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| 1 | + | Amended IN Assembly April 15, 2021 CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Assembly Bill No. 1430Introduced by Assembly Member ArambulaFebruary 19, 2021 An act to add Article 12.5 (commencing with Section 4178) to Chapter 9 of Division 2 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 1430, as amended, Arambula. Pharmacy: dispensing: controlled substances.The Pharmacy Law provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy, which is within the Department of Consumer Affairs. Existing law, except as specified, prohibits a person from possessing any controlled substance, except that furnished to a person upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or another of prescribed healing arts licensees pursuant to existing law. A violation of the Pharmacy Law is a crime.This bill, with certain exceptions, on and after June 30, 2022, would require a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act to dispense it in a lockable vial, as defined, provide an educational pamphlet on controlled substances, a specified opioid factsheet, and, if the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, would choose the code, except as specified. The bill would require the board to develop the educational pamphlet and provide it to pharmacists in printed form. The bill would require the manufacturer of a controlled substance to reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances within 30 days of receiving a claim for reimbursement, and would require the manufacturer to pay, among other costs, the net acquisition cost of the lockable vials and dispensing costs. The bill would make the manufacturer subject to a civil penalty of $1,000 for each day the manufacturer is delinquent in reimbursing the pharmacy. The bill would require a vendor that contracts with a pharmacy to provide lockable vials to make available at all times assistance online or through a toll-free phone number for patient use. The bill would make a prescriber not liable for adverse consequences resulting from specified events relating to the lockable vials. The bill would authorize the board to adopt regulations to carry out the bill. By expanding the scope of a crime, the bill would impose a state-mandated local program. The bill would require the board to assess a fine for a violation of these provisions by a pharmacist, but would also authorize the board to choose not to take administrative action against a pharmacy if the board determines that compliance with the law would create a financial hardship on the pharmacy or that the pharmacy is temporarily out of stock of lockable vials, as provided. The bill would specify that a violation of these provisions shall not be punishable as a misdemeanor.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: YESNO Bill TextThe people of the State of California do enact as follows:SECTION 1. Article 12.5 (commencing with Section 4178) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read: Article 12.5. California Safe Dispensing Act4178. (a) This article shall be known as the California Safe Dispensing Act.(b) This article shall become operative on June 30, 2022.4178.1. (a) As used in this section, lockable vial means a disposable container that is special packaging, as defined in Section 1471 of Title 15 of the United States Code, and that has a locking cap that can be unlocked using one of the following: prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5.(1)An alphanumeric passcode or other code.(2)A unique physical key.(3)A locking mechanism that is accessible only by the patient with a code, alphanumeric passcode, or key, or by another secure mechanism.(b) Except as provided in subdivision (d), (c), a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.) shall do all of the following:(1) Dispense the controlled substance in a lockable vial.(2) Provide the educational pamphlet described in subdivision (c). a copy of the Opioid Factsheet for Patients published by the federal Centers for Disease Control and Prevention.(3) (A) If the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, shall choose the code.(B) Subparagraph (A) shall not apply to medications prescribed for services specified in Sections 6924 to 6928, inclusive, of the Family Code or in Section 2397 of this code.(c)The board shall develop an educational pamphlet that includes information on the potential for the abuse and diversion of controlled substances. The board shall provide the educational pamphlet to pharmacists in printed form. (d)(c) A pharmacist is not required to dispense a controlled substance in Schedule II of the federal Controlled Substances Act in a lockable vial if one or more of the following applies:(1) The patient, because of a physical or mental condition, would have difficulty opening the lockable vial.(2) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3) The patient or patients representative requests that the patients medication not be dispensed in a lockable vial. (e)(d) (1) The manufacturer of a controlled substance shall reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances in that month.(2) The manufacturer of a controlled substance shall reimburse the pharmacy within 30 days of receiving the claim and shall pay a reasonable rate for the net acquisition cost of the lockable vials, dispensing costs, and services rendered, including any patient consultation and instruction.(3) (A) A manufacturer of a controlled substance that fails to reimburse a pharmacy within the time period and for the amount specified in this subdivision is liable for a civil penalty of one thousand dollars ($1,000) per day for each day the manufacturer is delinquent in reimbursing the pharmacy.(B) The civil penalty shall be assessed and recovered in a civil action brought by the board in the name of the people of the State of California.(C) Assessment of a civil penalty, at the request of the manufacturer of the controlled substance that was assessed the penalty, may be reviewed on appeal and the penalty may be reduced or waived for good cause.(f)(e) Any vendor that contracts with a pharmacy to provide a lockable vial shall make available at all times assistance online or through a toll-free number for patient use.(g)(f) A prescriber, or the prescribers professional corporation or other business entity, who prescribes a controlled substance dispensed in a lockable vial shall not be liable for any adverse consequences that result from either of the following:(1) The failure of any lockable vial to prevent unauthorized access.(2) A patient not being able to access medication in a lockable vial.(h)(g) The board may adopt regulations to carry out this section.(h) (1) The board shall assess a fine in an amount to be determined by the board for a violation of this section by a pharmacist.(2) The board may choose not to take administrative action against a pharmacy if it determines that compliance with this section would create a financial hardship on the pharmacy or that the pharmacy was temporarily out of stock of lockable vials after taking reasonable steps to ensure an adequate supply for all dispensations of Schedule II or Schedule IIN controlled substances.(i) Section 4321 shall not apply to a violation of this section.SEC. 2.No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution. | |
| 2 | 2 | ||
| 3 | - | ||
| 3 | + | Amended IN Assembly April 15, 2021 CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Assembly Bill No. 1430Introduced by Assembly Member ArambulaFebruary 19, 2021 An act to add Article 12.5 (commencing with Section 4178) to Chapter 9 of Division 2 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 1430, as amended, Arambula. Pharmacy: dispensing: controlled substances.The Pharmacy Law provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy, which is within the Department of Consumer Affairs. Existing law, except as specified, prohibits a person from possessing any controlled substance, except that furnished to a person upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or another of prescribed healing arts licensees pursuant to existing law. A violation of the Pharmacy Law is a crime.This bill, with certain exceptions, on and after June 30, 2022, would require a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act to dispense it in a lockable vial, as defined, provide an educational pamphlet on controlled substances, a specified opioid factsheet, and, if the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, would choose the code, except as specified. The bill would require the board to develop the educational pamphlet and provide it to pharmacists in printed form. The bill would require the manufacturer of a controlled substance to reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances within 30 days of receiving a claim for reimbursement, and would require the manufacturer to pay, among other costs, the net acquisition cost of the lockable vials and dispensing costs. The bill would make the manufacturer subject to a civil penalty of $1,000 for each day the manufacturer is delinquent in reimbursing the pharmacy. The bill would require a vendor that contracts with a pharmacy to provide lockable vials to make available at all times assistance online or through a toll-free phone number for patient use. The bill would make a prescriber not liable for adverse consequences resulting from specified events relating to the lockable vials. The bill would authorize the board to adopt regulations to carry out the bill. By expanding the scope of a crime, the bill would impose a state-mandated local program. The bill would require the board to assess a fine for a violation of these provisions by a pharmacist, but would also authorize the board to choose not to take administrative action against a pharmacy if the board determines that compliance with the law would create a financial hardship on the pharmacy or that the pharmacy is temporarily out of stock of lockable vials, as provided. The bill would specify that a violation of these provisions shall not be punishable as a misdemeanor.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: YESNO | |
| 4 | 4 | ||
| 5 | - | ||
| 5 | + | Amended IN Assembly April 15, 2021 | |
| 6 | 6 | ||
| 7 | - | Amended IN Assembly April 21, 2021 | |
| 8 | 7 | Amended IN Assembly April 15, 2021 | |
| 9 | 8 | ||
| 10 | 9 | CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION | |
| 11 | 10 | ||
| 12 | 11 | Assembly Bill | |
| 13 | 12 | ||
| 14 | 13 | No. 1430 | |
| 15 | 14 | ||
| 16 | 15 | Introduced by Assembly Member ArambulaFebruary 19, 2021 | |
| 17 | 16 | ||
| 18 | 17 | Introduced by Assembly Member Arambula | |
| 19 | 18 | February 19, 2021 | |
| 20 | 19 | ||
| 21 | 20 | An act to add Article 12.5 (commencing with Section 4178) to Chapter 9 of Division 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 | 26 | AB 1430, as amended, Arambula. Pharmacy: dispensing: controlled substances. | |
| 28 | 27 | ||
| 29 | - | The Pharmacy Law provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy, which is within the Department of Consumer Affairs. Existing law, except as specified, prohibits a person from possessing any controlled substance, except that furnished to a person upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or another of prescribed healing arts licensees pursuant to existing law. A violation of the Pharmacy Law is a crime.This bill, with certain exceptions, on and after June 30, 2022, would require a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act to dispense it in a lockable vial, as defined, provide a specified opioid factsheet, and, if the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, | |
| 28 | + | The Pharmacy Law provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy, which is within the Department of Consumer Affairs. Existing law, except as specified, prohibits a person from possessing any controlled substance, except that furnished to a person upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or another of prescribed healing arts licensees pursuant to existing law. A violation of the Pharmacy Law is a crime.This bill, with certain exceptions, on and after June 30, 2022, would require a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act to dispense it in a lockable vial, as defined, provide an educational pamphlet on controlled substances, a specified opioid factsheet, and, if the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, would choose the code, except as specified. The bill would require the board to develop the educational pamphlet and provide it to pharmacists in printed form. The bill would require the manufacturer of a controlled substance to reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances within 30 days of receiving a claim for reimbursement, and would require the manufacturer to pay, among other costs, the net acquisition cost of the lockable vials and dispensing costs. The bill would make the manufacturer subject to a civil penalty of $1,000 for each day the manufacturer is delinquent in reimbursing the pharmacy. The bill would require a vendor that contracts with a pharmacy to provide lockable vials to make available at all times assistance online or through a toll-free phone number for patient use. The bill would make a prescriber not liable for adverse consequences resulting from specified events relating to the lockable vials. The bill would authorize the board to adopt regulations to carry out the bill. By expanding the scope of a crime, the bill would impose a state-mandated local program. The bill would require the board to assess a fine for a violation of these provisions by a pharmacist, but would also authorize the board to choose not to take administrative action against a pharmacy if the board determines that compliance with the law would create a financial hardship on the pharmacy or that the pharmacy is temporarily out of stock of lockable vials, as provided. The bill would specify that a violation of these provisions shall not be punishable as a misdemeanor.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. | |
| 30 | 29 | ||
| 31 | 30 | The Pharmacy Law provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy, which is within the Department of Consumer Affairs. Existing law, except as specified, prohibits a person from possessing any controlled substance, except that furnished to a person upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or another of prescribed healing arts licensees pursuant to existing law. A violation of the Pharmacy Law is a crime. | |
| 32 | 31 | ||
| 33 | - | This bill, with certain exceptions, on and after June 30, 2022, would require a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act to dispense it in a lockable vial, as defined, provide a specified opioid factsheet, and, if the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, or the conservator of the patient if the conservator has been given the power to make health care decisions for the patient, would choose the code, except as specified. The bill would require the manufacturer of a controlled substance to reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances within 30 days of receiving a claim for reimbursement, and would require the manufacturer to pay, among other costs, the net acquisition cost of the lockable vials and dispensing costs. The bill would make the manufacturer subject to a civil penalty of $1,000 for each day the manufacturer is delinquent in reimbursing the pharmacy. The bill would require a vendor that contracts with a pharmacy to provide lockable vials to make available at all times assistance online or through a toll-free phone number for patient use. The bill would make a prescriber not liable for adverse consequences resulting from specified events relating to the lockable vials. vials, except as specified. The bill would authorize the board to adopt regulations to carry out the bill. The bill would require the board to assess a fine for a violation of these provisions by a pharmacist, but would also authorize the board to choose not to take administrative action against a pharmacy if the board determines that compliance with the law would create a financial hardship on the pharmacy or that the pharmacy is temporarily out of stock of lockable vials, as provided. The bill would specify that a violation of these provisions shall not be punishable as a misdemeanor. | |
| 32 | + | This bill, with certain exceptions, on and after June 30, 2022, would require a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act to dispense it in a lockable vial, as defined, provide an educational pamphlet on controlled substances, a specified opioid factsheet, and, if the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, would choose the code, except as specified. The bill would require the board to develop the educational pamphlet and provide it to pharmacists in printed form. The bill would require the manufacturer of a controlled substance to reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances within 30 days of receiving a claim for reimbursement, and would require the manufacturer to pay, among other costs, the net acquisition cost of the lockable vials and dispensing costs. The bill would make the manufacturer subject to a civil penalty of $1,000 for each day the manufacturer is delinquent in reimbursing the pharmacy. The bill would require a vendor that contracts with a pharmacy to provide lockable vials to make available at all times assistance online or through a toll-free phone number for patient use. The bill would make a prescriber not liable for adverse consequences resulting from specified events relating to the lockable vials. The bill would authorize the board to adopt regulations to carry out the bill. By expanding the scope of a crime, the bill would impose a state-mandated local program. The bill would require the board to assess a fine for a violation of these provisions by a pharmacist, but would also authorize the board to choose not to take administrative action against a pharmacy if the board determines that compliance with the law would create a financial hardship on the pharmacy or that the pharmacy is temporarily out of stock of lockable vials, as provided. The bill would specify that a violation of these provisions shall not be punishable as a misdemeanor. | |
| 33 | + | ||
| 34 | + | 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. | |
| 35 | + | ||
| 36 | + | ||
| 37 | + | ||
| 38 | + | This bill would provide that no reimbursement is required by this act for a specified reason. | |
| 39 | + | ||
| 40 | + | ||
| 34 | 41 | ||
| 35 | 42 | ## Digest Key | |
| 36 | 43 | ||
| 37 | 44 | ## Bill Text | |
| 38 | 45 | ||
| 39 | - | The people of the State of California do enact as follows:SECTION 1. Article 12.5 (commencing with Section 4178) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read: Article 12.5. California Safe Dispensing Act4178. (a) This article shall be known as the California Safe Dispensing Act.(b) This article shall become operative on June 30, 2022.4178.1. (a) As used in this section, lockable vial means a | |
| 46 | + | The people of the State of California do enact as follows:SECTION 1. Article 12.5 (commencing with Section 4178) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read: Article 12.5. California Safe Dispensing Act4178. (a) This article shall be known as the California Safe Dispensing Act.(b) This article shall become operative on June 30, 2022.4178.1. (a) As used in this section, lockable vial means a disposable container that is special packaging, as defined in Section 1471 of Title 15 of the United States Code, and that has a locking cap that can be unlocked using one of the following: prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5.(1)An alphanumeric passcode or other code.(2)A unique physical key.(3)A locking mechanism that is accessible only by the patient with a code, alphanumeric passcode, or key, or by another secure mechanism.(b) Except as provided in subdivision (d), (c), a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.) shall do all of the following:(1) Dispense the controlled substance in a lockable vial.(2) Provide the educational pamphlet described in subdivision (c). a copy of the Opioid Factsheet for Patients published by the federal Centers for Disease Control and Prevention.(3) (A) If the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, shall choose the code.(B) Subparagraph (A) shall not apply to medications prescribed for services specified in Sections 6924 to 6928, inclusive, of the Family Code or in Section 2397 of this code.(c)The board shall develop an educational pamphlet that includes information on the potential for the abuse and diversion of controlled substances. The board shall provide the educational pamphlet to pharmacists in printed form. (d)(c) A pharmacist is not required to dispense a controlled substance in Schedule II of the federal Controlled Substances Act in a lockable vial if one or more of the following applies:(1) The patient, because of a physical or mental condition, would have difficulty opening the lockable vial.(2) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3) The patient or patients representative requests that the patients medication not be dispensed in a lockable vial. (e)(d) (1) The manufacturer of a controlled substance shall reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances in that month.(2) The manufacturer of a controlled substance shall reimburse the pharmacy within 30 days of receiving the claim and shall pay a reasonable rate for the net acquisition cost of the lockable vials, dispensing costs, and services rendered, including any patient consultation and instruction.(3) (A) A manufacturer of a controlled substance that fails to reimburse a pharmacy within the time period and for the amount specified in this subdivision is liable for a civil penalty of one thousand dollars ($1,000) per day for each day the manufacturer is delinquent in reimbursing the pharmacy.(B) The civil penalty shall be assessed and recovered in a civil action brought by the board in the name of the people of the State of California.(C) Assessment of a civil penalty, at the request of the manufacturer of the controlled substance that was assessed the penalty, may be reviewed on appeal and the penalty may be reduced or waived for good cause.(f)(e) Any vendor that contracts with a pharmacy to provide a lockable vial shall make available at all times assistance online or through a toll-free number for patient use.(g)(f) A prescriber, or the prescribers professional corporation or other business entity, who prescribes a controlled substance dispensed in a lockable vial shall not be liable for any adverse consequences that result from either of the following:(1) The failure of any lockable vial to prevent unauthorized access.(2) A patient not being able to access medication in a lockable vial.(h)(g) The board may adopt regulations to carry out this section.(h) (1) The board shall assess a fine in an amount to be determined by the board for a violation of this section by a pharmacist.(2) The board may choose not to take administrative action against a pharmacy if it determines that compliance with this section would create a financial hardship on the pharmacy or that the pharmacy was temporarily out of stock of lockable vials after taking reasonable steps to ensure an adequate supply for all dispensations of Schedule II or Schedule IIN controlled substances.(i) Section 4321 shall not apply to a violation of this section.SEC. 2.No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution. | |
| 40 | 47 | ||
| 41 | 48 | The people of the State of California do enact as follows: | |
| 42 | 49 | ||
| 43 | 50 | ## The people of the State of California do enact as follows: | |
| 44 | 51 | ||
| 45 | - | SECTION 1. Article 12.5 (commencing with Section 4178) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read: Article 12.5. California Safe Dispensing Act4178. (a) This article shall be known as the California Safe Dispensing Act.(b) This article shall become operative on June 30, 2022.4178.1. (a) As used in this section, lockable vial means a prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5. | |
| 52 | + | SECTION 1. Article 12.5 (commencing with Section 4178) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read: Article 12.5. California Safe Dispensing Act4178. (a) This article shall be known as the California Safe Dispensing Act.(b) This article shall become operative on June 30, 2022.4178.1. (a) As used in this section, lockable vial means a disposable container that is special packaging, as defined in Section 1471 of Title 15 of the United States Code, and that has a locking cap that can be unlocked using one of the following: prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5.(1)An alphanumeric passcode or other code.(2)A unique physical key.(3)A locking mechanism that is accessible only by the patient with a code, alphanumeric passcode, or key, or by another secure mechanism.(b) Except as provided in subdivision (d), (c), a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.) shall do all of the following:(1) Dispense the controlled substance in a lockable vial.(2) Provide the educational pamphlet described in subdivision (c). a copy of the Opioid Factsheet for Patients published by the federal Centers for Disease Control and Prevention.(3) (A) If the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, shall choose the code.(B) Subparagraph (A) shall not apply to medications prescribed for services specified in Sections 6924 to 6928, inclusive, of the Family Code or in Section 2397 of this code.(c)The board shall develop an educational pamphlet that includes information on the potential for the abuse and diversion of controlled substances. The board shall provide the educational pamphlet to pharmacists in printed form. (d)(c) A pharmacist is not required to dispense a controlled substance in Schedule II of the federal Controlled Substances Act in a lockable vial if one or more of the following applies:(1) The patient, because of a physical or mental condition, would have difficulty opening the lockable vial.(2) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3) The patient or patients representative requests that the patients medication not be dispensed in a lockable vial. (e)(d) (1) The manufacturer of a controlled substance shall reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances in that month.(2) The manufacturer of a controlled substance shall reimburse the pharmacy within 30 days of receiving the claim and shall pay a reasonable rate for the net acquisition cost of the lockable vials, dispensing costs, and services rendered, including any patient consultation and instruction.(3) (A) A manufacturer of a controlled substance that fails to reimburse a pharmacy within the time period and for the amount specified in this subdivision is liable for a civil penalty of one thousand dollars ($1,000) per day for each day the manufacturer is delinquent in reimbursing the pharmacy.(B) The civil penalty shall be assessed and recovered in a civil action brought by the board in the name of the people of the State of California.(C) Assessment of a civil penalty, at the request of the manufacturer of the controlled substance that was assessed the penalty, may be reviewed on appeal and the penalty may be reduced or waived for good cause.(f)(e) Any vendor that contracts with a pharmacy to provide a lockable vial shall make available at all times assistance online or through a toll-free number for patient use.(g)(f) A prescriber, or the prescribers professional corporation or other business entity, who prescribes a controlled substance dispensed in a lockable vial shall not be liable for any adverse consequences that result from either of the following:(1) The failure of any lockable vial to prevent unauthorized access.(2) A patient not being able to access medication in a lockable vial.(h)(g) The board may adopt regulations to carry out this section.(h) (1) The board shall assess a fine in an amount to be determined by the board for a violation of this section by a pharmacist.(2) The board may choose not to take administrative action against a pharmacy if it determines that compliance with this section would create a financial hardship on the pharmacy or that the pharmacy was temporarily out of stock of lockable vials after taking reasonable steps to ensure an adequate supply for all dispensations of Schedule II or Schedule IIN controlled substances.(i) Section 4321 shall not apply to a violation of this section. | |
| 46 | 53 | ||
| 47 | 54 | SECTION 1. Article 12.5 (commencing with Section 4178) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read: | |
| 48 | 55 | ||
| 49 | 56 | ### SECTION 1. | |
| 50 | 57 | ||
| 51 | - | Article 12.5. California Safe Dispensing Act4178. (a) This article shall be known as the California Safe Dispensing Act.(b) This article shall become operative on June 30, 2022.4178.1. (a) As used in this section, lockable vial means a prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5. | |
| 58 | + | Article 12.5. California Safe Dispensing Act4178. (a) This article shall be known as the California Safe Dispensing Act.(b) This article shall become operative on June 30, 2022.4178.1. (a) As used in this section, lockable vial means a disposable container that is special packaging, as defined in Section 1471 of Title 15 of the United States Code, and that has a locking cap that can be unlocked using one of the following: prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5.(1)An alphanumeric passcode or other code.(2)A unique physical key.(3)A locking mechanism that is accessible only by the patient with a code, alphanumeric passcode, or key, or by another secure mechanism.(b) Except as provided in subdivision (d), (c), a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.) shall do all of the following:(1) Dispense the controlled substance in a lockable vial.(2) Provide the educational pamphlet described in subdivision (c). a copy of the Opioid Factsheet for Patients published by the federal Centers for Disease Control and Prevention.(3) (A) If the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, shall choose the code.(B) Subparagraph (A) shall not apply to medications prescribed for services specified in Sections 6924 to 6928, inclusive, of the Family Code or in Section 2397 of this code.(c)The board shall develop an educational pamphlet that includes information on the potential for the abuse and diversion of controlled substances. The board shall provide the educational pamphlet to pharmacists in printed form. (d)(c) A pharmacist is not required to dispense a controlled substance in Schedule II of the federal Controlled Substances Act in a lockable vial if one or more of the following applies:(1) The patient, because of a physical or mental condition, would have difficulty opening the lockable vial.(2) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3) The patient or patients representative requests that the patients medication not be dispensed in a lockable vial. (e)(d) (1) The manufacturer of a controlled substance shall reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances in that month.(2) The manufacturer of a controlled substance shall reimburse the pharmacy within 30 days of receiving the claim and shall pay a reasonable rate for the net acquisition cost of the lockable vials, dispensing costs, and services rendered, including any patient consultation and instruction.(3) (A) A manufacturer of a controlled substance that fails to reimburse a pharmacy within the time period and for the amount specified in this subdivision is liable for a civil penalty of one thousand dollars ($1,000) per day for each day the manufacturer is delinquent in reimbursing the pharmacy.(B) The civil penalty shall be assessed and recovered in a civil action brought by the board in the name of the people of the State of California.(C) Assessment of a civil penalty, at the request of the manufacturer of the controlled substance that was assessed the penalty, may be reviewed on appeal and the penalty may be reduced or waived for good cause.(f)(e) Any vendor that contracts with a pharmacy to provide a lockable vial shall make available at all times assistance online or through a toll-free number for patient use.(g)(f) A prescriber, or the prescribers professional corporation or other business entity, who prescribes a controlled substance dispensed in a lockable vial shall not be liable for any adverse consequences that result from either of the following:(1) The failure of any lockable vial to prevent unauthorized access.(2) A patient not being able to access medication in a lockable vial.(h)(g) The board may adopt regulations to carry out this section.(h) (1) The board shall assess a fine in an amount to be determined by the board for a violation of this section by a pharmacist.(2) The board may choose not to take administrative action against a pharmacy if it determines that compliance with this section would create a financial hardship on the pharmacy or that the pharmacy was temporarily out of stock of lockable vials after taking reasonable steps to ensure an adequate supply for all dispensations of Schedule II or Schedule IIN controlled substances.(i) Section 4321 shall not apply to a violation of this section. | |
| 52 | 59 | ||
| 53 | - | Article 12.5. California Safe Dispensing Act4178. (a) This article shall be known as the California Safe Dispensing Act.(b) This article shall become operative on June 30, 2022.4178.1. (a) As used in this section, lockable vial means a prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5. | |
| 60 | + | Article 12.5. California Safe Dispensing Act4178. (a) This article shall be known as the California Safe Dispensing Act.(b) This article shall become operative on June 30, 2022.4178.1. (a) As used in this section, lockable vial means a disposable container that is special packaging, as defined in Section 1471 of Title 15 of the United States Code, and that has a locking cap that can be unlocked using one of the following: prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5.(1)An alphanumeric passcode or other code.(2)A unique physical key.(3)A locking mechanism that is accessible only by the patient with a code, alphanumeric passcode, or key, or by another secure mechanism.(b) Except as provided in subdivision (d), (c), a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.) shall do all of the following:(1) Dispense the controlled substance in a lockable vial.(2) Provide the educational pamphlet described in subdivision (c). a copy of the Opioid Factsheet for Patients published by the federal Centers for Disease Control and Prevention.(3) (A) If the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, shall choose the code.(B) Subparagraph (A) shall not apply to medications prescribed for services specified in Sections 6924 to 6928, inclusive, of the Family Code or in Section 2397 of this code.(c)The board shall develop an educational pamphlet that includes information on the potential for the abuse and diversion of controlled substances. The board shall provide the educational pamphlet to pharmacists in printed form. (d)(c) A pharmacist is not required to dispense a controlled substance in Schedule II of the federal Controlled Substances Act in a lockable vial if one or more of the following applies:(1) The patient, because of a physical or mental condition, would have difficulty opening the lockable vial.(2) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3) The patient or patients representative requests that the patients medication not be dispensed in a lockable vial. (e)(d) (1) The manufacturer of a controlled substance shall reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances in that month.(2) The manufacturer of a controlled substance shall reimburse the pharmacy within 30 days of receiving the claim and shall pay a reasonable rate for the net acquisition cost of the lockable vials, dispensing costs, and services rendered, including any patient consultation and instruction.(3) (A) A manufacturer of a controlled substance that fails to reimburse a pharmacy within the time period and for the amount specified in this subdivision is liable for a civil penalty of one thousand dollars ($1,000) per day for each day the manufacturer is delinquent in reimbursing the pharmacy.(B) The civil penalty shall be assessed and recovered in a civil action brought by the board in the name of the people of the State of California.(C) Assessment of a civil penalty, at the request of the manufacturer of the controlled substance that was assessed the penalty, may be reviewed on appeal and the penalty may be reduced or waived for good cause.(f)(e) Any vendor that contracts with a pharmacy to provide a lockable vial shall make available at all times assistance online or through a toll-free number for patient use.(g)(f) A prescriber, or the prescribers professional corporation or other business entity, who prescribes a controlled substance dispensed in a lockable vial shall not be liable for any adverse consequences that result from either of the following:(1) The failure of any lockable vial to prevent unauthorized access.(2) A patient not being able to access medication in a lockable vial.(h)(g) The board may adopt regulations to carry out this section.(h) (1) The board shall assess a fine in an amount to be determined by the board for a violation of this section by a pharmacist.(2) The board may choose not to take administrative action against a pharmacy if it determines that compliance with this section would create a financial hardship on the pharmacy or that the pharmacy was temporarily out of stock of lockable vials after taking reasonable steps to ensure an adequate supply for all dispensations of Schedule II or Schedule IIN controlled substances.(i) Section 4321 shall not apply to a violation of this section. | |
| 54 | 61 | ||
| 55 | 62 | Article 12.5. California Safe Dispensing Act | |
| 56 | 63 | ||
| 57 | 64 | Article 12.5. California Safe Dispensing Act | |
| 58 | 65 | ||
| 59 | 66 | 4178. (a) This article shall be known as the California Safe Dispensing Act.(b) This article shall become operative on June 30, 2022. | |
| 60 | 67 | ||
| 61 | 68 | ||
| 62 | 69 | ||
| 63 | 70 | 4178. (a) This article shall be known as the California Safe Dispensing Act. | |
| 64 | 71 | ||
| 65 | 72 | (b) This article shall become operative on June 30, 2022. | |
| 66 | 73 | ||
| 67 | - | 4178.1. (a) As used in this section, lockable vial means a prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5. | |
| 74 | + | 4178.1. (a) As used in this section, lockable vial means a disposable container that is special packaging, as defined in Section 1471 of Title 15 of the United States Code, and that has a locking cap that can be unlocked using one of the following: prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5.(1)An alphanumeric passcode or other code.(2)A unique physical key.(3)A locking mechanism that is accessible only by the patient with a code, alphanumeric passcode, or key, or by another secure mechanism.(b) Except as provided in subdivision (d), (c), a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.) shall do all of the following:(1) Dispense the controlled substance in a lockable vial.(2) Provide the educational pamphlet described in subdivision (c). a copy of the Opioid Factsheet for Patients published by the federal Centers for Disease Control and Prevention.(3) (A) If the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, shall choose the code.(B) Subparagraph (A) shall not apply to medications prescribed for services specified in Sections 6924 to 6928, inclusive, of the Family Code or in Section 2397 of this code.(c)The board shall develop an educational pamphlet that includes information on the potential for the abuse and diversion of controlled substances. The board shall provide the educational pamphlet to pharmacists in printed form. (d)(c) A pharmacist is not required to dispense a controlled substance in Schedule II of the federal Controlled Substances Act in a lockable vial if one or more of the following applies:(1) The patient, because of a physical or mental condition, would have difficulty opening the lockable vial.(2) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3) The patient or patients representative requests that the patients medication not be dispensed in a lockable vial. (e)(d) (1) The manufacturer of a controlled substance shall reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances in that month.(2) The manufacturer of a controlled substance shall reimburse the pharmacy within 30 days of receiving the claim and shall pay a reasonable rate for the net acquisition cost of the lockable vials, dispensing costs, and services rendered, including any patient consultation and instruction.(3) (A) A manufacturer of a controlled substance that fails to reimburse a pharmacy within the time period and for the amount specified in this subdivision is liable for a civil penalty of one thousand dollars ($1,000) per day for each day the manufacturer is delinquent in reimbursing the pharmacy.(B) The civil penalty shall be assessed and recovered in a civil action brought by the board in the name of the people of the State of California.(C) Assessment of a civil penalty, at the request of the manufacturer of the controlled substance that was assessed the penalty, may be reviewed on appeal and the penalty may be reduced or waived for good cause.(f)(e) Any vendor that contracts with a pharmacy to provide a lockable vial shall make available at all times assistance online or through a toll-free number for patient use.(g)(f) A prescriber, or the prescribers professional corporation or other business entity, who prescribes a controlled substance dispensed in a lockable vial shall not be liable for any adverse consequences that result from either of the following:(1) The failure of any lockable vial to prevent unauthorized access.(2) A patient not being able to access medication in a lockable vial.(h)(g) The board may adopt regulations to carry out this section.(h) (1) The board shall assess a fine in an amount to be determined by the board for a violation of this section by a pharmacist.(2) The board may choose not to take administrative action against a pharmacy if it determines that compliance with this section would create a financial hardship on the pharmacy or that the pharmacy was temporarily out of stock of lockable vials after taking reasonable steps to ensure an adequate supply for all dispensations of Schedule II or Schedule IIN controlled substances.(i) Section 4321 shall not apply to a violation of this section. | |
| 68 | 75 | ||
| 69 | 76 | ||
| 70 | 77 | ||
| 71 | - | 4178.1. (a) As used in this section, lockable vial means a prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5. | |
| 78 | + | 4178.1. (a) As used in this section, lockable vial means a disposable container that is special packaging, as defined in Section 1471 of Title 15 of the United States Code, and that has a locking cap that can be unlocked using one of the following: prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5. | |
| 72 | 79 | ||
| 73 | - | (b) Except as provided in subdivision (c), a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.) shall do all of the following: | |
| 80 | + | (1)An alphanumeric passcode or other code. | |
| 81 | + | ||
| 82 | + | ||
| 83 | + | ||
| 84 | + | (2)A unique physical key. | |
| 85 | + | ||
| 86 | + | ||
| 87 | + | ||
| 88 | + | (3)A locking mechanism that is accessible only by the patient with a code, alphanumeric passcode, or key, or by another secure mechanism. | |
| 89 | + | ||
| 90 | + | ||
| 91 | + | ||
| 92 | + | (b) Except as provided in subdivision (d), (c), a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.) shall do all of the following: | |
| 74 | 93 | ||
| 75 | 94 | (1) Dispense the controlled substance in a lockable vial. | |
| 76 | 95 | ||
| 77 | - | (2) Provide a copy of the Opioid Factsheet for Patients published by the federal Centers for Disease Control and Prevention. | |
| 96 | + | (2) Provide the educational pamphlet described in subdivision (c). a copy of the Opioid Factsheet for Patients published by the federal Centers for Disease Control and Prevention. | |
| 78 | 97 | ||
| 79 | - | (3) (A)If the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The | |
| 98 | + | (3) (A) If the lockable vial uses an alphanumeric passcode or other code, include the code in any patient notes in the database or other system used by the pharmacy in the dispensing of prescription drugs. The patient, or the patients parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, shall choose the code. | |
| 80 | 99 | ||
| 81 | - | (A) | |
| 100 | + | (B) Subparagraph (A) shall not apply to medications prescribed for services specified in Sections 6924 to 6928, inclusive, of the Family Code or in Section 2397 of this code. | |
| 82 | 101 | ||
| 83 | - | (B) Subparagraph (A) shall not apply to In the case of medications prescribed for to a minor who may consent to services specified in Sections 6924 to 6928, inclusive, Chapter 3 (commencing with Section 6920) of Part 4 of Division 11 of the Family Code or in Section 2397 of this code. Code, the minor shall choose the code. | |
| 84 | - | ||
| 85 | - | (c) (1) A pharmacist is not required to shall not dispense a controlled substance in Schedule II of the federal Controlled Substances Act in a lockable vial if one or more of the following applies: | |
| 86 | - | ||
| 87 | - | (1)The patient, directly to a patient who, because of a physical or mental condition, would have difficulty opening the lockable vial. | |
| 88 | - | ||
| 89 | - | (2) A pharmacist is not required to dispense a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act in a lockable vial in either of the following circumstances: | |
| 90 | - | ||
| 91 | - | (2) | |
| 102 | + | (c)The board shall develop an educational pamphlet that includes information on the potential for the abuse and diversion of controlled substances. The board shall provide the educational pamphlet to pharmacists in printed form. | |
| 92 | 103 | ||
| 93 | 104 | ||
| 94 | 105 | ||
| 95 | - | (A) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility. | |
| 96 | - | ||
| 97 | - | (3) | |
| 106 | + | (d) | |
| 98 | 107 | ||
| 99 | 108 | ||
| 100 | 109 | ||
| 101 | - | (B) The patient patient, including a patient who is a minor who may consent to services specified in Chapter 3 (commencing with Section 6920) of Part 4 of Division 11 of the Family Code, or the patients representative who is authorized pursuant to paragraph (3) of subdivision (b) to choose the code for the lockable vial requests that the patients medication not be dispensed in a lockable vial. | |
| 110 | + | (c) A pharmacist is not required to dispense a controlled substance in Schedule II of the federal Controlled Substances Act in a lockable vial if one or more of the following applies: | |
| 111 | + | ||
| 112 | + | (1) The patient, because of a physical or mental condition, would have difficulty opening the lockable vial. | |
| 113 | + | ||
| 114 | + | (2) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility. | |
| 115 | + | ||
| 116 | + | (3) The patient or patients representative requests that the patients medication not be dispensed in a lockable vial. | |
| 117 | + | ||
| 118 | + | (e) | |
| 119 | + | ||
| 120 | + | ||
| 102 | 121 | ||
| 103 | 122 | (d) (1) The manufacturer of a controlled substance shall reimburse the pharmacy each month for the cost of lockable vials used by the pharmacy to dispense controlled substances in that month. | |
| 104 | 123 | ||
| 105 | 124 | (2) The manufacturer of a controlled substance shall reimburse the pharmacy within 30 days of receiving the claim and shall pay a reasonable rate for the net acquisition cost of the lockable vials, dispensing costs, and services rendered, including any patient consultation and instruction. | |
| 106 | 125 | ||
| 107 | 126 | (3) (A) A manufacturer of a controlled substance that fails to reimburse a pharmacy within the time period and for the amount specified in this subdivision is liable for a civil penalty of one thousand dollars ($1,000) per day for each day the manufacturer is delinquent in reimbursing the pharmacy. | |
| 108 | 127 | ||
| 109 | 128 | (B) The civil penalty shall be assessed and recovered in a civil action brought by the board in the name of the people of the State of California. | |
| 110 | 129 | ||
| 111 | 130 | (C) Assessment of a civil penalty, at the request of the manufacturer of the controlled substance that was assessed the penalty, may be reviewed on appeal and the penalty may be reduced or waived for good cause. | |
| 112 | 131 | ||
| 113 | - | (e) Any vendor that contracts with a pharmacy to provide a lockable vial shall make available at all times assistance online or through a toll-free number for patient use. | |
| 114 | - | ||
| 115 | - | (f) (1) A prescriber, or the prescribers professional corporation or other business entity, who prescribes a controlled substance dispensed in a lockable vial shall not be liable for any adverse consequences that result from either of the following: | |
| 116 | - | ||
| 117 | - | (1) | |
| 132 | + | (f) | |
| 118 | 133 | ||
| 119 | 134 | ||
| 120 | 135 | ||
| 121 | - | ( | |
| 136 | + | (e) Any vendor that contracts with a pharmacy to provide a lockable vial shall make available at all times assistance online or through a toll-free number for patient use. | |
| 122 | 137 | ||
| 123 | - | ( | |
| 138 | + | (g) | |
| 124 | 139 | ||
| 125 | 140 | ||
| 126 | 141 | ||
| 127 | - | ( | |
| 142 | + | (f) A prescriber, or the prescribers professional corporation or other business entity, who prescribes a controlled substance dispensed in a lockable vial shall not be liable for any adverse consequences that result from either of the following: | |
| 128 | 143 | ||
| 129 | - | (2) This subdivision does not affect a persons liability under existing law for damages caused by defective products, or as a result of willful or wanton misconduct, recklessness, or gross negligence. | |
| 144 | + | (1) The failure of any lockable vial to prevent unauthorized access. | |
| 145 | + | ||
| 146 | + | (2) A patient not being able to access medication in a lockable vial. | |
| 147 | + | ||
| 148 | + | (h) | |
| 149 | + | ||
| 150 | + | ||
| 130 | 151 | ||
| 131 | 152 | (g) The board may adopt regulations to carry out this section. | |
| 132 | 153 | ||
| 133 | 154 | (h) (1) The board shall assess a fine in an amount to be determined by the board for a violation of this section by a pharmacist. | |
| 134 | 155 | ||
| 135 | 156 | (2) The board may choose not to take administrative action against a pharmacy if it determines that compliance with this section would create a financial hardship on the pharmacy or that the pharmacy was temporarily out of stock of lockable vials after taking reasonable steps to ensure an adequate supply for all dispensations of Schedule II or Schedule IIN controlled substances. | |
| 136 | 157 | ||
| 137 | 158 | (i) Section 4321 shall not apply to a violation of this section. | |
| 159 | + | ||
| 160 | + | ||
| 161 | + | ||
| 162 | + | No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution. |