Amended IN Assembly April 21, 2021 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 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.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. 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. 4106.5 that is made of materials classified as Generally Recognized as Safe under Title 21 of the Code of Federal Regulations and meets the applicable standards specified in Part 1700 of Title 16 of the Code of Federal Regulations.(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:(1) Dispense the controlled substance in a lockable vial.(2) Provide 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(A) Except as provided in subparagraph (B), a 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, shall choose the code.(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.(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:(1)The patient, directly to a patient who, because of a physical or mental condition, would have difficulty opening the lockable vial.(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: (2)(A) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3)(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. (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.(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.(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:(1)(A) The failure of any lockable vial to prevent unauthorized access.(2)(B) A patient not being able to access medication in a lockable vial.(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.(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.
Amended IN Assembly April 21, 2021 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 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.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO
Amended IN Assembly April 21, 2021 Amended IN Assembly April 15, 2021
Amended IN Assembly April 21, 2021
Amended IN Assembly April 15, 2021
CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION
Assembly Bill
No. 1430
Introduced by Assembly Member ArambulaFebruary 19, 2021
Introduced by Assembly Member Arambula
February 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 DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 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 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.
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, 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.
## Digest Key
## Bill Text
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 prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5. 4106.5 that is made of materials classified as Generally Recognized as Safe under Title 21 of the Code of Federal Regulations and meets the applicable standards specified in Part 1700 of Title 16 of the Code of Federal Regulations.(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:(1) Dispense the controlled substance in a lockable vial.(2) Provide 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(A) Except as provided in subparagraph (B), a 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, shall choose the code.(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.(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:(1)The patient, directly to a patient who, because of a physical or mental condition, would have difficulty opening the lockable vial.(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: (2)(A) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3)(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. (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.(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.(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:(1)(A) The failure of any lockable vial to prevent unauthorized access.(2)(B) A patient not being able to access medication in a lockable vial.(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.(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.
The people of the State of California do enact as follows:
## 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 prescription locking vial that qualifies as a safe storage product as defined in paragraph (2) of subdivision (a) of Section 4106.5. 4106.5 that is made of materials classified as Generally Recognized as Safe under Title 21 of the Code of Federal Regulations and meets the applicable standards specified in Part 1700 of Title 16 of the Code of Federal Regulations.(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:(1) Dispense the controlled substance in a lockable vial.(2) Provide 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(A) Except as provided in subparagraph (B), a 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, shall choose the code.(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.(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:(1)The patient, directly to a patient who, because of a physical or mental condition, would have difficulty opening the lockable vial.(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: (2)(A) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3)(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. (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.(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.(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:(1)(A) The failure of any lockable vial to prevent unauthorized access.(2)(B) A patient not being able to access medication in a lockable vial.(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.(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.
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:
### SECTION 1.
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. 4106.5 that is made of materials classified as Generally Recognized as Safe under Title 21 of the Code of Federal Regulations and meets the applicable standards specified in Part 1700 of Title 16 of the Code of Federal Regulations.(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:(1) Dispense the controlled substance in a lockable vial.(2) Provide 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(A) Except as provided in subparagraph (B), a 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, shall choose the code.(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.(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:(1)The patient, directly to a patient who, because of a physical or mental condition, would have difficulty opening the lockable vial.(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: (2)(A) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3)(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. (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.(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.(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:(1)(A) The failure of any lockable vial to prevent unauthorized access.(2)(B) A patient not being able to access medication in a lockable vial.(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.(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.
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. 4106.5 that is made of materials classified as Generally Recognized as Safe under Title 21 of the Code of Federal Regulations and meets the applicable standards specified in Part 1700 of Title 16 of the Code of Federal Regulations.(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:(1) Dispense the controlled substance in a lockable vial.(2) Provide 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(A) Except as provided in subparagraph (B), a 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, shall choose the code.(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.(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:(1)The patient, directly to a patient who, because of a physical or mental condition, would have difficulty opening the lockable vial.(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: (2)(A) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3)(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. (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.(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.(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:(1)(A) The failure of any lockable vial to prevent unauthorized access.(2)(B) A patient not being able to access medication in a lockable vial.(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.(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.
Article 12.5. California Safe Dispensing Act
Article 12.5. California Safe Dispensing Act
4178. (a) This article shall be known as the California Safe Dispensing Act.(b) This article shall become operative on June 30, 2022.
4178. (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. 4106.5 that is made of materials classified as Generally Recognized as Safe under Title 21 of the Code of Federal Regulations and meets the applicable standards specified in Part 1700 of Title 16 of the Code of Federal Regulations.(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:(1) Dispense the controlled substance in a lockable vial.(2) Provide 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(A) Except as provided in subparagraph (B), a 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, shall choose the code.(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.(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:(1)The patient, directly to a patient who, because of a physical or mental condition, would have difficulty opening the lockable vial.(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: (2)(A) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.(3)(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. (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.(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.(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:(1)(A) The failure of any lockable vial to prevent unauthorized access.(2)(B) A patient not being able to access medication in a lockable vial.(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.(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.
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. 4106.5 that is made of materials classified as Generally Recognized as Safe under Title 21 of the Code of Federal Regulations and meets the applicable standards specified in Part 1700 of Title 16 of the Code of Federal Regulations.
(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:
(1) Dispense the controlled substance in a lockable vial.
(2) Provide 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
(A) Except as provided in subparagraph (B), a 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, shall choose the code.
(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.
(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:
(1)The patient, directly to a patient who, because of a physical or mental condition, would have difficulty opening the lockable vial.
(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:
(2)
(A) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.
(3)
(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.
(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.
(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.
(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:
(1)
(A) The failure of any lockable vial to prevent unauthorized access.
(2)
(B) A patient not being able to access medication in a lockable vial.
(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.
(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.