§ 6808-B — Registration of nonresident establishments

New York § 6808-B

• Jurisdiction: New York
• Law EDN: Education
• Title 8: The Professions
• Art. 137: Pharmacy

Text

§ 6808-b. Registration of nonresident establishments. * 1.\nDefinition. The term "nonresident establishment" shall mean any\npharmacy, manufacturer, wholesaler, or outsourcing facility located\noutside of the state that ships, mails or delivers prescription drugs or\ndevices to other establishments, authorized prescribers and/or patients\nresiding in this state. Such establishments shall include, but not be\nlimited to, pharmacies that transact business through the use of the\ninternet.\n * NB Effective until May 22, 2026\n * 1. Definition. The term "nonresident establishment" shall mean any\npharmacy located outside of the state that participates in shared\npharmacy services for registered pharmacies and/or patients residing in\nthis state or pharmacy, manufacturer, wholesaler, or outsourcing\nfacility located outside of the state that ships, mails or delivers\nprescription drugs or devices to other establishments, authorized\nprescribers and/or patients residing in this state. Such establishments\nshall include, but not be limited to, pharmacies that transact business\nthrough the use of the internet.\n * NB Effective May 22, 2026\n * 2. Registration. All nonresident establishments that ship, mail, or\ndeliver prescription drugs and/or devices to other registered\nestablishments, authorized prescribers, and/or patients into this state\nshall be registered with the department; except that such registration\nshall not apply to intra-company transfers between any division,\naffiliate, subsidiaries, parent or other entities under complete common\nownership and control. The provisions of this subdivision shall apply\nsolely to nonresident establishments and shall not affect any other\nprovision of this article.\n * NB Effective until May 22, 2026\n * 2. Registration. All nonresident establishments that participate in\nshared pharmacy services for registered pharmacies and/or patients\nresiding in this state or that ship, mail, or deliver prescription drugs\nand/or devices to other registered establishments, authorized\nprescribers, and/or patients into this state shall be registered with\nthe department; except that such registration shall not apply to\nintra-company transfers between any division, affiliate, subsidiaries,\nparent or other entities under complete common ownership and control.\nThe provisions of this subdivision shall apply solely to nonresident\nestablishments and shall not affect any other provision of this article.\n * NB Effective May 22, 2026\n * 3. Agent of record. Each nonresident establishment that ships, mails\nor delivers drugs and/or devices into this state shall designate a\nresident agent in this state for service of process pursuant to rule\nthree hundred eighteen of the civil practice law and rules.\n * NB Effective until May 22, 2026\n * 3. Agent of record. Each nonresident establishment that participates\nin shared pharmacy services or ships, mails or delivers drugs and/or\ndevices into this state shall designate a resident agent in this state\nfor service of process pursuant to rule three hundred eighteen of the\ncivil practice law and rules.\n * NB Effective May 22, 2026\n 4. Conditions of registration. As a condition of registration, a\nnonresident establishment shall comply with the following requirements:\n a. Be licensed and/or registered and in good standing with the state\nof residence;\n b. Maintain, in readily retrievable form, records of drugs and/or\ndevices shipped into this state;\n c. Supply, upon request, all information needed by the department to\ncarry out the department's responsibilities under the laws and rules and\nregulations pertaining to nonresident establishments;\n d. Comply with all statutory and regulatory requirements of the state\nwhere the nonresident establishment is located, for prescription drugs\nor devices shipped, mailed or delivered into this state, except that for\ncontrolled substances shipped, mailed or delivered into this state, the\nnonresident pharmacy shall follow federal law and New York law relating\nto controlled substances;\n e. The application shall be made in the manner and form prescribed by\nthe department;\n f. The application of establishments to be registered as a\nmanufacturer, wholesaler or outsourcing facility of drugs and/or devices\nshall be accompanied by a fee as provided in section sixty-eight hundred\neight of this article; and\n g. The application of establishments to be registered as a nonresident\npharmacy shall be accompanied by a fee of three hundred forty-five\ndollars and shall be renewed triennially at a fee of two hundred sixty\ndollars.\n 5. Additional requirements. Nonresident pharmacies registered pursuant\nto this section shall:\n a. Provide a toll-free telephone number that is available during\nnormal business hours and at least forty hours per week, to enable\ncommunication between a patient in this state and a pharmacist at the\npharmacy who has access to the patient's records; and\n b. Place such toll-free telephone number on a label affixed to each\ndrug or device container.\n 6. Disciplinary action. Except in emergencies that constitute an\nimmediate threat to public health, the department shall not prosecute a\ncomplaint or otherwise take formal action against a nonresident\nestablishment based upon delivery of a drug into this state or a\nviolation of law, rule, or regulation of this state if the agency having\njurisdiction in the state where the nonresident establishment is based\ncommences action on the violation complained of within one hundred\ntwenty days from the date that the violation was reported; provided\nhowever, that the department may prosecute a complaint or take formal\naction against a nonresident establishment if it determines that the\nagency having jurisdiction in the state where the nonresident\nestablishment is based has unreasonably delayed or otherwise failed to\ntake prompt and appropriate action on a reported violation.\n 7. Revocation or suspension. A nonresident establishment that fails to\ncomply with the requirements of this section shall be subject to\nrevocation or suspension of its registration and other applicable\npenalties in accordance with the provisions of article one hundred\nthirty of this chapter.\n 8. Exception. The department may grant an exception from the\nregistration requirements of this section on the application of a\nnonresident establishment that restricts its sale or dispensing of drugs\nand/or devices to residents of this state to isolated transactions.\n 9. Rules and regulations. The department shall promulgate rules and\nregulations to implement the provisions of this section.\n