NY Educ L § 6829 (2021)
2021 New York Laws EDN - Education Title 8 - The Professions Article 137 - Pharmacy 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.