A07467 Summary:

BILL NOA07467A
 
SAME ASSAME AS S05657-A
 
SPONSORGottfried
 
COSPNSRPeoples-Stokes, Lupardo, Abinanti, Ashby, Carroll, Cruz, DenDekker, Dickens, Englebright, Glick, Hevesi, Jaffee, Jean-Pierre, Hunter, Miller ML, McDonald, Ortiz, Paulin, Pichardo, Reyes, Rosenthal L, Simon, Wright, Sayegh, Crespo, Raynor, Fernandez
 
MLTSPNSR
 
Amd Pub Health L, generally
 
Provides that medical marihuana may be used as part of the treatment of a patient's condition and removes the "serious" designation of such condition; provides that a practitioner be authorized to prescribe controlled substances in the state and removes the requirement that a physician prescribe such medical marihuana; increases the supply amount of marihuana from thirty to sixty days; allows a designated caregiver facility or designated caregiver facility employee to possess, acquire, deliver, transfer, transport or administer medical marihuana; requires the commissioner of health to establish a medical marihuana research license; establishes a medical marihuana research program; requires the registration of designated caregiver facilities; authorizes the commissioner of health to approve and permit one or more independent laboratories to test medical marihuana; increases the number of dispensing sites of a registered organization from four to eight; and makes related provisions.
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A07467 Actions:

BILL NOA07467A
 
05/06/2019referred to health
05/21/2019reported referred to codes
05/22/2019amend and recommit to codes
05/22/2019print number 7467a
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A07467 Committee Votes:

HEALTH Chair:Gottfried DATE:05/21/2019AYE/NAY:22/4 Action: Favorable refer to committee Codes
GottfriedAyeRaiaNay
SchimmingerAyeMcDonoughNay
GalefAyeRaNay
DinowitzAyeGarbarinoNay
CahillAyeByrneAye
PaulinAyeByrnesAye
CymbrowitzAyeAshbyAye
GuntherAye
RosenthalAye
HevesiAye
JaffeeAye
SteckAye
AbinantiAye
BraunsteinAye
KimAye
SolagesAye
BichotteAye
BarronAye
SayeghAye

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A07467 Floor Votes:

There are no votes for this bill in this legislative session.
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A07467 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         7467--A
 
                               2019-2020 Regular Sessions
 
                   IN ASSEMBLY
 
                                       May 6, 2019
                                       ___________
 
        Introduced  by  M.  of  A. GOTTFRIED, PEOPLES-STOKES, LUPARDO, ABINANTI,
          ASHBY, CARROLL, CRUZ, DenDEKKER, DICKENS, ENGLEBRIGHT, GLICK,  HEVESI,
          JAFFEE,  JEAN-PIERRE,  HUNTER,  M. L. MILLER, McDONALD, ORTIZ, PAULIN,
          PICHARDO, REYES, L. ROSENTHAL, SIMON, WRIGHT, SAYEGH, CRESPO,  RAYNOR,
          FERNANDEZ  --  read  once  and  referred to the Committee on Health --
          reported  and  referred  to  the  Committee  on  Codes  --   committee
          discharged, bill amended, ordered reprinted as amended and recommitted
          to said committee
 
        AN ACT to amend the public health law, in relation to medical marihuana
 
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
 
     1    Section 1. Subdivisions 1, 5, 7 and 12 of section 3360 of  the  public
     2  health  law,  subdivisions  1, 5, 7 and 12 as added by chapter 90 of the
     3  laws of 2014, paragraph (a) of subdivision 7 as amended by  chapter  273
     4  of the laws of 2018, are amended and three new subdivisions 5-a, 5-b and
     5  19 are added to read as follows:
     6    1. "Certified medical use" means the acquisition, possession, use, or,
     7  transportation  of  medical  marihuana  by  a  certified patient, or the
     8  acquisition, possession, delivery, transportation or  administration  of
     9  medical  marihuana  by  a  designated  caregiver, for use as part of the
    10  treatment of the patient's  [serious]  condition,  as  authorized  in  a
    11  certification  under this title including enabling the patient to toler-
    12  ate treatment for the [serious] condition. [A certified medical use does
    13  not include smoking.]
    14    5. "Designated caregiver" means the individual or  caregiver  facility
    15  designated by a certified patient in a registry application. A certified
    16  patient  may  designate  up to two designated caregivers, not counting a
    17  designated caregiver facility or designated caregiver facility employee.
    18    5-a. "Designated caregiver facility" means an  entity  that  registers
    19  with  the commissioner to assist one or more certified patients with the
    20  acquisition, possession, delivery, transportation or  administration  of
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD11129-04-9

        A. 7467--A                          2
 
     1  medical  marihuana and is: a general hospital or residential health care
     2  facility operating under article twenty-eight of this chapter; an  adult
     3  care  facility  operating under title two of article seven of the social
     4  services  law;  a  community  mental  health residence established under
     5  section 41.44 of the mental hygiene  law;  a  hospital  operating  under
     6  section  7.17 of the mental hygiene law; a mental hygiene facility oper-
     7  ating under article thirty-one of the mental hygiene law;  an  inpatient
     8  or  residential  treatment program certified under article thirty-two of
     9  the mental hygiene law; a residential facility for the care  and  treat-
    10  ment  of persons with developmental disabilities operating under article
    11  sixteen of the mental hygiene law; a residential treatment facility  for
    12  children  and  youth  operating  under  article thirty-one of the mental
    13  hygiene law; a public school  or  private  school  operating  under  the
    14  education  law;  a research institution with an internal review board; a
    15  medical marihuana research program licensed under  section  thirty-three
    16  hundred  sixty-four-a of this title; or any other facility as determined
    17  by the commissioner in regulation.
    18    5-b. "Designated caregiver facility employee" means an employee  of  a
    19  designated caregiver facility.
    20    7. (a) ["Serious condition"] "Condition" means:
    21    (i) having one of the following [severe debilitating or life-threaten-
    22  ing]  conditions:  cancer,  positive  status  for human immunodeficiency
    23  virus or acquired immune deficiency syndrome, amyotrophic lateral scler-
    24  osis, Parkinson's disease, multiple sclerosis,  damage  to  the  nervous
    25  tissue  of  the  spinal  cord  with objective neurological indication of
    26  intractable spasticity, epilepsy, inflammatory bowel  disease,  neuropa-
    27  thies,  Huntington's  disease, post-traumatic stress disorder, pain that
    28  degrades health and functional capability where the use of medical mari-
    29  huana  is  an  alternative  to  opioid  use,  substance  use   disorder,
    30  Alzheimer's, muscular dystrophy, dystonia, rheumatoid arthritis, autism,
    31  or [as added by the commissioner; and
    32    (ii) any of the following conditions where it is clinically associated
    33  with,  or  a  complication  of,  a condition under this paragraph or its
    34  treatment: cachexia or wasting syndrome; severe or chronic pain;  severe
    35  nausea; seizures; severe or persistent muscle spasms; or such conditions
    36  as are added by the commissioner.
    37    (b)  No  later  than  eighteen  months from the effective date of this
    38  section, the commissioner shall determine whether to add  the  following
    39  serious  conditions:  Alzheimer's,  muscular  dystrophy, dystonia, post-
    40  traumatic stress disorder and rheumatoid arthritis] any other  condition
    41  certified by the practitioner.
    42    12.  "Practitioner"  means  a  practitioner  who  (i)  [is a physician
    43  licensed by New York state and practicing within the state,] is  author-
    44  ized  to prescribe controlled substances within the state; (ii) [who] by
    45  training or experience is qualified to treat a  [serious]  condition  as
    46  defined in subdivision seven of this section; and (iii) [has completed a
    47  two  to four hour course as determined by the commissioner in regulation
    48  and registered with the department;  provided  however,  a  registration
    49  shall  not  be  denied without cause. Such course may count toward board
    50  certification requirements. The commissioner shall consider  the  inclu-
    51  sion  of  nurse practitioners under this title based upon considerations
    52  including access and availability. After such consideration the  commis-
    53  sioner  is authorized to deem nurse practitioners as practitioners under
    54  this title] completes, at a minimum, a two hour course as determined  by
    55  the  commissioner.  A person's status as a practitioner under this title

        A. 7467--A                          3
 
     1  is deemed to be a "license" for purposes of section thirty-three hundred
     2  ninety of this article.
     3    19.  "Medical  marihuana  research  program" means a medical marihuana
     4  research   program   licensed   under   section   thirty-three   hundred
     5  sixty-four-a of this title.
     6    §  2.  Subdivisions  1,  2, and 9 of section 3361 of the public health
     7  law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and
     8  subdivision 9 as added by chapter 416 of the laws of 2015,  are  amended
     9  to read as follows:
    10    1.  A  patient certification may only be issued if: (a) a practitioner
    11  has been registered with the department  to  issue  a  certification  as
    12  determined  by  the commissioner; (b) the patient has a [serious] condi-
    13  tion, which shall be specified in the patient's health care record;  (c)
    14  the  practitioner  by  training  or experience is qualified to treat the
    15  [serious] condition; (d) the patient is under the practitioner's contin-
    16  uing care for the [serious] condition; and  (e)  in  the  practitioner's
    17  professional opinion and review of past treatments, the patient is like-
    18  ly  to  receive  therapeutic  or  palliative benefit from the primary or
    19  adjunctive treatment with medical use of  marihuana  for  the  [serious]
    20  condition.
    21    2.  The  certification  shall  include (a) the name, date of birth and
    22  address of the patient; (b) a statement that the patient has a [serious]
    23  condition and the patient is  under  the  practitioner's  care  for  the
    24  [serious]  condition; (c) a statement attesting that all requirements of
    25  subdivision one of this section have been satisfied; (d) the  date;  and
    26  (e)  the  name,  address, federal registration number, telephone number,
    27  and the  handwritten  signature  of  the  certifying  practitioner.  The
    28  commissioner  may  require by regulation that the certification shall be
    29  on a form provided by the department. The practitioner may state in  the
    30  certification  that,  in  the  practitioner's  professional opinion, the
    31  patient would benefit from medical  marihuana  only  until  a  specified
    32  date. The practitioner may state in the certification that, in the prac-
    33  titioner's  professional opinion, the patient is terminally ill and that
    34  the certification shall not expire until the patient dies.
    35    9.(a) A certification may be a special certification if,  in  addition
    36  to  the  other requirements for a certification, the practitioner certi-
    37  fies in the certification that  the  patient's  [serious]  condition  is
    38  progressive  and  degenerative  or that delay in the patient's certified
    39  medical use of marihuana poses a serious risk to the patient's  life  or
    40  health.
    41    (b)  The  department  shall  create  the form to be used for a special
    42  certification and shall make that form available to be  downloaded  from
    43  the department's website.
    44    § 3. Subdivisions 1 and 2 of section 3362 of the public health law, as
    45  added  by chapter 90 of the laws of 2014, are amended and a new subdivi-
    46  sion 3 is added to read as follows:
    47    1. The possession, acquisition, use, delivery,  transfer,  transporta-
    48  tion,  or  administration of medical marihuana by a certified patient or
    49  designated caregiver possessing a valid  registry  identification  card,
    50  for  certified  medical  use, shall be lawful under this title; provided
    51  that:
    52    (a) the marihuana that may be possessed by a certified  patient  shall
    53  not  exceed  a  [thirty] sixty day supply of the dosage as determined by
    54  the practitioner, consistent with any guidance and regulations issued by
    55  the commissioner, provided that during the last seven days of any [thir-

        A. 7467--A                          4

     1  ty] sixty day period, the certified patient may also possess up to  such
     2  amount for the next [thirty] sixty day period;
     3    (b)  the marihuana that may be possessed by designated caregivers does
     4  not exceed the quantities referred to in paragraph (a) of this  subdivi-
     5  sion for each certified patient for whom the caregiver possesses a valid
     6  registry identification card, up to five certified patients;
     7    (c) the marihuana that may be possessed by designated caregiver facil-
     8  ities  does  not  exceed  the quantities referred to in paragraph (a) of
     9  this subdivision for each certified patient under care or  treatment  of
    10  the facility;
    11    (d)  the  form  or forms of medical marihuana that may be possessed by
    12  the certified patient [or], designated caregiver, or designated caregiv-
    13  er facility pursuant to a certification shall be in compliance with  any
    14  recommendation or limitation by the practitioner as to the form or forms
    15  of  medical marihuana or dosage for the certified patient in the certif-
    16  ication; and
    17    [(d)] (e) the medical marihuana shall be kept in the original  package
    18  in  which  it  was dispensed under subdivision twelve of section thirty-
    19  three hundred sixty-four of this title, except for the  portion  removed
    20  for  immediate  consumption  for  certified medical use by the certified
    21  patient.
    22    2. Notwithstanding subdivision one of this section:
    23    (a) possession of medical marihuana shall not  be  lawful  under  this
    24  title  if it is smoked, consumed, vaporized, or grown in a public place,
    25  regardless of the form of medical  marihuana  stated  in  the  patient's
    26  certification.
    27    (b)  a  [person]  certified patient or designated caregiver possessing
    28  medical marihuana under this title shall possess  his  or  her  registry
    29  identification card at all times when in immediate possession of medical
    30  marihuana.
    31    (c) medical marihuana may not be smoked in any place where tobacco may
    32  not  be  smoked  under article thirteen-E of this chapter, regardless of
    33  the form of medical marihuana stated in the patient's certification.
    34    3. The possession, acquisition, delivery, transfer, transportation, or
    35  administration of medical marihuana by a designated  caregiver  facility
    36  or  designated  caregiver  facility  employee shall be lawful under this
    37  title provided that:
    38    (a) the designated caregiver facility registers with the department on
    39  a form provided by the commissioner;
    40    (b) such possession, acquisition, delivery, transfer,  transportation,
    41  or  administration  is  on  behalf  of  a certified patient possessing a
    42  registry identification card;
    43    (c) the designated caregiver facility maintains a copy of the registry
    44  identification card of each certified patient for  which  it  possesses,
    45  acquires,  delivers, transfers, transports, or administers medical mari-
    46  huana; and
    47    (d) a designated caregiver facility employee shall be identified as an
    48  employee when necessary, as provided by the commissioner.
    49    § 4. Subdivisions 2, 3, 5, and 11 of section 3363 of the public health
    50  law, as added by chapter 90 of the laws of 2014, are amended to read  as
    51  follows:
    52    2.  To obtain, amend or renew a registry identification card, a certi-
    53  fied patient or designated caregiver shall file a  registry  application
    54  with  the  department.  The  registry application or renewal application
    55  shall include:
    56    (a) in the case of a certified patient:

        A. 7467--A                          5
 
     1    (i) the patient's certification (a new written certification shall  be
     2  provided with a renewal application);
     3    (ii) the name, address, and date of birth of the patient;
     4    (iii) the date of the certification;
     5    (iv)  if  the  patient  has  a registry identification card based on a
     6  current valid certification,  the  registry  identification  number  and
     7  expiration date of that registry identification card;
     8    (v)  the  specified  date  until  which the patient would benefit from
     9  medical marihuana, if the certification states such a date;
    10    (vi) the name, address, federal  registration  number,  and  telephone
    11  number of the certifying practitioner;
    12    (vii)  any  recommendation or limitation by the practitioner as to the
    13  form or forms of medical marihuana or dosage for the certified  patient;
    14  and
    15    (viii)  other  individual  identifying  information  required  by  the
    16  department;
    17    (b) (i) in the case of a certified patient, if the patient  designates
    18  a  designated  caregiver,  the  name,  address, and date of birth of the
    19  designated  caregiver,  and  other  individual  identifying  information
    20  required by the department;
    21    (ii)  if  the  designated  caregiver  is  a medical marihuana research
    22  program, the name of  the  organization  conducting  the  research;  the
    23  address,  phone  number, and name of the individual leading the research
    24  or appropriate designee; and other identifying information  required  by
    25  the department;
    26    (c) in the case of a designated caregiver:
    27    (i) the name, address, and date of birth of the designated caregiver;
    28    (ii)  if  the designated caregiver has a registry identification card,
    29  the registry identification number and expiration date of that  registry
    30  identification card; and
    31    (iii) other individual identifying information required by the depart-
    32  ment;
    33    (d)  a  statement  that  a  false statement made in the application is
    34  punishable under section 210.45 of the penal law;
    35    (e) the date of the application and the  signature  of  the  certified
    36  patient or designated caregiver, as the case may be; and
    37    (f) [a fifty dollar application fee, provided, that the department may
    38  waive or reduce the fee in cases of financial hardship; and
    39    (g)] any other requirements determined by the commissioner.
    40    3. Where a certified patient is under the age of eighteen:
    41    (a)  The  application for a registry identification card shall be made
    42  by an appropriate person over twenty-one years of age.  The  application
    43  shall state facts demonstrating that the person is appropriate.
    44    (b)  The  designated caregiver shall be (i) a parent or legal guardian
    45  of the certified patient, (ii) a person designated by a parent or  legal
    46  guardian, [or] (iii) in the case of such a certified patient being cared
    47  for by a designated caregiver facility, the designated caregiver facili-
    48  ty  designated  by  the parent or legal guardian; or (iv) an appropriate
    49  person approved by the department upon  a  sufficient  showing  that  no
    50  parent or legal guardian is appropriate or available.
    51    5.  No  person may be a designated caregiver for more than five certi-
    52  fied patients at one time; provided however that this  limitation  shall
    53  not  apply  to  a  designated caregiver facility or designated caregiver
    54  facility employee.
    55    11. A certified patient or designated caregiver who has been issued  a
    56  registry  identification  card shall notify the department of any change

        A. 7467--A                          6
 
     1  in his or her name or address or, with respect to the patient, if he  or
     2  she  ceases  to  have the [serious] condition noted on the certification
     3  within ten days of such change. The certified  patient's  or  designated
     4  caregiver's  registry  identification  card  shall be deemed invalid and
     5  shall be returned promptly to the department.
     6    § 5. Subdivisions 3 and 5 of section 3364 of the public health law, as
     7  added by chapter 90 of the laws of 2014, are amended and a new  subdivi-
     8  sion 14 is added to read as follows:
     9    3.  Each  registered  organization  shall contract with an independent
    10  laboratory permitted under section thirty-three hundred sixty-four-c  of
    11  this  title  to  test  the  medical marihuana produced by the registered
    12  organization. The commissioner shall approve the laboratory and  require
    13  that the laboratory report testing results in a manner determined by the
    14  commissioner. The commissioner is authorized to issue regulation requir-
    15  ing the laboratory to perform certain tests and services.
    16    5.  (a)  No  registered  organization may sell, deliver, distribute or
    17  dispense to any certified patient or designated caregiver a quantity  of
    18  medical  marihuana  larger  than  that  individual  would  be allowed to
    19  possess under this title.
    20    (b) When dispensing medical marihuana to a certified patient or desig-
    21  nated caregiver, the registered organization (i) shall not  dispense  an
    22  amount  greater  than a [thirty] sixty day supply to a certified patient
    23  until the certified patient has exhausted all but  a  seven  day  supply
    24  provided  pursuant  to a previously issued certification, and (ii) shall
    25  verify the information in subparagraph (i) of this paragraph by consult-
    26  ing the prescription monitoring program registry under  section  thirty-
    27  three hundred forty-three-a of this article.
    28    (c)  Medical  marihuana dispensed to a certified patient or designated
    29  caregiver by a registered organization shall conform to any  recommenda-
    30  tion  or  limitation  by  the  practitioner  as  to the form or forms of
    31  medical marihuana or dosage for the certified patient.
    32    14. A registered organization may contract with a person or entity  to
    33  provide  facilities,  equipment  or  services  that are ancillary to the
    34  registered organization's functions or  activities  under  this  section
    35  (including,  but  not  limited  to, shipping, maintenance, construction,
    36  repair, and security),  but  not  including  any  function  or  activity
    37  directly  involving the planting, growing, tending, harvesting, process-
    38  ing, or packaging of plants; or any other  function  directly  involving
    39  manufacturing  or  retailing  of  medical  marihuana. All laws and regu-
    40  lations applicable to such  facilities,  equipment,  or  services  shall
    41  apply  to the contract. The registered organization and other parties to
    42  the contract shall each be responsible for compliance with such laws and
    43  regulations under the contract. The commissioner  may  make  regulations
    44  consistent  with  this  title  relating  to  contracts  and  parties  to
    45  contracts under this subdivision.
    46    § 6. The public health law is amended by adding a new  section  3364-a
    47  to read as follows:
    48    §  3364-a.  Medical  marihuana research licenses.  1. The commissioner
    49  shall establish a medical marihuana  research  license  that  permits  a
    50  licensee  to  produce,  process,  purchase,  possess, transfer, and sell
    51  marihuana, subject to this section, for the following  limited  research
    52  purposes:
    53    (a) to test chemical potency and composition levels;
    54    (b) to conduct clinical investigations of marihuana-derived products;
    55    (c)  to  conduct  research on the efficacy and safety of administering
    56  marihuana as part of medical treatment; or

        A. 7467--A                          7
 
     1    (d) to conduct genomic or agricultural research  relating  to  medical
     2  marihuana.
     3    2. As part of the application process for a medical marihuana research
     4  license,  an  applicant must submit to the commissioner a description of
     5  the research that is intended to be conducted as well as the  amount  of
     6  marihuana  to  be  grown  or purchased. The commissioner shall review an
     7  applicant's research project and determine whether it meets the require-
     8  ments of subdivision one of this section. In addition, the  commissioner
     9  shall assess the application based on the following criteria:
    10    (a) project quality, study design, value, and impact;
    11    (b)  whether  the  applicant has the appropriate personnel, expertise,
    12  facilities and infrastructure,  funding,  and  (to  the  extent  legally
    13  available)  approvals  relating to human or animal research, in place to
    14  successfully conduct the project; and
    15    (c) whether the amount of marihuana to be grown or  purchased  by  the
    16  applicant is consistent with the project's scope and goals.
    17    3.  If the commissioner determines that the research project meets the
    18  requirements of subdivision one of this section,  the  commissioner  may
    19  approve the application. If not, the application shall be denied.
    20    4.  A  medical  marihuana  research licensee may only sell or transfer
    21  marihuana grown or produced within its operation to other medical  mari-
    22  huana  research  licensees,  or otherwise for purposes of the licensee's
    23  research.
    24    5. In establishing a medical marihuana research license,  the  commis-
    25  sioner may make regulations on the following:
    26    (a) application requirements;
    27    (b)   license   renewal  requirements,  including  whether  additional
    28  research projects may be added or considered;
    29    (c) conditions for license revocation;
    30    (d) security measures to ensure marihuana is not diverted to  purposes
    31  other than research;
    32    (e)  amount  of  plants, useable marihuana, marihuana concentrates, or
    33  marihuana-infused products a licensee may have on its premises;
    34    (f) licensee reporting requirements;
    35    (g) conditions under which marihuana grown by licensed  medical  mari-
    36  huana  producers and other product types from licensed medical marihuana
    37  processors may be donated to medical marihuana research licensees; and
    38    (h) any additional requirements deemed necessary by the commissioner.
    39    6. A marihuana research license issued under  this  section  shall  be
    40  issued  in the name of the applicant or applicants, specify the location
    41  at which the marihuana researcher intends to  operate,  which  shall  be
    42  within  the  state,  and  shall  not  allow  any other person to use the
    43  license except as under subdivision four of this section.
    44    7. Participation  by  certified  patients  in  any  medical  marihuana
    45  research program shall be voluntary.
    46    8.  The application fee for a medical marihuana research license shall
    47  be determined by the commissioner on an annual basis.
    48    9. Each medical marihuana research  licensee  shall  issue  an  annual
    49  report  to  the  commissioner. The commissioner shall review such report
    50  and make a determination as to whether the research project continues to
    51  meet the research qualifications under this section.
    52    § 7. The public health law is amended by adding a new  section  3364-b
    53  to read as follows:
    54    §  3364-b.  Registration  of  designated caregiver facilities.   1. To
    55  obtain, amend or renew a registration as a designated caregiver  facili-

        A. 7467--A                          8

     1  ty,  the  facility  shall file an application with the commissioner. The
     2  application shall include:
     3    (a) the facility's full name and address;
     4    (b) operating certificate or license number where appropriate;
     5    (c)  name,  title,  and  signature of an authorized facility represen-
     6  tative;
     7    (d) a statement that the facility agrees to secure and  ensure  proper
     8  handling of all medical marihuana products;
     9    (e)  an  acknowledgement  that a false statement in the application is
    10  punishable under section 210.45 of the penal law; and
    11    (f) any other information that may be required by the commissioner.
    12    2. Prior to issuing or renewing a designated caregiver facility regis-
    13  tration, the commissioner may verify the information  submitted  by  the
    14  applicant.   The applicant shall provide, at the commissioner's request,
    15  such information and documentation, including any consents  or  authori-
    16  zations, that may be necessary for the commissioner to verify the infor-
    17  mation.
    18    3.  The application shall be approved, denied or determined incomplete
    19  or inaccurate by the commissioner within thirty days of receipt  of  the
    20  application.  If  the  application  is  approved, the commissioner shall
    21  issue a registration as soon as is reasonably practicable.
    22    4. Registrations under this section shall remain valid for  two  years
    23  from the date of issuance.
    24    §  8.  The public health law is amended by adding a new section 3364-c
    25  to read as follows:
    26    § 3364-c. Laboratory permits.  1. The commissioner shall  approve  and
    27  permit  one  or more independent laboratories to test medical marihuana.
    28  To be permitted as an independent laboratory under this section, a labo-
    29  ratory must apply to the department in a form and manner  prescribed  by
    30  the  commissioner and must demonstrate the following to the satisfaction
    31  of the commissioner:
    32    (a) the owners and directors of the laboratory are of good moral char-
    33  acter;
    34    (b) the laboratory and its  staff  have  the  skills,  resources,  and
    35  expertise  needed  to  accurately  and  consistently perform all testing
    36  required;
    37    (c) the laboratory has in place and will maintain  adequate  policies,
    38  procedures, and facility security to ensure proper collection, labeling,
    39  accessioning,  preparation,  analysis,  result  reporting, disposal, and
    40  storage of medical marihuana;
    41    (d) the laboratory is physically located in New York state;
    42    (e) the laboratory has a certificate of approval as  an  environmental
    43  laboratory issued by the commissioner under title one of article five of
    44  this chapter; and
    45    (f)  the  laboratory meets all requirements prescribed by this chapter
    46  and the commissioner in regulation.
    47    2. The owner of an independent laboratory permitted under this section
    48  shall not hold a registration as a registered organization and shall not
    49  have any direct or indirect ownership interest in such registered organ-
    50  ization.  No board member, manager, owner, partner, principal stakehold-
    51  er, or member of a registered organization, or such  person's  immediate
    52  family, shall have an interest or voting rights in any independent labo-
    53  ratory  permittee.  No  registered organization shall have any direct or
    54  indirect ownership interest in such laboratory.
    55    3. An independent laboratory shall not be required to be  licensed  by
    56  the federal drug enforcement administration.

        A. 7467--A                          9
 
     1    §  9. Subdivision 9 of section 3365 of the public health law, as added
     2  by chapter 90 of the laws of 2014, is amended to read as follows:
     3    9.  [The  commissioner  shall register no more than five] A registered
     4  [organizations] organization  that  [manufacture]  manufactures  medical
     5  marihuana  [with]  may  have  no more than [four] eight dispensing sites
     6  wholly owned and operated by [such]  the  registered  organization.  The
     7  commissioner  shall  ensure  that  such  [registered  organizations and]
     8  dispensing sites are geographically distributed across  the  state.  The
     9  commission  [may]  shall  register  additional  registered organizations
    10  reflecting the demographics of the state.
    11    § 10. Subdivision 1 of section 3365-a of the  public  health  law,  as
    12  added by chapter 416 of the laws of 2015, is amended to read as follows:
    13    1.  There is hereby established in the department an emergency medical
    14  marihuana access program (referred to in this section as the  "program")
    15  under this section. The purpose of the program is to expedite the avail-
    16  ability of medical marihuana to avoid suffering and loss of life, during
    17  the  period  before  full  implementation  of  and production under this
    18  title, especially in the case of patients whose [serious]  condition  is
    19  progressive  and  degenerative  or  is  such that delay in the patient's
    20  medical use of marihuana poses a serious risk to the patient's  life  or
    21  health. The commissioner shall implement the program as expeditiously as
    22  practicable, including by emergency regulation.
    23    § 11. Subdivision 1 of section 3369 of the public health law, as added
    24  by chapter 90 of the laws of 2014, is amended to read as follows:
    25    1.  Certified  patients,  designated  caregivers, designated caregiver
    26  facilities, designated caregiver facility employees,  medical  marihuana
    27  research  program employees, practitioners, registered organizations and
    28  the employees of  registered  organizations  shall  not  be  subject  to
    29  arrest,  prosecution,  or  penalty in any manner, or denied any right or
    30  privilege, including but not limited to civil  penalty  or  disciplinary
    31  action  by a business or occupational or professional licensing board or
    32  bureau, solely for the certified medical use or manufacture of  marihua-
    33  na, or for any other action or conduct in accordance with this title.
    34    §  12. Section 3369-d of the public health law, as added by chapter 90
    35  of the laws of 2014, is amended to read as follows:
    36    § 3369-d. Pricing. [1. Every sale of medical marihuana shall be at the
    37  price determined by the commissioner. Every charge made or demanded  for
    38  medical  marihuana  not  in  accordance with the price determined by the
    39  commissioner, is prohibited.
    40    2. The commissioner is hereby authorized to set the per dose price  of
    41  each  form  of medical marihuana sold by any registered organization. In
    42  setting the per dose price  of  each  form  of  medical  marihuana,  the
    43  commissioner  shall  consider  the fixed and variable costs of producing
    44  the form of marihuana and any other factor the commissioner, in  his  or
    45  her discretion, deems relevant to determining the per dose price of each
    46  form  of  medical  marihuana.]  Registered  organizations  shall  submit
    47  documentation of any price and change in price per dose for any  medical
    48  marihuana  product to the commissioner within fifteen days of setting or
    49  changing the price. Prior approval by  the  commissioner  shall  not  be
    50  required  for any price or change of price. However, the commissioner is
    51  authorized to modify the price per dose for any medical marihuana  prod-
    52  uct if necessary to maintain public access to appropriate medication.
    53    §  13. This act shall take effect immediately; provided, however, that
    54  the amendments to title 5-A of article 33 of the public health law  made
    55  by  sections  one, two, three, four, five, six, seven, eight, nine, ten,
    56  eleven and twelve of this act shall not affect the repeal of such  title

        A. 7467--A                         10
 
     1  and shall be deemed repealed therewith. Effective immediately, the addi-
     2  tion,  amendment  and/or  repeal of any rule or regulation necessary for
     3  the  implementation of this act on its effective date are authorized  to
     4  be made and completed on or before such effective date.
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