred dollars ($600)
12and may be increased to seven hundred eighty dollars ($780).
13(2) For nonresident wholesalers who have 21 or more facilities
14operating nationwide the application fees for the first 20 locations
15shall be six hundred dollars ($600) and may be increased to seven
16hundred eighty dollars ($780). The application fee for any
17additional location after licensure of the first 20 locations shall be
18two hundred twenty-five dollars ($225) and may be increased to
19three hundred dollars ($300). A temporary license fee shall be five
20hundred fifty dollars ($550) and may be increased to seven hundred
21fifteen dollars ($715).
22(3) The annual renewal fee for a nonresident wholesaler’s license
23issued pursuant to Section 4161 shall be six hundred dollars ($600)
24and may be increased to seven hundred eighty dollars ($780).
25(k) The fee for evaluation of continuing education courses for
26accreditation shall be set by the board at an amount not to exceed
27forty dollars ($40) per course hour.
28(l) The fee for an intern pharmacist license shall be ninety dollars
29($90) and may be increased to one hundred fifteen dollars ($115).
30The fee for transfer of intern hours or verification of licensure to
31another state shall be twenty-five dollars ($25) and may be
32increased to thirty dollars ($30).
33(m) The
board may waive or refund the additional fee for the
34issuance of a license where the license is issued less than 45 days
35before the next regular renewal date.
36(n) The fee for the reissuance of any license, or renewal thereof,
37that has been lost or destroyed or reissued due to a name change
38shall be thirty-five dollars ($35) and may be increased to forty-five
39dollars ($45).
P8 1(o) The fee for the reissuance of any license, or renewal thereof,
2
that must be reissued because of a change in the information, shall
3be one hundred dollars ($100) and may be increased to one hundred
4thirty dollars ($130).
5(p) It is the intent of the Legislature that, in setting fees pursuant
6to this section, the board shall seek to maintain a reserve in the
7Pharmacy Board Contingent Fund equal to approximately one
8year’s operating expenditures.
9(q) The fee for any applicant for a nongovernmental clinic
10license shall be four hundred dollars ($400) and may be increased
11to five hundred twenty dollars ($520) for each license. The annual
12fee for renewal of the license shall be two hundred fifty dollars
13($250) and may be increased to three hundred twenty-five dollars
14($325) for each license.
15(r) The fee for the issuance of a pharmacy technician license
16shall be eighty dollars ($80) and may be increased to one hundred
17five dollars ($105). The fee for renewal of a pharmacy technician
18license shall be one hundred dollars ($100) and may be increased
19to one hundred thirty dollars ($130).
20(s) The fee for a veterinary food-animal drug retailer license
21shall be four hundred five dollars ($405) and may be increased to
22four hundred twenty-five dollars ($425). The annual renewal fee
23for a veterinary food-animal drug retailer license shall be two
24hundred fifty dollars ($250) and may be increased to three hundred
25twenty-five dollars ($325).
26(t) The fee for issuance of a retired license pursuant to Section
274200.5 shall be thirty-five dollars ($35) and may be increased to
28forty-five
dollars ($45).
29(u) The fee for issuance or renewal of a nongovernmental sterile
30compounding pharmacy license shall be six hundred dollars ($600)
31and may be increased to seven hundred eighty dollars ($780). The
32fee for a temporary license shall be five hundred fifty dollars ($550)
33and may be increased to seven hundred fifteen dollars ($715).
34(v) The fee for a nonresident sterile compounding pharmacy
35license shall also require payment of the travel expenses incurred
36by the board in inspecting the pharmacy at least once annually.
37Failure to pay this fee within 30 days shall result in the suspension
38of the nonresident sterile compounding pharmacy license.
begin insertSection 4127.1 of the end insertbegin insertBusiness and Professions Codeend insert
40begin insert is amended to read:end insert
(a) A pharmacy shall not compound injectable sterile
2drug products in this state unless the pharmacy has obtained a
3license from the board pursuant to this section. The license shall
4be renewed annually and is not transferable.
5(b) A license to compound injectable sterile drug products may
6only be issued for a location that is licensed as a pharmacy.
7Furthermore, the license to compound injectable sterile drug
8products may only be issued to the owner of the pharmacy license
9at that location. A license to compound injectable sterile drug
10products may not be issued until the location is inspected by the
11board and found in compliance with this article and regulations
12adopted by the board.
13(c) A license to compound injectable sterile drug products may
14not be renewed until the location has been inspected by the
board
15and found to be in compliance with this article and regulations
16adopted by the board.
17(d) Pharmacies operated by entities that are licensed by either
18the board or the State Department of Public Health and that have
19current accreditation from the Joint Commission on Accreditation
20of Healthcare Organizations, or other private accreditation agencies
21approved by the board, are exempt from the requirement to obtain
22a license pursuant to this section.
23(e) The reconstitution of a sterile powder shall not require a
24license pursuant to this section if both of the following are met:
25(1) The sterile powder was obtained from a manufacturer.
26(2) The drug is reconstituted for administration to patients by
27a health care professional licensed to administer drugs by injection
28pursuant to this division.
29(f) 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.
begin insertSection 4127.1 is added to the end insertbegin insertBusiness and Professions
34Codeend insertbegin insert, to read:end insert
(a) A pharmacy shall not compound sterile drug
36products unless the pharmacy has obtained a sterile compounding
37pharmacy license from the board pursuant to this section. The
38license shall be renewed annually and is not transferable.
39(b) A license to compound sterile drug products shall be issued
40only to a location that is licensed as a pharmacy. Furthermore,
P10 1the license to compound sterile drug products shall be issued only
2to the owner of the pharmacy licensed at that location. A license
3to compound sterile drug products shall not be issued until the
4location is inspected by the board and found in compliance with
5this article and regulations adopted by the board.
6(c) A license to compound sterile drug products shall not be
7issued or renewed until the board does all of the following:
8(1) Performs an onsite inspection of the premises, and any
9deficiencies noted are corrected.
10(2) Reviews a current copy of the pharmacy’s policies and
11procedures for sterile compounding.
12(3) Reviews the pharmacy’s completed self-assessment form
13required by Section 1735.2 of Title 16 of the California Code of
14Regulations.
15(4) Is provided with copies of all inspection reports conducted
16of the pharmacy’s premises, and any reports from a private
17accrediting agency, conducted in the prior 12 months documenting
18the pharmacy’s operations.
19(5) Receives a list of all sterile medications compounded by the
20pharmacy since the last license renewal.
21(d) A pharmacy licensed pursuant to this section shall do all of
22the following:
23(1) Provide to the board a copy of any disciplinary or other
24action taken by another state within 10 days
of the action.
25(2) Notify the board within 10 days of the suspension of any
26accreditation held by the pharmacy.
27(3) Provide to the board, within 24 hours, any recall notice
28issued by the pharmacy for sterile drug products it has
29compounded.
30(e) Adverse effects reported or potentially attributable to a
31pharmacy’s sterile drug product shall be immediately reported to
32the board and the MedWatch program of the federal Food and
33Drug Administration.
34(f) The reconstitution of a sterile powder shall not require a
35license pursuant to this section if both of the following are met:
36(1) The sterile powder was obtained from a manufacturer.
37(2) The drug is reconstituted for administration to patients by
38a health care professional licensed to administer drugs by injection
39pursuant to this division.
40(g) This section shall become operative on July 1, 2014.
begin insertSection 4127.2 of the end insertbegin insertBusiness and Professions Codeend insert
2begin insert is amended to read:end insert
(a) A nonresident pharmacybegin delete mayend deletebegin insert shallend insert not compound
4injectable sterile drug products for shipment into the State of
5California without a license issued by the board pursuant to this
6section. The license shall be renewed annually and shall not be
7transferable.
8(b) A license to compound injectable sterile drug products may
9only be issued for a location that is licensed as a nonresident
10pharmacy. Furthermore, the license to compound injectable sterile
11drug products may only be issued to the owner of the nonresident
12pharmacy license at that location. A license to compound injectable
13sterile drug products may
not be issued or renewed until the board
14receives the following from the nonresident pharmacy:
15(1) A copy of an inspection report issued by the pharmacy’s
16licensing agency, or a report from a private accrediting agency
17approved by the board, in the prior 12 months documenting the
18pharmacy’s compliance with board regulations regarding the
19compounding of injectable sterile drug products.
20(2) A copy of the nonresident pharmacy’s proposed policies
21and procedures for sterile compounding.
22(c) Nonresident pharmacies operated by entities that are licensed
23as a hospital, home health agency, or a skilled nursing facility and
24have current accreditation from the Joint Commission on
25Accreditation of Healthcare Organizations, or other private
26accreditation agencies approved by the board, are exempt from
27the requirement to obtain a license pursuant to this section.
28(d) This section shall become effective on the earlier of July 1,
292003, or the effective date of regulations adopted by the board
30pursuant to Section 4127.
31(d) This section shall become inoperative on July 1, 2014, and,
32as of January 1, 2015, is repealed, unless a later enacted statute,
33that becomes operative on or before January 1, 2015, deletes or
34extends the dates on which it becomes inoperative and is repealed.
begin insertSection 4127.2 is added to the end insertbegin insertBusiness and Professions
36Codeend insertbegin insert, to read:end insert
(a) A nonresident pharmacy shall not compound sterile
38drug products for shipment into this state without a sterile
39compounding pharmacy license issued by the board pursuant to
P12 1this section. The license shall be renewed annually and shall not
2be transferable.
3(b) A license to compound sterile drug products shall be issued
4only to a location that is licensed as a nonresident pharmacy.
5Furthermore, the license to compound sterile drug products shall
6be issued only to the owner of the nonresident pharmacy licensed
7at that location. A license to compound sterile drug products shall
8not be issued until the location is inspected by the board and found
9in compliance with this article and any regulations adopted by the
10board.
11(c) A license to compound sterile drug products shall not be
12issued or
renewed until the board does all of the following:
13(1) Performs an onsite inspection of the premises, and any
14deficiencies noted are corrected. The nonresident pharmacy shall
15be responsible for payment of reasonable travel expenses incurred
16by the board in connection with inspecting the pharmacy at least
17once annually pursuant to subdivision (v) of Section 4400.
18(2) Reviews a current copy of the nonresident pharmacy’s
19policies and procedures for sterile compounding.
20(3) Reviews the pharmacy’s completed self-assessment form
21required by Section 1735.2 of Title 16 of the California Code of
22Regulations.
23(4) Is provided with copies of all inspection reports conducted
24of the nonresident pharmacy’s premises, and any reports from a
25private accrediting agency, conducted in the prior 12 months
26documenting the nonresident pharmacy’s operations.
27(5) Receives a list of all sterile
drug products compounded by
28the pharmacy within the prior 12 months.
29(d) A pharmacy licensed pursuant to this section shall do all of
30the following:
31(1) Provide to the board a copy of any disciplinary or other
32action taken by its state of residence or another state within 10
33days of the action.
34(2) Notify the board within 10 days of the suspension of any
35accreditation held by the pharmacy.
36(3) Provide to the board, within 24 hours, any recall notice
37issued by the pharmacy for sterile drug products it has compounded
38that have been shipped into, or dispensed in, California.
39(4) Advise the board of any complaint it receives from a
40provider, pharmacy, or patient in California.
P13 1(e) Adverse effects reported or potentially attributable to a
2nonresident pharmacy’s sterile compounded drug product shall
3be immediately reported to the board and the
MedWatch program
4of the federal Food and Drug Administration.
5(f) This section shall become operative on July 1, 2014.
begin insertSection 4400 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
7amended to read:end insert
The amount of fees and penalties prescribed by this
9chapter, except as otherwise provided, is that fixed by the board
10according to the following schedule:
11(a) The fee for a nongovernmental pharmacy license shall be
12four hundred dollars ($400) and may be increased to five hundred
13twenty dollars ($520). The fee for the issuance of a temporary
14nongovernmental pharmacy permit shall be two hundred fifty
15dollars ($250) and may be increased to three hundred twenty-five
16dollars ($325).
17(b) The fee for a nongovernmental pharmacy license annual
18renewal shall be two hundred fifty dollars ($250) and may be
19increased to three hundred twenty-five dollars ($325).
20(c) The
fee for the pharmacist application and examination shall
21be two hundred dollars ($200) and may be increased to two
22hundred sixty dollars ($260).
23(d) The fee for regrading an examination shall be ninety dollars
24($90) and may be increased to one hundred fifteen dollars ($115).
25If an error in grading is found and the applicant passes the
26examination, the regrading fee shall be refunded.
27(e) The fee for a pharmacist license and biennial renewal shall
28be one hundred fifty dollars ($150) and may be increased to one
29hundred ninety-five dollars ($195).
30(f) The fee for a nongovernmental wholesaler license and annual
31renewal shall be six hundred dollars ($600), and may be increased
32to seven hundred eighty dollars ($780). The application fee for
33any additional location after licensure of the first 20 locations shall
34be two
hundred twenty-five dollars ($225) and may be increased
35to three hundred dollars ($300). A temporary license fee shall be
36five hundred fifty dollars ($550) and may be increased to seven
37hundred fifteen dollars ($715).
38(g) The fee for a hypodermic license and renewal shall be one
39hundred twenty-five dollars ($125) and may be increased to one
40hundred sixty-five dollars ($165).
P14 1(h) (1) The fee for application, investigation, and issuance of
2license as a designated representative pursuant to Section 4053
3shall be two hundred fifty-five dollars ($255) and may be increased
4to three hundred thirty dollars ($330).
5(2) The fee for the annual renewal of a license as a designated
6representative shall be one hundred fifty dollars ($150) and may
7be increased to one hundred ninety-five dollars ($195).
8(i) (1) The fee for the application, investigation, and issuance
9of a license as a designated representative for a veterinary
10food-animal drug retailer pursuant to Section 4053 shall be two
11hundred fifty-five dollars ($255) and may be increased to three
12hundred thirty dollars ($330).
13(2) The fee for the annual renewal of a license as a designated
14representative for a veterinary food-animal drug retailer shall be
15one hundred fifty dollars ($150) and may be increased to one
16hundred ninety-five dollars ($195).
17(j) (1) The application 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(2) For
nonresident wholesalers who have 21 or more facilities
21operating nationwide the application fees for the first 20 locations
22shall be six hundred dollars ($600) and may be increased to seven
23hundred eighty dollars ($780). The application fee for any
24additional location after licensure of the first 20 locations shall be
25two hundred twenty-five dollars ($225) and may be increased to
26three hundred dollars ($300). A temporary license fee shall be five
27hundred fifty dollars ($550) and may be increased to seven hundred
28fifteen dollars ($715).
29(3) The annual renewal fee for a nonresident wholesaler’s license
30issued pursuant to Section 4161 shall be six hundred dollars ($600)
31and may be increased to seven hundred eighty dollars ($780).
32(k) The fee for evaluation of continuing education courses for
33accreditation shall be set by the board at an amount not to exceed
34forty dollars ($40) per
course hour.
35(l) The fee for an intern pharmacist license shall be ninety dollars
36($90) and may be increased to one hundred fifteen dollars ($115).
37The fee for transfer of intern hours or verification of licensure to
38another state shall be twenty-five dollars ($25) and may be
39increased to thirty dollars ($30).
P15 1(m) The board may waive or refund the additional fee for the
2issuance of a license where the license is issued less than 45 days
3before the next regular renewal date.
4(n) The fee for the reissuance of any license, or renewal thereof,
5that has been lost or destroyed or reissued due to a name change
6shall be thirty-five dollars ($35) and may be increased to forty-five
7dollars ($45).
8(o) The fee for the reissuance of any license, or renewal thereof,
9
that must be reissued because of a change in the information, shall
10be one hundred dollars ($100) and may be increased to one hundred
11thirty dollars ($130).
12(p) It is the intent of the Legislature that, in setting fees pursuant
13to this section, the board shall seek to maintain a reserve in the
14Pharmacy Board Contingent Fund equal to approximately one
15year’s operating expenditures.
16(q) The fee for any applicant for a nongovernmental clinic
17license shall be four hundred dollars ($400) and may be increased
18to five hundred twenty dollars ($520) for each license. The annual
19fee for renewal of the license shall be two hundred fifty dollars
20($250) and may be increased to three hundred twenty-five dollars
21($325) for each license.
22(r) The fee for the issuance of a pharmacy technician license
23shall be eighty dollars ($80) and
may be increased to one hundred
24five dollars ($105). The fee for renewal of a pharmacy technician
25license shall be one hundred dollars ($100) and may be increased
26to one hundred thirty dollars ($130).
27(s) The fee for a veterinary food-animal drug retailer license
28shall be four hundred five dollars ($405) and may be increased to
29four hundred twenty-five dollars ($425). The annual renewal fee
30for a veterinary food-animal drug retailer license shall be two
31hundred fifty dollars ($250) and may be increased to three hundred
32twenty-five dollars ($325).
33(t) The fee for issuance of a retired license pursuant to Section
344200.5 shall be thirty-five dollars ($35) and may be increased to
35forty-five dollars ($45).
36(u) The fee for issuance or renewal of a nongovernmental license
37to compound sterile drug products shall be six
hundred dollars
38($600) and may be increased to seven hundred eighty dollars
39($780). The fee for a temporary license shall be five hundred fifty
P16 1dollars ($550) and may be increased to seven hundred fifteen
2dollars ($715).
3(v) This section shall become inoperative on July 1, 2014, and,
4as of January 1, 2015, is repealed, unless a later enacted statute,
5that becomes operative on or before January 1, 2015, deletes or
6extends the dates on which it becomes inoperative and is repealed.
begin insertSection 4400 is added to the end insertbegin insertBusiness and Professions
8Codeend insertbegin insert, to read:end insert
The amount of fees and penalties prescribed by this
10chapter, except as otherwise provided, is that fixed by the board
11according to the following schedule:
12(a) The fee for a nongovernmental pharmacy license shall be
13four hundred dollars ($400) and may be increased to five hundred
14twenty dollars ($520). The fee for the issuance of a temporary
15nongovernmental pharmacy permit shall be two hundred fifty
16dollars ($250) and may be increased to three hundred twenty-five
17dollars ($325).
18(b) The fee for a nongovernmental pharmacy license annual
19renewal shall be two hundred fifty dollars ($250) and may be
20increased to three hundred twenty-five dollars ($325).
21(c) The fee for the pharmacist application and examination shall
22be two hundred dollars ($200) and may be increased to two
23hundred sixty dollars ($260).
24(d) The fee for regrading an examination shall be ninety dollars
25($90) and may be increased to one hundred fifteen dollars ($115).
26If an error in grading is found and the applicant passes the
27examination, the regrading fee shall be refunded.
28(e) The fee for a pharmacist license and biennial renewal shall
29be one hundred fifty dollars ($150) and may be increased to one
30hundred ninety-five dollars ($195).
31(f) The fee for a nongovernmental wholesaler license and annual
32renewal shall be six hundred dollars ($600), and may be increased
33to seven hundred eighty dollars ($780). The application fee for
34any additional location after licensure of the first 20
locations
35shall be two hundred twenty-five dollars ($225) and may be
36increased to three hundred dollars ($300). A temporary license
37fee shall be five hundred fifty dollars ($550) and may be increased
38to seven hundred fifteen dollars ($715).
P17 1(g) The fee for a hypodermic license and renewal shall be one
2hundred twenty-five dollars ($125) and may be increased to one
3hundred sixty-five dollars ($165).
4(h) (1) The fee for application, investigation, and issuance of
5license as a designated representative pursuant to Section 4053
6shall be two hundred fifty-five dollars ($255) and may be increased
7to three hundred thirty dollars ($330).
8(2) The fee for the annual renewal of a license as a designated
9representative shall be one hundred fifty dollars ($150) and may
10be increased to one hundred ninety-five
dollars ($195).
11(i) (1) The fee for the application, investigation, and issuance
12of a license as a designated representative for a veterinary
13food-animal drug retailer pursuant to Section 4053 shall be two
14hundred fifty-five dollars ($255) and may be increased to three
15hundred thirty dollars ($330).
16(2) The fee for the annual renewal of a license as a designated
17representative for a veterinary food-animal drug retailer shall be
18one hundred fifty dollars ($150) and may be increased to one
19hundred ninety-five dollars ($195).
20(j) (1) The application fee for a nonresident wholesaler’s license
21issued pursuant to Section 4161 shall be six hundred dollars ($600)
22and may be increased to seven hundred eighty dollars ($780).
23(2) For nonresident wholesalers who have 21 or more facilities
24operating nationwide the application fees for the first 20 locations
25shall be six hundred dollars ($600) and may be increased to seven
26hundred eighty dollars ($780). The application fee for any
27additional location after licensure of the first 20 locations shall
28be two hundred twenty-five dollars ($225) and may be increased
29to three hundred dollars ($300). A temporary license fee shall be
30five hundred fifty dollars ($550) and may be increased to seven
31hundred fifteen dollars ($715).
32(3) The annual renewal fee for a nonresident wholesaler’s
33license issued pursuant to Section 4161 shall be six hundred dollars
34($600) and may be increased to seven hundred eighty dollars
35($780).
36(k) The fee for evaluation of continuing education courses for
37accreditation shall be set by the board at an amount not to exceed
38forty
dollars ($40) per course hour.
39(l) The fee for an intern pharmacist license shall be ninety
40dollars ($90) and may be increased to one hundred fifteen dollars
P18 1($115). The fee for transfer of intern hours or verification of
2licensure to another state shall be twenty-five dollars ($25) and
3may be increased to thirty dollars ($30).
4(m) The board may waive or refund the additional fee for the
5issuance of a license where the license is issued less than 45 days
6before the next regular renewal date.
7(n) The fee for the reissuance of any license, or renewal thereof,
8that has been lost or destroyed or reissued due to a name change
9shall be thirty-five dollars ($35) and may be increased to forty-five
10dollars ($45).
11(o) The fee for the reissuance of any license, or
renewal thereof,
12that must be reissued because of a change in the information, shall
13be one hundred dollars ($100) and may be increased to one
14hundred thirty dollars ($130).
15(p) It is the intent of the Legislature that, in setting fees pursuant
16to this section, the board shall seek to maintain a reserve in the
17Pharmacy Board Contingent Fund equal to approximately one
18year’s operating expenditures.
19(q) The fee for any applicant for a nongovernmental clinic
20license shall be four hundred dollars ($400) and may be increased
21to five hundred twenty dollars ($520) for each license. The annual
22fee for renewal of the license shall be two hundred fifty dollars
23($250) and may be increased to three hundred twenty-five dollars
24($325) for each license.
25(r) The fee for the issuance of a pharmacy technician license
26shall be eighty
dollars ($80) and may be increased to one hundred
27five dollars ($105). The fee for renewal of a pharmacy technician
28license shall be one hundred dollars ($100) and may be increased
29to one hundred thirty dollars ($130).
30(s) The fee for a veterinary food-animal drug retailer license
31shall be four hundred five dollars ($405) and may be increased to
32four hundred twenty-five dollars ($425). The annual renewal fee
33for a veterinary food-animal drug retailer license shall be two
34hundred fifty dollars ($250) and may be increased to three hundred
35twenty-five dollars ($325).
36(t) The fee for issuance of a retired license pursuant to Section
374200.5 shall be thirty-five dollars ($35) and may be increased to
38forty-five dollars ($45).
39(u) The fee for issuance or renewal of a nongovernmental sterile
40compounding pharmacy license shall
be six hundred dollars ($600)
P19 1and may be increased to seven hundred eighty dollars ($780). The
2fee for a temporary license shall be five hundred fifty dollars ($550)
3and may be increased to seven hundred fifteen dollars ($715).
4(v) The board shall establish, by regulation, the fee for a
5nonresident sterile compounding pharmacy license in an amount
6not to exceed the reasonable regulatory costs of issuing and
7renewing the license, or two thousand eight hundred dollars
8($2,800), whichever is less. In addition to paying the license fee,
9the nonresident sterile compounding pharmacy shall reimburse
10the board for all costs incurred by the board in conducting an
11inspection of the pharmacy at least once annually, including, but
12not limited to, travel expenses, meals, lodging, and other actual
13and necessary costs incurred by the board in connection with the
14inspection. Failure to reimburse the board for all costs associated
15with the annual inspection, as
authorized by this subdivision, within
1630 days of the inspection shall result in the suspension of the
17nonresident sterile compounding pharmacy license.
18(w) This section shall become operative on July 1, 2014.
No reimbursement is required by this act pursuant to
21Section 6 of Article XIII B of the California Constitution because
22the only costs that may be incurred by a local agency or school
23district will be incurred because this act creates a new crime or
24infraction, eliminates a crime or infraction, or changes the penalty
25for a crime or infraction, within the meaning of Section 17556 of
26the Government Code, or changes the definition of a crime within
27the meaning of Section 6 of Article XIII B of the California
28Constitution.
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