§ 6829 — Interpretation and translation requirements for prescription drugs and standardized medication labeling

§ 6829. Interpretation and translation requirements for prescription\ndrugs and standardized medication labeling. 1. For the purposes of this\nsection, the following terms shall have the following meanings: (a)\n"Covered pharmacy" means any pharmacy that is part of a group of eight\nor more pharmacies, located within New York state and owned by the same\ncorporate entity. For purposes of this section, "corporate entity" shall\ninclude related subsidiaries, affiliates, successors, or assignees doing\nbusiness as or operating under a common name or trading symbol.\n (b) "Limited English proficient individual" or "LEP individual" means\nan individual who identifies as being, or is evidently, unable to speak,\nread or write English at a level that permits such individual to\nunderstand health-related and pharmaceutical information communicated in\nEnglish.\n (c) "Translation" shall mean the conversion of a written text from one\nlanguage into an equivalent written text in another language by an\nindividual competent to do so and utilizing all necessary pharmaceutical\nand health-related terminology. Such translation may occur, where\nappropriate, in a separate document provided to an LEP individual that\naccompanies his or her medication.\n (d) "Competent oral interpretation" means oral communication in which\na person acting as an interpreter comprehends a message and re-expresses\nthat message accurately in another language, utilizing all necessary\npharmaceutical and health-related terminology, so as to enable an LEP\nindividual to receive all necessary information in the LEP individual's\npreferred pharmacy primary language.\n (e) "Pharmacy primary languages" shall mean those languages spoken by\none percent or more of the population, as determined by the U.S. Census,\nfor each region, as established by regulations promulgated pursuant to\nthis section, provided, however, that the regulations shall not require\ntranslation or competent oral interpretation of more than seven\nlanguages in any region.\n (f) "Mail order pharmacy" shall mean a pharmacy that dispenses most of\nits prescriptions through the United States postal service or other\ndelivery system.\n 2. (a) Every covered pharmacy shall provide free, competent oral\ninterpretation services and translation services to each LEP individual\nrequesting such services or filling a prescription that indicates that\nthe individual is limited English proficient at such covered pharmacy in\nthe LEP individual's preferred pharmacy primary language for the\npurposes of counseling such individual about his or her prescription\nmedications or when soliciting information necessary to maintain a\npatient medication profile, unless the LEP individual is offered and\nrefuses such services.\n (b) Every covered pharmacy shall provide free, competent oral\ninterpretation services and translation services of prescription\nmedication labels, warning labels and other written material to each LEP\nindividual filling a prescription at such covered pharmacy, unless the\nLEP individual is offered and refuses such services or the medication\nlabel, warning labels and other written materials have already been\ntranslated into the language spoken by the LEP individual.\n (c) The services required by this section may be provided by a staff\nmember of the pharmacy or a third-party contractor. Such services must\nbe provided on an immediate basis but need not be provided in-person or\nface-to-face in order to meet the requirements of this section.\n 3. Every covered pharmacy shall conspicuously post, at or adjacent to\neach counter over which prescription drugs are sold, a notification of\nthe right to free, competent oral interpretation services and\ntranslation services for limited English proficient individuals as\nprovided for in subdivision two of this section. Such notifications\nshall be provided in the pharmacy primary languages. The size, style and\nplacement of such notice shall be determined in accordance with rules\npromulgated pursuant to this section.\n 4. The commissioner, in consultation with the commissioner of health,\nshall promulgate regulations requiring that mail order pharmacies\nconducting business in the state provide free, competent oral\ninterpretation services and translation services to persons filling a\nprescription through such mail order pharmacies whom are identified as\nLEP individuals. Such regulations shall take effect one year after the\neffective date of this section; provided, however, that they shall be\npromulgated pursuant to the requirements of the state administrative\nprocedure act, address the concerns of affected stakeholders, and\nreflect the findings of a thorough analysis of issues including:\n (a) how persons shall be identified as an LEP individual, in light of\nthe manner by which prescriptions are currently received by such mail\norder pharmacies;\n (b) which languages shall be considered;\n (c) the manner and circumstances in which competent oral\ninterpretation services and translation services shall be provided;\n (d) the information for which competent oral interpretation services\nand translation services shall be provided;\n (e) anticipated utilization, available resources, and cost\nconsiderations; and\n (f) standards for monitoring compliance with regulations and ensuring\nthe delivery of quality competent oral interpretation services and\ntranslation services.\n The commissioner, in consultation with the commissioner of health,\nshall provide a report on implementation, utilization, unanticipated\nproblems, and corrective actions undertaken and planned to the temporary\npresident of the senate and the speaker of the assembly no later than\ntwo years after the effective date of this section.\n 5. Covered pharmacies shall not be liable for injuries resulting from\nthe actions of third-party contractors taken pursuant to and within the\nscope of the contract with the covered pharmacy as long as the covered\npharmacy entered into such contract reasonably and in good faith to\ncomply with this section, and was not negligent with regard to the\nalleged misconduct of the third-party contractor.\n 6. The regulations promulgated pursuant to this section shall\nestablish a process by which covered pharmacies may apply and receive a\nwaiver from compliance with subdivisions two and three of this section\nupon a showing that implementation would be unnecessarily burdensome\nwhen compared to the need for such services.\n 7. The commissioner shall promulgate regulations in consultation with\nthe commissioner of health to effectuate the requirements of this\nsection.\n