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This entry was published on 2014-09-22
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SECTION 6829
Interpretation and translation requirements for prescription drugs and standardized medication labeling
Education (EDN) CHAPTER 16, TITLE 8, ARTICLE 137
§ 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.