Bill Text: CA SB1447 | 2017-2018 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Pharmacy: automated drug delivery systems.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2018-09-21 - Chaptered by Secretary of State. Chapter 666, Statutes of 2018. [SB1447 Detail]

Download: California-2017-SB1447-Amended.html

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Amended  IN  Senate  April 17, 2018

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Senate Bill

No. 1447

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Introduced by Senator Hernandez

February 16, 2018

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

LEGISLATIVE COUNSEL'S DIGEST

SB 1447, as amended, Hernandez. Pharmacy: automated drug delivery systems: licensing. 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 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 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 would repeal the general ADDS provisions. provisions and the additional conditions for an ADDS located in a licensed clinic or a health facility. The bill instead would prohibit an ADDS unit from being installed or operated in the state unless specified requirements are met, including a license for the ADDS unit issued by the board to the holder of a current, valid, and active pharmacy license, and would require the pharmacy holding the license to complete periodic self-assessments. license. The bill would limit the placement and operation of an ADDS unit to specified locations, including a the licensed pharmacy, pharmacy holding that ADDS license, a licensed health facility, a licensed clinic, or a specified medical office. The bill would require the pharmacy holding the ADDS license to own the ADDS and the drugs and devices located within the ADDS unit and it, 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 require additional conditions for automated patient dispensing systems, as defined. The bill would also authorize a pharmacy inspector employed by the board to enter the location, or proposed location, of an ADDS unit to inspect the location pursuant to these provisions. 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.

Digest Key

Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

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Bill Text

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. 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 pursuant to Article 25 (commencing with Section 4427).

SEC. 2.

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

4017.3.

 (a) “Automated Drug Delivery System” (ADDS) has the same meaning as paragraph (1) of subdivision (a) of Section 1261.6 of the Health and Safety Code. 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 unit from which health care providers with appropriate authority retrieve unit doses of drugs for administration to patients. 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 unit from which drugs and devices may be dispensed to patients pursuant to authorization by a pharmacist. for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist.

SEC. 3.

 Section 4105.5 of the Business and Professions Code is repealed.

SEC. 4.

 Section 4119.1 of the Business and Professions Code is repealed.

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.

SEC. 5.

 Section 4186 of the Business and Professions Code is repealed.

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.

SEC. 4.SEC. 6.

 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 an automated drug delivery system license shall be two hundred dollars ($200) and may be increased to two hundred fifty dollars ($250). The annual renewal of the license shall be two hundred dollars ($200) and may be increased to two hundred fifty dollars ($250).

(aa) This section shall become operative on July 1, 2017.

SEC. 5.SEC. 7.

 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 Units

4427.

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

4427.1.

 (a) An ADDS unit installed or operated in the State of California shall be licensed by the board.

(b) An ADDS license may shall only be issued to the holder of a current, valid, and active pharmacy license.

(c) A separate application and license shall be required for each ADDS unit. ADDS.

(d)A pharmacy may only obtain five simultaneous ADDS licenses.

(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 4427.2 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.

(5) The pharmacy license is not subject to suspension or disciplinary conditions.

(e) Prior to issuance of the license, the board shall conduct a prelicensure inspection at the proposed location of the ADDS unit. ADDS. Relocation or replacement of the ADDS shall require a new application for licensure.

(f) The ADDS license shall be canceled by operation of law if the underlying pharmacy license is not in good standing. 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 the use of the ADDS unit is discontinued.

(h) The ADDS license shall be renewed annually, and the renewal date shall be the same as the underlying pharmacy license. The ADDS license is nontransferable.

(i) An ADDS unit operated by a licensed hospital pharmacy, as defined in Section 4029, and used solely to provide doses administered to inpatients while in a facility operated under a license pursuant to Section 1250.8 of the Health and Safety Code, shall be exempt from the requirement of obtaining an ADDS license pursuant to this section.

4427.2.

 (a) An ADDS unit shall be placed and operated in inside or contiguous to an enclosed building building, with a premise address, at a location approved by the board.

(b) An ADDS unit may shall be placed and operated in any one of the following locations:

(1)A pharmacy licensed by the board.

(1) The pharmacy holding the ADDS license.

(2) A health facility as defined in licensed pursuant to Section 1250 of the Health and Safety Code. 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 medical office or other location where patients are regularly seen for purposes of diagnosis and treatment, and where drugs and devices are routinely dispensed pursuant to Section 4170. in compliance with Section 4170, except that paragraph (5) of subdivision (a) of Section 4170, requiring prescriber ownership of any dispensing device and its contents, shall not apply to that office or location.

(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.

4427.3.

 (a) Drugs The ADDS, and drugs and devices located within the ADDS unit ADDS, shall be owned by the pharmacy holding that ADDS unit’s license. 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.

(b)

(e) The stocking and restocking of an ADDS unit shall be performed by licensed pharmacy staff unless otherwise specified by law. 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.

(c)

(f) If drugs or devices are not immediately transferred into an ADDS unit upon arrival at the ADDS unit location, the drugs and devices shall be stored for no longer than 48 hours in a secured room. Upon retrieval of these drugs and devices from secured storage, an inventory shall be taken to detect any losses or overages.

4427.4.

 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 4427.2.

4427.4.

When an APDS unit is used to dispense drugs or devices directly to patients, the following conditions shall additionally apply:

4427.5.

 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 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 ADDS at the location where the ADDS is placed pursuant to subdivision (b) of Section 4427.2, 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 from an APDS, and whose use of the device 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.

(a)

(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.

(b)

(f) All drugs and devices dispensed from an APDS unit shall be accompanied by a consultation conducted by a pharmacist licensed by the board and consistent with Duty to Consult regulations promulgated by the board. via a telecommunications link that has two-way audio and video.

(c)

(g) The APDS unit shall include a notice, prominently posted on the APDS unit, APDS, providing the name of the pharmacy that holds that APDS unit’s license. The notice shall comply with Notice to Consumers regulations promulgated by the board. the ADDS license for that APDS.

(d)

(h) The labels on all medications dispensed by the APDS unit shall comply with Section 4076 and with Patient-Centered Labels of Prescription Drug Containers Requirement regulations promulgated by the board. 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) 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.

4427.5. 4427.6.

 (a) The pharmacist-in-charge of a A pharmacy holding an ADDS unit license shall complete a self-assessment, annually or upon designation of a new pharmacist-in-charge, 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 unit. 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.

SEC. 6.SEC. 8.

 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.