N.Y. Education Law § 6829: Interpretation and translation requirements for prescription drugs and standardized medication labeling

§ 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.

(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.