§ 6829. Interpretation and translation requirements for prescription drugs and standardized medication labeling. 1. For the purposes of this section, the following terms shall have the following meanings: (a) "Covered pharmacy" means any pharmacy that is part of a group of eight or more pharmacies, located within New York state and owned by the same corporate entity. For purposes of this section, "corporate entity" shall include related subsidiaries, affiliates, successors, or assignees doing business as or operating under a common name or trading symbol.

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(b) "Limited English proficient individual" or "LEP individual" means an individual who identifies as being, or is evidently, unable to speak, read or write English at a level that permits such individual to understand health-related and pharmaceutical information communicated in English.

(c) "Translation" shall mean the conversion of a written text from one language into an equivalent written text in another language by an individual competent to do so and utilizing all necessary pharmaceutical and health-related terminology. Such translation may occur, where appropriate, in a separate document provided to an LEP individual that accompanies his or her medication.

(d) "Competent oral interpretation" means oral communication in which a person acting as an interpreter comprehends a message and re-expresses that message accurately in another language, utilizing all necessary pharmaceutical and health-related terminology, so as to enable an LEP individual to receive all necessary information in the LEP individual's preferred pharmacy primary language.

(e) "Pharmacy primary languages" shall mean those languages spoken by one percent or more of the population, as determined by the U.S. Census, for each region, as established by regulations promulgated pursuant to this section, provided, however, that the regulations shall not require translation or competent oral interpretation of more than seven languages in any region.

(f) "Mail order pharmacy" shall mean a pharmacy that dispenses most of its prescriptions through the United States postal service or other delivery system.

2. (a) Every covered pharmacy shall provide free, competent oral interpretation services and translation services to each LEP individual requesting such services or filling a prescription that indicates that the individual is limited English proficient at such covered pharmacy in the LEP individual's preferred pharmacy primary language for the purposes of counseling such individual about his or her prescription medications or when soliciting information necessary to maintain a patient medication profile, unless the LEP individual is offered and refuses such services.

(b) Every covered pharmacy shall provide free, competent oral interpretation services and translation services of prescription medication labels, warning labels and other written material to each LEP individual filling a prescription at such covered pharmacy, unless the LEP individual is offered and refuses such services or the medication label, warning labels and other written materials have already been translated into the language spoken by the LEP individual.

(c) The services required by this section may be provided by a staff member of the pharmacy or a third-party contractor. Such services must be provided on an immediate basis but need not be provided in-person or face-to-face in order to meet the requirements of this section.

3. Every covered pharmacy shall conspicuously post, at or adjacent to each counter over which prescription drugs are sold, a notification of the right to free, competent oral interpretation services and translation services for limited English proficient individuals as provided for in subdivision two of this section. Such notifications shall be provided in the pharmacy primary languages. The size, style and placement of such notice shall be determined in accordance with rules promulgated pursuant to this section.

4. The commissioner, in consultation with the commissioner of health, shall promulgate regulations requiring that mail order pharmacies conducting business in the state provide free, competent oral interpretation services and translation services to persons filling a prescription through such mail order pharmacies whom are identified as LEP individuals. Such regulations shall take effect one year after the effective date of this section; provided, however, that they shall be promulgated pursuant to the requirements of the state administrative procedure act, address the concerns of affected stakeholders, and reflect the findings of a thorough analysis of issues including:

(a) how persons shall be identified as an LEP individual, in light of the manner by which prescriptions are currently received by such mail order pharmacies;

(b) which languages shall be considered;

(c) the manner and circumstances in which competent oral interpretation services and translation services shall be provided;

(d) the information for which competent oral interpretation services and translation services shall be provided;

(e) anticipated utilization, available resources, and cost considerations; and

(f) standards for monitoring compliance with regulations and ensuring the delivery of quality competent oral interpretation services and translation services.

The commissioner, in consultation with the commissioner of health, shall provide a report on implementation, utilization, unanticipated problems, and corrective actions undertaken and planned to the temporary president of the senate and the speaker of the assembly no later than two years after the effective date of this section.

5. Covered pharmacies shall not be liable for injuries resulting from the actions of third-party contractors taken pursuant to and within the scope of the contract with the covered pharmacy as long as the covered pharmacy entered into such contract reasonably and in good faith to comply with this section, and was not negligent with regard to the alleged misconduct of the third-party contractor.

6. The regulations promulgated pursuant to this section shall establish a process by which covered pharmacies may apply and receive a waiver from compliance with subdivisions two and three of this section upon a showing that implementation would be unnecessarily burdensome when compared to the need for such services.

7. The commissioner shall promulgate regulations in consultation with the commissioner of health to effectuate the requirements of this section.