Bill Text: NY S09448 | 2021-2022 | General Assembly | Introduced

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Bill Title: Permits an exception from registration for nonresident pharmacies in cases of a specific patient need or a declared public health emergency under certain conditions.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Vetoed) 2022-12-23 - VETOED MEMO.176 [S09448 Detail]

Download: New_York-2021-S09448-Introduced.html

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                STATE OF NEW YORK
        ________________________________________________________________________

                                          9448

                    IN SENATE

                                      May 27, 2022
                                       ___________

        Introduced  by  Sen.  BROUK  -- read twice and ordered printed, and when
          printed to be committed to the Committee on Higher Education

        AN ACT to amend the education law, in relation to  the  registration  of
          nonresident  pharmacies,  manufacturers,  wholesalers  and outsourcing
          facilities that deliver prescription drugs  to  other  establishments,
          authorized prescribers and patients residing in this state

          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:

     1    Section 1. Subdivision 2 of section 6808-b of the  education  law,  as
     2  amended  by  chapter  567  of  the  laws  of 2002, is amended to read as
     3  follows:
     4    2. Registration. (a) All nonresident establishments that  ship,  mail,
     5  or  deliver prescription drugs and/or devices to other registered estab-
     6  lishments, authorized prescribers, and/or patients into this state shall
     7  be registered with the department; except that such  registration  shall
     8  not  apply  to  intra-company transfers between any division, affiliate,
     9  subsidiaries, parent or other entities under complete  common  ownership
    10  and  control.  The  provisions of this subdivision shall apply solely to
    11  nonresident establishments and shall not affect any other  provision  of
    12  this article.
    13    (b)  Notwithstanding  the  provisions of this article, an unregistered
    14  nonresident establishment may ship, mail, or deliver prescription  drugs
    15  and/or  devices to registered establishments in this state in cases of a
    16  specific patient need or a declared public  health  emergency,  provided
    17  that:
    18    (i) the unlicensed establishment is appropriately licensed in its home
    19  state,  and  documentation of the license verification can be maintained
    20  by the resident establishment in a manner determined by the department;
    21    (ii) in cases of specific patient need, the  registered  establishment
    22  shall  maintain documentation that the transfer is for such purpose in a
    23  manner determined by the department;
    24    (iii) the resident pharmacy complies with all  recordkeeping  require-
    25  ments of the department for each drug or device received from any unreg-
    26  istered nonresident establishment;

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD09095-04-2
        S. 9448                             2

     1    (iv)  all  documentation  and  records  are  retained  and are readily
     2  retrievable by the resident establishment for a period of six years;
     3    (v)  the prescription drug or device was manufactured by an authorized
     4  FDA registered drug manufacturer and is not  a  compounded  drug.    The
     5  unregistered  nonresident  establishment  shall  only deliver or trade a
     6  drug or device salable on prescription only  that  it  receives  from  a
     7  manufacturer,  a  wholesale distributor or a pharmacy in accordance with
     8  the federal Drug Supply Chain Security Act (DSCSA);
     9    (vi) the nonresident  establishment  from  which  the  drug  is  being
    10  obtained  receives  a  request  for  the drug that identifies the drug's
    11  brand name or generic name, quality, quantity, and size. Such drug shall
    12  not be expired at the time of the exchange;
    13    (vii)  the drug being obtained includes  with  the  drug  a  packaging
    14  checklist confirming that the drug being delivered or traded matches the
    15  information  identified  on  the  request,  and the drug is delivered or
    16  traded in the  original  manufacturer's  packaging,  whether  sealed  or
    17  unsealed,  with  package  insert,  the  drug's  national  drug code, lot
    18  number, and expiration date conspicuously identified on  the  packaging.
    19  If  the original manufacturer's packaging is unsealed at the time of the
    20  delivery or trade, the delivery or trade may include a quantity  of  the
    21  drug  that  is less than the quantity contained in the original manufac-
    22  turer's packaging.  However, a pharmacy shall not trade or deliver  more
    23  than one unsealed or partial quantity of the drug during any consecutive
    24  ninety-day period;
    25    (viii)  notwithstanding the language of this section, nothing shall be
    26  interpreted  to  allow  for  the sale, trade or exchange of a controlled
    27  substance as defined by article thirty-three of the public  health  law;
    28  and
    29    (ix)  the sale/transfer price of any item exchanged under this section
    30  may  not  exceed one hundred percent of the item's Wholesale Acquisition
    31  Cost (WAC) at the time of the sale.
    32    (c)   A pharmacy  that  receives  notification  from  an  unregistered
    33  nonresident  establishment  that  a delivery or trade involved a drug or
    34  device salable on prescription only that is an  illegitimate,  recalled,
    35  or counterfeit product shall immediately notify the state board of phar-
    36  macy, and the FDA.
    37    (d)    Any  unregistered nonresident establishment involved in a sale,
    38  exchange, or transaction under this section is subject to the  jurisdic-
    39  tion  of  the  state of New York regarding said sale, exchange or trans-
    40  action.  Such establishment shall cooperate with agents of the state  of
    41  New  York if said agent is conducting an audit or investigation into the
    42  sale, exchange or transaction, and violations of this section  shall  be
    43  punishable  according  to  regulations promulgated by the department and
    44  the laws of this state.
    45    (e) For purposes  of  this  subdivision  "specific  patient  need"  is
    46  defined  as  the  transfer  of a product from one pharmacy to another to
    47  fill a prescription for  an  identified  patient.  Such  term  does  not
    48  include  the  transfer of a product from one pharmacy to another for the
    49  purpose of increasing or replenishing stock in anticipation of a  poten-
    50  tial need in accordance with the federal Drug Supply Chain Security Act.
    51    §  2.  This  act shall take effect on the ninetieth day after it shall
    52  become a law.