Amended in Assembly August 1, 2016

Amended in Assembly June 21, 2016

Amended in Senate May 31, 2016

Amended in Senate April 13, 2016

Senate Bill No. 1193

Introduced by Senator Hill

(Principal coauthor: Assembly Member Salas)

(Coauthor: Assembly Member Brough)

February 18, 2016

An act to amend Sections 4001, 4003, begin insert 4013, end insert 4081, 4107, 4110, 4119.1, 4127, 4127.3, 4127.7, 4127.8, 4127.9, 4128.6, 4161, 4180, 4201, begin insert 4301, end insert 4312, 4400, 4406, 4800, 4804.5, 4830, 4846.5, 4904, and 4905 of, to add Sections 4034, 4105.5, 4126.9, 4203.5, begin insert 4301.1, end insert 4303.1, 4316, 4826.5, 4848.1, and begin delete 4853.7, end delete begin insert 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 healing arts.

LEGISLATIVE COUNSEL’S DIGEST

SB 1193, as amended, Hill. Healing arts.

(1) The Pharmacy Law provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy, which is within the Department of Consumer Affairs, and authorizes the board to appoint, with the approval of the Director of Consumer Affairs, an executive officer, as specified. 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.

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.

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 begin insert (FDA) end insert within 10 days of the action. The bill would prohibit the issuance or renewal of an outsourcing facility begin insert license end insert 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.

begin insert

The Pharmacy Law requires a facility licensed by the board to join the board’s email notification list within 60 days of obtaining a license or at the time of license renewal and requires a facility to update its email address within 30 days of a change in the facility’s email address.

end insert begin insert

This bill would require each pharmacist, intern pharmacist, pharmacy technician, designated representative, and designated representative of a 3rd-party logistics provider licensed in this state to join the board’s email notification list within 60 days of obtaining a license or at the time of license renewal and to update the licensee’s email address within 30 days of a change in the licensee’s email address. The bill would prohibit the board from posting those email addresses on the board’s license verification system. The bill would make these provisions operative on July 1, 2017.

end insert begin insert

The Pharmacy Law requires the board to take action against any licensee who is guilty of unprofessional conduct or whose license has been procured by fraud or misrepresentation or by mistake and includes, among others, gross immorality as unprofessional conduct. That law also includes the revocation, suspension, or other discipline by another state of a license to practice pharmacy, operate a pharmacy, or do any other act for which a license is required under the Pharmacy Law as grounds for unprofessional conduct.

end insert begin insert

This bill would delete gross immorality as unprofessional conduct and instead provide that procurement of a license by fraud or misrepresentation is unprofessional conduct. This bill would require that revocation, suspension, or other discipline by another state as the basis for similar action under the pharmacy law be grounds for revocation, suspension, or other discipline under the Pharmacy Law and requires the board to take action coterminously with action taken by another state. The bill would authorize the board to exceed the term of discipline of another state consistent with the board’s enforcement guidelines and provide that evidence of discipline by another state is conclusive proof of unprofessional conduct. The bill would also require the board, to ensure that its resources are maximized for the protection of the public health and safety, to prioritize its investigative and prosecutorial resources to ensure that pharmacists representing the greatest threat of actual patient harm are identified and disciplined expeditiously.

end insert

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.

This bill would authorize the board to collect a fee of begin delete $4000 end delete begin insert $2,27 end insert begin insert 0 end insert for the issuance begin delete and renewal end delete of an outsourcing begin delete license end delete begin insert facility license, which may be increased to up to $3,180 by the board, a fee of $1,325 for the renewal of that license, which may be increased to up to $1,855 by the board, end insert and a fee of $715 for a temporary begin insert outsourcing facility end insert license, as specified. begin delete This end delete begin insert The bill would authorize the board to collect a fee of $2,380 for the issuance of a nonresident outsourcing facility license, which may be increased to up to $3,335 by the board, and a fee of $2,270 for the renewal of that license, which may be increased to up to $3,180 by the board, as specified. The end insert bill would provide that the Pharmacy Board Contingent Fund is available for expenditure only upon an appropriation by the Legislature.

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.

This bill would require begin insert an end insert outsourcing facility to keep a current inventory of these records.

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.

This 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 Pharmacy Law 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 pharmacy 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.

The Pharmacy Law, 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. begin insert Existing law authorizes the stocking of an automated drug delivery system to be done outside the facility if the automated drug delivery system utilizes removable pockets, cards, drawers, or similar technology and if certain conditions are met, including that the removable pockets, cards, or drawers are transported in a secured tamper-evident container. end insert

This bill would make these provisions operative by repealing the provision that made them inoperative on January 1, 2012. begin insert The bill would additionally authorize the stocking of an automated drug delivery system to be done outside the facility if the system utilizes unit of use or single dose containers, as specified. end insert

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.

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 to contact, as specified, 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.

This 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.

The Pharmacy Law 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. That 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.

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.

(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.

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

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.

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.

begin delete

The

end delete

begin insert This end insert bill would instead require begin delete veterinarians end delete begin insert a veterinarian end insert 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.

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.

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

(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.

By placing new requirements on a pharmacy, this bill would expand an existing crime and would, therefore, impose a state-mandated local program. 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.

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:

SECTION 1.  

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

4001.  

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

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

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

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

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

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

SEC. 2.  

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

4003.  

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

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

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

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

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

begin insert

begin insert SEC. 3. end insert   

end insert

begin insert Section 4013 of the end insert begin insert Business and Professions Code end insert begin insert is
amended to read: end insert

4013.  

(a) Any facility licensed by the board shall join the
board’s begin delete e-mail end delete begin insert email end insert notification list within 60 days of obtaining
a license or at the time of license renewal.

(b) Any facility licensed by the board shall update its begin delete e-mail end delete
begin insert email end insert address with the board’s begin delete e-mail end delete begin insert email end insert notification list within
30 days of a change in the facility’s begin delete e-mail end delete begin insert email end insert address.

(c) An owner of two or more facilities licensed by the board
may comply with subdivisions (a) and (b) by subscribing a single
begin delete e-mail end delete begin insert email end insert address to the board’s begin delete e-mail end delete begin insert email end insert notification list,
where the owner maintains an electronic notice system within all
of its licensed facilities that, upon receipt of an begin delete e-mail end delete begin insert email end insert
notification from the board, immediately transmits electronic notice
of the same notification to all of its licensed facilities. If an owner
chooses to comply with this section by using such an electronic
notice system, the owner shall register the electronic notice system
with the board by July 1, 2011, or within 60 days of initial
licensure, whichever is later, informing the board of the single
begin delete e-mail end delete begin insert email end insert address to be utilized by the owner, describing the
electronic notice system, and listing all facilities to which
immediate notice will be provided. The owner shall update its
begin delete e-mail end delete begin insert email end insert address with the board’s begin delete e-mail end delete begin insert email end insert notification
list within 30 days of any change in the owner’s begin delete e-mail end delete begin insert email end insert
address.

begin insert

(d) (1) Each pharmacist, intern pharmacist, pharmacy
technician, designated representative-3PL licensed in this state
shall join the board’s email notification list within 60 days of
obtaining a license or at the time of license renewal.

end insert begin insert

(2) Each pharmacist, intern pharmacist, pharmacy technician,
designated representative, and designated representative-3PL
licensed in this state shall update his or her email address with
the board’s email notification list within 30 days of a change in
the licensee’s email address.

end insert begin insert

(3) The email address provided by a licensee shall not be posted
on the board’s online license verification system.

end insert begin insert

(4) The board shall, with each renewal application, remind
licensees of their obligation to report and keep current their email
address with the board’s email notification list.

end insert begin delete

(d)

end delete

begin insert (5) end insert  This begin delete section end delete begin insert subdivision end insert shall become operative on July 1,

begin delete 2010. end delete begin insert 2017. end insert

begin delete SEC. 3. end delete

begin insert SEC. 4. end insert   

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

4034.  

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

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

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

(c) Is doing business within or into California.

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

begin delete SEC. 4. end delete

begin insert SEC. 5. end insert   

Section 4081 of the Business and Professions Code is
amended to read:

4081.  

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

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

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

begin delete SEC. 5. end delete

begin insert SEC. 6. end insert   

Section 4105.5 is added to the Business and Professions
Code, to read:

4105.5.  

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

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

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

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

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

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

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

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

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

begin delete SEC. 6. end delete

begin insert SEC. 7. end insert   

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

4107.  

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

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

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

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

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

begin delete SEC. 7. end delete

begin insert SEC. 8. end insert   

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

4110.  

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

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

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

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

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

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

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

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

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

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

begin delete SEC. 8. end delete

begin insert SEC. 9. end insert   

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

4119.1.  

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

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

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

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

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

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

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

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

begin delete SEC. 9. end delete

begin insert SEC. 10. end insert   

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

4126.9.  

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

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

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

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

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

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

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

(c) A pharmacy that has been advised that a patient has been
harmed by using a nonsterile compounded product potentially
attributable to the pharmacy shall report the event to MedWatch
within 72 hours of the pharmacy being advised.

begin delete SEC. 10. end delete

begin insert SEC. 11. end insert   

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

4127.  

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

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

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

begin delete SEC. 11. end delete

begin insert SEC. 12. end insert   

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

4127.3.  

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

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

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

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

begin delete SEC. 12. end delete

begin insert SEC. 13. end insert   

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

4127.7.  

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

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

(b) An ISO class 5 cleanroom.

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

begin delete SEC. 13. end delete

begin insert SEC. 14. end insert   

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

4127.8.  

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

begin delete SEC. 14. end delete

begin insert SEC. 15. end insert   

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

4127.9.  

(a) A pharmacy licensed pursuant to Section 4127.1
or 4127.2 that issues a recall notice regarding a sterile compounded
drug shall, in addition to any other duties, contact 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 both of
the following apply:

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

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

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

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

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

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

begin delete SEC. 15. end delete

begin insert SEC. 16. end insert   

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

4128.6.  

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

begin delete SEC. 16. end delete

begin insert SEC. 17. end insert   

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

 

Article 7.7.  Outsourcing Facilities

 

4129.  

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

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

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

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

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

4129.1.  

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

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

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

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

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

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

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

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

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

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

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

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

4129.2.  

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

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

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

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

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

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

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

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

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

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

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

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

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

4129.3.  

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

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

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

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

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

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

4129.4.  

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

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

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

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

4129.5.  

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

4129.8.  

The board, at its discretion, may issue a temporary
license to an outsourcing facility upon the conditions and for any
periods of time as the board determines to be in the public interest.
A temporary license fee shall be required as specified in
subdivision (w) of Section 4400. When needed to protect public
safety, a temporary license may be issued for a period not to exceed
180 days, and may be issued subject to terms and conditions the
board deems necessary. If the board determines a temporary license
was issued by mistake or denies the application for a permanent
license, the temporary license shall terminate upon the earlier of
personal service of the notice of termination upon the licenseholder
or service by certified mail with return receipt requested at the
licenseholder’s address of record with the board. The temporary
licenseholder shall not be deemed to have a vested property right
or interest in the license for purposes of retaining a temporary
license or for purposes of any disciplinary or license denial
proceeding before the board.

4129.9.  

(a) An outsourcing facility licensed pursuant to Section
4129.1 or 4129.2 that issues a recall notice for a sterile drug or
nonsterile drug compounded by the outsourcing facility, in addition
to any other duties, shall contact the recipient pharmacy, prescriber,
or patient of the recalled drug and the board as soon as possible
within 24 hours of the recall notice if both of the following apply:

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

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

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

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

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

begin delete SEC. 17. end delete

begin insert SEC. 18. end insert   

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

4161.  

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

begin delete SEC. 18. end delete

begin insert SEC. 19. end insert   

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

4180.  

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

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

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

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

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

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

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

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

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

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

begin delete SEC. 19. end delete

begin insert SEC. 20. end insert   

Section 4201 of the Business and Professions Code
is amended to read:

4201.  

(a) Each application to conduct a pharmacy, wholesaler,
third-party logistics provider, veterinary food-animal drug retailer,
or outsourcing facility shall be made on a form furnished by the
board and shall state the name, address, usual occupation, and
professional qualifications, if any, of the applicant. If the applicant
is other than a natural person, the application shall state the
information as to each person beneficially interested therein.

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

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

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

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

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

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

(e) Upon the approval of the application by the board and
payment of the fee required by this chapter for each pharmacy,
wholesaler, third-party logistics provider, or veterinary food-animal
drug retailer, the executive officer of the board shall issue a license
to conduct a pharmacy, wholesaler, third-party logistics provider,
veterinary food-animal drug retailer, or outsourcing facility if all
of the provisions of this chapter have been complied with.

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

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

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

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

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

begin delete SEC. 20. end delete

begin insert SEC. 21. end insert   

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

4203.5.  

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

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

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

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

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

begin insert

begin insert SEC. 22. end insert   

end insert

begin insert Section 4301 of the end insert begin insert Business and Professions Code end insert

begin insert is amended to read: end insert

4301.  

The board shall take action against any holder of a license
who is guilty of unprofessional conduct or whose license has been
begin delete procured by fraud or misrepresentation or end delete issued by mistake.
Unprofessional conduct shall include, but is not limited to, any of
the following:

begin delete

(a) Gross immorality.

end delete begin insert

(a) Procurement of a license by fraud or misrepresentation.

end insert

(b) Incompetence.

(c) Gross negligence.

(d) The clearly excessive furnishing of controlled substances
in violation of subdivision (a) of Section 11153 of the Health and
Safety Code.

(e) The clearly excessive furnishing of controlled substances in
violation of subdivision (a) of Section 11153.5 of the Health and
Safety Code. Factors to be considered in determining whether the
furnishing of controlled substances is clearly excessive shall
include, but not be limited to, the amount of controlled substances
furnished, the previous ordering pattern of the customer (including
size and frequency of orders), the type and size of the customer,
and where and to whom the customer distributes its product.

(f) The commission of any act involving moral turpitude,
dishonesty, fraud, deceit, or corruption, whether the act is
committed in the course of relations as a licensee or otherwise,
and whether the act is a felony or misdemeanor or not.

(g) Knowingly making or signing any certificate or other
document that falsely represents the existence or nonexistence of
a state of facts.

(h) The administering to oneself, of any controlled substance,
or the use of any dangerous drug or of alcoholic beverages to the
extent or in a manner as to be dangerous or injurious to oneself,
to a person holding a license under this chapter, or to any other
person or to the public, or to the extent that the use impairs the
ability of the person to conduct with safety to the public the practice
authorized by the license.

(i) Except as otherwise authorized by law, knowingly selling,
furnishing, giving away, or administering, or offering to sell,
furnish, give away, or administer, any controlled substance to an
addict.

(j) The violation of any of the statutes of this state, of any other
state, or of the United States regulating controlled substances and
dangerous drugs.

(k) The conviction of more than one misdemeanor or any felony
involving the use, consumption, or self-administration of any
dangerous drug or alcoholic beverage, or any combination of those
substances.

(l) The conviction of a crime substantially related to the
qualifications, functions, and duties of a licensee under this chapter.
The record of conviction of a violation of Chapter 13 (commencing
with Section 801) of Title 21 of the United States Code regulating
controlled substances or of a violation of the statutes of this state
regulating controlled substances or dangerous drugs shall be
conclusive evidence of unprofessional conduct. In all other cases,
the record of conviction shall be conclusive evidence only of the
fact that the conviction occurred. The board may inquire into the
circumstances surrounding the commission of the crime, in order
to fix the degree of discipline or, in the case of a conviction not
involving controlled substances or dangerous drugs, to determine
if the conviction is of an offense substantially related to the
qualifications, functions, and duties of a licensee under this chapter.
A plea or verdict of guilty or a conviction following a plea of nolo
contendere is deemed to be a conviction within the meaning of
this provision. The board may take action when the time for appeal
has elapsed, or the judgment of conviction has been affirmed on
appeal or when an order granting probation is made suspending
the imposition of sentence, irrespective of a subsequent order under
Section 1203.4 of the Penal Code allowing the person to withdraw
his or her plea of guilty and to enter a plea of not guilty, or setting
aside the verdict of guilty, or dismissing the accusation,
information, or indictment.

(m) The cash compromise of a charge of violation of Chapter
13 (commencing with Section 801) of Title 21 of the United States
Code regulating controlled substances or of Chapter 7
(commencing with Section 14000) of Part 3 of Division 9 of the
Welfare and Institutions Code relating to the Medi-Cal program.

begin delete The record of the compromise is conclusive evidence of
unprofessional conduct. end delete

(n) The revocation, suspension, or other discipline by another
state of a license to practice pharmacy, operate a pharmacy, or do
any other act for which a license is required by this begin delete chapter. end delete begin insert chapter
that would be grounds for revocation, suspension, or other
discipline under this chapter. Any disciplinary action taken by the
board pursuant to this section shall be coterminous with action
taken by another state, except that the term of any discipline taken
by the board may exceed that of another state, consistent with the
board’s enforcement guidelines. The evidence of discipline by
another state is conclusive proof of unprofessional conduct. end insert

(o) Violating or attempting to violate, directly or indirectly, or
assisting in or abetting the violation of or conspiring to violate any
provision or term of this chapter or of the applicable federal and
state laws and regulations governing pharmacy, including
regulations established by the board or by any other state or federal
regulatory agency.

(p) Actions or conduct that would have warranted denial of a
license.

(q) Engaging in any conduct that subverts or attempts to subvert
an investigation of the board.

(r) The selling, trading, transferring, or furnishing of drugs
obtained pursuant to Section 256b of Title 42 of the United States
Code to any person a licensee knows or reasonably should have
known, not to be a patient of a covered entity, as defined in
paragraph (4) of subsection (a) of Section 256b of Title 42 of the
United States Code.

(s) The clearly excessive furnishing of dangerous drugs by a
wholesaler to a pharmacy that primarily or solely dispenses
prescription drugs to patients of long-term care facilities. Factors
to be considered in determining whether the furnishing of
dangerous drugs is clearly excessive shall include, but not be
limited to, the amount of dangerous drugs furnished to a pharmacy
that primarily or solely dispenses prescription drugs to patients of
long-term care facilities, the previous ordering pattern of the
pharmacy, and the general patient population to whom the
pharmacy distributes the dangerous drugs. That a wholesaler has
established, and employs, a tracking system that complies with
the requirements of subdivision (b) of Section 4164 shall be
considered in determining whether there has been a violation of
this subdivision. This provision shall not be interpreted to require
a wholesaler to obtain personal medical information or be
authorized to permit a wholesaler to have access to personal
medical information except as otherwise authorized by Section 56
and following of the Civil Code. For purposes of this section,
“long-term care facility” shall have the same meaning given the
term in Section 1418 of the Health and Safety Code.

begin insert

begin insert SEC. 23. end insert   

end insert

begin insert Section 4301.1 is added to the end insert begin insert Business and
Professions Code end insert begin insert , to read: end insert

begin insert

begin insert 4301.1. end insert   

In order to ensure that the board’s resources are
maximized for the protection of the public health and safety, the
board shall prioritize its investigative and prosecutorial resources
to ensure that pharmacists representing the greatest threat of
actual patient harm are identified and disciplined expeditiously.

end insert

begin insert

begin insert SEC. 24. end insert   

end insert

begin insert Section 4303.1 is added to the end insert begin insert Business and
Professions Code end insert begin insert , to read: end insert

begin insert

begin insert 4303.1. end insert   

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

end insert

begin delete SEC. 21. end delete

begin insert SEC. 25. end insert   

Section 4312 of the Business and Professions Code
is amended to read:

4312.  

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

(b) If the license of a wholesaler, third-party logistics provider,
pharmacy, veterinary food-animal drug retailer, or outsourcing
facility is canceled pursuant to subdivision (a) or revoked pursuant
to Article 19 (commencing with Section 4300), or a wholesaler,
third-party logistics provider, pharmacy, veterinary food-animal
drug retailer, or outsourcing facility notifies the board of its intent
to remain closed or to discontinue business, the licensee shall,
within 10 days thereafter, arrange for the transfer of all dangerous
drugs and controlled substances or dangerous devices to another
licensee authorized to possess the dangerous drugs and controlled
substances or dangerous devices. The licensee transferring the
dangerous drugs and controlled substances or dangerous devices
shall immediately confirm in writing to the board that the transfer
has taken place.

(c) If a wholesaler, third-party logistics provider, pharmacy,
veterinary food-animal drug retailer, or outsourcing facility fails
to comply with subdivision (b), the board may seek and obtain an
order from the superior court in the county in which the wholesaler,
third-party logistics provider, pharmacy, veterinary food-animal
drug retailer, or outsourcing facility is located, authorizing the
board to enter the wholesaler, third-party logistics provider,
pharmacy, veterinary food-animal drug retailer, or 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 wholesaler, third-party logistics
provider, pharmacy, veterinary food-animal drug retailer, or
outsourcing facility.

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

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

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

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

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

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

begin delete

SEC. 22.  

Section 4303.1 is added to the Business and
Professions Code, to read:

4303.1.  

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

end delete

begin delete SEC. 23. end delete

begin insert SEC. 26. end insert   

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

4316.  

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

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

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

begin delete SEC. 24. end delete

begin insert SEC. 27. end insert   

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

4400.  

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

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

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

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

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

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

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

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

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

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

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

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

(j) (1) The application fee for a nonresident wholesaler or
third-party logistics provider license issued pursuant to Section
4161 shall be seven hundred eighty dollars ($780) and may be
decreased to no less than six hundred dollars ($600).

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

(3) The annual renewal fee for a nonresident wholesaler license
or third-party logistics provider license issued pursuant to Section
4161 shall be seven hundred eighty dollars ($780) and may be
decreased to no less than six hundred dollars ($600).

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

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

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

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

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

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

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

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

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

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

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

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

(w) The fee for the issuance begin delete or renewal end delete of an outsourcing facility
license shall be begin delete four thousand dollars ($4000). end delete begin insert two thousand two
hundred seventy dollars ($2,270) and may be increased to up to
three thousand one hundred eighty dollars ($3,180) by the board.
The fee for the renewal of an outsourcing facility license shall be
one thousand three hundred twenty-five dollars ($1,325) and may
be increased to up to one thousand eight hundred fifty-five dollars
($1,855) by the board. end insert The fee for a temporary outsourcing facility
license shall be seven hundred fifteen dollars ($715).

(x) The fee for the issuance begin delete or renewal end delete of a nonresident
outsourcing facility license shall be begin delete four thousand dollars ($4000). end delete
begin insert two thousand three hundred eighty dollars ($2,380) and may be
increased to up to three thousand three hundred thirty-five dollars
($3,335) by the board. The fee for the renewal of a nonresident
outsourcing facility license shall be two thousand two hundred
seventy dollars ($2,270) and may be increased to up to three
thousand one hundred eighty dollars ($3,180) by the board. end insert In
addition to paying that application fee, the nonresident outsourcing
facility shall deposit, when submitting the application, a reasonable
amount, as determined by the board, necessary to cover the board’s
estimated cost of performing the inspection required by Section
4129.2. If the required deposit is not submitted with the application,
the application shall be deemed to be incomplete. If the actual cost
of the inspection exceeds the amount deposited, the board shall
provide to the applicant a written invoice for the remaining amount
and shall not take action on the application until the full amount
has been paid to the board. If the amount deposited exceeds the
amount of actual and necessary costs incurred, the board shall
remit the difference to the applicant.

begin delete SEC. 25. end delete

begin insert SEC. 28. end insert   

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

4406.  

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

begin delete SEC. 26. end delete

begin insert SEC. 29. end insert   

Section 4800 of the Business and Professions Code
is amended to read:

4800.  

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

(1) Four licensed veterinarians.

(2) One registered veterinary technician.

(3) Three public members.

(b) This section shall remain in effect only until January 1, begin delete 2018, end delete
begin insert 2021, end insert and as of that date is repealed.

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

begin delete SEC. 27. end delete

begin insert SEC. 30. end insert   

Section 4804.5 of the Business and Professions Code
is amended to read:

4804.5.  

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

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

begin delete SEC. 28. end delete

begin insert SEC. 31. end insert   

Section 4826.5 is added to the Business and
Professions Code, to read:

4826.5.  

Notwithstanding any other law, a licensed veterinarian
or a registered veterinary technician under the supervision of a
licensed veterinarian may compound drugs for animal use pursuant
to Section 530 of Title 21 of the Code of Federal Regulations and
in accordance with regulations promulgated by the board. The
regulations promulgated by the board shall, 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 the safe compounding of drugs. Any
violation of the regulations adopted by the board pursuant to this
section shall constitute grounds for an enforcement or disciplinary
action.

begin delete SEC. 29. end delete

begin insert SEC. 32. end insert   

Section 4830 of the Business and Professions Code
is amended to read:

4830.  

(a) This chapter does not apply to:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

begin delete SEC. 30. end delete

begin insert SEC. 33. end insert   

Section 4846.5 of the Business and Professions Code
is amended to read:

4846.5.  

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

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

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

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

(C) The American Veterinary Medical Association.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(k) (1) Beginning January 1, 2018, a licensed veterinarian who
renews his or her license shall complete a minimum of one credit
hour of continuing education on the judicious use of medically
important antimicrobial drugs every four years as part of his or
her continuing education requirements.

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

begin delete SEC. 31. end delete

begin insert SEC. 34. end insert   

Section 4848.1 is added to the Business and
Professions Code, to read:

4848.1.  

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

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

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

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

(3) He or she successfully completes the approved educational
curriculum described in paragraph (5) of subdivision (b) of Section
4848 on regionally specific and important diseases and conditions.

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

(c) A university license:

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

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

(3) Shall be subject to the license renewal provisions in Section
4846.4 and the payment of the renewal fee pursuant to subdivision
(i) of Section 4905.

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

(5) Authorizes the holder to practice veterinary medicine only
at begin delete the end delete begin insert an end insert educational institution described in subdivision (a) and
any locations formally affiliated with those institutions.

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

begin delete SEC. 32. end delete

begin insert SEC. 35. end insert   

Section 4853.7 is added to the Business and
Professions Code, to read:

4853.7.  

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

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

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

begin delete SEC. 33. end delete

begin insert SEC. 36. end insert   

Section 4904 of the Business and Professions Code
is amended to read:

4904.  

All fees collected on behalf of the board and all receipts
of every kind and nature shall be reported each month for the month
preceding to the begin delete State end delete Controller and at the same time the entire
amount shall be paid into the State Treasury and shall be credited
to the Veterinary Medical Board Contingent Fund. This contingent
fund shall be available, upon appropriation by the Legislature, for
the use of the Veterinary Medical Board.

begin delete SEC. 34. end delete

begin insert SEC. 37. end insert   

Section 4905 of the Business and Professions Code
is amended to read:

4905.  

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

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

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

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

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

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

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

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

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

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

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

(k) The fee for issuance of a duplicate license is twenty-five
dollars ($25).

(l) Any charge made for duplication or other services shall be
set at the cost of rendering the service, except as specified in
subdivision (k).

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

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

(o) If the money transferred from the Veterinary Medical Board
Contingent Fund to the General Fund pursuant to the Budget Act
of 1991 is redeposited into the Veterinary Medical Board
Contingent Fund, the fees assessed by the board shall be reduced
correspondingly. However, the reduction shall not be so great as
to cause the Veterinary Medical Board Contingent Fund to have
a reserve of less than three months of annual authorized board
expenditures. The fees set by the board shall not result in a
Veterinary Medical Board Contingent Fund reserve of more than
10 months of annual authorized board expenditures.

begin delete SEC. 35. end delete

begin insert SEC. 38. end insert   

Section 13401.5 of the Corporations Code is amended
to read:

13401.5.  

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

(a) Medical corporation.

(1) Licensed doctors of podiatric medicine.

(2) Licensed psychologists.

(3) Registered nurses.

(4) Licensed optometrists.

(5) Licensed marriage and family therapists.

(6) Licensed clinical social workers.

(7) Licensed physician assistants.

(8) Licensed chiropractors.

(9) Licensed acupuncturists.

(10) Naturopathic doctors.

(11) Licensed professional clinical counselors.

(12) Licensed physical therapists.

(13) Licensed pharmacists.

(b) Podiatric medical corporation.

(1) Licensed physicians and surgeons.

(2) Licensed psychologists.

(3) Registered nurses.

(4) Licensed optometrists.

(5) Licensed chiropractors.

(6) Licensed acupuncturists.

(7) Naturopathic doctors.

(8) Licensed physical therapists.

(c) Psychological corporation.

(1) Licensed physicians and surgeons.

(2) Licensed doctors of podiatric medicine.

(3) Registered nurses.

(4) Licensed optometrists.

(5) Licensed marriage and family therapists.

(6) Licensed clinical social workers.

(7) Licensed chiropractors.

(8) Licensed acupuncturists.

(9) Naturopathic doctors.

(10) Licensed professional clinical counselors.

(d) Speech-language pathology corporation.

(1) Licensed audiologists.

(e) Audiology corporation.

(1) Licensed speech-language pathologists.

(f) Nursing corporation.

(1) Licensed physicians and surgeons.

(2) Licensed doctors of podiatric medicine.

(3) Licensed psychologists.

(4) Licensed optometrists.

(5) Licensed marriage and family therapists.

(6) Licensed clinical social workers.

(7) Licensed physician assistants.

(8) Licensed chiropractors.

(9) Licensed acupuncturists.

(10) Naturopathic doctors.

(11) Licensed professional clinical counselors.

(g) Marriage and family therapist corporation.

(1) Licensed physicians and surgeons.

(2) Licensed psychologists.

(3) Licensed clinical social workers.

(4) Registered nurses.

(5) Licensed chiropractors.

(6) Licensed acupuncturists.

(7) Naturopathic doctors.

(8) Licensed professional clinical counselors.

(h) Licensed clinical social worker corporation.

(1) Licensed physicians and surgeons.

(2) Licensed psychologists.

(3) Licensed marriage and family therapists.

(4) Registered nurses.

(5) Licensed chiropractors.

(6) Licensed acupuncturists.

(7) Naturopathic doctors.

(8) Licensed professional clinical counselors.

(i) Physician assistants corporation.

(1) Licensed physicians and surgeons.

(2) Registered nurses.

(3) Licensed acupuncturists.

(4) Naturopathic doctors.

(j) Optometric corporation.

(1) Licensed physicians and surgeons.

(2) Licensed doctors of podiatric medicine.

(3) Licensed psychologists.

(4) Registered nurses.

(5) Licensed chiropractors.

(6) Licensed acupuncturists.

(7) Naturopathic doctors.

(k) Chiropractic corporation.

(1) Licensed physicians and surgeons.

(2) Licensed doctors of podiatric medicine.

(3) Licensed psychologists.

(4) Registered nurses.

(5) Licensed optometrists.

(6) Licensed marriage and family therapists.

(7) Licensed clinical social workers.

(8) Licensed acupuncturists.

(9) Naturopathic doctors.

(10) Licensed professional clinical counselors.

(l) Acupuncture corporation.

(1) Licensed physicians and surgeons.

(2) Licensed doctors of podiatric medicine.

(3) Licensed psychologists.

(4) Registered nurses.

(5) Licensed optometrists.

(6) Licensed marriage and family therapists.

(7) Licensed clinical social workers.

(8) Licensed physician assistants.

(9) Licensed chiropractors.

(10) Naturopathic doctors.

(11) Licensed professional clinical counselors.

(m) Naturopathic doctor corporation.

(1) Licensed physicians and surgeons.

(2) Licensed psychologists.

(3) Registered nurses.

(4) Licensed physician assistants.

(5) Licensed chiropractors.

(6) Licensed acupuncturists.

(7) Licensed physical therapists.

(8) Licensed doctors of podiatric medicine.

(9) Licensed marriage and family therapists.

(10) Licensed clinical social workers.

(11) Licensed optometrists.

(12) Licensed professional clinical counselors.

(n) Dental corporation.

(1) Licensed physicians and surgeons.

(2) Dental assistants.

(3) Registered dental assistants.

(4) Registered dental assistants in extended functions.

(5) Registered dental hygienists.

(6) Registered dental hygienists in extended functions.

(7) Registered dental hygienists in alternative practice.

(o) Professional clinical counselor corporation.

(1) Licensed physicians and surgeons.

(2) Licensed psychologists.

(3) Licensed clinical social workers.

(4) Licensed marriage and family therapists.

(5) Registered nurses.

(6) Licensed chiropractors.

(7) Licensed acupuncturists.

(8) Naturopathic doctors.

(p) Physical therapy corporation.

(1) Licensed physicians and surgeons.

(2) Licensed doctors of podiatric medicine.

(3) Licensed acupuncturists.

(4) Naturopathic doctors.

(5) Licensed occupational therapists.

(6) Licensed speech-language therapists.

(7) Licensed audiologists.

(8) Registered nurses.

(9) Licensed psychologists.

(10) Licensed physician assistants.

(q) Registered dental hygienist in alternative practice
corporation.

(1) Registered dental assistants.

(2) Licensed dentists.

(3) Registered dental hygienists.

(4) Registered dental hygienists in extended functions.

begin delete SEC. 36. end delete

begin insert SEC. 39. end insert   

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

1261.6.  

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

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

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

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

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

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

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

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

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

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

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

(f) When used to provide pharmacy services pursuant to Section
4119.1 of the Business and Professions Code, the automated drug
delivery system shall be subject to all of the following
requirements:

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

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

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

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

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

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

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

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

(g) The stocking of an automated drug delivery system shall be
performed by a pharmacist. If the automated drug delivery system
utilizes removable pockets, cards, drawers, begin delete or end delete similar technology,
begin insert or unit of use or single dose containers as defined by the United
States Pharmacopoeia, end insert the stocking system may be done outside
of the facility and be delivered to the facility if all of the following
conditions are met:

(1) The task of placing drugs into the removable pockets, cards,
begin delete or drawers end delete begin insert drawers, or unit of use or single dose containers end insert is
performed by a begin delete pharmacist end delete begin insert pharmacist, end insert or by an intern pharmacist
or a pharmacy technician working under the direct supervision of
a pharmacist.

(2) The removable pockets, cards, begin delete or drawers end delete begin insert drawers, or end insert begin insert unit
of use or single dose containers end insert are transported between the
pharmacy and the facility in a secure tamper-evident container.

(3) The facility, in conjunction with the pharmacy, has
developed policies and procedures to ensure that the begin insert removable end insert
pockets, cards, begin delete or drawers end delete begin insert drawers, or unit of use or single dose
containers end insert are properly placed into the automated drug delivery
system.

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

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

begin delete SEC. 37. end delete

begin insert SEC. 40. end insert   

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

11164.5.  

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

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

begin delete SEC. 38. end delete

begin insert SEC. 41. end insert   

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