2023 New York Laws › EDN - Education › Title 8 - The Professions › Article 137 - Pharmacy › 6808-B - Registration of Nonresident Establishments.

§  6808-b. Registration of nonresident establishments.  1. Definition.
  The  term  "nonresident  establishment"   shall   mean   any   pharmacy,
  manufacturer, wholesaler, or outsourcing facility located outside of the
  state  that  ships,  mails  or delivers prescription drugs or devices to
  other establishments, authorized prescribers and/or patients residing in
  this state. Such establishments shall include, but not  be  limited  to,
  pharmacies that transact business through the use of the internet.
2.  Registration.  All  nonresident establishments that ship, mail, or
  deliver  prescription  drugs  and/or   devices   to   other   registered
  establishments,  authorized prescribers, and/or patients into this state
  shall be registered with the department; except that  such  registration
  shall  not  apply  to  intra-company  transfers  between  any  division,
  affiliate, subsidiaries, parent or other entities under complete  common
  ownership  and  control.  The provisions of this subdivision shall apply
  solely to nonresident establishments and  shall  not  affect  any  other
  provision of this article.
3.  Agent  of record. Each nonresident establishment that ships, mails
  or delivers drugs and/or devices  into  this  state  shall  designate  a
  resident  agent  in  this  state for service of process pursuant to rule
  three hundred eighteen of the civil practice law and rules.
4. Conditions of registration.  As  a  condition  of  registration,  a
  nonresident establishment shall comply with the following requirements:
a.  Be  licensed and/or registered and in good standing with the state
  of residence;
b. Maintain, in readily retrievable  form,  records  of  drugs  and/or
  devices shipped into this state;
c.  Supply,  upon request, all information needed by the department to
  carry out the department's responsibilities under the laws and rules and
  regulations pertaining to nonresident establishments;
d. Comply with all statutory and regulatory requirements of the  state
  where  the  nonresident establishment is located, for prescription drugs
  or devices shipped, mailed or delivered into this state, except that for
  controlled substances shipped, mailed or delivered into this state,  the
  nonresident  pharmacy shall follow federal law and New York law relating
  to controlled substances;
e. The application shall be made in the manner and form prescribed  by
  the department;
f.   The   application   of  establishments  to  be  registered  as  a
  manufacturer, wholesaler or outsourcing facility of drugs and/or devices
  shall be accompanied by a fee as provided in section sixty-eight hundred
  eight of this article; and
g. The application of establishments to be registered as a nonresident
  pharmacy shall be accompanied by  a  fee  of  three  hundred  forty-five
  dollars  and  shall be renewed triennially at a fee of two hundred sixty
  dollars.
5. Additional requirements. Nonresident pharmacies registered pursuant
  to this section shall:
a. Provide a toll-free  telephone  number  that  is  available  during
  normal  business  hours  and  at  least  forty hours per week, to enable
  communication between a patient in this state and a  pharmacist  at  the
  pharmacy who has access to the patient's records; and
b.  Place  such  toll-free telephone number on a label affixed to each
  drug or device container.
6. Disciplinary action.  Except  in  emergencies  that  constitute  an
  immediate  threat to public health, the department shall not prosecute a
  complaint  or  otherwise  take  formal  action  against  a   nonresident
  establishment  based  upon  delivery  of  a  drug  into  this state or a
  violation of law, rule, or regulation of this state if the agency having

  jurisdiction in the state where the nonresident establishment  is  based
  commences  action  on  the  violation  complained  of within one hundred
  twenty days from the date that  the  violation  was  reported;  provided
  however,  that  the  department may prosecute a complaint or take formal
  action against a nonresident establishment if  it  determines  that  the
  agency   having   jurisdiction   in  the  state  where  the  nonresident
  establishment is based has unreasonably delayed or otherwise  failed  to
  take prompt and appropriate action on a reported violation.
7. Revocation or suspension. A nonresident establishment that fails to
  comply  with  the  requirements  of  this  section  shall  be subject to
  revocation or  suspension  of  its  registration  and  other  applicable
  penalties  in  accordance  with  the  provisions  of article one hundred
  thirty of this chapter.
8.  Exception.  The  department  may  grant  an  exception  from   the
  registration  requirements  of  this  section  on  the  application of a
  nonresident establishment that restricts its sale or dispensing of drugs
  and/or devices to residents of this state to isolated transactions.
9. Rules and regulations. The department shall  promulgate  rules  and
  regulations to implement the provisions of this section.