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

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


CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Senate Bill No. 1447


Introduced by Senator Hernandez

February 16, 2018


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 of, the Business and Professions Code, relating to healing arts.


LEGISLATIVE COUNSEL'S DIGEST


SB 1447, as introduced, Hernandez. Pharmacy: automated drug delivery systems: licensing.
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 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. 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. The bill would limit the placement and operation of an ADDS unit to specified locations, including a licensed pharmacy, 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 drugs and devices located within the ADDS unit and would prescribe specified stocking and transfer requirements for those drugs and devices. 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.
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) 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.
(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.
(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.

SEC. 3.

 Section 4105.5 of the Business and Professions Code is repealed.
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).

SEC. 4.

 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).

(z)

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

SEC. 5.

 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 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.
(d) A pharmacy may only obtain five simultaneous ADDS licenses.
(e) Prior to issuance of the license, the board shall conduct a prelicensure inspection at the proposed location of the ADDS unit.
(f) The ADDS license shall be canceled by operation of law if the underlying pharmacy license is not in good standing. 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 an enclosed building at a location approved by the board.
(b) An ADDS unit may be placed and operated in any of the following locations:
(1) A pharmacy licensed by the board.
(2) A health facility as defined in Section 1250 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.

4427.3.
 (a) Drugs and devices located within the ADDS unit shall be owned by the pharmacy holding that ADDS unit’s license.
(b) The stocking and restocking of an ADDS unit shall be performed by licensed pharmacy staff unless otherwise specified by law.
(c) 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.
 When an APDS unit is used to dispense drugs or devices directly to patients, the following conditions shall additionally apply:
(a) 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.
(b) 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.
(c) The APDS unit shall include a notice, prominently posted on the APDS unit, 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.
(d) 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.

4427.5.
 (a) The pharmacist-in-charge of a pharmacy holding an ADDS unit license shall complete a self-assessment, annually or upon designation of a new pharmacist-in-charge, evaluating the pharmacy’s compliance with pharmacy law relating to the use of the ADDS unit.
(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.

 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.
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