CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Assembly Bill
No. 1902

Introduced by Assembly Member Alanis

January 23, 2024

An act to amend Section 4076.6 of, and to add Section 4076.8 to, the Business and Professions Code, relating to healing arts.


LEGISLATIVE COUNSEL'S DIGEST


AB 1902, as introduced, Alanis. Prescription drug labels: accessibility.
Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists, pharmacy technicians, and pharmacies by the California State Board of Pharmacy. Existing law requires the board to promulgate regulations that require a standardized, patient-centered, prescription drug label on all prescription medicine dispensed to patients in California. Existing law prohibits a pharmacist from dispensing a prescription except in a container that meets the requirements of state and federal law and is correctly labeled with prescribed information. Existing law makes a violation of its provisions a crime.
Existing law requires a dispenser, upon request, to provide translated directions for use, as prescribed. Existing law authorizes a dispenser to use translations made available by the board pursuant to specified regulations of the board and provides that a dispenser is not required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the board has made available in translated form. Existing law authorizes a dispenser to provide their own translated directions for use to comply with these provisions and prohibits the provisions from being construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form.
This bill would also expressly require a dispenser to provide translated directions for use in the languages the board has made available.
This bill would require a dispenser to notify each person to whom a prescription drug is dispensed that an accessible prescription label is available to the person upon request at no additional cost. The bill, except as specified, would require a dispenser, if a person informs a pharmacy that the person identifies as a person who is blind, visually impaired, otherwise print disabled, or limited English proficient, to provide to the person, at no additional cost, an accessible prescription label affixed to the container that meets prescribed requirements. The bill would require the board to promulgate regulations necessary to implement the bill.
By imposing new requirements on dispensers, the violation of which would be 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.

 Section 4076.6 of the Business and Professions Code is amended to read:

4076.6.
 (a) Upon the request of a patient or patient’s representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document. If translated directions for use appear on a prescription container or label, the English-language version of the directions for use shall also appear on the container or label, whenever possible, and may appear on other areas of the label outside the patient-centered area. When it is not possible for the English-language directions for use to appear on the container or label, it shall be provided on a supplemental document.
(b) A dispenser may use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations to comply with this section.
(c) A dispenser shall provide translated directions for use in the languages the board has made available, but shall not be required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the board has made available in translated form.
(d) A dispenser may provide his or her their own translated directions for use to comply with the requirements of this section, and nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form.
(e) A dispenser shall be responsible for the accuracy of the English-language directions for use provided to the patient. This section shall not affect a dispenser’s existing responsibility to correctly label a prescription pursuant to Section 4076.
(f) For purposes of this section, a dispenser does not include a veterinarian.

SEC. 2.

 Section 4076.8 is added to the Business and Professions Code, to read:

4076.8.
 (a) A dispenser shall notify each person to whom a prescription drug is dispensed that an accessible prescription label is available to the person upon request at no additional cost.
(b) If a person informs a pharmacy that the person identifies as a person who is blind, visually impaired, otherwise print disabled, or limited English proficient, the dispenser shall provide to the person, at no additional cost, an accessible prescription label affixed to the container that is all of the following:
(1) Available to the person in a timely manner comparable to other patient wait times and lasting for at least the duration of the prescription.
(2) Appropriate to the disability, preference, and language of the person making the request through use of audible, large print, Braille, or translated labels as required pursuant to Section 4076.6.
(3) Conforms to the format-specific best practices established by the United States Access Board and the National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health and Health Care, also referred to as the National CLAS Standards.
(4) Contains all the label information required by state statute and federal law, including cautions, warnings, and any information available to sighted and English-proficient persons reading the printed label.
(c) A dispenser shall ensure that the prescription label is compatible with the prescription reader if a reader is provided.
(d) This section does not apply to prescription drugs dispensed and administered by an institutional pharmacy or correctional institution. However, this section does apply to an institutional pharmacy when providing prescription drugs to a person with a disability for use by the individual upon their release from the health care facility.
(e) The board shall promulgate regulations necessary to implement this section.
(f) As used in this section:
(1) “Institutional pharmacy” means a pharmacy that is part of, or is operated in conjunction with, a health care facility, as defined in Section 1250 of the Health and Safety Code.
(2) “Prescription reader” means a device that is designed to audibly convey the information contained on the label of a prescription drug.

SEC. 3.

 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.