SB 1193

Bill Subjects

Abstract

(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. This bill would extend the existence of the board and the board's authorization to employ an executive officer to January 1, 2021. The 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. This 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. The 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. This 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. This 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. Existing 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. This bill would repeal this authorization. This bill would authorize the board to post on its Internet Web site the prescribed information regarding all current and former licensees. (2) 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 of 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. This bill would also define "person" to include, but not be limited to, a trust and would make conforming changes. The Pharmacy Law requires that fees collected on behalf of the board be credited to the Pharmacy Board Contingent Fund. Existing law continuously appropriates fees in the fund. This bill would authorize the board to collect a fee of $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. The Pharmacy Law makes a violation of any of its provisions punishable as a misdemeanor or an infraction, as specified. By placing new requirements on a pharmacy, this bill would expand an existing crime and would, therefore, impose a state-mandated local program. (3) 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. The Veterinary Medicine Practice Act makes a violation of any of its provisions punishable as a misdemeanor. 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. 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. 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. (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. (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. (6) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.