A00531 Summary:

BILL NOA00531
 
SAME ASNo Same As
 
SPONSORGottfried
 
COSPNSRPeoples-Stokes, Lupardo, Abinanti, Ashby, Carroll, Cruz, Dickens, Englebright, Glick, Hevesi, Jean-Pierre, Hunter, Miller M, Paulin, Pichardo, Reyes, Rosenthal L, Simon, Sayegh, Darling, Fernandez, Ramos, Fahy, Bronson, Zinerman, McDonald, Kelles, Burdick, Gallagher, Jackson, Forrest
 
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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A00531 Actions:

BILL NOA00531
 
01/06/2021referred to health
01/26/2021reported referred to codes
04/20/2021enacting clause stricken
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A00531 Committee Votes:

HEALTH Chair:Gottfried DATE:01/26/2021AYE/NAY:25/1 Action: Favorable refer to committee Codes
GottfriedAyeByrneAye
GalefAyeMcDonoughAye
DinowitzAyeByrnesNay
CahillAyeAshbyAye
PaulinAyeMillerAye
CymbrowitzAyeSalkaAye
GuntherAyeJensenAye
Rosenthal L Aye
HevesiAye
SteckAye
AbinantiAye
BraunsteinAye
SolagesAye
BichotteAye
BarronAye
SayeghAye
Rosenthal D Aye
McDonaldAye
ReyesAye

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A00531 Floor Votes:

There are no votes for this bill in this legislative session.
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A00531 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                           531
 
                               2021-2022 Regular Sessions
 
                   IN ASSEMBLY
 
                                       (Prefiled)
 
                                     January 6, 2021
                                       ___________
 
        Introduced  by  M.  of  A. GOTTFRIED, PEOPLES-STOKES, LUPARDO, ABINANTI,
          ASHBY,   CARROLL,   CRUZ,   DICKENS,   ENGLEBRIGHT,   GLICK,   HEVESI,
          JEAN-PIERRE, HUNTER, M. MILLER, PAULIN, PICHARDO, REYES, L. ROSENTHAL,
          SIMON,  SAYEGH,  DARLING, FERNANDEZ, RAMOS, FAHY, BRONSON -- read once
          and referred to the Committee on Health
 
        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
    21  medical marihuana and is: a general hospital or residential health  care
    22  facility  operating under article twenty-eight of this chapter; an adult
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD00363-01-1

        A. 531                              2
 
     1  care facility operating under title two of article seven of  the  social
     2  services  law;  a  community  mental  health residence established under
     3  section 41.44 of the mental hygiene  law;  a  hospital  operating  under
     4  section  7.17 of the mental hygiene law; a mental hygiene facility oper-
     5  ating under article thirty-one of the mental hygiene law;  an  inpatient
     6  or  residential  treatment program certified under article thirty-two of
     7  the mental hygiene law; a residential facility for the care  and  treat-
     8  ment  of persons with developmental disabilities operating under article
     9  sixteen of the mental hygiene law; a residential treatment facility  for
    10  children  and  youth  operating  under  article thirty-one of the mental
    11  hygiene law; a public school  or  private  school  operating  under  the
    12  education  law;  a research institution with an internal review board; a
    13  medical marihuana research program licensed under  section  thirty-three
    14  hundred  sixty-four-a of this title; or any other facility as determined
    15  by the commissioner in regulation.
    16    5-b. "Designated caregiver facility employee" means an employee  of  a
    17  designated caregiver facility.
    18    7. (a) ["Serious condition"] "Condition" means:
    19    (i) having one of the following [severe debilitating or life-threaten-
    20  ing]  conditions:  cancer,  positive  status  for human immunodeficiency
    21  virus or acquired immune deficiency syndrome, amyotrophic lateral scler-
    22  osis, Parkinson's disease, multiple sclerosis,  damage  to  the  nervous
    23  tissue  of  the  spinal  cord  with objective neurological indication of
    24  intractable spasticity, epilepsy, inflammatory bowel  disease,  neuropa-
    25  thies,  Huntington's  disease, post-traumatic stress disorder, pain that
    26  degrades health and functional capability where the use of medical mari-
    27  huana  is  an  alternative  to  opioid  use,  substance  use   disorder,
    28  Alzheimer's, muscular dystrophy, dystonia, rheumatoid arthritis, autism,
    29  or [as added by the commissioner; and
    30    (ii) any of the following conditions where it is clinically associated
    31  with,  or  a  complication  of,  a condition under this paragraph or its
    32  treatment: cachexia or wasting syndrome; severe or chronic pain;  severe
    33  nausea; seizures; severe or persistent muscle spasms; or such conditions
    34  as are added by the commissioner.
    35    (b)  No  later  than  eighteen  months from the effective date of this
    36  section, the commissioner shall determine whether to add  the  following
    37  serious  conditions:  Alzheimer's,  muscular  dystrophy, dystonia, post-
    38  traumatic stress disorder and rheumatoid arthritis] any other  condition
    39  certified by the practitioner.
    40    12.  "Practitioner"  means  a  practitioner  who  (i)  [is a physician
    41  licensed by New York state and practicing within the state,] is  author-
    42  ized  to prescribe controlled substances within the state; (ii) [who] by
    43  training or experience is qualified to treat a  [serious]  condition  as
    44  defined in subdivision seven of this section; and (iii) [has completed a
    45  two  to four hour course as determined by the commissioner in regulation
    46  and registered with the department;  provided  however,  a  registration
    47  shall  not  be  denied without cause. Such course may count toward board
    48  certification requirements. The commissioner shall consider  the  inclu-
    49  sion  of  nurse practitioners under this title based upon considerations
    50  including access and availability. After such consideration the  commis-
    51  sioner  is authorized to deem nurse practitioners as practitioners under
    52  this title] completes, at a minimum, a two hour course as determined  by
    53  the  commissioner.  A person's status as a practitioner under this title
    54  is deemed to be a "license" for purposes of section thirty-three hundred
    55  ninety of this article.

        A. 531                              3
 
     1    19. "Medical marihuana research program"  means  a  medical  marihuana
     2  research   program   licensed   under   section   thirty-three   hundred
     3  sixty-four-a of this title.
     4    §  2.  Subdivisions  1,  2, and 9 of section 3361 of the public health
     5  law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and
     6  subdivision 9 as added by chapter 416 of the laws of 2015,  are  amended
     7  to read as follows:
     8    1.  A  patient certification may only be issued if: (a) a practitioner
     9  has been registered with the department  to  issue  a  certification  as
    10  determined  by  the commissioner; (b) the patient has a [serious] condi-
    11  tion, which shall be specified in the patient's health care record;  (c)
    12  the  practitioner  by  training  or experience is qualified to treat the
    13  [serious] condition; (d) the patient is under the practitioner's contin-
    14  uing care for the [serious] condition; and  (e)  in  the  practitioner's
    15  professional opinion and review of past treatments, the patient is like-
    16  ly  to  receive  therapeutic  or  palliative benefit from the primary or
    17  adjunctive treatment with medical use of  marihuana  for  the  [serious]
    18  condition.
    19    2.  The  certification  shall  include (a) the name, date of birth and
    20  address of the patient; (b) a statement that the patient has a [serious]
    21  condition and the patient is  under  the  practitioner's  care  for  the
    22  [serious]  condition; (c) a statement attesting that all requirements of
    23  subdivision one of this section have been satisfied; (d) the  date;  and
    24  (e)  the  name,  address, federal registration number, telephone number,
    25  and the  handwritten  signature  of  the  certifying  practitioner.  The
    26  commissioner  may  require by regulation that the certification shall be
    27  on a form provided by the department. The practitioner may state in  the
    28  certification  that,  in  the  practitioner's  professional opinion, the
    29  patient would benefit from medical  marihuana  only  until  a  specified
    30  date. The practitioner may state in the certification that, in the prac-
    31  titioner's  professional opinion, the patient is terminally ill and that
    32  the certification shall not expire until the patient dies.
    33    9.(a) A certification may be a special certification if,  in  addition
    34  to  the  other requirements for a certification, the practitioner certi-
    35  fies in the certification that  the  patient's  [serious]  condition  is
    36  progressive  and  degenerative  or that delay in the patient's certified
    37  medical use of marihuana poses a serious risk to the patient's  life  or
    38  health.
    39    (b)  The  department  shall  create  the form to be used for a special
    40  certification and shall make that form available to be  downloaded  from
    41  the department's website.
    42    § 3. Subdivisions 1 and 2 of section 3362 of the public health law, as
    43  added  by chapter 90 of the laws of 2014, are amended and a new subdivi-
    44  sion 3 is added to read as follows:
    45    1. The possession, acquisition, use, delivery,  transfer,  transporta-
    46  tion,  or  administration of medical marihuana by a certified patient or
    47  designated caregiver possessing a valid  registry  identification  card,
    48  for  certified  medical  use, shall be lawful under this title; provided
    49  that:
    50    (a) the marihuana that may be possessed by a certified  patient  shall
    51  not  exceed  a  [thirty] sixty day supply of the dosage as determined by
    52  the practitioner, consistent with any guidance and regulations issued by
    53  the commissioner, provided that during the last seven days of any [thir-
    54  ty] sixty day period, the certified patient may also possess up to  such
    55  amount for the next [thirty] sixty day period;

        A. 531                              4
 
     1    (b)  the marihuana that may be possessed by designated caregivers does
     2  not exceed the quantities referred to in paragraph (a) of this  subdivi-
     3  sion for each certified patient for whom the caregiver possesses a valid
     4  registry identification card, up to five certified patients;
     5    (c) the marihuana that may be possessed by designated caregiver facil-
     6  ities  does  not  exceed  the quantities referred to in paragraph (a) of
     7  this subdivision for each certified patient under care or  treatment  of
     8  the facility;
     9    (d)  the  form  or forms of medical marihuana that may be possessed by
    10  the certified patient [or], designated caregiver, or designated caregiv-
    11  er facility pursuant to a certification shall be in compliance with  any
    12  recommendation or limitation by the practitioner as to the form or forms
    13  of  medical marihuana or dosage for the certified patient in the certif-
    14  ication; and
    15    [(d)] (e) the medical marihuana shall be kept in the original  package
    16  in  which  it  was dispensed under subdivision twelve of section thirty-
    17  three hundred sixty-four of this title, except for the  portion  removed
    18  for  immediate  consumption  for  certified medical use by the certified
    19  patient.
    20    2. Notwithstanding subdivision one of this section:
    21    (a) possession of medical marihuana shall not  be  lawful  under  this
    22  title  if it is smoked, consumed, vaporized, or grown in a public place,
    23  regardless of the form of medical  marihuana  stated  in  the  patient's
    24  certification.
    25    (b)  a  [person]  certified patient or designated caregiver possessing
    26  medical marihuana under this title shall possess  his  or  her  registry
    27  identification card at all times when in immediate possession of medical
    28  marihuana.
    29    (c) medical marihuana may not be smoked in any place where tobacco may
    30  not  be  smoked  under article thirteen-E of this chapter, regardless of
    31  the form of medical marihuana stated in the patient's certification.
    32    3. The possession, acquisition, delivery, transfer, transportation, or
    33  administration of medical marihuana by a designated  caregiver  facility
    34  or  designated  caregiver  facility  employee shall be lawful under this
    35  title provided that:
    36    (a) the designated caregiver facility registers with the department on
    37  a form provided by the commissioner;
    38    (b) such possession, acquisition, delivery, transfer,  transportation,
    39  or  administration  is  on  behalf  of  a certified patient possessing a
    40  registry identification card;
    41    (c) the designated caregiver facility maintains a copy of the registry
    42  identification card of each certified patient for  which  it  possesses,
    43  acquires,  delivers, transfers, transports, or administers medical mari-
    44  huana; and
    45    (d) a designated caregiver facility employee shall be identified as an
    46  employee when necessary, as provided by the commissioner.
    47    § 4. Subdivisions 2, 3, 5, and 11 of section 3363 of the public health
    48  law, as added by chapter 90 of the laws of 2014, are amended to read  as
    49  follows:
    50    2.  To obtain, amend or renew a registry identification card, a certi-
    51  fied patient or designated caregiver shall file a  registry  application
    52  with  the  department.  The  registry application or renewal application
    53  shall include:
    54    (a) in the case of a certified patient:
    55    (i) the patient's certification (a new written certification shall  be
    56  provided with a renewal application);

        A. 531                              5
 
     1    (ii) the name, address, and date of birth of the patient;
     2    (iii) the date of the certification;
     3    (iv)  if  the  patient  has  a registry identification card based on a
     4  current valid certification,  the  registry  identification  number  and
     5  expiration date of that registry identification card;
     6    (v)  the  specified  date  until  which the patient would benefit from
     7  medical marihuana, if the certification states such a date;
     8    (vi) the name, address, federal  registration  number,  and  telephone
     9  number of the certifying practitioner;
    10    (vii)  any  recommendation or limitation by the practitioner as to the
    11  form or forms of medical marihuana or dosage for the certified  patient;
    12  and
    13    (viii)  other  individual  identifying  information  required  by  the
    14  department;
    15    (b) (i) in the case of a certified patient, if the patient  designates
    16  a  designated  caregiver,  the  name,  address, and date of birth of the
    17  designated  caregiver,  and  other  individual  identifying  information
    18  required by the department;
    19    (ii)  if  the  designated  caregiver  is  a medical marihuana research
    20  program, the name of  the  organization  conducting  the  research;  the
    21  address,  phone  number, and name of the individual leading the research
    22  or appropriate designee; and other identifying information  required  by
    23  the department;
    24    (c) in the case of a designated caregiver:
    25    (i) the name, address, and date of birth of the designated caregiver;
    26    (ii)  if  the designated caregiver has a registry identification card,
    27  the registry identification number and expiration date of that  registry
    28  identification card; and
    29    (iii) other individual identifying information required by the depart-
    30  ment;
    31    (d)  a  statement  that  a  false statement made in the application is
    32  punishable under section 210.45 of the penal law;
    33    (e) the date of the application and the  signature  of  the  certified
    34  patient or designated caregiver, as the case may be; and
    35    (f) [a fifty dollar application fee, provided, that the department may
    36  waive or reduce the fee in cases of financial hardship; and
    37    (g)] any other requirements determined by the commissioner.
    38    3. Where a certified patient is under the age of eighteen:
    39    (a)  The  application for a registry identification card shall be made
    40  by an appropriate person over twenty-one years of age.  The  application
    41  shall state facts demonstrating that the person is appropriate.
    42    (b)  The  designated caregiver shall be (i) a parent or legal guardian
    43  of the certified patient, (ii) a person designated by a parent or  legal
    44  guardian, [or] (iii) in the case of such a certified patient being cared
    45  for by a designated caregiver facility, the designated caregiver facili-
    46  ty  designated  by  the parent or legal guardian; or (iv) an appropriate
    47  person approved by the department upon  a  sufficient  showing  that  no
    48  parent or legal guardian is appropriate or available.
    49    5.  No  person may be a designated caregiver for more than five certi-
    50  fied patients at one time; provided however that this  limitation  shall
    51  not  apply  to  a  designated caregiver facility or designated caregiver
    52  facility employee.
    53    11. A certified patient or designated caregiver who has been issued  a
    54  registry  identification  card shall notify the department of any change
    55  in his or her name or address or, with respect to the patient, if he  or
    56  she  ceases  to  have the [serious] condition noted on the certification

        A. 531                              6
 
     1  within ten days of such change. The certified  patient's  or  designated
     2  caregiver's  registry  identification  card  shall be deemed invalid and
     3  shall be returned promptly to the department.
     4    § 5. Subdivisions 3 and 5 of section 3364 of the public health law, as
     5  added  by chapter 90 of the laws of 2014, are amended and a new subdivi-
     6  sion 14 is added to read as follows:
     7    3. Each registered organization shall  contract  with  an  independent
     8  laboratory  permitted under section thirty-three hundred sixty-four-c of
     9  this title to test the medical  marihuana  produced  by  the  registered
    10  organization.  The commissioner shall approve the laboratory and require
    11  that the laboratory report testing results in a manner determined by the
    12  commissioner. The commissioner is authorized to issue regulation requir-
    13  ing the laboratory to perform certain tests and services.
    14    5. (a) No registered organization may  sell,  deliver,  distribute  or
    15  dispense  to any certified patient or designated caregiver a quantity of
    16  medical marihuana larger  than  that  individual  would  be  allowed  to
    17  possess under this title.
    18    (b) When dispensing medical marihuana to a certified patient or desig-
    19  nated  caregiver,  the registered organization (i) shall not dispense an
    20  amount greater than a [thirty] sixty day supply to a  certified  patient
    21  until  the  certified  patient  has exhausted all but a seven day supply
    22  provided pursuant to a previously issued certification, and  (ii)  shall
    23  verify the information in subparagraph (i) of this paragraph by consult-
    24  ing  the  prescription monitoring program registry under section thirty-
    25  three hundred forty-three-a of this article.
    26    (c) Medical marihuana dispensed to a certified patient  or  designated
    27  caregiver  by a registered organization shall conform to any recommenda-
    28  tion or limitation by the practitioner  as  to  the  form  or  forms  of
    29  medical marihuana or dosage for the certified patient.
    30    14.  A registered organization may contract with a person or entity to
    31  provide facilities, equipment or services  that  are  ancillary  to  the
    32  registered  organization's  functions  or  activities under this section
    33  (including, but not limited  to,  shipping,  maintenance,  construction,
    34  repair,  and  security),  but  not  including  any  function or activity
    35  directly involving the planting, growing, tending, harvesting,  process-
    36  ing,  or  packaging  of plants; or any other function directly involving
    37  manufacturing or retailing of medical  marihuana.  All  laws  and  regu-
    38  lations  applicable  to  such  facilities,  equipment, or services shall
    39  apply to the contract. The registered organization and other parties  to
    40  the contract shall each be responsible for compliance with such laws and
    41  regulations  under  the  contract. The commissioner may make regulations
    42  consistent  with  this  title  relating  to  contracts  and  parties  to
    43  contracts under this subdivision.
    44    §  6.  The public health law is amended by adding a new section 3364-a
    45  to read as follows:
    46    § 3364-a. Medical marihuana research licenses.   1.  The  commissioner
    47  shall  establish  a  medical  marihuana  research license that permits a
    48  licensee to produce, process,  purchase,  possess,  transfer,  and  sell
    49  marihuana,  subject  to this section, for the following limited research
    50  purposes:
    51    (a) to test chemical potency and composition levels;
    52    (b) to conduct clinical investigations of marihuana-derived products;
    53    (c) to conduct research on the efficacy and  safety  of  administering
    54  marihuana as part of medical treatment; or
    55    (d)  to  conduct  genomic or agricultural research relating to medical
    56  marihuana.

        A. 531                              7

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

        A. 531                              8
 
     1    (b) operating certificate or license number where appropriate;
     2    (c)  name,  title,  and  signature of an authorized facility represen-
     3  tative;
     4    (d) a statement that the facility agrees to secure and  ensure  proper
     5  handling of all medical marihuana products;
     6    (e)  an  acknowledgement  that a false statement in the application is
     7  punishable under section 210.45 of the penal law; and
     8    (f) any other information that may be required by the commissioner.
     9    2. Prior to issuing or renewing a designated caregiver facility regis-
    10  tration, the commissioner may verify the information  submitted  by  the
    11  applicant.   The applicant shall provide, at the commissioner's request,
    12  such information and documentation, including any consents  or  authori-
    13  zations, that may be necessary for the commissioner to verify the infor-
    14  mation.
    15    3.  The application shall be approved, denied or determined incomplete
    16  or inaccurate by the commissioner within thirty days of receipt  of  the
    17  application.  If  the  application  is  approved, the commissioner shall
    18  issue a registration as soon as is reasonably practicable.
    19    4. Registrations under this section shall remain valid for  two  years
    20  from the date of issuance.
    21    §  8.  The public health law is amended by adding a new section 3364-c
    22  to read as follows:
    23    § 3364-c. Laboratory permits.  1. The commissioner shall  approve  and
    24  permit  one  or more independent laboratories to test medical marihuana.
    25  To be permitted as an independent laboratory under this section, a labo-
    26  ratory must apply to the department in a form and manner  prescribed  by
    27  the  commissioner and must demonstrate the following to the satisfaction
    28  of the commissioner:
    29    (a) the owners and directors of the laboratory are of good moral char-
    30  acter;
    31    (b) the laboratory and its  staff  have  the  skills,  resources,  and
    32  expertise  needed  to  accurately  and  consistently perform all testing
    33  required;
    34    (c) the laboratory has in place and will maintain  adequate  policies,
    35  procedures, and facility security to ensure proper collection, labeling,
    36  accessioning,  preparation,  analysis,  result  reporting, disposal, and
    37  storage of medical marihuana;
    38    (d) the laboratory is physically located in New York state;
    39    (e) the laboratory has a certificate of approval as  an  environmental
    40  laboratory issued by the commissioner under title one of article five of
    41  this chapter; and
    42    (f)  the  laboratory meets all requirements prescribed by this chapter
    43  and the commissioner in regulation.
    44    2. The owner of an independent laboratory permitted under this section
    45  shall not hold a registration as a registered organization and shall not
    46  have any direct or indirect ownership interest in such registered organ-
    47  ization.  No board member, manager, owner, partner, principal stakehold-
    48  er, or member of a registered organization, or such  person's  immediate
    49  family, shall have an interest or voting rights in any independent labo-
    50  ratory  permittee.  No  registered organization shall have any direct or
    51  indirect ownership interest in such laboratory.
    52    3. An independent laboratory shall not be required to be  licensed  by
    53  the federal drug enforcement administration.
    54    §  9. Subdivision 9 of section 3365 of the public health law, as added
    55  by chapter 90 of the laws of 2014, is amended to read as follows:

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

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     1  the  implementation of this act on its effective date are authorized  to
     2  be made and completed on or before such effective date.
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