SB 1193, as amended, Hill. Healing arts.
begin insert(1) The Psychology Licensing Law establishes the Board of Psychology to license and regulate the practice of psychology, and authorizes the board to employ all personnel necessary to carry out that law and to employ an executive officer, as specified. These provisions are in effect only until January 1, 2017.
end insertbegin insertThis bill would extend the existence of the board and the board’s authorization to employ an executive officer to January 1, 2021.
end insertbegin insertThe Psychology Licensing Law defines the practice of psychology as rendering or offering to render, for a fee, psychological services involving the application of psychological principles and methods, including the diagnosis, prevention, and treatment of psychological problems and emotional and mental disorders. That law prohibits unlicensed persons from practicing psychology, but authorizes unlicensed persons, including psychological assistants who meet certain requirements and do not provide psychological services to the public, except as an employee of a licensed psychologist, licensed physician, contract clinic, psychological corporation, or medical corporation, to perform limited psychological functions. That law also prohibits its provisions from being construed as restricting or preventing specified nonprofit community agency employees from carrying out activities of a psychological nature or using their official employment title, as specified, provided the employees do not render or offer to render psychological services. That law provides that a violation of any of its provisions is a misdemeanor.
end insertbegin insertThis bill would recast these provisions to authorize an unlicensed person preparing for licensure as a psychologist to perform psychological functions under certain conditions, including registration with the board as a psychological assistant and immediate supervision by a licensed psychologist or physician and surgeon who is board certified in psychiatry, as specified. The bill would prohibit a psychological assistant from providing psychological services to the public except as a supervisee. The bill would expand the prohibition on construing the Psychology Licensing Law’s provisions as restricting or preventing specified activities of nonprofit community agency employees by making this prohibition contingent on the employees’ not rendering or offering to render psychological services to the public. By changing the definition of a crime, this bill would create a state-mandated local program.
end insertbegin insertThe Psychology Licensing Law conditions the issuance of a psychology license upon an applicant having received any of certain kinds of doctorate degrees, from an accredited educational institution. That law requires, with certain exceptions, the board to issue renewal licenses for psychology only to those applicants who have completed 36 hours of approved continuing education in the preceding two years. Existing law prescribes a biennial license renewal fee of not more than $500. Existing law also requires a person applying for relicensure or for reinstatement to an active license to certify under penalty of perjury that he or she is in compliance with the continuing education requirements. Existing law requires continuing education instruction to be completed within the state or be approved for credit by the American Psychological Association or its equivalent.
end insertbegin insertThis bill would revise and recast the doctorate degree requirements for licensure to include, until January 1, 2020, a doctorate degree from an unaccredited institution that is approved for operation by a specified entity. The bill would replace the term “continuing education” with “continuing professional development,” define “continuing professional development,” require a person applying for renewal or reinstatement to certify compliance with these requirements under penalty of perjury, require continuing professional courses to be approved by organizations approved by the board, as specified, and authorize the board to grant exemptions from, or extensions for compliance with, these requirements.
end insertbegin insertThis bill would authorize the board to issue a retired license to a licensed psychologist if the psychologist has applied to the board for a retired license and pays a fee of not more than $75. The bill would also prohibit the holder of a retired license from engaging in the practice of psychology in the same manner as an active licensee. Because a violation of this prohibition would be a crime, the bill would impose a state-mandated local program.
end insertbegin insertExisting law authorizes the board to appoint qualified persons to give the whole or any portion of any examination provided for in the law, to be designated as commissioners on examination.
end insertbegin insertThis bill would repeal this authorization.
end insertbegin insertThis bill would authorize the board to post on its Internet Web site the prescribed information regarding all current and former licensees.
end insert(1)
end deletebegin insert(2)end insert The Pharmacy Law provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy, which is within the Department of Consumer Affairs, and authorizes the board to appoint, with the approval of the Director of Consumer Affairs, an executive officer, as specified. 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 (FDA) within 10 days of the action. The bill would prohibit the issuance or renewal of an outsourcing facility license 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.
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.
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.
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.
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 ofbegin delete actualend delete patient harm are identified and disciplined expeditiously.
The Pharmacy Law defines “person” as including a firm, association, partnership, corporation, limited liability company, state governmental agency, or political subdivision. That law authorizes the board to deny or revoke any license of a corporation, as specified. That law prohibits a person who has, among other things, been denied a license or whose license has been revoked from serving as a manager, administrator, owner, member, officer, director, associate, or partner of a licensee, as specified, and requires the board to notify in writing each licensee for whom a person is prohibited from serving as a manager, administrator, owner, member, officer, director, associate, or partner of a licensee of the prohibition.
end insertbegin insertThis bill would also define “person” to include, but not be limited to, a trust and would make conforming changes.
end insertThe 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 $2,270 for the issuance of an outsourcing 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, and a fee of $715 for a temporary outsourcing facility license, as specified. 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 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 an 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. 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.
This bill would make these provisions operative by repealing the provision that made them inoperative on January 1, 2012. 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.
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.
begin insertThe Pharmacy Law makes a violation of any of its provisions punishable as a misdemeanor or an infraction, as specified.
end insertbegin insertBy placing new requirements on a pharmacy, this bill would expand an existing crime and would, therefore, impose a state-mandated local program.
end insert(2)
end deletebegin insert(3)end insert 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 insert end insertbegin insertThe Veterinary Medicine Practice Act makes a violation of any of its provisions punishable as a misdemeanor.end insert
This bill would instead require a veterinarian 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.begin insert By requiring additional persons to be licensed under the act that were previously exempt, the bill would expand the definition of an existing crime and, therefore, would result in a state-mandated local program.end insert
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.
end deleteBy 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.
end delete(4) This bill would incorporate additional changes in Section 4400 of the Business and Professions Code proposed by SB 1039 that would become operative only if SB 1039 and this bill are both chaptered and become effective on or before January 1, 2017, and this bill is chaptered last.
end insertbegin insert(5) This bill would incorporate additional changes in Section 4830 of the Business and Professions Code proposed by SB 1039 that would become operative only if SB 1039 and this bill are both chaptered and become effective on or before January 1, 2017, and this bill is chaptered last.
end insertThe
end deletebegin insert(6)end insertbegin insert end insertbegin insertTheend insert California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.
The people of the State of California do enact as follows:
begin insertSection 2909.5 of the end insertbegin insertBusiness and Professions
2Codeend insertbegin insert is amended to read:end insert
This chapter shall not be construed as restricting or
4preventing activities of a psychological nature or the use of the
5official title of the position for which persons were employed on
6the part of persons who meet the educational requirements of
7subdivision (b) of Section 2914 and who have one year or more
8of the supervised professional experience referenced in subdivision
9(c) of Section 2914, if they are employed by nonprofit community
10agencies that receive a minimum of 25 percent of their financial
11support from any federal, state, county, or municipal governmental
12organizations for the purpose of training and providing services,
13provided those persons are performing those activities as part of
14the duties for which they were employed, are performing those
15activities solely within the confines of or under the jurisdiction of
16the organization in
which they are employed and do not render or
17offer to render psychologicalbegin delete services,end deletebegin insert services to the public,end insert as
18defined in Section 2903. Those persons shall be registered by the
19agency with the board at the time of employment and shall be
20identified in the setting as a “registered psychologist.” Those
21persons shall be exempt from this chapter for a maximum period
22of 30 months from the date of registration.
begin insertSection 2913 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
24amended to read:end insert
A person other than a licensed psychologist maybegin delete be begin insert end insertbegin insertperform psychological functions
26employed by a licensed psychologist, by a licensed physician and
27surgeon who is board certified in psychiatry by the American Board
P14 1of Psychiatry and Neurology, by a clinic that provides mental
2health services under contract pursuant to Section 5614 of the
3Welfare and Institutions Code, by a psychological corporation, by
4a licensed psychology clinic as defined in Section 1204.1 of the
5Health and Safety Code, or by a medical corporation to perform
6limited psychological functionsend delete
7in preparation for
licensure as a psychologist onlyend insert
if all of the
8followingbegin delete apply:end deletebegin insert end insertbegin insertconditions are met:end insert
9(a) The personbegin delete is termedend deletebegin insert end insertbegin insertshall register himself or herself with
10the board asend insert a “psychological assistant.”begin insert This registration shall
11be renewed annually in accordance with regulations adopted by
12the board.end insert
13(b) The person (1) has completed a master’s degree in
14psychology or education with the field of specialization in
15psychology or counseling psychology, or (2) has been admitted to
16candidacy for a doctoral degree in psychology or education with
17the field of specialization in psychology or counseling psychology,
18after having satisfactorily completed three or more years of
19postgraduate education in psychology and having passed
20preliminary doctoral examinations, or (3) has completed a doctoral
21degree that qualifies for licensure under Sectionbegin delete 2914, in an begin insert 2914.end insert
22accredited or approved university, college, or professional school
23located in the United States or Canada.end delete
24(c) begin insert(1)end insertbegin insert end insert Thebegin delete personend deletebegin insert psychological assistantend insert is at all times under
25the immediate supervision, as defined in regulations adopted by
26the board, of a licensed psychologist, orbegin delete board certified psychiatrist,end delete
27begin insert a licensed physician and surgeon who is certified in psychiatry by
28the American Board of Psychiatry and Neurology or the American
29College of Osteopathic Board of Neurology and Psychiatry,end insert who
30shall be responsible for insuring that the extent, kind, and quality
31of the psychological servicesbegin delete he or sheend deletebegin insert
that the end insertbegin insertpsychological
32assistantend insert performs are consistent with his or her training and
33experience and be responsible forbegin delete his or herend deletebegin insert end insertbegin insertthe psychological
34assistant’send insert compliance with this chapter andbegin delete regulations duly begin insert regulations.end insert
35adopted hereunder, including those provisions set forth in Section
362960.end delete
37(d) (1) The licensed psychologist, board certified psychiatrist,
38contract clinic, psychological corporation, or medical corporation,
39has registered the psychological assistant with the board. The
P15 1registration shall be renewed annually in accordance with
2regulations adopted by the board.
3(2) begin deleteNo end deletebegin insertA end insertlicensed psychologistbegin delete may register, employ, or begin insert orend insert
4supervise more than three psychological assistants at any given
5time unless specifically authorized to do so by the board. Noend delete
6 board certified psychiatristbegin delete may register, employ, orend deletebegin insert shall nend insertbegin insertotend insert
7 supervise more thanbegin delete oneend deletebegin insert
threeend insert psychologicalbegin delete assistantend deletebegin insert assistantsend insert
8 at any given time. Nobegin delete contract clinic, psychological corporation,
9or medical corporation may employ more than 10
assistants at any
10one time. No contract clinic may register, employ, or provide
11supervision for more than one psychological assistant for each
12designated full-time staff psychiatrist who is qualified and
13supervises the psychological assistants. No psychological assistantend delete
14begin insertpsychological assistantend insert may provide psychological services to the
15public except asbegin delete an employee of a licensed psychologist, licensed begin insert end insertbegin inserta supervisee pursuant to this section.end insert
16physician, contract clinic, psychological corporation, or medical
17corporation.end delete
18(e)
end delete
19begin insert(d)end insert The psychological assistant shall comply with regulations
20that the board may, from time to time, duly adopt relating to the
21fulfillment of requirements in continuing education.
22(f) No person shall practice as a psychological assistant who is
23found by the board to be in violation of Section 2960 and the rules
24and regulations duly adopted pursuant to that section.
begin insertSection 2914 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
26amended to read:end insert
Each applicant for licensure shall comply with all of the
28following requirements:
29(a) Is not subject to denial of licensure under Division 1.5
30(commencing with Section 475).
31(b) begin delete(1)end deletebegin delete end deletePossess an earned doctorate degreebegin delete (A)end deletebegin insert (1)end insert in
32psychology,begin delete (B)end deletebegin insert
(2)end insert in educational psychology, orbegin delete (C)end deletebegin insert (3)end insert in
33education with the field of specialization in counseling psychology
34or educational psychology. Except as provided in subdivisionbegin delete (g),end delete
35begin insert (h),end insert this degree or training shall be obtained from an accredited
36university, college, or professional school. The board shall make
37the final determination as to whether a degree meets the
38requirements of this section.
39
(c) (1) On or after January
1, 2020, possess an earned doctorate
40degree in psychology, in educational psychology, or in education
P16 1with the field of specialization in counseling psychology or
2educational psychology from a college or institution of higher
3education that is accredited by a regional accrediting agency
4recognized by the United States Department of Education. Until
5January 1, 2020, the board may accept an applicant who possesses
6a doctorate degree in psychology, educational psychology, or in
7education with the field of specialization in counseling psychology
8or educational psychology from an institution that is not accredited
9by an accrediting agency recognized by the United States
10Department of Education, but is approved to operate in this state
11by the Bureau for Private Postsecondary Education.
12
(2) Paragraph (1) does not apply to any student who was
13
enrolled in a doctoral program in psychology, educational
14psychology, or in education with the field of specialization in
15counseling psychology or educational psychology at a nationally
16accredited or approved institution as of December 31, 2016.
17(2)
end delete
18begin insert(3)end insert No educational institution shall be denied recognition as an
19accredited academic institution solely because its program is not
20accredited by any professional organization of psychologists, and
21nothing in this chapter or in the administration of this chapter shall
22require the registration with the board by educational institutions
23of their departments of psychology or their doctoral programs in
24
psychology.
25(3)
end delete
26begin insert(4)end insert An applicant for licensure trained in an educational
27institution outside the United States or Canada shall demonstrate
28to the satisfaction of the board that he or she possesses a doctorate
29degree in psychology that is equivalent to a degree earned from a
30regionally accredited university in the United States or Canada.
31These applicants shall provide the board with a comprehensive
32evaluation of the degree performed by a foreign credential
33evaluation service that is a member of the National Association
34of Credential Evaluation Services (NACES), and any other
35documentation the board deems necessary.
36(c)
end delete
37begin insert(d)end insert (1) Have engaged for at least two years in supervised
38professional experience under the direction of a licensed
39psychologist, the specific requirements of which shall be defined
40by the board in its regulations, or under suitable alternative
P17 1supervision as determined by the board in regulations duly adopted
2under this chapter, at least one year of which shall be after being
3awarded the doctorate in psychology. The supervisor shall submit
4verification of the experience required by this subdivision to the
5trainee in a manner prescribed by the board. If the supervising
6licensed psychologist fails to provide verification to the trainee in
7a timely manner, the board may establish alternative procedures
8for obtaining the necessary documentation. Absent good cause,
9the failure of a supervising licensed psychologist to
provide the
10verification to the board upon request shall constitute
11unprofessional conduct.
12(2) The board shall establish qualifications by regulation for
13supervising psychologists.
14(d)
end delete
15begin insert(e)end insert Take and pass the examination required by Section 2941
16unless otherwise exempted by the board under this chapter.
17(e)
end delete
18begin insert(f)end insert Show by evidence satisfactory to the board that he or she
19has completed training in the detection and treatment of alcohol
20and other chemical substance dependency. This requirement applies
21only to applicants who matriculate on or after September 1, 1985.
22(f)
end delete
23begin insert(g)end insert (1) Show by evidence satisfactory to the board that he or
24she has completed coursework in spousal or partner abuse
25assessment, detection, and intervention. This requirement applies
26to applicants who began graduate training during the period
27commencing on January 1, 1995, and ending on December 31,
282003.
29(2) An
applicant who began graduate training on or after January
301, 2004, shall show by evidence satisfactory to the board that he
31or she has completed a minimum of 15 contact hours of coursework
32in spousal or partner abuse assessment, detection, and intervention
33strategies, including knowledge of community resources, cultural
34factors, and same gender abuse dynamics. An applicant may request
35an exemption from this requirement if he or she intends to practice
36in an area that does not include the direct provision of mental health
37services.
38(3) Coursework required under this subdivision may be
39satisfactory if taken either in fulfillment of other educational
40requirements for licensure or in a separate course. This requirement
P18 1for coursework shall be satisfied by, and the board shall accept in
2satisfaction of the requirement, a certification from the chief
3academic officer of the educational institution from which the
4applicant graduated that the required
coursework is included within
5the institution’s required curriculum for graduation.
6(g) An
end delete
7begin insert (h)end insertbegin insert end insertbegin insertUntil January 1, 2020, an end insertapplicant holding a doctoral
8degree in psychology from an approved institution is deemed to
9meet the requirements of this section if both of the following are
10true:
11(1) The approved institution offered a doctoral degree in
12psychology designed to prepare students for a license to practice
13psychology and was approved by the former Bureau for Private
14Postsecondary and
Vocational Education on or before July 1, 1999.
15(2) The approved institution has not, since July 1, 1999, had a
16new location, as described in Section 94823.5 of the Education
17Code.
begin insertSection 2914.1 of the end insertbegin insertBusiness and Professions Codeend insert
19
begin insert is amended to read:end insert
The board shall encourage every licensed psychologist
21to takebegin delete aend delete continuingbegin delete education course in geriatric pharmacology begin insert end insertbegin insertprofessional
22as a part of his or her continuing education.end delete
23development in geriatric pharmacology.end insert
begin insertSection 2914.2 of the end insertbegin insertBusiness and Professions Codeend insert
25
begin insert is amended to read:end insert
The board shall encourage licensed psychologists to
27take continuingbegin delete education coursesend deletebegin insert end insertbegin insertprofessional developmentend insert in
28psychopharmacology and biological basis ofbegin delete behavior as part of begin insert behavior.end insert
29their continuing education.end delete
begin insertSection 2915 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
31amended to read:end insert
(a) Except as provided in this section,begin delete on or after January the board shall
331, 1996,end deletebegin delete notend delete issuebegin delete any renewal license unless the begin insert
a renewal license only to an applicant who hasend insert completed
34applicant submits proof that he or she has completed no less than
3518 hours of approved continuing education in the preceding year.
36On or after January 1, 1997, except as provided in this section, the
37board shall issue renewal licenses only to those applicants who
38haveend delete
3936 hours of approved continuingbegin delete educationend deletebegin insert end insertbegin insertprofessional
40developmentend insert in the preceding two years.
P19 1(b) Each personbegin delete renewingend deletebegin insert end insertbegin insertwho applies to renew or reinstateend insert his
2or her license issued pursuant to this chapter shallbegin delete submit proof ofend delete
3begin insert
certify under penalty of perjury that he or she is inend insert compliance
4with this sectionbegin delete to the board.end deletebegin insert end insertbegin insertand shall retain proof of this
5compliance for submission to the board upon request.end insert False
6statements submitted pursuant to this section shall be a violation
7of Section 2970.
8(c) A person applying for relicensure or for reinstatement to an
9active license status shall certify under penalty of perjury that he
10or she is in compliance with this section.
11(d) (1) The continuing education requirement shall include, but
12shall not be limited to, courses required pursuant to Sections 25
13and 28. The requirement may include courses pursuant to Sections
1432 and 2914.1.
15
(c) Continuing professional development means certain
16continuing education learning activities approved in four different
17categories:
18
(1) Professional.
19
(2) Academic.
20
(3) Sponsored continuing education coursework.
21
(4) Board certification from the American Board of Professional
22Psychology.
23
The board may develop regulations further defining acceptable
24continuing professional development activities.
25(2) (A)
end delete
26begin insert(d)end insertbegin insert end insertbegin insert(end insertbegin insert1)end insert The board shall require a licensed psychologist who
27began graduate study prior to January 1, 2004, to take a continuing
28education course during his or her first renewal period after the
29operative date of this section in spousal or partner abuse
30assessment, detection, and intervention strategies, including
31community resources, cultural factors, and same gender abuse
32dynamics. Equivalent courses in spousal or partner abuse
33assessment, detection, and intervention strategies taken prior to
34the operative date of this section or proof of equivalent teaching
35or practice experience may be submitted to the board and at its
36discretion, may be accepted in satisfaction of this requirement.
37(B)
end delete
38begin insert(2)end insert Continuing education courses taken pursuant to this
39begin delete paragraphend deletebegin insert subdivisionend insert shall be applied to the 36 hours of approved
P20 1continuingbegin delete educationend deletebegin insert professional developmentend insert required under
2subdivision (a).
3(C) A licensed psychologist whose practice does not include
4the direct provision of mental health services may apply to the
5board for an exemption from the requirements of this paragraph.
6(3)
end delete
7begin insert(e)end insert Continuing educationbegin delete instructionend deletebegin insert
coursesend insert
approved to meet
8the requirements of this section shall bebegin delete completed within the State begin insert end insert
9of California, or shall be approved for continuing education credit
10by the American Psychological Association or its equivalent asend delete
11begin insertapproved by organizations approved by the board. An organization
12previouslyend insert approved by thebegin delete board.end deletebegin insert end insertbegin insertboard to provide or approve
13continuing education is deemed approved under this section.end insert
14(e) The board may establish a policy for exceptions from the
15continuing education requirement of this section.
16(f) The board maybegin delete recognizeend deletebegin insert acceptend insert continuing education
17coursesbegin delete that have been approved by one or more private nonprofit begin insert approved by an entity that has
18organizations that have at least 10 years’ experience managing
19continuing education programs for psychologists on a statewide
20basis, including, but not limited to:end delete
21demonstrated to the board in writing that it has, at a minimum, a
2210-year history of providing educational programming for
23psychologists and has documented procedures for maintaining a
24continuing education approval program. The board shall adopt
25regulations necessary for implementing
this section.end insert
26(1) Maintaining and managing related records and data.
end delete27(2) Monitoring and approving courses.
end delete
28(g) The board shall adopt regulations as necessary for
29implementation of this section.
30(h) A licensed psychologist shall choose continuing education
31instruction that is related to the assessment, diagnosis, and
32intervention for the client population being served or to the fields
33of psychology in which the psychologist intends to provide
34services, that may include new theoretical approaches, research,
35and applied techniques. Continuing education instruction shall
36include required courses specified in subdivision (d).
37(i) A psychologist shall not practice outside his or her particular
38field or fields of competence as established by his or her education,
39training, continuing education, and experience.
P21 1
(g) The board may grant an exemption, or an extension of the
2time for compliance with, from the continuing professional
3development requirement of this section.
4(j)
end delete
5begin insert(h)end insert The administration of this section may be funded through
6professional license fees and continuing education provider and
7course approval fees, or both. The fees related to the administration
8of this section shall not exceed the costs of administering the
9corresponding provisions of this section.
10(k) Continuing education credit may be approved for those
11licensees who serve as commissioners on any examination pursuant
12to Section 2947, subject to limitations established by the board.
13(l) This section shall become operative on January 1, 2004.
end delete
begin insertSection 2920 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
15amended to read:end insert
(a) The Board of Psychology shall enforce and
17administer this chapter. The board shall consist of nine members,
18four of whom shall be public members.
19(b) This section shall remain in effect only until January 1,begin delete 2017,end delete
20begin insert 2021,end insert and as of that date is begin deleterepealed, unless a later enacted statute,
21that is enacted before January 1, 2017, deletes or extends that date.end delete
22
begin insert
repealed.end insert
23(c) Notwithstanding any otherbegin delete provision ofend delete law, the repeal of
24this section renders the board subject to review by the appropriate
25policy committees of the Legislature.
begin insertSection 2933 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
27amended to read:end insert
begin insert(a)end insertbegin insert end insert Except as provided by Section 159.5, the board shall
29employ and shall make available to the board within the limits of
30the funds received by the board all personnel necessary to carry
31out this chapter. The board may employ, exempt from the State
32Civil Service Act, an executive officer to the Board of Psychology.
33The board shall make all expenditures to carry out this chapter.
34The board may accept contributions to effectuate the purposes of
35this chapter.
36This
end delete
37begin insert(b)end insertbegin insert end insertbegin insertThisend insert section shall remain in effect only until January 1,begin delete 2017,end delete
38begin insert
2021,end insert and as of that date is begin deleterepealed, unless a later enacted statute,
39that is enacted before January 1, 2017, deletes or extends that date.end delete
40
begin insert repealed.end insert
begin insertSection 2934.1 is added to the end insertbegin insertBusiness and Professions
2Codeend insertbegin insert, to read:end insert
(a) The board may post on its Internet Web site the
4following information on the current status of the license for all
5current and former licensees:
6
(1) Whether or not the licensee has a record of a disciplinary
7action.
8
(2) Any of the following enforcement actions or proceedings
9against the licensee:
10
(A) Temporary restraining orders.
11
(B) Interim suspension orders.
12
(C) Revocations, suspensions, probations, or limitations on
13practice ordered by the board or by a court with jurisdiction in
14
the state, including those made part of a probationary order, cease
15practice order, or stipulated agreement.
16
(D) Accusations filed by the board, including those accusations
17that are on appeal, excluding ones that have been dismissed or
18withdrawn where the action is no longer pending.
19
(E) Citations issued by the board. Unless withdrawn, citations
20shall be posted for five years from the date of issuance.
21
(b) The board may also post on its Internet Web site all of the
22following historical information in its possession, custody, or
23control regarding all current and former licensees:
24
(1) Institutions that awarded the qualifying educational degree
25and type of degree awarded.
26
(2) A link to the
licensee’s professional Internet Web site. Any
27link that provides access to a licensee’s professional Internet Web
28site, once clicked, shall be accompanied by a notification that
29informs the Internet Web site viewer that they are no longer on
30the board’s Internet Web site.
31
(c) The board may also post other information designated by
32the board in regulation.
begin insertSection 2947 of the end insertbegin insertBusiness and Professions Codeend insert
34
begin insert is repealed.end insert
The board may appoint qualified persons to give the
36whole or any portion of any examination provided for in this
37chapter, who shall be designated as commissioners on examination.
38A commissioner on examination need not be a member of the
39board but he or she shall have the same qualifications as a member
40of the board, including those set forth in Chapter 6 (commencing
P23 1with Section 450) of Division 1. The board may also appoint
2occasional professional commissioners for short-term specified
3periods to assist in its nonpolicy workload.
4Public commissioners may examine and evaluate candidates in
5areas of knowledge such as the law, ethics, and awareness of
6community resources.
begin insertSection 2988.5 is added to the end insertbegin insertBusiness and
8Professions Codeend insertbegin insert, to read:end insert
(a) The board may issue, upon an application
10prescribed by the board and payment of a fee not to exceed
11seventy-five dollars ($75), a retired license to a psychologist who
12holds a current license issued by the board, or one capable of
13being renewed, and whose license is not suspended, revoked, or
14otherwise restricted by the board or subject to discipline under
15this chapter.
16
(b) The holder of a retired license issued pursuant to this section
17shall not engage in any activity for which an active license is
18required. A psychologist holding a retired license shall be
19permitted to use the title “psychologist, retired” or “retired
20psychologist.” The designation of retired shall not be abbreviated
21in any way.
22
(c) A retired license shall not be subject to renewal.
23
(d) The holder of a retired license may apply to obtain an active
24status license as follows:
25
(1) If that retired license was issued less than three years prior
26to the application date, the applicant shall meet all of the following
27requirements:
28
(A) Has not committed an act or crime constituting grounds for
29denial or discipline of a license.
30
(B) Pays the renewal fee required by this chapter.
31
(C) Completes the continuing professional development required
32for the renewal of a license within two years of the date of
33application for restoration.
34
(D) Complies with the fingerprint submission requirements
35established by the board.
36
(2) Where the applicant has held a retired license for three or
37more years, the applicant shall do all of the following:
38
(A) Submit a complete application for a new license.
39
(B) Take and pass the California Psychology Law and Ethics
40Examination.
P24 1
(C) Pay all fees required to obtain a new license.
2
(D) Comply with the fingerprint submission requirements
3established by the board.
4
(E) Be deemed to have met the educational and experience
5requirements of subdivisions (b) and (c) of Section
2914.
6
(F) Establish that he or she has not been subject to denial or
7discipline of a license.
Section 4001 of the Business and Professions Code
10 is amended to read:
(a) There is in the Department of Consumer Affairs a
12California State Board of Pharmacy in which the administration
13and enforcement of this chapter is vested. The board consists of
1413 members.
15(b) The Governor shall appoint seven competent pharmacists
16who reside in different parts of the state to serve as members of
17the board. The Governor shall appoint four public members, and
18the Senate Committee on Rules and the Speaker of the Assembly
19shall each appoint a public member who shall not be a licensee of
20the board, any other board under this division, or any board referred
21to in Section 1000 or 3600.
22(c) At least five of the
seven pharmacist appointees to the board
23shall be pharmacists who are actively engaged in the practice of
24pharmacy. Additionally, the membership of the board shall include
25at least one pharmacist representative from each of the following
26practice settings: an acute care hospital, an independent community
27pharmacy, a chain community pharmacy, and a long-term health
28care or skilled nursing facility. The pharmacist appointees shall
29also include a pharmacist who is a member of a labor union that
30represents pharmacists. For the purposes of this subdivision, a
31“chain community pharmacy” means a chain of 75 or more stores
32in California under the same ownership, and an “independent
33community pharmacy” means a pharmacy owned by a person or
34entity who owns no more than four pharmacies in California.
35(d) Members of the board shall be appointed for a
term of four
36years. No person shall serve as a member of the board for more
37than two consecutive terms. Each member shall hold office until
38the appointment and qualification of his or her successor or until
39one year shall have elapsed since the expiration of the term for
40which the member was appointed, whichever first occurs.
P25 1Vacancies occurring shall be filled by appointment for the
2unexpired term.
3(e) Each member of the board shall receive a per diem and
4expenses as provided in Section 103.
5(f) This section shall remain in effect only until January 1, 2021,
6and as of that date is repealed. Notwithstanding any other law, the
7repeal of this section renders the board subject to review by the
8appropriate policy committees of the Legislature.
Section 4003 of the Business and Professions Code
11 is amended to read:
(a) The board, with the approval of the director, may
13appoint a person exempt from civil service who shall be designated
14as an executive officer and who shall exercise the powers and
15perform the duties delegated by the board and vested in him or her
16by this chapter. The executive officer may or may not be a member
17of the board as the board may determine.
18(b) The executive officer shall receive the compensation as
19established by the board with the approval of the Director of
20Finance. The executive officer shall also be entitled to travel and
21other expenses necessary in the performance of his or her duties.
22(c) The executive
officer shall maintain and update in a timely
23fashion records containing the names, titles, qualifications, and
24places of business of all persons subject to this chapter.
25(d) The executive officer shall give receipts for all money
26received by him or her and pay it to the department, taking its
27receipt therefor. Besides the duties required by this chapter, the
28executive officer shall perform other duties pertaining to the office
29as may be required of him or her by the board.
30(e) This section shall remain in effect only until January 1, 2021,
31and as of that date is repealed.
Section 4013 of the Business and Professions Code
34 is amended to read:
(a) Any facility licensed by the board shall join the
36board’s email notification list within 60 days of obtaining a license
37or at the time of license renewal.
38(b) Any facility licensed by the board shall update its email
39address with the board’s email notification list within 30 days of
40a change in the facility’s email address.
P26 1(c) An owner of two or more facilities licensed by the board
2may comply with subdivisions (a) and (b) by subscribing a single
3email address to the board’s email notification list, where the owner
4maintains an electronic notice system within all of its licensed
5facilities that, upon receipt of an email
notification from the board,
6immediately transmits electronic notice of the same notification
7to all of its licensed facilities. If an owner chooses to comply with
8this section by using such an electronic notice system, the owner
9shall register the electronic notice system with the board by July
101, 2011, or within 60 days of initial licensure, whichever is later,
11informing the board of the single email address to be utilized by
12the owner, describing the electronic notice system, and listing all
13facilities to which immediate notice will be provided. The owner
14shall update its email address with the board’s email notification
15list within 30 days of any change in the owner’s email address.
16(d) (1) Each pharmacist, intern pharmacist, pharmacy
17technician, designated representative-3PL licensed in this state
18shall
join the board’s email notification list within 60 days of
19obtaining a license or at the time of license renewal.
20(2) Each pharmacist, intern pharmacist, pharmacy technician,
21designated representative, and designated representative-3PL
22licensed in this state shall update his or her email address with the
23board’s email notification list within 30 days of a change in the
24licensee’s email address.
25(3) The email address provided by a licensee shall not be posted
26on the board’s online license verification system.
27(4) The board shall, with each renewal application, remind
28licensees of their obligation to report and keep current their email
29address with the board’s email notification list.
30(5) This subdivision shall become operative on July 1, 2017.
Section 4034 is added to the Business and Professions
33Code, to read:
“Outsourcing facility” means a facility that meets all of
35the following:
36(a) Is located within the United States of America at one address
37that is engaged in the compounding of sterile drugs and nonsterile
38drugs.
P27 1(b) Has registered as an outsourcing facility with the federal
2Food and Drug Administration under Section 503B of the Federal
3Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353b).
4(c) Is doing business within or into California.
5(d) Is licensed with the board as an outsourcing facility pursuant
6to
Article 7.7 (commencing with Section 4129).
begin insertSection 4035 of the end insertbegin insertBusiness and Professions Codeend insert
8
begin insert is amended to read:end insert
“Person”begin delete includesend deletebegin insert includes, but is not limited to,end insert firm,
10association, partnership, corporation, limited liability company,
11state governmental agency,begin insert trust,end insert or political subdivision.
Section 4081 of the Business and Professions Code
14 is amended to read:
(a) All records of manufacture and of sale, acquisition,
16receipt, shipment, or disposition of dangerous drugs or dangerous
17devices shall be at all times during business hours open to
18inspection by authorized officers of the law, and shall be preserved
19for at least three years from the date of making. A current inventory
20shall be kept by every manufacturer, wholesaler, third-party
21logistics provider, pharmacy, veterinary food-animal drug retailer,
22outsourcing facility, physician, dentist, podiatrist, veterinarian,
23laboratory, clinic, hospital, institution, or establishment holding a
24currently valid and unrevoked certificate, license, permit,
25registration, or exemption under Division 2 (commencing with
26Section 1200) of the Health and Safety Code or
under Part 4
27(commencing with Section 16000) of Division 9 of the Welfare
28and Institutions Code who maintains a stock of dangerous drugs
29or dangerous devices.
30(b) The owner, officer, and partner of a pharmacy, wholesaler,
31third-party logistics provider, or veterinary food-animal drug
32retailer shall be jointly responsible, with the pharmacist-in-charge,
33responsible manager, or designated representative-in-charge, for
34maintaining the records and inventory described in this section.
35(c) The pharmacist-in-charge, responsible manager, or
36designated representative-in-charge shall not be criminally
37responsible for acts of the owner, officer, partner, or employee
38that violate this section and of which the pharmacist-in-charge,
39responsible manager, or designated representative-in-charge
had
40no knowledge, or in which he or she did not knowingly participate.
Section 4105.5 is added to the Business and
3Professions Code, to read:
(a) For purposes of this section, an “automated drug
5delivery system” has the same meaning as that term is defined in
6paragraph (1) of subdivision (a) of Section 1261.6 of the Health
7and Safety Code.
8(b) Except as provided by subdivision (e), a pharmacy that owns
9or provides dangerous drugs dispensed through an automated drug
10delivery system shall register the automated drug delivery system
11by providing the board in writing with the location of each device
12within 30 days of installation of the device, and on an annual basis
13as part of the license renewal pursuant to subdivision (a) of Section
144110. The pharmacy shall also advise the board in writing within
1530
days if the pharmacy discontinues operating an automated drug
16delivery system.
17(c) A pharmacy may only use an automated drug delivery system
18if all of the following conditions are satisfied:
19(1) Use of the automated drug delivery system is consistent with
20legal requirements.
21(2) The pharmacy’s policies and procedures related to the
22automated drug delivery system to include appropriate security
23measures and monitoring of the inventory to prevent theft and
24diversion.
25(3) The pharmacy reports drug losses from the automated drug
26delivery system to the board as required by law.
27(4) The pharmacy
license is unexpired and not subject to
28disciplinary conditions.
29(d) The board may prohibit a pharmacy from using an automated
30drug delivery system if the board determines that the conditions
31provided in subdivision (c) are not satisfied. If such a determination
32is made, the board shall provide the pharmacy with written notice
33including the basis for the determination. The pharmacy may
34request an office conference to appeal the board’s decision within
3530 days of receipt of the written notice. The executive officer or
36designee may affirm or overturn the prohibition as a result of the
37office conference.
38(e) An automated drug delivery system operated by a licensed
39hospital pharmacy as defined in Section 4029 for doses
40administered in a facility operated under a consolidated license
P29 1under
Section 1250.8 of the Health and Safety Code shall be
2exempt from the requirements of subdivision (b).
Section 4107 of the Business and Professions Code
5 is amended to read:
(a) The board shall not issue more than one site license
7to a single premises except as follows:
8(1) To issue a veterinary food-animal drug retailer license to a
9wholesaler pursuant to Section 4196.
10(2) To issue a license to compound sterile drugs to a pharmacy
11pursuant to Section 4127.1 or 4127.2.
12(3) To issue a centralized hospital packaging license pursuant
13to Section 4128.
14(b) For the purposes of this subdivision, “premises” means a
15location with its own address and an independent means of ingress
16and
egress.
Section 4110 of the Business and Professions Code
19 is amended to read:
(a) No person shall conduct a pharmacy in the State of
21California unless he or she has obtained a license from the board.
22A license shall be required for each pharmacy owned or operated
23by a specific person. A separate license shall be required for each
24of the premises of any person operating a pharmacy in more than
25one location. The license shall be renewed annually. The board
26may, by regulation, determine the circumstances under which a
27license may be transferred.
28(b) The board may, at its discretion, issue a temporary permit
29upon the conditions and for any periods of time as the board
30determines to be in the public interest. A temporary permit fee
31shall be required in an amount
established by the board as specified
32in subdivision (a) of Section 4400. When needed to protect public
33safety, a temporary permit may be issued for a period not to exceed
34180 days, and may be issued subject to terms and conditions the
35board deems necessary. If the board determines a temporary permit
36was issued by mistake or denies the application for a permanent
37license or registration, the temporary license or registration shall
38terminate upon either personal service of the notice of termination
39upon the permitholder or service by certified mail, return receipt
40requested, at the permitholder’s address of record with the board,
P30 1whichever comes first. Neither for purposes of retaining a
2temporary permit nor for purposes of any disciplinary or license
3denial proceeding before the board shall the temporary
4
permitholder be deemed to have a vested property right or interest
5in the permit.
6(c) The board may allow the temporary use of a mobile
7pharmacy when a pharmacy is destroyed or damaged, the mobile
8pharmacy is necessary to protect the health and safety of the public,
9and the following conditions are met:
10(1) The mobile pharmacy shall provide services only on or
11immediately contiguous to the site of the damaged or destroyed
12pharmacy.
13(2) The mobile pharmacy is under the control and management
14of the pharmacist-in-charge of the pharmacy that was destroyed
15or damaged.
16(3) A licensed pharmacist is on the premises while drugs are
17being
dispensed.
18(4) Reasonable security measures are taken to safeguard the
19drug supply maintained in the mobile pharmacy.
20(5) The pharmacy operating the mobile pharmacy provides the
21board with records of the destruction of, or damage to, the
22pharmacy and an expected restoration date.
23(6) Within three calendar days of restoration of the pharmacy
24services, the board is provided with notice of the restoration of the
25permanent pharmacy.
26(7) The mobile pharmacy is not operated for more than 48 hours
27following the restoration of the permanent pharmacy.
Section 4119.1 of the Business and Professions Code
30 is amended to read:
(a) A pharmacy may provide pharmacy services to a
32health facility licensed pursuant to subdivision (c), (d), or both, of
33Section 1250 of the Health and Safety Code, through the use of
34an automated drug delivery system that need not be located at the
35same location as the pharmacy.
36(b) Drugs stored in an automated drug delivery system shall be
37part of the inventory of the pharmacy providing pharmacy services
38to that facility, and drugs dispensed from the pharmacy system
39shall be considered to have been dispensed by that pharmacy.
P31 1(c) (1) The pharmacy shall maintain records
of the acquisition
2and disposition of dangerous drugs and dangerous devices stored
3in the automated drug delivery system separate from other
4pharmacy records.
5(2) The pharmacy shall own and operate the automated drug
6delivery system.
7(3) The pharmacy shall provide training regarding the operation
8and use of the automated drug delivery system to both pharmacy
9and health facility personnel using the system.
10(4) The pharmacy shall operate the automated drug delivery
11system in compliance with Section 1261.6 of the Health and Safety
12Code.
13(d) The operation of the automated drug delivery system shall
14be under the supervision of a licensed pharmacist. To
qualify as a
15supervisor for an automated drug delivery system, the pharmacist
16need not be physically present at the site of the automated drug
17delivery system and may supervise the system electronically.
18(e) This section shall not be construed to revise or limit the use
19of automated drug delivery systems as permitted by the board in
20any licensed health facility other than a facility defined in
21subdivision (c) or (d), or both, of Section 1250 of the Health and
22Safety Code.
Section 4126.9 is added to the Business and
25Professions Code, to read:
(a) A pharmacy that issues a recall notice regarding
27a nonsterile compounded drug product shall, in addition to any
28other duties, contact the recipient pharmacy, prescriber, or patient
29of the recalled drug and the board within 12 hours of the recall
30notice if both of the following apply:
31(1) Use of or exposure to the recalled drug may cause serious
32adverse health consequences or death.
33(2) The recalled drug was dispensed, or is intended for use, in
34this state.
35(b) A recall notice issued pursuant to subdivision (a) shall be
36made as
follows:
37(1) If the recalled drug was dispensed directly to the patient,
38the notice shall be made to the patient.
P32 1(2) If the recalled drug was dispensed directly to the prescriber,
2the notice shall be made to the prescriber, who shall ensure the
3patient is notified.
4(3) If the recalled drug was dispensed directly to a pharmacy,
5the notice shall be made to the pharmacy, which shall notify the
6prescriber or patient, as appropriate. If the pharmacy notifies the
7prescriber, the prescriber shall ensure the patient is notified.
8(c) A pharmacy that has been advised that a patient has been
9harmed by using a nonsterile compounded product potentially
10
attributable to the pharmacy shall report the event to MedWatch
11within 72 hours of the pharmacy being advised.
Section 4127 of the Business and Professions Code
14 is amended to read:
(a) A pharmacy that compounds sterile drug products
16shall possess a sterile compounding pharmacy license as provided
17in this article.
18(b) The board shall adopt regulations in accordance with the
19Administrative Procedure Act (Chapter 3.5 (commencing with
20Section 11340) of Part 1 of Division 3 of Title 2 of the Government
21Code) to establish policies, guidelines, and procedures to
22implement this article.
23(c) The board shall review any formal revision to General
24Chapter 797 of the United States Pharmacopeia and The National
25Formulary (USP-NF), relating to the compounding of sterile
26preparations, not later than 90 days
after the revision becomes
27official, to determine whether amendments are necessary for the
28regulations adopted by the board pursuant to subdivision (b).
Section 4127.3 of the Business and Professions Code
31 is amended to read:
(a) Whenever the board has a reasonable belief, based
33on information obtained during an inspection or investigation by
34the board, that a pharmacy compounding sterile drug products
35poses an immediate threat to the public health or safety, the
36executive officer of the board may issue an order to the pharmacy
37to immediately cease and desist from compounding sterile drug
38products. The cease and desist order shall remain in effect for no
39more than 30 days or the date of a hearing seeking an interim
40suspension order, whichever is earlier.
P33 1(b) Whenever the board issues a cease and desist order pursuant
2to subdivision (a), the board shall immediately issue
the owner a
3notice setting forth the acts or omissions with which the owner is
4charged, specifying the pertinent code section or sections.
5(c) The order shall provide that the owner, within 15 days of
6receipt of the notice, may request a hearing before the president
7of the board to contest the cease and desist order. Consideration
8of the owner’s contest of the cease and desist order shall comply
9with the requirements of Section 11425.10 of the Government
10Code. The hearing shall be held no later than five days from the
11date the request of the owner is received by the board. The
12president shall render a written decision within five days of the
13hearing. In the absence of the president of the board, the vice
14president of the board may conduct the hearing permitted by this
15subdivision. Review of the decision of the president of the board
16may
be sought by the owner or person in possession or control of
17the pharmacy pursuant to Section 1094.5 of the Code of Civil
18Procedure.
19(d) Failure to comply with a cease and desist order issued
20pursuant to this section shall be unprofessional conduct.
Section 4127.7 of the Business and Professions Code
23 is amended to read:
A pharmacy shall compound sterile products from one
25or more nonsterile ingredients in one of the following
26environments:
27(a) An ISO class 5 laminar airflow hood within an ISO class 7
28cleanroom. The cleanroom must have a positive air pressure
29differential relative to adjacent areas.
30(b) An ISO class 5 cleanroom.
31(c) A barrier isolator that provides an ISO class 5 environment
32for compounding.
Section 4127.8 of the Business and Professions Code
35 is amended to read:
The board may, at its discretion, issue a temporary
37license to compound sterile drug products upon the conditions and
38for any periods of time as the board determines to be in the public
39interest. A temporary license fee shall be required in an amount
40established by the board as specified in subdivision (u) of Section
P34 14400. When needed to protect public safety, a temporary license
2may be issued for a period not to exceed 180 days, and may be
3issued subject to terms and conditions the board deems necessary.
4If the board determines a temporary license was issued by mistake
5or denies the application for a permanent license, the temporary
6license shall terminate upon either personal service of the notice
7of termination upon the licenseholder or service by certified mail,
8return
receipt requested at the licenseholder’s address of record
9with the board, whichever comes first. Neither for purposes of
10retaining a temporary license nor for purposes of any disciplinary
11or license denial proceeding before the board shall the temporary
12licenseholder be deemed to have a vested property right or interest
13in the license.
Section 4127.9 of the Business and Professions Code
16 is amended to read:
(a) A pharmacy licensed pursuant to Section 4127.1
18or 4127.2 that issues a recall notice regarding a sterile compounded
19drug shall, in addition to any other duties, contact the recipient
20pharmacy, prescriber, or patient of the recalled drug and the board
21as soon as possible within 12 hours of the recall notice if both of
22the following apply:
23(1) Use of or exposure to the recalled drug may cause serious
24adverse health consequences or death.
25(2) The recalled drug was dispensed, or is intended for use, in
26this state.
27(b) A recall notice issued pursuant to
subdivision (a) shall be
28made as follows:
29(1) If the recalled drug was dispensed directly to the patient,
30the notice shall be made to the patient.
31(2) If the recalled drug was dispensed directly to the prescriber,
32the notice shall be made to the prescriber, who shall ensure the
33patient is notified.
34(3) If the recalled drug was dispensed directly to a pharmacy,
35the notice shall be made to the pharmacy, who shall notify the
36prescriber or patient, as appropriate. If the pharmacy notifies the
37prescriber, the prescriber shall ensure the patient is notified.
Section 4128.6 of the Business and Professions Code
40 is amended to read:
All compounding and packaging functions specified
2in Section 4128 shall be performed only in the licensed centralized
3hospital packaging pharmacy and that pharmacy shall comply with
4all applicable federal and state statutes and regulations, including,
5but not limited to, regulations regarding compounding and, when
6appropriate, sterile compounding.
Article 7.7 (commencing with Section 4129) is added
9to Chapter 9 of Division 2 of the Business and Professions Code,
10to read:
11
(a) A facility licensed as an outsourcing facility with
15the federal Food and Drug Administration (FDA) shall be
16concurrently licensed with the board as an outsourcing facility if
17it compounds sterile medication or nonsterile medication for
18nonpatient-specific distribution within or into California.
19(b) A facility premises licensed with the board as a sterile
20compounding pharmacy shall not be concurrently licensed with
21the board as an outsourcing facility at the same location.
22(c) The board may adopt regulations in accordance with the
23Administrative Procedure Act (Chapter 3.5 (commencing with
24Section 11340)
of Part 1 of Division 3 of Title 2 of the Government
25Code) to establish policies, guidelines, and procedures to
26implement this article.
27(d) The board shall review any formal requirements or guidance
28documents developed by the FDA regarding outsourcing facilities
29within 90 days after their release in order to determine whether
30revisions are necessary for any regulations promulgated by the
31board.
32(e) An outsourcing facility licensed by the board shall not
33perform the duties of a pharmacy, such as filling individual
34prescriptions for individual patients.
(a) An outsourcing facility that is licensed with the
36federal Food and Drug Administration (FDA) and with an address
37in this state shall also be licensed by the board as an outsourcing
38facility before doing business within this state. The license shall
39be renewed annually and is not transferable.
P36 1(b) An outsourcing facility shall compound all sterile products
2and nonsterile products in compliance with regulations issued by
3the board and with federal current good manufacturing practices
4applicable to outsourcing facilities.
5(c) An outsourcing facility license shall not be issued or renewed
6until the location
is inspected by the board and found in compliance
7with this article and regulations adopted by the board.
8(d) An outsourcing facility license shall not be issued or renewed
9until the board does all of the following:
10(1) Prior to inspection, reviews a current copy of the outsourcing
11facility’s policies and procedures for sterile compounding and
12nonsterile compounding.
13(2) Is provided with copies of all federal and state regulatory
14agency inspection reports, as well as accreditation reports, and
15certification reports of facilities or equipment of the outsourcing
16facility’s premises conducted in the prior 12 months.
17(3) Prior to inspection, receives a list of all
sterile drugs and
18nonsterile drugs compounded by the outsourcing facility as reported
19to the FDA in the last 12 months.
20(e) An outsourcing facility licensed pursuant to this section shall
21provide the board with all of the following:
22(1) A copy of any disciplinary or other action taken by another
23state or the FDA within 10 days of the action.
24(2) Notice within 24 hours of any recall notice issued by the
25outsourcing facility.
26(3) A copy of any clinically related complaint it receives
27involving an outsourcing facility’s compounded products from or
28involving any provider, pharmacy, or patient in California within
2972 hours of receipt.
30(4) Notice within 24 hours after learning of adverse effects
31reported or potentially attributable to the outsourcing facility’s
32products.
(a) An outsourcing facility that is licensed with the
34federal Food and Drug Administration (FDA) as an outsourcing
35facility and has an address outside of this state but in the United
36States of America is a nonresident outsourcing facility. A
37nonresident outsourcing facility shall not compound sterile drug
38products or nonsterile drug products for distribution or use into
39this state without an outsourcing license issued by the board
P37 1pursuant to this section. The license shall be renewed annually and
2shall not be transferable.
3(b) A nonresident outsourcing facility shall compound all sterile
4products and nonsterile products to be distributed or used in this
5state in
compliance with regulations of the board and with federal
6current good manufacturing practices applicable to outsourcing
7facilities.
8(c) A license for a nonresident outsourcing facility shall not be
9issued or renewed until the location is inspected by the board and
10found in compliance with this article and any regulations adopted
11by the board. The nonresident outsourcing facility shall reimburse
12the board for all actual and necessary costs incurred by the board
13in conducting an inspection of the nonresident outsourcing facility
14at least once annually pursuant to subdivision (x) of Section 4400.
15(d) A license for a nonresident outsourcing facility shall not be
16issued or renewed until the board:
17(1) Prior to inspection,
reviews a current copy of the nonresident
18outsourcing facility’s policies and procedures for sterile
19compounding and nonsterile compounding.
20(2) (A) Is provided with copies of all federal and state regulatory
21agency inspection reports, as well as accreditation reports, and
22certification reports of facilities or equipment of the nonresident
23outsourcing facility’s premises conducted in the prior 12 months.
24(B) For purposes of this paragraph, “state” refers to the state in
25which the nonresident outsourcing facility resides.
26(3) Prior to inspection, receives a list of all sterile drug products
27and nonsterile drug products compounded by the pharmacy as
28reported to the FDA within the prior 12 months.
29(e) A nonresident outsourcing facility licensed pursuant to this
30section shall provide the board with all of the following:
31(1) A copy of any disciplinary or other action taken by another
32state or the FDA within 10 days of the action.
33(2) Notice within 24 hours of any recall notice issued by the
34nonresident outsourcing facility.
35(3) A copy of any complaint it receives involving an outsourcing
36facility’s compounded products from or involving any provider,
37pharmacy, or patient in California within 72 hours of receipt.
38(4) Notice within 24 hours after learning of adverse effects
39reported or potentially
attributable to a nonresident outsourcing
40facility’s products.
(a) On or before January 1, 2018, the board shall
2provide a report to the Legislature regarding the regulation of
3nonresident outsourcing facilities. The report shall be submitted
4to the Legislature in the manner required pursuant to Section 9795
5of the Government Code. At a minimum, the report shall address
6all of the following:
7(1) A detailed description of board activities related to the
8inspection and licensure of nonresident outsourcing facilities.
9(2) Whether fee revenue collected pursuant to subdivision (x)
10of Section 4400 and travel cost reimbursements collected pursuant
11to subdivision (c) of
Section 4129.2 provide revenue in an amount
12sufficient to support the board’s activities related to the inspection
13and licensure of nonresident outsourcing facilities.
14(3) The status of proposed changes to federal law that are under
15serious consideration and that would govern outsourcing facilities
16and compounding pharmacies, including, but not limited to,
17legislation pending before Congress, administrative rules,
18regulations or orders under consideration by the FDA or other
19appropriate federal agency, and cases pending before the courts.
20(4) If applicable, recommended modifications to the board’s
21statutory duties related to nonresident outsourcing facilities as a
22result of changes to federal law or any additional modifications
23necessary to protect the health and safety of the
public.
24(b) The requirement for submitting a report imposed under
25subdivision (a) is inoperative on January 1, 2022, pursuant to
26Section 10231.5 of the Government Code.
(a) Whenever the board has a reasonable belief, based
28on information obtained during an inspection or investigation by
29the board, that an outsourcing facility compounding sterile drug
30products or nonsterile drug products poses an immediate threat to
31the public health or safety, the executive officer of the board may
32issue an order to the outsourcing facility to immediately cease and
33desist compounding sterile drug products or nonsterile drug
34products. The cease and desist order shall remain in effect for no
35more than 30 days or the date of a hearing seeking an interim
36suspension order, whichever is earlier.
37(b) Whenever the board issues a cease and desist order
pursuant
38to subdivision (a), the board shall immediately issue a notice to
39the owner setting forth the acts or omissions with which the owner
P39 1is charged, specifying the pertinent code section or sections and
2any regulations.
3(c) The cease and desist order shall state that the owner, within
415 days of receipt of the notice, may request a hearing before the
5president of the board to contest the cease and desist order.
6Consideration of the owner’s contest of the cease and desist order
7shall comply with the requirements of Section 11425.10 of the
8Government Code. The hearing shall be held no later than five
9days after the date the request of the owner is received by the
10board. The president shall render a written decision within five
11days after the hearing. In the absence of the president of the board,
12the vice president of the board may
conduct the hearing permitted
13by this subdivision. Review of the decision may be sought by the
14owner or person in possession or control of the outsourcing facility
15pursuant to Section 1094.5 of the Code of Civil Procedure.
16(d) Failure to comply with a cease and desist order issued
17pursuant to this section shall be unprofessional conduct.
Notwithstanding any other law, a violation of this
19article, or regulation adopted pursuant thereto, may subject the
20person or entity that committed the violation to a fine of up to five
21thousand dollars ($5,000) per occurrence pursuant to a citation
22issued by the board.
The board, at its discretion, may issue a temporary
24license to an outsourcing facility upon the conditions and for any
25periods of time as the board determines to be in the public interest.
26A temporary license fee shall be required as specified in
27subdivision (w) of Section 4400. When needed to protect public
28safety, a temporary license may be issued for a period not to exceed
29180 days, and may be issued subject to terms and conditions the
30board deems necessary. If the board determines a temporary license
31was issued by mistake or denies the application for a permanent
32license, the temporary license shall terminate upon the earlier of
33personal service of the notice of termination upon the licenseholder
34or service by certified mail with return
receipt requested at the
35licenseholder’s address of record with the board. The temporary
36licenseholder shall not be deemed to have a vested property right
37or interest in the license for purposes of retaining a temporary
38license or for purposes of any disciplinary or license denial
39proceeding before the board.
(a) An outsourcing facility licensed pursuant to Section
24129.1 or 4129.2 that issues a recall notice for a sterile drug or
3nonsterile drug compounded by the outsourcing facility, in addition
4to any other duties, shall contact the recipient pharmacy, prescriber,
5or patient of the recalled drug and the board as soon as possible
6within 24 hours of the recall notice if both of the following apply:
7(1) Use of or exposure to the recalled drug may cause serious
8adverse health consequences or death.
9(2) The recalled drug was dispensed, or is intended for use, in
10this state.
11(b) A recall notice issued pursuant to subdivision (a) shall be
12made as follows:
13(1) If the recalled drug was dispensed directly to the prescriber,
14the notice shall be made to the prescriber and the prescriber shall
15ensure the patient is notified.
16(2) If the recalled drug was dispensed directly to a pharmacy,
17the notice shall be made to the pharmacy and that pharmacy shall
18notify the prescriber or patient, as appropriate. If the pharmacy
19notifies the prescriber, the prescriber shall ensure the patient is
20notified.
Section 4161 of the Business and Professions Code
23 is amended to read:
(a) A person located outside this state that (1) ships,
25sells, mails, warehouses, distributes, or delivers dangerous drugs
26or dangerous devices into this state or (2) sells, brokers,
27warehouses, or distributes dangerous drugs or devices within this
28state shall be considered a nonresident wholesaler or a nonresident
29third-party logistics provider.
30(b) A nonresident wholesaler or nonresident third-party logistics
31provider shall be licensed by the board prior to shipping, selling,
32mailing, warehousing, distributing, or delivering dangerous drugs
33or dangerous devices to a site located in this state or selling,
34brokering, warehousing, or distributing dangerous drugs or devices
35within
this state.
36(c) (1) A separate license shall be required for each place of
37business owned or operated by a nonresident wholesaler or
38nonresident third-party logistics provider from or through which
39dangerous drugs or dangerous devices are shipped, sold, mailed,
40warehoused, distributed, or delivered to a site located in this state
P41 1or sold, brokered, warehoused, or distributed within this state.
2Each place of business may only be issued a single license by the
3board, except as provided in paragraph (2). A license shall be
4renewed annually and shall not be transferable.
5(2) A nonresident wholesaler and a nonresident third-party
6logistics provider under common ownership may be licensed at
7the same place of business provided that all of the following
8requirements are
satisfied:
9(A) The wholesaler and the third-party logistics provider each
10separately maintain the records required under Section 4081.
11(B) Dangerous drugs and dangerous devices owned by the
12wholesaler are not commingled with the dangerous drugs and
13dangerous devices handled by the third-party logistics provider.
14(C) Any individual acting as a designated representative for the
15wholesaler is not concurrently acting as a designated
16representative-3PL on behalf of the third-party logistics provider.
17Nothing in this subparagraph shall be construed to prohibit an
18individual from concurrently holding a license to act as a
19designated representative and to act as a designated
20representative-3PL.
21(D) The wholesaler has its own designated
22representative-in-charge responsible for the operations of the
23wholesaler and the third-party logistics provider has its own
24responsible manager responsible for the operations of the
25
third-party logistics provider. The same individual shall not
26concurrently serve as the responsible manager and the designated
27representative-in-charge for a wholesaler and a third-party logistics
28provider licensed at the same place of business.
29(E) The third-party logistics provider does not handle the
30prescription drugs or prescription devices owned by a prescriber.
31(F) The third-party logistics provider is not a reverse third-party
32logistics provider.
33(G) The wholesaler is not acting as a reverse distributor.
34(d) The following information shall be reported, in writing, to
35the board at the time of initial application for licensure by a
36nonresident
wholesaler or a nonresident third-party logistics
37provider, on renewal of a nonresident wholesaler or nonresident
38third-party logistics provider license, or within 30 days of a change
39in that information:
40(1) Its agent for service of process in this state.
P42 1(2) Its principal corporate officers, as specified by the board, if
2any.
3(3) Its general partners, as specified by the board, if any.
4(4) Its owners if the applicant is not a corporation or partnership.
5(e) A report containing the information in subdivision (d) shall
6be made within 30 days of any change of ownership, office,
7corporate officer, or
partner.
8(f) A nonresident wholesaler or nonresident third-party logistics
9provider shall comply with all directions and requests for
10information from the regulatory or licensing agency of the state
11in which it is licensed, as well as with all requests for information
12made by the board.
13(g) A nonresident wholesaler or nonresident third-party logistics
14provider shall maintain records of dangerous drugs and dangerous
15devices sold, traded, transferred, warehoused, or distributed to
16persons in this state or within this state, so that the records are in
17a readily retrievable form.
18(h) A nonresident wholesaler or nonresident third-party logistics
19provider shall at all times maintain a valid, unexpired license,
20permit, or
registration to conduct the business of the wholesaler
21or nonresident third-party logistics provider in compliance with
22the laws of the state in which it is a resident. An application for a
23nonresident wholesaler or nonresident third-party logistics provider
24license in this state shall include a license verification from the
25licensing authority in the applicant’s state of residence.
26(i) (1) The board shall not issue or renew a nonresident
27wholesaler license until the nonresident wholesaler identifies a
28designated representative-in-charge and notifies the board in
29writing of the identity and license number of the designated
30representative-in-charge.
31(2) The board shall not issue or renew a nonresident third-party
32logistics provider license until the nonresident
third-party logistics
33provider identifies a responsible manager and notifies the board
34in writing of the identity and license number of the designated
35representative-3PL who will be the responsible manager.
36(j) The designated representative-in-charge shall be responsible
37for the compliance of the nonresident wholesaler with state and
38federal laws governing wholesalers. The responsible manager shall
39be responsible for the compliance of the nonresident third-party
40logistics provider’s place of business with state and federal laws
P43 1governing third-party logistics providers. A nonresident wholesaler
2or nonresident third-party logistics provider shall identify and
3notify the board of a new designated representative-in-charge or
4responsible manager within 30 days of the date that the prior
5designated representative-in-charge or responsible manager
ceases
6to be the designated representative-in-charge or responsible
7manager.
8(k) The board may issue a temporary license, upon conditions
9and for periods of time as the board determines to be in the public
10interest. A temporary license fee shall be five hundred fifty dollars
11($550) or another amount established by the board not to exceed
12the annual fee for renewal of a license to compound sterile drug
13products. When needed to protect public safety, a temporary license
14may be issued for a period not to exceed 180 days, subject to terms
15and conditions that the board deems necessary. If the board
16determines that a temporary license was issued by mistake or denies
17the application for a permanent license, the temporary license shall
18terminate upon either personal service of the notice of termination
19upon the licenseholder or service by
certified mail, return receipt
20requested, at the licenseholder’s address of record with the board,
21whichever occurs first. Neither for purposes of retaining a
22temporary license, nor for purposes of any disciplinary or license
23denial proceeding before the board, shall the temporary
24licenseholder be deemed to have a vested property right or interest
25in the license.
26(l) The registration fee shall be the fee specified in subdivision
27(f) of Section 4400.
Section 4180 of the Business and Professions Code
30 is amended to read:
(a) (1) Notwithstanding any provision of this chapter,
32any of the following clinics may purchase drugs at wholesale for
33administration or dispensing, under the direction of a physician
34and surgeon, to patients registered for care at the clinic:
35(A) A licensed nonprofit community clinic or free clinic as
36defined in paragraph (1) of subdivision (a) of Section 1204 of the
37Health and Safety Code.
38(B) A primary care clinic owned or operated by a county as
39referred to in subdivision (b) of Section 1206 of the Health and
40Safety Code.
P44 1(C) A clinic operated by a federally recognized Indian tribe or
2tribal organization as referred to in subdivision (c) of Section 1206
3of the Health and Safety Code.
4(D) A clinic operated by a primary care community or free
5clinic, operated on separate premises from a licensed clinic, and
6that is open no more than 20 hours per week as referred to in
7subdivision (h) of Section 1206 of the Health and Safety Code.
8(E) A student health center clinic operated by a public institution
9of higher education as referred to in subdivision (j) of Section 1206
10of the Health and Safety Code.
11(F) A nonprofit multispecialty clinic as referred to in subdivision
12(l) of Section 1206 of the Health and Safety Code.
13(2) The clinic shall keep records of the kind and amounts of
14drugs purchased, administered, and dispensed, and the records
15shall be available and maintained for a minimum of three years
16for inspection by all properly authorized personnel.
17(b) No clinic shall be entitled to the benefits of this section until
18it has obtained a license from the board. A separate license shall
19be required for each clinic location. A clinic shall notify the board
20of any change in the clinic’s address on a form furnished by the
21board.
22(c) The board shall synchronize license renewal dates and
23aggregate fees for multiple clinics under common nonprofit
24ownership at the request of the parent organization.
Section 4201 of the Business and Professions Code
27 is amended to read:
(a) Each application to conduct a pharmacy, wholesaler,
29third-party logistics provider, veterinary food-animal drug retailer,
30or outsourcing facility shall be made on a form furnished by the
31board and shall state the name, address, usual occupation, and
32professional qualifications, if any, of the applicant. If the applicant
33is other than a natural person, the application shall state the
34information as to each person beneficially interestedbegin delete therein.end delete
35
begin insert therein or any person with management or control over the license.end insert
36(b) As
used in this section, and subject to subdivision (c), the
37term “person beneficially interested” means and includes:
38(1) If the applicant is a partnership or other unincorporated
39association, each partner or member.
P45 1(2) If the applicant is a corporation, each of its officers, directors,
2and stockholders, provided that a natural person shall not be
3deemed to be beneficially interested in a nonprofit corporation.
4(3) If the applicant is a limited liability company, each officer,
5manager, or member.
6(c) If the applicant is a partnership or other unincorporated
7association, a limited liability company, or a corporation, and the
8number of partners, members, or stockholders, as
the case may
9be, exceeds five, the application shall so state, and shall further
10state the information required by subdivision (a) as to each of the
11five partners, members, or stockholders who own the five largest
12interests in the applicant entity. Upon request by the executive
13officer, the applicant shall furnish the board with the information
14required by subdivision (a) as to partners, members, or stockholders
15not named in the application, or shall refer the board to an
16appropriate source of that information.
17(d) The application shall contain a statement to the effect that
18the applicant has not been convicted of a felony and has not
19violated any of the provisions of this chapter. If the applicant
20cannot make this statement, the application shall contain a
21statement of the violation, if any, or reasons which will prevent
22the
applicant from being able to comply with the requirements
23with respect to the statement.
24(e) Upon the approval of the application by the board and
25payment of the fee required by this chapter for each pharmacy,
26wholesaler, third-party logistics provider, or veterinary food-animal
27drug retailer, the executive officer of the board shall issue a license
28to conduct a pharmacy, wholesaler, third-party logistics provider,
29
veterinary food-animal drug retailer, or outsourcing facility if all
30of the provisions of this chapter have been complied with.
31(f) Notwithstanding any other law, the pharmacy license shall
32authorize the holder to conduct a pharmacy. The license shall be
33renewed annually and shall not be transferable.
34(g) Notwithstanding any other law, the wholesaler license shall
35authorize the holder to wholesale dangerous drugs and dangerous
36devices. The license shall be renewed annually and shall not be
37transferable.
38(h) Notwithstanding any other law, the third-party logistics
39provider license shall authorize the holder to provide or coordinate
40warehousing, distribution, or other similar services of dangerous
P46 1drugs and
dangerous devices. The license shall be renewed annually
2and shall not be transferable.
3(i) Notwithstanding any other law, the veterinary food-animal
4drug retailer license shall authorize the holder to conduct a
5veterinary food-animal drug retailer and to sell and dispense
6veterinary food-animal drugs as defined in Section 4042.
7(j) For licenses referred to in subdivisions (f), (g), (h), and (i),
8any change in the proposed beneficial ownership interest shall be
9reported to the board within 30 days thereafter upon a form to be
10furnished by the board.
Section 4203.5 is added to the Business and
13Professions Code, to read:
(a) Notwithstanding any other law, when a clinic
15applicant submits either type of application described in subdivision
16(b), the board shall issue a license or incorporate the reported
17changes, as appropriate, within 30 days of receipt of a completed
18application and payment of any prescribed fees.
19(b) This section applies to the following types of applications:
20(1) A new clinic license application filed under Section 4180.
21(2) Applications to report changes to an existing site licensed
22under Section 4180, including, but not limited to, changes in
23professional
director, clinic administrator, corporate officers,
24
change of location, or change of address.
25(c) This section shall not be construed to limit the board’s
26authority to conduct an investigation to determine whether
27applicants and the premises for which an application is made
28qualify for a license.
Section 4301 of the Business and Professions Code
31 is amended to read:
The board shall take action against any holder of a license
33who is guilty of unprofessional conduct or whose license has been
34issued by mistake. Unprofessional conduct shall include, but is
35not limited to, any of the following:
36(a) Procurement of a license by fraud or misrepresentation.
37(b) Incompetence.
38(c) Gross negligence.
P47 1(d) The clearly excessive furnishing of controlled substances
2in violation of subdivision (a) of Section 11153 of the Health and
3Safety Code.
4(e) The clearly excessive furnishing of controlled substances in
5violation of subdivision (a) of Section 11153.5 of the Health and
6Safety Code. Factors to be considered in determining whether the
7furnishing of controlled substances is clearly excessive shall
8include, but not be limited to, the amount of controlled substances
9furnished, the previous ordering pattern of the customer (including
10size and frequency of orders), the type and size of the customer,
11and where and to whom the customer distributes its product.
12(f) The commission of any act involving moral turpitude,
13dishonesty, fraud, deceit, or corruption, whether the act is
14committed in the course of relations as a licensee or otherwise,
15and whether the act is a felony or misdemeanor or not.
16(g) Knowingly making or
signing any certificate or other
17document that falsely represents the existence or nonexistence of
18a state of facts.
19(h) The administering to oneself, of any controlled substance,
20or the use of any dangerous drug or of alcoholic beverages to the
21extent or in a manner as to be dangerous or injurious to oneself,
22to a person holding a license under this chapter, or to any other
23person or to the public, or to the extent that the use impairs the
24ability of the person to conduct with safety to the public the practice
25authorized by the license.
26(i) Except as otherwise authorized by law, knowingly selling,
27furnishing, giving away, or administering, or offering to sell,
28furnish, give away, or administer, any controlled substance to an
29addict.
30(j) The violation of any of the statutes of this state, of any other
31state, or of the United States regulating controlled substances and
32dangerous drugs.
33(k) The conviction of more than one misdemeanor or any felony
34involving the use, consumption, or self-administration of any
35dangerous drug or alcoholic beverage, or any combination of those
36substances.
37(l) The conviction of a crime substantially related to the
38qualifications, functions, and duties of a licensee under this chapter.
39The record of conviction of a violation of Chapter 13 (commencing
40with Section 801) of Title 21 of the United States Code regulating
P48 1controlled substances or of a violation of the statutes of this state
2regulating controlled substances or dangerous drugs shall be
3conclusive evidence of
unprofessional conduct. In all other cases,
4the record of conviction shall be conclusive evidence only of the
5fact that the conviction occurred. The board may inquire into the
6circumstances surrounding the commission of the crime, in order
7to fix the degree of discipline or, in the case of a conviction not
8involving controlled substances or dangerous drugs, to determine
9if the conviction is of an offense substantially related to the
10qualifications, functions, and duties of a licensee under this chapter.
11A plea or verdict of guilty or a conviction following a plea of nolo
12contendere is deemed to be a conviction within the meaning of
13this provision. The board may take action when the time for appeal
14has elapsed, or the judgment of conviction has been affirmed on
15appeal or when an order granting probation is made suspending
16the imposition of sentence, irrespective of a subsequent order under
17Section
1203.4 of the Penal Code allowing the person to withdraw
18his or her plea of guilty and to enter a plea of not guilty, or setting
19aside the verdict of guilty, or dismissing the accusation,
20information, or indictment.
21(m) The cash compromise of a charge of violation of Chapter
2213 (commencing with Section 801) of Title 21 of the United States
23Code regulating controlled substances or of Chapter 7
24(commencing with Section 14000) of Part 3 of Division 9 of the
25Welfare and Institutions Code relating to the Medi-Cal program.
26(n) The revocation, suspension, or other discipline by another
27state of a license to practice pharmacy, operate a pharmacy, or do
28any other act for which a license is required by this chapter that
29would be grounds for revocation, suspension, or other discipline
30
under this chapter. Any disciplinary action taken by the board
31pursuant to this section shall be coterminous with action taken by
32another state, except that the term of any discipline taken by the
33board may exceed that of another state, consistent with the board’s
34enforcement guidelines. The evidence of discipline by another
35state is conclusive proof of unprofessional conduct.
36(o) Violating or attempting to violate, directly or indirectly, or
37assisting in or abetting the violation of or conspiring to violate any
38provision or term of this chapter or of the applicable federal and
39state laws and regulations governing pharmacy, including
P49 1
regulations established by the board or by any other state or federal
2regulatory agency.
3(p) Actions or conduct that would have warranted denial of a
4license.
5(q) Engaging in any conduct that subverts or attempts to subvert
6an investigation of the board.
7(r) The selling, trading, transferring, or furnishing of drugs
8obtained pursuant to Section 256b of Title 42 of the United States
9Code to any person a licensee knows or reasonably should have
10known, not to be a patient of a covered entity, as defined in
11paragraph (4) of subsection (a) of Section 256b of Title 42 of the
12United States Code.
13(s) The clearly excessive furnishing of dangerous
drugs by a
14wholesaler to a pharmacy that primarily or solely dispenses
15prescription drugs to patients of long-term care facilities. Factors
16to be considered in determining whether the furnishing of
17dangerous drugs is clearly excessive shall include, but not be
18limited to, the amount of dangerous drugs furnished to a pharmacy
19that primarily or solely dispenses prescription drugs to patients of
20long-term care facilities, the previous ordering pattern of the
21pharmacy, and the general patient population to whom the
22pharmacy distributes the dangerous drugs. That a wholesaler has
23established, and employs, a tracking system that complies with
24the requirements of subdivision (b) of Section 4164 shall be
25considered in determining whether there has been a violation of
26this subdivision. This provision shall not be interpreted to require
27a wholesaler to obtain personal medical information or be
28authorized
to permit a wholesaler to have access to personal
29medical information except as otherwise authorized by Section 56
30and following of the Civil Code. For purposes of this section,
31“long-term care facility” shall have the same meaning given the
32term in Section 1418 of the Health and Safety Code.
Section 4301.1 is added to the Business and
35Professions Code, to read:
In order to ensure that the board’s resources are
37maximized for the protection of the public health and safety, the
38board shall prioritize its investigative and prosecutorial resources
39to ensure that pharmacists representing the greatest threat ofbegin delete actualend delete
40 patient harm are identified and disciplined expeditiously.
begin insertSection 4302 of the end insertbegin insertBusiness and Professions Codeend insert
2
begin insert is amended to read:end insert
The board may deny, suspend, or revoke any licensebegin delete of where conditions exist in relation to any person
4a corporationend delete
5holding 10 percent or more of thebegin delete corporate stock of the begin insert ownership interestend insert or where conditions exist in relation
6corporation,end delete
7to anybegin delete officer or directorend deletebegin insert officer, director, or other person with
8management or controlend insert of thebegin delete corporationend deletebegin insert
licenseend insert that would
9constitute grounds for disciplinary action against a licensee.
Section 4303.1 is added to the Business and
12Professions Code, to read:
If the federal Food and Drug Administration (FDA)
14cancels, revokes, or suspends an outsourcing facility’s registration
15for any reason, any license issued pursuant to Section 4129.2 shall
16be immediately canceled, revoked, or suspended by operation of
17law.
begin insertSection 4307 of the end insertbegin insertBusiness and Professions Codeend insert
19
begin insert is amended to read:end insert
(a) Any person who has been denied a license or whose
21license has been revoked or is under suspension, or who has failed
22to renew his or her license while it was under suspension, or who
23has been a manager, administrator, owner, member, officer,
24director, associate,begin delete or partnerend deletebegin insert partner, or any other person with
25management or controlend insert of any partnership, corporation,begin insert trust,end insert firm,
26or association whose application for a license has been denied or
27revoked, is under suspension or has been placed on
probation, and
28while acting as the manager, administrator, owner, member, officer,
29director, associate,begin delete or partnerend deletebegin insert partner, or any other person with
30management or controlend insert had knowledge of or knowingly
31participated in any conduct for which the license was denied,
32revoked, suspended, or placed on probation, shall be prohibited
33from serving as a manager, administrator, owner, member, officer,
34director, associate,begin delete or partnerend deletebegin insert partner, or in any other position with
35management or controlend insert of a licensee as follows:
36(1) Where a probationary license is issued or where an
existing
37license is placed on probation, this prohibition shall remain in
38effect for a period not to exceed five years.
39(2) Where the license is denied or revoked, the prohibition shall
40continue until the license is issued or reinstated.
P51 1(b) “Manager, administrator, owner, member, officer, director,
2associate,begin delete or partner,”end deletebegin insert partner, or any other person with
3management or control of a licenseend insertbegin insert”end insert as used in this section and
4Section 4308, may refer to a pharmacist or to any other person
5who serves inbegin delete thatend deletebegin insert
suchend insert capacity in or for a licensee.
6(c) The provisions of subdivision (a) may be alleged in any
7pleading filed pursuant to Chapter 5 (commencing with Section
811500) of Part 1 of Division 3 of the Government Code. However,
9no order may be issued in that case except as to a person who is
10named in the caption, as to whom the pleading alleges the
11applicability of this section, and where the person has been given
12notice of the proceeding as required by Chapter 5 (commencing
13with Section 11500) of Part 1 of Division 3 of the Government
14Code. The authority to proceed as provided by this subdivision
15shall be in addition to the board’s authority to proceed under
16Section 4339 or any other provision of law.
begin insertSection 4308 of the end insertbegin insertBusiness and Professions Codeend insert
18
begin insert is amended to read:end insert
Whenever a person is prohibited from serving as a
20manager, administrator, owner, member, officer, director, associate,
21begin delete or partnerend deletebegin insert partner, or in any other position with management or
22controlend insert of a licensee as provided by Section 4307, the board shall,
23in each case where it has that information, notify in writing each
24licensee for whom the person is a manager, administrator, owner,
25member, officer, director, associate,begin delete or partnerend deletebegin insert end insertbegin insertpartner,
or in any
26 other position with management or controlend insert of the prohibition. The
27board shall send the notification to the licensee’s address of record.
28The licensee shall have 30 days from the date that the notice is
29sent to remove and replace the prohibited person and, where
30appropriate, file a change of permit to reflect that change.
Section 4312 of the Business and Professions Code
33 is amended to read:
(a) The board may cancel the license of a wholesaler,
35third-party logistics provider, pharmacy, veterinary food-animal
36drug retailer, or outsourcing facility if the licensed premises remain
37closed, as defined in subdivision (e), other than by order of the
38board. For good cause shown, the board may cancel a license after
39a shorter period of closure. To cancel a license pursuant to this
40subdivision, the board shall make a diligent, good faith effort to
P52 1give notice by personal service on the licensee. If a written
2objection is not received within 10 days after personal service is
3made or a diligent, good faith effort to give notice by personal
4service on the licensee has failed, the board may cancel the license
5without the necessity of a hearing. If
the licensee files a written
6objection, the board shall file an accusation based on the licensee
7remaining closed. Proceedings shall be conducted in accordance
8with Chapter 5 (commencing with Section 11500) of Part 1 of
9Division 3 of Title 2 of the Government Code, and the board shall
10have all the powers granted in that chapter.
11(b) If the license of a wholesaler, third-party logistics provider,
12pharmacy, veterinary food-animal drug retailer, or outsourcing
13facility is canceled pursuant to subdivision (a) or revoked pursuant
14to Article 19 (commencing with Section 4300), or a wholesaler,
15third-party logistics provider, pharmacy, veterinary food-animal
16drug retailer, or outsourcing facility notifies the board of its intent
17to remain closed or to discontinue business, the licensee shall,
18within 10 days thereafter, arrange for the transfer
of all dangerous
19drugs and controlled substances or dangerous devices to another
20licensee authorized to possess the dangerous drugs and controlled
21substances or dangerous devices. The licensee transferring the
22dangerous drugs and controlled substances or dangerous devices
23shall immediately confirm in writing to the board that the transfer
24has taken place.
25(c) If a wholesaler, third-party logistics provider, pharmacy,
26veterinary food-animal drug retailer, or outsourcing facility fails
27to comply with subdivision (b), the board may seek and obtain an
28order from the superior court in the county in which the wholesaler,
29third-party logistics provider, pharmacy, veterinary food-animal
30drug retailer, or outsourcing facility is located, authorizing the
31board to enter the wholesaler, third-party logistics provider,
32pharmacy, veterinary food-animal
drug retailer, or outsourcing
33facility and inventory and store, transfer, sell, or arrange for the
34sale of, all dangerous drugs and controlled substances and
35dangerous devices found in the wholesaler, third-party logistics
36provider, pharmacy, veterinary food-animal drug retailer, or
37outsourcing facility.
38(d) If the board sells or arranges for the sale of any dangerous
39drugs, controlled substances, or dangerous devices pursuant to
40subdivision (c), the board may retain from the proceeds of the sale
P53 1an amount equal to the cost to the board of obtaining and enforcing
2an order issued pursuant to subdivision (c), including the cost of
3disposing of the dangerous drugs, controlled substances, or
4dangerous devices. The remaining proceeds, if any, shall be
5returned to the licensee from whose premises the dangerous drugs
6or controlled substances
or dangerous devices were removed.
7(1) The licensee shall be notified of his or her right to the
8remaining proceeds by personal service or by certified mail,
9postage prepaid.
10(2) If a statute or regulation requires the licensee to file with
11the board his or her address, and any change of address, the notice
12required by this subdivision may be sent by certified mail, postage
13prepaid, to the latest address on file with the board and service of
14notice in this manner shall be deemed completed on the 10th day
15after the mailing.
16(3) If the licensee is notified as provided in this subdivision,
17and the licensee fails to contact the board for the remaining
18proceeds within 30 calendar days after personal service has been
19made
or service by certified mail, postage prepaid, is deemed
20completed, the remaining proceeds shall be deposited by the board
21into the Pharmacy Board Contingent Fund. These deposits shall
22be deemed to have been received pursuant to Chapter 7
23(commencing with Section 1500) of Title 10 of Part 3 of the Code
24of Civil Procedure and shall be subject to claim or other disposition
25as provided in that chapter.
26(e) For the purposes of this section, “closed” means not engaged
27in the ordinary activity for which a license has been issued for at
28least one day each calendar week during any 120-day period.
29(f) Nothing in this section shall be construed as requiring a
30pharmacy to be open seven days a week.
Section 4316 is added to the Business and Professions
33Code, to read:
(a) The board is authorized to issue a cease and desist
35order for operating any facility under this chapter that requires
36licensure or for practicing any activity under this chapter that
37requires licensure.
38(b) Whenever the board issues a cease and desist order pursuant
39to subdivision (a), the board shall immediately issue the facility a
40notice setting forth the acts or omissions with which it is charged,
P54 1specifying the pertinent code section or sections and any
2regulations.
3(c) The order shall provide that the facility, within 15 days of
4receipt of the notice, may request a hearing before the president
5of
the board to contest the cease and desist order. Consideration
6of the facility’s contest of the cease and desist order shall comply
7with the requirements of Section 11425.10 of the Government
8Code. The hearing shall be held no later than five days from the
9date the request of the owner is received by the board. The
10president shall render a written decision within five days of the
11hearing. In the absence of the president of the board, the vice
12president of the board may conduct the hearing permitted by this
13subdivision. Review of the decision of the president of the board
14may be sought by the owner or person in possession or control of
15the pharmacy pursuant to Section 1094.5 of the Code of Civil
16Procedure.
Section 4400 of the Business and Professions Code
19 is amended to read:
The amount of fees and penalties prescribed by this
21chapter, except as otherwise provided, is that fixed by the board
22according to the following schedule:
23(a) The fee for a nongovernmental pharmacy license shall be
24four hundred dollars ($400) and may be increased to five hundred
25twenty dollars ($520). The fee for the issuance of a temporary
26nongovernmental pharmacy permit shall be two hundred fifty
27dollars ($250) and may be increased to three hundred twenty-five
28dollars ($325).
29(b) The fee for a nongovernmental pharmacy license annual
30renewal shall be two hundred fifty dollars ($250) and may be
31increased to three hundred twenty-five dollars
($325).
32(c) The fee for the pharmacist application and examination shall
33be two hundred dollars ($200) and may be increased to two
34hundred sixty dollars ($260).
35(d) The fee for regrading an examination shall be ninety dollars
36($90) and may be increased to one hundred fifteen dollars ($115).
37If an error in grading is found and the applicant passes the
38examination, the regrading fee shall be refunded.
P55 1(e) The fee for a pharmacist license and biennial renewal shall
2be one hundred fifty dollars ($150) and may be increased to one
3hundred ninety-five dollars ($195).
4(f) The fee for a nongovernmental wholesaler or third-party
5logistics provider license and annual
renewal shall be seven
6hundred eighty dollars ($780) and may be decreased to no less
7than six hundred dollars ($600). The application fee for any
8additional location after licensure of the first 20 locations shall be
9three hundred dollars ($300) and may be decreased to no less than
10two hundred twenty-five dollars ($225). A temporary license fee
11shall be seven hundred fifteen dollars ($715) and may be decreased
12to no less than five hundred fifty dollars ($550).
13(g) The fee for a hypodermic license and renewal shall be one
14hundred twenty-five dollars ($125) and may be increased to one
15hundred sixty-five dollars ($165).
16(h) (1) The fee for application, investigation, and issuance of
17a license as a designated representative pursuant to Section 4053,
18or as a
designated representative-3PL pursuant to Section 4053.1,
19shall be three hundred thirty dollars ($330) and may be decreased
20to no less than two hundred fifty-five dollars ($255).
21(2) The fee for the annual renewal of a license as a designated
22representative or designated representative-3PL shall be one
23hundred ninety-five dollars ($195) and may be decreased to no
24less than one hundred fifty dollars ($150).
25(i) (1) The fee for the application, investigation, and issuance
26of a license as a designated representative for a veterinary
27food-animal drug retailer pursuant to Section 4053 shall be three
28hundred thirty dollars ($330) and may be decreased to no less than
29two hundred fifty-five dollars ($255).
30(2) The fee for the annual renewal of a license as a designated
31representative for a veterinary food-animal drug retailer shall be
32one hundred ninety-five dollars ($195) and may be decreased to
33no less than one hundred fifty dollars ($150).
34(j) (1) The application fee for a nonresident wholesaler or
35third-party logistics provider license issued pursuant to Section
364161 shall be seven hundred eighty dollars ($780) and may be
37decreased to no less than six hundred dollars ($600).
38(2) For nonresident wholesalers or third-party logistics providers
39that have 21 or more facilities operating nationwide the application
40fees for the first 20 locations shall be seven hundred eighty dollars
P56 1($780) and may be decreased to no less than six hundred dollars
2($600).
The application fee for any additional location after
3licensure of the first 20 locations shall be three hundred dollars
4($300) and may be decreased to no less than two hundred
5twenty-five dollars ($225). A temporary license fee shall be seven
6hundred fifteen dollars ($715) and may be decreased to no less
7than five hundred fifty dollars ($550).
8(3) The annual renewal fee for a nonresident wholesaler license
9or third-party logistics provider license issued pursuant to Section
104161 shall be seven hundred eighty dollars ($780) and may be
11decreased to no less than six hundred dollars ($600).
12(k) The fee for evaluation of continuing education courses for
13accreditation shall be set by the board at an amount not to exceed
14forty dollars ($40) per course hour.
15(l) The fee for an intern pharmacist license shall be ninety dollars
16($90) and may be increased to one hundred fifteen dollars ($115).
17The fee for transfer of intern hours or verification of licensure to
18another state shall be twenty-five dollars ($25) and may be
19increased to thirty dollars ($30).
20(m) The board may waive or refund the additional fee for the
21issuance of a license where the license is issued less than 45 days
22before the next regular renewal date.
23(n) The fee for the reissuance of any license, or renewal thereof,
24that has been lost or destroyed or reissued due to a name change
25shall be thirty-five dollars ($35) and may be increased to forty-five
26dollars ($45).
27(o) The fee for the reissuance of any license, or renewal thereof,
28that must be reissued because of a change in the information, shall
29be one hundred dollars ($100) and may be increased to one hundred
30thirty dollars ($130).
31(p) It is the intent of the Legislature that, in setting fees pursuant
32to this section, the board shall seek to maintain a reserve in the
33Pharmacy Board Contingent Fund equal to approximately one
34year’s operating expenditures.
35(q) The fee for any applicant for a nongovernmental clinic
36license shall be four hundred dollars ($400) and may be increased
37to five hundred twenty dollars ($520) for each license. The annual
38fee for renewal of the license shall be two hundred fifty dollars
39($250) and may be increased to three hundred twenty-five dollars
40($325)
for each license.
P57 1(r) The fee for the issuance of a pharmacy technician license
2shall be eighty dollars ($80) and may be increased to one hundred
3five dollars ($105). The fee for renewal of a pharmacy technician
4license shall be one hundred dollars ($100) and may be increased
5to one hundred thirty dollars ($130).
6(s) The fee for a veterinary food-animal drug retailer license
7shall be four hundred five dollars ($405) and may be increased to
8four hundred twenty-five dollars ($425). The annual renewal fee
9for a veterinary food-animal drug retailer license shall be two
10hundred fifty dollars ($250) and may be increased to three hundred
11twenty-five dollars ($325).
12(t) The fee for issuance of a retired license pursuant to
Section
13
4200.5 shall be thirty-five dollars ($35) and may be increased to
14forty-five dollars ($45).
15(u) The fee for issuance or renewal of a nongovernmental sterile
16compounding pharmacy license shall be six hundred dollars ($600)
17and may be increased to seven hundred eighty dollars ($780). The
18fee for a temporary license shall be five hundred fifty dollars ($550)
19and may be increased to seven hundred fifteen dollars ($715).
20(v) The fee for the issuance or renewal of a nonresident sterile
21compounding pharmacy license shall be seven hundred eighty
22dollars ($780). In addition to paying that application fee, the
23nonresident sterile compounding pharmacy shall deposit, when
24submitting the application, a reasonable amount, as determined by
25the board, necessary to cover the board’s
estimated cost of
26performing the inspection required by Section 4127.2. If the
27required deposit is not submitted with the application, the
28application shall be deemed to be incomplete. If the actual cost of
29the inspection exceeds the amount deposited, the board shall
30provide to the applicant a written invoice for the remaining amount
31and shall not take action on the application until the full amount
32has been paid to the board. If the amount deposited exceeds the
33amount of actual and necessary costs incurred, the board shall
34remit the difference to the applicant.
35(w) The fee for the issuance of an outsourcing facility license
36shall be two thousand two hundred seventy dollars ($2,270) and
37may be increased to up to three thousand one hundred eighty
38dollars ($3,180) by the board. The fee for the renewal of an
39outsourcing facility license
shall be one thousand three hundred
40twenty-five dollars ($1,325) and may be increased to up to one
P58 1thousand eight hundred fifty-five dollars ($1,855) by the board.
2The fee for a temporary outsourcing facility license shall be seven
3hundred fifteen dollars ($715).
4(x) The fee for the issuance of a nonresident outsourcing facility
5license shall be
two thousand three hundred eighty dollars ($2,380)
6and may be increased to up to three thousand three hundred
7thirty-five dollars ($3,335) by the board. The fee for the renewal
8of a nonresident outsourcing facility license shall be two thousand
9two hundred seventy dollars ($2,270) and may be increased to up
10to three thousand one hundred eighty dollars ($3,180) by the board.
11In addition to paying that application fee, the nonresident
12outsourcing facility shall deposit, when submitting the application,
13a reasonable amount, as determined by the board, necessary to
14cover the board’s estimated cost of performing the inspection
15required by Section 4129.2. If the required deposit is not submitted
16with the application, the application shall be deemed to be
17incomplete. If the actual cost of the inspection exceeds the amount
18deposited, the board shall provide to the applicant a written invoice
19for
the remaining amount and shall not take action on the
20application until the full amount has been paid to the board. If the
21amount deposited exceeds the amount of actual and necessary
22costs incurred, the board shall remit the difference to the applicant.
begin insertSection 4400 of the end insertbegin insertBusiness and Professions Codeend insert
24
begin insert is amended to read:end insert
The amount of fees and penalties prescribed by this
26chapter, except as otherwise provided, is that fixed by the board
27according to the following schedule:
28(a) The fee for a nongovernmental pharmacy license shall be
29four hundred dollars ($400) and may be increased to five hundred
30twenty dollars ($520). The fee for the issuance of a temporary
31nongovernmental pharmacy permit shall be two hundred fifty
32dollars ($250) and may be increased to three hundred twenty-five
33dollars ($325).
34(b) The fee for a nongovernmental pharmacy license annual
35renewal shall be two hundred fifty dollars ($250) and may be
36increased to three hundred twenty-five dollars ($325).
37(c) The
fee for the pharmacist application and examination shall
38be two hundred dollars ($200) and may be increased to two
39hundred sixty dollars ($260).
P59 1(d) The fee for regrading an examination shall be ninety dollars
2($90) and may be increased to one hundred fifteen dollars ($115).
3If an error in grading is found and the applicant passes the
4examination, the regrading fee shall be refunded.
5(e) The fee for a pharmacist license and biennial renewal shall
6be one hundred fifty dollars ($150) and may be increased to one
7hundred ninety-five dollars ($195).
8(f) The fee for a nongovernmental wholesaler or third-party
9logistics provider license and annual renewal shall be seven
10hundred eighty dollars ($780) and may be decreased to no less
11than six hundred dollars ($600). The application fee for any
12additional location after
licensure of the first 20 locations shall be
13three hundred dollars ($300) and may be decreased to no less than
14two hundred twenty-five dollars ($225). A temporary license fee
15shall be seven hundred fifteen dollars ($715) and may be decreased
16to no less than five hundred fifty dollars ($550).
17(g) The fee for a hypodermic license and renewal shall be one
18hundred twenty-five dollars ($125) and may be increased to one
19hundred sixty-five dollars ($165).
20(h) (1) The fee for application, investigation, and issuance of
21a license as a designated representative pursuant to Section 4053,
22or as a designated representative-3PL pursuant to Section 4053.1,
23shall be three hundred thirty dollars ($330) and may be decreased
24to no less than two hundred fifty-five dollars ($255).
25(2) The fee for the annual renewal
of a license as a designated
26representative or designated representative-3PL shall be one
27hundred ninety-five dollars ($195) and may be decreased to no
28less than one hundred fifty dollars ($150).
29(i) (1) The fee for the application, investigation, and issuance
30of a license as a designated representative for a veterinary
31food-animal drug retailer pursuant to Section 4053 shall be three
32hundred thirty dollars ($330) and may be decreased to no less than
33two hundred fifty-five dollars ($255).
34(2) The fee for the annual renewal of a license as a designated
35representative for a veterinary food-animal drug retailer shall be
36one hundred ninety-five dollars ($195) and may be decreased to
37no less than one hundred fifty dollars ($150).
38(j) (1) The application fee for a nonresident
wholesaler or
39third-party logistics provider license issued pursuant to Section
P60 14161 shall be seven hundred eighty dollars ($780) and may be
2decreased to no less than six hundred dollars ($600).
3(2) For nonresident wholesalers or third-party logistics providers
4that have 21 or more facilities operating nationwide the application
5fees for the first 20 locations shall be seven hundred eighty dollars
6($780) and may be decreased to no less than six hundred dollars
7($600). The application fee for any additional location after
8licensure of the first 20 locations shall be three hundred dollars
9($300) and may be decreased to no less than two hundred
10twenty-five dollars ($225). A temporary license fee shall be seven
11hundred fifteen dollars ($715) and may be decreased to no less
12than five hundred fifty dollars ($550).
13(3) The annual renewal fee for a nonresident wholesaler license
14or
third-party logistics provider license issued pursuant to Section
154161 shall be seven hundred eighty dollars ($780) and may be
16decreased to no less than six hundred dollars ($600).
17(k) The fee for evaluation of continuing education courses for
18accreditation shall be set by the board at an amount not to exceed
19forty dollars ($40) per course hour.
20(l) The fee for an intern pharmacist license shall be ninety dollars
21($90) and may be increased to one hundred fifteen dollars ($115).
22The fee for transfer of intern hours or verification of licensure to
23another state shall be twenty-five dollars ($25) and may be
24increased to thirty dollars ($30).
25(m) The board may waive or refund the additional fee for the
26issuance of a license where the license is issued less than 45 days
27before the next regular renewal date.
28(n) The fee for the reissuance of any license, or renewal thereof,
29that has been lost or destroyed or reissued due to a name change
30shall be thirty-five dollars ($35) and may be increased to forty-five
31dollars ($45).
32(o) The fee for the reissuance of any license, or renewal thereof,
33that must be reissued because of a change in the information, shall
34be one hundred dollars ($100) and may be increased to one hundred
35thirty dollars ($130).
36(p) It is the intent of the Legislature that, in setting fees pursuant
37to this section, the board shall seek to maintain a reserve in the
38Pharmacy Board Contingent Fund equal to approximately one
39year’s operating expenditures.
P61 1(q) The fee for any applicant for a nongovernmental clinic
2license shall be four hundred dollars
($400) and may be increased
3to five hundred twenty dollars ($520) for each license. The annual
4fee for renewal of the license shall be two hundred fifty dollars
5($250) and may be increased to three hundred twenty-five dollars
6($325) for each license.
7(r) The fee for the issuance of a pharmacy technician license
8shall be eighty dollars ($80) and may be increased to one hundred
9five dollars ($105). The fee for renewal of a pharmacy technician
10license shall be one hundred dollars ($100) and may be increased
11to one hundred thirty dollars ($130).
12(s) The fee for a veterinary food-animal drug retailer license
13shall be four hundred five dollars ($405) and may be increased to
14four hundred twenty-five dollars ($425). The annual renewal fee
15for a veterinary food-animal drug retailer license shall be two
16hundred fifty dollars ($250) and may be increased to three hundred
17twenty-five dollars
($325).
18(t) The fee for issuance of a retired license pursuant to Section
194200.5 shall be thirty-five dollars ($35) and may be increased to
20forty-five dollars ($45).
21(u) The fee for issuance or renewal of a nongovernmental sterile
22compounding pharmacy license shall be six hundred dollars ($600)
23and may be increased to seven hundred eighty dollars ($780). The
24fee for a temporary license shall be five hundred fifty dollars ($550)
25and may be increased to seven hundred fifteen dollars ($715).
26(v) The fee for the issuance or renewal of a nonresident sterile
27compounding pharmacy license shall be seven hundred eighty
28dollars ($780). In addition to paying that application fee, the
29nonresident sterile compounding pharmacy shall deposit, when
30submitting the application, a reasonable amount, as determined by
31the board,
necessary to cover the board’s estimated cost of
32performing the inspection required by Section 4127.2. If the
33required deposit is not submitted with the application, the
34application shall be deemed to be incomplete. If the actual cost of
35the inspection exceeds the amount deposited, the board shall
36provide to the applicant a written invoice for the remaining amount
37and shall not take action on the application until the full amount
38has been paid to the board. If the amount deposited exceeds the
39amount of actual and necessary costs incurred, the board shall
40remit the difference to the applicant.
P62 1
(w) The fee for the issuance of an outsourcing facility license
2shall be two thousand two hundred seventy dollars ($2,270) and
3may be increased to up to three thousand one hundred eighty
4dollars ($3,180) by the board. The fee for the renewal of an
5outsourcing facility
license shall be one thousand three hundred
6twenty-five dollars ($1,325) and may be increased to up to one
7thousand eight hundred fifty-five dollars ($1,855) by the board.
8The fee for a temporary outsourcing facility license shall be seven
9hundred fifteen dollars ($715).
10
(x) The fee for the issuance of a nonresident outsourcing facility
11license shall be two thousand three hundred eighty dollars ($2,380)
12and may be increased to up to three thousand three hundred
13thirty-five dollars ($3,335) by the board. The fee for the renewal
14of a nonresident outsourcing facility license shall be two thousand
15two hundred seventy dollars ($2,270) and may be increased to up
16to three thousand one hundred eighty dollars ($3,180) by the board.
17In addition to paying that application fee, the nonresident
18outsourcing facility shall deposit, when submitting the
application,
19a reasonable amount, as determined by the board, necessary to
20cover the board’s estimated cost of performing the inspection
21required by Section 4129.2. If the required deposit is not submitted
22with the application, the application shall be deemed to be
23incomplete. If the actual cost of the inspection exceeds the amount
24deposited, the board shall provide to the applicant a written invoice
25for the remaining amount and shall not take action on the
26application until the full amount has been paid to the board. If the
27amount deposited exceeds the amount of actual and necessary
28costs incurred, the board shall remit the difference to the applicant.
29(w)
end delete
30begin insert(y)end insert This
section shall becomebegin delete operativeend deletebegin insert
inoperativeend insert on July 1,
31
begin delete 2014.end deletebegin insert 2017, and as of January 1, 2018, is repealed.end insert
Section 4406 of the Business and Professions Code
34 is amended to read:
All fees collected on behalf of the board and all receipts
36of every kind and nature shall be reported each month for the month
37preceding to the Controller and at the same time the entire amount
38shall be paid into the State Treasury and shall be credited to the
39Pharmacy Board Contingent Fund which is hereby created. This
P63 1contingent fund shall be available, upon appropriation of the
2Legislature, for the use of the board.
Section 4800 of the Business and Professions Code
5 is amended to read:
(a) There is in the Department of Consumer Affairs a
7Veterinary Medical Board in which the administration of this
8chapter is vested. The board consists of the following members:
9(1) Four licensed veterinarians.
10(2) One registered veterinary technician.
11(3) Three public members.
12(b) This section shall remain in effect only until January 1,
2021,
13and as of that date is repealed.
14(c) Notwithstanding any other law, the repeal of this section
15renders the board subject to review by the appropriate policy
16committees of the Legislature. However, the review of the board
17shall be limited to those issues identified by the appropriate policy
18committees of the Legislature and shall not involve the preparation
19or submission of a sunset review document or evaluative
20questionnaire.
Section 4804.5 of the Business and Professions Code
23 is amended to read:
The board may appoint a person exempt from civil
25service who shall be designated as an executive officer and who
26shall exercise the powers and perform the duties delegated by the
27board and vested in him or her by this chapter.
28This section shall remain in effect only until January 1, 2021,
29and as of that date is repealed.
Section 4826.5 is added to the Business and
32Professions Code, to read:
Notwithstanding any other law, a licensed veterinarian
34or a registered veterinary technician under the supervision of a
35licensed veterinarian may compound drugs for animal use pursuant
36to Section 530 of Title 21 of the Code of Federal Regulations and
37in accordance with regulations promulgated by the board. The
38regulations promulgated by the board shall, at a minimum, address
39the storage of drugs, the level and type of supervision required for
40compounding drugs by a registered veterinary technician, and the
P64 1equipment necessary for the safe compounding of drugs. Any
2violation of the regulations adopted by the board pursuant to this
3section shall constitute grounds for an enforcement or disciplinary
4action.
Section 4830 of the Business and Professions Code
7 is amended to read:
(a) This chapter does not apply to:
9(1) Veterinarians while serving in any armed branch of the
10military service of the United States or the United States
11Department of Agriculture while actually engaged and employed
12in their official capacity.
13(2) Regularly licensed veterinarians in actual consultation from
14other states.
15(3) Regularly licensed veterinarians actually called from other
16states to attend cases in this state, but who do not open an office
17or appoint a place to do business within this state.
18(4) Students in the School of Veterinary Medicine of the
19University of California or the College of Veterinary Medicine of
20the Western University of Health Sciences who participate in
21diagnosis and treatment as part of their educational experience,
22including those in off-campus educational programs under the
23direct supervision of a licensed veterinarian in good standing, as
24defined in paragraph (1) of subdivision (b) of Section 4848,
25appointed by the University of California, Davis, or the Western
26University of Health Sciences.
27(5) A veterinarian who is employed by the Meat and Poultry
28Inspection Branch of the California Department of Food and
29Agriculture while actually engaged and employed in his or her
30official capacity. A person exempt under this paragraph shall not
31otherwise engage in the practice of veterinary medicine unless he
32or
she is issued a license by the board.
33(6) Unlicensed personnel employed by the Department of Food
34and Agriculture or the United States Department of Agriculture
35when in the course of their duties they are directed by a veterinarian
36supervisor to conduct an examination, obtain biological specimens,
37apply biological tests, or administer medications or biological
38products as part of government disease or condition monitoring,
39investigation, control, or eradication activities.
P65 1(b) (1) For purposes of paragraph (3) of subdivision (a), a
2regularly licensed veterinarian in good standing who is called from
3another state by a law enforcement agency or animal control
4agency, as defined in Section 31606 of the Food and Agricultural
5Code, to attend to cases that are a part of
an investigation of an
6
alleged violation of federal or state animal fighting or animal
7cruelty laws within a single geographic location shall be exempt
8from the licensing requirements of this chapter if the law
9enforcement agency or animal control agency determines that it
10is necessary to call the veterinarian in order for the agency or
11officer to conduct the investigation in a timely, efficient, and
12effective manner. In determining whether it is necessary to call a
13veterinarian from another state, consideration shall be given to the
14availability of veterinarians in this state to attend to these cases.
15An agency, department, or officer that calls a veterinarian pursuant
16to this subdivision shall notify the board of the investigation.
17(2) Notwithstanding any other provision of this chapter, a
18regularly licensed veterinarian in good standing who is called
from
19another state to attend to cases that are a part of an investigation
20described in paragraph (1) may provide veterinary medical care
21for animals that are affected by the investigation with a temporary
22shelter facility, and the temporary shelter facility shall be exempt
23from the registration requirement of Section 4853 if all of the
24following conditions are met:
25(A) The temporary shelter facility is established only for the
26purpose of the investigation.
27(B) The temporary shelter facility provides veterinary medical
28care, shelter, food, and water only to animals that are affected by
29the investigation.
30(C) The temporary shelter facility complies with Section 4854.
31(D) The temporary shelter facility exists for not more than 60
32days, unless the law enforcement agency or animal control agency
33determines that a longer period of time is necessary to complete
34the investigation.
35(E) Within 30 calendar days upon completion of the provision
36of veterinary health care services at a temporary shelter facility
37established pursuant to this section, the veterinarian called from
38another state by a law enforcement agency or animal control agency
39to attend to a case shall file a report with the board. The report
40shall contain the date, place, type, and general description of the
P66 1care provided, along with a listing of the veterinary health care
2practitioners who participated in providing that care.
3(c) For purposes of paragraph (3) of subdivision (a),
the board
4may inspect temporary facilities established pursuant to this
5section.
begin insertSection 4830 of the end insertbegin insertBusiness and Professions Codeend insert
7
begin insert is amended to read:end insert
(a) This chapter does not apply to:
9(1) Veterinarians while serving in any armed branch of the
10military service of the United States or the United States
11Department of Agriculture while actually engaged and employed
12in their official capacity.
13(2) Regularly licensed veterinarians in actual consultation from
14other states.
15(3) Regularly licensed veterinarians actually called from other
16states to attend cases in this state, but who do not open an office
17or appoint a place to do business within this state.
18(4) Veterinarians employed by
the University of California
19while engaged in the performance of duties in connection with the
20College of Agriculture, the Agricultural Experiment Station, the
21School of Veterinary Medicine, or the agricultural extension work
22of the university or employed by the Western University of Health
23Sciences while engaged in the performance of duties in connection
24with the College of Veterinary Medicine or the agricultural
25extension work of the university.
26
(2) Veterinarians holding a current, valid license in good
27standing in another state or country who provide assistance to a
28California licensed veterinarian and attend on a specific case. The
29California licensed veterinarian shall maintain a valid
30veterinarian-client-patient relationship. The veterinarian providing
31the assistance shall not establish a veterinarian-client-patient
32relationship with
the client by attending the case or at a future
33time and shall not practice veterinary medicine, open an office,
34appoint a place to meet patients, communicate with clients who
35reside within the limits of this state, give orders, or have ultimate
36authority over the care or primary diagnosis of a patient that is
37located within this state.
38
(3) Veterinarians called into the state by a law enforcement
39agency or animal control agency pursuant to subdivision (b).
40(5)
end delete
P67 1begin insert(4)end insert Students in the School of Veterinary Medicine of the
2University of California or the College of Veterinary Medicine of
3the Western University of Health Sciences who participate in
4diagnosis and treatment as part of their educational experience,
5including those in off-campus educational programs under the
6direct supervision of a licensed veterinarian in good standing, as
7defined in paragraph (1) of subdivision (b) of Section 4848,
8appointed by the University of California, Davis, or the Western
9University of Health Sciences.
10(6)
end delete
11begin insert(5)end insert A veterinarian who is employed by the Meat and Poultry
12Inspection Branch of the California Department of Food and
13Agriculture
while actually engaged and employed in his or her
14official capacity. A person exempt under this paragraph shall not
15otherwise engage in the practice of veterinary medicine unless he
16or she is issued a license by the board.
17(7)
end delete
18begin insert(6)end insert Unlicensed personnel employed by the Department of Food
19and Agriculture or the United States Department of Agriculture
20when in the course of their duties they are directed by a veterinarian
21supervisor to conduct an examination, obtain biological specimens,
22apply biological tests, or administer medications or biological
23products as part of government disease or condition monitoring,
24investigation, control, or eradication activities.
25(b) (1) For purposes of paragraph (3) of subdivision (a), a
26regularly licensed veterinarian in good standing who is called from
27another state by a law enforcement agency or animal control
28agency, as defined in Section 31606 of the Food and Agricultural
29Code, to attend to cases that are a part of an investigation of an
30alleged violation of federal or state animal fighting or animal
31cruelty laws within a single geographic location shall be exempt
32from the licensing requirements of this chapter if the law
33enforcement agency or animal control agency determines that it
34is necessary to call the veterinarian in order for the agency or
35officer to conduct the investigation in a timely, efficient, and
36effective manner. In determining whether it is necessary to call a
37veterinarian from another state, consideration shall be given to the
38availability of veterinarians in this state to attend to these cases.
39An agency, department, or
officer that calls a veterinarian pursuant
40to this subdivision shall notify the board of the investigation.
P68 1(2) Notwithstanding any other provision of this chapter, a
2regularly licensed veterinarian in good standing who is called from
3another state to attend to cases that are a part of an investigation
4described in paragraph (1) may provide veterinary medical care
5for animals that are affected by the investigation with a temporary
6shelter facility, and the temporary shelter facility shall be exempt
7from the registration requirement of Section 4853 if all of the
8following conditions are met:
9(A) The temporary shelter facility is established only for the
10purpose of the investigation.
11(B) The temporary shelter facility provides veterinary medical
12care, shelter, food, and water only to animals that are affected by
13the
investigation.
14(C) The temporary shelter facility complies with Section 4854.
15(D) The temporary shelter facility exists for not more than 60
16days, unless the law enforcement agency or animal control agency
17determines that a longer period of time is necessary to complete
18the investigation.
19(E) Within 30 calendar days upon completion of the provision
20of veterinary health care services at a temporary shelter facility
21established pursuant to this section, the veterinarian called from
22another state by a law enforcement agency or animal control agency
23to attend to a case shall file a report with the board. The report
24shall contain the date, place, type, and general description of the
25care provided, along with a listing of the veterinary health care
26practitioners who participated in providing that care.
27(c) For purposes of paragraph (3) of subdivision (a), the board
28may inspect temporary facilities established pursuant to this
29section.
Section 4846.5 of the Business and Professions Code
32 is amended to read:
(a) Except as provided in this section, the board shall
34issue renewal licenses only to those applicants that have completed
35a minimum of 36 hours of continuing education in the preceding
36two years.
37(b) (1) Notwithstanding any other law, continuing education
38hours shall be earned by attending courses relevant to veterinary
39medicine and sponsored or cosponsored by any of the following:
P69 1(A) American Veterinary Medical Association (AVMA)
2accredited veterinary medical colleges.
3(B) Accredited colleges or universities offering programs
4relevant
to veterinary medicine.
5(C) The American Veterinary Medical Association.
6(D) American Veterinary Medical Association recognized
7specialty or affiliated allied groups.
8(E) American Veterinary Medical Association’s affiliated state
9veterinary medical associations.
10(F) Nonprofit annual conferences established in conjunction
11with state veterinary medical associations.
12(G) Educational organizations affiliated with the American
13Veterinary Medical Association or its state affiliated veterinary
14medical associations.
15(H) Local veterinary medical
associations affiliated with the
16California Veterinary Medical Association.
17(I) Federal, state, or local government agencies.
18(J) Providers accredited by the Accreditation Council for
19Continuing Medical Education (ACCME) or approved by the
20American Medical Association (AMA), providers recognized by
21the American Dental Association Continuing Education
22Recognition Program (ADA CERP), and AMA or ADA affiliated
23state, local, and specialty organizations.
24(2) Continuing education credits shall be granted to those
25veterinarians taking self-study courses, which may include, but
26are not limited to, reading journals, viewing video recordings, or
27listening to audio recordings. The taking of these courses shall be
28limited to
no more than six hours biennially.
29(3) The board may approve other continuing veterinary medical
30education providers not specified in paragraph (1).
31(A) The board has the authority to recognize national continuing
32education approval bodies for the purpose of approving continuing
33education providers not specified in paragraph (1).
34(B) Applicants seeking continuing education provider approval
35shall have the option of applying to the board or to a
36board-recognized national approval body.
37(4) For good cause, the board may adopt an order specifying,
38on a prospective basis, that a provider of continuing veterinary
39medical education authorized pursuant to paragraph (1) or
(3) is
40no longer an acceptable provider.
P70 1(5) Continuing education hours earned by attending courses
2sponsored or cosponsored by those entities listed in paragraph (1)
3between January 1, 2000, and January 1, 2001, shall be credited
4toward a veterinarian’s continuing education requirement under
5this section.
6(c) Every person renewing his or her license issued pursuant to
7Section 4846.4, or any person applying for relicensure or for
8reinstatement of his or her license to active status, shall submit
9proof of compliance with this section to the board certifying that
10he or she is in compliance with this section. Any false statement
11submitted pursuant to this section shall be a violation subject to
12Section 4831.
13(d) This section shall not apply to a veterinarian’s first license
14renewal. This section shall apply only to second and subsequent
15license renewals granted on or after January 1, 2002.
16(e) The board shall have the right to audit the records of all
17applicants to verify the completion of the continuing education
18
requirement. Applicants shall maintain records of completion of
19required continuing education coursework for a period of four
20years and shall make these records available to the board for
21auditing purposes upon request. If the board, during this audit,
22questions whether any course reported by the veterinarian satisfies
23the continuing education requirement, the veterinarian shall provide
24information to the board concerning the content of the course; the
25name of its sponsor and cosponsor, if any; and specify the specific
26curricula that was of benefit to the veterinarian.
27(f) A veterinarian desiring an inactive license or to restore an
28inactive license under Section 701 shall submit an application on
29a form provided by the board. In order to restore an inactive license
30to active status, the veterinarian shall have completed a minimum
31of
36 hours of continuing education within the last two years
32preceding application. The inactive license status of a veterinarian
33shall not deprive the board of its authority to institute or continue
34a disciplinary action against a licensee.
35(g) Knowing misrepresentation of compliance with this article
36by a veterinarian constitutes unprofessional conduct and grounds
37for disciplinary action or for the issuance of a citation and the
38imposition of a civil penalty pursuant to Section 4883.
39(h) The board, in its discretion, may exempt from the continuing
40education requirement any veterinarian who for reasons of health,
P71 1military service, or undue hardship cannot meet those requirements.
2Applications for waivers shall be submitted on a form provided
3by the board.
4(i) The administration of this section may be funded through
5professional license and continuing education provider fees. The
6fees related to the administration of this section shall not exceed
7the costs of administering the corresponding provisions of this
8section.
9(j) For those continuing education providers not listed in
10paragraph (1) of subdivision (b), the board or its recognized
11national approval agent shall establish criteria by which a provider
12of continuing education shall be approved. The board shall initially
13review and approve these criteria and may review the criteria as
14needed. The board or its recognized agent shall monitor, maintain,
15and manage related records and data. The board may impose an
16application fee, not to exceed two hundred dollars ($200)
17biennially,
for continuing education providers not listed in
18paragraph (1) of subdivision (b).
19(k) (1) Beginning January 1, 2018, a licensed veterinarian who
20renews his or her license shall complete a minimum of one credit
21hour of continuing education on the judicious use of medically
22important antimicrobial drugs every four years as part of his or
23her continuing education requirements.
24(2) For purposes of this subdivision, “medically important
25antimicrobial drug” means an antimicrobial drug listed in Appendix
26A of the federal Food and Drug Administration’s Guidance for
27Industry #152, including critically important, highly important,
28and important antimicrobial drugs, as that appendix may be
29amended.
Section 4848.1 is added to the Business and
32Professions Code, to read:
(a) A veterinarian engaged in the practice of veterinary
34medicine, as defined in Section 4826, employed by the University
35of California and engaged in the performance of duties in
36connection with the School of Veterinary Medicine or employed
37by the Western University of Health Sciences and engaged in the
38performance of duties in connection with the College of Veterinary
39Medicine shall be issued a university license pursuant to this
P72 1section or hold a license to practice veterinary medicine in this
2state.
3(b) An individual may apply for and be issued a university
4license if all of the following are satisfied:
5(1) He or she is currently employed by the University of
6California or Western University of Health Sciences, as defined
7in subdivision (a).
8(2) He or she passes an examination concerning the statutes and
9regulations of the Veterinary Medicine Practice Act, administered
10by the board, pursuant to subparagraph (C) of paragraph (2) of
11subdivision (a) of Section 4848.
12(3) He or she successfully completes the approved educational
13curriculum described in paragraph (5) of subdivision (b) of Section
144848 on regionally specific and important diseases and conditions.
15(4) He or she completes and submits the application specified
16by the board and pays the application fee, pursuant to subdivision
17(g) of Section 4905, and the
initial license fee, pursuant to
18subdivision (h) of Section 4905.
19(c) A university license:
20(1) Shall be numbered as described in Section 4847.
21(2) Shall automatically cease to be valid upon termination or
22cessation of employment by the University of California or by the
23Western University of Health Sciences.
24(3) Shall be subject to the license renewal provisions in Section
254846.4 and the payment of the renewal fee pursuant to subdivision
26(i) of Section 4905.
27(4) Shall be subject to denial, revocation, or suspension pursuant
28to Sections 480, 4875, and 4883.
29(5) Authorizes the holder to practice veterinary medicine only
30at an educational institution described in subdivision (a) and any
31locations formally affiliated with those institutions.
32(d) An individual who holds a university license is exempt from
33satisfying the license renewal requirements of Section 4846.5.
Section 4853.7 is added to the Business and
36Professions Code, to read:
A premise registration that is not renewed within five
38years after its expiration may not be renewed and shall not be
39restored, reissued, or reinstated thereafter. However, an application
P73 1for a new premise registration may be submitted and obtained if
2both of the following conditions are met:
3(a) No fact, circumstance, or condition exists that, if the premise
4registration was issued, would justify its revocation or suspension.
5(b) All of the fees that would be required for the initial premise
6registration are paid at the time of application.
Section 4904 of the Business and Professions Code
9 is amended to read:
All fees collected on behalf of the board and all receipts
11of every kind and nature shall be reported each month for the month
12preceding to the Controller and at the same time the entire amount
13shall be paid into the State Treasury and shall be credited to the
14Veterinary Medical Board Contingent Fund. This contingent fund
15shall be available, upon appropriation by the Legislature, for the
16use of the Veterinary Medical Board.
Section 4905 of the Business and Professions Code
19 is amended to read:
The following fees shall be collected by the board and
21shall be credited to the Veterinary Medical Board Contingent Fund:
22(a) The fee for filing an application for examination shall be set
23by the board in an amount it determines is reasonably necessary
24to provide sufficient funds to carry out the purpose of this chapter,
25not to exceed three hundred fifty dollars ($350).
26(b) The fee for the California state board examination shall be
27set by the board in an amount it determines is reasonably necessary
28to provide sufficient funds to carry out the purpose of this chapter,
29not to exceed three hundred fifty dollars
($350).
30(c) The fee for the Veterinary Medicine Practice Act
31examination shall be set by the board in an amount it determines
32reasonably necessary to provide sufficient funds to carry out the
33purpose of this chapter, not to exceed one hundred dollars ($100).
34(d) The initial license fee shall be set by the board not to exceed
35five hundred dollars ($500) except that, if the license is issued less
36than one year before the date on which it will expire, then the fee
37shall be set by the board not to exceed two hundred fifty dollars
38($250). The board may, by appropriate regulation, provide for the
39waiver or refund of the initial license fee where the license is issued
40less than 45 days before the date on which it will expire.
P74 1(e) The renewal fee shall be set by the board for each biennial
2renewal period in an amount it determines is reasonably necessary
3to provide sufficient funds to carry out the purpose of this chapter,
4not to exceed five hundred dollars ($500).
5(f) The temporary license fee shall be set by the board in an
6amount it determines is reasonably necessary to provide sufficient
7funds to carry out the purpose of this chapter, not to exceed two
8hundred fifty dollars ($250).
9(g) The fee for filing an application for a university license shall
10be one hundred twenty-five dollars ($125), which may be revised
11by the board in regulation but shall not exceed three hundred fifty
12dollars ($350).
13(h) The initial license fee for a university license shall be two
14hundred ninety dollars ($290), which may be revised by the board
15in regulation but shall not exceed five hundred dollars ($500).
16(i) The biennial renewal fee for a university license shall be two
17hundred ninety dollars ($290), which may be revised by the board
18in regulation but shall not exceed five hundred dollars ($500).
19(j) The delinquency fee shall be set by the board, not to exceed
20fifty dollars ($50).
21(k) The fee for issuance of a duplicate license is twenty-five
22dollars ($25).
23(l) Any charge made for duplication or other services
shall be
24set at the cost of rendering the service, except as specified in
25subdivision (k).
26(m) The fee for failure to report a change in the mailing address
27is twenty-five dollars ($25).
28(n) The initial and annual renewal fees for registration of
29veterinary premises shall be set by the board in an amount not to
30exceed four hundred dollars ($400) annually.
31(o) If the money transferred from the Veterinary Medical Board
32Contingent Fund to the General Fund pursuant to the Budget Act
33of 1991 is redeposited into the Veterinary Medical Board
34Contingent Fund, the fees assessed by the board shall be reduced
35correspondingly. However, the reduction shall not be so great as
36to cause the Veterinary Medical Board Contingent Fund
to have
37a reserve of less than three months of annual authorized board
38expenditures. The fees set by the board shall not result in a
39Veterinary Medical Board Contingent Fund reserve of more than
4010 months of annual authorized board expenditures.
Section 13401.5 of the Corporations Code is amended
3to read:
Notwithstanding subdivision (d) of Section 13401
5and any other provision of law, the following licensed persons
6may be shareholders, officers, directors, or professional employees
7of the professional corporations designated in this section so long
8as the sum of all shares owned by those licensed persons does not
9exceed 49 percent of the total number of shares of the professional
10corporation so designated herein, and so long as the number of
11those licensed persons owning shares in the professional
12corporation so designated herein does not exceed the number of
13persons licensed by the governmental agency regulating the
14designated professional corporation. This section does not limit
15employment by a professional corporation designated in this section
16to only those
licensed professionals listed under each subdivision.
17Any person duly licensed under Division 2 (commencing with
18Section 500) of the Business and Professions Code, the
19Chiropractic Act, or the Osteopathic Act may be employed to
20render professional services by a professional corporation
21designated in this section.
22(a) Medical corporation.
23(1) Licensed doctors of podiatric medicine.
24(2) Licensed psychologists.
25(3) Registered nurses.
26(4) Licensed optometrists.
27(5) Licensed marriage and family therapists.
28(6) Licensed clinical social workers.
29(7) Licensed physician assistants.
30(8) Licensed chiropractors.
31(9) Licensed acupuncturists.
32(10) Naturopathic doctors.
33(11) Licensed professional clinical counselors.
34(12) Licensed physical therapists.
35(13) Licensed pharmacists.
36(b) Podiatric medical corporation.
37(1) Licensed physicians and surgeons.
38(2) Licensed psychologists.
39(3) Registered nurses.
40(4) Licensed optometrists.
P76 1(5) Licensed chiropractors.
2(6) Licensed acupuncturists.
3(7) Naturopathic doctors.
4(8) Licensed physical therapists.
5(c) Psychological corporation.
6(1) Licensed physicians and surgeons.
7(2) Licensed doctors of podiatric medicine.
8(3) Registered nurses.
9(4) Licensed optometrists.
10(5) Licensed marriage and family therapists.
11(6) Licensed clinical social workers.
12(7) Licensed chiropractors.
13(8) Licensed acupuncturists.
14(9) Naturopathic doctors.
15(10) Licensed professional clinical counselors.
16(d) Speech-language pathology corporation.
17(1) Licensed audiologists.
18(e) Audiology corporation.
19(1) Licensed speech-language pathologists.
20(f) Nursing corporation.
21(1) Licensed physicians and surgeons.
22(2) Licensed doctors of podiatric medicine.
23(3) Licensed psychologists.
24(4) Licensed optometrists.
25(5) Licensed marriage and family therapists.
26(6) Licensed clinical social workers.
27(7) Licensed physician assistants.
28(8) Licensed chiropractors.
29(9) Licensed acupuncturists.
30(10) Naturopathic doctors.
31(11) Licensed professional clinical counselors.
32(g) Marriage and family therapist corporation.
33(1) Licensed physicians and surgeons.
34(2) Licensed psychologists.
35(3) Licensed clinical social workers.
36(4) Registered nurses.
37(5) Licensed chiropractors.
38(6) Licensed acupuncturists.
39(7) Naturopathic doctors.
40(8) Licensed professional clinical counselors.
P77 1(h) Licensed clinical social worker corporation.
2(1) Licensed physicians and surgeons.
3(2) Licensed psychologists.
4(3) Licensed marriage and family therapists.
5(4) Registered nurses.
6(5) Licensed chiropractors.
7(6) Licensed acupuncturists.
8(7) Naturopathic doctors.
9(8) Licensed professional clinical counselors.
10(i) Physician assistants corporation.
11(1) Licensed physicians and surgeons.
12(2) Registered nurses.
13(3) Licensed acupuncturists.
14(4) Naturopathic doctors.
15(j) Optometric corporation.
16(1) Licensed physicians and surgeons.
17(2) Licensed doctors of podiatric medicine.
18(3) Licensed psychologists.
19(4) Registered nurses.
20(5) Licensed chiropractors.
21(6) Licensed acupuncturists.
22(7) Naturopathic doctors.
23(k) Chiropractic corporation.
24(1) Licensed physicians and surgeons.
25(2) Licensed doctors of podiatric medicine.
26(3) Licensed psychologists.
27(4) Registered nurses.
28(5) Licensed optometrists.
29(6) Licensed marriage and family therapists.
30(7) Licensed clinical social workers.
31(8) Licensed acupuncturists.
32(9) Naturopathic doctors.
33(10) Licensed professional clinical counselors.
34(l) Acupuncture corporation.
35(1) Licensed physicians and surgeons.
36(2) Licensed doctors of podiatric medicine.
37(3) Licensed psychologists.
38(4) Registered nurses.
39(5) Licensed optometrists.
40(6) Licensed marriage and family therapists.
P78 1(7) Licensed clinical social workers.
2(8) Licensed physician assistants.
3(9) Licensed chiropractors.
4(10) Naturopathic doctors.
5(11) Licensed professional clinical counselors.
6(m) Naturopathic doctor corporation.
7(1) Licensed physicians and surgeons.
8(2) Licensed psychologists.
9(3) Registered nurses.
10(4) Licensed physician assistants.
11(5) Licensed chiropractors.
12(6) Licensed acupuncturists.
13(7) Licensed physical therapists.
14(8) Licensed doctors of podiatric medicine.
15(9) Licensed marriage and family therapists.
16(10) Licensed clinical social workers.
17(11) Licensed optometrists.
18(12) Licensed professional clinical counselors.
19(n) Dental corporation.
20(1) Licensed physicians and surgeons.
21(2) Dental assistants.
22(3) Registered dental assistants.
23(4) Registered dental assistants in extended functions.
24(5) Registered dental hygienists.
25(6) Registered dental hygienists in extended functions.
26(7) Registered dental hygienists in alternative practice.
27(o) Professional clinical counselor corporation.
28(1) Licensed physicians and surgeons.
29(2) Licensed psychologists.
30(3) Licensed clinical social workers.
31(4) Licensed marriage and family therapists.
32(5) Registered nurses.
33(6) Licensed chiropractors.
34(7) Licensed acupuncturists.
35(8) Naturopathic doctors.
36(p) Physical therapy corporation.
37(1) Licensed physicians and surgeons.
38(2) Licensed doctors of podiatric medicine.
39(3) Licensed acupuncturists.
40(4) Naturopathic doctors.
P79 1(5) Licensed occupational therapists.
2(6) Licensed speech-language therapists.
3(7) Licensed audiologists.
4(8) Registered nurses.
5(9) Licensed psychologists.
6(10) Licensed physician assistants.
7(q) Registered dental hygienist in alternative practice
8corporation.
9(1) Registered dental assistants.
10(2) Licensed dentists.
11(3) Registered dental hygienists.
12(4) Registered dental hygienists in extended functions.
Section 1261.6 of the Health and Safety Code is
15amended to read:
(a) (1) For purposes of this section and Section 1261.5,
17an “automated drug delivery system” means a mechanical system
18that performs operations or activities, other than compounding or
19administration, relative to the storage, dispensing, or distribution
20of drugs. An automated drug delivery system shall collect, control,
21and maintain all transaction information to accurately track the
22movement of drugs into and out of the system for security,
23accuracy, and accountability.
24(2) For purposes of this section, “facility” means a health facility
25licensed pursuant to subdivision (c), (d), or (k), of Section 1250
26that has an automated
drug delivery system provided by a
27pharmacy.
28(3) For purposes of this section, “pharmacy services” means
29the provision of both routine and emergency drugs and biologicals
30to meet the needs of the patient, as prescribed by a physician.
31(b) Transaction information shall be made readily available in
32a written format for review and inspection by individuals
33authorized by law. These records shall be maintained in the facility
34for a minimum of three years.
35(c) Individualized and specific access to automated drug delivery
36systems shall be limited to facility and contract personnel
37authorized by law to administer drugs.
38(d) (1) The facility and
the pharmacy shall develop and
39implement written policies and procedures to ensure safety,
40accuracy, accountability, security, patient confidentiality, and
P80 1maintenance of the quality, potency, and purity of stored drugs.
2Policies and procedures shall define access to the automated drug
3delivery system and limits to access to equipment and drugs.
4(2) All policies and procedures shall be maintained at the
5pharmacy operating the automated drug delivery system and the
6location where the automated drug delivery system is being used.
7(e) When used as an emergency pharmaceutical supplies
8container, drugs removed from the automated drug delivery system
9shall be limited to the following:
10(1) A new drug order given by a prescriber
for a patient of the
11facility for administration prior to the next scheduled delivery from
12the pharmacy, or 72 hours, whichever is less. The drugs shall be
13retrieved only upon authorization by a pharmacist and after the
14pharmacist has reviewed the prescriber’s order and the patient’s
15profile for potential contraindications and adverse drug reactions.
16(2) Drugs that a prescriber has ordered for a patient on an
17as-needed basis, if the utilization and retrieval of those drugs are
18subject to ongoing review by a pharmacist.
19(3) Drugs designed by the patient care policy committee or
20pharmaceutical service committee of the facility as emergency
21drugs or acute onset drugs. These drugs may be retrieved from an
22automated drug delivery system pursuant to the order of a
23prescriber for
emergency or immediate administration to a patient
24of the facility. Within 48 hours after retrieval under this paragraph,
25the case shall be reviewed by a pharmacist.
26(f) When used to provide pharmacy services pursuant to Section
274119.1 of the Business and Professions Code, the automated drug
28delivery system shall be subject to all of the following
29requirements:
30(1) Drugs removed from the automated drug delivery system
31for administration to a patient shall be in properly labeled units of
32administration containers or packages.
33(2) A pharmacist shall review and approve all orders prior to a
34drug being removed from the automated drug delivery system for
35administration to a patient. The pharmacist shall review the
36prescriber’s
order and the patient’s profile for potential
37contraindications and adverse drug reactions.
38(3) The pharmacy providing services to the facility pursuant to
39Section 4119.1 of the Business and Professions Code shall control
40access to the drugs stored in the automated drug delivery system.
P81 1(4) Access to the automated drug delivery system shall be
2controlled and tracked using an identification or password system
3or biosensor.
4(5) The automated drug delivery system shall make a complete
5and accurate record of all transactions that will include all users
6accessing the system and all drugs added to, or removed from, the
7system.
8(6) After the pharmacist reviews the
prescriber’s order, access
9by licensed personnel to the automated drug delivery system shall
10 be limited only to drugs ordered by the prescriber and reviewed
11by the pharmacist and that are specific to the patient. When the
12prescriber’s order requires a dosage variation of the same drug,
13licensed personnel shall have access to the drug ordered for that
14scheduled time of administration.
15(7) (A) Systems that allow licensed personnel to have access
16to multiple drugs and are not patient specific in their design, shall
17be allowed under this subdivision if those systems have electronic
18and mechanical safeguards in place to ensure that the drugs
19delivered to the patient are specific to that patient. Each facility
20using such an automated drug system shall notify the department
21in writing prior to the utilization of the system. The
notification
22submitted to the department pursuant to this paragraph shall
23include, but is not limited to, information regarding system design,
24personnel with system access, and policies and procedures covering
25staff training, storage, and security, and the facility’s administration
26of these types of systems.
27(B) As part of its routine oversight of these facilities, the
28department shall review a facility’s medication training, storage,
29and security, and its administration procedures related to its use
30of an automated drug delivery system to ensure that adequate staff
31training and safeguards are in place to make sure that the drugs
32delivered are appropriate for the patient. If the department
33determines that a facility is not in compliance with this section,
34the department may revoke its authorization to use automated drug
35delivery
systems granted under subparagraph (A).
36(g) The stocking of an automated drug delivery system shall be
37performed by a pharmacist. If the automated drug delivery system
38utilizes removable pockets, cards, drawers, similar technology, or
39unit of use or single dose containers as defined by the United States
40Pharmacopoeia, the stocking system may be done outside of the
P82 1facility and be delivered to the facility if all of the following
2conditions are met:
3(1) The task of placing drugs into the removable pockets, cards,
4drawers, or unit of use or single dose containers is performed by
5a pharmacist, or by an intern pharmacist or a pharmacy technician
6working under the direct supervision of a pharmacist.
7(2) The removable
pockets, cards, drawers, or unit of use or
8single dose containers are transported between the pharmacy and
9the facility in a secure tamper-evident container.
10(3) The facility, in conjunction with the pharmacy, has
11developed policies and procedures to ensure that the removable
12pockets, cards, drawers, or unit of use or single dose containers
13are properly placed into the automated drug delivery system.
14(h) Review of the drugs contained within, and the operation and
15maintenance of, the automated drug delivery system shall be done
16in accordance with law and shall be the responsibility of the
17pharmacy. The review shall be conducted on a monthly basis by
18a pharmacist and shall include a physical inspection of the drugs
19in the automated drug delivery system, an inspection of the
20automated
drug delivery system machine for cleanliness, and a
21review of all transaction records in order to verify the security and
22accountability of the system.
23(i) Drugs dispensed from an automated drug delivery system
24that meets the requirements of this section shall not be subject to
25the labeling requirements of Section 4076 of the Business and
26Professions Code or Section 111480 of this code if the drugs to
27be placed into the automated drug delivery system are in unit dose
28packaging or unit of use and if the information required by Section
294076 of the Business and Professions Code and Section 111480
30of this code is readily available at the time of drug administration.
31For purposes of this section, unit dose packaging includes blister
32pack cards.
Section 11164.5 of the Health and Safety Code is
35amended to read:
(a) Notwithstanding Section 11164, if only recorded
37and stored electronically, on magnetic media, or in any other
38computerized form, the pharmacy’s or hospital’s computer system
39shall not permit the received information or the controlled
40substance dispensing information required by this section to be
P83 1changed, obliterated, destroyed, or disposed of, for the record
2maintenance period required by law, once the information has been
3received by the pharmacy or the hospital and once the controlled
4substance has been dispensed, respectively. Once the controlled
5substance has been dispensed, if the previously created record is
6determined to be incorrect, a correcting addition may be made
7only by or with the
approval of a pharmacist. After a pharmacist
8enters the change or enters his or her approval of the change into
9the computer, the resulting record shall include the correcting
10addition and the date it was made to the record, the identity of the
11person or pharmacist making the correction, and the identity of
12the pharmacist approving the correction.
13(b) Nothing in this section shall be construed to exempt any
14pharmacy or hospital dispensing Schedule II controlled substances
15pursuant to electronic transmission prescriptions from existing
16
reporting requirements.
Section 42.5 of this bill incorporates amendments to
18Section 4400 of the Business and Professions Code proposed by
19both this bill and Senate Bill 1039. It shall only become operative
20if (1) both bills are enacted and become effective on or before
21January 1, 2017, (2) each bill amends Section 4400 of the Business
22and Professions Code, and (3) this bill is enacted after Senate Bill
231039, in which case Section 42 of this bill shall not become
24operative.
Section 47.5 of this bill incorporates amendments to
26Section 4830 of the Business and Professions Code proposed by
27both this bill and Senate Bill 1039. It shall only become operative
28if (1) both bills are enacted and become effective on or before
29January 1, 2017, (2) each bill amends Section 4830 of the Business
30and Professions Code, and (3) this bill is enacted after Senate Bill
311039, in which case Section 47 of this bill shall not become
32operative.
No reimbursement is required by this act pursuant to
35Section 6 of Article XIII B of the California Constitution because
36the only costs that may be incurred by a local agency or school
37district will be incurred because this act creates a new crime or
38infraction, eliminates a crime or infraction, or changes the penalty
39for a crime or infraction, within the meaning of Section 17556 of
40the Government Code, or changes the definition of a crime within
P84 1the meaning of Section 6 of Article XIII B of the California
2Constitution.
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94