Bill Text: NY S05657 | 2019-2020 | General Assembly | Amended


Bill Title: 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.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced) 2019-05-22 - PRINT NUMBER 5657A [S05657 Detail]

Download: New_York-2019-S05657-Amended.html



                STATE OF NEW YORK
        ________________________________________________________________________

                                         5657--A

                               2019-2020 Regular Sessions

                    IN SENATE

                                      May 10, 2019
                                       ___________

        Introduced  by  Sen.  SAVINO -- read twice and ordered printed, and when
          printed to be committed  to  the  Committee  on  Health  --  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
    21  medical  marihuana and is: a general hospital or residential health care
    22  facility operating under article twenty-eight of this chapter; an  adult
    23  care  facility  operating under title two of article seven of the social
    24  services law; a community  mental  health  residence  established  under
    25  section  41.44  of  the  mental  hygiene law; a hospital operating under
    26  section 7.17 of the mental hygiene law; a mental hygiene facility  oper-
    27  ating  under  article thirty-one of the mental hygiene law; an inpatient

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD11129-05-9

        S. 5657--A                          2

     1  or residential treatment program certified under article  thirty-two  of
     2  the  mental  hygiene law; a residential facility for the care and treat-
     3  ment of persons with developmental disabilities operating under  article
     4  sixteen  of the mental hygiene law; a residential treatment facility for
     5  children and youth operating under  article  thirty-one  of  the  mental
     6  hygiene  law;  a  public  school  or  private school operating under the
     7  education law; a research institution with an internal review  board;  a
     8  medical  marihuana  research program licensed under section thirty-three
     9  hundred sixty-four-a of this title; or any other facility as  determined
    10  by the commissioner in regulation.
    11    5-b.  "Designated  caregiver facility employee" means an employee of a
    12  designated caregiver facility.
    13    7. (a) ["Serious condition"] "Condition" means:
    14    (i) having one of the following [severe debilitating or life-threaten-
    15  ing] conditions: cancer,  positive  status  for  human  immunodeficiency
    16  virus or acquired immune deficiency syndrome, amyotrophic lateral scler-
    17  osis,  Parkinson's  disease,  multiple  sclerosis, damage to the nervous
    18  tissue of the spinal cord  with  objective  neurological  indication  of
    19  intractable  spasticity,  epilepsy, inflammatory bowel disease, neuropa-
    20  thies, Huntington's disease, post-traumatic stress disorder,  pain  that
    21  degrades health and functional capability where the use of medical mari-
    22  huana   is  an  alternative  to  opioid  use,  substance  use  disorder,
    23  Alzheimer's, muscular dystrophy, dystonia, rheumatoid arthritis, autism,
    24  or [as added by the commissioner; and
    25    (ii) any of the following conditions where it is clinically associated
    26  with, or a complication of, a condition  under  this  paragraph  or  its
    27  treatment:  cachexia or wasting syndrome; severe or chronic pain; severe
    28  nausea; seizures; severe or persistent muscle spasms; or such conditions
    29  as are added by the commissioner.
    30    (b) No later than eighteen months from  the  effective  date  of  this
    31  section,  the  commissioner shall determine whether to add the following
    32  serious conditions: Alzheimer's,  muscular  dystrophy,  dystonia,  post-
    33  traumatic  stress disorder and rheumatoid arthritis] any other condition
    34  certified by the practitioner.
    35    12. "Practitioner" means  a  practitioner  who  (i)  [is  a  physician
    36  licensed  by New York state and practicing within the state,] is author-
    37  ized to prescribe controlled substances within the state; (ii) [who]  by
    38  training  or  experience  is qualified to treat a [serious] condition as
    39  defined in subdivision seven of this section; and (iii) [has completed a
    40  two to four hour course as determined by the commissioner in  regulation
    41  and  registered  with  the  department; provided however, a registration
    42  shall not be denied without cause. Such course may  count  toward  board
    43  certification  requirements.  The commissioner shall consider the inclu-
    44  sion of nurse practitioners under this title based  upon  considerations
    45  including  access and availability. After such consideration the commis-
    46  sioner is authorized to deem nurse practitioners as practitioners  under
    47  this  title] completes, at a minimum, a two hour course as determined by
    48  the commissioner. A person's status as a practitioner under  this  title
    49  is deemed to be a "license" for purposes of section thirty-three hundred
    50  ninety of this article.
    51    19.  "Medical  marihuana  research  program" means a medical marihuana
    52  research   program   licensed   under   section   thirty-three   hundred
    53  sixty-four-a of this title.
    54    §  2.  Subdivisions  1,  2, and 9 of section 3361 of the public health
    55  law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and

        S. 5657--A                          3

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

        S. 5657--A                          4

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

        S. 5657--A                          5

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

        S. 5657--A                          6

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

        S. 5657--A                          7

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

        S. 5657--A                          8

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

        S. 5657--A                          9

     1  commissioner shall  ensure  that  such  [registered  organizations  and]
     2  dispensing  sites  are  geographically distributed across the state. The
     3  commission [may]  shall  register  additional  registered  organizations
     4  reflecting the demographics of the state.
     5    §  10.  Subdivision  1  of section 3365-a of the public health law, as
     6  added by chapter 416 of the laws of 2015, is amended to read as follows:
     7    1. There is hereby established in the department an emergency  medical
     8  marihuana  access program (referred to in this section as the "program")
     9  under this section. The purpose of the program is to expedite the avail-
    10  ability of medical marihuana to avoid suffering and loss of life, during
    11  the period before full  implementation  of  and  production  under  this
    12  title,  especially  in the case of patients whose [serious] condition is
    13  progressive and degenerative or is such  that  delay  in  the  patient's
    14  medical  use  of marihuana poses a serious risk to the patient's life or
    15  health. The commissioner shall implement the program as expeditiously as
    16  practicable, including by emergency regulation.
    17    § 11. Subdivision 1 of section 3369 of the public health law, as added
    18  by chapter 90 of the laws of 2014, is amended to read as follows:
    19    1. Certified patients,  designated  caregivers,  designated  caregiver
    20  facilities,  designated  caregiver facility employees, medical marihuana
    21  research program employees, practitioners, registered organizations  and
    22  the  employees  of  registered  organizations  shall  not  be subject to
    23  arrest, prosecution, or penalty in any manner, or denied  any  right  or
    24  privilege,  including  but  not limited to civil penalty or disciplinary
    25  action by a business or occupational or professional licensing board  or
    26  bureau,  solely for the certified medical use or manufacture of marihua-
    27  na, or for any other action or conduct in accordance with this title.
    28    § 12. Section 3369-d of the public health law, as added by chapter  90
    29  of the laws of 2014, is amended to read as follows:
    30    § 3369-d. Pricing. [1. Every sale of medical marihuana shall be at the
    31  price  determined by the commissioner. Every charge made or demanded for
    32  medical marihuana not in accordance with the  price  determined  by  the
    33  commissioner, is prohibited.
    34    2.  The commissioner is hereby authorized to set the per dose price of
    35  each form of medical marihuana sold by any registered  organization.  In
    36  setting  the  per  dose  price  of  each  form of medical marihuana, the
    37  commissioner shall consider the fixed and variable  costs  of  producing
    38  the  form  of marihuana and any other factor the commissioner, in his or
    39  her discretion, deems relevant to determining the per dose price of each
    40  form  of  medical  marihuana.]  Registered  organizations  shall  submit
    41  documentation  of any price and change in price per dose for any medical
    42  marihuana product to the commissioner within fifteen days of setting  or
    43  changing  the  price.  Prior  approval  by the commissioner shall not be
    44  required for any price or change of price. However, the commissioner  is
    45  authorized  to modify the price per dose for any medical marihuana prod-
    46  uct if necessary to maintain public access to appropriate medication.
    47    § 13. This act shall take effect immediately; provided, however,  that
    48  the  amendments to title 5-A of article 33 of the public health law made
    49  by sections one, two, three, four, five, six, seven, eight,  nine,  ten,
    50  eleven  and twelve of this act shall not affect the repeal of such title
    51  and shall be deemed repealed therewith. Effective immediately, the addi-
    52  tion, amendment and/or repeal of any rule or  regulation  necessary  for
    53  the   implementation of this act on its effective date are authorized to
    54  be made and completed on or before such effective date.
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