BILL NUMBER: AB 809 CHAPTERED 09/19/01 CHAPTER 310 FILED WITH SECRETARY OF STATE SEPTEMBER 19, 2001 APPROVED BY GOVERNOR SEPTEMBER 18, 2001 PASSED THE ASSEMBLY AUGUST 30, 2001 PASSED THE SENATE AUGUST 27, 2001 AMENDED IN SENATE JULY 3, 2001 AMENDED IN ASSEMBLY APRIL 17, 2001 AMENDED IN ASSEMBLY MARCH 27, 2001 INTRODUCED BY Assembly Member Salinas FEBRUARY 22, 2001 An act to add Section 4186 to the Business and Professions Code, relating to automated drug delivery systems, and making an appropriation therefor. LEGISLATIVE COUNSEL'S DIGEST AB 809, Salinas. Automated drug delivery systems. Existing law provides for the licensing and regulation of pharmacies by the California State Board of Pharmacy in the Department of Consumer Affairs. This bill would authorize automated drug delivery systems to be located in specified clinics. The bill would require clinics with automated drug delivery systems to develop and implement written policies and procedures. The bill would also require patient consultation with a pharmacist via a telecommunications link with 2-way audio and video capabilities, and would require that the pharmacist review the prescription and the patient profile, that he or she be located in California, and that he or she authorize the release of the dangerous drugs or devices from the automated drug delivery system. The bill would further require a pharmacist to perform the stocking, inventory maintenance, and review of the operation and maintenance of the system. Because this bill would provide additional penalties that would be deposited into the Pharmacy Board Contingent Fund which is continuously appropriated, the bill would make an appropriation. Existing law generally makes it a misdemeanor to knowingly violate the Pharmacy Law. Because operating an automated drug delivery system in violation of the bill's requirements would be a crime, the bill would impose a state-mandated local program by creating a new crime. 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. Appropriation: yes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 4186 is added to the Business and Professions Code, 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. SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.