Today's Law As Amended


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



As Amends the Law Today


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 prescription locking vial that qualifies as a “safe storage product” as defined in paragraph (2) of subdivision (a) of Section 4106.5.
(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 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) 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 patient’s representative requests that the patient’s 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) 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.
(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.