Amended in Assembly June 21, 2016

Amended in Senate May 31, 2016

Amended in Senate April 13, 2016

Senate BillNo. 1193


Introduced by Senator Hill

(Principal coauthor: Assembly Member Salas)

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(Coauthor: Assembly Member Brough)

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February 18, 2016


An act to amend Sections 4001, 4003,begin insert 4081,end insert 4107, 4110, 4119.1, 4127, 4127.3, 4127.7, 4127.8, 4127.9, 4128.6, 4161, 4180,begin insert 4201, 4312,end insert 4400,begin delete and 4406end deletebegin insert 4406, 4800, 4804.5, 4830, 4846.5, 4904, and 4905end insert of, to add Sections 4034,begin insert 4105.5,end insert 4126.9, 4203.5,begin delete and 4316end deletebegin insert 4303.1, 4316, 4826.5, 4848.1, and 4853.7,end insert to, and to add Article 7.7 (commencing with Section 4129) to Chapter 9 of Division 2 of, the Business and Professions Code, to amend Section 13401.5 of the Corporations Code, and to amend Sections 1261.6 and 11164.5 of the Health and Safety Code, relating to healingbegin delete arts, and making an appropriation therefor.end deletebegin insert arts.end insert

LEGISLATIVE COUNSEL’S DIGEST

SB 1193, as amended, Hill. begin deletePharmacy: Law. end deletebegin insertHealing arts.end insert

begin insert(1)end insertbegin insertend insertThe 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. That 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.

This bill would extend the operation of the board and the board’s authorization to appoint an executive officer until January 1, 2021.

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The Pharmacy Law requires each application to conduct a pharmacy, wholesaler, 3rd-party logistics provider, or veterinary food-animal drug retailer to be made on a form furnished by the board and to state specified information. That law requires the executive officer to issue a license to conduct a pharmacy, wholesaler, 3rd-party logistics provider, or veterinary food-animal drug retailer, if specified conditions are met. That law authorizes the board to cancel a license if the licensed premises remains closed, as defined, other than by order of the board. That law requires a licensee whose license is canceled or who notifies the board of its intent to remain closed or to discontinue business to arrange for the transfer of all dangerous drugs and controlled substances or dangerous devices to another licensee within 10 days. That law authorizes the board to seek and obtain a specified court order authorizing the board to enter the premises, and inventory and store, transfer, sell, or arrange for the sale of, all dangerous drugs and controlled substances and dangerous devices found in the premises if the licensee does not comply with the requirement to do so.

end insert
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This bill would require an outsourcing facility, as defined, to be licensed with the board before doing business within or into the state. The bill would require each application to conduct an outsourcing facility to be made on a form furnished by the board and to state specified information. The bill would require the executive officer to issue a license if specified conditions are met. The bill would prohibit an outsourcing facility from being concurrently licensed with the board as a sterile compounding pharmacy at the same location. The bill 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 prohibit the issuance or renewal of an outsourcing facility until the board inspects the location of an outsourcing facility to ensure that the outsourcing facility is in compliance with all laws and regulations. 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 immediately cancel, revoke, or suspend by operation of law the license of any nonresident outsourcing facility whose registration is canceled, revoked, or suspended by the FDA. The bill would authorize the board to cancel an outsourcing facility license if the outsourcing facility remains closed, as defined, other than by order of the board. The bill would require an outsourcing facility licensee whose license is canceled or who notifies the board of its intent to remain closed or to discontinue business to arrange for the transfer of all dangerous drugs and controlled substances or dangerous devices to another licensee within 10 days. The bill would authorize the board to seek and obtain a specified court order authorizing the board to enter the outsourcing facility, and inventory and store, transfer, sell, or arrange for the sale of, all dangerous drugs and controlled substances and dangerous devices found in the outsourcing facility if the licensee does not comply with the requirement to do so. 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.

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The Pharmacy Law requires that fees collected on behalf of the board be credited to the Pharmacy Board Contingent Fund. Existing law continuously appropriates fees in the fund.

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This bill would authorize the board to collect a fee of $4000 for the issuance and renewal of an outsourcing license and a fee of $715 for a temporary license, as specified. This bill would provide that the Pharmacy Board Contingent Fund is available for expenditure only upon an appropriation by the Legislature.

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The Pharmacy Law requires all records of manufacture, and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices to be at all times, during business hours, open to inspection by authorized officers of the law, and to be preserved for at least 3 years from the date of making. That law requires specified entities and individuals to keep a current inventory of these records.

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This bill would require outsourcing facility to keep a current inventory of these records.

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The Pharmacy Law authorizes the board to issue a temporary permit to own or operate a pharmacy when the ownership of a pharmacy is transferred from one person to another, as specified.

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The

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begin insertThisend insert bill would authorize the board to issue a temporary permit, as specified, regardless of whether the ownership of a pharmacy is transferred from one person to another.

The Pharmacybegin delete lawend deletebegin insert Lawend insert authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system.

This bill would require a pharmacybegin delete to register use of an automated drug delivery system with the board, including the address and location of use.end deletebegin insert that owns or provides dangerous drugs dispensed through an automated drug delivery system to register the system by providing the board in writing with the location of each automated drug delivery system within 30 days of installation and on an annual basis as part of the license renewal. The bill would also require the pharmacy to advise the board in writing within 30 days if the pharmacy discontinues operating an automated drug delivery system. The bill would exempt from these requirements an automated drug delivery system operated by a licensed hospital pharmacy for doses administered in a facility operated under a consolidated license. The bill would authorize a pharmacy to use an automated drug delivery system only if certain conditions are satisfied, including, among other conditions, that the pharmacy report to the board drug losses from the system. The bill would authorize the board to prohibit a pharmacy from using an automated drug delivery system if the board determines that those conditions are not satisfied. The bill would require the board to provide the pharmacy with written notice, as specified, if the board determines those conditions are not satisfied. The bill would authorize the pharmacy, within 30 days of receipt of the written notice, to request an office conference to appeal the board’s decision. The bill would authorize the executive officer or designee to affirm or overturn the prohibition as a result of the office conference.end insert

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Existing law,

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begin insertThe Pharmacy Law,end insert until January 1, 2012, permitted access by licensed personnel to multiple drugs that are not patient specific only if an automated drug delivery system had both electronic and mechanical safeguards in place to ensure that the only drugs delivered to the patient were specific to that patient. Existing law, until January 1, 2012, required each facility using an automated drug delivery system to notify the State Department of Health Care Services in writing prior to utilization of the system, as provided. Existing law, until January 1, 2012, required the department, as part of its oversight of those facilities, to review a facility’s medication training, storage, and security and its administration procedures related to its use of an automated drug delivery system.

This bill would make these provisions operative by repealing the provision that made them inoperative on January 1, 2012.

The Pharmacy Law requires 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.begin delete Existing law makes a violation of any provision of the Pharmacy Law punishable as an infraction if no other penalty is provided.end delete

This 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 require that this provision not be construed to limit the board’s authority to investigate to determine whether the applicant and the premises qualify for a license.

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. That law prohibits the board from issuing more than one site license to a single premises with specified exceptions, including issuing a license to compound sterile injectable drugs to a resident pharmacy.

This bill would expand the exception under which the board may issue more than one site license to a single premises to include issuing a license to compound sterile drugs to a pharmacy, regardless of whether those drugs are injectable and regardless of whether the pharmacy is a nonresident pharmacy.

The Pharmacy Law requires a pharmacy that compounds sterile drug products for injection, administration into the eye, or inhalation to possess a sterile compounding pharmacy license.

This bill would require a pharmacy that compounds any sterile drug products to possess a sterile compounding pharmacy license.

The Pharmacy Law authorizes the executive officer of the board, based on a reasonable belief obtained during an investigation or pharmacy inspection by the board, to issue a cease and desist order to a pharmacy requiring the pharmacy to refrain from compounding injectable sterile drug products if that activity poses an immediate threat to the public health or safety.

This bill would expand the authorization of the executive officer of the board to issue a cease and desist order to include requiring the pharmacy to refrain from compounding any sterile drug products if that activity poses an immediate threat to public health or safety.

The Pharmacy Law requires a pharmacy to compound injectable sterile products from one or more nonsterile ingredients in a specified environment.

This bill would require a pharmacy to compound any sterile products from one or more nonsterile ingredients in a specified environment.

The Pharmacy Law authorizes the board to issue a temporary license to compound injectable sterile drug products when the ownership of a pharmacy that is licensed to compound injectable sterile drug products is transferred from one person to another, as specified.

This bill would authorize the board to issue a temporary permit to compound sterile drug products, as specified, regardless of whether the drug product is injectable and regardless of whether the ownership of the pharmacy is transferred from one person to another.

The Pharmacy Law requires a resident or a nonresident pharmacy that issues a recall notice regarding a sterile compounded drug tobegin delete contactend deletebegin insert contact, as specified,end insert the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 12 hours of the recall notice, if use of or exposure to the recalled drug may cause serious adverse health consequences or death and if the recalled drug was dispensed or is intended for use in this state.

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The

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begin insertThisend insert bill would make a technical correction to this provision and would require a pharmacy that issues a recall notice regarding a nonsterile compounded drug to contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 12 hours of the recall notice, if use of or exposure to the recalled drug may cause serious adverse health consequences or death and if the recalled drug was dispensed or is intended for use in this state. The bill would also require a pharmacy that has been advised that a patient has been harmed by using a nonsterile compounded product potentially attributable to the pharmacy to report the event to the MedWatch program of the federal Food and Drug Administration within 72 hours.

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This 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.

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begin delete

Existing law

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begin insertThe Pharmacy Lawend insert authorizes specified clinics to purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to the clinic’s patients.begin delete Existingend deletebegin insert Thatend insert law requires each clinic location to have a separate license.

This bill would require the board to synchronize license renewal dates and aggregate fees for multiple clinics under common nonprofit ownership at the request of the parent organization.

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Existing law requires that fees collected on behalf of the board be credited to the Pharmacy Board Contingent Fund. Existing law continuously appropriates fees in the fund.

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This bill would 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. This bill would provide that the Pharmacy Board Contingent Fund is available for expenditure only upon an appropriation by the Legislature.

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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.

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.

Existing law authorizes, with the approval of the board and the Department of Justice, a pharmacy or hospital to receive electronic data transmission prescriptions and computer entry prescriptions or orders for controlled substances in Schedule II, III, IV, or V, if authorized by federal law and in accordance with regulations promulgated by the federal Drug Enforcement Administration. Existing law requires the board to maintain a list of all requests and approvals granted. Existing law prohibits an approved pharmacy or hospital receiving an electronic transmission prescription or a computer entry prescription or order for a controlled substance in Schedule II, III, IV, or V from being required to reduce that prescription or order to writing or to hard copy form as long as the pharmacy or hospital is able to immediately produce a specified hard copy upon request.

This bill would remove these provisions.

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(2) The Veterinary Medicine Practice Act provides for the licensure and registration of veterinarians and registered veterinary technicians and the regulation of the practice of veterinary medicine by the Veterinary Medical Board, which is within the Department of Consumer Affairs, and authorizes the board to appoint an executive officer, as specified.

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Existing law repeals the provisions establishing the board and authorizing the board to appoint an executive officer as of January 1, 2017.

end insert
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This bill would extend the operation of the board and the authorization of the board to appoint an executive officer until January 1, 2021. The bill would authorize a veterinarian or registered veterinary technician who is under the direct supervision of a licensed veterinarian to compound a drug for animal use pursuant to federal law and regulations promulgated by the board and would require those regulations to, at a minimum, address the storage of drugs, the level and type of supervision required for compounding drugs by a registered veterinary technician, and the equipment necessary for safe compounding of drugs.

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The Veterinary Medicine Practice Act exempts certain persons from the requirements of the act, including a veterinarian employed by the University of California or the Western University of Health Sciences while engaged in the performance of specified duties. That act requires all premises where veterinary medicine, dentistry, and surgery is being practiced to register with the board.

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The bill would instead require veterinarians engaged in the practice of veterinary medicine employed by the University of California or by the Western University of Health Sciences and engaged in the performance of specified duties to be licensed as a veterinarian in the state or be issued a university license, as specified. The bill would authorize an individual to apply for and be issued a university license if he or she meets certain requirements, including paying an application and license fee. The bill would require a university license, among other things, to automatically cease to be valid upon termination or cessation of employment by the University of California or the Western University of Health Sciences. The bill would also prohibit a premise registration that is not renewed within 5 years after its expiration from being renewed, restored, reissued, or reinstated; however, the bill would authorize a new premise registration to be issued to an applicant if no fact, circumstance, or condition exists that would justify the revocation or suspension of the registration if the registration was issued and if specified fees are paid.

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The Veterinary Medicine Practice Act requires all fees collected on behalf of the board to be deposited into the Veterinary Medical Board Contingent Fund, which continuously appropriates fees deposited into the fund.

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This bill would provide that the Veterinary Medical Board Contingent Fund is available for expenditure only upon an appropriation by the Legislature.

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(3) The Pharmacy Law makes a violation of any of its provisions punishable as an infraction if no other penalty is provided. The Veterinary Medicine Practice Act makes a violation of any of its provisions punishable as a misdemeanor.

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By placing new requirements on a pharmacy, this bill would expand an existing crime and would, therefore, impose a state-mandated local program.begin insert The bill would also expand the definition of an existing crime and, therefore, result in a state-mandated local program by requiring additional persons to be licensed under the act that were previously exempt.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:

P9    1

SECTION 1.  

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

P10   1

4001.  

(a) There is in the Department of Consumer Affairs a
2California State Board of Pharmacy in which the administration
3and enforcement of this chapter is vested. The board consists of
413 members.

5(b) The Governor shall appoint seven competent pharmacists
6who reside in different parts of the state to serve as members of
7the board. The Governor shall appoint four public members, and
8the Senate Committee on Rules and the Speaker of the Assembly
9shall each appoint a public member who shall not be a licensee of
10the board, any other board under this division, or any board referred
11to in Section 1000 or 3600.

12(c) At least five of the seven pharmacist appointees to the board
13shall be pharmacists who are actively engaged in the practice of
14pharmacy. Additionally, the membership of the board shall include
15at least one pharmacist representative from each of the following
16practice settings: an acute care hospital, an independent community
17pharmacy, a chain community pharmacy, and a long-term health
18care or skilled nursing facility. The pharmacist appointees shall
19also include a pharmacist who is a member of a labor union that
20represents pharmacists. For the purposes of this subdivision, a
21“chain community pharmacy” means a chain of 75 or more stores
22in California under the same ownership, and an “independent
23community pharmacy” means a pharmacy owned by a person or
24entity who owns no more than four pharmacies in California.

25(d) Members of the board shall be appointed for a term of four
26years. No person shall serve as a member of the board for more
27than two consecutive terms. Each member shall hold office until
28the appointment and qualification of his or her successor or until
29one year shall have elapsed since the expiration of the term for
30which the member was appointed, whichever first occurs.
31Vacancies occurring shall be filled by appointment for the
32unexpired term.

33(e) Each member of the board shall receive a per diem and
34expenses as provided in Section 103.

35(f) This section shall remain in effect only until January 1, 2021,
36and as of that date is repealed. Notwithstanding any other law, the
37repeal of this section renders the board subject to review by the
38appropriate policy committees of the Legislature.

39

SEC. 2.  

Section 4003 of the Business and Professions Code is
40amended to read:

P11   1

4003.  

(a) The board, with the approval of the director, may
2appoint a person exempt from civil service who shall be designated
3as an executive officer and who shall exercise the powers and
4perform the duties delegated by the board and vested in him or her
5by this chapter. The executive officer may or may not be a member
6of the board as the board may determine.

7(b) The executive officer shall receive the compensation as
8established by the board with the approval of the Director of
9Finance. The executive officer shall also be entitled to travel and
10other expenses necessary in the performance of his or her duties.

11(c) The executive officer shall maintain and update in a timely
12fashion records containing the names, titles, qualifications, and
13places of business of all persons subject to this chapter.

14(d) The executive officer shall give receipts for all money
15received by him or her and pay it to the department, taking its
16receipt therefor. Besides the duties required by this chapter, the
17executive officer shall perform other duties pertaining to the office
18as may be required of him or her by the board.

19(e) This section shall remain in effect only until January 1, 2021,
20and as of that date is repealed.

21

SEC. 3.  

Section 4034 is added to the Business and Professions
22Code
, to read:

23

4034.  

“Outsourcing facility” means a facility that meets all of
24the following:

25(a) Is located within the United States of America at one address
26that is engaged in the compounding of sterile drugs and nonsterile
27drugs.

28(b) Has registered as an outsourcing facility with the federal
29Food and Drug Administration under Section 503B of the Federal
30Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353b).

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

32(d) Is licensed with the board as an outsourcing facility pursuant
33to Article 7.7 (commencing with Section 4129).

34begin insert

begin insertSEC. 4.end insert  

end insert

begin insertSection 4081 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
35amended to read:end insert

36

4081.  

(a) All records of manufacture and of sale, acquisition,
37receipt, shipment, or disposition of dangerous drugs or dangerous
38devices shall be at all times during business hours open to
39inspection by authorized officers of the law, and shall be preserved
40for at least three years from the date of making. A current inventory
P12   1shall be kept by every manufacturer, wholesaler, third-party
2logistics provider, pharmacy, veterinary food-animal drug retailer,
3begin insert outsourcing facility,end insert physician, dentist, podiatrist, veterinarian,
4laboratory, clinic, hospital, institution, or establishment holding a
5currently valid and unrevoked certificate, license, permit,
6registration, or exemption under Division 2 (commencing with
7Section 1200) of the Health and Safety Code or under Part 4
8(commencing with Section 16000) of Division 9 of the Welfare
9and Institutions Code who maintains a stock of dangerous drugs
10or dangerous devices.

11(b) The owner, officer, and partner of a pharmacy, wholesaler,
12third-party logistics provider, or veterinary food-animal drug
13retailer shall be jointly responsible, with the pharmacist-in-charge,
14responsible manager, or designated representative-in-charge, for
15maintaining the records and inventory described in this section.

16(c) The pharmacist-in-charge, responsible manager, or
17designated representative-in-charge shall not be criminally
18responsible for acts of the owner, officer, partner, or employee
19that violate this section and of which the pharmacist-in-charge,
20responsible manager, or designated representative-in-charge had
21no knowledge, or in which he or she did not knowingly participate.

22begin insert

begin insertSEC. 5.end insert  

end insert

begin insertSection 4105.5 is added to the end insertbegin insertBusiness and Professions
23Code
end insert
begin insert, to read:end insert

begin insert
24

begin insert4105.5.end insert  

(a) For purposes of this section, an “automated drug
25delivery system” has the same meaning as that term is defined in
26paragraph (1) of subdivision (a) of Section 1261.6 of the Health
27and Safety Code.

28
(b) Except as provided by subdivision (e), a pharmacy that owns
29or provides dangerous drugs dispensed through an automated
30drug delivery system shall register the automated drug delivery
31system by providing the board in writing with the location of each
32device within 30 days of installation of the device, and on an
33annual basis as part of the license renewal pursuant to subdivision
34(a) of Section 4110. The pharmacy shall also advise the board in
35writing within 30 days if the pharmacy discontinues operating an
36automated drug delivery system.

37
(c) A pharmacy may only use an automated drug delivery system
38if all of the following conditions are satisfied:

39
(1) Use of the automated drug delivery system is consistent with
40legal requirements.

P13   1
(2) The pharmacy’s policies and procedures related to the
2automated drug delivery system to include appropriate security
3measures and monitoring of the inventory to prevent theft and
4diversion.

5
(3) The pharmacy reports drug losses from the automated drug
6delivery system to the board as required by law.

7
(4) The pharmacy license is unexpired and not subject to
8disciplinary conditions.

9
(d) The board may prohibit a pharmacy from using an
10 automated drug delivery system if the board determines that the
11conditions provided in subdivision (c) are not satisfied. If such a
12determination is made, the board shall provide the pharmacy with
13written notice including the basis for the determination. The
14pharmacy may request an office conference to appeal the board’s
15decision within 30 days of receipt of the written notice. The
16executive officer or designee may affirm or overturn the prohibition
17as a result of the office conference.

18
(e) An automated drug delivery system operated by a licensed
19hospital pharmacy as defined in Section 4029 for doses
20administered in a facility operated under a consolidated license
21under Section 1250.8 of the Health and Safety Code shall be exempt
22from the requirements of subdivision (b).

end insert
23

begin deleteSEC. 4.end delete
24
begin insertSEC. 6.end insert  

Section 4107 of the Business and Professions Code is
25amended to read:

26

4107.  

(a) The board shall not issue more than one site license
27to a single premises except as follows:

28(1) To issue a veterinary food-animal drug retailer license to a
29wholesaler pursuant to Section 4196.

30(2) To issue a license to compound sterile drugs to a pharmacy
31pursuant to Section 4127.1 or 4127.2.

32(3) To issue a centralized hospital packaging license pursuant
33to Section 4128.

34(b) For the purposes of this subdivision, “premises” means a
35location with its own address and an independent means of ingress
36and egress.

37

begin deleteSEC. 5.end delete
38
begin insertSEC. 7.end insert  

Section 4110 of the Business and Professions Code is
39amended to read:

P14   1

4110.  

(a) No person shall conduct a pharmacy in the State of
2California unless he or she has obtained a license from the board.
3A license shall be required for each pharmacy owned or operated
4by a specific person. A separate license shall be required for each
5of the premises of any person operating a pharmacy in more than
6one location. The license shall be renewed annually. The board
7may, by regulation, determine the circumstances under which a
8license may be transferred.

9(b) The board may, at its discretion, issue a temporary permit
10upon the conditions and for any periods of time as the board
11determines to be in the public interest. A temporary permit fee
12shall be required in an amount established by the board as specified
13in subdivision (a) of Section 4400. When needed to protect public
14safety, a temporary permit may be issued for a period not to exceed
15180 days, and may be issued subject to terms and conditions the
16board deems necessary. If the board determines a temporary permit
17was issued by mistake or denies the application for a permanent
18license or registration, the temporary license or registration shall
19terminate upon either personal service of the notice of termination
20upon the permitholder or service by certified mail, return receipt
21requested, at the permitholder’s address of record with the board,
22whichever comes first. Neither for purposes of retaining a
23temporary permit nor for purposes of any disciplinary or license
24denial proceeding before the board shall the temporary
25 permitholder be deemed to have a vested property right or interest
26in the permit.

27(c) The board may allow the temporary use of a mobile
28pharmacy when a pharmacy is destroyed or damaged, the mobile
29pharmacy is necessary to protect the health and safety of the public,
30and the following conditions are met:

31(1) The mobile pharmacy shall provide services only on or
32immediately contiguous to the site of the damaged or destroyed
33pharmacy.

34(2) The mobile pharmacy is under the control and management
35of the pharmacist-in-charge of the pharmacy that was destroyed
36or damaged.

37(3) A licensed pharmacist is on the premises while drugs are
38being dispensed.

39(4) Reasonable security measures are taken to safeguard the
40drug supply maintained in the mobile pharmacy.

P15   1(5) The pharmacy operating the mobile pharmacy provides the
2board with records of the destruction of, or damage to, the
3pharmacy and an expected restoration date.

4(6) Within three calendar days of restoration of the pharmacy
5services, the board is provided with notice of the restoration of the
6permanent pharmacy.

7(7) The mobile pharmacy is not operated for more than 48 hours
8following the restoration of the permanent pharmacy.

9

begin deleteSEC. 6.end delete
10
begin insertSEC. 8.end insert  

Section 4119.1 of the Business and Professions Code
11 is amended to read:

12

4119.1.  

(a) A pharmacy may provide pharmacy services to a
13health facility licensed pursuant to subdivision (c), (d), or both, of
14Section 1250 of the Health and Safety Code, through the use of
15an automated drug delivery system that need not be located at the
16same location as the pharmacy.

17(b) Drugs stored in an automated drug delivery system shall be
18part of the inventory of the pharmacy providing pharmacy services
19to that facility, and drugs dispensed from the pharmacy system
20shall be considered to have been dispensed by that pharmacy.

21(c) (1) The pharmacy shall maintain records of the acquisition
22and disposition of dangerous drugs and dangerous devices stored
23in the automated drug delivery system separate from other
24pharmacy records.

25(2) The pharmacy shall own and operate the automated drug
26delivery system.

27(3) The pharmacy shall provide training regarding the operation
28and use of the automated drug delivery system to both pharmacy
29and health facility personnel using the system.

30(4) The pharmacy shall operate the automated drug delivery
31system in compliance with Section 1261.6 of the Health and Safety
32Code.

33(d) The operation of the automated drug delivery system shall
34be under the supervision of a licensed pharmacist. To qualify as a
35supervisor for an automated drug delivery system, the pharmacist
36need not be physically present at the site of the automated drug
37delivery system and may supervise the system electronically.

begin delete

38(e) The pharmacy shall register use of an automated drug
39delivery system with the board, including the address and location
40of use.

end delete
begin delete

P16   1 (f)

end delete

2begin insert(e)end insert This section shall not be construed to revise or limit the use
3of automated drug delivery systems as permitted by the board in
4any licensed health facility other than a facility defined in
5subdivision (c) or (d), or both, of Section 1250 of the Health and
6Safety Code.

7

begin deleteSEC. 7.end delete
8
begin insertSEC. 9.end insert  

Section 4126.9 is added to the Business and Professions
9Code
, to read:

10

4126.9.  

(a) A pharmacy that issues a recall notice regarding
11a nonsterile compounded drug product shall, in addition to any
12other duties, contact the recipient pharmacy, prescriber, or patient
13of the recalled drug and the board within 12 hours of the recall
14notice if both of the following apply:

15(1) Use of or exposure to the recalled drug may cause serious
16adverse health consequences or death.

17(2) The recalled drug was dispensed, or is intended for use, in
18this state.

19(b) A recall notice issued pursuant to subdivision (a) shall be
20made as follows:

21(1) If the recalled drug was dispensed directly to the patient,
22the notice shall be made to the patient.

23(2) If the recalled drug was dispensed directly to the prescriber,
24the notice shall be made to the prescriber, who shall ensure the
25patient is notified.

26(3) If the recalled drug was dispensed directly to a pharmacy,
27the notice shall be made to the pharmacy, which shall notify the
28prescriber or patient, as appropriate. If the pharmacy notifies the
29prescriber, the prescriber shall ensure the patient is notified.

30(c) begin deleteIn cases where patient harm has occurred resulting from use
31of the compounded product, the event shall be reported end delete
begin insertA pharmacy
32that has been advised that a patient has been harmed by using a
33nonsterile compounded product potentially attributable to the
34pharmacy shall report the event end insert
to MedWatch within 72 hours of
35the pharmacy being advised.

36

begin deleteSEC. 8.end delete
37
begin insertSEC. 10.end insert  

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

P17   1

4127.  

(a) A pharmacy that compounds sterile drug products
2shall possess a sterile compounding pharmacy license as provided
3in this article.

4(b) The board shall adopt regulations in accordance with the
5Administrative Procedure Act (Chapter 3.5 (commencing with
6Section 11340) of Part 1 of Division 3 of Title 2 of the Government
7Code) to establish policies, guidelines, and procedures to
8implement this article.

9(c) The board shall review any formal revision to General
10Chapter 797 of the United States Pharmacopeia and The National
11Formulary (USP-NF), relating to the compounding of sterile
12preparations, not later than 90 days after the revision becomes
13official, to determine whether amendments are necessary for the
14regulations adopted by the board pursuant to subdivision (b).

15

begin deleteSEC. 9.end delete
16
begin insertSEC. 11.end insert  

Section 4127.3 of the Business and Professions Code
17 is amended to read:

18

4127.3.  

(a) Whenever the board has a reasonable belief, based
19on information obtained during an inspection or investigation by
20the board, that a pharmacy compounding sterile drug products
21poses an immediate threat to the public health or safety, the
22executive officer of the board may issue an order to the pharmacy
23to immediately cease and desist from compounding sterile drug
24products. The cease and desist order shall remain in effect for no
25more than 30 days or the date of a hearing seeking an interim
26suspension order, whichever is earlier.

27(b) Whenever the board issues a cease and desist order pursuant
28to subdivision (a), the board shall immediately issue the owner a
29notice setting forth the acts or omissions with which the owner is
30charged, specifying the pertinent code section or sections.

31(c) The order shall provide that the owner, within 15 days of
32receipt of the notice, may request a hearing before the president
33of the board to contest the cease and desist order. Consideration
34of the owner’s contest of the cease and desist order shall comply
35with the requirements of Section 11425.10 of the Government
36Code. The hearing shall be held no later than five days from the
37date the request of the owner is received by the board. The
38president shall render a written decision within five days of the
39hearing. In the absence of the president of the board, the vice
40president of the board may conduct the hearing permitted by this
P18   1subdivision. Review of the decision of the president of the board
2may be sought by the owner or person in possession or control of
3the pharmacy pursuant to Section 1094.5 of the Code of Civil
4Procedure.

5(d) Failure to comply with a cease and desist order issued
6pursuant to this section shall be unprofessional conduct.

7

begin deleteSEC. 10.end delete
8
begin insertSEC. 12.end insert  

Section 4127.7 of the Business and Professions Code
9 is amended to read:

10

4127.7.  

A pharmacy shall compound sterile products from one
11or more nonsterile ingredients in one of the following
12environments:

13(a) An ISO class 5 laminar airflow hood within an ISO class 7
14cleanroom. The cleanroom must have a positive air pressure
15differential relative to adjacent areas.

16(b) An ISO class 5 cleanroom.

17(c) A barrier isolator that provides an ISO class 5 environment
18for compounding.

19

begin deleteSEC. 11.end delete
20
begin insertSEC. 13.end insert  

Section 4127.8 of the Business and Professions Code
21 is amended to read:

22

4127.8.  

The board may, at its discretion, issue a temporary
23license to compoundbegin delete injectableend delete sterile drug products upon the
24conditions and for any periods of time as the board determines to
25be in the public interest. A temporary license fee shall be required
26in an amount established by the board as specified in subdivision
27(u) of Section 4400. When needed to protect public safety, a
28temporary license may be issued for a period not to exceed 180
29days, and may be issued subject to terms and conditions the board
30deems necessary. If the board determines a temporary license was
31issued by mistake or denies the application for a permanent license,
32the temporary license shall terminate upon either personal service
33of the notice of termination upon the licenseholder or service by
34certified mail, return receipt requested at the licenseholder’s address
35of record with the board, whichever comes first. Neither for
36purposes of retaining a temporary license nor for purposes of any
37disciplinary or license denial proceeding before the board shall
38the temporary licenseholder be deemed to have a vested property
39right or interest in the license.

P19   1

begin deleteSEC. 12.end delete
2
begin insertSEC. 14.end insert  

Section 4127.9 of the Business and Professions Code
3 is amended to read:

4

4127.9.  

(a) A pharmacy licensed pursuant to Section 4127.1
5or 4127.2 that issues a recall notice regarding a sterile compounded
6drug shall, in addition to any other duties, contact the recipient
7pharmacy, prescriber, or patient of the recalled drug and the board
8as soon as possible within 12 hours of the recall notice if both of
9the following apply:

10(1) Use of or exposure to the recalled drug may cause serious
11adverse health consequences or death.

12(2) The recalled drug was dispensed, or is intended for use, in
13this state.

14(b) A recall notice issued pursuant to subdivision (a) shall be
15made as follows:

16(1) If the recalled drug was dispensed directly to the patient,
17the notice shall be made to the patient.

18(2) If the recalled drug was dispensed directly to the prescriber,
19the notice shall be made to the prescriber, who shall ensure the
20patient is notified.

21(3) If the recalled drug was dispensed directly to a pharmacy,
22the notice shall be made to the pharmacy, who shall notify the
23prescriber or patient, as appropriate. If the pharmacy notifies the
24prescriber, the prescriber shall ensure the patient is notified.

25

begin deleteSEC. 13.end delete
26
begin insertSEC. 15.end insert  

Section 4128.6 of the Business and Professions Code
27 is amended to read:

28

4128.6.  

All compounding and packaging functions specified
29in Section 4128 shall be performed only in the licensed centralized
30hospital packaging pharmacy and that pharmacy shall comply with
31all applicable federal and state statutes and regulations, including,
32but not limited to, regulations regarding compounding and, when
33appropriate, sterile compounding.

34

begin deleteSEC. 14.end delete
35
begin insertSEC. 16.end insert  

Article 7.7 (commencing with Section 4129) is added
36to Chapter 9 of Division 2 of the Business and Professions Code,
37to read:

 

P20   1Article 7.7.  Outsourcing Facilities
2

 

3

4129.  

(a) A facility licensed as an outsourcing facility with
4the federal Food and Drug Administration (FDA) shall be
5concurrently licensed with the board as an outsourcing facility if
6it compounds sterile medication or nonsterile medication for
7nonpatient-specific distribution within or into California.

8(b) A facility premises licensed with the board as a sterile
9compounding pharmacy shall not be concurrently licensed with
10the board as an outsourcing facility at the same location.

11(c) The board may adopt regulations in accordance with the
12Administrative Procedure Act (Chapter 3.5 (commencing with
13Section 11340) of Part 1 of Division 3 of Title 2 of the Government
14Code) to establish policies, guidelines, and procedures to
15implement this article.

16(d) The board shall review any formal requirements or guidance
17documents developed by the FDA regarding outsourcing facilities
18within 90 days after their release in order to determine whether
19revisions are necessary for any regulations promulgated by the
20board.

21(e) An outsourcing facility licensed by the board shall not
22perform the duties of a pharmacy, such as filling individual
23prescriptions for individual patients.

24

4129.1.  

(a) An outsourcing facility that is licensed with the
25federal Food and Drug Administration (FDA) and with an address
26in this state shall also be licensed by the board as an outsourcing
27facility before doing business within this state. The license shall
28be renewed annually and is not transferable.

29(b) An outsourcing facility shall compound all sterile products
30and nonsterile products in compliance with regulations issued by
31the board and with federal current good manufacturing practices
32applicable to outsourcing facilities.

33(c) An outsourcing facility license shall not be issued or renewed
34until the location is inspected by the board and found in compliance
35with this article and regulations adopted by the board.

36(d) An outsourcing facility license shall not be issued or renewed
37until the board does all of the following:

38(1) Prior to inspection, reviews a current copy of the outsourcing
39facility’s policies and procedures for sterile compounding and
40nonsterile compounding.

P21   1(2) Is provided with copies of all federal and state regulatory
2agency inspection reports, as well as accreditation reports, and
3certification reports of facilities or equipment of the outsourcing
4facility’s premises conducted in the prior 12 months.

5(3) Prior to inspection, receives a list of all sterile drugs and
6nonsterile drugs compounded by the outsourcing facility as reported
7to the FDA in the last 12 months.

8(e) An outsourcing facility licensed pursuant to this section shall
9provide the board with all of the following:

10(1) A copy of any disciplinary or other action taken by another
11state or the FDA within 10 days of the action.

12(2) Notice within 24 hours of any recall notice issued by the
13outsourcing facility.

14(3) A copy of any clinically related complaint it receives
15involving an outsourcing facility’s compounded products from or
16involving any provider, pharmacy, or patient in California within
1772 hours of receipt.

18(4) Notice within 24 hours after learning of adverse effects
19reported or potentially attributable to the outsourcing facility’s
20products.

21

4129.2.  

(a) An outsourcing facility that is licensed with the
22federal Food and Drug Administration (FDA) as an outsourcing
23facility and has an address outside of this state but in the United
24States of America is a nonresident outsourcing facility. A
25nonresident outsourcing facility shall not compound sterile drug
26products or nonsterile drug products for distribution or use into
27this state without an outsourcing license issued by the board
28pursuant to this section. The license shall be renewed annually and
29shall not be transferable.

30(b) A nonresident outsourcing facility shall compound all sterile
31products and nonsterile products to be distributed or used in this
32state in compliance with regulations of the board and with federal
33current good manufacturing practices applicable to outsourcing
34facilities.

35(c) A license for a nonresident outsourcing facility shall not be
36issued or renewed until the location is inspected by the board and
37found in compliance with this article and any regulations adopted
38by the board. The nonresident outsourcing facility shall reimburse
39the board for all actual and necessary costs incurred by the board
P22   1in conducting an inspection of the nonresident outsourcing facility
2at least once annually pursuant to subdivision (x) of Section 4400.

3(d) A license for a nonresident outsourcing facility shall not be
4issued or renewed until the board:

5(1) Prior to inspection, reviews a current copy of the nonresident
6outsourcing facility’s policies and procedures for sterile
7compounding and nonsterile compounding.

8(2) (A) Is provided with copies of all federal and state regulatory
9agency inspection reports, as well as accreditation reports, and
10certification reports of facilities or equipment of the nonresident
11outsourcing facility’s premises conducted in the prior 12 months.

12(B) For purposes of this paragraph, “state” refers to the state in
13which the nonresident outsourcing facility resides.

14(3) Prior to inspection, receives a list of all sterile drug products
15and nonsterile drug products compounded by the pharmacy as
16reported to the FDA within the prior 12 months.

17(e) A nonresident outsourcing facility licensed pursuant to this
18section shall provide the board with all of the following:

19(1) A copy of any disciplinary or other action taken by another
20state or the FDA within 10 days of the action.

21(2) Notice within 24 hours of any recall notice issued by the
22nonresident outsourcing facility.

23(3) A copy of any complaint it receives involving an outsourcing
24facility’s compounded products from or involving any provider,
25pharmacy, or patient in California within 72 hours of receipt.

26(4) Notice within 24 hours after learning of adverse effects
27reported or potentially attributable to a nonresident outsourcing
28facility’s products.

29

4129.3.  

(a) On or before January 1, 2018, the board shall
30provide a report to the Legislature regarding the regulation of
31nonresident outsourcing facilities. The report shall be submitted
32to the Legislature in the manner required pursuant to Section 9795
33of the Government Code. At a minimum, the report shall address
34all of the following:

35(1) A detailed description of board activities related to the
36inspection and licensure of nonresident outsourcing facilities.

37(2) Whether fee revenue collected pursuant to subdivision (x)
38of Section 4400 and travel cost reimbursements collected pursuant
39to subdivision (c) of Section 4129.2 provide revenue in an amount
P23   1sufficient to support the board’s activities related to the inspection
2and licensure of nonresident outsourcing facilities.

3(3) The status of proposed changes to federal law that are under
4serious consideration and that would govern outsourcing facilities
5and compounding pharmacies, including, but not limited to,
6legislation pending before Congress, administrative rules,
7regulations or orders under consideration by the FDA or other
8appropriate federal agency, and cases pending before the courts.

9(4) If applicable, recommended modifications to the board’s
10statutory duties related to nonresident outsourcing facilities as a
11result of changes to federal law or any additional modifications
12necessary to protect the health and safety of the public.

13(b) The requirement for submitting a report imposed under
14subdivision (a) is inoperative on January 1, 2022, pursuant to
15Section 10231.5 of the Government Code.

16

4129.4.  

(a) Whenever the board has a reasonable belief, based
17on information obtained during an inspection or investigation by
18the board, that an outsourcing facility compounding sterile drug
19products or nonsterile drug products poses an immediate threat to
20the public health or safety, the executive officer of the board may
21issue an order to the outsourcing facility to immediately cease and
22desist compounding sterile drug products or nonsterile drug
23products. The cease and desist order shall remain in effect for no
24more than 30 days or the date of a hearing seeking an interim
25suspension order, whichever is earlier.

26(b) Whenever the board issues a cease and desist order pursuant
27to subdivision (a), the board shall immediately issue a notice to
28the owner setting forth the acts or omissions with which the owner
29is charged, specifying the pertinent code section or sections and
30any regulations.

31(c) The cease and desist order shall state that the owner, within
3215 days of receipt of the notice, may request a hearing before the
33president of the board to contest the cease and desist order.
34Consideration of the owner’s contest of the cease and desist order
35shall comply with the requirements of Section 11425.10 of the
36Government Code. The hearing shall be held no later than five
37days after the date the request of the owner is received by the
38board. The president shall render a written decision within five
39days after the hearing. In the absence of the president of the board,
40the vice president of the board may conduct the hearing permitted
P24   1by this subdivision. Review of the decision may be sought by the
2owner or person in possession or control of the outsourcing facility
3pursuant to Section 1094.5 of the Code of Civil Procedure.

4(d) Failure to comply with a cease and desist order issued
5pursuant to this section shall be unprofessional conduct.

6

4129.5.  

Notwithstanding any other law, a violation of this
7article, or regulation adopted pursuant thereto, may subject the
8person or entity that committed the violation to a fine of up to five
9thousand dollars ($5,000) per occurrence pursuant to a citation
10issued by the board.

begin delete
11

4129.6.  

For purposes of this article, “sterile compounded
12products” means compounded preparations for injection,
13administration into the eye, or inhalation.

end delete
14

4129.8.  

The board, at its discretion, may issue a temporary
15license to an outsourcing facilitybegin delete when the ownership of the
16outsourcing facility is transferred from one person to another,end delete
upon
17the conditions and for any periods of time as the board determines
18to be in the public interest. A temporary license fee shall be
19required as specified in subdivision (w) of Section 4400. When
20needed to protect public safety, a temporary license may be issued
21for a period not to exceed 180 days, and may be issued subject to
22terms and conditions the board deems necessary. If the board
23determines a temporary license was issued by mistake or denies
24the application for a permanent license, the temporary license shall
25terminate upon the earlier of personal service of the notice of
26termination upon the licenseholder or service by certified mail
27with return receipt requested at the licenseholder’s address of
28record with the board. The temporary licenseholder shall not be
29deemed to have a vested property right or interest in the license
30for purposes of retaining a temporary license or for purposes of
31any disciplinary or license denial proceeding before the board.

32

4129.9.  

(a) An outsourcing facility licensed pursuant to Section
334129.1 or 4129.2 that issues a recall notice for a sterile drug or
34nonsterile drug compounded by the outsourcing facility, in addition
35to any other duties, shall contact the recipient pharmacy, prescriber,
36or patient of the recalled drug and the board as soon as possible
37within 24 hours of the recall notice if both of the following apply:

38(1) Use of or exposure to the recalled drug may cause serious
39adverse health consequences or death.

P25   1(2) The recalled drug was dispensed, or is intended for use, in
2this state.

3(b) A recall notice issued pursuant to subdivision (a) shall be
4made as follows:

5(1) If the recalled drug was dispensed directly to the prescriber,
6the notice shall be made to the prescriber and the prescriber shall
7ensure the patient is notified.

8(2) If the recalled drug was dispensed directly to a pharmacy,
9the notice shall be made to the pharmacy and that pharmacy shall
10notify the prescriber or patient, as appropriate. If the pharmacy
11notifies the prescriber, the prescriber shall ensure the patient is
12notified.

13

begin deleteSEC. 15.end delete
14
begin insertSEC. 17.end insert  

Section 4161 of the Business and Professions Code
15 is amended to read:

16

4161.  

(a) A person located outside this state that (1) ships,
17sells, mails, warehouses, distributes, or delivers dangerous drugs
18or dangerous devices into this state or (2) sells, brokers,
19warehouses, or distributes dangerous drugs or devices within this
20state shall be considered a nonresident wholesaler or a nonresident
21third-party logistics provider.

22(b) A nonresident wholesaler or nonresident third-party logistics
23provider shall be licensed by the board prior to shipping, selling,
24mailing, warehousing, distributing, or delivering dangerous drugs
25or dangerous devices to a site located in this state or selling,
26brokering, warehousing, or distributing dangerous drugs or devices
27within this state.

28(c) (1) A separate license shall be required for each place of
29business owned or operated by a nonresident wholesaler or
30nonresident third-party logistics provider from or through which
31dangerous drugs or dangerous devices are shipped, sold, mailed,
32warehoused, distributed, or delivered to a site located in this state
33or sold, brokered, warehoused, or distributed within this state.
34Each place of business may only be issued a single license by the
35board, except as provided in paragraph (2). A license shall be
36renewed annually and shall not be transferable.

37(2) A nonresident wholesaler and a nonresident third-party
38logistics provider under common ownership may be licensed at
39the same place of business provided that all of the following
40requirements are satisfied:

P26   1(A) The wholesaler and the third-party logistics provider each
2separately maintain the records required under Section 4081.

3(B) Dangerous drugs and dangerous devices owned by the
4wholesaler are not commingled with the dangerous drugs and
5dangerous devices handled by the third-party logistics provider.

6(C) Any individual acting as a designated representative for the
7wholesaler is not concurrently acting as a designated
8representative-3PL on behalf of the third-party logistics provider.
9Nothing in this subparagraph shall be construed to prohibit an
10individual from concurrently holding a license to act as a
11designated representative and to act as a designated
12representative-3PL.

13(D) The wholesaler has its own designated
14representative-in-charge responsible for the operations of the
15wholesaler and the third-party logistics provider has its own
16responsible manager responsible for the operations of the
17 third-party logistics provider. The same individual shall not
18concurrently serve as the responsible manager and the designated
19representative-in-charge for a wholesaler and a third-party logistics
20provider licensed at the same place of business.

21(E) The third-party logistics provider does not handle the
22prescription drugs or prescription devices owned by a prescriber.

23(F) The third-party logistics provider is not a reverse third-party
24logistics provider.

25(G) The wholesaler is not acting as a reverse distributor.

26(d) The following information shall be reported, in writing, to
27the board at the time of initial application for licensure by a
28nonresident wholesaler or a nonresident third-party logistics
29provider, on renewal of a nonresident wholesaler or nonresident
30third-party logistics provider license, or within 30 days of a change
31in that information:

32(1) Its agent for service of process in this state.

33(2) Its principal corporate officers, as specified by the board, if
34any.

35(3) Its general partners, as specified by the board, if any.

36(4) Its owners if the applicant is not a corporation or partnership.

37(e) A report containing the information in subdivision (d) shall
38be made within 30 days of any change of ownership, office,
39corporate officer, or partner.

P27   1(f) A nonresident wholesaler or nonresident third-party logistics
2provider shall comply with all directions and requests for
3information from the regulatory or licensing agency of the state
4in which it is licensed, as well as with all requests for information
5made by the board.

6(g) A nonresident wholesaler or nonresident third-party logistics
7provider shall maintain records of dangerous drugs and dangerous
8devices sold, traded, transferred, warehoused, or distributed to
9persons in this state or within this state, so that the records are in
10a readily retrievable form.

11(h) A nonresident wholesaler or nonresident third-party logistics
12provider shall at all times maintain a valid, unexpired license,
13permit, or registration to conduct the business of the wholesaler
14or nonresident third-party logistics provider in compliance with
15the laws of the state in which it is a resident. An application for a
16nonresident wholesaler or nonresident third-party logistics provider
17license in this state shall include a license verification from the
18licensing authority in the applicant’s state of residence.

19(i) (1) The board shall not issue or renew a nonresident
20wholesaler license until the nonresident wholesaler identifies a
21designated representative-in-charge and notifies the board in
22writing of the identity and license number of the designated
23representative-in-charge.

24(2) The board shall not issue or renew a nonresident third-party
25logistics provider license until the nonresident third-party logistics
26provider identifies a responsible manager and notifies the board
27in writing of the identity and license number of the designated
28representative-3PL who will be the responsible manager.

29(j) The designated representative-in-charge shall be responsible
30for the compliance of the nonresident wholesaler with state and
31federal laws governing wholesalers. The responsible manager shall
32be responsible for the compliance of the nonresident third-party
33logistics provider’s place of business with state and federal laws
34governing third-party logistics providers. A nonresident wholesaler
35or nonresident third-party logistics provider shall identify and
36notify the board of a new designated representative-in-charge or
37responsible manager within 30 days of the date that the prior
38designated representative-in-charge or responsible manager ceases
39to be the designated representative-in-charge or responsible
40manager.

P28   1(k) The board may issue a temporary license, upon conditions
2and for periods of time as the board determines to be in the public
3interest. A temporary license fee shall be five hundred fifty dollars
4($550) or another amount established by the board not to exceed
5the annual fee for renewal of a license to compound sterile drug
6products. When needed to protect public safety, a temporary license
7may be issued for a period not to exceed 180 days, subject to terms
8and conditions that the board deems necessary. If the board
9determines that a temporary license was issued by mistake or denies
10the application for a permanent license, the temporary license shall
11terminate upon either personal service of the notice of termination
12upon the licenseholder or service by certified mail, return receipt
13requested, at the licenseholder’s address of record with the board,
14whichever occurs first. Neither for purposes of retaining a
15temporary license, nor for purposes of any disciplinary or license
16denial proceeding before the board, shall the temporary
17licenseholder be deemed to have a vested property right or interest
18in the license.

19(l) The registration fee shall be the fee specified in subdivision
20(f) of Section 4400.

21

begin deleteSEC. 16.end delete
22
begin insertSEC. 18.end insert  

Section 4180 of the Business and Professions Code
23 is amended to read:

24

4180.  

(a) (1) Notwithstanding any provision of this chapter,
25any of the following clinics may purchase drugs at wholesale for
26administration or dispensing, under the direction of a physician
27and surgeon, to patients registered for care at the clinic:

28(A) A licensed nonprofit community clinic or free clinic as
29defined in paragraph (1) of subdivision (a) of Section 1204 of the
30Health and Safety Code.

31(B) A primary care clinic owned or operated by a county as
32referred to in subdivision (b) of Section 1206 of the Health and
33Safety Code.

34(C) A clinic operated by a federally recognized Indian tribe or
35tribal organization as referred to in subdivision (c) of Section 1206
36of the Health and Safety Code.

37(D) A clinic operated by a primary care community or free
38clinic, operated on separate premises from a licensed clinic, and
39that is open no more than 20 hours per week as referred to in
40subdivision (h) of Section 1206 of the Health and Safety Code.

P29   1(E) A student health center clinic operated by a public institution
2of higher education as referred to in subdivision (j) of Section 1206
3of the Health and Safety Code.

4(F) A nonprofit multispecialty clinic as referred to in subdivision
5(l) of Section 1206 of the Health and Safety Code.

6(2) The clinic shall keep records of the kind and amounts of
7drugs purchased, administered, and dispensed, and the records
8shall be available and maintained for a minimum of three years
9for inspection by all properly authorized personnel.

10(b) No clinic shall be entitled to the benefits of this section until
11it has obtained a license from the board. A separate license shall
12be required for each clinic location. A clinic shall notify the board
13of any change in the clinic’s address on a form furnished by the
14board.

15(c) The board shall synchronize license renewal dates and
16aggregate fees for multiple clinics under common nonprofit
17ownership at the request of the parent organization.

18begin insert

begin insertSEC. 19.end insert  

end insert

begin insertSection 4201 of the end insertbegin insertBusiness and Professions Codeend insert
19
begin insert is amended to read:end insert

20

4201.  

(a) Each application to conduct a pharmacy, wholesaler,
21third-party logistics provider,begin delete orend delete veterinary food-animal drug
22begin delete retailerend deletebegin insert retailer, or outsourcing facilityend insert shall be made on a form
23furnished by the board and shall state the name, address, usual
24occupation, and professional qualifications, if any, of the applicant.
25If the applicant is other than a natural person, the application shall
26state the information as to each person beneficially interested
27therein.

28(b) As used in this section, and subject to subdivision (c), the
29term “person beneficially interested” means and includes:

30(1) If the applicant is a partnership or other unincorporated
31association, each partner or member.

32(2) If the applicant is a corporation, each of its officers, directors,
33and stockholders, provided that a natural person shall not be
34deemed to be beneficially interested in a nonprofit corporation.

35(3) If the applicant is a limited liability company, each officer,
36manager, or member.

37(c) If the applicant is a partnership or other unincorporated
38association, a limited liability company, or a corporation, and the
39number of partners, members, or stockholders, as the case may
40be, exceeds five, the application shall so state, and shall further
P30   1state the information required by subdivision (a) as to each of the
2five partners, members, or stockholders who own the five largest
3interests in the applicant entity. Upon request by the executive
4officer, the applicant shall furnish the board with the information
5required by subdivision (a) as to partners, members, or stockholders
6not named in the application, or shall refer the board to an
7appropriate source of that information.

8(d) The application shall contain a statement to the effect that
9the applicant has not been convicted of a felony and has not
10violated any of the provisions of this chapter. If the applicant
11cannot make this statement, the application shall contain a
12statement of the violation, if any, or reasons which will prevent
13the applicant from being able to comply with the requirements
14with respect to the statement.

15(e) Upon the approval of the application by the board and
16payment of the fee required by this chapter for each pharmacy,
17wholesaler, third-party logistics provider, or veterinary food-animal
18drug retailer, the executive officer of the board shall issue a license
19to conduct a pharmacy, wholesaler, third-party logistics provider,
20begin delete orend delete veterinary food-animal drugbegin delete retailerend deletebegin insert retailer, or outsourcing
21facilityend insert
if all of the provisions of this chapter have been complied
22with.

23(f) Notwithstanding any other law, the pharmacy license shall
24authorize the holder to conduct a pharmacy. The license shall be
25renewed annually and shall not be transferable.

26(g) Notwithstanding any other law, the wholesaler license shall
27authorize the holder to wholesale dangerous drugs and dangerous
28devices. The license shall be renewed annually and shall not be
29transferable.

30(h) Notwithstanding any other law, the third-party logistics
31provider license shall authorize the holder to provide or coordinate
32warehousing, distribution, or other similar services of dangerous
33drugs and dangerous devices. The license shall be renewed annually
34and shall not be transferable.

35(i) Notwithstanding any other law, the veterinary food-animal
36drug retailer license shall authorize the holder to conduct a
37veterinary food-animal drug retailer and to sell and dispense
38veterinary food-animal drugs as defined in Section 4042.

39(j) For licenses referred to in subdivisions (f), (g), (h), and (i),
40any change in the proposed beneficial ownership interest shall be
P31   1reported to the board within 30 days thereafter upon a form to be
2furnished by the board.

3

begin deleteSEC. 17.end delete
4
begin insertSEC. 20.end insert  

Section 4203.5 is added to the Business and
5Professions Code
, to read:

6

4203.5.  

(a) Notwithstanding any other law, when a clinic
7applicant submits either type of application described in subdivision
8(b), the board shall issue a license or incorporate the reported
9changes, as appropriate, within 30 days of receipt of a completed
10application and payment of any prescribed fees.

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

12(1) A new clinic license application filed under Section 4180.

13(2) Applications to report changes to an existing site licensed
14under Section 4180, including, but not limited to, changes in
15professional director, clinic administrator, corporate officers,
16 change of location, or change of address.

17(c) This section shall not be construed to limit the board’s
18authority to conduct an investigation to determine whether
19applicants and the premises for which an application is made
20qualify for a license.

21begin insert

begin insertSEC. 21.end insert  

end insert

begin insertSection 4312 of the end insertbegin insertBusiness and Professions Codeend insert
22
begin insert is amended to read:end insert

23

4312.  

(a) The board may cancel the license of a wholesaler,
24third-party logistics provider, pharmacy,begin delete orend delete veterinary food-animal
25drugbegin delete retailerend deletebegin insert retailer, or outsourcing facilityend insert if the licensed premises
26remain closed, as defined in subdivision (e), other than by order
27of the board. For good cause shown, the board may cancel a license
28after a shorter period of closure. To cancel a license pursuant to
29this subdivision, the board shall make a diligent, good faith effort
30to give notice by personal service on the licensee. If a written
31objection is not received within 10 days after personal service is
32made or a diligent, good faith effort to give notice by personal
33service on the licensee has failed, the board may cancel the license
34without the necessity of a hearing. If the licensee files a written
35objection, the board shall file an accusation based on the licensee
36remaining closed. Proceedings shall be conducted in accordance
37with Chapter 5 (commencing with Section 11500) of Part 1 of
38Division 3 of Title 2 of the Government Code, and the board shall
39have all the powers granted in that chapter.

P32   1(b) If the license of a wholesaler, third-party logistics provider,
2pharmacy,begin delete orend delete veterinary food-animal drugbegin delete retailerend deletebegin insert retailer, or
3outsourcing facilityend insert
is canceled pursuant to subdivision (a) or
4revoked pursuant to Article 19 (commencing with Section 4300),
5or a wholesaler, third-party logistics provider, pharmacy,begin delete orend delete
6 veterinary food-animal drugbegin delete retailerend deletebegin insert retailer, or outsourcing facilityend insert
7 notifies the board of its intent to remain closed or to discontinue
8business, the licensee shall, within 10 days thereafter, arrange for
9the transfer of all dangerous drugs and controlled substances or
10dangerous devices to another licensee authorized to possess the
11dangerous drugs and controlled substances or dangerous devices.
12The licensee transferring the dangerous drugs and controlled
13substances or dangerous devices shall immediately confirm in
14writing to the board that the transfer has taken place.

15(c) If a wholesaler, third-party logistics provider, pharmacy,begin delete orend delete
16 veterinary food-animal drugbegin delete retailerend deletebegin insert retailer, or outsourcing facilityend insert
17 fails to comply with subdivision (b), the board may seek and obtain
18an order from the superior court in the county in which the
19wholesaler, third-party logistics provider, pharmacy,begin delete orend delete veterinary
20food-animal drugbegin delete retailerend deletebegin insert retailer, or outsourcing facilityend insert is located,
21authorizing the board to enter the wholesaler, third-party logistics
22provider, pharmacy,begin delete orend delete veterinary food-animal drugbegin delete retailerend deletebegin insert retailer,
23or outsourcing facilityend insert
and inventory and store, transfer, sell, or
24arrange for the sale of, all dangerous drugs and controlled
25substances and dangerous devices found in the wholesaler,
26third-party logistics provider, pharmacy,begin delete orend delete veterinary food-animal
27drugbegin delete retailer.end deletebegin insert retailer, or outsourcing facility.end insert

28(d) If the board sells or arranges for the sale of any dangerous
29drugs, controlled substances, or dangerous devices pursuant to
30subdivision (c), the board may retain from the proceeds of the sale
31an amount equal to the cost to the board of obtaining and enforcing
32an order issued pursuant to subdivision (c), including the cost of
33disposing of the dangerous drugs, controlled substances, or
34dangerous devices. The remaining proceeds, if any, shall be
35returned to the licensee from whose premises the dangerous drugs
36or controlled substances or dangerous devices were removed.

37(1) The licensee shall be notified of his or her right to the
38remaining proceeds by personal service or by certified mail,
39postage prepaid.

P33   1(2) If a statute or regulation requires the licensee to file with
2the board his or her address, and any change of address, the notice
3required by this subdivision may be sent by certified mail, postage
4prepaid, to the latest address on file with the board and service of
5notice in this manner shall be deemed completed on the 10th day
6after the mailing.

7(3) If the licensee is notified as provided in this subdivision,
8and the licensee fails to contact the board for the remaining
9proceeds within 30 calendar days after personal service has been
10made or service by certified mail, postage prepaid, is deemed
11completed, the remaining proceeds shall be deposited by the board
12into the Pharmacy Board Contingent Fund. These deposits shall
13be deemed to have been received pursuant to Chapter 7
14(commencing with Section 1500) of Title 10 of Part 3 of the Code
15of Civil Procedure and shall be subject to claim or other disposition
16as provided in that chapter.

17(e) For the purposes of this section, “closed” means not engaged
18in the ordinary activity for which a license has been issued for at
19least one day each calendar week during any 120-day period.

20(f) Nothing in this section shall be construed as requiring a
21pharmacy to be open seven days a week.

22begin insert

begin insertSEC. 22.end insert  

end insert

begin insertSection 4303.1 is added to the end insertbegin insertBusiness and
23Professions Code
end insert
begin insert, to read:end insert

begin insert
24

begin insert4303.1.end insert  

If the federal Food and Drug Administration (FDA)
25cancels, revokes, or suspends an outsourcing facility’s registration
26for any reason, any license issued pursuant to Section 4129.2 shall
27be immediately canceled, revoked, or suspended by operation of
28law.

end insert
29

begin deleteSEC. 18.end delete
30
begin insertSEC. 23.end insert  

Section 4316 is added to the Business and Professions
31Code
, to read:

32

4316.  

(a) The board is authorized to issue a cease and desist
33order for operating any facility under this chapter that requires
34licensure or for practicing any activity under this chapter that
35requires licensure.

36(b) Whenever the board issues a cease and desist order pursuant
37to subdivision (a), the board shall immediately issue the facility a
38notice setting forth the acts or omissions with which it is charged,
39specifying the pertinent code section or sections and any
40regulations.

P34   1(c) The order shall provide that the facility, within 15 days of
2receipt of the notice, may request a hearing before the president
3of the board to contest the cease and desist order. Consideration
4of the facility’s contest of the cease and desist order shall comply
5with the requirements of Section 11425.10 of the Government
6Code. The hearing shall be held no later than five days from the
7date the request of the owner is received by the board. The
8president shall render a written decision within five days of the
9hearing. In the absence of the president of the board, the vice
10president of the board may conduct the hearing permitted by this
11subdivision. Review of the decision of the president of the board
12may be sought by the owner or person in possession or control of
13the pharmacy pursuant to Section 1094.5 of the Code of Civil
14Procedure.

15

begin deleteSEC. 19.end delete
16
begin insertSEC. 24.end insert  

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

18

4400.  

The amount of fees and penalties prescribed by this
19chapter, except as otherwise provided, is that fixed by the board
20according to the following schedule:

21(a) The fee for a nongovernmental pharmacy license shall be
22four hundred dollars ($400) and may be increased to five hundred
23twenty dollars ($520). The fee for the issuance of a temporary
24nongovernmental pharmacy permit shall be two hundred fifty
25dollars ($250) and may be increased to three hundred twenty-five
26dollars ($325).

27(b) The fee for a nongovernmental pharmacy license annual
28renewal shall be two hundred fifty dollars ($250) and may be
29increased to three hundred twenty-five dollars ($325).

30(c) The fee for the pharmacist application and examination shall
31be two hundred dollars ($200) and may be increased to two
32hundred sixty dollars ($260).

33(d) The fee for regrading an examination shall be ninety dollars
34($90) and may be increased to one hundred fifteen dollars ($115).
35If an error in grading is found and the applicant passes the
36examination, the regrading fee shall be refunded.

37(e) The fee for a pharmacist license and biennial renewal shall
38be one hundred fifty dollars ($150) and may be increased to one
39hundred ninety-five dollars ($195).

P35   1(f) The fee for a nongovernmental wholesaler or third-party
2logistics provider license and annual renewal shall be seven
3hundred eighty dollars ($780) and may be decreased to no less
4than six hundred dollars ($600). The application fee for any
5additional location after licensure of the first 20 locations shall be
6three hundred dollars ($300) and may be decreased to no less than
7two hundred twenty-five dollars ($225). A temporary license fee
8shall be seven hundred fifteen dollars ($715) and may be decreased
9to no less than five hundred fifty dollars ($550).

10(g) The fee for a hypodermic license and renewal shall be one
11hundred twenty-five dollars ($125) and may be increased to one
12hundred sixty-five dollars ($165).

13(h) (1) The fee for application, investigation, and issuance of
14a license as a designated representative pursuant to Section 4053,
15or as a designated representative-3PL pursuant to Section 4053.1,
16shall be three hundred thirty dollars ($330) and may be decreased
17to no less than two hundred fifty-five dollars ($255).

18(2) The fee for the annual renewal of a license as a designated
19representative or designated representative-3PL shall be one
20hundred ninety-five dollars ($195) and may be decreased to no
21less than one hundred fifty dollars ($150).

22(i) (1) The fee for the application, investigation, and issuance
23of a license as a designated representative for a veterinary
24food-animal drug retailer pursuant to Section 4053 shall be three
25hundred thirty dollars ($330) and may be decreased to no less than
26two hundred fifty-five dollars ($255).

27(2) The fee for the annual renewal of a license as a designated
28representative for a veterinary food-animal drug retailer shall be
29one hundred ninety-five dollars ($195) and may be decreased to
30no less than one hundred fifty dollars ($150).

31(j) (1) The application fee for a nonresident wholesaler or
32third-party logistics provider license issued pursuant to Section
334161 shall be seven hundred eighty dollars ($780) and may be
34decreased to no less than six hundred dollars ($600).

35(2) For nonresident wholesalers or third-party logistics providers
36that have 21 or more facilities operating nationwide the application
37fees for the first 20 locations shall be seven hundred eighty dollars
38($780) and may be decreased to no less than six hundred dollars
39($600). The application fee for any additional location after
40licensure of the first 20 locations shall be three hundred dollars
P36   1($300) and may be decreased to no less than two hundred
2twenty-five dollars ($225). A temporary license fee shall be seven
3hundred fifteen dollars ($715) and may be decreased to no less
4than five hundred fifty dollars ($550).

5(3) The annual renewal fee for a nonresident wholesaler license
6or third-party logistics provider license issued pursuant to Section
74161 shall be seven hundred eighty dollars ($780) and may be
8decreased to no less than six hundred dollars ($600).

9(k) The fee for evaluation of continuing education courses for
10accreditation shall be set by the board at an amount not to exceed
11forty dollars ($40) per course hour.

12(l) The fee for an intern pharmacist license shall be ninety dollars
13($90) and may be increased to one hundred fifteen dollars ($115).
14The fee for transfer of intern hours or verification of licensure to
15another state shall be twenty-five dollars ($25) and may be
16increased to thirty dollars ($30).

17(m) The board may waive or refund the additional fee for the
18issuance of a license where the license is issued less than 45 days
19before the next regular renewal date.

20(n) The fee for the reissuance of any license, or renewal thereof,
21that has been lost or destroyed or reissued due to a name change
22shall be thirty-five dollars ($35) and may be increased to forty-five
23dollars ($45).

24(o) The fee for the reissuance of any license, or renewal thereof,
25that must be reissued because of a change in the information, shall
26be one hundred dollars ($100) and may be increased to one hundred
27thirty dollars ($130).

28(p) It is the intent of the Legislature that, in setting fees pursuant
29to this section, the board shall seek to maintain a reserve in the
30Pharmacy Board Contingent Fund equal to approximately one
31year’s operating expenditures.

32(q) The fee for any applicant for a nongovernmental clinic
33license shall be four hundred dollars ($400) and may be increased
34to five hundred twenty dollars ($520) for each license. The annual
35fee for renewal of the license shall be two hundred fifty dollars
36($250) and may be increased to three hundred twenty-five dollars
37($325) for each license.

38(r) The fee for the issuance of a pharmacy technician license
39shall be eighty dollars ($80) and may be increased to one hundred
40five dollars ($105). The fee for renewal of a pharmacy technician
P37   1license shall be one hundred dollars ($100) and may be increased
2to one hundred thirty dollars ($130).

3(s) The fee for a veterinary food-animal drug retailer license
4shall be four hundred five dollars ($405) and may be increased to
5four hundred twenty-five dollars ($425). The annual renewal fee
6for a veterinary food-animal drug retailer license shall be two
7hundred fifty dollars ($250) and may be increased to three hundred
8twenty-five dollars ($325).

9(t) The fee for issuance of a retired license pursuant to Section
10 4200.5 shall be thirty-five dollars ($35) and may be increased to
11forty-five dollars ($45).

12(u) The fee for issuance or renewal of a nongovernmental sterile
13compounding pharmacy license shall be six hundred dollars ($600)
14and may be increased to seven hundred eighty dollars ($780). The
15fee for a temporary license shall be five hundred fifty dollars ($550)
16and may be increased to seven hundred fifteen dollars ($715).

17(v) The fee for the issuance or renewal of a nonresident sterile
18compounding pharmacy license shall be seven hundred eighty
19dollars ($780). In addition to paying that application fee, the
20nonresident sterile compounding pharmacy shall deposit, when
21submitting the application, a reasonable amount, as determined by
22the board, necessary to cover the board’s estimated cost of
23performing the inspection required by Section 4127.2. If the
24required deposit is not submitted with the application, the
25application shall be deemed to be incomplete. If the actual cost of
26the inspection exceeds the amount deposited, the board shall
27provide to the applicant a written invoice for the remaining amount
28and shall not take action on the application until the full amount
29has been paid to the board. If the amount deposited exceeds the
30amount of actual and necessary costs incurred, the board shall
31remit the difference to the applicant.

32(w) The fee for the issuance or renewal of an outsourcing facility
33license shall bebegin delete seven hundred eighty dollars ($780).end deletebegin insert four thousand
34dollars ($4000).end insert
The fee for a temporary outsourcing facility
35license shall be seven hundred fifteen dollars ($715).

36(x) The fee for the issuance or renewal of a nonresident
37outsourcing facility license shall bebegin delete seven hundred eighty dollars
38($780).end delete
begin insert four thousand dollars ($4000).end insert In addition to paying that
39application fee, the nonresident outsourcing facility shall deposit,
40when submitting the application, a reasonable amount, as
P38   1determined by the board, necessary to cover the board’s estimated
2cost of performing the inspection required by Section 4129.2. If
3the required deposit is not submitted with the application, the
4application shall be deemed to be incomplete. If the actual cost of
5the inspection exceeds the amount deposited, the board shall
6provide to the applicant a written invoice for the remaining amount
7and shall not take action on the application until the full amount
8has been paid to the board. If the amount deposited exceeds the
9amount of actual and necessary costs incurred, the board shall
10remit the difference to the applicant.

11

begin deleteSEC. 20.end delete
12
begin insertSEC. 25.end insert  

Section 4406 of the Business and Professions Code
13 is amended to read:

14

4406.  

All fees collected on behalf of the board and all receipts
15of every kind and nature shall be reported each month for the month
16preceding to thebegin delete Stateend delete Controller and at the same time the entire
17amount shall be paid into the State Treasury and shall be credited
18to the Pharmacy Board Contingent Fund which is hereby created.
19This contingent fund shall be available, upon appropriation of the
20Legislature, for the use of the board.

21begin insert

begin insertSEC. 26.end insert  

end insert

begin insertSection 4800 of the end insertbegin insertBusiness and Professions Codeend insert
22
begin insert is amended to read:end insert

23

4800.  

(a) There is in the Department of Consumer Affairs a
24Veterinary Medical Board in which the administration of this
25chapter is vested. The board consists of the following members:

26(1) Four licensed veterinarians.

27(2) One registered veterinary technician.

28(3) Three public members.

29(b) This section shall remain in effect only until January 1,begin delete 2017,end delete
30begin insert 2018,end insert and as of that date isbegin delete repealed, unless a later enacted statute,
31that is enacted before January 1, 2017, deletes or extends that date.end delete

32
begin insert repealed.end insert

33(c) Notwithstanding any other law, the repeal of this section
34renders the board subject to review by the appropriate policy
35committees of the Legislature. However, the review of the board
36shall be limited to those issues identified by the appropriate policy
37committees of the Legislature and shall not involve the preparation
38or submission of a sunset review document or evaluative
39questionnaire.

P39   1begin insert

begin insertSEC. 27.end insert  

end insert

begin insertSection 4804.5 of the end insertbegin insertBusiness and Professions Codeend insert
2
begin insert is amended to read:end insert

3

4804.5.  

The board may appoint a person exempt from civil
4service who shall be designated as an executive officer and who
5shall exercise the powers and perform the duties delegated by the
6board and vested in him or her by this chapter.

7This section shall remain in effect only until January 1,begin delete 2017,end delete
8begin insert 2021,end insert and as of that date isbegin delete repealed, unless a later enacted statute,
9that is enacted before January 1, 2017, deletes or extends that date.end delete

10
begin insert repealed.end insert

11begin insert

begin insertSEC. 28.end insert  

end insert

begin insertSection 4826.5 is added to the end insertbegin insertBusiness and
12Professions Code
end insert
begin insert, to read:end insert

begin insert
13

begin insert4826.5.end insert  

Notwithstanding any other law, a licensed veterinarian
14or a registered veterinary technician under the supervision of a
15licensed veterinarian may compound drugs for animal use pursuant
16to Section 530 of Title 21 of the Code of Federal Regulations and
17in accordance with regulations promulgated by the board. The
18regulations promulgated by the board shall, at a minimum, address
19the storage of drugs, the level and type of supervision required for
20compounding drugs by a registered veterinary technician, and the
21equipment necessary for the safe compounding of drugs. Any
22violation of the regulations adopted by the board pursuant to this
23section shall constitute grounds for an enforcement or disciplinary
24action.

end insert
25begin insert

begin insertSEC. 29.end insert  

end insert

begin insertSection 4830 of the end insertbegin insertBusiness and Professions Codeend insert
26
begin insert is amended to read:end insert

27

4830.  

(a) This chapter does not apply to:

28(1) Veterinarians while serving in any armed branch of the
29military service of the United States or the United States
30Department of Agriculture while actually engaged and employed
31in their official capacity.

32(2) Regularly licensed veterinarians in actual consultation from
33other states.

34(3) Regularly licensed veterinarians actually called from other
35states to attend cases in this state, but who do not open an office
36or appoint a place to do business within this state.

begin delete

37(4) Veterinarians employed by the University of California
38while engaged in the performance of duties in connection with the
39College of Agriculture, the Agricultural Experiment Station, the
40School of Veterinary Medicine, or the agricultural extension work
P40   1of the university or employed by the Western University of Health
2Sciences while engaged in the performance of duties in connection
3with the College of Veterinary Medicine or the agricultural
4extension work of the university.

5(5)

end delete

6begin insert(4)end insert Students in the School of Veterinary Medicine of the
7University of California or the College of Veterinary Medicine of
8the Western University of Health Sciences who participate in
9diagnosis and treatment as part of their educational experience,
10including those in off-campus educational programs under the
11direct supervision of a licensed veterinarian in good standing, as
12defined in paragraph (1) of subdivision (b) of Section 4848,
13appointed by the University of California, Davis, or the Western
14University of Health Sciences.

begin delete

15(6)

end delete

16begin insert(5)end insert A veterinarian who is employed by the Meat and Poultry
17Inspection Branch of the California Department of Food and
18Agriculture while actually engaged and employed in his or her
19official capacity. A person exempt under this paragraph shall not
20otherwise engage in the practice of veterinary medicine unless he
21or she is issued a license by the board.

begin delete

22(7)

end delete

23begin insert(6)end insert Unlicensed personnel employed by the Department of Food
24and Agriculture or the United States Department of Agriculture
25when in the course of their duties they are directed by a veterinarian
26supervisor to conduct an examination, obtain biological specimens,
27apply biological tests, or administer medications or biological
28products as part of government disease or condition monitoring,
29investigation, control, or eradication activities.

30(b) (1) For purposes of paragraph (3) of subdivision (a), a
31regularly licensed veterinarian in good standing who is called from
32another state by a law enforcement agency or animal control
33agency, as defined in Section 31606 of the Food and Agricultural
34Code, to attend to cases that are a part of an investigation of an
35 alleged violation of federal or state animal fighting or animal
36cruelty laws within a single geographic location shall be exempt
37from the licensing requirements of this chapter if the law
38enforcement agency or animal control agency determines that it
39is necessary to call the veterinarian in order for the agency or
40officer to conduct the investigation in a timely, efficient, and
P41   1effective manner. In determining whether it is necessary to call a
2veterinarian from another state, consideration shall be given to the
3availability of veterinarians in this state to attend to these cases.
4An agency, department, or officer that calls a veterinarian pursuant
5to this subdivision shall notify the board of the investigation.

6(2) Notwithstanding any other provision of this chapter, a
7regularly licensed veterinarian in good standing who is called from
8another state to attend to cases that are a part of an investigation
9described in paragraph (1) may provide veterinary medical care
10for animals that are affected by the investigation with a temporary
11shelter facility, and the temporary shelter facility shall be exempt
12from the registration requirement of Section 4853 if all of the
13following conditions are met:

14(A) The temporary shelter facility is established only for the
15purpose of the investigation.

16(B) The temporary shelter facility provides veterinary medical
17care, shelter, food, and water only to animals that are affected by
18the investigation.

19(C) The temporary shelter facility complies with Section 4854.

20(D) The temporary shelter facility exists for not more than 60
21days, unless the law enforcement agency or animal control agency
22determines that a longer period of time is necessary to complete
23the investigation.

24(E) Within 30 calendar days upon completion of the provision
25of veterinary health care services at a temporary shelter facility
26established pursuant to this section, the veterinarian called from
27another state by a law enforcement agency or animal control agency
28to attend to a case shall file a report with the board. The report
29shall contain the date, place, type, and general description of the
30care provided, along with a listing of the veterinary health care
31practitioners who participated in providing that care.

32(c) For purposes of paragraph (3) of subdivision (a), the board
33may inspect temporary facilities established pursuant to this
34section.

35begin insert

begin insertSEC. 30.end insert  

end insert

begin insertSection 4846.5 of the end insertbegin insertBusiness and Professions Codeend insert
36
begin insert is amended to read:end insert

37

4846.5.  

(a) Except as provided in this section, the board shall
38issue renewal licenses only to those applicants that have completed
39a minimum of 36 hours of continuing education in the preceding
40two years.

P42   1(b) (1) Notwithstanding any other law, continuing education
2hours shall be earned by attending courses relevant to veterinary
3medicine and sponsored or cosponsored by any of the following:

4(A) American Veterinary Medical Association (AVMA)
5accredited veterinary medical colleges.

6(B) Accredited colleges or universities offering programs
7relevant to veterinary medicine.

8(C) The American Veterinary Medical Association.

9(D) American Veterinary Medical Association recognized
10specialty or affiliated allied groups.

11(E) American Veterinary Medical Association’s affiliated state
12veterinary medical associations.

13(F) Nonprofit annual conferences established in conjunction
14with state veterinary medical associations.

15(G) Educational organizations affiliated with the American
16Veterinary Medical Association or its state affiliated veterinary
17medical associations.

18(H) Local veterinary medical associations affiliated with the
19California Veterinary Medical Association.

20(I) Federal, state, or local government agencies.

21(J) Providers accredited by the Accreditation Council for
22Continuing Medical Education (ACCME) or approved by the
23American Medical Association (AMA), providers recognized by
24the American Dental Association Continuing Education
25Recognition Program (ADA CERP), and AMA or ADA affiliated
26state, local, and specialty organizations.

27(2) Continuing education credits shall be granted to those
28veterinarians taking self-study courses, which may include, but
29are not limited to, reading journals, viewing video recordings, or
30listening to audio recordings. The taking of these courses shall be
31limited to no more than six hours biennially.

32(3) The board may approve other continuing veterinary medical
33education providers not specified in paragraph (1).

34(A) The board has the authority to recognize national continuing
35education approval bodies for the purpose of approving continuing
36education providers not specified in paragraph (1).

37(B) Applicants seeking continuing education provider approval
38shall have the option of applying to the board or to a
39board-recognized national approval body.

P43   1(4) For good cause, the board may adopt an order specifying,
2on a prospective basis, that a provider of continuing veterinary
3medical education authorized pursuant to paragraph (1) or (3) is
4no longer an acceptable provider.

5(5) Continuing education hours earned by attending courses
6sponsored or cosponsored by those entities listed in paragraph (1)
7between January 1, 2000, and January 1, 2001, shall be credited
8toward a veterinarian’s continuing education requirement under
9this section.

10(c) Every person renewing his or her license issued pursuant to
11Section 4846.4, or any person applying for relicensure or for
12reinstatement of his or her license to active status, shall submit
13proof of compliance with this section to the board certifying that
14he or she is in compliance with this section. Any false statement
15submitted pursuant to this section shall be a violation subject to
16Section 4831.

17(d) This section shall not apply to a veterinarian’s first license
18renewal. This section shall apply only to second and subsequent
19license renewals granted on or after January 1, 2002.

20(e) The board shall have the right to audit the records of all
21applicants to verify the completion of the continuing education
22 requirement. Applicants shall maintain records of completion of
23required continuing education coursework for a period of four
24years and shall make these records available to the board for
25auditing purposes upon request. If the board, during this audit,
26questions whether any course reported by the veterinarian satisfies
27the continuing education requirement, the veterinarian shall provide
28information to the board concerning the content of the course; the
29name of its sponsor and cosponsor, if any; and specify the specific
30curricula that was of benefit to the veterinarian.

31(f) A veterinarian desiring an inactive license or to restore an
32inactive license under Section 701 shall submit an application on
33a form provided by the board. In order to restore an inactive license
34to active status, the veterinarian shall have completed a minimum
35of 36 hours of continuing education within the last two years
36preceding application. The inactive license status of a veterinarian
37shall not deprive the board of its authority to institute or continue
38a disciplinary action against a licensee.

39(g) Knowing misrepresentation of compliance with this article
40by a veterinarian constitutes unprofessional conduct and grounds
P44   1for disciplinary action or for the issuance of a citation and the
2imposition of a civil penalty pursuant to Section 4883.

3(h) The board, in its discretion, may exempt from the continuing
4education requirement any veterinarian who for reasons of health,
5military service, or undue hardship cannot meet those requirements.
6Applications for waivers shall be submitted on a form provided
7by the board.

8(i) The administration of this section may be funded through
9professional license and continuing education provider fees. The
10fees related to the administration of this section shall not exceed
11the costs of administering the corresponding provisions of this
12section.

13(j) For those continuing education providers not listed in
14paragraph (1) of subdivision (b), the board or its recognized
15national approval agent shall establish criteria by which a provider
16of continuing education shall be approved. The board shall initially
17review and approve these criteria and may review the criteria as
18needed. The board or its recognized agent shall monitor, maintain,
19and manage related records and data. The board may impose an
20application fee, not to exceed two hundred dollars ($200)
21biennially, for continuing education providers not listed in
22paragraph (1) of subdivision (b).

23(k) (1) begin deleteOn or after end deletebegin insertBeginning end insertJanuary 1, 2018, a licensed
24veterinarian who renews his or her license shall complete a
25minimum of one credit hour of continuing education on the
26judicious use of medically important antimicrobial drugs every
27four years as part of his or her continuing education requirements.

28(2) For purposes of this subdivision, “medically important
29antimicrobial drug” means an antimicrobial drug listed in Appendix
30A of the federal Food and Drug Administration’s Guidance for
31Industry #152, including critically important, highly important,
32and important antimicrobial drugs, as that appendix may be
33amended.

34begin insert

begin insertSEC. 31.end insert  

end insert

begin insertSection 4848.1 is added to the end insertbegin insertBusiness and
35Professions Code
end insert
begin insert, to read:end insert

begin insert
36

begin insert4848.1.end insert  

(a) A veterinarian engaged in the practice of veterinary
37medicine, as defined in Section 4826, employed by the University
38of California and engaged in the performance of duties in
39connection with the School of Veterinary Medicine or employed
40by the Western University of Health Sciences and engaged in the
P45   1performance of duties in connection with the College of Veterinary
2Medicine shall be issued a university license pursuant to this
3section or hold a license to practice veterinary medicine in this
4state.

5
(b) An individual may apply for and be issued a university
6license if all of the following are satisfied:

7
(1) He or she is currently employed by the University of
8California or Western University of Health Sciences, as defined
9in subdivision (a).

10
(2) He or she passes an examination concerning the statutes
11and regulations of the Veterinary Medicine Practice Act,
12administered by the board, pursuant to subparagraph (C) of
13paragraph (2) of subdivision (a) of Section 4848.

14
(3) He or she successfully completes the approved educational
15curriculum described in paragraph (5) of subdivision (b) of Section
164848 on regionally specific and important diseases and conditions.

17
(4) He or she completes and submits the application specified
18by the board and pays the application fee, pursuant to subdivision
19(g) of Section 4905, and the initial license fee, pursuant to
20subdivision (h) of Section 4905.

21
(c) A university license:

22
(1) Shall be numbered as described in Section 4847.

23
(2) Shall automatically cease to be valid upon termination or
24cessation of employment by the University of California or by the
25Western University of Health Sciences.

26
(3) Shall be subject to the license renewal provisions in Section
274846.4 and the payment of the renewal fee pursuant to subdivision
28(i) of Section 4905.

29
(4) Shall be subject to denial, revocation, or suspension pursuant
30to Sections 480, 4875, and 4883.

31
(5) Authorizes the holder to practice veterinary medicine only
32at the educational institution described in subdivision (a) and any
33locations formally affiliated with those institutions.

34
(d) An individual who holds a university license is exempt from
35satisfying the license renewal requirements of Section 4846.5.

end insert
36begin insert

begin insertSEC. 32.end insert  

end insert

begin insertSection 4853.7 is added to the end insertbegin insertBusiness and
37Professions Code
end insert
begin insert, to read:end insert

begin insert
38

begin insert4853.7.end insert  

A premise registration that is not renewed within five
39years after its expiration may not be renewed and shall not be
40restored, reissued, or reinstated thereafter. However, an
P46   1application for a new premise registration may be submitted and
2obtained if both of the following conditions are met:

3
(a) No fact, circumstance, or condition exists that, if the premise
4registration was issued, would justify its revocation or suspension.

5
(b) All of the fees that would be required for the initial premise
6registration are paid at the time of application.

end insert
7begin insert

begin insertSEC. 33.end insert  

end insert

begin insertSection 4904 of the end insertbegin insertBusiness and Professions Codeend insert
8
begin insert is amended to read:end insert

9

4904.  

All fees collected on behalf of the board and all receipts
10of every kind and nature shall be reported each month for the month
11preceding to the State Controller and at the same time the entire
12amount shall be paid into the State Treasury and shall be credited
13to the Veterinary Medical Board Contingent Fund. This contingent
14fund shall bebegin insert available, upon appropriation by the Legislature,end insert
15 for the use of the Veterinary Medicalbegin delete Board and out of it and not
16otherwise shall be paid all expenses of the board.end delete
begin insert Board.end insert

17begin insert

begin insertSEC. 34.end insert  

end insert

begin insertSection 4905 of the end insertbegin insertBusiness and Professions Codeend insert
18
begin insert is amended to read:end insert

19

4905.  

The following fees shall be collected by the board and
20shall be credited to the Veterinary Medical Board Contingent Fund:

21(a) The fee for filing an application for examination shall be set
22by the board in an amount it determines is reasonably necessary
23to provide sufficient funds to carry out the purpose of this chapter,
24not to exceed three hundred fifty dollars ($350).

25(b) The fee for the California state board examination shall be
26set by the board in an amount it determines is reasonably necessary
27to provide sufficient funds to carry out the purpose of this chapter,
28not to exceed three hundred fifty dollars ($350).

29(c) The fee for the Veterinary Medicine Practice Act
30examination shall be set by the board in an amount it determines
31reasonably necessary to provide sufficient funds to carry out the
32purpose of this chapter, not to exceed one hundred dollars ($100).

33(d) The initial license fee shall be set by the board not to exceed
34five hundred dollars ($500) except that, if the license is issued less
35than one year before the date on which it will expire, then the fee
36shall be set by the boardbegin delete atend delete not to exceed two hundred fifty dollars
37($250). The board may, by appropriate regulation, provide for the
38waiver or refund of the initial license fee where the license is issued
39less than 45 days before the date on which it will expire.

P47   1(e) The renewal fee shall be set by the board for each biennial
2renewal period in an amount it determines is reasonably necessary
3to provide sufficient funds to carry out the purpose of this chapter,
4not to exceed five hundred dollars ($500).

5(f) The temporary license fee shall be set by the board in an
6amount it determines is reasonably necessary to provide sufficient
7funds to carry out the purpose of this chapter, not to exceed two
8hundred fifty dollars ($250).

begin insert

9
(g) The fee for filing an application for a university license shall
10be one hundred twenty-five dollars ($125), which may be revised
11by the board in regulation but shall not exceed three hundred fifty
12dollars ($350).

end insert
begin insert

13
(h) The initial license fee for a university license shall be two
14hundred ninety dollars ($290), which may be revised by the board
15in regulation but shall not exceed five hundred dollars ($500).

end insert
begin insert

16
(i) The biennial renewal fee for a university license shall be two
17hundred ninety dollars ($290), which may be revised by the board
18in regulation but shall not exceed five hundred dollars ($500).

end insert
begin delete

19(g)

end delete

20begin insert(j)end insert The delinquency fee shall be set by the board, not to exceed
21fifty dollars ($50).

begin delete

22(h)

end delete

23begin insert(k)end insert The fee for issuance of a duplicate license is twenty-five
24dollars ($25).

begin delete

25(i)

end delete

26begin insert(l)end insert Any charge made for duplication or other services shall be
27set at the cost of rendering the service, except as specified in
28subdivisionbegin delete (h).end deletebegin insert (k).end insert

begin delete

29(j)

end delete

30begin insert(m)end insert The fee for failure to report a change in the mailing address
31is twenty-five dollars ($25).

begin delete

32(k)

end delete

33begin insert(n)end insert The initial and annual renewal fees for registration of
34veterinary premises shall be set by the board in an amount not to
35exceed four hundred dollars ($400) annually.

begin delete

36(l)

end delete

37begin insert(o)end insert If the money transferred from the Veterinary Medical Board
38Contingent Fund to the General Fund pursuant to the Budget Act
39of 1991 is redeposited into the Veterinary Medical Board
40Contingent Fund, the fees assessed by the board shall be reduced
P48   1correspondingly. However, the reduction shall not be so great as
2to cause the Veterinary Medical Board Contingent Fund to have
3a reserve of less than three months of annual authorized board
4expenditures. The fees set by the board shall not result in a
5Veterinary Medical Board Contingent Fund reserve of more than
610 months of annual authorized board expenditures.

7

begin deleteSEC. 21.end delete
8
begin insertSEC. 35.end insert  

Section 13401.5 of the Corporations Code is amended
9to read:

10

13401.5.  

Notwithstanding subdivision (d) of Section 13401
11and any other provision of law, the following licensed persons
12may be shareholders, officers, directors, or professional employees
13of the professional corporations designated in this section so long
14as the sum of all shares owned by those licensed persons does not
15exceed 49 percent of the total number of shares of the professional
16corporation so designated herein, and so long as the number of
17those licensed persons owning shares in the professional
18corporation so designated herein does not exceed the number of
19persons licensed by the governmental agency regulating the
20designated professional corporation. This section does not limit
21employment by a professional corporation designated in this section
22to only those licensed professionals listed under each subdivision.
23Any person duly licensed under Division 2 (commencing with
24Section 500) of the Business and Professions Code, the
25Chiropractic Act, or the Osteopathic Act may be employed to
26render professional services by a professional corporation
27designated in this section.

28(a) Medical corporation.

29(1) Licensed doctors of podiatric medicine.

30(2) Licensed psychologists.

31(3) Registered nurses.

32(4) Licensed optometrists.

33(5) Licensed marriage and family therapists.

34(6) Licensed clinical social workers.

35(7) Licensed physician assistants.

36(8) Licensed chiropractors.

37(9) Licensed acupuncturists.

38(10) Naturopathic doctors.

39(11) Licensed professional clinical counselors.

40(12) Licensed physical therapists.

P49   1(13) Licensed pharmacists.

2(b) Podiatric medical corporation.

3(1) Licensed physicians and surgeons.

4(2) Licensed psychologists.

5(3) Registered nurses.

6(4) Licensed optometrists.

7(5) Licensed chiropractors.

8(6) Licensed acupuncturists.

9(7) Naturopathic doctors.

10(8) Licensed physical therapists.

11(c) Psychological corporation.

12(1) Licensed physicians and surgeons.

13(2) Licensed doctors of podiatric medicine.

14(3) Registered nurses.

15(4) Licensed optometrists.

16(5) Licensed marriage and family therapists.

17(6) Licensed clinical social workers.

18(7) Licensed chiropractors.

19(8) Licensed acupuncturists.

20(9) Naturopathic doctors.

21(10) Licensed professional clinical counselors.

22(d) Speech-language pathology corporation.

23(1) Licensed audiologists.

24(e) Audiology corporation.

25(1) Licensed speech-language pathologists.

26(f) Nursing corporation.

27(1) Licensed physicians and surgeons.

28(2) Licensed doctors of podiatric medicine.

29(3) Licensed psychologists.

30(4) Licensed optometrists.

31(5) Licensed marriage and family therapists.

32(6) Licensed clinical social workers.

33(7) Licensed physician assistants.

34(8) Licensed chiropractors.

35(9) Licensed acupuncturists.

36(10) Naturopathic doctors.

37(11) Licensed professional clinical counselors.

38(g) Marriage and family therapist corporation.

39(1) Licensed physicians and surgeons.

40(2) Licensed psychologists.

P50   1(3) Licensed clinical social workers.

2(4) Registered nurses.

3(5) Licensed chiropractors.

4(6) Licensed acupuncturists.

5(7) Naturopathic doctors.

6(8) Licensed professional clinical counselors.

7(h) Licensed clinical social worker corporation.

8(1) Licensed physicians and surgeons.

9(2) Licensed psychologists.

10(3) Licensed marriage and family therapists.

11(4) Registered nurses.

12(5) Licensed chiropractors.

13(6) Licensed acupuncturists.

14(7) Naturopathic doctors.

15(8) Licensed professional clinical counselors.

16(i) Physician assistants corporation.

17(1) Licensed physicians and surgeons.

18(2) Registered nurses.

19(3) Licensed acupuncturists.

20(4) Naturopathic doctors.

21(j) Optometric corporation.

22(1) Licensed physicians and surgeons.

23(2) Licensed doctors of podiatric medicine.

24(3) Licensed psychologists.

25(4) Registered nurses.

26(5) Licensed chiropractors.

27(6) Licensed acupuncturists.

28(7) Naturopathic doctors.

29(k) Chiropractic corporation.

30(1) Licensed physicians and surgeons.

31(2) Licensed doctors of podiatric medicine.

32(3) Licensed psychologists.

33(4) Registered nurses.

34(5) Licensed optometrists.

35(6) Licensed marriage and family therapists.

36(7) Licensed clinical social workers.

37(8) Licensed acupuncturists.

38(9) Naturopathic doctors.

39(10) Licensed professional clinical counselors.

40(l) Acupuncture corporation.

P51   1(1) Licensed physicians and surgeons.

2(2) Licensed doctors of podiatric medicine.

3(3) Licensed psychologists.

4(4) Registered nurses.

5(5) Licensed optometrists.

6(6) Licensed marriage and family therapists.

7(7) Licensed clinical social workers.

8(8) Licensed physician assistants.

9(9) Licensed chiropractors.

10(10) Naturopathic doctors.

11(11) Licensed professional clinical counselors.

12(m) Naturopathic doctor corporation.

13(1) Licensed physicians and surgeons.

14(2) Licensed psychologists.

15(3) Registered nurses.

16(4) Licensed physician assistants.

17(5) Licensed chiropractors.

18(6) Licensed acupuncturists.

19(7) Licensed physical therapists.

20(8) Licensed doctors of podiatric medicine.

21(9) Licensed marriage and family therapists.

22(10) Licensed clinical social workers.

23(11) Licensed optometrists.

24(12) Licensed professional clinical counselors.

25(n) Dental corporation.

26(1) Licensed physicians and surgeons.

27(2) Dental assistants.

28(3) Registered dental assistants.

29(4) Registered dental assistants in extended functions.

30(5) Registered dental hygienists.

31(6) Registered dental hygienists in extended functions.

32(7) Registered dental hygienists in alternative practice.

33(o) Professional clinical counselor corporation.

34(1) Licensed physicians and surgeons.

35(2) Licensed psychologists.

36(3) Licensed clinical social workers.

37(4) Licensed marriage and family therapists.

38(5) Registered nurses.

39(6) Licensed chiropractors.

40(7) Licensed acupuncturists.

P52   1(8) Naturopathic doctors.

2(p) Physical therapy corporation.

3(1) Licensed physicians and surgeons.

4(2) Licensed doctors of podiatric medicine.

5(3) Licensed acupuncturists.

6(4) Naturopathic doctors.

7(5) Licensed occupational therapists.

8(6) Licensed speech-language therapists.

9(7) Licensed audiologists.

10(8) Registered nurses.

11(9) Licensed psychologists.

12(10) Licensed physician assistants.

13(q) Registered dental hygienist in alternative practice
14corporation.

15(1) Registered dental assistants.

16(2) Licensed dentists.

17(3) Registered dental hygienists.

18(4) Registered dental hygienists in extended functions.

19

begin deleteSEC. 22.end delete
20
begin insertSEC. 36.end insert  

Section 1261.6 of the Health and Safety Code is
21amended to read:

22

1261.6.  

(a) (1) For purposes of this section and Section 1261.5,
23an “automated drug delivery system” means a mechanical system
24that performs operations or activities, other than compounding or
25administration, relative to the storage, dispensing, or distribution
26of drugs. An automated drug delivery system shall collect, control,
27and maintain all transaction information to accurately track the
28movement of drugs into and out of the system for security,
29accuracy, and accountability.

30(2) For purposes of this section, “facility” means a health facility
31licensed pursuant to subdivision (c), (d), or (k), of Section 1250
32that has an automated drug delivery system provided by a
33pharmacy.

34(3) For purposes of this section, “pharmacy services” means
35the provision of both routine and emergency drugs and biologicals
36to meet the needs of the patient, as prescribed by a physician.

37(b) Transaction information shall be made readily available in
38a written format for review and inspection by individuals
39authorized by law. These records shall be maintained in the facility
40for a minimum of three years.

P53   1(c) Individualized and specific access to automated drug delivery
2systems shall be limited to facility and contract personnel
3authorized by law to administer drugs.

4(d) (1) The facility and the pharmacy shall develop and
5implement written policies and procedures to ensure safety,
6accuracy, accountability, security, patient confidentiality, and
7maintenance of the quality, potency, and purity of stored drugs.
8Policies and procedures shall define access to the automated drug
9delivery system and limits to access to equipment and drugs.

10(2) All policies and procedures shall be maintained at the
11pharmacy operating the automated drug delivery system and the
12location where the automated drug delivery system is being used.

13(e) When used as an emergency pharmaceutical supplies
14container, drugs removed from the automated drug delivery system
15shall be limited to the following:

16(1) A new drug order given by a prescriber for a patient of the
17facility for administration prior to the next scheduled delivery from
18the pharmacy, or 72 hours, whichever is less. The drugs shall be
19retrieved only upon authorization by a pharmacist and after the
20pharmacist has reviewed the prescriber’s order and the patient’s
21profile for potential contraindications and adverse drug reactions.

22(2) Drugs that a prescriber has ordered for a patient on an
23as-needed basis, if the utilization and retrieval of those drugs are
24subject to ongoing review by a pharmacist.

25(3) Drugs designed by the patient care policy committee or
26pharmaceutical service committee of the facility as emergency
27drugs or acute onset drugs. These drugs may be retrieved from an
28automated drug delivery system pursuant to the order of a
29prescriber for emergency or immediate administration to a patient
30of the facility. Within 48 hours after retrieval under this paragraph,
31the case shall be reviewed by a pharmacist.

32(f) When used to provide pharmacy services pursuant to Section
334119.1 of the Business and Professions Code, the automated drug
34delivery system shall be subject to all of the following
35requirements:

36(1) Drugs removed from the automated drug delivery system
37for administration to a patient shall be in properly labeled units of
38administration containers or packages.

39(2) A pharmacist shall review and approve all orders prior to a
40drug being removed from the automated drug delivery system for
P54   1administration to a patient. The pharmacist shall review the
2prescriber’s order and the patient’s profile for potential
3contraindications and adverse drug reactions.

4(3) The pharmacy providing services to the facility pursuant to
5Section 4119.1 of the Business and Professions Code shall control
6access to the drugs stored in the automated drug delivery system.

7(4) Access to the automated drug delivery system shall be
8controlled and tracked using an identification or password system
9or biosensor.

10(5) The automated drug delivery system shall make a complete
11and accurate record of all transactions that will include all users
12accessing the system and all drugs added to, or removed from, the
13system.

14(6) After the pharmacist reviews the prescriber’s order, access
15by licensed personnel to the automated drug delivery system shall
16be limited only to drugs ordered by the prescriber and reviewed
17by the pharmacist and that are specific to the patient. When the
18prescriber’s order requires a dosage variation of the same drug,
19licensed personnel shall have access to the drug ordered for that
20scheduled time of administration.

21(7) (A) Systems that allow licensed personnel to have access
22to multiple drugs and are not patient specific in their design, shall
23be allowed under this subdivision if those systems have electronic
24and mechanical safeguards in place to ensure that the drugs
25delivered to the patient are specific to that patient. Each facility
26using such an automated drug system shall notify the department
27in writing prior to the utilization of the system. The notification
28submitted to the department pursuant to this paragraph shall
29include, but is not limited to, information regarding system design,
30personnel with system access, and policies and procedures covering
31staff training, storage, and security, and the facility’s administration
32of these types of systems.

33(B) As part of its routine oversight of these facilities, the
34department shall review a facility’s medication training, storage,
35and security, and its administration procedures related to its use
36of an automated drug delivery system to ensure that adequate staff
37training and safeguards are in place to make sure that the drugs
38delivered are appropriate for the patient. If the department
39determines that a facility is not in compliance with this section,
P55   1the department may revoke its authorization to use automated drug
2delivery systems granted under subparagraph (A).

3(g) The stocking of an automated drug delivery system shall be
4performed by a pharmacist. If the automated drug delivery system
5utilizes removable pockets, cards, drawers, or similar technology,
6the stocking system may be done outside of the facility and be
7 delivered to the facility if all of the following conditions are met:

8(1) The task of placing drugs into the removable pockets, cards,
9or drawers is performed by a pharmacist or by an intern pharmacist
10or a pharmacy technician working under the direct supervision of
11a pharmacist.

12(2) The removable pockets, cards, or drawers are transported
13between the pharmacy and the facility in a secure tamper-evident
14container.

15(3) The facility, in conjunction with the pharmacy, has
16developed policies and procedures to ensure that the pockets, cards,
17or drawers are properly placed into the automated drug delivery
18system.

19(h) Review of the drugs contained within, and the operation and
20maintenance of, the automated drug delivery system shall be done
21in accordance with law and shall be the responsibility of the
22pharmacy. The review shall be conducted on a monthly basis by
23a pharmacist and shall include a physical inspection of the drugs
24in the automated drug delivery system, an inspection of the
25automated drug delivery system machine for cleanliness, and a
26review of all transaction records in order to verify the security and
27accountability of the system.

28(i) Drugs dispensed from an automated drug delivery system
29that meets the requirements of this section shall not be subject to
30the labeling requirements of Section 4076 of the Business and
31Professions Code or Section 111480 of this code if the drugs to
32be placed into the automated drug delivery system are in unit dose
33packaging or unit of use and if the information required by Section
344076 of the Business and Professions Code and Section 111480
35of this code is readily available at the time of drug administration.
36For purposes of this section, unit dose packaging includes blister
37pack cards.

38

begin deleteSEC. 23.end delete
39
begin insertSEC. 37.end insert  

Section 11164.5 of the Health and Safety Code is
40amended to read:

P56   1

11164.5.  

(a) Notwithstanding Section 11164, if only recorded
2and stored electronically, on magnetic media, or in any other
3computerized form, the pharmacy’s or hospital’s computer system
4shall not permit the received information or the controlled
5substance dispensing information required by this section to be
6changed, obliterated, destroyed, or disposed of, for the record
7maintenance period required by law, once the information has been
8received by the pharmacy or the hospital and once the controlled
9substance has been dispensed, respectively. Once the controlled
10substance has been dispensed, if the previously created record is
11determined to be incorrect, a correcting addition may be made
12only by or with the approval of a pharmacist. After a pharmacist
13enters the change or enters his or her approval of the change into
14the computer, the resulting record shall include the correcting
15addition and the date it was made to the record, the identity of the
16person or pharmacist making the correction, and the identity of
17the pharmacist approving the correction.

18(b) Nothing in this section shall be construed to exempt any
19pharmacy or hospital dispensing Schedule II controlled substances
20pursuant to electronic transmission prescriptions from existing
21 reporting requirements.

22

begin deleteSEC. 24.end delete
23
begin insertSEC. 38.end insert  

No reimbursement is required by this act pursuant to
24Section 6 of Article XIII B of the California Constitution because
25 the only costs that may be incurred by a local agency or school
26district will be incurred because this act creates a new crime or
27infraction, eliminates a crime or infraction, or changes the penalty
28for a crime or infraction, within the meaning of Section 17556 of
29the Government Code, or changes the definition of a crime within
30the meaning of Section 6 of Article XIII B of the California
31Constitution.



O

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