| Old | New | Differences | |
|---|---|---|---|
| 1 | - | Amended IN Assembly | |
| 1 | + | Amended IN Assembly March 28, 2025 CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION Assembly Bill No. 447Introduced by Assembly Member Mark GonzlezFebruary 06, 2025 An act to amend Section 4068 Sections 4068 and 4427.2 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 447, as amended, Mark Gonzlez. Emergency room patient prescriptions: dispensing unused portions upon discharge. prescriptions.Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy for the licensure and regulation of pharmacists and pharmacies. Existing law authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the dangerous drug is acquired by the hospital pharmacy.This bill would, notwithstanding any other law, authorize a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under certain conditions, including that the dangerous drug is not a controlled substance and that dispensing the unused portion of the dangerous drug is required to continue treatment of the patient.Existing law requires an automated drug delivery system (ADDS) that is installed, leased, owned, or operated in California to be licensed by the board. Existing law exempts an automated unit dose system (AUDS), a type of ADDS, from licensure if the AUDS is used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS.This bill would also exempt from licensure an AUDS that is used to provide doses administered to emergency room patients in accordance with specified requirements.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 4068 of the Business and Professions Code is amended to read:4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.(2) The dangerous drug is acquired by the hospital pharmacy.(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.(b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:(1) The dangerous drug is not a controlled substance.(2) The dangerous drug has been ordered and administered to the emergency room patient.(3) Dispensing the unused portion of the dangerous drug is required to continue treatment of the emergency room patient. (c) The prescriber shall be responsible for any error or omission related to the drugs dispensed.SEC. 2. Section 4427.2 of the Business and Professions Code is amended to read: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 pharmacys policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.(4) The pharmacys 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 facility, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivisions (a) and subdivision (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. | |
| 2 | 2 | ||
| 3 | - | ||
| 3 | + | Amended IN Assembly March 28, 2025 CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION Assembly Bill No. 447Introduced by Assembly Member Mark GonzlezFebruary 06, 2025 An act to amend Section 4068 Sections 4068 and 4427.2 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 447, as amended, Mark Gonzlez. Emergency room patient prescriptions: dispensing unused portions upon discharge. prescriptions.Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy for the licensure and regulation of pharmacists and pharmacies. Existing law authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the dangerous drug is acquired by the hospital pharmacy.This bill would, notwithstanding any other law, authorize a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under certain conditions, including that the dangerous drug is not a controlled substance and that dispensing the unused portion of the dangerous drug is required to continue treatment of the patient.Existing law requires an automated drug delivery system (ADDS) that is installed, leased, owned, or operated in California to be licensed by the board. Existing law exempts an automated unit dose system (AUDS), a type of ADDS, from licensure if the AUDS is used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS.This bill would also exempt from licensure an AUDS that is used to provide doses administered to emergency room patients in accordance with specified requirements.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO | |
| 4 | 4 | ||
| 5 | - | ||
| 5 | + | Amended IN Assembly March 28, 2025 | |
| 6 | 6 | ||
| 7 | - | Amended IN Assembly April 09, 2025 | |
| 8 | 7 | Amended IN Assembly March 28, 2025 | |
| 9 | 8 | ||
| 10 | 9 | CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION | |
| 11 | 10 | ||
| 12 | 11 | Assembly Bill | |
| 13 | 12 | ||
| 14 | 13 | No. 447 | |
| 15 | 14 | ||
| 16 | 15 | Introduced by Assembly Member Mark GonzlezFebruary 06, 2025 | |
| 17 | 16 | ||
| 18 | 17 | Introduced by Assembly Member Mark Gonzlez | |
| 19 | 18 | February 06, 2025 | |
| 20 | 19 | ||
| 21 | - | An act to amend Sections 4068 and 4427.2 of the Business and Professions Code, relating to healing arts. | |
| 20 | + | An act to amend Section 4068 Sections 4068 and 4427.2 of the Business and Professions Code, relating to healing arts. | |
| 22 | 21 | ||
| 23 | 22 | LEGISLATIVE COUNSEL'S DIGEST | |
| 24 | 23 | ||
| 25 | 24 | ## LEGISLATIVE COUNSEL'S DIGEST | |
| 26 | 25 | ||
| 27 | - | AB 447, as amended, Mark Gonzlez. Emergency room patient prescriptions. | |
| 26 | + | AB 447, as amended, Mark Gonzlez. Emergency room patient prescriptions: dispensing unused portions upon discharge. prescriptions. | |
| 28 | 27 | ||
| 29 | 28 | Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy for the licensure and regulation of pharmacists and pharmacies. Existing law authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the dangerous drug is acquired by the hospital pharmacy.This bill would, notwithstanding any other law, authorize a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under certain conditions, including that the dangerous drug is not a controlled substance and that dispensing the unused portion of the dangerous drug is required to continue treatment of the patient.Existing law requires an automated drug delivery system (ADDS) that is installed, leased, owned, or operated in California to be licensed by the board. Existing law exempts an automated unit dose system (AUDS), a type of ADDS, from licensure if the AUDS is used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS.This bill would also exempt from licensure an AUDS that is used to provide doses administered to emergency room patients in accordance with specified requirements. | |
| 30 | 29 | ||
| 31 | 30 | Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy for the licensure and regulation of pharmacists and pharmacies. Existing law authorizes a prescriber to dispense a dangerous drug, including a controlled substance, to an emergency room patient if specified requirements are met, including that the dangerous drug is acquired by the hospital pharmacy. | |
| 32 | 31 | ||
| 33 | 32 | This bill would, notwithstanding any other law, authorize a prescriber to dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under certain conditions, including that the dangerous drug is not a controlled substance and that dispensing the unused portion of the dangerous drug is required to continue treatment of the patient. | |
| 34 | 33 | ||
| 35 | 34 | Existing law requires an automated drug delivery system (ADDS) that is installed, leased, owned, or operated in California to be licensed by the board. Existing law exempts an automated unit dose system (AUDS), a type of ADDS, from licensure if the AUDS is used solely to provide doses administered to patients while in a licensed general acute care hospital facility or a licensed acute psychiatric hospital facility if the licensed hospital pharmacy owns or leases the AUDS and owns the dangerous drugs and dangerous devices in the AUDS. | |
| 36 | 35 | ||
| 37 | 36 | This bill would also exempt from licensure an AUDS that is used to provide doses administered to emergency room patients in accordance with specified requirements. | |
| 38 | 37 | ||
| 39 | 38 | ## Digest Key | |
| 40 | 39 | ||
| 41 | 40 | ## Bill Text | |
| 42 | 41 | ||
| 43 | - | The people of the State of California do enact as follows:SECTION 1. Section 4068 of the Business and Professions Code is amended to read:4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.(2) The dangerous drug is acquired by the hospital pharmacy.(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.(b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:(1) The dangerous drug is not a controlled substance.(2) The dangerous drug has been ordered and administered to the emergency room patient.(3) | |
| 42 | + | The people of the State of California do enact as follows:SECTION 1. Section 4068 of the Business and Professions Code is amended to read:4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.(2) The dangerous drug is acquired by the hospital pharmacy.(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.(b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:(1) The dangerous drug is not a controlled substance.(2) The dangerous drug has been ordered and administered to the emergency room patient.(3) Dispensing the unused portion of the dangerous drug is required to continue treatment of the emergency room patient. (c) The prescriber shall be responsible for any error or omission related to the drugs dispensed.SEC. 2. Section 4427.2 of the Business and Professions Code is amended to read: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 pharmacys policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.(4) The pharmacys 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 facility, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivisions (a) and subdivision (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. | |
| 44 | 43 | ||
| 45 | 44 | The people of the State of California do enact as follows: | |
| 46 | 45 | ||
| 47 | 46 | ## The people of the State of California do enact as follows: | |
| 48 | 47 | ||
| 49 | - | SECTION 1. Section 4068 of the Business and Professions Code is amended to read:4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.(2) The dangerous drug is acquired by the hospital pharmacy.(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.(b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:(1) The dangerous drug is not a controlled substance.(2) The dangerous drug has been ordered and administered to the emergency room patient.(3) | |
| 48 | + | SECTION 1. Section 4068 of the Business and Professions Code is amended to read:4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.(2) The dangerous drug is acquired by the hospital pharmacy.(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.(b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:(1) The dangerous drug is not a controlled substance.(2) The dangerous drug has been ordered and administered to the emergency room patient.(3) Dispensing the unused portion of the dangerous drug is required to continue treatment of the emergency room patient. (c) The prescriber shall be responsible for any error or omission related to the drugs dispensed. | |
| 50 | 49 | ||
| 51 | 50 | SECTION 1. Section 4068 of the Business and Professions Code is amended to read: | |
| 52 | 51 | ||
| 53 | 52 | ### SECTION 1. | |
| 54 | 53 | ||
| 55 | - | 4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.(2) The dangerous drug is acquired by the hospital pharmacy.(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.(b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:(1) The dangerous drug is not a controlled substance.(2) The dangerous drug has been ordered and administered to the emergency room patient.(3) | |
| 54 | + | 4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.(2) The dangerous drug is acquired by the hospital pharmacy.(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.(b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:(1) The dangerous drug is not a controlled substance.(2) The dangerous drug has been ordered and administered to the emergency room patient.(3) Dispensing the unused portion of the dangerous drug is required to continue treatment of the emergency room patient. (c) The prescriber shall be responsible for any error or omission related to the drugs dispensed. | |
| 56 | 55 | ||
| 57 | - | 4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.(2) The dangerous drug is acquired by the hospital pharmacy.(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.(b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:(1) The dangerous drug is not a controlled substance.(2) The dangerous drug has been ordered and administered to the emergency room patient.(3) | |
| 56 | + | 4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.(2) The dangerous drug is acquired by the hospital pharmacy.(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.(b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:(1) The dangerous drug is not a controlled substance.(2) The dangerous drug has been ordered and administered to the emergency room patient.(3) Dispensing the unused portion of the dangerous drug is required to continue treatment of the emergency room patient. (c) The prescriber shall be responsible for any error or omission related to the drugs dispensed. | |
| 58 | 57 | ||
| 59 | - | 4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.(2) The dangerous drug is acquired by the hospital pharmacy.(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.(b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:(1) The dangerous drug is not a controlled substance.(2) The dangerous drug has been ordered and administered to the emergency room patient.(3) | |
| 58 | + | 4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:(1) The hospital pharmacy is closed and there is no pharmacist available in the hospital.(2) The dangerous drug is acquired by the hospital pharmacy.(3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.(4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.(5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.(6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply.(7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076.(b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions:(1) The dangerous drug is not a controlled substance.(2) The dangerous drug has been ordered and administered to the emergency room patient.(3) Dispensing the unused portion of the dangerous drug is required to continue treatment of the emergency room patient. (c) The prescriber shall be responsible for any error or omission related to the drugs dispensed. | |
| 60 | 59 | ||
| 61 | 60 | ||
| 62 | 61 | ||
| 63 | 62 | 4068. (a) Notwithstanding any provision of this chapter, except as provided in subdivision (b), a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply: | |
| 64 | 63 | ||
| 65 | 64 | (1) The hospital pharmacy is closed and there is no pharmacist available in the hospital. | |
| 66 | 65 | ||
| 67 | 66 | (2) The dangerous drug is acquired by the hospital pharmacy. | |
| 68 | 67 | ||
| 69 | 68 | (3) The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens. | |
| 70 | 69 | ||
| 71 | 70 | (4) The hospital pharmacy retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code. | |
| 72 | 71 | ||
| 73 | 72 | (5) The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient. | |
| 74 | 73 | ||
| 75 | 74 | (6) The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or accessible, but shall not exceed a 72-hour supply. | |
| 76 | 75 | ||
| 77 | 76 | (7) The prescriber shall ensure that the label on the drug contains all the information required by Section 4076. | |
| 78 | 77 | ||
| 79 | 78 | (b) Notwithstanding any provision of this chapter, including subdivision (a), a prescriber may dispense an unused portion of a dangerous drug acquired by the hospital pharmacy to an emergency room patient upon discharge under the following conditions: | |
| 80 | 79 | ||
| 81 | 80 | (1) The dangerous drug is not a controlled substance. | |
| 82 | 81 | ||
| 83 | 82 | (2) The dangerous drug has been ordered and administered to the emergency room patient. | |
| 84 | 83 | ||
| 85 | - | (3) The dangerous drug was administered from multiuse packaging and can be self-administered by the patient, including, but not limited to, an inhaler, eye drop, ear drop, nose drop or spray, topical product, or liquid product. | |
| 86 | - | ||
| 87 | - | (3) | |
| 88 | - | ||
| 89 | - | ||
| 90 | - | ||
| 91 | - | (4) Dispensing the unused portion of the dangerous drug is required to continue treatment of the emergency room patient. | |
| 92 | - | ||
| 93 | - | (5) The prescriber shall ensure that the label on the drug contains all of the information required by Section 4076. | |
| 84 | + | (3) Dispensing the unused portion of the dangerous drug is required to continue treatment of the emergency room patient. | |
| 94 | 85 | ||
| 95 | 86 | (c) The prescriber shall be responsible for any error or omission related to the drugs dispensed. | |
| 96 | 87 | ||
| 97 | - | SEC. 2. Section 4427.2 of the Business and Professions Code is amended to read: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 pharmacys policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.(4) The pharmacys 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, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivision (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. | |
| 88 | + | SEC. 2. Section 4427.2 of the Business and Professions Code is amended to read: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 pharmacys policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.(4) The pharmacys 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 facility, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivisions (a) and subdivision (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. | |
| 98 | 89 | ||
| 99 | 90 | SEC. 2. Section 4427.2 of the Business and Professions Code is amended to read: | |
| 100 | 91 | ||
| 101 | 92 | ### SEC. 2. | |
| 102 | 93 | ||
| 103 | - | 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 pharmacys policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.(4) The pharmacys 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, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivision (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. | |
| 94 | + | 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 pharmacys policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.(4) The pharmacys 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 facility, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivisions (a) and subdivision (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. | |
| 104 | 95 | ||
| 105 | - | 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 pharmacys policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.(4) The pharmacys 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, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivision (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. | |
| 96 | + | 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 pharmacys policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.(4) The pharmacys 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 facility, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivisions (a) and subdivision (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. | |
| 106 | 97 | ||
| 107 | - | 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 pharmacys policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.(4) The pharmacys 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, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivision (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. | |
| 98 | + | 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 pharmacys policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion.(4) The pharmacys 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 facility, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivisions (a) and subdivision (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. | |
| 108 | 99 | ||
| 109 | 100 | ||
| 110 | 101 | ||
| 111 | 102 | 4427.2. (a) An ADDS installed, leased, owned, or operated in California shall be licensed by the board. | |
| 112 | 103 | ||
| 113 | 104 | (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. | |
| 114 | 105 | ||
| 115 | 106 | (c) A separate application and license shall be required for each ADDS. | |
| 116 | 107 | ||
| 117 | 108 | (d) An ADDS license shall only be issued when the following conditions are met: | |
| 118 | 109 | ||
| 119 | 110 | (1) Use of the ADDS is consistent with legal requirements. | |
| 120 | 111 | ||
| 121 | 112 | (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. | |
| 122 | 113 | ||
| 123 | 114 | (3) The pharmacys policies and procedures related to the ADDS include appropriate security measures and monitoring of the inventory to prevent theft and diversion. | |
| 124 | 115 | ||
| 125 | 116 | (4) The pharmacys policies and procedures include provisions for reporting to the board drug losses from the ADDS inventory, as required by law. | |
| 126 | 117 | ||
| 127 | 118 | (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. | |
| 128 | 119 | ||
| 129 | 120 | (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. | |
| 130 | 121 | ||
| 131 | 122 | (g) The holder of an ADDS license shall advise the board in writing within 30 days if use of the ADDS is discontinued. | |
| 132 | 123 | ||
| 133 | 124 | (h) The ADDS license shall be renewed annually, and the renewal date shall be the same as the underlying pharmacy license. | |
| 134 | 125 | ||
| 135 | - | (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, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivision (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. | |
| 126 | + | (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 facility, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, to patients pursuant to Section 4068, or to patients while in a licensed acute psychiatric hospital facility, as defined in subdivisions (a) and subdivision (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. | |
| 136 | 127 | ||
| 137 | 128 | (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. |