Bill Text: CA AB1902 | 2023-2024 | Regular Session | Chaptered
Bill Title: Prescription drug labels: accessibility.
Spectrum: Partisan Bill (Republican 5-0)
Status: (Passed) 2024-09-21 - Chaptered by Secretary of State - Chapter 330, Statutes of 2024. [AB1902 Detail]
Download: California-2023-AB1902-Chaptered.html
Assembly Bill
No. 1902
CHAPTER 330
An act to amend Section 4076.6 of, and to add Section 4076.8 to, the Business and Professions Code, relating to healing arts.
[
Approved by
Governor
September 21, 2024.
Filed with
Secretary of State
September 21, 2024.
]
LEGISLATIVE COUNSEL'S DIGEST
AB 1902, 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, except as specified, would require a dispenser, if a person informs a pharmacy that the person identifies as a person who is blind, has low-vision, or is otherwise print disabled, to
provide to the person or their authorized representative, at no additional cost, an accessible prescription label affixed to the container that meets prescribed requirements. If the accessible prescription label does not fit on the container, the bill would require the dispenser, upon dispensing the prescription drug, to provide the patient or their authorized representative with a supplemental document that otherwise meets those prescribed requirements. The bill would
not apply to prescriptions issued by a veterinarian. 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.
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YESBill Text
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 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) This section does not include prescriptions issued by a veterinarian.
SEC. 2.
Section 4076.8 is added to the Business and Professions Code, to read:4076.8.
(a) If a person informs a pharmacy that the person identifies as a person who is blind, has low-vision, or is otherwise print disabled, the dispenser shall provide to the person or their authorized representative, 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 and language of the person making the request through use of audible, large print, Braille, or translated
directions 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.
(b) A dispenser shall ensure that the prescription label is compatible with the prescription reader if a reader is provided.
(c) If the accessible prescription label cannot be affixed to the container because it does not fit on the container, the dispenser, upon dispensing the prescription drug, shall provide the patient or their authorized representative with a supplemental document
that meets the requirements specified in this section.
(d) This section does not apply to prescription drugs dispensed and administered by an institutional pharmacy, correctional institution, or licensed correctional pharmacy. 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) This
section does not include prescriptions issued by a veterinarian.
(f) The board shall promulgate regulations necessary to implement this section.
(g) 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, with the exception of a licensed correctional pharmacy.
(2) “Prescription reader” means a device that is designed to audibly convey the information contained on the label of a prescription drug.
