2010 New York Code
EDN - Education
Title 8 - THE PROFESSIONS
Article 137 - (6800 - 6828) PHARMACY
6808-B - Registration of nonresident establishments.

§  6808-b.  Registration of nonresident establishments. 1. Definition.
  The  term  "nonresident  establishment"   shall   mean   any   pharmacy,
  manufacturer  or  wholesaler  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  or wholesaler 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.