Amended in Assembly June 24, 2013

Amended in Senate May 28, 2013

Senate BillNo. 294


Introduced by Senator Emmerson

February 15, 2013


An act to amend the heading of Article 7.5 (commencing with Section 4127) of Chapter 9 of Division 2 of, and to amend, repeal, and add Sections 4127, 4127.1, 4127.2, and 4400 of, the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

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 billbegin insert, commencing July 1, 2014,end insert 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 billbegin insert, commencing July 1, 2014,end insert would specify requirements for the board for the issuance or renewal of a license, and requirements for the pharmacy as a licensee.begin insert The bill would require the board to adopt regulations to implement these provisions, as specified.end insert 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 billbegin insert, commencing July 1, 2014,end insert wouldbegin delete require the board to establish, by regulation,end deletebegin insert establishend insert the fee for the issuance or renewal of a nonresident sterile compounding pharmacybegin delete 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 deletebegin insert 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 specifiedend insert.

begin delete

(3) The provisions of the bill would become operative on July 1, 2014.

end delete
begin delete

(4)

end delete

begin insert (3)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:

P2    1

SECTION 1.  

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:

 

P3    1Article 7.5.  Sterile Drug Products
2

 

3

SEC. 2.  

Section 4127 of the Business and Professions Code is
4amended to read:

5

4127.  

(a) The board shall adopt regulations establishing
6standards for compounding injectable sterile drug products in a
7pharmacy.

begin insert

8(b) The board shall adopt emergency regulations in accordance
9with the Administrative Procedure Act (Chapter 3.5 (commencing
10with Section 11340) of Part 1 of Division 3 of Title 2 of the
11Government Code) to establish policies, guidelines, and procedures
12to initially implement the provisions of this article that become
13operative on July 1, 2014, including, but not limited to, building
14standards adopted pursuant to Part 2.5 (commencing with Section
1518901) of Division 13 of the Health and Safety Code. The initial
16 adoption, amendment, or repeal of a regulation authorized by this
17section is deemed to address an emergency for purposes of Sections
1811346.1 and 11346.6 of the Government Code, and the board is
19hereby exempted for that purpose from the requirements of
20subdivision (b) of Section 11346.1 of the Government Code. After
21the initial adoption, amendment, or repeal of an emergency
22regulation pursuant to this section, the board shall not request
23approval from the Office of Administrative Law to readopt the
24regulation as an emergency regulation pursuant to Section 11346.1
25of the Government Code.

end insert
begin delete

26(b)

end delete

27begin insert(c)end insert This section shall become inoperative on July 1, 2014, and,
28as of January 1, 2015, is repealed, unless a later enacted statute,
29that becomes operative on or before January 1, 2015, deletes or
30extends the dates on which it becomes inoperative and is repealed.

31

SEC. 3.  

Section 4127 is added to the Business and Professions
32Code
, to read:

33

4127.  

(a) A pharmacy that compounds sterile drug products
34for injection, administration into the eye, or inhalation shall possess
35a sterile compounding pharmacy license as provided in this article
36begin delete before dispensing the compounded medicationend delete.

begin insert

37(b) The board shall adopt regulations in accordance with the
38Administrative Procedure Act (Chapter 3.5 (commencing with
39Section 11340) of Part 1 of Division 3 of Title 2 of the Government
40Code) to establish policies, guidelines, and procedures to
P4    1implement this article, including, but not limited to, building
2standards adopted pursuant to Part 2.5 (commencing with Section
318901) of Division 13 of the Health and Safety Code.

end insert
begin delete

4(b)

end delete

5begin insert(end insertbegin insertc)end insert This section shall become operative on July 1, 2014.

6

SEC. 4.  

Section 4127.1 of the Business and Professions Code
7 is amended to read:

8

4127.1.  

(a) A pharmacy shall not compound injectable sterile
9drug products in this state unless the pharmacy has obtained a
10license from the board pursuant to this section. The license shall
11be renewed annually and is not transferable.

12(b) A license to compound injectable sterile drug products may
13only be issued for a location that is licensed as a pharmacy.
14Furthermore, the license to compound injectable sterile drug
15products may only be issued to the owner of the pharmacy license
16at that location. A license to compound injectable sterile drug
17products may not be issued until the location is inspected by the
18board and found in compliance with this article and regulations
19adopted by the board.

20(c) A license to compound injectable sterile drug products may
21not be renewed until the location has been inspected by the board
22and found to be in compliance with this article and regulations
23adopted by the board.

24(d) Pharmacies operated by entities that are licensed by either
25the board or the State Department of Public Health and that have
26current accreditation from the Joint Commission on Accreditation
27of Healthcare Organizations, or other private accreditation agencies
28approved by the board, are exempt from the requirement to obtain
29a license pursuant to this section.

30(e) The reconstitution of a sterile powder shall not require a
31license pursuant to this section if both of the following are met:

32(1) The sterile powder was obtained from a manufacturer.

33(2) The drug is reconstituted for administration to patients by
34a health care professional licensed to administer drugs by injection
35pursuant to this division.

36(f) This section shall become inoperative on July 1, 2014, and,
37as of January 1, 2015, is repealed, unless a later enacted statute,
38that becomes operative on or before January 1, 2015, deletes or
39extends the dates on which it becomes inoperative and is repealed.

P5    1

SEC. 5.  

Section 4127.1 is added to the Business and Professions
2Code
, to read:

3

4127.1.  

(a) A pharmacy shall not compound sterile drug
4products unless the pharmacy has obtained a sterile compounding
5pharmacy license from the board pursuant to this section. The
6license shall be renewed annually and is not transferable.

7(b) A license to compound sterile drug products shall be issued
8only to a location that is licensed as abegin delete pharmacy. Furthermore, the
9license to compound sterile drug productsend delete
begin insert pharmacy andend insert shall be
10issued only to the owner of the pharmacy licensed at that location.
11begin delete Aend delete

12begin insert(c)end insertbegin insertend insertbegin insertAend insert license to compound sterile drug products shall not be
13issuedbegin insert or renewedend insert until the location is inspected by the board and
14found in compliance with this article and regulations adopted by
15the board.

begin delete

16(c)

end delete

17begin insert(end insertbegin insertd)end insert A license to compound sterile drug products shall not be
18issued or renewed until the board does all of the following:

begin delete

19(1) Performs an onsite inspection of the premises, and any
20deficiencies noted are corrected.

end delete
begin delete

21(2)

end delete

22begin insert(end insertbegin insert1)end insert Reviews a current copy of the pharmacy’s policies and
23procedures for sterile compounding.

begin delete

24(3)

end delete

25begin insert(end insertbegin insert2)end insert Reviews the pharmacy’s completed self-assessment form
26required by Section 1735.2 of Title 16 of the California Code of
27Regulations.

begin delete

28(4)

end delete

29begin insert(end insertbegin insert3)end insert Is provided with copies of all inspection reports conducted
30of the pharmacy’s premises, and any reports from a private
31accrediting agency, conducted in the prior 12 months documenting
32the pharmacy’s operations.

begin delete

33(5)

end delete

34begin insert(end insertbegin insert4)end insert Receives a list of all sterile medications compounded by the
35pharmacy since the last license renewal.

begin delete

36(d)

end delete

37begin insert(end insertbegin inserte)end insert A pharmacy licensed pursuant to this section shall do all of
38the following:

39(1) Provide to the board a copy of any disciplinary or other
40action taken by another state within 10 days of the action.

P6    1(2) Notify the board within 10 days of the suspension of any
2accreditation held by the pharmacy.

3(3) Provide to the board, withinbegin delete 24end deletebegin insert 12end insert hours, any recall notice
4issued by the pharmacy for sterile drug products it has
5compounded.

begin delete

6(e)

end delete

7begin insert(end insertbegin insertf)end insert Adverse effects reported or potentially attributable to a
8pharmacy’s sterile drug product shall be immediately reported to
9the board and the MedWatch program of the federal Food and
10Drug Administration.

begin delete

11(f)

end delete

12begin insert(end insertbegin insertg)end insert The reconstitution of a sterile powder shall not require a
13license pursuant to this section if both of the following
14begin insert requirementsend insert are met:

15(1) The sterile powder was obtained from a manufacturer.

16(2) The drug is reconstituted for administration to patients by
17a health care professional licensed to administer drugs by injection
18pursuant to this division.

begin delete

19(g)

end delete

20begin insert(end insertbegin inserth)end insert This section shall become operative on July 1, 2014.

21

SEC. 6.  

Section 4127.2 of the Business and Professions Code
22 is amended to read:

23

4127.2.  

(a) A nonresident pharmacy shall not compound
24injectable sterile drug products for shipment into the State of
25California without a license issued by the board pursuant to this
26section. The license shall be renewed annually and shall not be
27transferable.

28(b) A license to compound injectable sterile drug products may
29only be issued for a location that is licensed as a nonresident
30pharmacy. Furthermore, the license to compound injectable sterile
31drug products may only be issued to the owner of the nonresident
32pharmacy license at that location. A license to compound injectable
33sterile drug products may not be issued or renewed until the board
34receives the following from the nonresident pharmacy:

35(1) A copy of an inspection report issued by the pharmacy’s
36licensing agency, or a report from a private accrediting agency
37approved by the board, in the prior 12 months documenting the
38pharmacy’s compliance with board regulations regarding the
39compounding of injectable sterile drug products.

P7    1(2) A copy of the nonresident pharmacy’s proposed policies
2and procedures for sterile compounding.

3(c) Nonresident pharmacies operated by entities that are licensed
4as a hospital, home health agency, or a skilled nursing facility and
5have current accreditation from the Joint Commission on
6Accreditation of Healthcare Organizations, or other private
7accreditation agencies approved by the board, are exempt from
8the requirement to obtain a license pursuant to this section.

9(d) This section shall become inoperative on July 1, 2014, and,
10as of January 1, 2015, is repealed, unless a later enacted statute,
11that becomes operative on or before January 1, 2015, deletes or
12extends the dates on which it becomes inoperative and is repealed.

13

SEC. 7.  

Section 4127.2 is added to the Business and Professions
14Code
, to read:

15

4127.2.  

(a) A nonresident pharmacy shall not compound sterile
16drug products for shipment into this state without a sterile
17compounding pharmacy license issued by the board pursuant to
18this section. The license shall be renewed annually and shall not
19be transferable.

20(b) A license to compound sterile drug products shall be issued
21only to a location that is licensed as a nonresidentbegin delete pharmacy.
22Furthermore, the license to compound sterile drug productsend delete

23begin insert pharmacy andend insert shall be issued only to the owner of the nonresident
24pharmacy licensed at that location.begin delete Aend delete

25begin insert(c)end insertbegin insertend insertbegin insertAend insert license to compound sterile drug products shall not be
26issuedbegin insert or renewedend insert until the location is inspected by the board and
27found in compliance with this article and any regulations adopted
28by the board.begin insert The nonresident pharmacy shall reimburse the board
29for all actual and necessary costs incurred by the board in
30conducting an inspection of the pharmacy at least once annually
31pursuant to subdivision (v) of Section 4400.end insert

begin delete

32(c)

end delete

33begin insert(end insertbegin insertd)end insert A license to compound sterile drug products shall not be
34issued or renewed until the board does all of the following:

begin delete

35(1) Performs an onsite inspection of the premises, and any
36deficiencies noted are corrected. The nonresident pharmacy shall
37be responsible for payment of reasonable travel expenses incurred
38by the board in connection with inspecting the pharmacy at least
39once annually pursuant to subdivision (v) of Section 4400.

end delete
begin delete

40(2)

end delete

P8    1begin insert(end insertbegin insert1)end insert Reviews a current copy of the nonresident pharmacy’s
2policies and procedures for sterile compounding.

begin delete

3(3)

end delete

4begin insert(end insertbegin insert2)end insert Reviews the pharmacy’s completed self-assessment form
5required by Section 1735.2 of Title 16 of the California Code of
6Regulations.

begin delete

7(4)

end delete

8begin insert(end insertbegin insert3)end insert Is provided with copies of all inspection reports conducted
9of the nonresident pharmacy’s premises, and any reports from a
10private accrediting agency, conducted in the prior 12 months
11documenting the nonresident pharmacy’s operations.

begin delete

12(5)

end delete

13begin insert(end insertbegin insert4)end insert Receives a list of all sterile drug products compounded by
14the pharmacy within the prior 12 months.

begin delete

15(d)

end delete

16begin insert(end insertbegin inserte)end insert 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, withinbegin delete 24end deletebegin insert 12end insert 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.

begin delete

28(e)

end delete

29begin insert(end insertbegin insertf)end insert Adverse effects reported or potentially attributable to a
30nonresident pharmacy’s sterile compounded drug product shall be
31immediately reported to the board and the MedWatch program of
32the federal Food and Drug Administration.

begin delete

33(f)

end delete

34begin insert(end insertbegin insertg)end insert This section shall become operative on July 1, 2014.

35

SEC. 8.  

Section 4400 of the Business and Professions Code is
36amended to read:

37

4400.  

The amount of fees and penalties prescribed by this
38chapter, except as otherwise provided, is that fixed by the board
39according to the following schedule:

P9    1(a) The fee for a nongovernmental pharmacy license shall be
2four hundred dollars ($400) and may be increased to five hundred
3twenty dollars ($520). The fee for the issuance of a temporary
4nongovernmental pharmacy permit shall be two hundred fifty
5dollars ($250) and may be increased to three hundred twenty-five
6dollars ($325).

7(b) The fee for a nongovernmental pharmacy license annual
8renewal shall be two hundred fifty dollars ($250) and may be
9increased to three hundred twenty-five dollars ($325).

10(c) The fee for the pharmacist application and examination shall
11be two hundred dollars ($200) and may be increased to two
12hundred sixty dollars ($260).

13(d) The fee for regrading an examination shall be ninety dollars
14($90) and may be increased to one hundred fifteen dollars ($115).
15If an error in grading is found and the applicant passes the
16examination, the regrading fee shall be refunded.

17(e) The fee for a pharmacist license and biennial renewal shall
18be one hundred fifty dollars ($150) and may be increased to one
19hundred ninety-five dollars ($195).

20(f) The fee for a nongovernmental wholesaler license and annual
21renewal shall be six hundred dollars ($600), and may be increased
22to seven hundred eighty dollars ($780). The application fee for
23any additional location after licensure of the first 20 locations shall
24be two hundred twenty-five dollars ($225) and may be increased
25to three hundred dollars ($300). A temporary license fee shall be
26five hundred fifty dollars ($550) and may be increased to seven
27hundred fifteen dollars ($715).

28(g) The fee for a hypodermic license and renewal shall be one
29hundred twenty-five dollars ($125) and may be increased to one
30hundred sixty-five dollars ($165).

31(h) (1) The fee for application, investigation, and issuance of
32license as a designated representative pursuant to Section 4053
33shall be two hundred fifty-five dollars ($255) and may be increased
34to three hundred thirty dollars ($330).

35(2) The fee for the annual renewal of a license as a designated
36representative shall be one hundred fifty dollars ($150) and may
37be increased to one hundred ninety-five dollars ($195).

38(i) (1) The fee for the application, investigation, and issuance
39of a license as a designated representative for a veterinary
40food-animal drug retailer pursuant to Section 4053 shall be two
P10   1hundred fifty-five dollars ($255) and may be increased to three
2hundred thirty dollars ($330).

3(2) The fee for the annual renewal of a license as a designated
4representative for a veterinary food-animal drug retailer shall be
5one hundred fifty dollars ($150) and may be increased to one
6hundred ninety-five dollars ($195).

7(j) (1) The application fee for a nonresident wholesaler’s license
8issued pursuant to Section 4161 shall be six hundred dollars ($600)
9and may be increased to seven hundred eighty dollars ($780).

10(2) For nonresident wholesalers who have 21 or more facilities
11operating nationwide the application fees for the first 20 locations
12shall be six hundred dollars ($600) and may be increased to seven
13hundred eighty dollars ($780). The application fee for any
14additional location after licensure of the first 20 locations shall be
15two hundred twenty-five dollars ($225) and may be increased to
16three hundred dollars ($300). A temporary license fee shall be five
17hundred fifty dollars ($550) and may be increased to seven hundred
18fifteen dollars ($715).

19(3) The annual renewal fee for a nonresident wholesaler’s license
20issued pursuant to Section 4161 shall be six hundred dollars ($600)
21and may be increased to seven hundred eighty dollars ($780).

22(k) The fee for evaluation of continuing education courses for
23accreditation shall be set by the board at an amount not to exceed
24forty dollars ($40) per course hour.

25(l) The fee for an intern pharmacist license shall be ninety dollars
26($90) and may be increased to one hundred fifteen dollars ($115).
27The fee for transfer of intern hours or verification of licensure to
28another state shall be twenty-five dollars ($25) and may be
29increased to thirty dollars ($30).

30(m) The board may waive or refund the additional fee for the
31issuance of a license where the license is issued less than 45 days
32before the next regular renewal date.

33(n) The fee for the reissuance of any license, or renewal thereof,
34that has been lost or destroyed or reissued due to a name change
35shall be thirty-five dollars ($35) and may be increased to forty-five
36dollars ($45).

37(o) The fee for the reissuance of any license, or renewal thereof,
38 that must be reissued because of a change in the information, shall
39be one hundred dollars ($100) and may be increased to one hundred
40thirty dollars ($130).

P11   1(p) It is the intent of the Legislature that, in setting fees pursuant
2to this section, the board shall seek to maintain a reserve in the
3Pharmacy Board Contingent Fund equal to approximately one
4year’s operating expenditures.

5(q) The fee for any applicant for a nongovernmental clinic
6license shall be four hundred dollars ($400) and may be increased
7to five hundred twenty dollars ($520) for each license. The annual
8fee for renewal of the license shall be two hundred fifty dollars
9($250) and may be increased to three hundred twenty-five dollars
10($325) for each license.

11(r) The fee for the issuance of a pharmacy technician license
12shall be eighty dollars ($80) and may be increased to one hundred
13five dollars ($105). The fee for renewal of a pharmacy technician
14license shall be one hundred dollars ($100) and may be increased
15to one hundred thirty dollars ($130).

16(s) The fee for a veterinary food-animal drug retailer license
17shall be four hundred five dollars ($405) and may be increased to
18four hundred twenty-five dollars ($425). The annual renewal fee
19for a veterinary food-animal drug retailer license shall be two
20hundred fifty dollars ($250) and may be increased to three hundred
21twenty-five dollars ($325).

22(t) The fee for issuance of a retired license pursuant to Section
234200.5 shall be thirty-five dollars ($35) and may be increased to
24forty-five dollars ($45).

25(u) The fee for issuance or renewal of a nongovernmental license
26to compound sterile drug products shall be six hundred dollars
27($600) and may be increased to seven hundred eighty dollars
28($780). The fee for a temporary license shall be five hundred fifty
29dollars ($550) and may be increased to seven hundred fifteen
30dollars ($715).

31(v) 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.

35

SEC. 9.  

Section 4400 is added to the Business and Professions
36Code
, to read:

37

4400.  

The amount of fees and penalties prescribed by this
38chapter, except as otherwise provided, is that fixed by the board
39according to the following schedule:

P12   1(a) The fee for a nongovernmental pharmacy license shall be
2four hundred dollars ($400) and may be increased to five hundred
3twenty dollars ($520). The fee for the issuance of a temporary
4nongovernmental pharmacy permit shall be two hundred fifty
5dollars ($250) and may be increased to three hundred twenty-five
6dollars ($325).

7(b) The fee for a nongovernmental pharmacy license annual
8renewal shall be two hundred fifty dollars ($250) and may be
9increased to three hundred twenty-five dollars ($325).

10(c) The fee for the pharmacist application and examination shall
11be two hundred dollars ($200) and may be increased to two
12hundred sixty dollars ($260).

13(d) The fee for regrading an examination shall be ninety dollars
14($90) and may be increased to one hundred fifteen dollars ($115).
15If an error in grading is found and the applicant passes the
16examination, the regrading fee shall be refunded.

17(e) The fee for a pharmacist license and biennial renewal shall
18be one hundred fifty dollars ($150) and may be increased to one
19hundred ninety-five dollars ($195).

20(f) The fee for a nongovernmental wholesaler license and annual
21renewal shall be six hundred dollars ($600), and may be increased
22to seven hundred eighty dollars ($780). The application fee for
23any additional location after licensure of the first 20 locations shall
24be two hundred twenty-five dollars ($225) and may be increased
25to three hundred dollars ($300). A temporary license fee shall be
26five hundred fifty dollars ($550) and may be increased to seven
27hundred fifteen dollars ($715).

28(g) The fee for a hypodermic license and renewal shall be one
29hundred twenty-five dollars ($125) and may be increased to one
30hundred sixty-five dollars ($165).

31(h) (1) The fee for application, investigation, and issuance of
32license as a designated representative pursuant to Section 4053
33shall be two hundred fifty-five dollars ($255) and may be increased
34to three hundred thirty dollars ($330).

35(2) The fee for the annual renewal of a license as a designated
36representative shall be one hundred fifty dollars ($150) and may
37be increased to one hundred ninety-five dollars ($195).

38(i) (1) The fee for the application, investigation, and issuance
39of a license as a designated representative for a veterinary
40food-animal drug retailer pursuant to Section 4053 shall be two
P13   1hundred fifty-five dollars ($255) and may be increased to three
2hundred thirty dollars ($330).

3(2) The fee for the annual renewal of a license as a designated
4representative for a veterinary food-animal drug retailer shall be
5one hundred fifty dollars ($150) and may be increased to one
6hundred ninety-five dollars ($195).

7(j) (1) The application fee for a nonresident wholesaler’s license
8issued pursuant to Section 4161 shall be six hundred dollars ($600)
9and may be increased to seven hundred eighty dollars ($780).

10(2) For nonresident wholesalers who have 21 or more facilities
11operating nationwide the application fees for the first 20 locations
12shall be six hundred dollars ($600) and may be increased to seven
13hundred eighty dollars ($780). The application fee for any
14additional location after licensure of the first 20 locations shall be
15two hundred twenty-five dollars ($225) and may be increased to
16three hundred dollars ($300). A temporary license fee shall be five
17hundred fifty dollars ($550) and may be increased to seven hundred
18fifteen dollars ($715).

19(3) The annual renewal fee for a nonresident wholesaler’s license
20issued pursuant to Section 4161 shall be six hundred dollars ($600)
21and may be increased to seven hundred eighty dollars ($780).

22(k) The fee for evaluation of continuing education courses for
23accreditation shall be set by the board at an amount not to exceed
24forty dollars ($40) per course hour.

25(l) The fee for an intern pharmacist license shall be ninety dollars
26($90) and may be increased to one hundred fifteen dollars ($115).
27The fee for transfer of intern hours or verification of licensure to
28another state shall be twenty-five dollars ($25) and may be
29increased to thirty dollars ($30).

30(m) The board may waive or refund the additional fee for the
31issuance of a license where the license is issued less than 45 days
32before the next regular renewal date.

33(n) The fee for the reissuance of any license, or renewal thereof,
34that has been lost or destroyed or reissued due to a name change
35shall be thirty-five dollars ($35) and may be increased to forty-five
36dollars ($45).

37(o) The fee for the reissuance of any license, or renewal thereof,
38that must be reissued because of a change in the information, shall
39be one hundred dollars ($100) and may be increased to one hundred
40thirty dollars ($130).

P14   1(p) It is the intent of the Legislature that, in setting fees pursuant
2to this section, the board shall seek to maintain a reserve in the
3Pharmacy Board Contingent Fund equal to approximately one
4year’s operating expenditures.

5(q) The fee for any applicant for a nongovernmental clinic
6license shall be four hundred dollars ($400) and may be increased
7to five hundred twenty dollars ($520) for each license. The annual
8fee for renewal of the license shall be two hundred fifty dollars
9($250) and may be increased to three hundred twenty-five dollars
10($325) for each license.

11(r) The fee for the issuance of a pharmacy technician license
12shall be eighty dollars ($80) and may be increased to one hundred
13five dollars ($105). The fee for renewal of a pharmacy technician
14license shall be one hundred dollars ($100) and may be increased
15to one hundred thirty dollars ($130).

16(s) The fee for a veterinary food-animal drug retailer license
17shall be four hundred five dollars ($405) and may be increased to
18four hundred twenty-five dollars ($425). The annual renewal fee
19for a veterinary food-animal drug retailer license shall be two
20hundred fifty dollars ($250) and may be increased to three hundred
21twenty-five dollars ($325).

22(t) The fee for issuance of a retired license pursuant to Section
234200.5 shall be thirty-five dollars ($35) and may be increased to
24forty-five dollars ($45).

25(u) The fee for issuance or renewal of a nongovernmental sterile
26compounding pharmacy license shall be six hundred dollars ($600)
27and may be increased to seven hundred eighty dollars ($780). The
28fee for a temporary license shall be five hundred fifty dollars ($550)
29and may be increased to seven hundred fifteen dollars ($715).

30(v) Thebegin delete board shall establish, by regulation, theend delete fee forbegin insert the
31issuance or renewal ofend insert
a nonresident sterile compounding
32pharmacy licensebegin delete in an amount not to exceed the reasonable
33regulatory costs of issuing and renewing the license, or two
34thousand eight hundred dollars ($2,800), whichever is lessend delete
begin insert shall
35be seven hundred eighty dollars ($780)end insert
. In addition to payingbegin delete the
36licenseend delete
begin insert that applicationend insert fee, the nonresident sterile compounding
37pharmacy shall begin delete reimburse the board for all costs incurred by the
38board in conducting an inspection of the pharmacy at least once
39annually, including, but not limited to, travel expenses, meals,
40lodging, and other actual and necessary costs incurred by the board
P15   1in connection with the inspection. Failure to reimburse the board
2for all costs associated with the annual inspection, as authorized
3by this subdivision, within 30 days of the inspection shall result
4in the suspension of the nonresident sterile compounding pharmacy
5licenseend delete
begin insert deposit, when submitting the application, a reasonable
6amount, as determined by the board, necessary to cover the board’s
7estimated cost of performing the inspection required by Section
84127.2. If the required deposit is not submitted with the application,
9the application shall be deemed to be incomplete. If the actual cost
10of the inspection exceeds the amount deposited, the board shall
11provide to the applicant a written invoice for the remaining amount
12and shall not take action on the application until the full amount
13has been paid to the board. If the amount deposited exceeds the
14amount of actual and necessary costs incurred, the board shall
15remit the difference to the applicantend insert
.

16(w) This section shall become operative on July 1, 2014.

17

SEC. 10.  

No reimbursement is required by this act pursuant to
18Section 6 of Article XIII B of the California Constitution because
19the only costs that may be incurred by a local agency or school
20district will be incurred because this act creates a new crime or
21infraction, eliminates a crime or infraction, or changes the penalty
22for a crime or infraction, within the meaning of Section 17556 of
23the Government Code, or changes the definition of a crime within
24the meaning of Section 6 of Article XIII B of the California
25Constitution.



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