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A08569 Summary:

BILL NOA08569
 
SAME ASNo Same As
 
SPONSORBurke
 
COSPNSR
 
MLTSPNSR
 
Add Art 33 Title 5-B §§3369-aa - 3369-rr, Pub Health L; add §97-uuuu, St Fin L
 
Relates to medical use of psilocybin and the establishment of psilocybin service centers; makes an appropriation therefor.
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A08569 Actions:

BILL NOA08569
 
12/13/2021referred to health
01/05/2022referred to health
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A08569 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER:  A8569
 
SPONSOR: Burke
  TITLE OF BILL: An act to amend the public health law and the state finance law, in relation to medical use of psilocybin; and making an appropriation therefor   PURPOSE OR GENERAL IDEA OF BILL: To create psilocybin service centers to provide innovative treatment options for ailments such as PTSD, depression, alcohol dependency, anxiety, among others.   SUMMARY OF PROVISIONS: Section 1 amends public health law adding a new title for Medical Use of Psilocybin. Details include: *Certified patients or designated caregivers for medical psilocybin use are to be provided with identification cards lasting one year or less other than for terminal illness. Practitioners must complete a two hour course offered by the department of health in order to certify patients for psilocybin. *All psilocybin service centers must be registered with the Department of Health. Considerations for whether the psilocybin service center is a minority-and/or women-owned business enterprise, a service-disabled veteran-owned business, provides education and outreach to practition- ers, affordability, and cultural/linguistic competence will impact registration approval decisions. Fees for registration will be deter- mined by the department. *Acquiring, possessing, manufacturing, selling, delivering, transport- ing, distributing or dispensing medical psilocybin will be conducted by registered organizations only. When psilocybin is given to a service center, the registered organization will provide a safety insert, simi- lar to what is found on traditional prescriptions, including information on safety and dosage. Manufacturing and dispensing psilocybin must be done in facilities located in New York. Medical psilocybin will not be dispensed directly to a certified patient. *The Department of Health may analyze and evaluate the implementation and effectiveness of Medical Use of Psilocybin. They will make recommen- dations to the Governor and legislature every two years. *A psilocybin research license will be established for testing potency, conducting clinical investigations, researching efficacy and safety, and agricultural research. *Psilocybin services will include a preparation, administration, and integration session all of which are guided and monitored by a psilocy- bin service facilitator. *One must acquire a license to facilitate psilocybin administration sessions. To receive a license that person must have a high school diploma or equivalent, complete training requirements as determined by the department, meet examination requirements, and demonstrate facili- tation and support skills. *The psilocybin services advisory board will be created and consist of fourteen voting members and the commissioner and representative of the department serving as non-voting ex-officio members. The board will make recommendations to the health department regarding available medical, psychological, scientific studies and research, specifications and guidelines for providing services, safety standards, industry best prac- tices, code of professional conduct, education, training, and examina- tion for facilitators, production, and a long term strategic plan for•services. Section 2 amends the state finance law by creating the psilocybin services grant program fund for veterans and first responders to be jointly managed by the commissioner of health and the state comptroller. Section 3 denotes $2 million for the grant program. Section 4 sets the effective date.   JUSTIFICATION: Struggles with diseases like PTSD, depression, anxiety, and alcoholism can be major disruptors to a person's livelihood as well as their fami- ly's. These mental health detriments can deteriorate physical health, result in performance deficits on tasks, and increase rates of suicide. Psilocybin therapy is a breakthrough avenue for providing people with treatment for these ailments. Certain occupations, particularly those that serve society by running into danger, have increased prevalence of these health disruptors. Data from the RAND Corporation show that 8,000 New York veterans from the Wars in Iraq and Afghanistan suffer from PTSD. Firefighters, police officers, and EMS workers have a higher prevalence of depression, PTSD, and substance abuse than the general population. The FDA recognizes psilocybin therapy as substantially better than pres- ent treatment options. Establishing a widespread route to provide New Yorker's with this medical treatment would be a monumental step in providing mental health care to improve lives. Oregon, Texas, and several cities have taken similar steps to increase access to psilocybin treatment. These therapy centers would offer a safe physical environment supervised by trained monitors to negate the minimal risk involved with psilocybin. Researchers at Johns Hopkins Medicine report that psilocybin shows low potential for abuse and can be classified as 'least harm to users and society.' Beyond enabling the creation of treatment centers, this legislation would also create a $2 million fund for veterans, firefighters, police officers, and EMS workers who can apply for financial support towards treatment. Our first responders expose themselves to potential trauma on a daily basis to keep us safe and well. Ensuring their access to this treatment demonstrates our reciprocity to keep them safe and well.   PRIOR LEGISLATIVE HISTORY: New bill   FISCAL IMPLICATIONS: To be determined   EFFECTIVE DATE: 90 days after becoming law
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A08569 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          8569
 
                               2021-2022 Regular Sessions
 
                   IN ASSEMBLY
 
                                    December 13, 2021
                                       ___________
 
        Introduced  by M. of A. BURKE -- read once and referred to the Committee
          on Health
 
        AN ACT to amend the public health law and  the  state  finance  law,  in
          relation  to  medical  use  of psilocybin; and making an appropriation
          therefor
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section  1. Article 33 of the public health law is amended by adding a
     2  new title 5-B to read as follows:
     3                                  TITLE V-B
     4                          MEDICAL USE OF PSILOCYBIN
     5  Section 3369-aa. Definitions.
     6          3369-bb. Certification of patients.
     7          3369-cc. Lawful medical use.
     8          3369-dd. Registry identification cards.
     9          3369-ee. Registration as a psilocybin service center.
    10          3369-ff. Registered organizations.
    11          3369-gg. Registering of registered organizations.
    12          3369-hh. Reports of registered organizations.
    13          3369-ii. Evaluation; research programs; report by department.
    14          3369-jj. Psilocybin research license.
    15          3369-kk. Relation to other laws.
    16          3369-ll. Psilocybin service facilitator license requirements.
    17          3369-mm. Protections for the medical use of psilocybin.
    18          3369-nn. Regulations.
    19          3369-oo. Suspend; terminate.
    20          3369-pp. Pricing.
    21          3369-qq. Psilocybin services grant program.
    22          3369-rr. Psilocybin services advisory board.
    23    § 3369-aa. Definitions. For the purposes of this title, the  following
    24  terms shall have the following meanings:
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD11894-04-1

        A. 8569                             2
 
     1    1.  "Psilocybin"  means  a  naturally  occurring  psychedelic  prodrug
     2  compound produced by fungi, including but not limited to members of  the
     3  genus  Psilocybe.   Such term shall include psilocin, the substance into
     4  which psilocybin is converted in the human body.
     5    2. "Psilocybin product" means psilocybin, concentrated psilocybin, and
     6  psilocybin-infused products for use by a certified patient.
     7    3.  "Psilocybin-infused  products" means products that have been manu-
     8  factured and contain either psilocybin or  concentrated  psilocybin  and
     9  other ingredients that are intended for use or consumption.
    10    4.  "Caring  for" means treating a patient, in the course of which the
    11  practitioner has completed a full assessment of  the  patient's  medical
    12  history and current medical condition.
    13    5.  "Certified  medical  use"  includes  the acquisition, cultivation,
    14  manufacture,  delivery,  harvest,  possession,  preparation,   transfer,
    15  transportation, or use of medical psilocybin for a certified patient, or
    16  paraphernalia  relating  to the administration of psilocybin to treat or
    17  alleviate a certified patient's medical condition or symptoms associated
    18  with the patient's medical condition.
    19    6. "Certified patient" means a patient who is a resident of  New  York
    20  state or receiving care and treatment in New York state as determined by
    21  the board in regulation, and is certified under this chapter.
    22    7.  "Condition" means having one of the following conditions:  cancer,
    23  positive status for human  immunodeficiency  virus  or  acquired  immune
    24  deficiency syndrome, amyotrophic lateral sclerosis, Parkinson's disease,
    25  multiple sclerosis, damage to the nervous tissue of the spinal cord with
    26  objective  neurological  indication of intractable spasticity, epilepsy,
    27  inflammatory bowel disease, neuropathies,  Huntington's  disease,  post-
    28  traumatic  stress  disorder,  pain  that  degrades health and functional
    29  capability where the use of medical cannabis is an alternative to opioid
    30  use, substance use disorder, Alzheimer's, muscular dystrophy,  dystonia,
    31  rheumatoid  arthritis,  autism  or  any other condition certified by the
    32  practitioner.
    33    8. "Cultivation" means growing, cloning, harvesting,  drying,  curing,
    34  grading,  and  trimming  of  psilocybin plants for sale to certain other
    35  categories of psilocybin license- and permit-holders.
    36    9. "Psilocybin service center" means a facility  that  registers  with
    37  the  department  to  assist  one  or  more  certified  patients with the
    38  purchase, acquisition, possession,  use  or  administration  of  medical
    39  psilocybin.
    40    10.  "Designated caregiver" means an individual designated by a certi-
    41  fied patient in a registry application. A certified patient  may  desig-
    42  nate  up to five designated caregivers not counting designated caregiver
    43  facilities or designated caregiver facilities' employees.
    44    11. "Psilocybin services"  means  services  provided  to  a  certified
    45  patient before, during and after the patient's consumption of a psilocy-
    46  bin product, including a preparation session and integration session.
    47    12. "Psilocybin service center employee" means an employee of a psilo-
    48  cybin service center.
    49    13.  "Form of medical psilocybin" means characteristics of the medical
    50  psilocybin recommended or limited for a  particular  certified  patient,
    51  including  the method of consumption and any particular strain, variety,
    52  and quantity or percentage of psilocybin or particular  active  ingredi-
    53  ent, or whole psilocybin.
    54    14.  "Laboratory  testing  facility"  means any independent laboratory
    55  capable of testing psilocybin and psilocybin products for medical-use.

        A. 8569                             3
 
     1    15. "License" means a written authorization  as  provided  under  this
     2  title  permitting  persons  to engage in a specified activity authorized
     3  pursuant to this title.
     4    16. "Licensee" means an individual or an entity who has been granted a
     5  license under this title.
     6    17.  "Medical psilocybin" means psilocybin as defined in this section,
     7  intended for a certified medical use, as determined by the department.
     8    18. "Package" means any  container  or  receptacle  used  for  holding
     9  psilocybin or psilocybin products.
    10    19. "Practitioner" means a practitioner who is licensed, registered or
    11  certified  by  New  York state to prescribe controlled substances within
    12  the state.  Nothing in this title shall be interpreted so as to give any
    13  such person authority to act outside their scope of practice as  defined
    14  by title eight of the education law. Additionally, nothing in this title
    15  shall  be interpreted to allow any unlicensed, unregistered, or uncerti-
    16  fied person to act in a manner that would require a  license,  registra-
    17  tion, or certification pursuant to title eight of the education law.
    18    20. "Processor" means a licensee that extracts concentrated psilocybin
    19  and/or  compounds,  blends, extracts, infuses, or otherwise manufactures
    20  concentrated psilocybin or psilocybin products, but not the  cultivation
    21  of the psilocybin contained in the psilocybin product.
    22    21.  "Registered  organization" means an organization registered under
    23  this title.
    24    22. "Registry application" means an application properly completed and
    25  filed with the department by a certified patient under this title.
    26    23. "Registry identification card" means a document that identifies  a
    27  certified patient or designated caregiver, as provided under this title.
    28    24. "Psilocybin service center operator" means a person or entity that
    29  operates a psilocybin service center.
    30    25.  "Psilocybin service facilitator" means a person or entity that is
    31  licensed  in  accordance  with  this  title  to  administer   psilocybin
    32  services.
    33    26.  "Small  business"  means small business as defined in section one
    34  hundred thirty-one of the economic development law and shall  apply  for
    35  purposes of this chapter where any inconsistencies exist.
    36    27.  "Terminally ill" means an individual has a medical prognosis that
    37  the individual's life expectancy is approximately one year  or  less  if
    38  the illness runs its normal course.
    39    28.  "Warehouse"  means  and  includes  a  place  in  which psilocybin
    40  products are securely housed or stored.
    41    29. "Wholesale" means to solicit or receive an order for, to  keep  or
    42  expose  for  sale, and to keep with intent to sell, made by any licensed
    43  person, whether principal, proprietor, agent, or employee of  any  medi-
    44  cal-use psilocybin or psilocybin product, for purposes of resale.
    45    30.  "Administration  session"  means  a  session held at a psilocybin
    46  service center at which a  certified  patient  purchases,  consumes  and
    47  experiences the effects of a psilocybin product under the supervision of
    48  a psilocybin service facilitator.
    49    31.  "Integration session" means a meeting between a certified patient
    50  and a psilocybin service facilitator that may occur  after  the  patient
    51  completes an administration session.
    52    32.  "Preparation session" means a meeting between a certified patient
    53  and a psilocybin service facilitator that must occur before such patient
    54  participates in an administration session.
    55    33. "Premises" means all public and private enclosed areas, as well as
    56  areas outside of a building at a location, other than a person's primary

        A. 8569                             4
 
     1  residence, that are used for  activities  permitted  under  this  title,
     2  including  manufacturing  psilocybin  products,  operating  a psilocybin
     3  service center or providing psilocybin services to  certified  patients.
     4  Such  definition  shall include offices, kitchens, rest rooms and store-
     5  rooms.
     6    § 3369-bb. Certification of patients. 1. A patient  certification  may
     7  only be issued if:
     8    (a)  the  patient  has  a  condition,  which shall be specified in the
     9  patient's health care record;
    10    (b) the practitioner by training or experience is qualified  to  treat
    11  the condition;
    12    (c)  the  patient  is under the practitioner's continuing care for the
    13  condition; and
    14    (d) in the practitioner's professional  opinion  and  review  of  past
    15  treatments,  the  patient is likely to receive therapeutic or palliative
    16  benefit from the primary or adjunctive treatment  with  medical  use  of
    17  psilocybin for the condition.
    18    2.  The  certification  shall include: (a) the name, date of birth and
    19  address of the patient; (b) a statement that the patient has a condition
    20  and the patient is under the practitioner's care for the condition;  (c)
    21  a  statement  attesting that all requirements of subdivision one of this
    22  section have been satisfied; (d) the date; and (e)  the  name,  address,
    23  telephone number, and the signature of the certifying practitioner.  The
    24  department  may require by regulation that the certification shall be on
    25  a form provided by the department.  The practitioner may  state  in  the
    26  certification  that,  in  the  practitioner's  professional opinion, the
    27  patient would benefit from medical psilocybin  only  until  a  specified
    28  date. The practitioner may state in the certification that, in the prac-
    29  titioner's  professional opinion, the patient is terminally ill and that
    30  the certification shall not expire until the patient dies.
    31    3. In making a certification, the practitioner may consider  the  form
    32  of  medical  psilocybin the patient should consume, including the method
    33  of consumption and any  particular  strain,  variety,  and  quantity  or
    34  percentage  of psilocybin or particular active ingredient, and appropri-
    35  ate dosage. The practitioner may state in the certification  any  recom-
    36  mendation  or  limitation  the practitioner makes, in his or her profes-
    37  sional opinion, concerning the appropriate  form  or  forms  of  medical
    38  psilocybin and dosage.
    39    4.  Every  practitioner  shall  consult  the  prescription  monitoring
    40  program registry prior to making or issuing  a  certification,  for  the
    41  purpose  of  reviewing  a  patient's  controlled  substance history. For
    42  purposes of this section, a practitioner may  authorize  a  designee  to
    43  consult  the  prescription  monitoring  program  registry  on his or her
    44  behalf, provided that such designation is  in  accordance  with  section
    45  thirty-three hundred forty-three-a of this article.
    46    5.  The  practitioner  shall  give  the certification to the certified
    47  patient and place a copy in the patient's health care record.
    48    6. No practitioner shall issue a certification under this section  for
    49  themselves.
    50    7.  A  registry  identification  card  based  on a certification shall
    51  expire one year after the date the certification is signed by the  prac-
    52  titioner, except as provided for in subdivision eight of this section.
    53    8.  (a)  If  the practitioner states in the certification that, in the
    54  practitioner's professional opinion,  the  patient  would  benefit  from
    55  medical  psilocybin only until a specified earlier date, then the regis-
    56  try identification card shall expire on that date; (b)  if  the  practi-

        A. 8569                             5
 
     1  tioner  states  in  the certification that in the practitioner's profes-
     2  sional opinion the patient is terminally ill and that the  certification
     3  shall  not  expire until the patient dies, then the registry identifica-
     4  tion  card  shall  state that the patient is terminally ill and that the
     5  registration card shall not expire until the patient dies;  (c)  if  the
     6  practitioner  re-issues the certification to terminate the certification
     7  on an earlier date, then the registry identification card  shall  expire
     8  on  that  date and shall be promptly destroyed by the certified patient;
     9  (d) if the certification so provides, the registry  identification  card
    10  shall  state  any recommendation or limitation by the practitioner as to
    11  the form or forms of medical psilocybin  or  dosage  for  the  certified
    12  patient; and (e) the department shall make regulations to implement this
    13  subdivision.
    14    9.  (a) A certification may be a special certification if, in addition
    15  to the other requirements for a certification, the  practitioner  certi-
    16  fies  in  the  certification that the patient's condition is progressive
    17  and degenerative or that delay in the patient's certified medical use of
    18  psilocybin poses a risk to the patient's life or health.
    19    (b) The department shall create the form to  be  used  for  a  special
    20  certification  and  shall make that form available to be downloaded from
    21  the department's website.
    22    10. Prior to issuing a certification a practitioner must complete,  at
    23  a  minimum,  a  two-hour course as determined by the department in regu-
    24  lation. For the purposes of this title a person's status  as  a  practi-
    25  tioner  is  deemed to be a "license" for the purposes of section thirty-
    26  three hundred ninety of this article and shall be subject  to  the  same
    27  revocation process.
    28    §  3369-cc. Lawful medical use. The purchase, possession, acquisition,
    29  use, delivery, transfer, transportation, or  administration  of  medical
    30  psilocybin  by  a  certified  patient,  designated caregiver, registered
    31  organization or the employees of a psilocybin service center, for certi-
    32  fied medical use, shall be lawful under this title provided that:
    33    1. The psilocybin purchased, possessed, acquired or used by  a  certi-
    34  fied  patient  shall  have occurred at a psilocybin service center under
    35  the supervision of a psilocybin service facilitator;
    36    2. The psilocybin that may be possessed by a certified  patient  shall
    37  not  exceed  the  dosage determined by the practitioner, consistent with
    38  any guidance and regulations issued by the department;
    39    3. The form or forms of medical  psilocybin  that  may  be  purchased,
    40  possessed,  acquired  or  used  by  the  certified patient pursuant to a
    41  certification shall be in compliance with any recommendation or  limita-
    42  tion  by  the practitioner as to the form or forms of medical psilocybin
    43  or dosage for the certified patient in the certification; and
    44    4. The medical psilocybin shall be kept in  the  original  package  in
    45  which  it was dispensed under this title, except for the portion removed
    46  for immediate consumption for certified medical  use  by  the  certified
    47  patient.
    48    §  3369-dd.  Registry  identification  cards.  1. Upon approval of the
    49  certification, the department shall issue registry identification  cards
    50  for certified patients and designated caregivers. A registry identifica-
    51  tion  card  shall  expire  as  provided  in  this  title or as otherwise
    52  provided in this section. The department shall  begin  issuing  registry
    53  identification  cards  as  soon  as practicable after the certifications
    54  required by this title are granted. The department may  specify  a  form
    55  for  a  registry application, in which case the department shall provide

        A. 8569                             6
 
     1  the form on request, reproductions of the form may be used, and the form
     2  shall be available for downloading from the department's website.
     3    2.  To obtain, amend or renew a registry identification card, a certi-
     4  fied patient or designated caregiver shall file a  registry  application
     5  with  the  department,  unless  otherwise  exempted by the department in
     6  regulation.  The  registry  application  or  renewal  application  shall
     7  include:
     8    (a) in the case of a certified patient:
     9    (i)  the patient's certification, a new written certification shall be
    10  provided with a renewal application if required by the department;
    11    (ii) the name, address, and date of birth of the patient;
    12    (iii) the date of the certification;
    13    (iv) if the patient has a registry  identification  card  based  on  a
    14  current  valid  certification,  the  registry  identification number and
    15  expiration date of that registry identification card;
    16    (v) the specified date until which  the  patient  would  benefit  from
    17  medical psilocybin, if the certification states such a date;
    18    (vi) the name, address, and telephone number of the certifying practi-
    19  tioner;
    20    (vii)  any  recommendation or limitation by the practitioner as to the
    21  form or forms of medical psilocybin or dosage for the certified patient;
    22    (viii) if the certified patient designates a designated caregiver, the
    23  name, address, and date of birth of the designated caregiver, and  other
    24  individual identifying information required by the department; and
    25    (ix)  other individual identifying information required by the depart-
    26  ment;
    27    (b) in the case of a designated caregiver:
    28    (i) the name, address, and date of birth of the designated caregiver;
    29    (ii) if the designated caregiver has a registry  identification  card,
    30  the  registry identification number and expiration date of that registry
    31  identification card; and
    32    (iii) other individual identifying information required by the depart-
    33  ment;
    34    (c) a statement that a false statement  made  in  the  application  is
    35  punishable under section 210.45 of the penal law;
    36    (d)  the  date  of  the application and the signature of the certified
    37  patient or designated caregiver, as the case may be; and
    38    (e) any other requirements determined by the department.
    39    3. Where a certified patient is under the age of eighteen or otherwise
    40  incapable of consent, the application for a registry identification card
    41  shall be made by the person responsible for making health care decisions
    42  for the patient.  Such designated caregiver shall be: (a)  a  parent  or
    43  legal  guardian  of  the certified patient; (b) a person designated by a
    44  parent or legal guardian; or (c) an appropriate person approved  by  the
    45  department upon a sufficient showing that no parent or legal guardian is
    46  appropriate or available.
    47    4.  No  person  may  be  a designated caregiver if the person is under
    48  twenty-one years of age unless a  sufficient  showing  is  made  to  the
    49  department  that the person should be permitted to serve as a designated
    50  caregiver. The requirements for such a showing shall  be  determined  by
    51  the department.
    52    5.  No  person may be a designated caregiver for more than four certi-
    53  fied patients at one time.
    54    6. If a certified patient wishes to change or  terminate  his  or  her
    55  designated  caregiver,  for whatever reason, the certified patient shall
    56  notify the department as soon as practicable. The department shall issue

        A. 8569                             7
 
     1  a notification to the designated caregiver that their registration  card
     2  is invalid and must be promptly destroyed. The newly designated caregiv-
     3  er must comply with all requirements set forth in this section.
     4    7.  If the certification so provides, the registry identification card
     5  shall contain any recommendation or limitation by the practitioner as to
     6  the form or forms of medical psilocybin  or  dosage  for  the  certified
     7  patient.
     8    8.  The  department shall issue separate registry identification cards
     9  for certified patients and designated caregivers as soon  as  reasonably
    10  practicable  after  receiving a complete application under this section,
    11  unless it determines that the application  is  incomplete  or  factually
    12  inaccurate, in which case it shall promptly notify the applicant.
    13    9.  If the application of a certified patient designates an individual
    14  as a designated caregiver who is not authorized to be a designated care-
    15  giver, that portion of the application shall be denied by the department
    16  but that shall not affect the approval of the balance  of  the  applica-
    17  tion.
    18    10. A registry identification card shall:
    19    (a)  contain the name of the certified patient or the designated care-
    20  giver as the case may be;
    21    (b) contain the date of issuance and expiration date of  the  registry
    22  identification card;
    23    (c) contain a registry identification number for the certified patient
    24  or  designated  caregiver, as the case may be and a registry identifica-
    25  tion number;
    26    (d) contain a photograph of the individual to whom the registry  iden-
    27  tification  card is being issued, which shall be obtained by the depart-
    28  ment in a manner specified by the department in  regulations;  provided,
    29  however,  that  if  the department requires certified patients to submit
    30  photographs for this purpose, there shall be a reasonable  accommodation
    31  of  certified  patients  who  are  confined  to their homes due to their
    32  medical conditions and may therefore have  difficulty  procuring  photo-
    33  graphs;
    34    (e) be a secure document as determined by the department;
    35    (f) plainly state any recommendation or limitation by the practitioner
    36  as  to  the form or forms of medical psilocybin or dosage for the certi-
    37  fied patient; and
    38    (g) any other requirements determined by the department.
    39    11. A certified patient or designated caregiver who has been issued  a
    40  registry  identification  card shall notify the department of any change
    41  in his or her name or address or, with respect to the patient, if he  or
    42  she  ceases  to have the condition noted on the certification within ten
    43  days of such change. The certified patient's or  designated  caregiver's
    44  registry  identification  card  shall  be  deemed  invalid  and shall be
    45  promptly destroyed.
    46    12. If a certified patient or designated caregiver loses  his  or  her
    47  registry  identification  card,  he  or  she shall notify the department
    48  within ten days of losing the card.  The department shall  issue  a  new
    49  registry identification card as soon as practicable, which may contain a
    50  new  registry  identification number, to the certified patient or desig-
    51  nated caregiver, as the case may be.
    52    13. The department shall maintain a confidential list of  the  persons
    53  to  whom it has issued registry identification cards. Individual identi-
    54  fying information obtained by the department under this title  shall  be
    55  confidential  and exempt from disclosure under article six of the public
    56  officers law.

        A. 8569                             8
 
     1    14. The department shall verify to law  enforcement  personnel  in  an
     2  appropriate case whether a registry identification card is valid and any
     3  other  relevant  information  necessary  to  protect patients' rights to
     4  medical psilocybin by confirming compliance with this title.
     5    15.  If a certified patient or designated caregiver willfully violates
     6  any provision of this title as determined by the department, his or  her
     7  certification  and  registry  identification  card  may  be suspended or
     8  revoked. This is in addition to any other penalty that may apply.
     9    16. The department shall make regulations for special  certifications,
    10  which  shall  include  expedited  procedures  and  which may require the
    11  applicant to submit additional documentation establishing  the  clinical
    12  basis  for  the  special certification. If the department has not estab-
    13  lished and made available a form for a registry application  or  renewal
    14  application,  then  in  the  case of a special certification, a registry
    15  application or renewal application  that  otherwise  conforms  with  the
    16  requirements of this section shall not require the use of a form.
    17    § 3369-ee. Registration as a psilocybin service center. 1.  To obtain,
    18  amend or renew a registration as a psilocybin service center, the facil-
    19  ity  shall file a registry application with the department. The registry
    20  application or renewal application shall include:
    21    (a) the facility's full name and address;
    22    (b) operating certificate or license number where appropriate;
    23    (c) name, title, and signature of  an  authorized  facility  represen-
    24  tative;
    25    (d)  a  statement that the facility agrees to secure and ensure proper
    26  handling of all medical psilocybin products;
    27    (e) an acknowledgement that a false statement in  the  application  is
    28  punishable under section 210.45 of the penal law; and
    29    (f) any other information that may be required by the department.
    30    2.  Prior to issuing or renewing a psilocybin service center registra-
    31  tion, the department may verify the information submitted by the  appli-
    32  cant.  The  applicant  shall  provide, at the department's request, such
    33  information and documentation, including any consents or  authorizations
    34  that may be necessary for the department to verify the information.
    35    3. The department shall approve, deny or determine incomplete or inac-
    36  curate  an  initial or renewal application within thirty days of receipt
    37  of the application. If the application is approved within the thirty-day
    38  period, the department shall issue a registration as soon as is  reason-
    39  ably practicable.
    40    4. An applicant shall have thirty days from the date of a notification
    41  of an incomplete or factually inaccurate application to submit the mate-
    42  rials  required  to  complete, revise or substantiate information in the
    43  application. If the applicant fails to  submit  the  required  materials
    44  within  such  thirty-day time period, the application shall be denied by
    45  the department.
    46    5. The applicant shall be under a continuing duty  to  report  to  the
    47  department  any change in facts or circumstances reflected in the appli-
    48  cation or any newly discovered or occurring fact or  circumstance  which
    49  is required to be included in the application.
    50    6.  (a)  The  department  shall grant a registration or amendment to a
    51  registration under this section if it is satisfied that:
    52    (i) the applicant will be able to maintain effective  control  against
    53  diversion of psilocybin;
    54    (ii)  the  applicant  will be able to comply with all applicable state
    55  laws;

        A. 8569                             9
 
     1    (iii) the applicant and its officers are ready, willing  and  able  to
     2  properly carry on the activities for which a registration is sought;
     3    (iv)  the applicant possesses or has the right to use sufficient land,
     4  buildings and equipment to properly carry on the activity  described  in
     5  the application;
     6    (v)  it  is  in the public interest that such registration be granted,
     7  including but not limited to:
     8    (A) whether the number of psilocybin service centers in an  area  will
     9  be adequate or excessive to reasonably serve the area;
    10    (B)  whether  the  psilocybin  service  center  is  a minority- and/or
    11  women-owned business enterprise, a service-disabled veteran-owned  busi-
    12  ness,  or from communities disproportionally impacted by the enforcement
    13  of psilocybin prohibition;
    14    (C) whether the  psilocybin  service  center  provides  education  and
    15  outreach to practitioners;
    16    (D)  whether  the  psilocybin service center promotes the research and
    17  development of medical psilocybin and patient outreach;
    18    (E) the affordability of medical psilocybin products  offered  by  the
    19  psilocybin service center;
    20    (F)  whether  the  psilocybin  service  center is culturally, linguis-
    21  tically, and medically competent to provide  services  to  unserved  and
    22  underserved areas; and
    23    (G) whether the psilocybin service center promotes racial, ethnic, and
    24  gender diversity in its workforce;
    25    (vi) the applicant and its managing officers are of good moral charac-
    26  ter;
    27    (vii)  the  applicant  has entered into a labor peace agreement with a
    28  bona fide labor organization that is actively engaged in representing or
    29  attempting to represent the applicant's employees; and  the  maintenance
    30  of  such  a labor peace agreement shall be an ongoing material condition
    31  of registration; and
    32    (viii) the applicant satisfies any other conditions as  determined  by
    33  the department.
    34    (b)  If  the  department is not satisfied that the applicant should be
    35  issued a registration, the department  shall  notify  the  applicant  in
    36  writing of those factors upon which further evidence is required. Within
    37  thirty  days  of  the  receipt  of  such notification, the applicant may
    38  submit additional material to the department or  demand  a  hearing,  or
    39  both.
    40    (c)  The  fee for a registration under this section shall be an amount
    41  determined by the department in regulations; provided, however,  if  the
    42  registration is issued for a period greater than two years the fee shall
    43  be increased, pro rata, for each additional month of validity.
    44    (d)  Registrations  issued  under this section shall be effective only
    45  for the psilocybin service center and shall specify:
    46    (i) the name and address of the psilocybin service center;
    47    (ii) which activities of a psilocybin service center are permitted  by
    48  the registration;
    49    (iii)  the  land,  buildings  and  facilities that may be used for the
    50  permitted activities of the psilocybin service center; and
    51    (iv) such other information as the department shall reasonably provide
    52  to ensure compliance with this title.
    53    (e) Upon application of a psilocybin service  center,  a  registration
    54  may be amended to allow the psilocybin service center to relocate within
    55  the state or to add or delete permitted psilocybin service center activ-
    56  ities  or  facilities. The fee for such amendment shall be determined by

        A. 8569                            10
 
     1  the department in regulation and be based off the administrative  burden
     2  to  process  and review the amendment by the department, provided no fee
     3  shall be greater than two thousand dollars.
     4    7.  Registrations issued under this section shall remain valid for two
     5  years from the date of issuance, except that in order to facilitate  the
     6  renewals  of  such  registrations,  the  department may upon the initial
     7  application for a  registration,  issue  some  registrations  which  may
     8  remain valid for a period of time greater than two years but not exceed-
     9  ing an additional eleven months.
    10    8. (a) An application for the renewal of any registration issued under
    11  this section shall be filed with the department not more than six months
    12  nor  less than four months prior to the expiration thereof. A late-filed
    13  application for the renewal of a registration may, in the discretion  of
    14  the department, be treated as an application for an initial license.
    15    (b)  The  application  for  renewal  shall  include  such  information
    16  prepared in the manner and detail as the department may require, includ-
    17  ing but not limited to:
    18    (i) any material change in the  circumstances  or  factors  listed  in
    19  subdivision one of this section; and
    20    (ii)  every known charge or investigation, pending or concluded during
    21  the period of the registration, by any  governmental  or  administrative
    22  agency with respect to:
    23    (A)  each  incident  or alleged incident involving the theft, loss, or
    24  possible diversion of medical psilocybin manufactured or distributed  by
    25  the applicant; and
    26    (B)  compliance  by  the  applicant  with  the  laws of the state with
    27  respect to the distribution or sale of medical psilocybin, where  appli-
    28  cable.
    29    (c)  An  applicant  for  renewal  shall  be under a continuing duty to
    30  report to the department any change in facts or circumstances  reflected
    31  in  the application or any newly discovered or occurring fact or circum-
    32  stance which is required to be included in the application and to obtain
    33  approval prior to any material change in management, interest or  owner-
    34  ship.
    35    (d)  If  the  department  is not satisfied that the psilocybin service
    36  center applicant is entitled to  a  renewal  of  the  registration,  the
    37  department  shall  within a reasonably practicable time as determined by
    38  the commissioner, serve upon the psilocybin service center or its attor-
    39  ney of record in person or by registered  or  certified  mail  an  order
    40  directing  the  psilocybin service center to show cause why its applica-
    41  tion for renewal should not be denied. The order shall specify in detail
    42  the respects in which the applicant has  not  satisfied  the  department
    43  that the registration should be renewed.
    44    (e)  Within a reasonably practicable time as determined by the depart-
    45  ment of such order, the applicant may submit additional material to  the
    46  department  or  demand  a  hearing or both; if a hearing is demanded the
    47  department shall fix a date as soon as reasonably practicable.
    48    9. (a) The department shall renew a registration unless it  determines
    49  and finds that:
    50    (i)  the  applicant  is  unlikely  to  maintain or be able to maintain
    51  effective control against diversion;
    52    (ii) the applicant is unlikely to comply with all state laws  applica-
    53  ble to the activities in which it may engage under the registration;
    54    (iii)  it  is  not  in  the  public interest to renew the registration
    55  because the number of psilocybin service centers in an area is excessive
    56  to reasonably serve the area;

        A. 8569                            11
 
     1    (iv) the applicant has either violated or terminated its  labor  peace
     2  agreement; or
     3    (v)  the  applicant  has  substantively  violated  the laws of another
     4  jurisdiction, in which it operates or have operated a psilocybin license
     5  or registration, related to the operation of a psilocybin business.
     6    (b) For purposes of this section,  proof  that  a  psilocybin  service
     7  center,  during  the  period of its registration, has failed to maintain
     8  effective control against diversion,  violated  any  provision  of  this
     9  title,  or has knowingly or negligently failed to comply with applicable
    10  state laws relating to the activities in  which  it  engages  under  the
    11  registration,  may  constitute  grounds  for  suspension, termination or
    12  limitation of the psilocybin service center's registration or as  deter-
    13  mined  by  the  department.  The psilocybin service center shall also be
    14  under a continuing duty to report to the department any material  change
    15  in  facts or circumstances to the information provided in the psilocybin
    16  service center's application.
    17    10. The department may suspend or  terminate  the  registration  of  a
    18  psilocybin  service  center,  on grounds and using procedures under this
    19  title relating to a license, to the extent consistent with  this  title.
    20  The  department shall suspend or terminate the registration in the event
    21  that a psilocybin service center violates or terminates  the  applicable
    22  labor  peace  agreement. Conduct in compliance with this title which may
    23  violate conflicting federal law, shall not  be  grounds  to  suspend  or
    24  terminate a registration.
    25    11.  In  coordination  with  the  chief equity officer, the department
    26  shall register  additional  registered  psilocybin  service  centers  to
    27  provide  services  to  unserved and underserved areas of the state. Such
    28  additional registered psilocybin service centers shall be reflective  of
    29  the  demographics of the state, be representative of communities dispro-
    30  portionately impacted by  psilocybin  prohibition,  and  be  culturally,
    31  linguistically,  and  medically  competent  to serve unserved and under-
    32  served areas of the state. The department shall actively promote racial,
    33  ethnic, and gender  diversity  when  registering  additional  registered
    34  psilocybin service centers.
    35    §  3369-ff.  Registered  organizations.  1.  A registered organization
    36  shall be a for-profit  business  entity  or  not-for-profit  corporation
    37  organized for the purpose of acquiring, possessing, manufacturing, sell-
    38  ing,  delivering, transporting, distributing or dispensing psilocybin to
    39  psilocybin service centers for certified medical use.
    40    2. The acquiring, possession, manufacture, sale, delivery,  transport-
    41  ing,  distributing  or  dispensing of medical psilocybin by a registered
    42  organization under this title in accordance with its registration  under
    43  this title or a renewal thereof shall be lawful under this title.
    44    3.  Each  registered  organization  shall contract with an independent
    45  laboratory permitted by the department to test  the  medical  psilocybin
    46  produced  by  the  registered organization. The department shall approve
    47  the laboratories used by the registered organization, including sampling
    48  and testing protocols and standards used by the  laboratories,  and  may
    49  require  that the registered organization use a particular testing labo-
    50  ratory. The department is authorized to issue regulations requiring  the
    51  laboratory to perform certain tests and services.
    52    4.  (a)  A  registered organization may lawfully, in good faith, sell,
    53  deliver, distribute or  dispense  medical  psilocybin  to  a  psilocybin
    54  service  center registered pursuant to this title for use by a certified
    55  patient.

        A. 8569                            12
 
     1    (b) The proprietor of a registered organization shall file or cause to
     2  be filed any receipt and certification information with  the  department
     3  by electronic means on a real-time basis as the department shall require
     4  by  regulation.  When filing receipt and certification information elec-
     5  tronically  pursuant to this paragraph, the proprietor of the registered
     6  organization shall dispose of any electronically  recorded  prescription
     7  information  in  such  manner  as  the  department  shall  by regulation
     8  require.
     9    5.  No  registered  organization  may  sell,  deliver,  distribute  or
    10  dispense  medical  psilocybin  directly to a certified patient or desig-
    11  nated caregiver.
    12    6. When a registered  organization  sells,  delivers,  distributes  or
    13  dispenses  medical  psilocybin  to a psilocybin service center, it shall
    14  provide to that facility a safety insert, developed  by  the  registered
    15  organization  subject  to  regulations  issued  by  the  department  and
    16  include, but not be limited to, information on:
    17    (a) methods for administering medical psilocybin;
    18    (b) any potential dangers stemming from the use of medical psilocybin;
    19    (c) how to recognize what may be problematic usage of medical psilocy-
    20  bin and obtain appropriate services or treatment for problematic  usage;
    21  and
    22    (d) other information as determined by the department.
    23    7.  Registered  organizations shall not be managed by or employ anyone
    24  who has been convicted within three years of the date of  hire,  of  any
    25  felony  related  to  the  functions  or  duties of operating a business,
    26  except that if the department determines that the manager or employee is
    27  otherwise suitable to be hired, and hiring the manager or employee would
    28  not compromise public safety, the department shall  conduct  a  thorough
    29  review  of  the  nature  of  the  crime,  conviction, circumstances, and
    30  evidence of rehabilitation of the manager or employee, and shall  evalu-
    31  ate  the  suitability  of  the manager or employee based on the evidence
    32  found through the review. In determining which offenses are substantial-
    33  ly related to the functions or  duties  of  operating  a  business,  the
    34  department shall include, but not be limited to, the following:
    35    (a) a felony conviction involving fraud, money laundering, forgery and
    36  other unlawful conduct related to owning and operating a business; and
    37    (b)  a  felony  conviction  for  hiring, employing or using a minor in
    38  transporting, carrying, selling, giving away,  preparing  for  sale,  or
    39  peddling,  any  controlled  substance,  or  selling,  offering  to sell,
    40  furnishing, offering to furnish, administering, or giving any controlled
    41  substance to a minor.
    42    A felony conviction for the sale or possession of drugs, narcotics, or
    43  controlled substances is not  substantially  related.  This  subdivision
    44  shall  only apply to managers or employees who come into contact with or
    45  handle medical psilocybin.
    46    8. Manufacturing of medical psilocybin by  a  registered  organization
    47  shall only be done in a secure facility located in New York state, which
    48  may  include  a  greenhouse. The department shall promulgate regulations
    49  establishing requirements for such facilities.
    50    9. Dispensing of medical psilocybin by a registered organization shall
    51  only be done in an indoor, enclosed, secure facility located in New York
    52  state. The department shall promulgate regulations establishing require-
    53  ments for such facilities.
    54    10. A registered organization may contract with a person or entity  to
    55  provide  facilities,  equipment  or  services  that are ancillary to the
    56  registered organization's  functions  or  activities  under  this  title

        A. 8569                            13
 
     1  including,  but  not  limited  to,  shipping, maintenance, construction,
     2  repair, and security, provided that  the  person  or  entity  shall  not
     3  perform  any function or activity directly involving the planting, grow-
     4  ing, tending, harvesting, processing, or packaging of psilocybin plants,
     5  medical psilocybin, or medical psilocybin products being produced by the
     6  registered  organization; or any other function directly involving manu-
     7  facturing or retailing of medical psilocybin. All laws  and  regulations
     8  applicable to such facilities, equipment, or services shall apply to the
     9  contract.  The registered organization and other parties to the contract
    10  shall each be responsible for compliance with such laws and  regulations
    11  under  the contract. The department may make regulations consistent with
    12  this title relating to contracts and parties  to  contracts  under  this
    13  subdivision.
    14    11. A registered organization shall, based on the findings of an inde-
    15  pendent  laboratory,  provide  documentation  of the quality, safety and
    16  clinical strength of the medical psilocybin manufactured or dispensed by
    17  the registered organization to the  department  and  to  any  psilocybin
    18  service center to which the medical psilocybin is sold or dispensed.
    19    12.  Medical  psilocybin  shall  be  dispensed to a psilocybin service
    20  center in a sealed and properly  labeled  package.  The  labeling  shall
    21  contain:  (a)  the  packaging date; (b) any applicable date by which the
    22  medical psilocybin should be used; (c) a warning stating, "This  product
    23  is  for medicinal use only. Women should not consume during pregnancy or
    24  while breastfeeding except on the advice of the certifying  health  care
    25  practitioner,  and  in  the case of breastfeeding mothers, including the
    26  infant's pediatrician. This product might impair the ability  to  drive.
    27  Keep  out  of  reach  of  children."; (d) the amount of individual doses
    28  contained within; and (e) a warning that the medical psilocybin must  be
    29  kept in the original container in which it was dispensed.
    30    13.  The  department  is  authorized  to  make  rules  and regulations
    31  restricting the advertising and marketing of medical psilocybin.
    32    14. A registered organization shall operate in accordance with minimum
    33  operating and recordkeeping requirements determined by the department in
    34  regulation.
    35    § 3369-gg. Registering of registered organizations. 1. (a)  An  appli-
    36  cant  for  registration as a registered organization under section thir-
    37  ty-three hundred sixty-nine-ff of this title shall include such informa-
    38  tion prepared in such manner and detail as the department  may  require,
    39  including but not limited to:
    40    (i) a description of the activities in which it intends to engage as a
    41  registered organization;
    42    (ii) that the applicant:
    43    (A) is of good moral character;
    44    (B)  possesses or has the right to use sufficient land, buildings, and
    45  other premises, which shall be specified in the application, and  equip-
    46  ment  to properly carry on the activity described in the application, or
    47  in the alternative posts a bond of not less than two million dollars;
    48    (C) is able to maintain effective  security  and  control  to  prevent
    49  diversion,  abuse, and other illegal conduct relating to the psilocybin;
    50  and
    51    (D) is able to comply with all applicable state laws  and  regulations
    52  relating  to  the  activities  in  which  it intends to engage under the
    53  registration;
    54    (iii) that the applicant has entered into a labor peace agreement with
    55  a bona fide labor organization that is actively engaged in  representing
    56  or attempting to represent the applicant's employees and the maintenance

        A. 8569                            14
 
     1  of  such  a labor peace agreement shall be an ongoing material condition
     2  of certification;
     3    (iv)  the  applicant's  status as a for-profit business entity or not-
     4  for-profit corporation; and
     5    (v) the application shall include  the  name,  residence  address  and
     6  title  of  each of the officers and directors and the name and residence
     7  address of any person or entity that is a member of the applicant.  Each
     8  such person, if an individual, or lawful representative if a legal enti-
     9  ty, shall submit an affidavit with the application setting forth:
    10    (A)  any  position  of  management,  interest  or ownership during the
    11  preceding ten years of a ten per centum or greater interest in any other
    12  psilocybin business, or applicant, located in  or  outside  this  state,
    13  manufacturing  or  distributing  drugs  including  indirect  management,
    14  interest, or ownership of parent companies, subsidiaries, or affiliates;
    15    (B) whether such person or any such business has been convicted  of  a
    16  felony  or  had  a  registration  or license suspended or revoked in any
    17  administrative or judicial proceeding, and if applicable, the history of
    18  violations or administrative penalties with respect to  any  license  to
    19  cultivate, manufacture, distribute or sell medical psilocybin; and
    20    (C) such other information as the department may reasonably require.
    21    2.  The  applicant  shall  be under a continuing duty to report to the
    22  department any change in facts or circumstances reflected in the  appli-
    23  cation  or  any newly discovered or occurring fact or circumstance which
    24  is required to be included in the application.
    25    3. (a) The department shall grant a registration  or  amendment  to  a
    26  registration under this section if they are satisfied that:
    27    (i)  the  applicant will be able to maintain effective control against
    28  diversion of psilocybin;
    29    (ii) the applicant will be able to comply with  all  applicable  state
    30  laws;
    31    (iii)  the  applicant  and its officers are ready, willing and able to
    32  properly carry on the manufacturing or distributing activity for which a
    33  registration is sought;
    34    (iv) the applicant possesses or has the right to use sufficient  land,
    35  buildings  and  equipment to properly carry on the activity described in
    36  the application;
    37    (v) it is in the public interest that such  registration  be  granted,
    38  including but not limited to:
    39    (A)  whether the number of registered organizations in an area will be
    40  adequate or excessive to reasonably serve the area;
    41    (B) whether the registered organization is  a  minority  and/or  woman
    42  owned business enterprise, a service-disabled veteran-owned business, or
    43  from communities disproportionally impacted by the enforcement of psilo-
    44  cybin prohibition;
    45    (C)   whether  the  registered  organization  provides  education  and
    46  outreach to practitioners;
    47    (D) whether the registered  organization  promotes  the  research  and
    48  development of medical psilocybin and patient outreach;
    49    (E)  the  affordability  of medical psilocybin products offered by the
    50  registered organization;
    51    (F) whether the registered organization is culturally, linguistically,
    52  and medically competent to provide services to unserved and  underserved
    53  areas; and
    54    (G)  whether  the registered organization promotes racial, ethnic, and
    55  gender diversity in their workforce;

        A. 8569                            15
 
     1    (vi) the applicant and its managing officers are of good moral charac-
     2  ter;
     3    (vii)  the  applicant  has entered into a labor peace agreement with a
     4  bona fide labor organization that is actively engaged in representing or
     5  attempting to represent the applicant's employees; and  the  maintenance
     6  of  such  a labor peace agreement shall be an ongoing material condition
     7  of registration; and
     8    (viii) the applicant satisfies any other conditions as  determined  by
     9  the department.
    10    (b)  If  the  department is not satisfied that the applicant should be
    11  issued a registration, the department  shall  notify  the  applicant  in
    12  writing of those factors upon which further evidence is required. Within
    13  thirty  days  of  the  receipt  of  such notification, the applicant may
    14  submit additional material to the department or  demand  a  hearing,  or
    15  both.
    16    (c)  The  fee for a registration under this section shall be an amount
    17  determined by the department in regulations; provided, however,  if  the
    18  registration is issued for a period greater than two years the fee shall
    19  be increased, pro rata, for each additional month of validity.
    20    (d)  Registrations  issued  under this section shall be effective only
    21  for the registered organization and shall specify:
    22    (i) the name and address of the registered organization;
    23    (ii) which activities of a registered organization  are  permitted  by
    24  the registration;
    25    (iii)  the  land,  buildings  and  facilities that may be used for the
    26  permitted activities of the registered organization; and
    27    (iv) such other information as the department shall reasonably provide
    28  to assure compliance with this title.
    29    (e) Upon application of a registered organization, a registration  may
    30  be  amended  to allow the registered organization to relocate within the
    31  state or to add or delete permitted registered  organization  activities
    32  or  facilities.  The  fee  for such amendment shall be determined by the
    33  department in regulation and be based off the administrative  burden  to
    34  process  and  review  the  amendment  by the department, provided no fee
    35  shall be greater than two thousand dollars.
    36    4. A registration issued under this section shall  be  valid  for  two
    37  years  from  the  date  of issue, except that in order to facilitate the
    38  renewals of such registrations, the  department  may  upon  the  initial
    39  application  for  a  registration,  issue  some  registrations which may
    40  remain valid for a period of time greater than two years but not exceed-
    41  ing an additional eleven months.
    42    5. (a) An application for the renewal of any registration issued under
    43  this section shall be filed with the department not more than six months
    44  nor less than four months prior to the expiration thereof. A  late-filed
    45  application  for the renewal of a registration may, in the discretion of
    46  the department, be treated as an application for an initial license.
    47    (b)  The  application  for  renewal  shall  include  such  information
    48  prepared in the manner and detail as the department may require, includ-
    49  ing but not limited to:
    50    (i)  any  material  change  in  the circumstances or factors listed in
    51  subdivision one of this section; and
    52    (ii) every known charge or investigation, pending or concluded  during
    53  the  period  of  the registration, by any governmental or administrative
    54  agency with respect to:

        A. 8569                            16

     1    (A) each incident or alleged incident involving the  theft,  loss,  or
     2  possible  diversion of medical psilocybin manufactured or distributed by
     3  the applicant; and
     4    (B)  compliance  by  the  applicant  with  the  laws of the state with
     5  respect to  the  cultivation,  manufacture,  distribution,  or  sale  of
     6  medical psilocybin or adult-use psilocybin, where applicable.
     7    (c)  An  applicant  for  renewal  shall  be under a continuing duty to
     8  report to the department any change in facts or circumstances  reflected
     9  in  the application or any newly discovered or occurring fact or circum-
    10  stance which is required to be included in the application and to obtain
    11  approval prior to any material change in management, interest or  owner-
    12  ship.
    13    (d)  If  the department is not satisfied that the registered organiza-
    14  tion applicant is entitled to a renewal of the registration, the depart-
    15  ment shall within a reasonably practicable time  as  determined  by  the
    16  executive director, serve upon the registered organization or its attor-
    17  ney  of  record  in  person  or by registered or certified mail an order
    18  directing the registered organization to show cause why its  application
    19  for  renewal should not be denied. The order shall specify in detail the
    20  respects in which the applicant has not satisfied  the  department  that
    21  the registration should be renewed.
    22    (e)  Within a reasonably practicable time as determined by the depart-
    23  ment of such order, the applicant may submit additional material to  the
    24  department  or  demand  a  hearing or both; if a hearing is demanded the
    25  department shall fix a date as soon as reasonably practicable.
    26    6. (a) The department shall renew a registration unless it  determines
    27  and finds that:
    28    (i)  the  applicant  is  unlikely  to  maintain or be able to maintain
    29  effective control against diversion;
    30    (ii) the applicant is unlikely to comply with all state laws  applica-
    31  ble to the activities in which it may engage under the registration;
    32    (iii)  it  is  not  in  the  public interest to renew the registration
    33  because the number of registered organizations in an area  is  excessive
    34  to reasonably serve the area;
    35    (iv)  the  applicant has either violated or terminated its labor peace
    36  agreement; or
    37    (v) the applicant has  substantively  violated  the  laws  of  another
    38  jurisdiction,  in  which  they  operate  or  have  operated a psilocybin
    39  license or registration, related to the operation of a psilocybin  busi-
    40  ness.
    41    (b)  For  purposes  of this section, proof that a registered organiza-
    42  tion, during the period of its  registration,  has  failed  to  maintain
    43  effective  control  against  diversion,  violates  any provision of this
    44  title, or has knowingly or negligently failed to comply with  applicable
    45  state  laws  relating  to  the  activities in which it engages under the
    46  registration, may constitute  grounds  for  suspension,  termination  or
    47  limitation  of  the  registered organization's registration or as deter-
    48  mined by the department. The registered organization shall also be under
    49  a continuing duty to report to the department  any  material  change  or
    50  fact  or  circumstance  to  the  information  provided in the registered
    51  organization's application.
    52    7. The department may suspend  or  terminate  the  registration  of  a
    53  registered  organization,  on  grounds  and  using procedures under this
    54  title relating to a license, to the extent consistent with  this  title.
    55  The  department shall suspend or terminate the registration in the event
    56  that a registered organization violates  or  terminates  the  applicable

        A. 8569                            17
 
     1  labor  peace  agreement. Conduct in compliance with this title which may
     2  violate conflicting federal law, shall not  be  grounds  to  suspend  or
     3  terminate a registration.
     4    8.  A registered organization that manufactures medical psilocybin may
     5  have no more than four sites wholly owned and operated  by  such  regis-
     6  tered  organization. Such registered organization may have an additional
     7  four sites; provided, however, that the first two additional sites shall
     8  be located in underserved or unserved geographic  locations,  as  deter-
     9  mined  by  the  department. The department shall ensure that such regis-
    10  tered organizations and sites are geographically distributed across  the
    11  state and that their ownership reflects the demographics of the state.
    12    9.  In coordination with the chief equity officer the department shall
    13  register additional registered  organizations  to  provide  services  to
    14  unserved  and underserved areas of the state. Such additional registered
    15  organizations shall be reflective of the demographics of the  state,  be
    16  representative  of communities disproportionately impacted by psilocybin
    17  prohibition, and be culturally, linguistically, and medically  competent
    18  to  serve  unserved  and  underserved areas of the state. The department
    19  shall actively promote racial, ethnic, and gender diversity when  regis-
    20  tering additional registered organizations.
    21    §  3369-hh.  Reports  of  registered  organizations. 1. The department
    22  shall, by regulation,  require  each  registered  organization  to  file
    23  reports  by  the registered organization during a particular period. The
    24  department shall determine the information to be reported and the forms,
    25  time, and manner of the reporting.
    26    2. The department shall, by regulation, require each registered organ-
    27  ization to adopt and maintain security, tracking, recordkeeping,  record
    28  retention  and  surveillance systems, relating to all medical psilocybin
    29  at every stage of acquiring, possession,  manufacture,  sale,  delivery,
    30  transporting,  distributing,  or  dispensing by the registered organiza-
    31  tion, subject to regulations of the department.
    32    § 3369-ii. Evaluation; research programs; report by  department.    1.
    33  The department may provide for the analysis and evaluation of the opera-
    34  tion of this title. The department may enter into agreements with one or
    35  more  persons,  not-for-profit  corporations or other organizations, for
    36  the performance of an evaluation of the implementation and effectiveness
    37  of this title.
    38    2. The department may develop, seek  any  necessary  federal  approval
    39  for, and carry out research programs relating to medical use of psilocy-
    40  bin.    Participation in any such research program shall be voluntary on
    41  the part of practitioners, patients, and designated caregivers.
    42    3. The department shall report every two years,  beginning  two  years
    43  after the effective date of this title, to the governor and the legisla-
    44  ture  on  the medical use of psilocybin under this title and make appro-
    45  priate recommendations.
    46    § 3369-jj. Psilocybin research license. 1. The department shall estab-
    47  lish a psilocybin research license that permits a licensee  to  produce,
    48  process,  purchase  and/or  possess psilocybin for the following limited
    49  research purposes:
    50    (a) to test chemical potency and composition levels;
    51    (b) to conduct  clinical  investigations  of  psilocybin-derived  drug
    52  products;
    53    (c)  to  conduct  research on the efficacy and safety of administering
    54  psilocybin as part of medical treatment; and
    55    (d) to conduct genomic or agricultural research.

        A. 8569                            18
 
     1    2. As part of  the  application  process  for  a  psilocybin  research
     2  license, an applicant must submit to the department a description of the
     3  research  that  is  intended  to  be  conducted as well as the amount of
     4  psilocybin to be grown or purchased.  The  department  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 department
     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  human, animal, or other
    11  approvals in place to successfully conduct the project; and
    12    (c) whether the amount of psilocybin to be grown or purchased  by  the
    13  applicant  is  consistent  with  the  project's  scope and goals. If the
    14  department determines that  the  research  project  does  not  meet  the
    15  requirements of subdivision one of this section, the application must be
    16  denied.
    17    3.  A  psilocybin  research licensee may only sell psilocybin grown or
    18  within its operation to other psilocybin research licensees. The depart-
    19  ment may revoke a psilocybin research license  for  violations  of  this
    20  section.
    21    4.  A psilocybin research licensee may contract with an institution of
    22  higher education, including but not limited to  a  hospital  within  the
    23  state  university  of  New York, to perform research in conjunction with
    24  such institution. All research projects, entered into under this section
    25  must be approved by the department and meet the requirements of subdivi-
    26  sion one of this section.
    27    5. In establishing a psilocybin research license, the  department  may
    28  adopt regulations on the following:
    29    (a) application requirements;
    30    (b) psilocybin research license renewal requirements, including wheth-
    31  er additional research projects may be added or considered;
    32    (c) conditions for license revocation;
    33    (d) security measures to ensure psilocybin is not diverted to purposes
    34  other than research;
    35    (e)  amount of plants, useable psilocybin, psilocybin concentrates, or
    36  psilocybin-infused products a licensee may have on its premises;
    37    (f) licensee reporting requirements;
    38    (g) conditions under which psilocybin  grown  by  licensed  psilocybin
    39  producers  and  other  product types from licensed psilocybin processors
    40  may be donated to psilocybin research licensees; and
    41    (h) any additional requirements deemed necessary by the department.
    42    6. A psilocybin research license issued pursuant to this section  must
    43  be issued in the name of the applicant and specify the location at which
    44  the  psilocybin  researcher intends to operate, which must be within the
    45  state of New York.
    46    7. The application fee for a  psilocybin  research  license  shall  be
    47  determined  by the department on an annual basis and may be based on the
    48  size, scope and duration of the research proposed.
    49    8. Each psilocybin research licensee shall issue an annual  report  to
    50  the  department.    The  department  shall review such report and make a
    51  determination as to whether the research project continues to  meet  the
    52  research qualifications under this section.
    53    §  3369-kk.  Relation  to  other laws. 1. The provisions of this title
    54  shall apply, except that where a provision of this title conflicts  with
    55  another provision of this chapter, this title shall apply.

        A. 8569                            19

     1    2.  Medical psilocybin shall not be deemed to be a "drug" for purposes
     2  of article one hundred thirty-seven of the education law.
     3    § 3369-ll. Psilocybin service facilitator license requirements.  1. An
     4  applicant  for  a  psilocybin service facilitator license shall meet the
     5  following requirements:
     6    (a) Have a high school diploma or equivalent education;
     7    (b) Any additional education or training requirements  established  by
     8  the  department,  except  that the department shall not require a degree
     9  from an institution of higher education;
    10    (c) Any examination requirements established by the department, except
    11  that the department may provide for waivers of examination  requirements
    12  in  cases  it deems appropriate. The department shall offer any required
    13  examination at least twice annually. The department may appoint a person
    14  to conduct or supervise examinations of  applicants.  An  applicant  may
    15  retake  any  failed  section of the examination in accordance with rules
    16  adopted by the department; and
    17    (d) Any other  training,  education,  skill  or  fitness  requirements
    18  adopted by the department, such as:
    19    (i)  Facilitation  skills that are affirming, nonjudgmental and nondi-
    20  rective; and
    21    (ii) Support skills for  clients  during  an  administration  session,
    22  including  specialized  skills relating to client safety and clients who
    23  may have mental health conditions, ability to establish a  proper  envi-
    24  ronment  in  which  psilocybin  services  occur  and social and cultural
    25  skills.
    26    2. The department shall establish a process to approve training cours-
    27  es for psilocybin service facilitators. To obtain approval of a  course,
    28  the  person  providing the course shall submit an outline of instruction
    29  to the department and to the department of education that  includes  the
    30  course  topics,  total hours of instruction, hours of lectures in theory
    31  and hours of instruction in application of practical skills.
    32    3. The department shall establish  a  code  of  professional  conduct,
    33  including  a  code  of  ethics, for psilocybin service facilitators. The
    34  department  shall  establish  standards  of  practice  and  professional
    35  responsibility for psilocybin service facilitators.
    36    4. A psilocybin service facilitator licensee may engage in the follow-
    37  ing activities in accordance with rules adopted by the department:
    38    (a)  Deliver  psilocybin  products to premises for which a license has
    39  been issued under this title;
    40    (b) Receive psilocybin products  from  a  registered  organization  or
    41  another psilocybin service center licensee; and
    42    (c)  Sell  psilocybin  products to a certified patient on the premises
    43  for which the license has been issued.
    44    § 3369-mm. Protections for the medical use of psilocybin. 1.    Certi-
    45  fied  patients,  designated  caregivers,  psilocybin service centers and
    46  employees  of  psilocybin  service  centers,  practitioners,  registered
    47  organizations  and the employees of registered organizations, and psilo-
    48  cybin researchers shall not be subject to arrest, prosecution, or penal-
    49  ty in any manner, or denied any right or privilege,  including  but  not
    50  limited to civil penalty or disciplinary action by a business or occupa-
    51  tional  or professional licensing board or bureau, solely for the certi-
    52  fied medical use or manufacture of psilocybin, or for any  other  action
    53  or conduct in accordance with this title.
    54    2. Being a certified patient shall be deemed to be having a "disabili-
    55  ty"  under  article fifteen of the executive law, section forty-c of the
    56  civil rights law and sections 240.00, 485.00, and 485.05  of  the  penal

        A. 8569                            20
 
     1  law.  This subdivision shall not bar the enforcement of a policy prohib-
     2  iting an employee from performing his or  her  employment  duties  while
     3  impaired  by  a controlled substance. This subdivision shall not require
     4  any  person  or entity to do any act that would put the person or entity
     5  in direct violation of federal  law  or  cause  it  to  lose  a  federal
     6  contract or funding.
     7    3.  The  fact  that  a  person is a certified patient and/or acting in
     8  accordance with this title, shall not be a consideration in a proceeding
     9  pursuant to applicable sections  of  the  domestic  relations  law,  the
    10  social services law and the family court act.
    11    4.  (a) Certification applications, certification forms, any certified
    12  patient information contained within a database, and copies of  registry
    13  identification cards shall be deemed exempt from public disclosure under
    14  sections  eighty-seven  and eighty-nine of the public officers law. Upon
    15  specific request by a certified patient to the department,  the  depart-
    16  ment  shall  verify the requesting patient's status as a valid certified
    17  patient to the patient's school or employer or other  designated  party,
    18  to ensure compliance with the protections afforded by this section.
    19    (b)  The  name, contact information, and other information relating to
    20  practitioners registered with the department under this title  shall  be
    21  public  information  and shall be maintained on the department's website
    22  accessible to the public in searchable form.  However, if a practitioner
    23  notifies the department in writing that he or she does not want  his  or
    24  her  name  and other information disclosed, that practitioner's name and
    25  other information shall thereafter not be public  information  or  main-
    26  tained  on the department's website, unless the practitioner cancels the
    27  request.
    28    5. A person currently under parole, probation or other state or  local
    29  supervision,  or  released on bail awaiting trial may not be punished or
    30  otherwise penalized for conduct allowed under this title.
    31    6. Employees who use medical psilocybin shall  be  afforded  the  same
    32  rights,  procedures and protections that are available and applicable to
    33  injured workers under the workers' compensation law,  or  any  rules  or
    34  regulations  promulgated  thereunder,  when  such  injured  workers  are
    35  prescribed medications that  may  prohibit,  restrict,  or  require  the
    36  modification of the performance of their duties.
    37    § 3369-nn. Regulations. The department shall promulgate regulations to
    38  implement this title.
    39    §  3369-oo.  Suspend;  terminate. Based upon the recommendation of the
    40  department, executive director and/or the superintendent of state police
    41  that there is a risk to the public health or safety,  the  governor  may
    42  immediately  suspend  or  terminate  all  licenses  issued to registered
    43  organizations.
    44    § 3369-pp. Pricing. Registered organizations shall  submit  documenta-
    45  tion to the executive director of any change in pricing per dose for any
    46  medical  psilocybin  product  within  fifteen days of such change. Prior
    47  approval by the executive director shall not be required  for  any  such
    48  change; provided however that the department is authorized to modify the
    49  price  per dose for any medical psilocybin product if necessary to main-
    50  tain public access to appropriate medication.
    51    § 3369-qq. Psilocybin services grant  program.  The  department  shall
    52  establish  a program of awarded grants within the amount in the psilocy-
    53  bin services grant program fund established under section  ninety-seven-
    54  uuuu  of  the  state  finance  law  for veterans and first responders to
    55  receive monetary assistance for psilocybin  services  pursuant  to  this
    56  title.  The  department  shall  promulgate any necessary rules and regu-

        A. 8569                            21
 
     1  lations for the application and distribution of any  funds  pursuant  to
     2  this section.
     3    §  3369-rr.  Psilocybin  services  advisory  board.  1. The psilocybin
     4  services advisory board or "advisory board" is  established  within  the
     5  department  to  advise  and  issue recommendations on the use of medical
     6  psilocybin in the state of New York.
     7    2. (a) The advisory board shall consist of fourteen  voting  appointed
     8  members, along with the following members serving as non-voting ex-offi-
     9  cio  members:  (i)  the commissioner, or his or her designee; and (ii) a
    10  representative from the department who is familiar  with  public  health
    11  programs and public health activities in the state.
    12    (b)  The  governor shall have eight appointments, the temporary presi-
    13  dent of the senate and the speaker of the assembly shall each have three
    14  appointments to the board. Advisory board members shall  have  statewide
    15  geographic  representation  that is balanced and diverse in its composi-
    16  tion. Appointed members shall have an expertise in public and behavioral
    17  health,  substance  use  disorder  treatment,  effective  rehabilitative
    18  treatment  for  adults and juveniles, homelessness and housing, economic
    19  development, environmental conservation,  job  training  and  placement,
    20  criminal  justice,  and  drug  policy. Further, the advisory board shall
    21  include residents from communities most impacted by psilocybin  prohibi-
    22  tion, people with prior drug convictions, the formerly incarcerated, and
    23  representatives  from  the  farming  industry,  psilocybin industry, and
    24  organizations serving communities impacted by  past  federal  and  state
    25  drug policies.
    26    3.  The members shall be appointed to the advisory board to each serve
    27  four-year terms and in the event of a  vacancy,  the  vacancy  shall  be
    28  filled  in  the  manner of the original appointment for the remainder of
    29  the term. The appointed members and  representatives  shall  receive  no
    30  compensation  for  their  services but shall be allowed their actual and
    31  necessary expenses incurred in the performance of their duties as  board
    32  members.
    33    4.  The  chairperson  of  the  advisory board and the vice chairperson
    34  shall be elected from among the members of the  advisory  board  by  the
    35  members of such advisory board. The vice chairperson shall represent the
    36  advisory  board  in the absence of the chairperson at all official advi-
    37  sory board functions.
    38    5. The advisory board shall enact and from  time  to  time  may  amend
    39  bylaws  or  rules in relation to its meetings and the transaction of its
    40  business. The board may  also  establish  committees  and  subcommittees
    41  necessary for the operation of the board. A majority of the total number
    42  of  voting  members  which the board would have were there no vacancies,
    43  shall constitute a quorum and shall be required for the board to conduct
    44  business. All meetings of the  advisory  board  shall  be  conducted  in
    45  accordance  with  the provisions of article seven of the public officers
    46  law.
    47    6. Within the first two years of the  establishment  of  the  advisory
    48  board, the board shall meet at least once every two calendar months at a
    49  time and place determined by the chairperson or a majority of the voting
    50  members  of  the  board.  After  the first two years, the advisory board
    51  shall meet at least once every calendar quarter  at  a  time  and  place
    52  determined by the chairperson or a majority of the voting members of the
    53  board. The advisory board may also meet at other times and places speci-
    54  fied  by  the  call  of  the  chairperson or of a majority of the voting
    55  members of the board.
    56    7. The advisory board shall have the following duties:

        A. 8569                            22
 
     1    (a) Provide advice to the department regarding the provisions of  this
     2  title  and  make  recommendations  on  available medical, psychological,
     3  scientific studies, research and other information relating to the safe-
     4  ty and efficacy of psilocybin  in  treating  mental  health  conditions,
     5  including  but  not  limited to addiction, depression, anxiety disorders
     6  and end-of-life psychological distress.
     7    (b) Make recommendations to the department on the requirements,  spec-
     8  ifications and guidelines for providing psilocybin services to a client,
     9  including:
    10    (i)  The  requirements,  specifications and guidelines for holding and
    11  verifying the completion of a  preparation  session,  an  administration
    12  session and an integration session; and
    13    (ii)  The  contents  of  the certified patient information form that a
    14  certified patient must complete and sign before the patient participates
    15  in an administration session, giving particular consideration to:
    16    (A) The information that should  be  solicited  from  the  patient  to
    17  determine  whether such patient should participate in the administration
    18  session, including  information  that  may  identify  risk  factors  and
    19  contraindications;
    20    (B)  The  information  that  should  be  solicited from the patient to
    21  assist the psilocybin service center operator and the psilocybin service
    22  facilitator in meeting any public health and safety standards and indus-
    23  try best practices during the administration session; and
    24    (C) The health and safety warnings and other disclosures  that  should
    25  be  made to the patient before such patient participates in the adminis-
    26  tration session.
    27    (c) Make recommendations to the department on public health and safety
    28  standards and industry best practices for each type  of  licensee  under
    29  this title.
    30    (d)  Make  recommendations  to  the department on the formulation of a
    31  code of professional conduct for psilocybin service facilitators, giving
    32  particular consideration to a code of ethics.
    33    (e) Make recommendations to the department on the education and train-
    34  ing that psilocybin service facilitators must  complete,  including  but
    35  not  limited  to whether such education and training should be available
    36  through online resources. Giving particular consideration to:
    37    (i) Facilitation skills that are affirming, non-judgmental and non-di-
    38  rective;
    39    (ii) Support skills for  clients  during  an  administration  session,
    40  including  specialized skills for client safety and clients who may have
    41  a mental health condition;
    42    (iii) The environment in which psilocybin services should occur; and
    43    (iv) Social and cultural considerations.
    44    (f) Make recommendations to the department on  the  examinations  that
    45  psilocybin service facilitators must pass.
    46    (g)  Make recommendations to the department on public health and safe-
    47  ty  standards  and industry best practices for holding and completing an
    48  administration session, including:
    49    (i) Whether group administration sessions should be available;
    50    (ii) Whether certified patients should be able  to  access  common  or
    51  outside  areas on the premises of the psilocybin service center at which
    52  the administration session is held;
    53    (iii) The circumstances  under  which  an  administration  session  is
    54  considered complete; and
    55    (iv)  The  transportation  needs of the client after the completion of
    56  the administration session.

        A. 8569                            23
 
     1    (h) In consultation with the department of agriculture and markets and
     2  the department of environmental conservation, promulgate necessary rules
     3  and regulations governing the safe production of  psilocybin,  including
     4  environmental and energy standards and restrictions on the use of pesti-
     5  cides and best practices for water and energy conservation.
     6    (i)  Develop  a  long-term strategic plan for ensuring that psilocybin
     7  services will become and remain a safe, accessible and affordable thera-
     8  peutic option for all persons twenty-one years of age and older  in  the
     9  state for whom psilocybin services may be appropriate.
    10    (j) Monitor and study federal laws, regulations and policies regarding
    11  psilocybin.
    12    §  2. The state finance law is amended by adding a new section 97-uuuu
    13  to read as follows:
    14    §  97-uuuu. Psilocybin services grant program fund. 1. There is hereby
    15  established in the joint custody of the commissioner of health  and  the
    16  comptroller a fund to be known as the "psilocybin services grant program
    17  fund".
    18    2.  The fund shall consist of all monies appropriated for its purpose,
    19  and all monies required by this section or any other provision of law to
    20  be paid into or credited to such fund. The fund shall  not  contain  any
    21  monies which are not intended for the fund.
    22    3.  Monies of the fund, when allocated, shall be available pursuant to
    23  section thirty-three hundred sixty-nine-qq of the public health law.
    24    4. Monies shall be payable from the fund on the audit and  warrant  of
    25  the  state comptroller on vouchers approved and certified by the commis-
    26  sioner of health.
    27    § 3. The sum of two million dollars ($2,000,000), or so  much  thereof
    28  as  may be necessary, is hereby appropriated to the department of health
    29  out of any moneys in the state treasury in the general fund to the cred-
    30  it of the psilocybin services grant program, not otherwise appropriated,
    31  and made immediately available, for the  purpose  of  carrying  out  the
    32  provisions  of  this  act. Such moneys shall be payable on the audit and
    33  warrant of the comptroller on vouchers  certified  or  approved  by  the
    34  commissioner of health in the manner prescribed by law.
    35    §  4.  This  act shall take effect on the ninetieth day after it shall
    36  have become a law.
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