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AB-1430 Pharmacy: dispensing: controlled substances.(2021-2022)

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Date Published: 02/19/2021 09:00 PM
AB1430:v99#DOCUMENT


CALIFORNIA LEGISLATURE— 2021–2022 REGULAR SESSION

Assembly Bill
No. 1430


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


AB 1430, as introduced, 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, 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 patient’s 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 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.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

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 Act

4178.
 (a) This article shall be known as the California Safe Dispensing Act.
(b) This article shall become operative on June 30, 2022.

4178.1.
 (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:
(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), 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).
(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 patient’s 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) 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.
(e) (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) 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) A prescriber, or the prescriber’s 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) The board may adopt regulations to carry out 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.