Amended in Senate April 13, 2016

Senate BillNo. 1193


Introduced by Senator Hill

begin insert

(Principal coauthor: Assembly Member Salas)

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February 18, 2016


An act to amend Sectionsbegin delete 4001 and 4003 of end deletebegin insert 4001, 4003, 4119.1, and 4400 of, to add Sections 4034, 4203.5, and 4316 to, and to add Article 7.7 (commencing with Section 4129) to Chapter 9 of Division 2 of,end insert the Business and Professions Code,begin insert and to amend Section 13401.5 of the Corporations Code,end insert relating to healingbegin delete arts.end deletebegin insert arts, and making an appropriation therefor.end insert

LEGISLATIVE COUNSEL’S DIGEST

SB 1193, as amended, Hill. begin deleteCalifornia State Board of Pharmacy: executive officer. end deletebegin insertPharmacy: outsourcing facilities.end insert

The Pharmacy Law provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy, which is within the Department of Consumer Affairs, and authorizes the board to appoint, with the approval of the Director of Consumer Affairs, an executive officer, as specified.begin delete Existingend deletebegin insert Thatend insert law repeals the provisions establishing the board and authorizing the board to appoint an executive officer as of January 1, 2017. Under existing law, the board is subject to evaluation by the Joint Sunset Review Committee upon its repeal.begin insert That law authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system. That law also provides for the board to issue a license, after an investigation to determine whether the applicant and the premises qualify for a license, that authorizes specified clinics to purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic. Existing law makes a violation of any provision of the Pharmacy Law punishable as an infraction if no other penalty is provided.end insert

This bill would extend the operation of the board and the board’s authorization to appoint an executive officer until January 1, 2021.begin insert The bill would require a pharmacy to register use of an automated drug delivery system with the board, including the address and location of use. The bill would require the board, when a clinic applicant submits specified types of applications, to issue a license or incorporate changes to an existing license within 30 days of receipt of a completed application and payment of fees. The bill would not limit the board’s authority to investigate to determine whether the applicant and the premises qualify for a license. By placing new requirements on a pharmacy, this bill would expand an existing crime and would, therefore, impose a state-mandated local program.end insert

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The Pharmacy Law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board and prohibits the board from issuing or renewing that license until the board has, among other things, reviewed a current copy of the pharmacy’s procedures and policies for sterile compounding. Existing law provides that fees collected on behalf of the board are credited to the Pharmacy Board Contingent Fund, which continuously appropriates fees in the fund.

end insert
begin insert

The bill would require the board to license an outsourcing facility, as defined, and would prohibit an outsourcing facility to be concurrently licensed with the board as a sterile compounding pharmacy at the same location. The bill would require an outsourcing facility to be licensed with the board before doing business within or into the state and would require an outsourcing facility to, among other things, notify the board of any disciplinary or other action taken by another state or the federal Food and Drug Administration within 10 days of the action. The bill would require the board to, among other things, inspect the location of an outsourcing facility to ensure that the outsourcing facility is in compliance with all laws and regulations before issuing or renewing an outsourcing facility’s license. The bill would make a violation of any of these provisions or regulations adopted thereto punishable by a fine of up to $5,000 per occurrence. The bill would, on or after January 1, 2018, require the board to provide a report, as specified, to the Legislature regarding the regulation of nonresident outsourcing facilities. The bill would also authorize the board to collect a fee of $780 for the issuance and renewal of an outsourcing license and a fee of $715 for a temporary license, as specified. By increasing the amount of money deposited into a continuously appropriated fund, the bill would make an appropriation.

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Existing law authorizes specified healing arts licensees to be shareholders, officers, directors, or professional employees of a designated professional corporation, subject to certain limitations relating to ownership of shares.

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This bill would additionally authorize licensed pharmacists to be shareholders, officers, directors, or professional employees of a designated professional corporation, subject to certain limitations relating to ownership of shares.

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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.

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begin insert

This bill would provide that no reimbursement is required by this act for a specified reason.

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Vote: majority. Appropriation: begin deleteno end deletebegin insertyesend insert. Fiscal committee: yes. State-mandated local program: begin deleteno end deletebegin insertyesend insert.

The people of the State of California do enact as follows:

P3    1

SECTION 1.  

Section 4001 of the Business and Professions
2Code
is amended to read:

3

4001.  

(a) There is in the Department of Consumer Affairs a
4California State Board of Pharmacy in which the administration
5and enforcement of this chapter is vested. The board consists of
613 members.

7(b) The Governor shall appoint seven competent pharmacists
8who reside in different parts of the state to serve as members of
9the board. The Governor shall appoint four public members, and
10the Senate Committee on Rules and the Speaker of the Assembly
11shall each appoint a public member who shall not be a licensee of
12the board, any other board under this division, or any board referred
13to in Section 1000 or 3600.

14(c) At least five of the seven pharmacist appointees to the board
15shall be pharmacists who are actively engaged in the practice of
16pharmacy. Additionally, the membership of the board shall include
P4    1at least one pharmacist representative from each of the following
2practice settings: an acute care hospital, an independent community
3pharmacy, a chain community pharmacy, and a long-term health
4care or skilled nursing facility. The pharmacist appointees shall
5also include a pharmacist who is a member of a labor union that
6represents pharmacists. For the purposes of this subdivision, a
7“chain community pharmacy” means a chain of 75 or more stores
8in California under the same ownership, and an “independent
9community pharmacy” means a pharmacy owned by a person or
10entity who owns no more than four pharmacies in California.

11(d) Members of the board shall be appointed for a term of four
12years. No person shall serve as a member of the board for more
13than two consecutive terms. Each member shall hold office until
14the appointment and qualification of his or her successor or until
15one year shall have elapsed since the expiration of the term for
16which the member was appointed, whichever first occurs.
17Vacancies occurring shall be filled by appointment for the
18unexpired term.

19(e) Each member of the board shall receive a per diem and
20expenses as provided in Section 103.

21(f) This section shall remain in effect only until January 1, 2021,
22and as of that date is repealed. Notwithstanding any other law, the
23repeal of this section renders the board subject to review by the
24appropriate policy committees of the Legislature.

25

SEC. 2.  

Section 4003 of the Business and Professions Code is
26amended to read:

27

4003.  

(a) The board, with the approval of the director, may
28appoint a person exempt from civil service who shall be designated
29as an executive officer and who shall exercise the powers and
30perform the duties delegated by the board and vested in him or her
31by this chapter. The executive officer may or may not be a member
32of the board as the board may determine.

33(b) The executive officer shall receive the compensation as
34established by the board with the approval of the Director of
35Finance. The executive officer shall also be entitled to travel and
36other expenses necessary in the performance of his or her duties.

37(c) The executive officer shall maintain and update in a timely
38fashion records containing the names, titles, qualifications, and
39places of business of all persons subject to this chapter.

P5    1(d) The executive officer shall give receipts for all money
2received by him or her and pay it to the department, taking its
3receipt therefor. Besides the duties required by this chapter, the
4executive officer shall perform other duties pertaining to the office
5as may be required of him or her by the board.

6(e) This section shall remain in effect only until January 1, 2021,
7and as of that date is repealed.

8begin insert

begin insertSEC. 3.end insert  

end insert

begin insertSection 4034 is added to the end insertbegin insertBusiness and Professions
9Code
end insert
begin insert, to read:end insert

begin insert
10

begin insert4034.end insert  

“Outsourcing facility” means a facility that meets all of
11the following:

12
(a) Is located within the United States of America at one address
13that is engaged in the compounding of sterile drugs and nonsterile
14drugs.

15
(b) Has registered as an outsourcing facility with the federal
16Food and Drug Administration under Section 503B of the Federal
17Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353b).

18
(c) Is doing business within or into California.

19
(d) Is licensed with the board as an outsourcing facility pursuant
20to Article 7.7 (commencing with Section 4129).

end insert
21begin insert

begin insertSEC. 4.end insert  

end insert

begin insertSection 4119.1 of the end insertbegin insertBusiness and Professions Codeend insert
22
begin insert is amended to read:end insert

23

4119.1.  

(a) A pharmacy may provide pharmacy services to a
24health facility licensed pursuant to subdivision (c), (d), or both, of
25Section 1250 of the Health and Safety Code, through the use of
26an automated drug delivery system that need not be located at the
27same location as the pharmacy.

28(b) Drugs stored in an automated drug delivery system shall be
29part of the inventory of the pharmacy providing pharmacy services
30to that facility, and drugs dispensed from the pharmacy system
31shall be considered to have been dispensed by that pharmacy.

32(c) (1) The pharmacy shall maintain records of the acquisition
33and disposition of dangerous drugs and dangerous devices stored
34in the automated drug delivery system separate from other
35pharmacy records.

36(2) The pharmacy shall own and operate the automated drug
37delivery system.

38(3) The pharmacy shall provide training regarding the operation
39and use of the automated drug delivery system to both pharmacy
40and health facility personnel using the system.

P6    1(4) The pharmacy shall operate the automated drug delivery
2system in compliance with Section 1261.6 of the Health and Safety
3Code.

4(d) The operation of the automated drug delivery system shall
5be under the supervision of a licensed pharmacist. To qualify as a
6supervisor for an automated drug delivery system, the pharmacist
7need not be physically present at the site of the automated drug
8delivery system and may supervise the system electronically.

begin insert

9
(e) The pharmacy shall register use of an automated drug
10delivery system with the board, including the address and location
11of use.

end insert
begin delete

12(e) Nothing in this

end delete

13begin insert(f)end insertbegin insertend insertbegin insertThisend insert section shallbegin insert notend insert be construed to revise or limit the use
14of automated drug delivery systems as permitted by the board in
15any licensed health facility other than a facility defined in
16subdivision (c) or (d), or both, of Section 1250 of the Health and
17Safety Code.

18begin insert

begin insertSEC. 5.end insert  

end insert

begin insertArticle 7.7 (commencing with Section 4129) is added
19to Chapter 9 of Division 2 of the end insert
begin insertBusiness and Professions Codeend insertbegin insert,
20to read:end insert

begin insert

21 

22Article begin insert7.7.end insert  Outsourcing Facilities
23

 

24

begin insert4129.end insert  

(a) A facility licensed as an outsourcing facility with
25the federal Food and Drug Administration (FDA) shall be
26concurrently licensed with the board as an outsourcing facility if
27it compounds sterile medication or nonsterile medication for
28nonpatient-specific distribution within or into California.

29
(b) A facility premises licensed with the board as a sterile
30compounding pharmacy shall not be concurrently licensed with
31the board as an outsourcing facility at the same location.

32
(c) The board may adopt regulations in accordance with the
33Administrative Procedure Act (Chapter 3.5 (commencing with
34Section 11340) of Part 1 of Division 3 of Title 2 of the Government
35Code) to establish policies, guidelines, and procedures to
36implement this article.

37
(d) The board shall review any formal requirements or guidance
38documents developed by the FDA regarding outsourcing facilities
39within 90 days after their release in order to determine whether
P7    1revisions are necessary for any regulations promulgated by the
2board.

3
(e) An outsourcing facility licensed by the board shall not
4perform the duties of a pharmacy, such as filling individual
5prescriptions for individual patients.

6

begin insert4129.1.end insert  

(a) An outsourcing facility that is licensed with the
7federal Food and Drug Administration (FDA) and with an address
8in this state shall also be licensed by the board as an outsourcing
9facility before doing business within this state. The license shall
10be renewed annually and is not transferable.

11
(b) An outsourcing facility shall compound all sterile products
12and nonsterile products in compliance with regulations issued by
13the board and with federal current good manufacturing practices
14applicable to outsourcing facilities.

15
(c) An outsourcing facility license shall not be issued or renewed
16until the location is inspected by the board and found in compliance
17with this article and regulations adopted by the board.

18
(d) An outsourcing facility license shall not be issued or renewed
19until the board does all of the following:

20
(1) Prior to inspection, reviews a current copy of the outsourcing
21facility’s policies and procedures for sterile compounding and
22nonsterile compounding.

23
(2) Is provided with copies of all federal and state regulatory
24agency inspection reports, as well as accreditation reports, and
25certification reports of facilities or equipment of the outsourcing
26facility’s premises conducted in the prior 12 months.

27
(3) Prior to inspection, receives a list of all sterile drugs and
28nonsterile drugs compounded by the outsourcing facility as
29reported to the FDA in the last 12 months.

30
(e) An outsourcing facility licensed pursuant to this section shall
31provide the board with all of the following:

32
(1) A copy of any disciplinary or other action taken by another
33state or the FDA within 10 days of the action.

34
(2) Notice within 24 hours of any recall notice issued by the
35outsourcing facility.

36
(3) A copy of any clinically related complaint it receives
37involving an outsourcing facility’s compounded products from or
38involving any provider, pharmacy, or patient in California within
3972 hours of receipt.

P8    1
(4) Notice within 24 hours after learning of adverse effects
2reported or potentially attributable to the outsourcing facility’s
3products.

4

begin insert4129.2.end insert  

(a) An outsourcing facility that is licensed with the
5federal Food and Drug Administration (FDA) as an outsourcing
6facility and has an address outside of this state but in the United
7States of America is a nonresident outsourcing facility. A
8nonresident outsourcing facility shall not compound sterile drug
9products or nonsterile drug products for distribution or use into
10this state without an outsourcing license issued by the board
11pursuant to this section. The license shall be renewed annually
12and shall not be transferable.

13
(b) A nonresident outsourcing facility shall compound all sterile
14products and nonsterile products to be distributed or used in this
15state in compliance with regulations of the board and with federal
16current good manufacturing practices applicable to outsourcing
17facilities.

18
(c) A license for a nonresident outsourcing facility shall not be
19issued or renewed until the location is inspected by the board and
20found in compliance with this article and any regulations adopted
21by the board. The nonresident outsourcing facility shall reimburse
22the board for all actual and necessary costs incurred by the board
23in conducting an inspection of the nonresident outsourcing facility
24at least once annually pursuant to subdivision (x) of Section 4400.

25
(d) A license for a nonresident outsourcing facility shall not be
26issued or renewed until the board:

27
(1) Prior to inspection, reviews a current copy of the nonresident
28outsourcing facility’s policies and procedures for sterile
29compounding and nonsterile compounding.

30
(2) Is provided with copies of all federal and state regulatory
31agency inspection reports, as well as accreditation reports, and
32certification reports of facilities or equipment of the nonresident
33outsourcing facility’s premises conducted in the prior 12 months.

34
(3) Prior to inspection, receives a list of all sterile drug products
35and nonsterile drug products compounded by the pharmacy as
36reported to the FDA within the prior 12 months.

37
(e) A nonresident outsourcing facility licensed pursuant to this
38section shall provide the board with all of the following:

39
(1) A copy of any disciplinary or other action taken by another
40state or the FDA within 10 days of the action.

P9    1
(2) Notice within 24 hours of any recall notice issued by the
2nonresident outsourcing facility.

3
(3) A copy of any complaint it receives involving an outsourcing
4facility’s compounded products from or involving any provider,
5pharmacy, or patient in California within 72 hours of receipt.

6
(4) Notice within 24 hours after learning of adverse effects
7reported or potentially attributable to a nonresident outsourcing
8facility’s products.

9

begin insert4129.3.end insert  

(a) On or before January 1, 2018, the board shall
10provide a report to the Legislature regarding the regulation of
11nonresident outsourcing facilities. The report shall be submitted
12to the Legislature in the manner required pursuant to Section 9795
13of the Government Code. At a minimum, the report shall address
14all of the following:

15
(1) A detailed description of board activities related to the
16inspection and licensure of nonresident outsourcing facilities.

17
(2) Whether fee revenue collected pursuant to subdivision (x)
18of Section 4400 and travel cost reimbursements collected pursuant
19to subdivision (c) of Section 4129.2 provide revenue in an amount
20sufficient to support the board’s activities related to the inspection
21and licensure of nonresident outsourcing facilities.

22
(3) The status of proposed changes to federal law that are under
23serious consideration and that would govern outsourcing facilities
24and compounding pharmacies, including, but not limited to,
25legislation pending before Congress, administrative rules,
26regulations or orders under consideration by the FDA or other
27appropriate federal agency, and cases pending before the courts.

28
(4) If applicable, recommended modifications to the board’s
29statutory duties related to nonresident outsourcing facilities as a
30result of changes to federal law or any additional modifications
31necessary to protect the health and safety of the public.

32
(b) The requirement for submitting a report imposed under
33subdivision (a) is inoperative on January 1, 2022, pursuant to
34Section 10231.5 of the Government Code.

35

begin insert4129.4.end insert  

(a) Whenever the board has a reasonable belief, based
36on information obtained during an inspection or investigation by
37the board, that an outsourcing facility compounding sterile drug
38products or nonsterile drug products poses an immediate threat
39to the public health or safety, the executive officer of the board
40may issue an order to the outsourcing facility to immediately cease
P10   1and desist compounding sterile drug products or nonsterile drug
2products. The cease and desist order shall remain in effect for no
3more than 30 days or the date of a hearing seeking an interim
4suspension order, whichever is earlier.

5
(b) Whenever the board issues a cease and desist order pursuant
6to subdivision (a), the board shall immediately issue a notice to
7the owner setting forth the acts or omissions with which the owner
8is charged, specifying the pertinent code section or sections and
9any regulations.

10
(c) The cease and desist order shall state that the owner, within
1115 days of receipt of the notice, may request a hearing before the
12president of the board to contest the cease and desist order.
13Consideration of the owner’s contest of the cease and desist order
14shall comply with the requirements of Section 11425.10 of the
15Government Code. The hearing shall be held no later than five
16days after the date the request of the owner is received by the
17board. The president shall render a written decision within five
18days after the hearing. In the absence of the president of the board,
19the vice president of the board may conduct the hearing permitted
20by this subdivision. Review of the decision may be sought by the
21owner or person in possession or control of the outsourcing facility
22pursuant to Section 1094.5 of the Code of Civil Procedure.

23
(d) Failure to comply with a cease and desist order issued
24pursuant to this section shall be unprofessional conduct.

25

begin insert4129.5.end insert  

Notwithstanding any other law, a violation of this
26article, or regulation adopted pursuant thereto, may subject the
27person or entity that committed the violation to a fine of up to five
28thousand dollars ($5,000) per occurrence pursuant to a citation
29issued by the board.

30

begin insert4129.6.end insert  

For purposes of this article, “sterile compounded
31products” means compounded preparations for injection,
32administration into the eye, or inhalation.

33

begin insert4129.8.end insert  

The board, at its discretion, may issue a temporary
34license to an outsourcing facility when the ownership of the
35outsourcing facility is transferred from one person to another,
36upon the conditions and for any periods of time as the board
37determines to be in the public interest. A temporary license fee
38shall be required as specified in subdivision (w) of Section 4400.
39When needed to protect public safety, a temporary license may be
40issued for a period not to exceed 180 days, and may be issued
P11   1subject to terms and conditions the board deems necessary. If the
2board determines a temporary license was issued by mistake or
3denies the application for a permanent license, the temporary
4license shall terminate upon the earlier of personal service of the
5notice of termination upon the licenseholder or service by certified
6mail with return receipt requested at the licenseholder’s address
7of record with the board. The temporary licenseholder shall not
8be deemed to have a vested property right or interest in the license
9for purposes of retaining a temporary license or for purposes of
10any disciplinary or license denial proceeding before the board.

11

begin insert4129.9.end insert  

(a) An outsourcing facility licensed pursuant to Section
124129.1 or 4129.2 that issues a recall notice for a sterile drug or
13nonsterile drug compounded by the outsourcing facility, in addition
14to any other duties, shall contact the recipient pharmacy,
15prescriber, or patient of the recalled drug and the board as soon
16as possible within 24 hours of the recall notice if both of the
17following apply:

18
(1) Use of or exposure to the recalled drug may cause serious
19adverse health consequences or death.

20
(2) The recalled drug was dispensed, or is intended for use, in
21this state.

22
(b) A recall notice issued pursuant to subdivision (a) shall be
23made as follows:

24
(1) If the recalled drug was dispensed directly to the prescriber,
25the notice shall be made to the prescriber and the prescriber shall
26ensure the patient is notified.

27
(2) If the recalled drug was dispensed directly to a pharmacy,
28the notice shall be made to the pharmacy and that pharmacy shall
29notify the prescriber or patient, as appropriate. If the pharmacy
30notifies the prescriber, the prescriber shall ensure the patient is
31notified.

end insert
32begin insert

begin insertSEC. 6.end insert  

end insert

begin insertSection 4203.5 is added to the end insertbegin insertBusiness and Professions
33Code
end insert
begin insert, to read:end insert

begin insert
34

begin insert4203.5.end insert  

(a) Notwithstanding any other law, when a clinic
35applicant submits either type of application described in
36subdivision (b), the board shall issue a license or incorporate the
37reported changes, as appropriate, within 30 days of receipt of a
38completed application and payment of any prescribed fees.

39
(b) This section applies to the following types of applications:

40
(1) A new clinic license application filed under Section 4180.

P12   1
(2) Applications to report changes to an existing site licensed
2under Section 4180, including, but not limited to, changes in
3professional director, clinic administrator, corporate officers,
4 change of location, or change of address.

5
(c) This section shall not be construed to limit the board’s
6authority to conduct an investigation to determine whether
7applicants and the premises for which an application is made
8qualify for a license.

end insert
9begin insert

begin insertSEC. 7.end insert  

end insert

begin insertSection 4316 is added to the end insertbegin insertBusiness and Professions
10Code
end insert
begin insert, to read:end insert

begin insert
11

begin insert4316.end insert  

(a) The board is authorized to issue a cease and desist
12order for operating any facility under this chapter that requires
13licensure or for practicing any activity under this chapter that
14requires licensure.

15
(b) Whenever the board issues a cease and desist order pursuant
16to subdivision (a), the board shall immediately issue the facility a
17notice setting forth the acts or omissions with which it is charged,
18specifying the pertinent code section or sections and any
19regulations.

20
(c) The order shall provide that the facility, within 15 days of
21receipt of the notice, may request a hearing before the president
22of the board to contest the cease and desist order. Consideration
23of the facility’s contest of the cease and desist order shall comply
24with the requirements of Section 11425.10 of the Government
25Code. The hearing shall be held no later than five days from the
26date the request of the owner is received by the board. The
27president shall render a written decision within five days of the
28hearing. In the absence of the president of the board, the vice
29president of the board may conduct the hearing permitted by this
30subdivision. Review of the decision of the president of the board
31may be sought by the owner or person in possession or control of
32the pharmacy pursuant to Section 1094.5 of the Code of Civil
33Procedure.

end insert
34begin insert

begin insertSEC. 8.end insert  

end insert

begin insertSection 4400 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
35amended to read:end insert

36

4400.  

The amount of fees and penalties prescribed by this
37chapter, except as otherwise provided, is that fixed by the board
38according to the following schedule:

39(a) The fee for a nongovernmental pharmacy license shall be
40four hundred dollars ($400) and may be increased to five hundred
P13   1twenty dollars ($520). The fee for the issuance of a temporary
2nongovernmental pharmacy permit shall be two hundred fifty
3dollars ($250) and may be increased to three hundred twenty-five
4dollars ($325).

5(b) The fee for a nongovernmental pharmacy license annual
6renewal shall be two hundred fifty dollars ($250) and may be
7increased to three hundred twenty-five dollars ($325).

8(c) The fee for the pharmacist application and examination shall
9be two hundred dollars ($200) and may be increased to two
10hundred sixty dollars ($260).

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

15(e) The fee for a pharmacist license and biennial renewal shall
16be one hundred fifty dollars ($150) and may be increased to one
17hundred ninety-five dollars ($195).

18(f) The fee for a nongovernmental wholesaler or third-party
19logistics provider license and annual renewal shall be seven
20hundred eighty dollars ($780) and may be decreased to no less
21than six hundred dollars ($600). The application fee for any
22additional location after licensure of the first 20 locations shall be
23three hundred dollars ($300) and may be decreased to no less than
24two hundred twenty-five dollars ($225). A temporary license fee
25shall be seven hundred fifteen dollars ($715) and may be decreased
26to no less than five hundred fifty dollars ($550).

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

30(h) (1) The fee for application, investigation, and issuance of
31a license as a designated representative pursuant to Section 4053,
32or as a designated representative-3PL pursuant to Section 4053.1,
33shall be three hundred thirty dollars ($330) and may be decreased
34to no less than two hundred fifty-five dollars ($255).

35(2) The fee for the annual renewal of a license as a designated
36representative or designated representative-3PL shall be one
37hundred ninety-five dollars ($195) and may be decreased to no
38less than one hundred fifty dollars ($150).

39(i) (1) The fee for the application, investigation, and issuance
40of a license as a designated representative for a veterinary
P14   1food-animal drug retailer pursuant to Section 4053 shall be three
2hundred thirty dollars ($330) and may be decreased to no less than
3two hundred fifty-five dollars ($255).

4(2) The fee for the annual renewal of a license as a designated
5representative for a veterinary food-animal drug retailer shall be
6one hundred ninety-five dollars ($195) and may be decreased to
7no less than one hundred fifty dollars ($150).

8(j) (1) The application fee for a nonresident wholesaler or
9third-party logistics provider license issued pursuant to Section
104161 shall be seven hundred eighty dollars ($780) and may be
11decreased to no less than six hundred dollars ($600).

12(2) For nonresident wholesalers or third-party logistics providers
13that have 21 or more facilities operating nationwide the application
14fees for the first 20 locations shall be seven hundred eighty dollars
15($780) and may be decreased to no less than six hundred dollars
16($600). The application fee for any additional location after
17licensure of the first 20 locations shall be three hundred dollars
18($300) and may be decreased to no less than two hundred
19twenty-five dollars ($225). A temporary license fee shall be seven
20hundred fifteen dollars ($715) and may be decreased to no less
21than five hundred fifty dollars ($550).

22(3) The annual renewal fee for a nonresident wholesaler license
23or third-party logistics provider license issued pursuant to Section
244161 shall be seven hundred eighty dollars ($780) and may be
25decreased to no less than six hundred dollars ($600).

26(k) The fee for evaluation of continuing education courses for
27accreditation shall be set by the board at an amount not to exceed
28forty dollars ($40) per course hour.

29(l) The fee for an intern pharmacist license shall be ninety dollars
30($90) and may be increased to one hundred fifteen dollars ($115).
31The fee for transfer of intern hours or verification of licensure to
32another state shall be twenty-five dollars ($25) and may be
33increased to thirty dollars ($30).

34(m) The board may waive or refund the additional fee for the
35issuance of a license where the license is issued less than 45 days
36before the next regular renewal date.

37(n) The fee for the reissuance of any license, or renewal thereof,
38that has been lost or destroyed or reissued due to a name change
39shall be thirty-five dollars ($35) and may be increased to forty-five
40dollars ($45).

P15   1(o) The fee for the reissuance of any license, or renewal thereof,
2that 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 the issuance or renewal of a nonresident sterile
35compounding pharmacy license shall be seven hundred eighty
36dollars ($780). In addition to paying that application fee, the
37nonresident sterile compounding pharmacy shall deposit, when
38submitting the application, a reasonable amount, as determined by
39the board, necessary to cover the board’s estimated cost of
40performing the inspection required by Section 4127.2. If the
P16   1required deposit is not submitted with the application, the
2application shall be deemed to be incomplete. If the actual cost of
3the inspection exceeds the amount deposited, the board shall
4provide to the applicant a written invoice for the remaining amount
5and shall not take action on the application until the full amount
6has been paid to the board. If the amount deposited exceeds the
7amount of actual and necessary costs incurred, the board shall
8remit the difference to the applicant.

begin delete

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

end delete
begin insert

10
(w) The fee for the issuance or renewal of an outsourcing facility
11license shall be seven hundred eighty dollars ($780). The fee for
12a temporary outsourcing facility license shall be seven hundred
13fifteen dollars ($715).

end insert
begin insert

14
(x) The fee for the issuance or renewal of a nonresident
15outsourcing facility license shall be seven hundred eighty dollars
16($780). In addition to paying that application fee, the nonresident
17outsourcing facility shall deposit, when submitting the application,
18a reasonable amount, as determined by the board, necessary to
19cover the board’s estimated cost of performing the inspection
20required by Section 4129.2. If the required deposit is not submitted
21with the application, the application shall be deemed to be
22incomplete. If the actual cost of the inspection exceeds the amount
23deposited, the board shall provide to the applicant a written invoice
24for the remaining amount and shall not take action on the
25application until the full amount has been paid to the board. If the
26amount deposited exceeds the amount of actual and necessary
27costs incurred, the board shall remit the difference to the applicant.

end insert
28begin insert

begin insertSEC. 9.end insert  

end insert

begin insertSection 13401.5 of the end insertbegin insertCorporations Codeend insertbegin insert is amended
29to read:end insert

30

13401.5.  

Notwithstanding subdivision (d) of Section 13401
31and any other provision of law, the following licensed persons
32may be shareholders, officers, directors, or professional employees
33of the professional corporations designated in this section so long
34as the sum of all shares owned by those licensed persons does not
35exceed 49 percent of the total number of shares of the professional
36corporation so designated herein, and so long as the number of
37those licensed persons owning shares in the professional
38corporation so designated herein does not exceed the number of
39persons licensed by the governmental agency regulating the
40designated professional corporation. This section does not limit
P17   1employment by a professional corporation designated in this section
2to only those licensed professionals listed under each subdivision.
3Any person duly licensed under Division 2 (commencing with
4Section 500) of the Business and Professions Code, the
5Chiropractic Act, or the Osteopathic Act may be employed to
6render professional services by a professional corporation
7designated in this section.

8(a) Medical corporation.

9(1) Licensed doctors of podiatric medicine.

10(2) Licensed psychologists.

11(3) Registered nurses.

12(4) Licensed optometrists.

13(5) Licensed marriage and family therapists.

14(6) Licensed clinical social workers.

15(7) Licensed physician assistants.

16(8) Licensed chiropractors.

17(9) Licensed acupuncturists.

18(10) Naturopathic doctors.

19(11) Licensed professional clinical counselors.

20(12) Licensed physical therapists.

begin insert

21
(13) Licensed pharmacists.

end insert

22(b) Podiatric medical corporation.

23(1) Licensed physicians and surgeons.

24(2) Licensed psychologists.

25(3) Registered nurses.

26(4) Licensed optometrists.

27(5) Licensed chiropractors.

28(6) Licensed acupuncturists.

29(7) Naturopathic doctors.

30(8) Licensed physical therapists.

31(c) Psychological corporation.

32(1) Licensed physicians and surgeons.

33(2) Licensed doctors of podiatric medicine.

34(3) Registered nurses.

35(4) Licensed optometrists.

36(5) Licensed marriage and family therapists.

37(6) Licensed clinical social workers.

38(7) Licensed chiropractors.

39(8) Licensed acupuncturists.

40(9) Naturopathic doctors.

P18   1(10) Licensed professional clinical counselors.

2(d) Speech-language pathology corporation.

3(1) Licensed audiologists.

4(e) Audiology corporation.

5(1) Licensed speech-language pathologists.

6(f) Nursing corporation.

7(1) Licensed physicians and surgeons.

8(2) Licensed doctors of podiatric medicine.

9(3) Licensed psychologists.

10(4) Licensed optometrists.

11(5) Licensed marriage and family therapists.

12(6) Licensed clinical social workers.

13(7) Licensed physician assistants.

14(8) Licensed chiropractors.

15(9) Licensed acupuncturists.

16(10) Naturopathic doctors.

17(11) Licensed professional clinical counselors.

18(g) Marriage and family therapist corporation.

19(1) Licensed physicians and surgeons.

20(2) Licensed psychologists.

21(3) Licensed clinical social workers.

22(4) Registered nurses.

23(5) Licensed chiropractors.

24(6) Licensed acupuncturists.

25(7) Naturopathic doctors.

26(8) Licensed professional clinical counselors.

27(h) Licensed clinical social worker corporation.

28(1) Licensed physicians and surgeons.

29(2) Licensed psychologists.

30(3) Licensed marriage and family therapists.

31(4) Registered nurses.

32(5) Licensed chiropractors.

33(6) Licensed acupuncturists.

34(7) Naturopathic doctors.

35(8) Licensed professional clinical counselors.

36(i) Physician assistants corporation.

37(1) Licensed physicians and surgeons.

38(2) Registered nurses.

39(3) Licensed acupuncturists.

40(4) Naturopathic doctors.

P19   1(j) Optometric corporation.

2(1) Licensed physicians and surgeons.

3(2) Licensed doctors of podiatric medicine.

4(3) Licensed psychologists.

5(4) Registered nurses.

6(5) Licensed chiropractors.

7(6) Licensed acupuncturists.

8(7) Naturopathic doctors.

9(k) Chiropractic corporation.

10(1) Licensed physicians and surgeons.

11(2) Licensed doctors of podiatric medicine.

12(3) Licensed psychologists.

13(4) Registered nurses.

14(5) Licensed optometrists.

15(6) Licensed marriage and family therapists.

16(7) Licensed clinical social workers.

17(8) Licensed acupuncturists.

18(9) Naturopathic doctors.

19(10) Licensed professional clinical counselors.

20(l) Acupuncture corporation.

21(1) Licensed physicians and surgeons.

22(2) Licensed doctors of podiatric medicine.

23(3) Licensed psychologists.

24(4) Registered nurses.

25(5) Licensed optometrists.

26(6) Licensed marriage and family therapists.

27(7) Licensed clinical social workers.

28(8) Licensed physician assistants.

29(9) Licensed chiropractors.

30(10) Naturopathic doctors.

31(11) Licensed professional clinical counselors.

32(m) Naturopathic doctor corporation.

33(1) Licensed physicians and surgeons.

34(2) Licensed psychologists.

35(3) Registered nurses.

36(4) Licensed physician assistants.

37(5) Licensed chiropractors.

38(6) Licensed acupuncturists.

39(7) Licensed physical therapists.

40(8) Licensed doctors of podiatric medicine.

P20   1(9) Licensed marriage and family therapists.

2(10) Licensed clinical social workers.

3(11) Licensed optometrists.

4(12) Licensed professional clinical counselors.

5(n) Dental corporation.

6(1) Licensed physicians and surgeons.

7(2) Dental assistants.

8(3) Registered dental assistants.

9(4) Registered dental assistants in extended functions.

10(5) Registered dental hygienists.

11(6) Registered dental hygienists in extended functions.

12(7) Registered dental hygienists in alternative practice.

13(o) Professional clinical counselor corporation.

14(1) Licensed physicians and surgeons.

15(2) Licensed psychologists.

16(3) Licensed clinical social workers.

17(4) Licensed marriage and family therapists.

18(5) Registered nurses.

19(6) Licensed chiropractors.

20(7) Licensed acupuncturists.

21(8) Naturopathic doctors.

22(p) Physical therapy corporation.

23(1) Licensed physicians and surgeons.

24(2) Licensed doctors of podiatric medicine.

25(3) Licensed acupuncturists.

26(4) Naturopathic doctors.

27(5) Licensed occupational therapists.

28(6) Licensed speech-language therapists.

29(7) Licensed audiologists.

30(8) Registered nurses.

31(9) Licensed psychologists.

32(10) Licensed physician assistants.

33(q) Registered dental hygienist in alternative practice
34corporation.

35(1) Registered dental assistants.

36(2) Licensed dentists.

37(3) Registered dental hygienists.

38(4) Registered dental hygienists in extended functions.

39begin insert

begin insertSEC. 10.end insert  

end insert
begin insert

No reimbursement is required by this act pursuant
40to Section 6 of Article XIII B of the California Constitution because
P21   1the only costs that may be incurred by a local agency or school
2district will be incurred because this act creates a new crime or
3infraction, eliminates a crime or infraction, or changes the penalty
4for a crime or infraction, within the meaning of Section 17556 of
5the Government Code, or changes the definition of a crime within
6the meaning of Section 6 of Article XIII B of the California
7Constitution.

end insert


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