CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Assembly Bill No. 602Introduced by Assembly Member BontaFebruary 14, 2017 An act to amend Section 4081 of, and to add Sections 4025.2 and 4301.01 to, the Business and Professions Code, relating to pharmacy. LEGISLATIVE COUNSEL'S DIGESTAB 602, as introduced, Bonta. Pharmacy: nonprescription diabetes devices. The Pharmacy Law provides for the licensing and regulation of the practice of pharmacy by the California State Board of Pharmacy within the Department of Consumer Affairs. That law authorizes the board to take disciplinary action against any holder of a license who is guilty of unprofessional conduct, as described, or whose license has been issued by mistake. That law also requires the records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices to be open for inspection during business hours and preserved for at least 3 years, as specified. Under that law, a person who fails to maintain or produce those records is guilty of a crime.This bill would authorize the board to take disciplinary action against a licensee for unprofessional conduct involving the dispensing of a nonprescription diabetes device, as defined, pursuant to a prescription. The bill would require pharmacies that dispense nonprescription diabetes devices pursuant to prescriptions to retain records of acquisition and sale of those nonprescription diabetes devices for at least 3 years and keep those records open to inspection during business hours, as described above. By expanding the scope of a crime, this bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 4025.2 is added to the Business and Professions Code, to read:4025.2. Nonprescription diabetes device means a device for use in the treatment of prediabetic or diabetic individuals that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.SEC. 2. Section 4081 of the Business and Professions Code is amended to read:4081. (a) All records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the date of making. A current inventory shall be kept by every manufacturer, wholesaler, third-party logistics provider, pharmacy, veterinary food-animal drug retailer, outsourcing facility, physician, dentist, podiatrist, veterinarian, laboratory, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices.(b) The owner, officer, and partner of a pharmacy, wholesaler, third-party logistics provider, or veterinary food-animal drug retailer shall be jointly responsible, with the pharmacist-in-charge, responsible manager, or designated representative-in-charge, for maintaining the records and inventory described in this section.(c) The pharmacist-in-charge, responsible manager, or designated representative-in-charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the pharmacist-in-charge, responsible manager, or designated representative-in-charge had no knowledge, or in which he or she did not knowingly participate.(d) Notwithstanding Section 4057, pharmacies that dispense nonprescription diabetes devices pursuant to prescriptions shall retain records of acquisition and sale of those nonprescription diabetes devices for at least three years from the date of making. The records shall be at all times during business hours open to inspection by authorized officers of the law.SEC. 3. Section 4301.01 is added to the Business and Professions Code, to read:4301.01. Section 4301 shall apply when a nonprescription diabetes device is dispensed pursuant to a prescription.SEC. 4. 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.
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Assembly Bill No. 602Introduced by Assembly Member BontaFebruary 14, 2017 An act to amend Section 4081 of, and to add Sections 4025.2 and 4301.01 to, the Business and Professions Code, relating to pharmacy. LEGISLATIVE COUNSEL'S DIGESTAB 602, as introduced, Bonta. Pharmacy: nonprescription diabetes devices. The Pharmacy Law provides for the licensing and regulation of the practice of pharmacy by the California State Board of Pharmacy within the Department of Consumer Affairs. That law authorizes the board to take disciplinary action against any holder of a license who is guilty of unprofessional conduct, as described, or whose license has been issued by mistake. That law also requires the records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices to be open for inspection during business hours and preserved for at least 3 years, as specified. Under that law, a person who fails to maintain or produce those records is guilty of a crime.This bill would authorize the board to take disciplinary action against a licensee for unprofessional conduct involving the dispensing of a nonprescription diabetes device, as defined, pursuant to a prescription. The bill would require pharmacies that dispense nonprescription diabetes devices pursuant to prescriptions to retain records of acquisition and sale of those nonprescription diabetes devices for at least 3 years and keep those records open to inspection during business hours, as described above. By expanding the scope of a crime, this bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION
Assembly Bill No. 602
Introduced by Assembly Member BontaFebruary 14, 2017
Introduced by Assembly Member Bonta
February 14, 2017
An act to amend Section 4081 of, and to add Sections 4025.2 and 4301.01 to, the Business and Professions Code, relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 602, as introduced, Bonta. Pharmacy: nonprescription diabetes devices.
The Pharmacy Law provides for the licensing and regulation of the practice of pharmacy by the California State Board of Pharmacy within the Department of Consumer Affairs. That law authorizes the board to take disciplinary action against any holder of a license who is guilty of unprofessional conduct, as described, or whose license has been issued by mistake. That law also requires the records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices to be open for inspection during business hours and preserved for at least 3 years, as specified. Under that law, a person who fails to maintain or produce those records is guilty of a crime.This bill would authorize the board to take disciplinary action against a licensee for unprofessional conduct involving the dispensing of a nonprescription diabetes device, as defined, pursuant to a prescription. The bill would require pharmacies that dispense nonprescription diabetes devices pursuant to prescriptions to retain records of acquisition and sale of those nonprescription diabetes devices for at least 3 years and keep those records open to inspection during business hours, as described above. By expanding the scope of a crime, this bill would impose 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.
The Pharmacy Law provides for the licensing and regulation of the practice of pharmacy by the California State Board of Pharmacy within the Department of Consumer Affairs. That law authorizes the board to take disciplinary action against any holder of a license who is guilty of unprofessional conduct, as described, or whose license has been issued by mistake. That law also requires the records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices to be open for inspection during business hours and preserved for at least 3 years, as specified. Under that law, a person who fails to maintain or produce those records is guilty of a crime.
This bill would authorize the board to take disciplinary action against a licensee for unprofessional conduct involving the dispensing of a nonprescription diabetes device, as defined, pursuant to a prescription. The bill would require pharmacies that dispense nonprescription diabetes devices pursuant to prescriptions to retain records of acquisition and sale of those nonprescription diabetes devices for at least 3 years and keep those records open to inspection during business hours, as described above. By expanding the scope of a crime, this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 4025.2 is added to the Business and Professions Code, to read:4025.2. Nonprescription diabetes device means a device for use in the treatment of prediabetic or diabetic individuals that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.SEC. 2. Section 4081 of the Business and Professions Code is amended to read:4081. (a) All records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the date of making. A current inventory shall be kept by every manufacturer, wholesaler, third-party logistics provider, pharmacy, veterinary food-animal drug retailer, outsourcing facility, physician, dentist, podiatrist, veterinarian, laboratory, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices.(b) The owner, officer, and partner of a pharmacy, wholesaler, third-party logistics provider, or veterinary food-animal drug retailer shall be jointly responsible, with the pharmacist-in-charge, responsible manager, or designated representative-in-charge, for maintaining the records and inventory described in this section.(c) The pharmacist-in-charge, responsible manager, or designated representative-in-charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the pharmacist-in-charge, responsible manager, or designated representative-in-charge had no knowledge, or in which he or she did not knowingly participate.(d) Notwithstanding Section 4057, pharmacies that dispense nonprescription diabetes devices pursuant to prescriptions shall retain records of acquisition and sale of those nonprescription diabetes devices for at least three years from the date of making. The records shall be at all times during business hours open to inspection by authorized officers of the law.SEC. 3. Section 4301.01 is added to the Business and Professions Code, to read:4301.01. Section 4301 shall apply when a nonprescription diabetes device is dispensed pursuant to a prescription.SEC. 4. 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.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Section 4025.2 is added to the Business and Professions Code, to read:4025.2. Nonprescription diabetes device means a device for use in the treatment of prediabetic or diabetic individuals that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.
SECTION 1. Section 4025.2 is added to the Business and Professions Code, to read:
### SECTION 1.
4025.2. Nonprescription diabetes device means a device for use in the treatment of prediabetic or diabetic individuals that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.
4025.2. Nonprescription diabetes device means a device for use in the treatment of prediabetic or diabetic individuals that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.
4025.2. Nonprescription diabetes device means a device for use in the treatment of prediabetic or diabetic individuals that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.
4025.2. Nonprescription diabetes device means a device for use in the treatment of prediabetic or diabetic individuals that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.
SEC. 2. Section 4081 of the Business and Professions Code is amended to read:4081. (a) All records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the date of making. A current inventory shall be kept by every manufacturer, wholesaler, third-party logistics provider, pharmacy, veterinary food-animal drug retailer, outsourcing facility, physician, dentist, podiatrist, veterinarian, laboratory, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices.(b) The owner, officer, and partner of a pharmacy, wholesaler, third-party logistics provider, or veterinary food-animal drug retailer shall be jointly responsible, with the pharmacist-in-charge, responsible manager, or designated representative-in-charge, for maintaining the records and inventory described in this section.(c) The pharmacist-in-charge, responsible manager, or designated representative-in-charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the pharmacist-in-charge, responsible manager, or designated representative-in-charge had no knowledge, or in which he or she did not knowingly participate.(d) Notwithstanding Section 4057, pharmacies that dispense nonprescription diabetes devices pursuant to prescriptions shall retain records of acquisition and sale of those nonprescription diabetes devices for at least three years from the date of making. The records shall be at all times during business hours open to inspection by authorized officers of the law.
SEC. 2. Section 4081 of the Business and Professions Code is amended to read:
### SEC. 2.
4081. (a) All records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the date of making. A current inventory shall be kept by every manufacturer, wholesaler, third-party logistics provider, pharmacy, veterinary food-animal drug retailer, outsourcing facility, physician, dentist, podiatrist, veterinarian, laboratory, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices.(b) The owner, officer, and partner of a pharmacy, wholesaler, third-party logistics provider, or veterinary food-animal drug retailer shall be jointly responsible, with the pharmacist-in-charge, responsible manager, or designated representative-in-charge, for maintaining the records and inventory described in this section.(c) The pharmacist-in-charge, responsible manager, or designated representative-in-charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the pharmacist-in-charge, responsible manager, or designated representative-in-charge had no knowledge, or in which he or she did not knowingly participate.(d) Notwithstanding Section 4057, pharmacies that dispense nonprescription diabetes devices pursuant to prescriptions shall retain records of acquisition and sale of those nonprescription diabetes devices for at least three years from the date of making. The records shall be at all times during business hours open to inspection by authorized officers of the law.
4081. (a) All records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the date of making. A current inventory shall be kept by every manufacturer, wholesaler, third-party logistics provider, pharmacy, veterinary food-animal drug retailer, outsourcing facility, physician, dentist, podiatrist, veterinarian, laboratory, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices.(b) The owner, officer, and partner of a pharmacy, wholesaler, third-party logistics provider, or veterinary food-animal drug retailer shall be jointly responsible, with the pharmacist-in-charge, responsible manager, or designated representative-in-charge, for maintaining the records and inventory described in this section.(c) The pharmacist-in-charge, responsible manager, or designated representative-in-charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the pharmacist-in-charge, responsible manager, or designated representative-in-charge had no knowledge, or in which he or she did not knowingly participate.(d) Notwithstanding Section 4057, pharmacies that dispense nonprescription diabetes devices pursuant to prescriptions shall retain records of acquisition and sale of those nonprescription diabetes devices for at least three years from the date of making. The records shall be at all times during business hours open to inspection by authorized officers of the law.
4081. (a) All records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the date of making. A current inventory shall be kept by every manufacturer, wholesaler, third-party logistics provider, pharmacy, veterinary food-animal drug retailer, outsourcing facility, physician, dentist, podiatrist, veterinarian, laboratory, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices.(b) The owner, officer, and partner of a pharmacy, wholesaler, third-party logistics provider, or veterinary food-animal drug retailer shall be jointly responsible, with the pharmacist-in-charge, responsible manager, or designated representative-in-charge, for maintaining the records and inventory described in this section.(c) The pharmacist-in-charge, responsible manager, or designated representative-in-charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the pharmacist-in-charge, responsible manager, or designated representative-in-charge had no knowledge, or in which he or she did not knowingly participate.(d) Notwithstanding Section 4057, pharmacies that dispense nonprescription diabetes devices pursuant to prescriptions shall retain records of acquisition and sale of those nonprescription diabetes devices for at least three years from the date of making. The records shall be at all times during business hours open to inspection by authorized officers of the law.
4081. (a) All records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the date of making. A current inventory shall be kept by every manufacturer, wholesaler, third-party logistics provider, pharmacy, veterinary food-animal drug retailer, outsourcing facility, physician, dentist, podiatrist, veterinarian, laboratory, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices.
(b) The owner, officer, and partner of a pharmacy, wholesaler, third-party logistics provider, or veterinary food-animal drug retailer shall be jointly responsible, with the pharmacist-in-charge, responsible manager, or designated representative-in-charge, for maintaining the records and inventory described in this section.
(c) The pharmacist-in-charge, responsible manager, or designated representative-in-charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the pharmacist-in-charge, responsible manager, or designated representative-in-charge had no knowledge, or in which he or she did not knowingly participate.
(d) Notwithstanding Section 4057, pharmacies that dispense nonprescription diabetes devices pursuant to prescriptions shall retain records of acquisition and sale of those nonprescription diabetes devices for at least three years from the date of making. The records shall be at all times during business hours open to inspection by authorized officers of the law.
SEC. 3. Section 4301.01 is added to the Business and Professions Code, to read:4301.01. Section 4301 shall apply when a nonprescription diabetes device is dispensed pursuant to a prescription.
SEC. 3. Section 4301.01 is added to the Business and Professions Code, to read:
### SEC. 3.
4301.01. Section 4301 shall apply when a nonprescription diabetes device is dispensed pursuant to a prescription.
4301.01. Section 4301 shall apply when a nonprescription diabetes device is dispensed pursuant to a prescription.
4301.01. Section 4301 shall apply when a nonprescription diabetes device is dispensed pursuant to a prescription.
4301.01. Section 4301 shall apply when a nonprescription diabetes device is dispensed pursuant to a prescription.
SEC. 4. 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.
SEC. 4. 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.
SEC. 4. 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.
### SEC. 4.