S07637 Summary:

BILL NOS07637
 
SAME ASSAME AS A10623
 
SPONSORLANZA
 
COSPNSRHANNON, GOLDEN, SALAND, ALESI, AVELLA, BALL, BONACIC, CARLUCCI, DEFRANCISCO, FARLEY, FLANAGAN, FUSCHILLO, GALLIVAN, GRIFFO, GRISANTI, HASSELL-THOMPSON, JOHNSON, KENNEDY, KLEIN, LARKIN, LAVALLE, LIBOUS, LITTLE, MARCELLINO, MARTINS, MAZIARZ, MCDONALD, MONTGOMERY, NOZZOLIO, O'MARA, PERALTA, RANZENHOFER, RITCHIE, ROBACH, SAVINO, SEWARD, SKELOS, STOROBIN, VALESKY, YOUNG, ZELDIN
 
MLTSPNSR
 
Rpld S21, S3306 schedule II sub (b) 6, amd Pub Health L, generally; amd S6810, Ed L; amd S220.00, Pen L
 
Enacts the Internet system for tracking over-prescribing (I-STOP) act and creates a prescription monitoring program registry (part A); relates to prescription drug forms, electronic prescribing and language assistance (part B); relates to schedules of controlled substances (part C); relates to continuing education for practitioners and pharmacists in prescription pain medication awareness and the duties of the pain management awareness workgroup (part D); relates to the safe disposal of controlled substances (part E).
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S07637 Actions:

BILL NOS07637
 
06/08/2012REFERRED TO HEALTH
06/11/2012REPORTED AND COMMITTED TO RULES
06/11/2012ORDERED TO THIRD READING CAL.1142
06/11/2012PASSED SENATE
06/11/2012DELIVERED TO ASSEMBLY
06/11/2012referred to ways and means
06/11/2012substituted for a10623
06/11/2012ordered to third reading rules cal.142
06/11/2012passed assembly
06/11/2012returned to senate
08/27/2012DELIVERED TO GOVERNOR
08/27/2012SIGNED CHAP.447
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S07637 Memo:

Memo not available
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S07637 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          7637
 
                    IN SENATE
 
                                      June 8, 2012
                                       ___________
 
        Introduced  by Sens. LANZA, HANNON, GOLDEN, SALAND -- (at request of the
          Governor) -- (at request of the Attorney General) --  read  twice  and
          ordered  printed, and when printed to be committed to the Committee on
          Health
 
        AN ACT to amend the public health  law,  in  relation  to  enacting  the
          internet  system for tracking over-prescribing (I-STOP) act and creat-

          ing a prescription monitoring program registry (Part A); to amend  the
          public  health  law and the education law, in relation to prescription
          drug forms, electronic prescribing and  language  assistance;  and  to
          repeal section 21 of the public health law, relating thereto (Part B);
          to amend the public health law and the penal law, in relation to sche-
          dules  of  controlled  substances; and to repeal certain provisions of
          the public health law relating thereto (Part C); to amend  the  public
          health  law, in relation to continuing education for practitioners and
          pharmacists in prescription pain medication awareness and  the  duties
          of  the prescription pain management awareness workgroup (Part D); and
          to amend the public health law, in relation to the  safe  disposal  of
          controlled substances (Part E)
 

          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
 
     1    Section 1. Legislative findings and intent.    The  legislature  finds
     2  that   prescription   drugs,  particularly  controlled  substances,  are
     3  increasingly subject to criminal diversion and abuse, which  can  result
     4  in  addiction,  adverse  drug  events, accidental death due to overdose,
     5  violent or self-injurious  behavior,  family  conflicts,  and  increased
     6  costs to businesses and the health care system.
     7    The  legislature  further  finds that such diversion and abuse will be
     8  mitigated by: establishing a prescription  monitoring  program  registry
     9  containing  data  about  controlled substances dispensed to individuals,
    10  reported on a real time basis; requiring health care  practitioners  and

    11  permitting  pharmacists  to  access  such registry before prescribing or
    12  dispensing additional such substances; and requiring that  prescriptions
    13  be transmitted electronically from practitioners to pharmacists.  There-
    14  fore,  the legislature finds it appropriate and necessary to establish a
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
        S                                                          LBD12123-11-2

        S. 7637                             2
 
     1  prescription monitoring program registry that  is  designed  to  utilize
     2  real time data, integrate electronic prescribing, combat overprescribing
     3  and  doctor-shopping,  and  curtail  abuse and illegal diversion without
     4  compromising  access to controlled substances for legitimate health care

     5  purposes.  The legislature further finds that these objectives  will  be
     6  promoted  by  updating  the  state's schedules of controlled substances,
     7  establishing a program for the safe disposal of controlled substances by
     8  consumers,  and  enhancing  opportunities  to  promote  education  about
     9  controlled substances for the public and practitioners.
    10    §  2.  This  act enacts into law major components of legislation which
    11  are necessary to implement fundamental changes  to  the  way  controlled
    12  substances  are  prescribed, dispensed and monitored in this state. Each
    13  component is wholly contained  within  a  Part  identified  as  Parts  A
    14  through  E.  The  effective  date of each particular provision contained
    15  within such Part is set forth in the last  section  of  such  Part.  Any
    16  provision  in  any section contained within a Part, including the effec-

    17  tive date of the Part, which makes reference to a section "of this act",
    18  when used in connection with that particular component, shall be  deemed
    19  to  mean  and refer to the corresponding section of the Part in which it
    20  is found. Section four of this act sets forth the general effective date
    21  of this act.
 
    22                                   PART A
 
    23    Section 1. This act shall be known and may be cited as  the  "Internet
    24  System for Tracking Over-Prescribing (I-STOP) Act".
    25    §  2.  The public health law is amended by adding a new section 3343-a
    26  to read as follows:
    27    § 3343-a. Prescription monitoring program registry.  1.  Establishment
    28  of system. (a) The commissioner shall, in accordance with the provisions
    29  of  this  section,  establish  and  maintain  an  electronic  system for

    30  collecting,  monitoring  and  reporting   information   concerning   the
    31  prescribing  and dispensing of controlled substances, to be known as the
    32  prescription monitoring program registry.   The registry  shall  include
    33  information reported by pharmacies on a real time basis, as set forth in
    34  subdivision  four  of  section thirty-three hundred thirty-three of this
    35  article.
    36    (b) The registry shall include, for each person to whom a prescription
    37  for controlled  substances  has  been  dispensed,  all  patient-specific
    38  information  covering  such  period of time as is deemed appropriate and
    39  feasible by the commissioner, but no less than six months  and  no  more
    40  than  five  years.   Such patient-specific information shall be obtained

    41  from the prescription information reported  by  pharmacies  pursuant  to
    42  subdivision  four  of  section thirty-three hundred thirty-three of this
    43  article and by practitioners who dispense pursuant to subdivision six of
    44  section thirty-three hundred thirty-one of this article,  and  shall  be
    45  processed  and  included in the registry by the department without undue
    46  delay. For purposes  of  this  article,  "patient-specific  information"
    47  means  information  pertaining  to  individual  patients included in the
    48  registry, which shall include the following information and  such  other
    49  information as is required by the department in regulation:
    50    (i) the patient's name;
    51    (ii) the patient's residential address;

    52    (iii) the patient's date of birth;
    53    (iv) the patient's gender;
    54    (v) the date on which the prescription was issued;

        S. 7637                             3
 
     1    (vi) the date on which the controlled substance was dispensed;
     2    (vii) the metric quantity of the controlled substance dispensed;
     3    (viii)   the  number  of  days  supply  of  the  controlled  substance
     4  dispensed;
     5    (ix) the name of the prescriber;
     6    (x) the prescriber's identification number, as assigned  by  the  drug
     7  enforcement administration;
     8    (xi) the name or identifier of the drug that was dispensed; and
     9    (xii) the payment method.

    10    (c)  The  registry shall be secure, easily accessible by practitioners
    11  and pharmacists, and compatible  with  the  electronic  transmission  of
    12  prescriptions  for  controlled  substances,  as  required by section two
    13  hundred eighty-one of this chapter, and section sixty-eight hundred  ten
    14  of  the education law, and any regulations promulgated pursuant thereto.
    15  To the extent practicable, implementation of the electronic transmission
    16  of prescriptions for controlled substances  shall  serve  to  streamline
    17  consultation   of   the  registry  by  practitioners  and  reporting  of
    18  prescription information by pharmacists.  The registry shall be interop-
    19  erable with other  similar  registries  operated  by  federal  or  state

    20  governments,  to  the extent deemed appropriate by the commissioner, and
    21  subject to the provisions of section thirty-three hundred  seventy-one-a
    22  of this article.
    23    (d) The department shall establish and implement such protocols as are
    24  reasonably  necessary to ensure that information contained in the regis-
    25  try is maintained in a secure and confidential manner and is  accessible
    26  only  by  practitioners, pharmacists or their designees for the purposes
    27  established in subdivisions two and three of this section, or as  other-
    28  wise  set forth in sections thirty-three hundred seventy-one and thirty-
    29  three hundred seventy-one-a of  this  article.    Such  protocols  shall
    30  include  a  mechanism for the department to monitor and record access to

    31  the registry, which shall identify the authorized  individual  accessing
    32  and each controlled substance history accessed.
    33    2.  Duty  to consult prescription monitoring program registry; practi-
    34  tioners. (a) Every practitioner shall consult the prescription  monitor-
    35  ing  program  registry prior to prescribing or dispensing any controlled
    36  substance listed on schedule II,  III  or  IV  of  section  thirty-three
    37  hundred  six  of  this article, for the purpose of reviewing a patient's
    38  controlled substance history as set forth in  such  registry;  provided,
    39  however, that nothing in this section shall preclude an authorized prac-
    40  titioner, other than a veterinarian, from consulting the registry at his

    41  or  her  option  prior  to  prescribing  or  dispensing  any  controlled
    42  substance. The duty to consult the registry shall not apply to:
    43    (i) veterinarians;
    44    (ii) a  practitioner  dispensing  pursuant  to  subdivision  three  of
    45  section thirty-three hundred fifty-one of this article;
    46    (iii) a practitioner administering a controlled substance;
    47    (iv) a practitioner prescribing or ordering a controlled substance for
    48  use  on  the  premises of an institutional dispenser pursuant to section
    49  thirty-three hundred forty-two of this title;
    50    (v) a practitioner prescribing a controlled substance in the emergency
    51  department  of  a  general  hospital,  provided  that  the  quantity  of

    52  controlled substance prescribed does not exceed a five day supply if the
    53  controlled  substance  were  used  in accordance with the directions for
    54  use;

        S. 7637                             4
 
     1    (vi) a practitioner prescribing a controlled substance  to  a  patient
     2  under  the care of a hospice, as defined by section four thousand two of
     3  this chapter;
     4    (vii) a practitioner when:
     5    (A)  it  is not reasonably possible for the practitioner to access the
     6  registry in a timely manner;
     7    (B) no other practitioner or designee authorized to access the  regis-
     8  try, pursuant to paragraph (b) of this subdivision, is reasonably avail-
     9  able; and

    10    (C)  the quantity of controlled substance prescribed does not exceed a
    11  five day supply if the controlled substance were used in accordance with
    12  the directions for use;
    13    (viii) a practitioner acting in compliance with regulations  that  may
    14  be  promulgated  by  the  commissioner  as  to circumstances under which
    15  consultation of the registry would result in a  patient's  inability  to
    16  obtain  a  prescription  in a timely manner, thereby adversely impacting
    17  the medical condition of such patient;
    18    (ix) a situation where the registry is not operational  as  determined
    19  by the department or where it cannot be accessed by the practitioner due
    20  to  a  temporary  technological  or  electrical failure, as set forth in
    21  regulation; or

    22    (x) a practitioner who has been granted a waiver due to  technological
    23  limitations  that  are  not reasonably within the control of the practi-
    24  tioner, or other exceptional circumstance demonstrated  by  the  practi-
    25  tioner,  pursuant  to  a  process  established in regulation, and in the
    26  discretion of the commissioner.
    27    (b) For purposes of this  section,  a  practitioner  may  authorize  a
    28  designee  to consult the prescription monitoring program registry on his
    29  or her behalf, provided that: (i) the designee so authorized is employed
    30  by the same professional practice or is under contract with  such  prac-
    31  tice;  (ii)  the practitioner takes reasonable steps to ensure that such

    32  designee is sufficiently competent in the use of the registry; (iii) the
    33  practitioner remains responsible for ensuring that access to the  regis-
    34  try  by  the  designee is limited to authorized purposes and occurs in a
    35  manner that protects the confidentiality  of  the  information  obtained
    36  from  the  registry, and remains responsible for any breach of confiden-
    37  tiality; and (iv)  the  ultimate  decision  as  to  whether  or  not  to
    38  prescribe  or  dispense  a controlled substance remains with the practi-
    39  tioner and is reasonably informed by the relevant  controlled  substance
    40  history  information obtained from the registry.  The commissioner shall
    41  establish in regulation reasonable parameters with regard to  a  practi-

    42  tioner's  ability to authorize designees pursuant to this section, which
    43  shall include processes necessary to allow the department to: (A)  grant
    44  access  to  the registry in a reasonably prompt manner to as many desig-
    45  nees as are authorized by practitioners, up to the number deemed  appro-
    46  priate  by  the  commissioner  for  particular professional practices or
    47  types of practices, taking into account the need to maintain security of
    48  the registry and the patient-specific  information  maintained  therein,
    49  and  the  objective of minimizing burdens to practitioners to the extent
    50  practicable; (B) require that practitioners notify the  department  upon
    51  terminating the authorization of any designee; and (C) establish a mech-

    52  anism  to  prevent such terminated designees from accessing the registry
    53  in a reasonably prompt manner following such notification.
    54    3. Authority to  consult  prescription  monitoring  program  registry;
    55  pharmacists.  (a)  A  pharmacist may consult the prescription monitoring
    56  program registry in order to review the controlled substance history  of

        S. 7637                             5
 
     1  an  individual  for  whom  one  or  more  prescriptions  for  controlled
     2  substances is presented to such pharmacist.
     3    (b)  For  purposes of this section, a pharmacist may designate another
     4  pharmacist, a pharmacy intern, as defined by section sixty-eight hundred
     5  six of the education law, or other individual as may be permitted by the

     6  commissioner in  regulation,  to  consult  the  prescription  monitoring
     7  program registry on the pharmacist's behalf, provided that such designee
     8  is  employed by the same pharmacy or is under contract with such pharma-
     9  cy.  The commissioner shall establish in regulation  reasonable  parame-
    10  ters with regard to a pharmacist's ability to authorize designees pursu-
    11  ant  to  this  section, which shall include processes necessary to allow
    12  the department to: (A) grant access to  the  registry  in  a  reasonably
    13  prompt  manner to as many designees as are authorized by pharmacists, up
    14  to the number deemed appropriate  by  the  commissioner  for  particular
    15  pharmacies,  taking  into  account  the need to maintain security of the

    16  registry and the patient-specific information  maintained  therein,  and
    17  the objective of minimizing burdens to pharmacists to the extent practi-
    18  cable; (B) require that pharmacists notify the department upon terminat-
    19  ing  the authorization of any designee; and (C) establish a mechanism to
    20  prevent such terminated designees  from  accessing  the  registry  in  a
    21  reasonably prompt manner following such notification.
    22    4.  Immunity.  No  practitioner or pharmacist, and no person acting on
    23  behalf of such  practitioner  or  pharmacist  as  permitted  under  this
    24  section,  acting with reasonable care and in good faith shall be subject
    25  to civil liability arising from  any  false,  incomplete  or  inaccurate

    26  information  submitted to or reported by the registry or for any result-
    27  ing failure of the system to accurately or timely report  such  informa-
    28  tion;  provided,  however,  that  nothing  in  this subdivision shall be
    29  deemed to alter the obligation to submit or report prescription informa-
    30  tion to the department as otherwise set forth  in  this  article  or  in
    31  regulations promulgated pursuant thereto.
    32    5.  Guidance to practitioners and pharmacists. The commissioner shall,
    33  in consultation with the commissioner of education, provide guidance  to
    34  practitioners,  pharmacists,  and  pharmacies regarding the purposes and
    35  uses of the registry established by this section and the means by  which

    36  practitioners  and  pharmacists  can  access the registry. Such guidance
    37  shall  reference  educational  information  available  pursuant  to  the
    38  prescription  pain  medication awareness program established pursuant to
    39  section thirty-three hundred nine-a of this article.
    40    6. Individual access to controlled substance  histories.  The  commis-
    41  sioner  shall  establish  procedures  by  which  an  individual may: (a)
    42  request and obtain his or her own controlled substances history consist-
    43  ing of patient-specific information or,  in  appropriate  circumstances,
    44  that  of  a patient who lacks capacity to make health care decisions and
    45  for whom the individual has legal authority to make such  decisions  and

    46  would  have  legal  access  to the patient's health care records; or (b)
    47  seek review of any part of his or her controlled substances history  or,
    48  in  appropriate  circumstances,  that of a patient who lacks capacity to
    49  make health care decisions and for whom the individual has legal author-
    50  ity to make such decisions and would have legal access to the  patient's
    51  health  care  records,  that  such  individual disputes. Such procedures
    52  shall require the department to promptly revise any information accessi-
    53  ble through the registry that the department determines  to  be  inaccu-
    54  rate. Such procedures shall be described on the department's website and
    55  included  with the controlled substances history provided to an individ-

    56  ual pursuant to a request made under this subdivision or under  subpara-

        S. 7637                             6
 
     1  graph  (iv)  of paragraph (a) of subdivision two of section thirty-three
     2  hundred seventy-one of this article.
     3    7.  Department  analysis  of  data.  The department shall periodically
     4  analyze data contained in the prescription monitoring  program  registry
     5  to identify information that indicates that a violation of law or breach
     6  of  professional  standards may have occurred and, as warranted, provide
     7  any relevant information to  appropriate  entities  as  permitted  under
     8  section  thirty-three  hundred seventy-one of this article.  The depart-

     9  ment shall keep a record of the information provided, including, but not
    10  limited to, the specific information provided and the  agency  to  which
    11  such  information  was  provided,  including  the  name and title of the
    12  person to whom such information was provided  and  an  attestation  from
    13  such person that he or she has authority to receive such information.
    14    8.  Funding  the  prescription  monitoring program registry.   (a) The
    15  commissioner shall make reasonable efforts to apply for monies available
    16  from the federal government and other institutions, to the extent deemed
    17  appropriate by the commissioner, and  use  any  monies  so  obtained  to
    18  supplement  any  other  monies  made  available for the purposes of this
    19  title.

    20    (b) Operation of the registry established by this section shall not be
    21  funded, in whole or in part,  by  fees  imposed  specifically  for  such
    22  purposes  upon practitioners, pharmacists, designees or patients subject
    23  to this section.
    24    9. Rules and regulations. The commissioner shall promulgate such rules
    25  and regulations as are necessary to effectuate the  provisions  of  this
    26  section,  in  consultation  with  the work group established pursuant to
    27  subdivision three of section thirty-three hundred nine-a of  this  arti-
    28  cle.
    29    §  3.  Subdivision  4  of  section  3333  of the public health law, as
    30  amended by chapter 178 of the laws  of  2010,  is  amended  to  read  as
    31  follows:
    32    4. The endorsed original prescription shall be retained by the propri-

    33  etor  of  the pharmacy for a period of five years. The proprietor of the
    34  pharmacy shall file or cause to be filed such  prescription  information
    35  with the department by electronic means [in such manner and detail] on a
    36  real time basis as the commissioner in consultation with the commission-
    37  er  of  education shall, by regulation, require; provided, however, that
    38  the commissioner may, pursuant to a process established  in  regulation,
    39  grant  a waiver allowing a pharmacy to make such filings within a longer
    40  period of time if and to the  extent  that  the  commissioner  finds  it
    41  warranted,  in  his or her discretion, due to economic hardship, techno-
    42  logical limitations that are not reasonably within the  control  of  the

    43  pharmacy,   or   other  exceptional  circumstance  demonstrated  by  the
    44  pharmacy; and provided, further, however, that  such  regulations  shall
    45  specify  the manner in which such requirements shall apply to the deliv-
    46  ery of controlled substances to individuals in this state  by  means  of
    47  mail or licensed express delivery services.
    48    §  4.  Paragraphs  (d) and (e) of subdivision 1 of section 3371 of the
    49  public health law, as amended by chapter 178 of the laws  of  2010,  are
    50  amended  and five new paragraphs (f), (g), (h), (i) and (j) are added to
    51  read as follows:
    52    (d) to  [a  central]  the  prescription  monitoring  program  registry
    53  [established  pursuant  to this article; and] and to authorized users of

    54  such registry as set forth in subdivision two of this section;
    55    (e) to a practitioner to inform him or her that a patient may be under
    56  treatment with a controlled substance by another practitioner[.] for the

        S. 7637                             7
 
     1  purposes of subdivision two of  this  section,  and  to  facilitate  the
     2  department's   review  of  individual  challenges  to  the  accuracy  of
     3  controlled substances histories pursuant to subdivision six  of  section
     4  thirty-three hundred forty-three-a of this article;
     5    (f) to a pharmacist to provide information regarding prescriptions for
     6  controlled  substances  presented  to the pharmacist for the purposes of

     7  subdivision two of this  section  and  to  facilitate  the  department's
     8  review of individual challenges to the accuracy of controlled substances
     9  histories  pursuant  to  subdivision six of section thirty-three hundred
    10  forty-three-a of this article;
    11    (g) to the deputy attorney general for medicaid fraud control, or  his
    12  or  her  designee, in furtherance of an investigation of fraud, waste or
    13  abuse of the Medicaid program, pursuant to an agreement with the depart-
    14  ment;
    15    (h) to a local health department for the purpose of conducting  public
    16  health  research  or  education:  (i)  pursuant to an agreement with the
    17  commissioner; (ii) when the release of such information is deemed appro-

    18  priate by the commissioner; (iii) for use in  accordance  with  measures
    19  required  by  the commissioner to ensure that the security and confiden-
    20  tiality of the data is protected; and (iv) provided that  disclosure  is
    21  restricted  to  individuals  within  the local health department who are
    22  engaged in the research or education;
    23    (i) to a medical examiner or coroner who is an officer of or  employed
    24  by  a state or local government, pursuant to his or her official duties;
    25  and
    26    (j) to an individual for the purpose of providing such individual with
    27  his or her own controlled substance history or, in  appropriate  circum-
    28  stances, in the case of a patient who lacks capacity to make health care

    29  decisions,  a  person who has legal authority to make such decisions for
    30  the patient and who would have legal access to the patient's health care
    31  records, if requested from the department pursuant to subdivision six of
    32  section thirty-three hundred forty-three-a of this  article  or  from  a
    33  treating  practitioner pursuant to subparagraph (iv) of paragraph (a) of
    34  subdivision two of this section.
    35    § 5. Subdivision 2 of section 3371 of the public health law is  renum-
    36  bered  subdivision  4 and two new subdivisions 2 and 3 are added to read
    37  as follows:
    38    2. The prescription monitoring program registry may be accessed, under
    39  such terms and conditions as  are  established  by  the  department  for

    40  purposes of maintaining the security and confidentiality of the informa-
    41  tion contained in the registry, by:
    42    (a)  a  practitioner,  or  a  designee authorized by such practitioner
    43  pursuant to paragraph (b) of subdivision  two  of  section  thirty-three
    44  hundred forty-three-a of this article, for the purposes of:  (i) inform-
    45  ing  the  practitioner  that  a  patient  may  be under treatment with a
    46  controlled substance by another practitioner; (ii) providing the practi-
    47  tioner with notifications of controlled  substance  activity  as  deemed
    48  relevant  by the department, including but not limited to a notification
    49  made available on a monthly or other periodic basis through the registry

    50  of controlled substances activity pertaining  to  his  or  her  patient;
    51  (iii)   allowing   the   practitioner,   through   consultation  of  the
    52  prescription monitoring program registry, to review his or her patient's
    53  controlled  substances  history  as  required  by  section  thirty-three
    54  hundred  forty-three-a of this article; and (iv) providing to his or her
    55  patient, or person authorized pursuant to paragraph (j)  of  subdivision
    56  one  of  this section, upon request, a copy of such patient's controlled

        S. 7637                             8
 
     1  substance history as  is  available  to  the  practitioner  through  the
     2  prescription monitoring program registry; or

     3    (b)  a pharmacist, pharmacy intern or other designee authorized by the
     4  pharmacist pursuant to paragraph (b) of  subdivision  three  of  section
     5  thirty-three hundred forty-three-a of this article, for the purposes of:
     6  (i)  consulting  the  prescription monitoring program registry to review
     7  the controlled substances history of an individual for whom one or  more
     8  prescriptions  for controlled substances is presented to the pharmacist,
     9  pursuant to section thirty-three hundred forty-three-a of this  article;
    10  and  (ii) receiving from the department such notifications of controlled
    11  substance activity as are made available by the department.
    12    3. Where it has reason to believe that a crime related to  the  diver-

    13  sion  of  controlled  substances  has been committed, the department may
    14  notify appropriate law enforcement agencies and provide relevant  infor-
    15  mation  about  the  suspected  criminal  activity,  including controlled
    16  substances prescribed or dispensed, as reasonably appears to  be  neces-
    17  sary.    The department shall keep a record of the information provided,
    18  including, but not limited to: the specific information provided and the
    19  agency to which such information was provided, including  the  name  and
    20  title  of the person to whom such information was provided and an attes-
    21  tation from such person that he or she has  authority  to  receive  such
    22  information.
    23    §  6. Section 3302 of the public health law is amended by adding a new

    24  subdivision 41 to read as follows:
    25    41. "Registry" or "prescription monitoring program registry" means the
    26  prescription monitoring program registry established pursuant to section
    27  thirty-three hundred forty-three-a of this article.
    28    § 7. This act shall take effect one year after it shall have become  a
    29  law; provided, however, that:
    30    (a)  the  commissioners of health and education are authorized to add,
    31  amend or repeal any rule or regulation necessary and take  other  action
    32  necessary  for  the  implementation of such provisions on such effective
    33  date;
    34    (b) prior to such effective  date,  to  the  extent  practicable,  the
    35  department  of  health  shall  authorize  practitioners, pharmacists and
    36  designees to access the prescription monitoring registry as set forth in

    37  this act and shall permit such access prior to such effective  date,  to
    38  the extent practicable; and
    39    (c) nothing in subdivision (b) of this section shall require a practi-
    40  tioner to consult the registry prior to the effective date of this act.
 
    41                                   PART B
 
    42    Section  1. Sections 270 through 276 and section 277 of article 2-A of
    43  the public health law are designated title I and a new title heading  is
    44  added to read as follows:
    45              PREFERRED DRUG AND CLINICAL DRUG REVIEW PROGRAMS
    46    §  1-a.  Sections  276-a and 276-b of article 2-A of the public health
    47  law are renumbered sections 278 and 279, respectively, and such sections
    48  and section 280 of such article are designated title II and a new  title
    49  heading is added to read as follows:
    50                   PRESCRIPTION DRUGS; VARIOUS PROVISIONS

    51    §  2.  Article 2-A of the public health law is amended by adding a new
    52  title III to read as follows:
    53                                  TITLE III
    54     PRESCRIPTION FORMS, ELECTRONIC PRESCRIBING AND LANGUAGE ASSISTANCE

        S. 7637                             9
 
     1  Section 281. Official New York state prescription forms.
     2    §  281.  Official New York state prescription forms. 1. In addition to
     3  the requirements of section sixty-eight hundred ten of the education law
     4  or article thirty-three of this chapter, all  prescriptions  written  in
     5  this  state  by  a  person  authorized  by  this  state  to  issue  such
     6  prescriptions  shall  be  on  serialized   official   New   York   state

     7  prescription  forms  provided  by  the  department.  Such forms shall be
     8  furnished to practitioners authorized  to  write  prescriptions  and  to
     9  institutional  dispensers,  and shall be non-reproducible and non-trans-
    10  ferable. The commissioner, in  consultation  with  the  commissioner  of
    11  education, may promulgate emergency regulations for the electronic tran-
    12  smission  of prescriptions from prescribers to pharmacists or for order-
    13  ing and filling requirements of  prescription  drugs  for  prescriptions
    14  written for recipients eligible for medical assistance pursuant to title
    15  eleven  of  article five of the social services law, for participants in
    16  the program for elderly pharmaceutical insurance  coverage  pursuant  to

    17  title  three of article two of the elder law and for prescriptions writ-
    18  ten pursuant to article thirty-three of this chapter.   Nothing in  this
    19  section shall prohibit the commissioner in consultation with the commis-
    20  sioner  of  education  from  promulgating any additional emergency regu-
    21  lations in furtherance of this subdivision.
    22    2. The commissioner, in consultation with the commissioner  of  educa-
    23  tion, shall promulgate regulations requiring that prescription forms and
    24  electronic  prescriptions include: (a) a section wherein prescribers may
    25  indicate whether an individual is limited English proficient, as defined
    26  in section sixty-eight hundred twenty-nine of the education law; and (b)

    27  if the patient is limited English proficient, a line where the  prescri-
    28  ber  may specify the preferred language indicated by the patient.  Fail-
    29  ure to include such indication on the part of the prescriber  shall  not
    30  invalidate the prescription.
    31    3.  On  or  before  December  thirty-first,  two  thousand twelve, the
    32  commissioner shall promulgate  regulations,  in  consultation  with  the
    33  commissioner   of   education,  establishing  standards  for  electronic
    34  prescriptions. Notwithstanding any other provision of  this  section  or
    35  any  other  law  to  the contrary, effective two years subsequent to the
    36  date on which such regulations are promulgated, no  person  shall  issue

    37  any prescription in this state unless such prescription is made by elec-
    38  tronic  prescription from the person issuing the prescription to a phar-
    39  macy  in  accordance  with  such  regulatory   standards,   except   for
    40  prescriptions:  (a) issued by veterinarians; (b) issued in circumstances
    41  where electronic prescribing is not available due to  temporary  techno-
    42  logical or electrical failure, as set forth in regulation; (c) issued by
    43  practitioners  who  have  received  a  waiver or a renewal thereof for a
    44  specified period determined by the commissioner, not to exceed one year,
    45  from the requirement to use electronic prescribing, pursuant to a  proc-
    46  ess  established in regulation by the commissioner, in consultation with

    47  the commissioner of education, due to economic  hardship,  technological
    48  limitations  that  are  not reasonably within the control of the practi-
    49  tioner, or other exceptional circumstance demonstrated  by  the  practi-
    50  tioner; (d) issued by a practitioner under circumstances where, notwith-
    51  standing  the  practitioner's  present  ability  to  make  an electronic
    52  prescription as required by this subdivision, such practitioner  reason-
    53  ably  determines  that it would be impractical for the patient to obtain
    54  substances prescribed by electronic prescription in a timely manner, and
    55  such delay would  adversely  impact  the  patient's  medical  condition,
    56  provided  that  if  such prescription is for a controlled substance, the


        S. 7637                            10
 
     1  quantity of controlled substances does not exceed a five day  supply  if
     2  the controlled substance were used in accordance with the directions for
     3  use;  or  (e)  issued  by  a  practitioner to be dispensed by a pharmacy
     4  located outside the state, as set forth in regulation.
     5    4.  In the case of a prescription for a controlled substance issued by
     6  a practitioner under paragraph (b) of subdivision three of this section,
     7  the practitioner shall file  information  about  the  issuance  of  such
     8  prescription with the department as soon as practicable, as set forth in
     9  regulation.
    10    5.  In the case of a prescription for a controlled substance issued by

    11  a practitioner under paragraph (d) or (e) of subdivision three  of  this
    12  section,  the  practitioner  shall, upon issuing such prescription, file
    13  information about the issuance of such prescription with the  department
    14  by electronic means, as set forth in regulation.
    15    6.  The waiver process established in regulation pursuant to paragraph
    16  (c) of subdivision three of this section shall provide  that  a  practi-
    17  tioner  prescribing under a waiver must notify the department in writing
    18  promptly upon gaining the capability to use electronic prescribing,  and
    19  that  a  waiver  shall terminate within a specified period of time after
    20  the practitioner gains such capability.
    21    § 3. Section 6810 of the education law is amended by adding  four  new

    22  subdivisions 10, 11, 12 and 13 to read as follows:
    23    10.  Notwithstanding  any other provision of this section or any other
    24  law to the contrary, effective two years subsequent to the date on which
    25  regulations establishing  standards  for  electronic  prescriptions  are
    26  promulgated  by  the  commissioner  of  health, in consultation with the
    27  commissioner pursuant to subdivision three of section two hundred eight-
    28  y-one of  the  public  health  law,  no  practitioner  shall  issue  any
    29  prescription  in  this  state, unless such prescription is made by elec-
    30  tronic prescription from the practitioner  to  a  pharmacy,  except  for
    31  prescriptions:  (a)  issued by veterinarians; (b) issued or dispensed in

    32  circumstances where electronic  prescribing  is  not  available  due  to
    33  temporary  technological  or  electrical  failure, as set forth in regu-
    34  lation; (c) issued by practitioners who have  received  a  waiver  or  a
    35  renewal thereof for a specified period determined by the commissioner of
    36  health,  not  to exceed one year, from the requirement to use electronic
    37  prescribing, pursuant to a process  established  in  regulation  by  the
    38  commissioner  of  health,  in  consultation with the commissioner due to
    39  economic hardship, technological limitations  that  are  not  reasonably
    40  within  the  control  of  the practitioner, or other exceptional circum-
    41  stance demonstrated by the practitioner; (d) issued  by  a  practitioner

    42  under  circumstances  where,  notwithstanding the practitioner's present
    43  ability to make an electronic prescription as required by this  subdivi-
    44  sion, such practitioner reasonably determines that it would be impracti-
    45  cal  for  the  patient  to  obtain  substances  prescribed by electronic
    46  prescription in a timely manner, and such delay would  adversely  impact
    47  the  patient's  medical condition, provided that if such prescription is
    48  for a controlled substance, the quantity that does not exceed a five day
    49  supply if the controlled substance  was  used  in  accordance  with  the
    50  directions for use; or (e) issued by a practitioner to be dispensed by a
    51  pharmacy located outside the state, as set forth in regulation.

    52    11. In the case of a prescription issued by a practitioner under para-
    53  graph  (b) of subdivision ten of this section, the practitioner shall be
    54  required to file information about the  issuance  of  such  prescription
    55  with  the  department  of health as soon as practicable, as set forth in
    56  regulation.

        S. 7637                            11
 
     1    12. In the case of a prescription issued by a practitioner under para-
     2  graph (d) or (e) of subdivision ten of this  section,  the  practitioner
     3  shall,  upon issuing such prescription, file information about the issu-
     4  ance of such prescription with the department of  health  by  electronic
     5  means, as set forth in regulation.

     6    13. The waiver process established in regulation pursuant to paragraph
     7  (c) of subdivision ten of this section shall provide that a practitioner
     8  prescribing under a waiver must notify the department in writing prompt-
     9  ly upon gaining the capability to use electronic prescribing, and that a
    10  waiver shall terminate within a specified period of time after the prac-
    11  titioner gains such capability.
    12    § 4. Section 21 of the public health law is REPEALED.
    13    §  5.  This act shall take effect immediately; provided, however, that
    14  the provisions of subdivision 2 of section 281 of the public health law,
    15  as added by section two of this act, shall take effect March  30,  2013,
    16  except that as of such date, the commissioner of health, the commission-

    17  er  of education and the state board of pharmacy are immediately author-
    18  ized and directed to take actions necessary to implement such provisions
    19  as of such date; provided, further, that any rules or  regulations  that
    20  have  been  adopted  or proposed prior to the effective date of this act
    21  which are applicable to section 21 of the public health  law  shall  now
    22  apply to section 281 of the public health law as added by section two of
    23  this act; and provided, further, that any rules or regulations that have
    24  been  adopted  or proposed prior to the effective date of this act which
    25  are applicable to sections 276-a and 276-b  of  the  public  health  law
    26  shall now apply to section 278 and 279 of the public health law, respec-
    27  tively, renumbered by section one-a of this act.
 
    28                                   PART C
 
    29    Section  1.   Paragraph 1 of subdivision (b) of schedule II of section

    30  3306 of the public health law, as amended by chapter 457 of the laws  of
    31  2006, is amended to read as follows:
    32    (1)  Opium and opiate, and any salt, compound, derivative, or prepara-
    33  tion of opium or opiate, excluding apomorphine, dextrorphan, nalbuphine,
    34  nalmefene, naloxone, and naltrexone, and  their  respective  salts,  but
    35  including the following:
    36    1. Raw opium.
    37    2. Opium extracts.
    38    3. Opium fluid.
    39    4. Powdered opium.
    40    5. Granulated opium.
    41    6. Tincture of opium.
    42    7. Codeine.
    43    8. Ethylmorphine.
    44    9. Etorphine hydrochloride.
    45    10. Hydrocodone (also known as dihydrocodeinone).
    46    11. Hydromorphone.
    47    12. Metopon.
    48    13. Morphine.
    49    14. Oxycodone.
    50    15. Oxymorphone.
    51    16. Thebaine.
    52    17. Dihydroetorphine.
    53    18. Oripavine.


        S. 7637                            12
 
     1    §  2.  Schedule II of section 3306 of the public health law is amended
     2  by adding a new subdivision (b-1) to read as follows:
     3    (b-1)  Unless specifically excepted or unless listed in another sched-
     4  ule, any material, compound, mixture, or preparation containing  any  of
     5  the  following,  or their salts calculated as the free anhydrous base or
     6  alkaloid, in limited quantities as set forth below:
     7    (1) Not more than three hundred milligrams of dihydrocodeinone (hydro-
     8  codone) per one hundred milliliters or not more than fifteen  milligrams
     9  per  dosage unit, with a fourfold or greater quantity of an isoquinoline
    10  alkaloid of opium.
    11    (2) Not more than three hundred milligrams of dihydrocodeinone (hydro-

    12  codone) per one hundred milliliters or not more than fifteen  milligrams
    13  per  dosage  unit,  with  one  or more active nonnarcotic ingredients in
    14  recognized therapeutic amounts.
    15    § 3. Section 3307 of the public health law is amended by adding a  new
    16  subdivision 5 to read as follows:
    17    5. The commissioner shall establish minimum standards for the storage,
    18  reporting,  ordering  and record keeping of controlled substances speci-
    19  fied in subdivision (b-1) of schedule II of section thirty-three hundred
    20  six of this  article  by  manufacturers  and  distributors  as  if  such
    21  substances  were  set  forth  in  schedule  III  of section thirty-three
    22  hundred six of this article.
    23    § 4. Paragraph 6 of subdivision (b) of schedule II of section 3306  of

    24  the public health law is REPEALED.
    25    §  5.  Subdivision  (c)  of  schedule II of section 3306 of the public
    26  health law is amended by adding a new paragraph 28 to read as follows:
    27    (28) Tapentadol.
    28    § 6. Subdivision (d) of schedule II of  section  3306  of  the  public
    29  health  law, as added by chapter 664 of the laws of 1985, paragraph 5 as
    30  added by chapter 178 of the laws of 2010, is amended to read as follows:
    31    (d) Stimulants. Unless  specifically  excepted  or  unless  listed  in
    32  another  schedule, any material, compound, mixture, or preparation which
    33  contains any quantity of the following  substances  having  a  stimulant
    34  effect  on the central nervous system, including its salts, isomers, and
    35  salts of isomers:
    36    (1) Amphetamine[, its salts, optical isomers, and salts of its optical

    37  isomers].
    38    (2) Methamphetamine[, its salts, isomers, and salts of its isomers].
    39    (3) Phenmetrazine [and its salts].
    40    (4) Methylphenidate.
    41    (5) Lisdexamfetamine.
    42    § 7.  Subdivision (g) of schedule II of section  3306  of  the  public
    43  health law is amended by adding a new paragraph 3 to read as follows:
    44    (3) Immediate precursor to fentanyl:
    45    (i) 4-anilino-N-phenethyl-4-piperidine (ANPP).
    46    §  8.  Subdivision  (h)  of  schedule II of section 3306 of the public
    47  health law, as amended by chapter 178 of the laws of 2010, is amended to
    48  read as follows:
    49    (h) Anabolic steroids. Unless specifically excepted or  unless  listed
    50  in  another schedule, "anabolic steroid" shall mean any drug or hormonal
    51  substance, chemically  and  pharmacologically  related  to  testosterone

    52  (other than estrogens, progestins, corticosteroids and dehydroepiandros-
    53  terone)  [that  promotes  muscle  growth,  or  any  material,  compound,
    54  mixture, or preparation which  contains  any  amount  of  the  following
    55  substances] and includes:
    56    (1) 3{beta}, 17-dihydroxy-5a-androstane.

        S. 7637                            13
 
     1    (2) 3{alpha}, 17{beta}-dihydroxy-5a-androstane.
     2    (3) 5{alpha}-androstan-3,17-dione.
     3    (4) 1-androstenediol (3{beta},17{beta}-dihydroxy-5{alpha}-androst-1-
     4  ene).
     5    (5) 1-androstenediol (3{alpha},17{beta}-dihydroxy-5{alpha}-androst-1-
     6  ene).
     7    (6) 4-androstenediol (3{beta}, 17{beta}-dihydroxy-androst-4-ene).
     8    (7) 5-androstenediol (3{beta}, 17{beta}-dihydroxy-androst-5-ene).
     9    (8) 1-androstenedione ({5{alpha}}-androst-1-en-3,17-dione).

    10    (9) 4-androstenedione (androst-4-en-3,17-dione).
    11    (10) 5-androstenedione (androst-5-en-3,17-dione).
    12    (11) Bolasterone (7{alpha},17{alpha}-dimethyl-17{beta}-hydroxyandrost-
    13  4-en-3-one).
    14    (12) Boldenone (17{beta}-hydroxyandrost-1, 4,-diene-3-one).
    15    (13) Boldione (androsta-1,4-diene-3,17-dione).
    16    (14) Calusterone (7{beta}, 17{alpha}-dimethyl-17{beta}-hydroxyandrost-
    17  4-en-3-one).
    18    [(14)] (15) Clostebol (4-chloro-17{beta}-hydroxyandrost-4-en-3-one).
    19    [(15)]    (16) Dehydrochloromethyltestosterone    [(4-chloro-17{beta}-
    20  hydroxy-17{alpha}-methyl-androst-1]        (4-chloro-17{beta}-hydroxy-17
    21  {alpha}-methyl-androst-1, 4-dien-3-one).
    22    [(16)]  (17)  {Delta}  1-dihydrotestosterone (a.k.a. '1-testosterone')

    23  (17 {beta}-hydroxy-5{alpha}-androst-1-en-3-one).
    24    [(17)] (18) 4-dihydrotestosterone (17{beta}-hydroxy-androstan-3-one).
    25    [(18)]  (19)  Drostanolone  (17{beta}-hydroxy-2{alpha}-methyl-5{alpha}
    26  -androstan-3-one).
    27    [(19)]   (20)   Ethylestrenol   (17{alpha}-ethyl-17{beta}-hydroxyestr-
    28  4-ene).
    29    [(20)] (21)  Fluoxymesterone  (9-fluoro-17{alpha}-methyl-11{beta},  17
    30  {beta}-[dihydroxandrost]dihydroxyandrost-4-en-3-one).
    31    [(21)]    (22)    Formebolone    (2-formyl-17{alpha}-methyl-11{alpha},
    32  17{beta}-dihydroxyandrost-1, 4-dien-3-one).
    33    [(22)]     (23) Furazabol (17{alpha}-methyl-17{beta}-hydroxyandrostano
    34  {2, 3-c}-furazan).
    35    [(23) 13{beta}-ethyl-17{alpha}-hydroxygon-4-en-3-one]

    36    (24) 13{beta}-ethyl-17{beta}-hyroxygon-4-en-3-one.
    37    [(24)]  (25)  4-hydroxytestosterone  [(4,17 {beta}-dihydroxyandrost-4-
    38  en-3-one)] (4, 17{beta}-dihydroxy-androst-4-en-3-one).
    39    [(25)]                (26)                4-hydroxy-19-nortestosterone
    40  (4,17{beta}-dihydroxy-estr-4-en-3-one).
    41    [(26)]                  (27)                  desoxymethyltestosterone
    42  (17{alpha}-methyl-5{alpha}-androst-2-en-17{beta}-ol) (a.k.a., madol).
    43    (28) Mestanolone                   (17{alpha}-methyl-17{beta}-hydroxy-
    44  5-androstan-3-one).
    45    [(27)]           (29) Mesterolone (1{alpha}[-]methyl-17{beta}-hydroxy-
    46  {5{alpha}}-androstan-3-one).

    47    [(28)] (30) Methandienone (17{alpha}-methyl-17{beta}-hydroxyandrost-1,
    48  4-dien-3-one).
    49    [(29)]       (31)        Methandriol        (17{alpha}-methyl-3{beta},
    50  17{beta}-dihydroxyandrost-5-ene).
    51    [(30)]  (32)  Methenolone (1-methyl-17{beta}-hydroxy-5{alpha}-androst-
    52  1-en-3-one).
    53    [(31)] (33) 17{alpha}-methyl-3{beta},17{beta}-dihydroxy-5a-androstane.
    54    [(32)]     (34)     17{alpha}-methyl-3{alpha},     17{beta}-dihydroxy-
    55  5a-androstane.
    56    [(33)] (35) 17{alpha}-methyl-3{beta}, 17{beta}-dihydroxyandrost-4-ene.

        S. 7637                            14
 
     1    [(34)]  (36) 17{alpha}-methyl-4-hydroxynandrolone (17{alpha}-methyl-4-

     2  hydroxy-17{beta}-hydroxyestr-4-en-3-one).
     3    [(35)]  (37)  Methyldienolone (17{alpha}-methyl-17{beta}-hydroxyestra-
     4  4,9(10)-dien-3-one).
     5    [(36)]                             (38)               Methyltrienolone
     6  (17{alpha}-methyl-17{beta}-hydroxyestra-4, 9-11-trien-3-one).
     7    [(37)]                     (39)                     Methyltestosterone
     8  (17{alpha}-methyl-17{beta}-hydroxyandrost- 4-en-3-one).
     9    [(38)]                         (40)                         Mibolerone
    10  (7{alpha},17{alpha}-dimethyl-17{beta}-hydroxyestr- 4-en-3-one).
    11    [(39)]             (41) 17{alpha}-methyl-{Delta} 1-dihydrotestosterone
    12  (17b{beta}-hydroxy-17{alpha}-methyl-5{alpha}-androst-1-en-3-one)
    13  (a.k.a. '17-{alpha}-methyl-1-testosterone').

    14    [(40)] (42) Nandrolone(17{beta}-hydroxyestr-4-en-3-one).
    15    [(41)]  (43)  19-nor-4-androstenediol  (3{beta},17{beta}-dihydroxyestr
    16  -4-ene).
    17    [(42)]  (44) 19-nor-4-androstenediol (3{alpha},17{beta}-dihydroxyestr-
    18  4-ene).
    19    [(43)]  (45)  19-nor-5-androstenediol  (3{beta},17{beta}-dihydroxyestr
    20  -5-ene).
    21    [(44)]  (46) 19-nor-5-androstenediol (3{alpha},17{beta}-dihydroxyestr-
    22  5-ene).
    23    [(45)]             (47)              19-nor-4,9(10)-androstadienedione
    24  (estra-4,9(10)-diene-3,17-dione).
    25    (48) 19-nor-4-androstenedione (estr-4-en-3,17-dione).
    26    [(46)] (49) 19-nor-5-androstenedione (estr-5-en-3,17-dione).

    27    [(47)]   (50)   Norbolethone   (13{beta},   17{alpha}-diethyl-17{beta}
    28  -hydroxygon-4-en-3-one).
    29    [(48)] (51) Norclostebol (4-chloro-17{beta}-hydroxyestr-4-en-3-one).
    30    [(49)]  (52)  Norethandrolone   (17{alpha}-ethyl-17{beta}-hydroxyestr-
    31  4-en-3-one).
    32    [(50)]      (53)      Normethandrolone      (17{alpha}-methyl-17{beta}
    33  -hydroxyestr-4-en-3-one).
    34    [(51)]  (54)   Oxandrolone   (17{alpha}-methyl-17{beta}-hydroxy-2-oxa-
    35  {5{alpha}}-androstan-3-one).
    36    [(52)]  (55)  Oxymesterone  (17{alpha}-methyl-4, 17{beta}-dihydroxy[-]
    37  androst-4-en-3-one).
    38    [(53)]  (56)  Oxymetholone  (17   {alpha}-methyl-2-hydroxymethylene-17
    39  {beta}-hydroxy-{5{alpha}}- androstan-3-one).

    40    [(54)]  (57) Stanozolol (17{alpha}-methyl-17{beta}-hydroxy-{5{alpha}}-
    41  androst-2-eno{3, 2-c}-pyrazole).
    42    [(55)] (58) Stenbolone  (17{beta}-hydroxy-2-methyl-{5{alpha}}-androst-
    43  1-en-3-one).
    44    [(56)]   (59)  Testolactone  (13-hydroxy-3-oxo-13,  17-secoandrosta-1,
    45  4-dien-17-oic acid lactone).
    46    [(57)] (60) Testosterone (17{beta}-hydroxyandrost-4-en-3-one).
    47    [(58)]   (61)   Tetrahydrogestrinone   (13{beta},    17{alpha}-diethyl
    48  -17{beta}-hydroxygon-4, 9, 11-trien-3-one).
    49    [(59)] (62) Trenbolone (17{beta}-hydroxyestr-4, 9, 11-trien-3-one).
    50    [(60)]  (63) Any salt, ester or ether of a drug or substance described
    51  or listed in this subdivision.

    52    § 9.  The opening paragraph of subdivision  (c)  of  schedule  III  of
    53  section  3306  of  the public health law, as added by chapter 664 of the
    54  laws of 1985, is amended to read as follows:
    55    Unless specifically excepted or unless listed in another schedule, any
    56  material, compound, mixture, or preparation which contains any  quantity

        S. 7637                            15
 
     1  of  the  following  substances having a depressant effect on the central
     2  nervous system, including its salts, isomers, and salts of isomers:
     3    §  10.  Subdivision  (e) of schedule III of section 3306 of the public
     4  health law, as added by chapter 664 of the laws of  1985,  paragraphs  3
     5  and  4  as amended by chapter 589 of the laws of 1996 and paragraph 9 as
     6  added by chapter 457 of the laws of 2006, is amended to read as follows:

     7    (e) Narcotic drugs. Unless specifically excepted or unless  listed  in
     8  another  schedule,  any  material,  compound,  mixture,  or  preparation
     9  containing any of the following narcotic drugs, or  their  salts  calcu-
    10  lated  as  the free anhydrous base or alkaloid, in limited quantities as
    11  set forth below:
    12    (1) Not more than 1.8 grams of codeine per one hundred milliliters  or
    13  not more than ninety milligrams per dosage unit, with an equal or great-
    14  er quantity of an isoquinoline alkaloid of opium.
    15    (2)  Not more than 1.8 grams of codeine per one hundred milliliters or
    16  not more than ninety milligrams  per  dosage  unit,  with  one  or  more
    17  active, nonnarcotic ingredients in recognized therapeutic amounts.
    18    (3)  [Not  more  than  three  hundred  milligrams  of dihydrocodeinone
    19  (hydrocodone) per one hundred  milliliters  or  not  more  than  fifteen

    20  milligrams  per  dosage  unit, with a fourfold or greater quantity of an
    21  isoquinoline alkaloid of opium.
    22    (4) Not more than three hundred milligrams of dihydrocodeinone (hydro-
    23  codone) per one hundred milliliters or not more than fifteen  milligrams
    24  per  dosage  unit,  with  one  or more active nonnarcotic ingredients in
    25  recognized therapeutic amounts.
    26    (5)] Not more than 1.8 grams of dihydrocodeine per one hundred  milli-
    27  liters  or  not more than ninety milligrams per dosage unit, with one or
    28  more active nonnarcotic ingredients in recognized therapeutic amounts.
    29    [(6)] (4) Not more than three hundred milligrams of ethylmorphine  per
    30  one  hundred  milliliters or not more than fifteen milligrams per dosage

    31  unit, with one or more active,  nonnarcotic  ingredients  in  recognized
    32  therapeutic amounts.
    33    [(7)]  (5)  Not  more  than  five  hundred milligrams of opium per one
    34  hundred milliliters or per one hundred grams or not  more  than  twenty-
    35  five  milligrams  per  dosage unit, with one or more active, nonnarcotic
    36  ingredients in recognized therapeutic amounts.
    37    [(8)] (6) Not more than fifty milligrams of morphine per  one  hundred
    38  milliliters  or  per one hundred grams, with one or more active, nonnar-
    39  cotic ingredients in recognized therapeutic amounts.
    40    [(9)] (7) Buprenorphine in any quantities.
    41    § 11. Subdivision (f) of schedule III of section 3306  of  the  public
    42  health law, as amended by chapter 178 of the laws of 2010, is amended to
    43  read as follows:

    44    (f)  [(i)]  Dronabinol (synthetic) in sesame oil and encapsulated in a
    45  soft gelatin capsule in a [drug product approved for marketing  by  the]
    46  U.S. Food and Drug Administration [(FDA)] approved product.
    47    [(ii)  Any  drug  product in tablet or capsule form containing natural
    48  dronabinol derived from the cannabis  (plant)  or  synthetic  dronabinol
    49  (produced  from  synthetic  materials) for which an abbreviated new drug
    50  application (ANDA) has been approved by the FDA under section 505(j)  of
    51  the  Federal Food, Drug, and Cosmetic Act which references as its listed
    52  drug the drug product referred to in paragraph (i) of this subdivision.]
    53  Some other names for dronabinol include: (6aR-trans)-6a, 7, 8,  10a-tet-

    54  rahydro-6,   6,   9-trimethyl-3-pentyl-6H-dibenzo{b,d}   pyran-1-o1,  or
    55  (-)-delta-9-(trans) - tetrahydrocannabinol.

        S. 7637                            16
 
     1    § 12. Subdivision (c) of schedule IV of section  3306  of  the  public
     2  health  law is amended by adding two new paragraphs 52 and 53 to read as
     3  follows:
     4    (52) Fospropofol.
     5    (53) Carisoprodol.
     6    §  13.  Paragraph 11 of subdivision (e) of schedule IV of section 3306
     7  of the public health law, as added by chapter 457 of the laws  of  2006,
     8  is amended to read as follows:
     9    (11) [Modafanil] Modafinil.
    10    §  14.  Subdivision  (f)  of schedule IV of section 3306 of the public
    11  health law is amended by adding a new paragraph 3 to read as follows:
    12    (3) Tramadol in any quantities.

    13    § 15. Subdivision (b) of schedule V of  section  3306  of  the  public
    14  health  law,  as added by chapter 664 of the laws of 1985, is amended to
    15  read as follows:
    16    (b) Narcotic drugs containing nonnarcotic  active  medicinal  ingredi-
    17  ents.  Any  compound,  mixture,  or  preparation  containing  any of the
    18  following narcotic drugs, or their salts calculated as the  free  anhyd-
    19  rous  base  or alkaloid, in limited quantities as set forth below, which
    20  shall include one or more nonnarcotic active  medicinal  ingredients  in
    21  sufficient  proportion to confer upon the compound, mixture, or prepara-
    22  tion  valuable  medicinal  [qualitites]  qualities  other   than   those
    23  possessed by narcotic drugs alone:
    24    (1)  Not  more  than two hundred milligrams of codeine per one hundred
    25  milliliters or per one hundred grams.

    26    (2) Not more than one hundred milligrams  of  dihydrocodeine  per  one
    27  hundred milliliters or per one hundred grams.
    28    (3)  Not  more  than  one  hundred milligrams of ethylmorphine per one
    29  hundred milliliters or per one hundred grams.
    30    (4) Not more than 2.5 milligrams of diphenoxylate and  not  less  than
    31  twenty-five micrograms of atropine sulfate per dosage unit.
    32    (5)  Not  more  than  one  hundred milligrams of opium per one hundred
    33  milliliters or per one hundred grams.
    34    (6) Not more than 0.5 milligram of difenoxin and not less  than  twen-
    35  ty-five micrograms of atropine sulfate per dosage unit.
    36    §  16.  Subdivision  (d)  of  schedule V of section 3306 of the public
    37  health law, as added by chapter 178 of the laws of 2010, is  amended  to
    38  read as follows:
    39    (d)  Depressants.  Unless  specifically exempted or excluded or unless

    40  listed in another schedule, any material, compound, mixture, or prepara-
    41  tion which contains any quantity of the following  substances  having  a
    42  depressant  effect  on  the central nervous system, including its salts,
    43  isomers, and salts of isomers:
    44    (1)   Ezogabine   {N-{2-amino-4-(4-fluorobenzylamino)-phenyl}-carbamic
    45  acid ethyl ester}.
    46    (2) Lacosamide {(R)-2-acetoamido-N-benzyl-3-methoxy-propionamide}.
    47    (3) Pregabalin [(]{(S)-3-(aminomethyl)-5-methylhexanoic acid[)]}.
    48    §  17.  Subdivision  7  of  section  3331 of the public health law, as
    49  amended by chapter 640 of the laws  of  1990,  is  amended  to  read  as
    50  follows:
    51    7.  A  practitioner  may  not  administer,  prescribe  or dispense any

    52  substance referred to in subdivision (h) [or subdivision (j)] of  Sched-
    53  ule  II,  and subdivision (g) of Schedule III, of section three thousand
    54  three hundred six of this article for other than therapeutic purposes. A
    55  practitioner  may  not  administer,  prescribe  or  dispense  any   such
    56  substance to any individual without first obtaining the informed consent

        S. 7637                            17
 
     1  of  such individual, or where the individual lacks capacity to give such
     2  consent, a person legally authorized to consent on his or her behalf.
     3    §  18. Subdivision 8 of section 220.00 of the penal law, as amended by
     4  chapter 664 of the laws of 1985, is amended to read as follows:
     5    8. "Narcotic preparation" means any  controlled  substance  listed  in
     6  schedule II(b-1), III(d) or III(e).

     7    §  19.  This act shall take effect on the ninetieth day after it shall
     8  have become a law; provided that sections two, three, ten, fourteen  and
     9  eighteen  shall  take  effect  on the one hundred eightieth day after it
    10  shall have become a law; and provided that sections fifteen  and  seven-
    11  teen of this act shall take effect immediately.
 
    12                                   PART D
 
    13    Section  1.  Subparagraphs  (i),  (ii)  and  (iii) of paragraph (b) of
    14  subdivision 2 of section 3309-a of the public health law,  as  added  by
    15  section  52 of part D of chapter 56 of the laws of 2012, are amended and
    16  a new subparagraph (iv) is added to read as follows:
    17    (i) Report to the commissioner regarding the development of  recommen-
    18  dations  and  model  courses for continuing medical education, refresher
    19  courses and other training materials for licensed  health  care  profes-

    20  sionals  on appropriate use of prescription pain medication. Such recom-
    21  mendations, model courses and other training materials shall be  submit-
    22  ted  to  the commissioner, who shall make such information available for
    23  the use in medical education, residency programs,  fellowship  programs,
    24  and  for  use  in continuing medication education programs no later than
    25  January first, two thousand thirteen. Such  recommendations  also  shall
    26  include  recommendations  on:  (A)  educational  and  continuing medical
    27  education  requirements  for  practitioners   appropriate   to   address
    28  prescription  pain medication awareness among health care professionals;
    29  (B)  continuing  education  requirements  for  pharmacists  related   to
    30  prescription  pain medication awareness; and (C) continuing education in

    31  palliative care as it relates to pain management, for which purpose  the
    32  work  group  shall  consult the New York state palliative care education
    33  and training council;
    34    (ii) No later than  January  first,  two  thousand  thirteen,  provide
    35  outreach  and  assistance  to  health care professional organizations to
    36  encourage and facilitate continuing medical education training  programs
    37  for  their  members  regarding appropriate prescribing practices for the
    38  best patient care and the risks associated with [prescription] overpres-
    39  cribing and underprescribing pain medication; [and]
    40    (iii) Provide information to the commissioner for use in the  develop-
    41  ment  and  continued  update of the public awareness campaign, including

    42  information, resources, and active web links that should be included  on
    43  the website[.]; and
    44    (iv)  Consider  other  issues  deemed  relevant  by  the commissioner,
    45  including how to protect and promote  the  access  of  patients  with  a
    46  legitimate  need  for  controlled  substances,  particularly medications
    47  needed for pain management by oncology patients, and whether and how  to
    48  encourage or require the use or substitution of opioid drugs that employ
    49  tamper-resistance  technology  as  a  mechanism  for  reducing abuse and
    50  diversion of opioid drugs.
    51    § 2.  Subdivision 3 of section 3309-a of the  public  health  law,  as
    52  added  by  section  52  of  part D of chapter 56 of the laws of 2012, is
    53  amended to read as follows:


        S. 7637                            18
 
     1    3. On or before September first, two thousand twelve, the  commission-
     2  er,  in  consultation  with the commissioner of the office of alcoholism
     3  and substance abuse services, the commissioner  of  education,  and  the
     4  executive  secretary  of  the  state board of pharmacy, shall add to the
     5  workgroup  such  additional members as appropriate so that the workgroup
     6  may provide guidance in furtherance of the implementation of the  I-STOP
     7  act.  For  such purposes, the workgroup shall include but not be limited
     8  to  consumer  advisory  organizations,  health  care  practitioners  and
     9  providers,  oncologists,  addiction  treatment  providers, practitioners
    10  with experience in pain  management,  pharmacists  and  pharmacies,  and

    11  representatives of law enforcement agencies.
    12    4. The commissioner shall report to the governor, the temporary presi-
    13  dent  of  the senate and the speaker of the assembly no later than March
    14  first, two thousand thirteen,  and  annually  thereafter,  on  the  work
    15  group's  findings.  The report shall include information on opioid over-
    16  dose deaths, emergency room utilization  for  the  treatment  of  opioid
    17  overdose,  the utilization of pre-hospital addiction services and recom-
    18  mendations to reduce opioid addiction and the consequences thereof.  The
    19  report shall also include a recommendation as to whether subdivision two
    20  of  section thirty-three hundred forty-three-a of this article should be
    21  amended to require practitioners prescribing or dispensing certain iden-

    22  tified schedule V controlled substances to comply with the  consultation
    23  requirements of such subdivision.
    24    § 3. This act shall take effect immediately.
 
    25                                   PART E
 
    26  Section  1.    The  public health law is amended by adding a new section
    27  3343-b to read as follows:
    28    § 3343-b. Safe disposal of unused controlled substances.  The  depart-
    29  ment  shall  establish  a  program  for  the  safe  disposal  of  unused
    30  controlled substances by consumers in accordance with federal  law.  The
    31  program  shall  permit  individual  members of the public to voluntarily
    32  surrender controlled substances listed on schedule II, III, IV or  V  of
    33  section  thirty-three  hundred  six  of this article in a secure manner,

    34  without identifying themselves, and shall be publicized consistent  with
    35  the  prescription pain medication awareness program established pursuant
    36  to section thirty-three hundred nine-a of this article. The surrender of
    37  a controlled substance pursuant to the program established  pursuant  to
    38  this  section  shall  not constitute the possession, transfer or sale of
    39  such controlled substance for purposes of this article or the penal law.
    40  In developing such program, the department shall consider the following:
    41  appropriate sites for disposal throughout the state;  the  role  of  law
    42  enforcement  and  federal authorities, as appropriate; and the manner in
    43  which potential costs to localities or to the state will  be  addressed.

    44  Disposal sites shall be operated by law enforcement agencies on a volun-
    45  tary  basis  in  collaboration  with  the  department.   Nothing in this
    46  section shall require any political subdivision of the state to  partic-
    47  ipate in the program established in this section.
    48    § 2. This act shall take effect immediately.
    49    § 3. Severability clause. If any clause, sentence, paragraph, subdivi-
    50  sion,  section  or  part  of  this act shall be adjudged by any court of
    51  competent jurisdiction to be invalid, such judgment  shall  not  affect,
    52  impair or invalidate the remainder thereof, but shall be confined in its
    53  operation  to  the  clause, sentence, paragraph, subdivision, section or
    54  part thereof directly involved in the controversy in which such judgment

        S. 7637                            19
 

     1  shall have been rendered. It is hereby declared to be the intent of  the
     2  legislature  that  this act would have been enacted even if such invalid
     3  provisions had not been included herein.
     4    §  4.  This act shall take effect immediately; provided, however, that
     5  the applicable effective date of Parts A through E of this act shall  be
     6  as specifically set forth in the last section of such Parts.
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