California Senate Bill SB1193 Amended / Bill

 BILL NUMBER: SB 1193AMENDED BILL TEXT AMENDED IN SENATE MAY 31, 2016 AMENDED IN SENATE APRIL 13, 2016 INTRODUCED BY Senator Hill (Principal coauthor: Assembly Member Salas) FEBRUARY 18, 2016 An act to amend Sections 4001, 4003,  4107, 4110,  4119.1,  4127, 4127.3, 4127.7, 4127.8, 4127.9, 4128.6, 4161, 4180, 4400,  and  4400   4406  of, to add Sections 4034,  4126.9,  4203.5, and 4316 to, and to add Article 7.7 (commencing with Section 4129) to Chapter 9 of Division 2 of, the Business and Professions Code,  and  to amend Section 13401.5 of the Corporations Code,  and to amend Sections 1261.6 and 11164.5 of the Health and Safety Code,  relating to healing arts, and making an appropriation therefor. LEGISLATIVE COUNSEL'S DIGEST SB 1193, as amended, Hill. Pharmacy:  outsourcing facilities.   Law.  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.  That   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 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.   The 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.  That law also provides for  This bill would require a pharmacy to register use of an automated drug delivery system with the board, including the address and location of use.   Existing 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.   This bill would make these provisions operative by repealing the provision that made them inoperative on January 1, 2012.   The Pharmacy Law requires  the board to issue a license, after an investigation to determine whether the applicant and the premises qualify for a license, that authorizes specified clinics to purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic. Existing law makes a violation of any provision of the Pharmacy Law punishable as an infraction if no other penalty is provided. This bill would  extend the operation of the board and the board's authorization to appoint an executive officer until January 1, 2021. The bill would require a pharmacy to register use of an automated drug delivery system with the board, including the address and location of use. The bill would  require the board, when a clinic applicant submits specified types of applications, to issue a license or incorporate changes to an existing license within 30 days of receipt of a completed application and payment of fees. The bill would  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.  By placing new requirements on a pharmacy, this bill would expand an existing crime and would, therefore, impose a state-mandated local program.  The Pharmacy Law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board and prohibits the board from issuing or renewing that license until the board has, among other things, reviewed a current copy of the pharmacy's procedures and policies for sterile compounding.  Existing law provides that fees collected on behalf of the board are credited to the Pharmacy Board Contingent Fund, which continuously appropriates fees in the fund.   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 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.   The 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   This  bill would require the board to license an outsourcing facility, as defined, and would prohibit an outsourcing facility to be concurrently licensed with the board as a sterile compounding pharmacy at the same location. The bill would require an outsourcing facility to be licensed with the board before doing business within or into the state and would require an outsourcing facility to, among other things, notify the board of any disciplinary or other action taken by another state or the federal Food and Drug Administration within 10 days of the action. The bill would require the board to, among other things, inspect the location of an outsourcing facility to ensure that the outsourcing facility is in compliance with all laws and regulations before issuing or renewing an outsourcing facility's license. The bill would make a violation of any of these provisions or regulations adopted thereto punishable by a fine of up to $5,000 per occurrence. The bill would, on or after January 1, 2018, require the board to provide a report, as specified, to the Legislature regarding the regulation of nonresident outsourcing facilities.  The   Existing 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. Existing 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 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  also  authorize the board to collect a fee of $780 for the issuance and renewal of an outsourcing license and a fee of $715 for a temporary license, as specified.  By increasing the amount of money deposited into a continuously appropriated fund, the bill would make an appropriation.   This bill would provide that the Pharmacy Board Contingent Fund is available for expenditure only upon an appropriation by the Legislature.  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.   By placing new requirements on a pharmacy, this bill would expand an existing crime and would, therefore, impose a state-mandated local program.  The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. Vote: majority. Appropriation:  yes   no  . Fiscal committee: yes. State-mandated local program: yes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 4001 of the Business and Professions Code is amended to read: 4001. (a) There is in the Department of Consumer Affairs a California State Board of Pharmacy in which the administration and enforcement of this chapter is vested. The board consists of 13 members. (b) The Governor shall appoint seven competent pharmacists who reside in different parts of the state to serve as members of the board. The Governor shall appoint four public members, and the Senate Committee on Rules and the Speaker of the Assembly shall each appoint a public member who shall not be a licensee of the board, any other board under this division, or any board referred to in Section 1000 or 3600. (c) At least five of the seven pharmacist appointees to the board shall be pharmacists who are actively engaged in the practice of pharmacy. Additionally, the membership of the board shall include at least one pharmacist representative from each of the following practice settings: an acute care hospital, an independent community pharmacy, a chain community pharmacy, and a long-term health care or skilled nursing facility. The pharmacist appointees shall also include a pharmacist who is a member of a labor union that represents pharmacists. For the purposes of this subdivision, a "chain community pharmacy" means a chain of 75 or more stores in California under the same ownership, and an "independent community pharmacy" means a pharmacy owned by a person or entity who owns no more than four pharmacies in California. (d) Members of the board shall be appointed for a term of four years. No person shall serve as a member of the board for more than two consecutive terms. Each member shall hold office until the appointment and qualification of his or her successor or until one year shall have elapsed since the expiration of the term for which the member was appointed, whichever first occurs. Vacancies occurring shall be filled by appointment for the unexpired term. (e) Each member of the board shall receive a per diem and expenses as provided in Section 103. (f) This section shall remain in effect only until January 1, 2021, and as of that date is repealed. Notwithstanding any other law, the repeal of this section renders the board subject to review by the appropriate policy committees of the Legislature. SEC. 2. Section 4003 of the Business and Professions Code is amended to read: 4003. (a) The board, with the approval of the director, may appoint a person exempt from civil service who shall be designated as an executive officer and who shall exercise the powers and perform the duties delegated by the board and vested in him or her by this chapter. The executive officer may or may not be a member of the board as the board may determine. (b) The executive officer shall receive the compensation as established by the board with the approval of the Director of Finance. The executive officer shall also be entitled to travel and other expenses necessary in the performance of his or her duties. (c) The executive officer shall maintain and update in a timely fashion records containing the names, titles, qualifications, and places of business of all persons subject to this chapter. (d) The executive officer shall give receipts for all money received by him or her and pay it to the department, taking its receipt therefor. Besides the duties required by this chapter, the executive officer shall perform other duties pertaining to the office as may be required of him or her by the board. (e) This section shall remain in effect only until January 1, 2021, and as of that date is repealed. SEC. 3. Section 4034 is added to the Business and Professions Code, to read: 4034. "Outsourcing facility" means a facility that meets all of the following: (a) Is located within the United States of America at one address that is engaged in the compounding of sterile drugs and nonsterile drugs. (b) Has registered as an outsourcing facility with the federal Food and Drug Administration under Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353b). (c) Is doing business within or into California. (d) Is licensed with the board as an outsourcing facility pursuant to Article 7.7 (commencing with Section 4129).  SEC. 4.   Section 4107 of the   Business and Professions Code   is amended to read:  4107. (a) The board  may   shall  not issue more than one site license to a single premises except as follows: (1) To issue a veterinary food-animal drug retailer license to a wholesaler pursuant to Section 4196. (2) To issue a license to compound sterile  injectable  drugs to a pharmacy pursuant to Section  4127.1.   4127.1 or 4127.2.  (3) To issue a centralized hospital packaging license pursuant to Section 4128. (b) For the purposes of this subdivision, "premises" means a location with its own address and an independent means of ingress and egress.  SEC. 5.   Section 4110 of the   Business and Professions Code   is amended to read: 4110. (a) No person shall conduct a pharmacy in the State of California unless he or she has obtained a license from the board. A license shall be required for each pharmacy owned or operated by a specific person. A separate license shall be required for each of the premises of any person operating a pharmacy in more than one location. The license shall be renewed annually. The board may, by regulation, determine the circumstances under which a license may be transferred. (b) The board may, at its discretion, issue a temporary  permit, when the ownership of a pharmacy is transferred from one person to another,   permit  upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary permit fee shall be required in an amount established by the board as specified in subdivision (a) of Section 4400. When needed to protect public safety, a temporary permit may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary permit was issued by mistake or denies the application for a permanent license or registration, the temporary license or registration shall terminate upon either personal service of the notice of termination upon the permitholder or service by certified mail, return receipt requested, at the permitholder's address of record with the board, whichever comes first. Neither for purposes of retaining a temporary permit nor for purposes of any disciplinary or license denial proceeding before the board shall the temporary permitholder be deemed to have a vested property right or interest in the permit. (c) The board may allow the temporary use of a mobile pharmacy when a pharmacy is destroyed or damaged, the mobile pharmacy is necessary to protect the health and safety of the public, and the following conditions are met: (1) The mobile pharmacy shall provide services only on or immediately contiguous to the site of the damaged or destroyed pharmacy. (2) The mobile pharmacy is under the control and management of the pharmacist-in-charge of the pharmacy that was destroyed or damaged. (3) A licensed pharmacist is on the premises while drugs are being dispensed. (4) Reasonable security measures are taken to safeguard the drug supply maintained in the mobile pharmacy. (5) The pharmacy operating the mobile pharmacy provides the board with records of the destruction of, or damage to, the pharmacy and an expected restoration date. (6) Within three calendar days of restoration of the pharmacy services, the board is provided with notice of the restoration of the permanent pharmacy. (7) The mobile pharmacy is not operated for more than 48 hours following the restoration of the permanent pharmacy.  SEC. 4.   SEC. 6.  Section 4119.1 of the Business and Professions Code is amended to read: 4119.1. (a) A pharmacy may provide pharmacy services to a health facility licensed pursuant to subdivision (c), (d), or both, of Section 1250 of the Health and Safety Code, through the use of an automated drug delivery system that need not be located at the same location as the pharmacy. (b) Drugs stored in an automated drug delivery system shall be part of the inventory of the pharmacy providing pharmacy services to that facility, and drugs dispensed from the pharmacy system shall be considered to have been dispensed by that pharmacy. (c) (1) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs and dangerous devices stored in the automated drug delivery system separate from other pharmacy records. (2) The pharmacy shall own and operate the automated drug delivery system. (3) The pharmacy shall provide training regarding the operation and use of the automated drug delivery system to both pharmacy and health facility personnel using the system. (4) The pharmacy shall operate the automated drug delivery system in compliance with Section 1261.6 of the Health and Safety Code. (d) The operation of the automated drug delivery system shall be under the supervision of a licensed pharmacist. To qualify as a supervisor for an automated drug delivery system, the pharmacist need not be physically present at the site of the automated drug delivery system and may supervise the system electronically. (e) The pharmacy shall register use of an automated drug delivery system with the board, including the address and location of use. (f) This section shall not be construed to revise or limit the use of automated drug delivery systems as permitted by the board in any licensed health facility other than a facility defined in subdivision (c) or (d), or both, of Section 1250 of the Health and Safety Code.  SEC. 7.   Section 4126.9 is added to the   Business and Professions Code   , to read:   4126.9. (a) A pharmacy that issues a recall notice regarding a nonsterile compounded drug product shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 12 hours of the recall notice if both of the following apply: (1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death. (2) The recalled drug was dispensed, or is intended for use, in this state. (b) A recall notice issued pursuant to subdivision (a) shall be made as follows: (1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient. (2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified. (3) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy, which shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified. (c) In cases where patient harm has occurred resulting from use of the compounded product, the event shall be reported to MedWatch within 72 hours of the pharmacy being advised.   SEC. 8.   Section 4127 of the   Business and Professions Code   is amended to read:  4127. (a) A pharmacy that compounds sterile drug products  for injection, administration into the eye, or inhalation  shall possess a sterile compounding pharmacy license as provided in this article. (b) The board shall adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to establish policies, guidelines, and procedures to implement this article. (c) The board shall review any formal revision to General Chapter 797 of the United States Pharmacopeia and The National Formulary (USP-NF), relating to the compounding of sterile preparations, not later than 90 days after the revision becomes official, to determine whether amendments are necessary for the regulations adopted by the board pursuant to subdivision (b).  (d) This section shall become operative on July 1, 2014.   SEC. 9.   Section 4127.3 of the   Business and Professions Code   is amended to read:  4127.3. (a) Whenever the board has a reasonable belief, based on information obtained during an inspection or investigation by the board, that a pharmacy compounding  injectable  sterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the pharmacy to immediately cease and desist from compounding  injectable  sterile drug products. The cease and desist order shall remain in effect for no more than 30 days or the date of a hearing seeking an interim suspension order, whichever is earlier. (b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue the owner a notice setting forth the acts or omissions with which the owner is charged, specifying the pertinent code section or sections. (c) The order shall provide that the owner, within 15 days of receipt of the notice, may request a hearing before the president of the board to contest the cease and desist order. Consideration of the owner's contest of the cease and desist order shall comply with the requirements of Section 11425.10 of the Government Code. The hearing shall be held no later than five days from the date the request of the owner is received by the board. The president shall render a written decision within five days of the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. Review of the decision of the president of the board may be sought by the owner or person in possession or control of the pharmacy pursuant to Section 1094.5 of the Code of Civil Procedure. (d) Failure to comply with a cease and desist order issued pursuant to this section shall be unprofessional conduct.  SEC. 10.   Section 4127.7 of the   Business and Professions Code   is amended to read:  4127.7.  On and after July 1, 2005, a   A  pharmacy shall compound sterile  injectable  products from one or more nonsterile ingredients in one of the following environments: (a) An ISO class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative to adjacent areas. (b) An ISO class 5 cleanroom. (c) A barrier isolator that provides an ISO class 5 environment for compounding.  SEC. 11.   Section 4127.8 of the   Business and Professions Code   is amended to read:  4127.8. The board may, at its discretion, issue a temporary license to compound 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,   products  upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (u) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested at the licenseholder's address of record with the board, whichever comes first. Neither for purposes of retaining a temporary license nor for purposes of any disciplinary or license denial proceeding before the board shall the temporary licenseholder be deemed to have a vested property right or interest in the license.  SEC. 12.   Section 4127.9 of the   Business and Professions Code   is amended to read:  4127.9. (a) A pharmacy licensed pursuant to Section 4127.1 or  4127.2, including a pharmacy that is exempt from licensure pursuant to subdivision (d) of Section 4127.1 and subdivision (c) of Section 4127.2,   4127.2  that issues a recall notice regarding a sterile compounded drug shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 12 hours of the recall notice if both of the following apply: (1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death. (2) The recalled drug was dispensed, or is intended for use, in this state. (b) A recall notice issued pursuant to subdivision (a) shall be made as follows: (1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient. (2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified. (3) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy, who shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified.  SEC. 13.   Section 4128.6 of the   Business and Professions Code   is amended to read:  4128.6. All compounding and packaging functions specified in Section 4128 shall be performed only in the licensed centralized hospital packaging pharmacy and that pharmacy shall comply with all applicable federal and state statutes and regulations, including, but not limited to, regulations regarding compounding and, when appropriate, sterile  injectable  compounding.  SEC. 5.   SEC. 14.  Article 7.7 (commencing with Section 4129) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read: Article 7.7. Outsourcing Facilities 4129. (a) A facility licensed as an outsourcing facility with the federal Food and Drug Administration (FDA) shall be concurrently licensed with the board as an outsourcing facility if it compounds sterile medication or nonsterile medication for nonpatient-specific distribution within or into California. (b) A facility premises licensed with the board as a sterile compounding pharmacy shall not be concurrently licensed with the board as an outsourcing facility at the same location. (c) The board may adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to establish policies, guidelines, and procedures to implement this article. (d) The board shall review any formal requirements or guidance documents developed by the FDA regarding outsourcing facilities within 90 days after their release in order to determine whether revisions are necessary for any regulations promulgated by the board. (e) An outsourcing facility licensed by the board shall not perform the duties of a pharmacy, such as filling individual prescriptions for individual patients. 4129.1. (a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) and with an address in this state shall also be licensed by the board as an outsourcing facility before doing business within this state. The license shall be renewed annually and is not transferable. (b) An outsourcing facility shall compound all sterile products and nonsterile products in compliance with regulations issued by the board and with federal current good manufacturing practices applicable to outsourcing facilities. (c) An outsourcing facility license shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and regulations adopted by the board. (d) An outsourcing facility license shall not be issued or renewed until the board does all of the following: (1) Prior to inspection, reviews a current copy of the outsourcing facility's policies and procedures for sterile compounding and nonsterile compounding. (2) Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the outsourcing facility's premises conducted in the prior 12 months. (3) Prior to inspection, receives a list of all sterile drugs and nonsterile drugs compounded by the outsourcing facility as reported to the FDA in the last 12 months. (e) An outsourcing facility licensed pursuant to this section shall provide the board with all of the following: (1) A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action. (2) Notice within 24 hours of any recall notice issued by the outsourcing facility. (3) A copy of any clinically related complaint it receives involving an outsourcing facility's compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt. (4) Notice within 24 hours after learning of adverse effects reported or potentially attributable to the outsourcing facility's products. 4129.2. (a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) as an outsourcing facility and has an address outside of this state but in the United States of America is a nonresident outsourcing facility. A nonresident outsourcing facility shall not compound sterile drug products or nonsterile drug products for distribution or use into this state without an outsourcing license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable. (b) A nonresident outsourcing facility shall compound all sterile products and nonsterile products to be distributed or used in this state in compliance with regulations of the board and with federal current good manufacturing practices applicable to outsourcing facilities. (c) A license for a nonresident outsourcing facility shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and any regulations adopted by the board. The nonresident outsourcing facility shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the nonresident outsourcing facility at least once annually pursuant to subdivision (x) of Section 4400. (d) A license for a nonresident outsourcing facility shall not be issued or renewed until the board: (1) Prior to inspection, reviews a current copy of the nonresident outsourcing facility's policies and procedures for sterile compounding and nonsterile compounding. (2)  (A)    Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the nonresident outsourcing facility's premises conducted in the prior 12 months.  (B) For purposes of this paragraph, "state" refers to the state in which the nonresident outsourcing facility resides.  (3) Prior to inspection, receives a list of all sterile drug products and nonsterile drug products compounded by the pharmacy as reported to the FDA within the prior 12 months. (e) A nonresident outsourcing facility licensed pursuant to this section shall provide the board with all of the following: (1) A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action. (2) Notice within 24 hours of any recall notice issued by the nonresident outsourcing facility. (3) A copy of any complaint it receives involving an outsourcing facility's compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt. (4) Notice within 24 hours after learning of adverse effects reported or potentially attributable to a nonresident outsourcing facility's products. 4129.3. (a) On or before January 1, 2018, the board shall provide a report to the Legislature regarding the regulation of nonresident outsourcing facilities. The report shall be submitted to the Legislature in the manner required pursuant to Section 9795 of the Government Code. At a minimum, the report shall address all of the following: (1) A detailed description of board activities related to the inspection and licensure of nonresident outsourcing facilities. (2) Whether fee revenue collected pursuant to subdivision (x) of Section 4400 and travel cost reimbursements collected pursuant to subdivision (c) of Section 4129.2 provide revenue in an amount sufficient to support the board's activities related to the inspection and licensure of nonresident outsourcing facilities. (3) The status of proposed changes to federal law that are under serious consideration and that would govern outsourcing facilities and compounding pharmacies, including, but not limited to, legislation pending before Congress, administrative rules, regulations or orders under consideration by the FDA or other appropriate federal agency, and cases pending before the courts. (4) If applicable, recommended modifications to the board's statutory duties related to nonresident outsourcing facilities as a result of changes to federal law or any additional modifications necessary to protect the health and safety of the public. (b) The requirement for submitting a report imposed under subdivision (a) is inoperative on January 1, 2022, pursuant to Section 10231.5 of the Government Code. 4129.4. (a) Whenever the board has a reasonable belief, based on information obtained during an inspection or investigation by the board, that an outsourcing facility compounding sterile drug products or nonsterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the outsourcing facility to immediately cease and desist compounding sterile drug products or nonsterile drug products. The cease and desist order shall remain in effect for no more than 30 days or the date of a hearing seeking an interim suspension order, whichever is earlier. (b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue a notice to the owner setting forth the acts or omissions with which the owner is charged, specifying the pertinent code section or sections and any regulations. (c) The cease and desist order shall state that the owner, within 15 days of receipt of the notice, may request a hearing before the president of the board to contest the cease and desist order. Consideration of the owner's contest of the cease and desist order shall comply with the requirements of Section 11425.10 of the Government Code. The hearing shall be held no later than five days after the date the request of the owner is received by the board. The president shall render a written decision within five days after the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. Review of the decision may be sought by the owner or person in possession or control of the outsourcing facility pursuant to Section 1094.5 of the Code of Civil Procedure. (d) Failure to comply with a cease and desist order issued pursuant to this section shall be unprofessional conduct. 4129.5. Notwithstanding any other law, a violation of this article, or regulation adopted pursuant thereto, may subject the person or entity that committed the violation to a fine of up to five thousand dollars ($5,000) per occurrence pursuant to a citation issued by the board. 4129.6. For purposes of this article, "sterile compounded products" means compounded preparations for injection, administration into the eye, or inhalation. 4129.8. The board, at its discretion, may issue a temporary license to an outsourcing facility when the ownership of the outsourcing facility is transferred from one person to another, upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required as specified in subdivision (w) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon the earlier of personal service of the notice of termination upon the licenseholder or service by certified mail with return receipt requested at the licenseholder's address of record with the board. The temporary licenseholder shall not be deemed to have a vested property right or interest in the license for purposes of retaining a temporary license or for purposes of any disciplinary or license denial proceeding before the board. 4129.9. (a) An outsourcing facility licensed pursuant to Section 4129.1 or 4129.2 that issues a recall notice for a sterile drug or nonsterile drug compounded by the outsourcing facility, in addition to any other duties, shall contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible within 24 hours of the recall notice if both of the following apply: (1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death. (2) The recalled drug was dispensed, or is intended for use, in this state. (b) A recall notice issued pursuant to subdivision (a) shall be made as follows: (1) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber and the prescriber shall ensure the patient is notified. (2) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy and that pharmacy shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified.  SEC. 15.   Section 4161 of the   Business and Professions Code   is amended to read:  4161. (a) A person located outside this state that (1) ships, sells, mails, warehouses, distributes, or delivers dangerous drugs or dangerous devices into this state or (2) sells, brokers, warehouses, or distributes dangerous drugs or devices within this state shall be considered a nonresident wholesaler or a nonresident third-party logistics provider. (b) A nonresident wholesaler or nonresident third-party logistics provider shall be licensed by the board prior to shipping, selling, mailing, warehousing, distributing, or delivering dangerous drugs or dangerous devices to a site located in this state or selling, brokering, warehousing, or distributing dangerous drugs or devices within this state. (c) (1) A separate license shall be required for each place of business owned or operated by a nonresident wholesaler or nonresident third-party logistics provider from or through which dangerous drugs or dangerous devices are shipped, sold, mailed, warehoused, distributed, or delivered to a site located in this state or sold, brokered, warehoused, or distributed within this state. Each place of business may only be issued a single license by the board, except as provided in paragraph (2). A license shall be renewed annually and shall not be transferable. (2) A nonresident wholesaler and a nonresident third-party logistics provider under common ownership may be licensed at the same place of business provided that all of the following requirements are satisfied: (A) The wholesaler and the third-party logistics provider each separately maintain the records required under Section 4081. (B) Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the third-party logistics provider. (C) Any individual acting as a designated representative for the wholesaler is not concurrently acting as a designated representative-3PL on behalf of the third-party logistics provider. Nothing in this subparagraph shall be construed to prohibit an individual from concurrently holding a license to act as a designated representative and to act as a designated representative-3PL. (D) The wholesaler has its own designated representative-in-charge responsible for the operations of the wholesaler and the third-party logistics provider has its own responsible manager responsible for the operations of the third-party logistics provider. The same individual shall not concurrently serve as the responsible manager and the designated representative-in-charge for a wholesaler and a third-party logistics provider licensed at the same place of business. (E) The third-party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber. (F) The third-party logistics provider is not a reverse third-party logistics provider. (G) The wholesaler is not acting as a reverse distributor. (d) The following information shall be reported, in writing, to the board at the time of initial application for licensure by a nonresident wholesaler or a nonresident third-party logistics provider, on renewal of a nonresident wholesaler or nonresident third-party logistics provider license, or within 30 days of a change in that information: (1) Its agent for service of process in this state. (2) Its principal corporate officers, as specified by the board, if any. (3) Its general partners, as specified by the board, if any. (4) Its owners if the applicant is not a corporation or partnership. (e) A report containing the information in subdivision (d) shall be made within 30 days of any change of ownership, office, corporate officer, or partner. (f) A nonresident wholesaler or nonresident third-party logistics provider shall comply with all directions and requests for information from the regulatory or licensing agency of the state in which it is licensed, as well as with all requests for information made by the board. (g) A nonresident wholesaler or nonresident third-party logistics provider shall maintain records of dangerous drugs and dangerous devices sold, traded, transferred, warehoused, or distributed to persons in this state or within this state, so that the records are in a readily retrievable form. (h) A nonresident wholesaler or nonresident third-party logistics provider shall at all times maintain a valid, unexpired license, permit, or registration to conduct the business of the wholesaler or nonresident third-party logistics provider in compliance with the laws of the state in which it is a resident. An application for a nonresident wholesaler or nonresident third-party logistics provider license in this state shall include a license verification from the licensing authority in the applicant's state of residence. (i) (1) The board shall not issue or renew a nonresident wholesaler license until the nonresident wholesaler identifies a designated representative-in-charge and notifies the board in writing of the identity and license number of the designated representative-in-charge. (2) The board shall not issue or renew a nonresident third-party logistics provider license until the nonresident third-party logistics provider identifies a responsible manager and notifies the board in writing of the identity and license number of the designated representative-3PL who will be the responsible manager. (j) The designated representative-in-charge shall be responsible for the compliance of the nonresident wholesaler with state and federal laws governing wholesalers. The responsible manager shall be responsible for the compliance of the nonresident third-party logistics provider's place of business with state and federal laws governing third-party logistics providers. A nonresident wholesaler or nonresident third-party logistics provider shall identify and notify the board of a new designated representative-in-charge or responsible manager within 30 days of the date that the prior designated representative-in-charge or responsible manager ceases to be the designated representative-in-charge or responsible manager. (k) The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be five hundred fifty dollars ($550) or another amount established by the board not to exceed the annual fee for renewal of a license to compound  injectable  sterile drug products. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines that a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested, at the licenseholder's address of record with the board, whichever occurs first. Neither for purposes of retaining a temporary license, nor for purposes of any disciplinary or license denial proceeding before the board, shall the temporary licenseholder be deemed to have a vested property right or interest in the license. (  l  ) The registration fee shall be the fee specified in subdivision (f) of Section 4400.  SEC. 16.   Section 4180 of the   Business and Professions Code   is amended to read:  4180. (a) (1) Notwithstanding any provision of this chapter, any of the following clinics may purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic: (A) A licensed nonprofit community clinic or free clinic as defined in paragraph (1) of subdivision (a) of Section 1204 of the Health and Safety Code. (B) A primary care clinic owned or operated by a county as referred to in subdivision (b) of Section 1206 of the Health and Safety Code. (C) A clinic operated by a federally recognized Indian tribe or tribal organization as referred to in subdivision (c) of Section 1206 of the Health and Safety Code. (D) A clinic operated by a primary care community or free clinic, operated on separate premises from a licensed clinic, and that is open no more than 20 hours per week as referred to in subdivision (h) of Section 1206 of the Health and Safety Code. (E) A student health center clinic operated by a public institution of higher education as referred to in subdivision (j) of Section 1206 of the Health and Safety Code. (F) A nonprofit multispecialty clinic as referred to in subdivision (  l  ) of Section 1206 of the Health and Safety Code. (2) The clinic shall keep records of the kind and amounts of drugs purchased, administered, and dispensed, and the records shall be available and maintained for a minimum of three years for inspection by all properly authorized personnel. (b) No clinic shall be entitled to the benefits of this section until it has obtained a license from the board. A separate license shall be required for each clinic location. A clinic shall notify the board of any change in the clinic's address on a form furnished by the board.  (c) The board shall synchronize license renewal dates and aggregate fees for multiple clinics under common nonprofit ownership at the request of the parent organization.   SEC. 6.   SEC. 17.  Section 4203.5 is added to the Business and Professions Code, to read: 4203.5. (a) Notwithstanding any other law, when a clinic applicant submits either type of application described in subdivision (b), the board shall issue a license or incorporate the reported changes, as appropriate, within 30 days of receipt of a completed application and payment of any prescribed fees. (b) This section applies to the following types of applications: (1) A new clinic license application filed under Section 4180. (2) Applications to report changes to an existing site licensed under Section 4180, including, but not limited to, changes in professional director, clinic administrator, corporate officers, change of location, or change of address. (c) This section shall not be construed to limit the board's authority to conduct an investigation to determine whether applicants and the premises for which an application is made qualify for a license.  SEC. 7.   SEC. 18.  Section 4316 is added to the Business and Professions Code, to read: 4316. (a) The board is authorized to issue a cease and desist order for operating any facility under this chapter that requires licensure or for practicing any activity under this chapter that requires licensure. (b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue the facility a notice setting forth the acts or omissions with which it is charged, specifying the pertinent code section or sections and any regulations. (c) The order shall provide that the facility, within 15 days of receipt of the notice, may request a hearing before the president of the board to contest the cease and desist order. Consideration of the facility's contest of the cease and desist order shall comply with the requirements of Section 11425.10 of the Government Code. The hearing shall be held no later than five days from the date the request of the owner is received by the board. The president shall render a written decision within five days of the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. Review of the decision of the president of the board may be sought by the owner or person in possession or control of the pharmacy pursuant to Section 1094.5 of the Code of Civil Procedure.  SEC. 8.  SEC. 19.  Section 4400 of the Business and Professions Code is amended to read: 4400. The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule: (a) The fee for a nongovernmental pharmacy license shall be four hundred dollars ($400) and may be increased to five hundred twenty dollars ($520). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325). (b) The fee for a nongovernmental pharmacy license annual renewal shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325). (c) The fee for the pharmacist application and examination shall be two hundred dollars ($200) and may be increased to two hundred sixty dollars ($260). (d) The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded. (e) The fee for a pharmacist license and biennial renewal shall be one hundred fifty dollars ($150) and may be increased to one hundred ninety-five dollars ($195). (f) The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be decreased to no less than six hundred dollars ($600). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550). (g) The fee for a hypodermic license and renewal shall be one hundred twenty-five dollars ($125) and may be increased to one hundred sixty-five dollars ($165). (h) (1) The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, or as a designated representative-3PL pursuant to Section 4053.1, shall be three hundred thirty dollars ($330) and may be decreased to no less than two hundred fifty-five dollars ($255). (2) The fee for the annual renewal of a license as a designated representative or designated representative-3PL shall be one hundred ninety-five dollars ($195) and may be decreased to no less than one hundred fifty dollars ($150). (i) (1) The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be three hundred thirty dollars ($330) and may be decreased to no less than two hundred fifty-five dollars ($255). (2) The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be one hundred ninety-five dollars ($195) and may be decreased to no less than one hundred fifty dollars ($150). (j) (1) The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be decreased to no less than six hundred dollars ($600). (2) For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be decreased to no less than six hundred dollars ($600). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550). (3) The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be decreased to no less than six hundred dollars ($600). (k) The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour. (  l  ) The fee for an intern pharmacist license shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30). (m) The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date. (n) The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45). (o) The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130). (p) It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one year' s operating expenditures. (q) The fee for any applicant for a nongovernmental clinic license shall be four hundred dollars ($400) and may be increased to five hundred twenty dollars ($520) for each license. The annual fee for renewal of the license shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325) for each license. (r) The fee for the issuance of a pharmacy technician license shall be eighty dollars ($80) and may be increased to one hundred five dollars ($105). The fee for renewal of a pharmacy technician license shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130). (s) The fee for a veterinary food-animal drug retailer license shall be four hundred five dollars ($405) and may be increased to four hundred twenty-five dollars ($425). The annual renewal fee for a veterinary food-animal drug retailer license shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325). (t) The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45). (u) The fee for issuance or renewal of a nongovernmental sterile compounding pharmacy license shall be six hundred dollars ($600) and may be increased to seven hundred eighty dollars ($780). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). (v) The fee for the issuance or renewal of a nonresident sterile compounding pharmacy license shall be seven hundred eighty dollars ($780). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the board's estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant. (w) The fee for the issuance or renewal of an outsourcing facility license shall be seven hundred eighty dollars ($780). The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715). (x) The fee for the issuance or renewal of a nonresident outsourcing facility license shall be seven hundred eighty dollars ($780). In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the board's estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.  SEC. 20.   Section 4406 of the   Business and Professions Code   is amended to read:  4406. All fees collected on behalf of the board and all receipts of every kind and nature shall be reported each month for the month preceding to the State Controller and at the same time the entire amount shall be paid into the State Treasury and shall be credited to the Pharmacy Board Contingent Fund which is hereby created. This contingent fund shall be  available, upon appropriation of the Legislature,  for the use of the  board and out of it and not otherwise shall be paid all expenses of the  board.  SEC. 9.   SEC. 21.  Section 13401.5 of the Corporations Code is amended to read: 13401.5. Notwithstanding subdivision (d) of Section 13401 and any other provision of law, the following licensed persons may be shareholders, officers, directors, or professional employees of the professional corporations designated in this section so long as the sum of all shares owned by those licensed persons does not exceed 49 percent of the total number of shares of the professional corporation so designated herein, and so long as the number of those licensed persons owning shares in the professional corporation so designated herein does not exceed the number of persons licensed by the governmental agency regulating the designated professional corporation. This section does not limit employment by a professional corporation designated in this section to only those licensed professionals listed under each subdivision. Any person duly licensed under Division 2 (commencing with Section 500) of the Business and Professions Code, the Chiropractic Act, or the Osteopathic Act may be employed to render professional services by a professional corporation designated in this section. (a) Medical corporation. (1) Licensed doctors of podiatric medicine. (2) Licensed psychologists. (3) Registered nurses. (4) Licensed optometrists. (5) Licensed marriage and family therapists. (6) Licensed clinical social workers. (7) Licensed physician assistants. (8) Licensed chiropractors. (9) Licensed acupuncturists. (10) Naturopathic doctors. (11) Licensed professional clinical counselors. (12) Licensed physical therapists. (13) Licensed pharmacists. (b) Podiatric medical corporation. (1) Licensed physicians and surgeons. (2) Licensed psychologists. (3) Registered nurses. (4) Licensed optometrists. (5) Licensed chiropractors. (6) Licensed acupuncturists. (7) Naturopathic doctors. (8) Licensed physical therapists. (c) Psychological corporation. (1) Licensed physicians and surgeons. (2) Licensed doctors of podiatric medicine. (3) Registered nurses. (4) Licensed optometrists. (5) Licensed marriage and family therapists. (6) Licensed clinical social workers. (7) Licensed chiropractors. (8) Licensed acupuncturists. (9) Naturopathic doctors. (10) Licensed professional clinical counselors. (d) Speech-language pathology corporation. (1) Licensed audiologists. (e) Audiology corporation. (1) Licensed speech-language pathologists. (f) Nursing corporation. (1) Licensed physicians and surgeons. (2) Licensed doctors of podiatric medicine. (3) Licensed psychologists. (4) Licensed optometrists. (5) Licensed marriage and family therapists. (6) Licensed clinical social workers. (7) Licensed physician assistants. (8) Licensed chiropractors. (9) Licensed acupuncturists. (10) Naturopathic doctors. (11) Licensed professional clinical counselors. (g) Marriage and family therapist corporation. (1) Licensed physicians and surgeons. (2) Licensed psychologists. (3) Licensed clinical social workers. (4) Registered nurses. (5) Licensed chiropractors. (6) Licensed acupuncturists. (7) Naturopathic doctors. (8) Licensed professional clinical counselors. (h) Licensed clinical social worker corporation. (1) Licensed physicians and surgeons. (2) Licensed psychologists. (3) Licensed marriage and family therapists. (4) Registered nurses. (5) Licensed chiropractors. (6) Licensed acupuncturists. (7) Naturopathic doctors. (8) Licensed professional clinical counselors. (i) Physician assistants corporation. (1) Licensed physicians and surgeons. (2) Registered nurses. (3) Licensed acupuncturists. (4) Naturopathic doctors. (j) Optometric corporation. (1) Licensed physicians and surgeons. (2) Licensed doctors of podiatric medicine. (3) Licensed psychologists. (4) Registered nurses. (5) Licensed chiropractors. (6) Licensed acupuncturists. (7) Naturopathic doctors. (k) Chiropractic corporation. (1) Licensed physicians and surgeons. (2) Licensed doctors of podiatric medicine. (3) Licensed psychologists. (4) Registered nurses. (5) Licensed optometrists. (6) Licensed marriage and family therapists. (7) Licensed clinical social workers. (8) Licensed acupuncturists. (9) Naturopathic doctors. (10) Licensed professional clinical counselors. (  l  ) Acupuncture corporation. (1) Licensed physicians and surgeons. (2) Licensed doctors of podiatric medicine. (3) Licensed psychologists. (4) Registered nurses. (5) Licensed optometrists. (6) Licensed marriage and family therapists. (7) Licensed clinical social workers. (8) Licensed physician assistants. (9) Licensed chiropractors. (10) Naturopathic doctors. (11) Licensed professional clinical counselors. (m) Naturopathic doctor corporation. (1) Licensed physicians and surgeons. (2) Licensed psychologists. (3) Registered nurses. (4) Licensed physician assistants. (5) Licensed chiropractors. (6) Licensed acupuncturists. (7) Licensed physical therapists. (8) Licensed doctors of podiatric medicine. (9) Licensed marriage and family therapists. (10) Licensed clinical social workers. (11) Licensed optometrists. (12) Licensed professional clinical counselors. (n) Dental corporation. (1) Licensed physicians and surgeons. (2) Dental assistants. (3) Registered dental assistants. (4) Registered dental assistants in extended functions. (5) Registered dental hygienists. (6) Registered dental hygienists in extended functions. (7) Registered dental hygienists in alternative practice. (o) Professional clinical counselor corporation. (1) Licensed physicians and surgeons. (2) Licensed psychologists. (3) Licensed clinical social workers. (4) Licensed marriage and family therapists. (5) Registered nurses. (6) Licensed chiropractors. (7) Licensed acupuncturists. (8) Naturopathic doctors. (p) Physical therapy corporation. (1) Licensed physicians and surgeons. (2) Licensed doctors of podiatric medicine. (3) Licensed acupuncturists. (4) Naturopathic doctors. (5) Licensed occupational therapists. (6) Licensed speech-language therapists. (7) Licensed audiologists. (8) Registered nurses. (9) Licensed psychologists. (10) Licensed physician assistants. (q) Registered dental hygienist in alternative practice corporation. (1) Registered dental assistants. (2) Licensed dentists. (3) Registered dental hygienists. (4) Registered dental hygienists in extended functions.  SEC. 22.   Section 1261.6 of the   Health and Safety Code   is amended to read: 1261.6. (a) (1) For purposes of this section and Section 1261.5, an "automated drug delivery system" means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An automated drug delivery system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) For purposes of this section, "facility" means a health facility licensed pursuant to subdivision (c), (d), or (k), of Section 1250 that has an automated drug delivery system provided by a pharmacy. (3) For purposes of this section, "pharmacy services" means the provision of both routine and emergency drugs and biologicals to meet the needs of the patient, as prescribed by a physician. (b) Transaction information shall be made readily available in a written format for review and inspection by individuals authorized by law. These records shall be maintained in the facility for a minimum of three years. (c) Individualized and specific access to automated drug delivery systems shall be limited to facility and contract personnel authorized by law to administer drugs. (d) (1) The facility and the pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs. (2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used. (e) When used as an emergency pharmaceutical supplies container, drugs removed from the automated drug delivery system shall be limited to the following: (1) A new drug order given by a prescriber for a patient of the facility for administration prior to the next scheduled delivery from the pharmacy, or 72 hours, whichever is less. The drugs shall be retrieved only upon authorization by a pharmacist and after the pharmacist has reviewed the prescriber's order and the patient's profile for potential contraindications and adverse drug reactions. (2) Drugs that a prescriber has ordered for a patient on an as-needed basis, if the utilization and retrieval of those drugs are subject to ongoing review by a pharmacist. (3) Drugs designed by the patient care policy committee or pharmaceutical service committee of the facility as emergency drugs or acute onset drugs. These drugs may be retrieved from an automated drug delivery system pursuant to the order of a prescriber for emergency or immediate administration to a patient of the facility. Within 48 hours after retrieval under this paragraph, the case shall be reviewed by a pharmacist. (f) When used to provide pharmacy services pursuant to Section 4119.1 of the Business and Professions Code, the automated drug delivery system shall be subject to all of the following requirements: (1) Drugs removed from the automated drug delivery system for administration to a patient shall be in properly labeled units of administration containers or packages. (2) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for administration to a patient. The pharmacist shall review the prescriber's order and the patient's profile for potential contraindications and adverse drug reactions. (3) The pharmacy providing services to the facility pursuant to Section 4119.1 of the Business and Professions Code shall control access to the drugs stored in the automated drug delivery system. (4) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. (5) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system. (6) After the pharmacist reviews the prescriber's order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient. When the prescriber' s order requires a dosage variation of the same drug, licensed personnel shall have access to the drug ordered for that scheduled time of administration. (7) (A) Systems that allow licensed personnel to have access to multiple drugs and are not patient specific in their design, shall be allowed under this subdivision if those systems have electronic and mechanical safeguards in place to ensure that the drugs delivered to the patient are specific to that patient. Each facility using such an automated drug system shall notify the department in writing prior to the utilization of the system. The notification submitted to the department pursuant to this paragraph shall include, but is not limited to, information regarding system design, personnel with system access, and policies and procedures covering staff training, storage, and security, and the facility's administration of these types of systems. (B) As part of its routine oversight of these facilities, the department shall review a facility's medication training, storage, and security, and its administration procedures related to its use of an automated drug delivery system to ensure that adequate staff training and safeguards are in place to make sure that the drugs delivered are appropriate for the patient. If the department determines that a facility is not in compliance with this section, the department may revoke its authorization to use automated drug delivery systems granted under subparagraph (A).  (C) This paragraph shall remain in effect only until January 1, 2012, unless a later enacted statute is enacted on or before January 1, 2012, deletes or extends that date.  (g) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, or similar technology, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met: (1) The task of placing drugs into the removable pockets, cards, or drawers is performed by a pharmacist or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist. (2) The removable pockets, cards, or drawers are transported between the pharmacy and the facility in a secure tamper-evident container. (3) The facility, in conjunction with the pharmacy, has developed policies and procedures to ensure that the pockets, cards, or drawers are properly placed into the automated drug delivery system. (h) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system. (i) Drugs dispensed from an automated drug delivery system that meets the requirements of this section shall not be subject to the labeling requirements of Section 4076 of the Business and Professions Code or Section 111480 of this code if the drugs to be placed into the automated drug delivery system are in unit dose packaging or unit of use and if the information required by Section 4076 of the Business and Professions Code and Section 111480 of this code is readily available at the time of drug administration. For purposes of this section, unit dose packaging includes blister pack cards.  SEC. 23.   Section 11164.5 of the   Health and Safety Code   is amended to read:   11164.5. (a) Notwithstanding Section 11164, with the approval of the California State Board of Pharmacy and the Department of Justice, a pharmacy or hospital may receive electronic data transmission prescriptions or computer entry prescriptions or orders as specified in Section 4071.1 of the Business and Professions Code, for controlled substances in Schedule II, III, IV, or V if authorized by federal law and in accordance with regulations promulgated by the Drug Enforcement Administration. The California State Board of Pharmacy shall maintain a list of all requests and approvals granted pursuant to this subdivision. (b) Notwithstanding Section 11164, if approved pursuant to subdivision (a), a pharmacy or hospital receiving an electronic transmission prescription or a computer entry prescription or order for a controlled substance classified in Schedule II, III, IV, or V shall not be required to reduce that prescription or order to writing or to hard copy form, if for three years from the last day of dispensing that prescription, the pharmacy or hospital is able, upon request of the board or the Department of Justice, to immediately produce a hard copy report that includes for each date of dispensing of a controlled substance in Schedules II, III, IV, and V pursuant to the prescription all of the information described in subparagraphs (A) to (E), inclusive, of paragraph (1) of subdivision (a) of Section 4040 of the Business and Professions Code and the name or identifier of the pharmacist who dispensed the controlled substance. (c)   11164.5.   (a)  Notwithstanding Section 11164, if only recorded and stored electronically, on magnetic media, or in any other computerized form, the pharmacy's or hospital's computer system shall not permit the received information or the controlled substance dispensing information required by this section to be changed, obliterated, destroyed, or disposed of, for the record maintenance period required by law, once the information has been received by the pharmacy or the hospital and once the controlled substance has been dispensed, respectively. Once the controlled substance has been dispensed, if the previously created record is determined to be incorrect, a correcting addition may be made only by or with the approval of a pharmacist. After a pharmacist enters the change or enters his or her approval of the change into the computer, the resulting record shall include the correcting addition and the date it was made to the record, the identity of the person or pharmacist making the correction, and the identity of the pharmacist approving the correction.  (d)   (b)  Nothing in this section shall be construed to exempt any pharmacy or hospital dispensing Schedule II controlled substances pursuant to electronic transmission prescriptions from existing reporting requirements.  SEC. 10.   SEC. 24.  No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.