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SB-1447 Pharmacy: automated drug delivery systems.(2017-2018)

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Date Published: 09/24/2018 02:00 PM
SB1447:v92#DOCUMENT

Senate Bill No. 1447
CHAPTER 666

An act to amend Section 4400 of, to amend and repeal Sections 4105.5 and 4119.1 of, to amend, repeal, and add Sections 4008 and 4186 of, to add Section 4017.3 to, and to add Article 25 (commencing with Section 4427) to Chapter 9 of Division 2 of, the Business and Professions Code, and to amend, repeal, and add Section 1261.6 of the Health and Safety Code, relating to healing arts.

[ Approved by Governor  September 21, 2018. Filed with Secretary of State  September 21, 2018. ]

LEGISLATIVE COUNSEL'S DIGEST


SB 1447, Hernandez. Pharmacy: automated drug delivery systems.
Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy, within the Department of Consumer Affairs, to license and regulate the practice of pharmacy. Existing law makes any violation of the Pharmacy Law punishable as a crime.
Existing law generally requires a pharmacy that owns or provides dangerous drugs or dangerous devices dispensed through an automated drug delivery system (ADDS) to register the system, as provided, and authorizes the pharmacy to use the ADDS only if certain conditions are satisfied. Existing law authorizes the board to prohibit a pharmacy from using an ADDS if the board determines that those conditions are not satisfied. Existing law exempts from these requirements an ADDS operated by a licensed hospital pharmacy for doses administered in a facility operated under a consolidated license. Existing law specifies additional conditions for an ADDS located in a licensed clinic, a correctional clinic, or a health facility, as defined. Existing law authorizes a pharmacy or licensed wholesaler that is also an emergency medical services provider agency to restock dangerous drugs or dangerous devices into an emergency medical services automated drug delivery system that is licensed by the board, as provided. Existing law authorizes an inspector employed by the board to enter specified locations to inspect those locations for compliance with the Pharmacy Law.
This bill, beginning on July 1, 2019, would repeal the general ADDS provisions and the additional conditions for an ADDS located in a health facility. The bill instead would require an ADDS, as defined, to meet specified requirements in order to be installed, leased, owned, or operated in the state, including a license for the ADDS issued by the board to the holder of a current, valid, and active pharmacy license of a pharmacy located and licensed in the state. The bill would limit the placement and operation of an ADDS to specified locations, including the licensed pharmacy holding that ADDS license, a licensed health facility, a licensed clinic, or a specified medical office if the ADDS is an automated patient dispensing system (APDS), as defined. The bill would require the pharmacy holding the ADDS license to own or lease the ADDS and the drugs and devices located within it, as provided, and would require that pharmacy to supervise the operation of the ADDS. The bill would prescribe specified stocking and transfer requirements for those drugs and devices. The bill would require the pharmacy holding the ADDS license to provide training on the operation and use of that ADDS to specified individuals and would require the pharmacy to complete periodic self-assessments. The bill would also authorize a pharmacy inspector employed by the board to enter the location, or proposed location, of an ADDS to inspect the ADDS or the location pursuant to these provisions. This bill would require additional conditions for an APDS. The bill would exempt an automated unit dose system (AUDS) from licensure under these provisions if the AUDS is operated by a licensed hospital pharmacy and used to provide doses to specified patients, but would require the AUDS to comply with all other ADDS requirements described above.
This bill would require, on or before January 1, 2024, the board to report to the appropriate policy committees of the Legislature on the regulation of ADDS units, as provided. Because a violation of the Pharmacy Law is punishable as a crime, the bill would expand the scope of an existing crime, thereby imposing 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: NO   Fiscal Committee: YES   Local Program: YES  

The people of the State of California do enact as follows:


SECTION 1.

 Section 4008 of the Business and Professions Code is amended to read:

4008.
 (a) Except as provided by Section 159.5, the board may employ legal counsel and inspectors of pharmacy. The inspectors, whether the inspectors are employed by the board or the department’s Division of Investigation, may inspect during business hours all pharmacies, wholesalers, dispensaries, stores, or places where drugs or devices are compounded, prepared, furnished, dispensed, or stored.
(b) Notwithstanding subdivision (a), a pharmacy inspector may inspect or examine a physician’s office or clinic that does not have a permit under Section 4180 or 4190 only to the extent necessary to determine compliance with and to enforce either Section 4080 or 4081.
(c) (1) (A) A pharmacy inspector employed by the board or in the department’s Division of Investigation shall have the authority, as a public officer, to arrest, without warrant, any person whenever the officer has reasonable cause to believe that the person to be arrested has, in his or her presence, violated a provision of this chapter or of Division 10 (commencing with Section 11000) of the Health and Safety Code.
(B) If the violation is a felony, or if the arresting officer has reasonable cause to believe that the person to be arrested has violated any provision that is declared to be a felony, although no felony has in fact been committed, he or she may make an arrest although the violation or suspected violation did not occur in his or her presence.
(2) In any case in which an arrest authorized by this subdivision is made for an offense declared to be a misdemeanor, and the person arrested does not demand to be taken before a magistrate, the arresting inspector may, instead of taking the person before a magistrate, follow the procedure prescribed by Chapter 5C (commencing with Section 853.5) of Title 3 of Part 2 of the Penal Code. That chapter shall thereafter apply with reference to any proceeding based upon the issuance of a citation pursuant to this authority.
(d) There shall be no civil liability on the part of, and no cause of action shall arise against, a person, acting pursuant to subdivision (a) within the scope of his or her authority, for false arrest or false imprisonment arising out of an arrest that is lawful, or that the arresting officer, at the time of the arrest, had reasonable cause to believe was lawful. An inspector shall not be deemed an aggressor or lose his or her right to self-defense by the use of reasonable force to effect the arrest, to prevent escape, or to overcome resistance.
(e) Any inspector may serve all processes and notices throughout the state.
(f) A pharmacy inspector employed by the board may enter a facility licensed pursuant to subdivision (c) or (d) of Section 1250 of the Health and Safety Code to inspect an automated drug delivery system operated pursuant to Section 4119 or 4119.1.
(g) This section shall become inoperative on July 1, 2019, and, as of January 1, 2020, is repealed.

SEC. 2.

 Section 4008 is added to the Business and Professions Code, to read:

4008.
 (a) Except as provided by Section 159.5, the board may employ legal counsel and inspectors of pharmacy. The inspectors, whether the inspectors are employed by the board or the department’s Division of Investigation, may inspect during business hours all pharmacies, wholesalers, dispensaries, stores, or places where drugs or devices are compounded, prepared, furnished, dispensed, or stored.
(b) Notwithstanding subdivision (a), a pharmacy inspector may inspect or examine a physician’s office or clinic that does not have a permit under Section 4180 or 4190 only to the extent necessary to determine compliance with and to enforce either Section 4080 or 4081.
(c) (1) (A) A pharmacy inspector employed by the board or in the department’s Division of Investigation shall have the authority, as a public officer, to arrest, without warrant, any person whenever the officer has reasonable cause to believe that the person to be arrested has, in his or her presence, violated a provision of this chapter or of Division 10 (commencing with Section 11000) of the Health and Safety Code.
(B) If the violation is a felony, or if the arresting officer has reasonable cause to believe that the person to be arrested has violated any provision that is declared to be a felony, although no felony has in fact been committed, he or she may make an arrest although the violation or suspected violation did not occur in his or her presence.
(2) In any case in which an arrest authorized by this subdivision is made for an offense declared to be a misdemeanor, and the person arrested does not demand to be taken before a magistrate, the arresting inspector may, instead of taking the person before a magistrate, follow the procedure prescribed by Chapter 5C (commencing with Section 853.5) of Title 3 of Part 2 of the Penal Code. That chapter shall thereafter apply with reference to any proceeding based upon the issuance of a citation pursuant to this authority.
(d) There shall be no civil liability on the part of, and no cause of action shall arise against, a person, acting pursuant to subdivision (a) within the scope of his or her authority, for false arrest or false imprisonment arising out of an arrest that is lawful, or that the arresting officer, at the time of the arrest, had reasonable cause to believe was lawful. An inspector shall not be deemed an aggressor or lose his or her right to self-defense by the use of reasonable force to effect the arrest, to prevent escape, or to overcome resistance.
(e) Any inspector may serve all processes and notices throughout the state.
(f) A pharmacy inspector employed by the board may enter a facility licensed pursuant to subdivision (c) or (d) of Section 1250 of the Health and Safety Code to inspect an automated drug delivery system operated pursuant to Section 4119.
(g) A pharmacy inspector employed by the board may enter the location, or proposed location, of an automated drug delivery system to inspect that automated drug delivery system or proposed location pursuant to Article 25 (commencing with Section 4427).
(h) This section shall become operative on July 1, 2019.

SEC. 3.

 Section 4017.3 is added to the Business and Professions Code, to read:

4017.3.
 (a) An “automated drug delivery system” (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS 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.
(b) An “automated unit dose system” (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions.
(c) An “automated patient dispensing system” (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist.
(d) This section shall become operative on July 1, 2019.

SEC. 4.

 Section 4105.5 of the Business and Professions Code is amended to read:

4105.5.
 (a) For purposes of this section, an “automated drug delivery system” has the same meaning as that term is defined in paragraph (1) of subdivision (a) of Section 1261.6 of the Health and Safety Code.
(b) Except as provided by subdivision (e), a pharmacy that owns or provides dangerous drugs dispensed through an automated drug delivery system shall register the automated drug delivery system by providing the board in writing with the location of each device within 30 days of installation of the device, and on an annual basis as part of the license renewal pursuant to subdivision (a) of Section 4110. The pharmacy shall also advise the board in writing within 30 days if the pharmacy discontinues operating an automated drug delivery system.
(c) A pharmacy may only use an automated drug delivery system if all of the following conditions are satisfied:
(1) Use of the automated drug delivery system is consistent with legal requirements.
(2) The pharmacy’s policies and procedures related to the automated drug delivery system to include appropriate security measures and monitoring of the inventory to prevent theft and diversion.
(3) The pharmacy reports drug losses from the automated drug delivery system to the board as required by law.
(4) The pharmacy license is unexpired and not subject to disciplinary conditions.
(d) The board may prohibit a pharmacy from using an automated drug delivery system if the board determines that the conditions provided in subdivision (c) are not satisfied. If such a determination is made, the board shall provide the pharmacy with written notice including the basis for the determination. The pharmacy may request an office conference to appeal the board’s decision within 30 days of receipt of the written notice. The executive officer or designee may affirm or overturn the prohibition as a result of the office conference.
(e) An automated drug delivery system operated by a licensed hospital pharmacy as defined in Section 4029 for doses administered in a facility operated under a consolidated license under Section 1250.8 of the Health and Safety Code shall be exempt from the requirements of subdivision (b).
(f) This section shall become inoperative on July 1, 2019, and, as of January 1, 2020, is repealed.

SEC. 5.

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

4119.1.
 (a) A pharmacy may provide pharmacy services to a health facility licensed pursuant to subdivision (c), (d), or both, of Section 1250 of the Health and Safety Code, through the use of an automated drug delivery system that need not be located at the same location as the pharmacy.
(b) Drugs stored in an automated drug delivery system shall be part of the inventory of the pharmacy providing pharmacy services to that facility, and drugs dispensed from the pharmacy system shall be considered to have been dispensed by that pharmacy.
(c) (1) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs and dangerous devices stored in the automated drug delivery system separate from other pharmacy records.
(2) The pharmacy shall own and operate the automated drug delivery system.
(3) The pharmacy shall provide training regarding the operation and use of the automated drug delivery system to both pharmacy and health facility personnel using the system.
(4) The pharmacy shall operate the automated drug delivery system in compliance with Section 1261.6 of the Health and Safety Code.
(d) The operation of the automated drug delivery system shall be under the supervision of a licensed pharmacist. To qualify as a supervisor for an automated drug delivery system, the pharmacist need not be physically present at the site of the automated drug delivery system and may supervise the system electronically.
(e) This section shall not be construed to revise or limit the use of automated drug delivery systems as permitted by the board in any licensed health facility other than a facility defined in subdivision (c) or (d), or both, of Section 1250 of the Health and Safety Code.
(f) This section shall become inoperative on July 1, 2019, and, as of January 1, 2020, is repealed.

SEC. 6.

 Section 4186 of the Business and Professions Code is amended to read:

4186.
 (a) Automated drug delivery systems, as defined in subdivision (h), may be located in any clinic licensed by the board pursuant to Section 4180. If an automated drug delivery system is located in a clinic, the clinic 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 drugs. All policies and procedures shall be maintained at the location where the automated drug system is being used.
(b) Drugs shall be removed from the automated drug delivery system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patient’s profile for potential contraindications and adverse drug reactions. Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.
(c) The stocking of an automated drug delivery system shall be performed by a pharmacist.
(d) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be the responsibility of the clinic. 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.
(e) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
(f) The pharmacist operating the automated drug delivery system shall be located in California.
(g) Drugs dispensed from the automated drug delivery system shall comply with the labeling requirements in Section 4076.
(h) For purposes of this section, an “automated drug delivery system” means a mechanical system controlled remotely by a pharmacist that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of prepackaged dangerous drugs or dangerous devices. 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.
(i) This section shall become inoperative on July 1, 2019, and, as of January 1, 2020, is repealed.

SEC. 7.

 Section 4186 is added to the Business and Professions Code, to read:

4186.
 (a) Automated drug delivery systems, as defined in Section 4017.3, may be located in any clinic licensed by the board pursuant to Section 4180. If an automated drug delivery system is located in a clinic, the clinic 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 drugs. All policies and procedures shall be maintained at the location where the automated drug system is being used.
(b) Drugs shall be removed from the automated drug delivery system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patient’s profile for potential contraindications and adverse drug reactions. Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.
(c) The stocking of an automated drug delivery system shall be performed by a pharmacist.
(d) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be the responsibility of the clinic. 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.
(e) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
(f) The pharmacist operating the automated drug delivery system shall be located in California.
(g) Drugs dispensed from the automated drug delivery system shall comply with the labeling requirements in Section 4076 and with Section 1707.5 of Title 16 of the California Code of Regulations.
(h) This section shall become operative on July 1, 2019.

SEC. 8.

 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 five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). 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 six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c) The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(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 shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(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 increased to eight hundred twenty dollars ($820). 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 shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h) (1) The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2) The fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(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 one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2) The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(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 increased to eight hundred twenty dollars ($820).
(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 increased to eight hundred twenty dollars ($820). 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 increased to eight hundred twenty dollars ($820).
(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 one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). 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 five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r) The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s) The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(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 of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v) The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). 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 of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x) The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. 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.
(y) The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z) The fee for the issuance of a license to a correctional clinic pursuant to Article 13.5 (commencing with Section 4187) that is not owned by the state shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The annual renewal fee for that correctional clinic license shall be three hundred twenty-five dollars ($325) and may be increased to three hundred sixty dollars ($360).
(aa) Beginning on and after July 1, 2019, the fee for an ADDS license shall be two hundred dollars ($200) and may be increased to two hundred fifty dollars ($250). The fee for the annual renewal of the license shall be two hundred dollars ($200) and may be increased to two hundred fifty dollars ($250).

SEC. 9.

 Article 25 (commencing with Section 4427) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:
Article  25. Automated Drug Delivery System

4427.
 As used in this article, “drugs” or “dangerous drugs” shall have the same meaning as “dangerous drug” as provided in Section 4022 and “devices” or “dangerous devices” shall have the same meaning as “dangerous device” as provided in Section 4022.

4427.1.
 An ADDS shall not be installed or operated in California unless it meets the requirements of this article.

4427.2.
 (a) An ADDS installed, leased, owned, or operated in California shall be licensed by the board.
(b) An ADDS license shall only be issued to the holder of a current, valid, and active pharmacy license of a pharmacy located and licensed in California.
(c) A separate application and license shall be required for each ADDS.
(d) An ADDS license shall only be issued when the following conditions are met:
(1) Use of the ADDS is consistent with legal requirements.
(2) The proposed location for installation of the ADDS meets the requirements of Section 4427.3 and the ADDS is secure from access and removal by unauthorized individuals.
(3) The pharmacy’s policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.
(4) The pharmacy’s policies and procedures include provisions for reporting to the board drug losses from the ADDS inventory, as required by law.
(e) Prior to issuance of the license, the board shall conduct a prelicensure inspection, within 30 days of a completed application for an ADDS license, at the proposed location of the ADDS. Relocation of the ADDS shall require a new application for licensure. Replacement of an ADDS shall require notification to the board within 30 days.
(f) The ADDS license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an ADDS license may be submitted to the board.
(g) The holder of an ADDS license shall advise the board in writing within 30 days if use of the ADDS is discontinued.
(h) The ADDS license shall be renewed annually, and the renewal date shall be the same as the underlying pharmacy license.
(i) An AUDS operated by a licensed hospital pharmacy, as defined in Section 4029, and used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility, as defined in subdivisions (a) and (b) of Section 1250 of the Health and Safety Code, shall be exempt from the requirement of obtaining an ADDS license pursuant to this section if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS. The AUDS shall comply with all other requirements for an ADDS in this article. The licensed hospital pharmacy shall maintain a list of the locations of each AUDS it operates and shall make the list available to the board upon request.
(j) An ADDS license is not required for technology, installed within the secured licensed premises area of a pharmacy, used in the selecting, counting, packaging, and labeling of dangerous drugs and dangerous devices.

4427.3.
 (a) An ADDS shall be placed and operated inside an enclosed building, with a premises address, at a location approved by the board.
(b) An ADDS shall be placed and operated in one of the following locations:
(1) Adjacent to the secured pharmacy area of the pharmacy holding the ADDS license.
(2) A health facility licensed pursuant to Section 1250 of the Health and Safety Code that complies with Section 1261.6 of the Health and Safety Code.
(3) A clinic licensed pursuant to Section 1204 or 1204.1 of the Health and Safety Code, or Section 4180 or 4190 of this code.
(4) A correctional clinic licensed pursuant to Section 4187.1.
(5) If the ADDS is an APDS, in a location as provided in Section 4427.6.
(c) Prior to installation, the pharmacy holding the ADDS license and the location where the ADDS is placed pursuant to subdivision (b) shall jointly develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the ADDS, as well as quality, potency, and purity of the drugs and devices. These policies and procedures shall be maintained at the location of the ADDS and at the pharmacy holding the ADDS license.

4427.4.
 (a) The ADDS shall be owned or leased by the pharmacy holding the license for the ADDS.
(b) Each ADDS shall only be operated under the supervision of the pharmacy holding the ADDS license.
(c) An ADDS shall be considered an extension and part of the pharmacy holding the ADDS license, regardless of the ADDS location, and shall be subject to inspection pursuant to Section 4008.
(d) Drugs and devices stored in an ADDS shall be deemed part of the inventory and the responsibility of the pharmacy holding the ADDS license, and drugs and devices dispensed from the ADDS shall be considered to have been dispensed by that pharmacy.
(e) (1) The stocking and restocking of an ADDS shall be performed by a pharmacist, or by a pharmacy technician or intern pharmacist under the supervision of a pharmacist, except for an ADDS located in a health facility licensed pursuant to Section 1250 of the Health and Safety Code, where the stocking and restocking of the ADDS may be performed in compliance with Section 1261.6 of the Health and Safety Code.
(2) Access to the ADDS shall be controlled and tracked using an identification or password system or biosensor.
(3) The ADDS shall make a complete and accurate record of all transactions that includes all users accessing the system and all drugs added to, or removed from, the system.
(f) If drugs or devices are not immediately transferred into an ADDS upon arrival at the ADDS location, the drugs and devices shall be stored for no longer than 48 hours in a secured room within the ADDS location approved by the board under Section 4427.3. Upon retrieval of these drugs and devices from secured storage, an inventory shall be taken to detect any losses or overages.

4427.5.
 Prior to installation, and annually thereafter, the pharmacy holding the ADDS license shall provide training on the operation and use of the ADDS to pharmacy personnel and to personnel using the ADDS at the location where the ADDS is placed pursuant to subdivision (b) of Section 4427.3.

4427.6.
 In addition to any other requirements imposed by this article, an APDS shall additionally meet the following requirements:
(a) The pharmacy shall develop and implement, and review annually, written policies and procedures pertaining to the APDS, including all of the following:
(1) Maintaining the security of the APDS and the dangerous drugs and dangerous devices within that APDS.
(2) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the APDS and for which patients.
(3) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including for those delivered via the APDS.
(4) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the APDS at the location where the APDS is placed pursuant to subdivision (b) of Section 4427.3, regarding maintenance and filing procedures for the APDS.
(5) Orienting participating patients on the use of the APDS, notifying patients when expected prescription medications are not available in the APDS, and ensuring that patient use of the APDS does not interfere with delivery of drugs and devices.
(6) Ensuring delivery of drugs and devices to patients expecting to receive them from the APDS in the event the APDS is disabled or malfunctions.
(b) The APDS shall only be used for patients who have signed a written consent form demonstrating their informed consent to receive prescribed drugs and devices from an APDS, and whose use of the APDS meets inclusion criteria established pursuant to subdivision (a).
(c) The APDS shall have a means to identify each patient and only release the identified patient’s drugs and devices to the patient or the patient’s agent.
(d) A pharmacist licensed by the board shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.
(e) Drugs shall be dispensed from the APDS only upon authorization by a licensed pharmacist after the pharmacist has reviewed the prescription and the patient’s profile for potential contraindications and adverse drug reactions.
(f) All prescribed drugs and devices dispensed to a patient from an APDS for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.
(g) The APDS shall include a notice, prominently posted on the APDS, providing the name, address, and phone number of the pharmacy that holds the ADDS license for that APDS.
(h) The labels on all drugs and devices dispensed by the APDS shall comply with Section 4076 and with Section 1707.5 of Title 16 of the California Code of Regulations.
(i) Any incident involving the APDS where a complaint, error, or omission has occurred shall be reviewed as part of the pharmacy’s quality assurance program pursuant to Section 4125.
(j) An APDS may be located and operated in a medical office or other location where patients are regularly seen for purposes of diagnosis and treatment, and the APDS is only used to dispense dangerous drugs and dangerous devices to patients of the practice.
(k) The board shall not issue a pharmacy more than 15 ADDS licenses for APDS units. Consistent with Section 4001.1, the board, by regulation, may reduce the number of ADDS licenses a pharmacy may be issued for APDS units.
(l) The pharmacy holding the ADDS license for an APDS shall maintain the policies and procedures developed pursuant to subdivision (a) for three years after the last date of use of that APDS.

4427.7.
 (a) A pharmacy holding an ADDS license shall complete an annual self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacy’s compliance with pharmacy law relating to the use of the ADDS. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the ADDS shall be included in the self-assessment.
(b) The pharmacy shall comply with all recordkeeping and quality assurance requirements established in pharmacy law and regulation, and shall maintain those records within the licensed pharmacy holding the ADDS license and separate from other pharmacy records.

4427.8.
 (a) This article shall become operative on July 1, 2019.
(b) On or before January 1, 2024, as part of the board’s sunset evaluation process, and notwithstanding Sections 9795 and 10231.5 of the Government Code, the board shall report to the appropriate committees of the Legislature on the regulation of ADDS units as provided in this article. At a minimum, this report shall require all of the following:
(1) The use and dispersion of ADDS throughout the health care system.
(2) The number of ADDS inspections conducted by the board each year and the findings from the inspections.
(3) Public safety concerns relating to the use of ADDS as identified by the board.

SEC. 10.

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

1261.6.
 (a) (1) For purposes of this section and Section 1261.5, an “automated drug delivery system” means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An automated drug delivery system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.
(2) For purposes of this section, “facility” means a health facility licensed pursuant to subdivision (c), (d), or (k) of Section 1250 that has an automated drug delivery system provided by a pharmacy.
(3) For purposes of this section, “pharmacy services” means the provision of both routine and emergency drugs and biologicals to meet the needs of the patient, as prescribed by a physician.
(b) Transaction information shall be made readily available in a written format for review and inspection by individuals authorized by law. These records shall be maintained in the facility for a minimum of three years.
(c) Individualized and specific access to automated drug delivery systems shall be limited to facility and contract personnel authorized by law to administer drugs.
(d) (1) The facility and the pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.
(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.
(e) When used as an emergency pharmaceutical supplies container, drugs removed from the automated drug delivery system shall be limited to the following:
(1) A new drug order given by a prescriber for a patient of the facility for administration prior to the next scheduled delivery from the pharmacy, or 72 hours, whichever is less. The drugs shall be retrieved only upon authorization by a pharmacist and after the pharmacist has reviewed the prescriber’s order and the patient’s profile for potential contraindications and adverse drug reactions.
(2) Drugs that a prescriber has ordered for a patient on an as-needed basis, if the utilization and retrieval of those drugs are subject to ongoing review by a pharmacist.
(3) Drugs designed by the patient care policy committee or pharmaceutical service committee of the facility as emergency drugs or acute onset drugs. These drugs may be retrieved from an automated drug delivery system pursuant to the order of a prescriber for emergency or immediate administration to a patient of the facility. Within 48 hours after retrieval under this paragraph, the case shall be reviewed by a pharmacist.
(f) When used to provide pharmacy services pursuant to Section 4119.1 of the Business and Professions Code, the automated drug delivery system shall be subject to all of the following requirements:
(1) Drugs removed from the automated drug delivery system for administration to a patient shall be in properly labeled units of administration containers or packages.
(2) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for administration to a patient. The pharmacist shall review the prescriber’s order and the patient’s profile for potential contraindications and adverse drug reactions.
(3) The pharmacy providing services to the facility pursuant to Section 4119.1 of the Business and Professions Code shall control access to the drugs stored in the automated drug delivery system.
(4) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor.
(5) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.
(6) After the pharmacist reviews the prescriber’s order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient. When the prescriber’s order requires a dosage variation of the same drug, licensed personnel shall have access to the drug ordered for that scheduled time of administration.
(7) (A) Systems that allow licensed personnel to have access to multiple drugs and are not patient specific in their design, shall be allowed under this subdivision if those systems have electronic and mechanical safeguards in place to ensure that the drugs delivered to the patient are specific to that patient. Each facility using such an automated drug system shall notify the department in writing prior to the utilization of the system. The notification submitted to the department pursuant to this paragraph shall include, but is not limited to, information regarding system design, personnel with system access, and policies and procedures covering staff training, storage, and security, and the facility’s administration of these types of systems.
(B) As part of its routine oversight of these facilities, the department shall review a facility’s medication training, storage, and security, and its administration procedures related to its use of an automated drug delivery system to ensure that adequate staff training and safeguards are in place to make sure that the drugs delivered are appropriate for the patient. If the department determines that a facility is not in compliance with this section, the department may revoke its authorization to use automated drug delivery systems granted under subparagraph (A).
(g) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, 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, drawers, or unit of use or single dose containers 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, drawers, or unit of use or single dose containers 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 removable pockets, cards, drawers, or unit of use or single dose containers 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.
(j) This section shall become inoperative on July 1, 2019, and, as of January 1, 2020, is repealed.

SEC. 11.

 Section 1261.6 is added to the Health and Safety Code, 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 4017.3 of, and Article 25 (commencing with Section 4427) of Chapter 9 of Division 2 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 Article 25 (commencing with Section 4427) of Chapter 9 of Division 2 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 delivery system shall notify the department in writing prior to the utilization of the system. The notification submitted to the department pursuant to this paragraph shall include, but is not limited to, information regarding system design, personnel with system access, and policies and procedures covering staff training, storage, and security, and the facility’s administration of these types of systems.
(B) As part of its routine oversight of these facilities, the department shall review a facility’s medication training, storage, and security, and its administration procedures related to its use of an automated drug delivery system to ensure that adequate staff training and safeguards are in place to make sure that the drugs delivered are appropriate for the patient. If the department determines that a facility is not in compliance with this section, the department may revoke its authorization to use automated drug delivery systems granted under subparagraph (A).
(g) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, 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, drawers, or unit of use or single dose containers 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, drawers, or unit of use or single dose containers 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 removable pockets, cards, drawers, or unit of use or single dose containers 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.
(j) This section shall become operative on July 1, 2019.

SEC. 12.

 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.