•  Summary 
  •  Actions 
  •  Committee Votes 
  •  Floor Votes 
  •  Memo 
  •  Text 
  •  LFIN 
  •  Chamber Video/Transcript 

A10375 Summary:

SPONSORRules (Paulin)
Add Art 33 Title 5-B §§3369-aa - 3369-ii, Pub Health L
Allows the growth, cultivation, and regulated adult use of psilocybin for the treatment of certain health conditions; provides for the certification of support service providers and the licensure of cultivators.
Go to top    

A10375 Actions:

05/21/2024referred to health
Go to top

A10375 Memo:

submitted in accordance with Assembly Rule III, Sec 1(f)
SPONSOR: Rules (Paulin)
  TITLE OF BILL: An act to amend the public health law, in relation to promoting the health and well-being of the citizens of the state of New York by estab- lishing a comprehensive framework supporting public health and safety through regulated adult use, support services, and cultivation of psilo- cybin-containing fungi   PURPOSE: This bill would comprehensively regulate the manufacture, sale, and adult use of psilocybin in connection with a public health framework. Psilocybin has been shown to support wellbeing, resilience, and public health and may be used safely, particularly with education, health screening, safe sourcing, and support services. The public health frame- work established in this bill supports and provides protections for adult use of psilocybin, cultivators, and the providers of optional support services that will improve the general health of families and communities and address the harmful impact of certain physical and mental health conditions. Legal adult use of psilocybin with regulated educational requirements and other harm reduction mechanisms, culti- vation, and, optionally, support services during such use increases safety. The bill requires that persons engage in a prerequisite health screening process to identify health conditions and potential exclusion criteria and participate in an educational course, which is regularly updated with scientific and functional information, in order to receive a psilo- cybin permit. This requirement of health screening and education would address health issues and risks to the permit holder and the public. Permit holders will receive education during the health screening on the availability of medical healthcare options related to symptoms or diag- nosis of current or past health conditions and the risks of psilocybin use generally and particularly where there is exclusion criteria. Permit holders who are screened and well-informed will be authorized and empowered to purchase, grow, and gift to other permit holders psilocy- bin-containing fungi and engage optional support service providers during use of psilocybin, only where such providers are certified upon satisfying the requirement of ongoing educational training and satisfac- tion of ethical standards. Licensed healthcare professionals who desire to support the health screening process, provide advice on benefits and risks of psilocybin, or separately provide certified support services to clients will be enabled by protections in the bill, creating continuity of care within the psilocybin access framework. The bill regulates and requires psilocybin cultivation standards, test- ing, and disclosures. Licensing of cultivators will increase safe access to psilocybin-containing fungi within an intrastate system requiring testing and appropriate disclosures related to potency and dosing. With education on risk reduction and emergency protocol, a person may be certified as a support services provider with continuing education and ethical accountability for authorized non-medical, non-therapeutic, and non-directive risk reduction services. Support services for adult use of psilocybin will be authorized to permit holders with review of health screening forms and the opportunity to communicate with their clients' licensed healthcare providers with appropriate consent. Support services providers are required to provide additional education and receive a state-approved informed consent in provision of support services. The bill establishes an optional reporting system for permit holders to identify experience data with adult use of psilocybin and concerning conduct or breaches by support services providers. The Department of Health will oversee the educational programs, registry and reporting systems, permits for adult use of psilocybin, licensure of cultivators, and regulatory certification and requirements of support service providers to establish a functional and safety-oriented public health framework of access to psilocybin.   SUMMARY OF PROVISIONS: The bill would create a new Title V-B in Article 33 of the Public Health Law entitled "Regulated Health Access and Support Services for Psilocy- bin," a comprehensive regulatory structure governing every aspect of the adult use of psilocybin in connection with a public health framework. Section 3369-aa establishes definitions for the purpose of this bill. Section 3369-bb establishes authority for the Department of Health to manage and promulgate rules to regulate a public health framework for the adult use of psilocybin with a Department issued permit. Section 3369-bb establishes a reporting system for permit holders to optionally identify health and experience data and allege violations or concerns about support services providers. Section 3369-bb requires the Depart- ment to report to the governor and the legislature on the regulated adult use of psilocybin. Section 3359-cc establishes the authority of a psilocybin permit for lawful use and cultivation of psilocybin in connection with a public health framework. Section 3359-cc establishes procedures and require- ments for a person to engage in a health screening and educational permit course as a prerequisite to a psilocybin, permit Section 3359-cc requires that permit holders update the health screening form periodically and complete a renewal permit course every four years. Section 3369-dd authorizes the Department to issue a certification to support services providers to any person that completes a risk reduction support services training course and participates in biennial continued education courses provided by the Department. Section 3369-dd requires that support services providers review a health screening of any permit holder prior to provision of services and that a permit holder confirms details in the health screening form. Section 3369-dd establishes that support services providers shall be subject to ethical conduct standards and accountability for provision of services with the reporting system established by the Department. Section 3369-ee authorizes the Department to issue, regulate, and record licenses to persons or business entities to cultivate and sell psilocy- bin-containing fungi to psilocybin permit holders within an intrastate system. Section 3369-d establishes requirements for licensed cultivators to cultivate, test for potency, make disclosures, and securely store psilocybin-containing fungi. Section 3369-ff provides the relation of this bill to other laws, including the removal of terms applicable to lawful use of psilocybin in the schedule of controlled substances under the public health law, the exclusion of psilocybin-containing fungi from the definition of food under the agriculture and,markets law, the distinction of psilocybin from drugs as provided in a pharmacy under the education law, and mini- mizes criminal penalties for unauthorized use of psilocybin under the penal law. Section 3369-gg establishes certain protections for psilocybin permit holders, licensed cultivators, and certified support services providers to eliminate penalties or disqualifications in connection with author- ized adult use and other activities under this title, while authorizing law enforcement to prohibit dangerous conduct, including intoxication in public or while operating a vehicle. Section 3369-gg establishes protections for licensed professionals to allow for lawful adult use of psilocybin or providing professional services to any permit holder. Section 3369-gg protects data received from permit holders about adult use of psilocybin and any registry established pursuant to this bill. Section 3369-hh establishes the Regulated Psilocybin Advisory Board within the Department to issue recommendations on the lawful use of psilocybin. Section 3369-hh establishes the criteria on the appointment of. 13 voting members of the Regulated Psilocybin Advisory Board, with each voting member serving four-year terms. Section 3369-hh establishes additional duties of the Regulated Psilocybin Advisory Board. Section 3369-ii establishes that the Department shall issue regulations to impose a tax on lawful use of psilocybin. Any fees or proceeds collected would be used to support the administration cost of the program under this bill, including but not limited to public education.   JUSTIFICATION: The people of New York need a public health framework to improve commu- nity and address struggles with healthy lifestyles and mental and phys- ical health conditions, such as PTSD, depression, anxiety, cluster head- aches, chronic pain, and substance use and behavioral disorders. Daily stress and obstacles for healthy persons and difficulties as a result of health conditions are affecting a significant population requiring whole health support. General failures in systems promoting health, safety, and support have disrupted the well-being and livelihoods of many and have deteriorated physical, mental, and spiritual health, resulting in disconnection, inability to engage fully in professional and social opportunities, substance use and behavioral disorders, chronic pain, and increased rates of suicide. Moreover, these harms disproportionately impact persons who have had traumatic experiences, such as military veterans, first responders, and victims of abuse, as well as their families and communities. With studies demonstrating positive outcomes with psilocy- bin for both healthy people and people with certain health conditions, including FDA designation of psilocybin as a breakthrough therapy, it is imperative to establish regulated access to psilocybin in connection with a public health framework to empower certain populations to make informed, safer, and legal decisions. An access framework that allows for persons to acquire a permit for adult use of psilocybin will provide the opportunity to improve quality of life, address personal growth and spiritual development, and attend to the impact of trauma, grief, and health condition distress and recov- ery. While a public health framework supporting adult use of psilocybin would not directly provide medical or therapeutic treatment with psilocybin for any particular health condition, there is evidence of increased health and safety where licensed professionals may engage in aspects of support through professional services to a person considering or engag- ing in adult use of psilocybin. Optional support services by trained and certified support services providers who offer a risk reduction approach will increase the safety of psilocybin permit holders. A continuity of care model with licensed professionals in collaboration with, certified support services providers creates a crucial system of support. The framework provided in this bill would ensure that the large number of people that may benefit from adult use of psilocybin are educated sufficiently to make informed decisions, attain access to clearly labeled and well-sourced psilocybin-containing fungi, and ensure the training and strength of support services with accountability systems in place. These empowered permit holders, as well as cultivators, support services providers, and licensed professionals, may participate in a system without fear of prosecution, stigma from prohibition, or risk to their professions or custody of their children as a result of efforts to improve the quality of life for themselves and others. To expand and support the state's agricultural industry, and to ensure the supply of psilocybin is safe and sufficient for those that are authorized for adult use, persons and business entities would be given a legal pathway to grow psilocybin under stringent conditions, including as licensed cultivators. This bill would also ensure that sale and distribution of psilocybin would not be halted by burdensome licensing limitations and cultivation requirements. By ensuring that the state fosters substantial public education on psilocybin benefits and risks based on available medical information and establishing specific criteria for use, sale, and distribution of psilo- cybin, existing psilocybin use and services can be normalized and legal- ized to allow for safer access, professional legitimacy, elimination of criminal penalties, and taxation for the benefit of the state and its citizens.   LEGISLATIVE HISTORY: This is a new bill.   BUDGET IMPLICATIONS: TBD   EFFECTIVE DATE: This bill would take effect immediately
Go to top

A10375 Text:

                STATE OF NEW YORK
                   IN ASSEMBLY
                                      May 21, 2024
        Introduced  by  COMMITTEE ON RULES -- (at request of M. of A. Paulin) --
          read once and referred to the Committee on Health
        AN ACT to amend the public health law,  in  relation  to  promoting  the
          health  and  well-being  of  the  citizens of the state of New York by
          establishing a comprehensive framework supporting  public  health  and
          safety  through regulated adult use, support services, and cultivation
          of psilocybin-containing fungi
          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
     5  Section 3369-aa. Definitions.
     6          3369-bb. Regulation of psilocybin programs.
     7          3369-cc. Regulated adult use of psilocybin  in  connection  with
     8          public health framework.
     9          3369-dd. Certification   and   authorized  services  of  support
    10          services provider.
    11          3369-ee. Cultivator license and requirements.
    12          3369-ff. Relation to other laws.
    13          3369-gg. Protections.
    14          3369-hh. Regulated psilocybin advisory board.
    15          3369-ii. Taxation of psilocybin regulated activities.
    16    § 3369-aa. Definitions. For the purposes of this title, the  following
    17  terms shall have the following meanings:
    18    1.  "Business  enterprise" means any entity, including a sole proprie-
    19  torship, partnership, limited liability partnership,  limited  liability
    20  company  or corporation, including not-for-profit corporations, which is
    21  authorized to and engages in lawful business transactions in  accordance
    22  with New York law.
    23    2.  "Adult  use of psilocybin" means the authorized adult, non-commer-
    24  cial use of psilocybin in connection with a public health  framework  as
    25  provided under this title.
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.

        A. 10375                            2
     1    3.    "Cultivator  license"  means  a written authorization permitting
     2  natural persons or business  enterprises  to  engage  in  the  specified
     3  activities  of  cultivation, distribution, and testing of psilocybin, as
     4  authorized pursuant to this title. Only a person or business  enterprise
     5  with  a  cultivator  license  may engage in commercial transactions with
     6  psilocybin-containing fungi.
     7    4. "Department" shall mean New York state department of health.
     8    5. "Exclusion criteria" means certain health conditions,  prescription
     9  medications, or consumption of other substances that, based on currently
    10  available  medical information and research, are contraindicated or have
    11  a risk of negative interaction with the  use  of  psilocybin.  Exclusion
    12  criteria shall be added or removed by the department.
    13    6.  "Health  screening"  means  a  screening form to allow a person to
    14  certify symptoms or prior or current diagnosis of  one  or  more  health
    15  conditions or exclusion criteria.
    16    7.  "Licensed healthcare provider" means a person with a valid license
    17  or certificate  from  the  department  of  education  for  a  profession
    18  provided  in article one hundred thirty-one, one hundred thirty-two, one
    19  hundred thirty-six, one hundred  thirty-nine,  one  hundred  forty,  one
    20  hundred forty-one, one hundred forty-three, one hundred fifty-three, one
    21  hundred fifty-four, one hundred fifty-seven, one hundred fifty-nine, one
    22  hundred  sixty,  one hundred sixty-three, one hundred sixty-four, or one
    23  hundred sixty-seven or otherwise related to wellness, medicine,  health-
    24  care,  mental  health, or behavioral health. To be a licensed healthcare
    25  provider under this title, such licensed professional's authorized scope
    26  of practice does not need  to  but  may  include  medical  diagnosis  or
    27  prescription of medications.
    28    8. "Health conditions" mean certain health conditions that include but
    29  are not limited to:
    30    (a) adjustment disorder;
    31    (b) amyotrophic lateral sclerosis;
    32    (c) attention deficit/hyperactivity disorder;
    33    (d) arthritis;
    34    (e) autism;
    35    (f) Alzheimer's;
    36    (g) anxiety;
    37    (h) anorexia nervosa;
    38    (i) bacterial infection or disease;
    39    (j)  behavioral/process addiction, including gambling, pornography, or
    40  shopping;
    41    (k) body dysmorphia;
    42    (l) cataracts;
    43    (m) cancer;
    44    (n) cancer-related distress;
    45    (o) chronic pain;
    46    (p) chronic fatigue;
    47    (q) cluster headaches;
    48    (r) depressive disorder;
    49    (s) degenerative disc or joint disease;
    50    (t) eating disorder;
    51    (u) effects from stroke;
    52    (v) epilepsy;
    53    (w) episodic migraines;
    54    (x) fibromyalgia;
    55    (y) functional gastrointestinal disorder,  including  irritable  bowel
    56  syndrome (IBS) and inflammatory bowel disease (IBD);

        A. 10375                            3
     1    (z) glaucoma;
     2    (aa) headache disorders;
     3    (bb) HIV/AIDS;
     4    (cc) insomnia;
     5    (dd) Lyme disease;
     6    (ee) mood disorder;
     7    (ff) motor neuron disease;
     8    (gg) migraine;
     9    (hh) multiple sclerosis;
    10    (ii) muscular dystrophy;
    11    (jj) neurodegenerative disease including neuropathy;
    12    (kk) obsessive-compulsive disorder;
    13    (ll) Parkinson's disease;
    14    (mm) panic disorder;
    15    (nn) paresthesia;
    16    (oo) phantom limb pain;
    17    (pp) premenstrual syndrome or premenstrual dysphoric disorder;
    18    (qq) prolonged grief disorder;
    19    (rr) postpartum mental health disorder;
    20    (ss) post-acute COVID-19 infection condition;
    21    (tt)  post-traumatic  stress disorder (PTSD) or complex post-traumatic
    22  stress disorder;
    23    (uu) psychogenic pain disorder;
    24    (vv) restless leg syndrome;
    25    (ww) rheumatoid arthritis;
    26    (xx) sexual disorder;
    27    (yy) sensory processing disorder;
    28    (zz) sleep disorder;
    29    (aaa) substance use disorder, including for use of  opiates,  tobacco,
    30  and alcohol;
    31    (bbb) terminal illness or end-of-life distress;
    32    (ccc) traumatic brain injury (TBI), including concussion;
    33    (ddd) treatment resistant depression;
    34    (eee) unspecified mood disorder; and
    35    (fff)  any  novel  or emergent health condition not categorized in the
    36  Diagnostic and Statistical Manual of Mental Disorders or known  physical
    37  health conditions where there is evidence of potential use of psilocybin
    38  with  positive  outcomes  in connection with such health conditions that
    39  has been identified in a study published  in  a  medical  or  scientific
    40  journal, including preprint servers.
    41    9.  "Licensed  cultivator"  means  a  person  or  business enterprise,
    42  including  a  sole  proprietorship,  partnership,  corporation,  limited
    43  liability company, or other business enterprise, that possesses a culti-
    44  vator license pursuant to this title.
    45    10.  "Noncommercial"  means  an action or transaction of goods that is
    46  without remuneration or the exchange of money.
    47    11. "Permit course" means the psilocybin regulation educational permit
    48  (PREP) course that includes educational material and a test that must be
    49  successfully completed by a person who has received a  health  screening
    50  and  is  applying for a psilocybin permit. There will be no limit in the
    51  number of attempts to complete the test component of the  permit  course
    52  in  order to receive a psilocybin permit, as the purpose of such test is
    53  to enable education and information to increase safety of adult  use  of
    54  psilocybin.
    55    12. "Person" means a natural person.

        A. 10375                            4
     1    13. "Psilocybin" means fungi that contain naturally-occurring psilocy-
     2  bin  and  psilocin  compounds  produced by such fungi, including but not
     3  limited to members of the genus Psilocybin.
     4    14. "Psilocybin permit" means a written authorization from the depart-
     5  ment  issued  to a person at least eighteen years old who has received a
     6  health screening and successfully completed the permit course  to  allow
     7  adult use of psilocybin in connection with a public health framework.
     8    15.  "School  grounds"  means any building, structure, and surrounding
     9  outdoor grounds, including entrances or exits, contained within a public
    10  or private pre-school, nursery school, elementary or secondary  school's
    11  legally  defined  property  boundaries as registered in a county clerk's
    12  office.
    13    16. "Support services" mean the services consistent  with  this  title
    14  through  actions  of  supportive  care  and  response  to adverse health
    15  circumstances, provision of educational information, and  other  conduct
    16  provided  by  a  certified  support  services provider that increase the
    17  safety and reduce potential risks associated with  a  psilocybin  permit
    18  holder's authorized use of psilocybin.
    19    17.  "Support  services  provider certification" means a certification
    20  that is regulated and issued  by  the  department  that  authorizes  the
    21  support services of a support services provider.
    22    18.  "Support services provider" means a person who has been granted a
    23  certification  to  provide  risk  reduction   support   services,   upon
    24  completion  and continued satisfaction of all requirements under section
    25  thirty-three hundred sixty-nine-cc  of  this  title,  including  ongoing
    26  education and training in connection with a permit holder's adult use of
    27  psilocybin.
    28    §  3369-bb. Regulation of psilocybin programs. 1. The department shall
    29  manage all operations of this title.
    30    2. The department  shall  promulgate  regulations  to  implement  this
    31  title.
    32    3.  The  department may provide for the analysis and evaluation of the
    33  operation of this title. The department may enter into  agreements  with
    34  one or more persons, not-for-profit corporations, universities, or other
    35  organizations,  for  the performance of an evaluation of the implementa-
    36  tion and effectiveness of this title.
    37    4. The department shall be responsible for regulating the adult use of
    38  psilocybin with a permit, cultivation licenses and  licensed  cultivator
    39  operation requirements, certification of support services providers, and
    40  other authorized and related programs.
    41    5.  The  department  shall  create a reporting program to allow permit
    42  holders the optional opportunity to identify health and experience  data
    43  in  connection  with adult use of psilocybin, including on health condi-
    44  tions and potential exclusion criteria, and also to make  reports  about
    45  certified  support  services  providers  and  the  provision  of ethical
    46  services.
    47    6. The department shall report every two years,  beginning  two  years
    48  after the effective date of this title, to the governor and the legisla-
    49  ture  on  the  regulated  access of psilocybin under this title and make
    50  appropriate recommendations.
    51    § 3369-cc. Regulated adult use of psilocybin in connection with public
    52  health framework. A psilocybin  permit  holder  shall  be  permitted  to
    53  engage  in  the  adult  use  of psilocybin in connection with qualifying
    54  health conditions, provided that:
    55    1. A person shall be provided a psilocybin permit upon completion of a
    56  health screening and the permit course.

        A. 10375                            5
     1    2. A person shall complete a health screening that certifies  symptoms
     2  or  diagnosis  of  any  health  conditions and no existence of exclusion
     3  criteria.
     4    3.  A  health  screening  shall include a structured screening process
     5  with a form where a person applying for a psilocybin permit self-reports
     6  symptoms or diagnosis that indicate any health  condition  or  exclusion
     7  criteria.
     8    4.  A  health  screening form shall be updated by the permit holder if
     9  there are any  changes  to  the  certifications  of  health  conditions,
    10  including  any  new  symptoms  or  diagnosis,  that constitute exclusion
    11  criteria on the form filed with the department and recompleted biennial-
    12  ly to maintain the psilocybin permit. Any changes to such form shall not
    13  precipitate a requirement to engage in the permit course until the  four
    14  year requirement provided in this section.
    15    5. A health screening shall include clear disclosure that adult use of
    16  psilocybin  under  this  title is not to treat any health conditions and
    17  the existence of health assessments and  treatments  for  any  potential
    18  health conditions.
    19    6.  A  health  screening shall include clear disclosure that exclusion
    20  criteria in connection with use of psilocybin may  increase  significant
    21  health and safety risks.
    22    7. Any indication of exclusion criteria shall disqualify a person from
    23  a psilocybin permit due to health risks to such person or others.
    24    8.  A  health  screening  shall  be allowed to be taken in an entirely
    25  online format provided by the department or with a  licensed  healthcare
    26  provider, who shall then submit such screening to the department.
    27    9. The permit course, which shall be no longer than five (5) hours and
    28  allowed  to  be  taken  in an in-person or entirely online format, shall
    29  provide the appropriate education and information about  psilocybin  and
    30  psilocybin-containing  fungi using a curriculum developed by the depart-
    31  ment regarding the history of indigenous, religious, and  cultural  use,
    32  safety,  potency  and  effects of dosing amounts, contraindicated health
    33  conditions and substances, the value of preparation and integration, the
    34  appropriate setting for use, and any  medically  available  evidence  of
    35  benefits,  health risks, and the sensitivity period subsequent to psilo-
    36  cybin use, and optional support services available, appropriate  conduct
    37  and  informed  consent  required  for  such services, and the department
    38  reporting system established pursuant  to  this  title.  The  department
    39  shall  update the curriculum for the permit course with medically avail-
    40  able information biennially.
    41    10. A permit holder must successfully complete an abbreviated  renewal
    42  permit  course  based  on  changes to the curriculum or this title every
    43  four years to maintain such permit holder's permit.
    44    11. The cost of the permit course and the permit application shall not
    45  exceed reasonable, accessible fees consistent with other state  permits.
    46  A  permit  course  shall  not  exceed one hundred dollars and the permit
    47  application shall not exceed eighty dollars.
    48    12. The department may approve a permit course developed by  a  person
    49  or  business  enterprise  that satisfies the curriculum requirements and
    50  will provide certification that such permit course, including the  test,
    51  was successfully completed to the department.
    52    13.  A psilocybin permit may be granted to a citizen of any state, but
    53  such rights granted by the psilocybin permit only  authorize  the  regu-
    54  lated activities in this title within the state of New York.
    55    14.  A  psilocybin permit holder may only lawfully purchase psilocybin
    56  from a licensed cultivator pursuant to this title, cultivate  their  own

        A. 10375                            6
     1  psilocybin,  or  receive it as a non-commercial gift from another permit
     2  holder.
     3    15.  Permit holders have the option to engage support services provid-
     4  ers for risk reduction support services during adult use of psilocybin.
     5    16. Adult use of  psilocybin  shall  not  be  permitted  in  a  public
     6  location within five hundred feet of a school grounds.
     7    17. A permit holder is authorized to purchase from a licensed cultiva-
     8  tor,  as provided under this title, an allowable amount of two ounces of
     9  processed, dried psilocybin-containing fungi each  calendar  month.  The
    10  department may increase this allowable amount.
    11    18.  Measuring  weight  of  psilocybin-containing  fungi for adult use
    12  shall be measured based on the dried, processed  condition  of  psilocy-
    13  bin-containing fungi, and does not include the weight of any material of
    14  which  the  substance  is  a  part  or  to which the substance is added,
    15  dissolved, held in solution, or suspended, or any ingredient or material
    16  combined with the substance as part of a preparation.
    17    19. A permit holder is authorized to personally cultivate  psilocybin-
    18  containing  fungi  in  a  cultivation space that produces no more than a
    19  limited space in volume, as regulated by the department, for  adult  use
    20  of  psilocybin.  No  psilocybin  permit  holder  shall  be penalized for
    21  possession in excess of the allowable amount if it is stored in a locked
    22  container within their residence  for  adult  use.  Notwithstanding  any
    23  provision  to the contrary, personal cultivation does not permit commer-
    24  cial sales or rights granted by a cultivation license.
    25    20. A permit holder may provide psilocybin  to  other  permit  holders
    26  only  if the psilocybin is a non-commercial transaction and a psilocybin
    27  permit is provided to demonstrate authorization pursuant to this  title.
    28  A  permit  holder  is  prohibited  from  the transfer of psilocybin as a
    29  remunerated commercial transaction unless  authorized  to  do  so  as  a
    30  licensed  cultivator  pursuant  to  section three thousand three hundred
    31  sixty-nine-ee of this title.
    32    21. A licensed healthcare provider  may,  within  the  scope  of  such
    33  healthcare  provider's  practice, offer professional services to support
    34  patients and clients who are permit holders in such patients' adult  use
    35  of  psilocybin with respect to the health screening or in preparation or
    36  subsequent to support services.
    37    22. Psilocybin permit holders who are in violation of  this  title  in
    38  more  than  two  instances may be penalized by loss of such permit for a
    39  period of two years and, after such penalization  period,  shall  subse-
    40  quently be entitled to apply for a psilocybin permit.
    41    §  3369-dd.  Certification and authorized services of support services
    42  provider. 1. State-certified  support  services  providers  may  provide
    43  non-medical,  non-therapeutic,  and non-directive risk reduction support
    44  services to increase the health and safety of a permit holder.
    45    2.  No  support  services  certification  establishes  any  licensure,
    46  certification,  or  other  authority  to  provide  therapy, coaching, or
    47  treatment in connection  with  adult  use  of  psilocybin,  but  support
    48  services providers are not precluded from contracting or providing sepa-
    49  rately for such services.
    50    3.  In order to receive a support services provider certification from
    51  the department, a person shall  complete  a  support  services  training
    52  course  with  a  curriculum and written exam that includes education and
    53  information about psilocybin regarding its history of indigenous use and
    54  cultural relevance, benefits and health risks based on currently  avail-
    55  able medical evidence, effects of dosing amounts, contraindicated health
    56  conditions  and  interacting  substances  that  increase risks, informed

        A. 10375                            7
     1  consent, risk reduction strategies,  and  adverse  event  and  emergency
     2  protocol, as determined by the department in regulation.
     3    4. The cost of any support services training course shall be a reason-
     4  able, accessible amount and not exceed one thousand five hundred dollars
     5  and the certification application shall not exceed eighty dollars.
     6    5. A support services provider is obligated to participate in biennial
     7  continued  education courses with a curriculum determined by the depart-
     8  ment in regulation.
     9    6. Any training course for support services providers shall be  avail-
    10  able  for a reasonable fee and may be provided entirely online to create
    11  affordability, accessibility, recognize need  for  culturally  competent
    12  risk reduction support, and diversity.
    13    7.  The  department  may  approve  a  support services training course
    14  developed by a person or business enterprise that satisfies the  curric-
    15  ulum  requirements  under this title and will provide certification that
    16  such training course, including the exam, was successfully completed  to
    17  the department.
    18    8.    Support  services  providers may provide support services in any
    19  location, as determined by the department and to  create  accessibility,
    20  including  but  not  limited  to  appropriately  zoned  settings such as
    21  private offices and commercial use, or residences of the  permit  holder
    22  or the support services provider where a home occupation is allowed.
    23    9. The department shall develop an informed consent document that must
    24  be  used  and  may be modified to include additional but not conflicting
    25  information by a support services provider in each instance of provision
    26  of such services to a psilocybin permit holder.
    27    10. One  or  more  support  services  providers  may  provide  support
    28  services  to  one  or more permit holders simultaneously consistent with
    29  certain rules, such as the proportion of  service  providers  to  permit
    30  holders, as determined by the department in regulation.
    31    11.  A  person  may,  but  shall not be required to, have a psilocybin
    32  permit and support services certification concurrently.
    33    12. The department may establish additional  levels  of  certification
    34  pursuant to research and medical standards.
    35    13.  The  department  shall  create  a  certification  board to review
    36  support services provider certification and the compliance of a  support
    37  services provider.
    38    14.  A  support  services  provider shall be entitled to offer support
    39  services in exchange for compensation as a commercial transaction.
    40    15. A support services provider may engage in  the  commercial  trans-
    41  action  of  their authorized support services under this title and, if a
    42  permit holder, simultaneously engage in the noncommercial transaction of
    43  gifting psilocybin to the  permit  holder  engaging  such  provider  for
    44  support services.
    45    16.  A support services provider shall require confirmation of a valid
    46  psilocybin permit and review the health screening form provided  by  the
    47  permit  holder  engaging support services prior to provision of services
    48  during the adult use of psilocybin authorized under this title. A permit
    49  holder shall confirm accuracy of responses on the health screening  form
    50  before each instance of support services.
    51    17.  A  support services certification under this title shall not be a
    52  professional license under the education law.
    53    18. The department of education, the department,  and  any  applicable
    54  state  licensing  boards  may  establish  certifications,  licensure, or
    55  related regulations to allow a licensed professional to provide  profes-
    56  sional  services  simultaneously  with  support  services with a support

        A. 10375                            8
     1  services provider certification or  as  otherwise  determined  in  regu-
     2  lation.
     3    19.  This  title  shall  allow  the  licensed  professionals  to share
     4  patient-approved information  with  support  service  providers  through
     5  lawful  disclosures and agreements, as consistent with the health insur-
     6  ance portability and accountability act, as applicable.
     7    § 3369-ee. Cultivator license and requirements.  1. For  the  purposes
     8  of  this  title,  psilocybin-containing  fungi  shall  not  constitute a
     9  "food," or "food product," as defined and regulated by section 161.21 of
    10  title one of the compilation of codes, rules,  and  regulations  of  the
    11  state  of  New  York, to be distinguished from fungi that do not contain
    12  psilocybin that are cultivated under controlled conditions.
    13    2. The department may issue a cultivator license to  a  cultivator  of
    14  psilocybin-containing fungi to cultivate and engage in commercial trans-
    15  actions  of  psilocybin-containing  fungi  consistent with this title to
    16  psilocybin permit holders. Cultivation  of  psilocybin-containing  fungi
    17  includes  production,  manufacture, processing, and required testing and
    18  disclosures.  Commercial  transaction  of  psilocybin-containing   fungi
    19  include, sale, distribution, and delivery.
    20    3.  To  obtain a cultivator license, an applicant must show ability to
    21  satisfy the requirements of this section. Maintenance  of  a  cultivator
    22  license  requires  the demonstration of the satisfaction of all require-
    23  ments of this section and any regulations promulgated by the  department
    24  pursuant to this section.
    25    4. A licensed cultivator must cultivate psilocybin-containing fungi in
    26  a  properly zoned and licensed facility approved for cultivation.  Proc-
    27  essing and packaging of psilocybin-containing fungi must be performed in
    28  a manner consistent with the relevant safety regulations.    Psilocybin-
    29  containing fungi must be stored under sanitary conditions.
    30    5.  A  licensed cultivator shall cultivate psilocybin-containing fungi
    31  using controlled conditions that adhere to current food safety  protocol
    32  in order to reasonably reduce fungi contaminants.
    33    6. A licensed cultivator shall clearly label the psilocybin-containing
    34  fungi  with the required disclosures, including the full registered name
    35  of  the  licensed  cultivator,  such  cultivator's  office  address,   a
    36  description  of contents providing the disclosure of the strain, and the
    37  culture-specific approximate psilocybin equivalent potency of the psilo-
    38  cybin-containing fungi.
    39    7. A licensed cultivator shall  engage  in  annual  testing  for  each
    40  culture used for cultivation in order to reasonably confirm satisfaction
    41  of  all relevant protocol, including strain and potency, through author-
    42  ized in-state testing facilities, as regulated by  the  department.  Any
    43  new cultures shall be subject to the requirements of this section.
    44    8. A licensed cultivator may sell directly to permit holders within an
    45  intrastate  system  established  by  the  department.  Sales by licensed
    46  cultivators may  be  accomplished  using  direct  to  consumer  delivery
    47  services solely to permit holders in the state. Deliveries may be facil-
    48  itated  by  contracting  with additional persons or business enterprises
    49  and remain an authorized activity pursuant to a cultivator license.
    50    9.   Sales shall not need to be  through  a  dispensary,  however  the
    51  department  may promulgate rules related to a dispensary contracted with
    52  a licensed cultivator and meets other applicable  requirements  of  this
    53  title.
    54    10.  Any commercial transaction requires provision of an informational
    55  document  that gives information about strength of psilocybin-containing
    56  fungi and dosing and identifies optional support service providers.

        A. 10375                            9
     1    11. Any person or business enterprise that is contracted for  services
     2  by  a  licensed  cultivator, for or to accomplish an authorized activity
     3  under such cultivator license, such as delivery services to permit hold-
     4  ers or testing of potency, shall be considered a licensee to the  extent
     5  of  the  performance  of  the  contracted  services  and shall not be in
     6  violation of this title.
     7    12. Licensed cultivators shall maintain secure storage  of  psilocybin
     8  prior  to  distribution  to  prevent diversion and in a manner that will
     9  maintain the disclosed potency and prevent contamination.
    10    13. Licensed cultivators must  maintain  records  of  all  cultivation
    11  production  and sales. Upon request by the department, licensed cultiva-
    12  tors must provide these records and engage in annual inspections.
    13    14. The department shall maintain a registry of  cultivators  who  are
    14  licensed for permit holders to purchase psilocybin-containing fungi.
    15    § 3369-ff. Relation to other laws. 1. Nothing under this title permits
    16  or  authorizes  the promotion of use of psilocybin as a drug, substance,
    17  or product intended to diagnose, treat, cure, or prevent any disease  or
    18  mental health or other health conditions.
    19    2.  Section  three thousand three hundred six of this article shall be
    20  amended to remove "psilocybin" and  "psilocin"  from  the  schedules  of
    21  controlled  substances  and to provide an exception for "psilocybin" and
    22  "psilocin" from "hallucinogenic substances".
    23    3. For the purposes of this title, psilocybin and psilocin  shall  not
    24  be  deemed  to be a "drug" for purposes of subdivision twelve of section
    25  three thousand three hundred two of this article.
    26    4. For the purposes of  this  title,  psilocybin-containing  mushrooms
    27  shall  not  be  deemed  a food or food product under the agriculture and
    28  markets law.
    29    5. For the purposes of this title, psilocybin shall not be  deemed  to
    30  be  a  "drug"  for  purposes  of article one hundred thirty-seven of the
    31  education law and is not intended to be distributed through any  pharma-
    32  cy.
    33    6.  To use, manufacture, deliver, sell, or distribute psilocybin with-
    34  out authorization by psilocybin permit or cultivator license  shall  not
    35  exceed  a  finding of a violation pursuant to section 55.10 of the penal
    36  law.
    37    7. Where a provision of this title conflicts with another provision of
    38  this chapter, this title shall apply.
    39    § 3369-gg. Protections. 1. Psilocybin permit holders, licensed  culti-
    40  vators, and certified support services providers shall not be subject to
    41  arrest,  prosecution,  or  penalty in any manner, or denied any right or
    42  privilege, including but not limited to civil  penalty  or  disciplinary
    43  action  by a business or occupational or professional licensing board or
    44  bureau, solely for the adult use of psilocybin or for any  other  action
    45  or conduct in accordance with this title.
    46    2.  An  applicant or holder of a professional or occupational license,
    47  certification, or registration under  state  law  and  through  a  state
    48  department shall not be subject to disqualification, denial, suspension,
    49  revocation,  professional  discipline, or loss of a professional license
    50  or certification for any activities authorized under this title.
    51    3. No  person  shall  be  disqualified  from  any  authorized  rights,
    52  programs,  or  provision of this title due to a violation of any federal
    53  or state laws relating to controlled substances.
    54    4. A professional or occupational licensee or any person  with  licen-
    55  sure,  certification, or registration under state law or through a state
    56  department shall have the right to provide services within the scope  of

        A. 10375                           10
     1  such  license  or  certification  to support clients or patients who are
     2  seeking to become or are psilocybin permit holders  in  connection  with
     3  conduct  authorized  under  this  title,  including  but  not limited to
     4  discussions  with  such licensee's patients about the potential benefits
     5  and risks of adult use of psilocybin.
     6    5. This subdivision shall not bar the enforcement of a policy  prohib-
     7  iting  an  employee  from  performing  such employee's employment duties
     8  while impaired by a controlled substance.  This  subdivision  shall  not
     9  require  any  person  or  business  enterprise to engage in any act that
    10  would put the person or  business  enterprise  in  direct  violation  of
    11  federal law or cause it to lose a federal contract or funding.
    12    6. An otherwise enforceable contract related to programs or activities
    13  authorized  under  this title shall not be unenforceable on the basis of
    14  state or federal controlled substances laws.
    15    7. Use of psilocybin by ingestion may only be considered to  cause  an
    16  intoxicated  state when substantially impaired, and any related conduct,
    17  including driving, shall be regulated consistent with  applicable  state
    18  laws  including  laws  restricting  driving  under the influence. A drug
    19  screening that contains positive results of the use of psilocybin is not
    20  sufficient evidence to demonstrate intoxication  without  other  conduct
    21  that indicates impairment.
    22    8. (a) The fact that a person is a psilocybin permit holder, a support
    23  services  provider,  a  licensed  cultivator and/or acting in accordance
    24  with this title shall not be a consideration in a proceeding pursuant to
    25  applicable sections of the domestic relations law, the family court act,
    26  or the social services law.
    27    (b) Conduct permitted by this title shall not, by itself:
    28    (i) constitute child abuse or neglect  without  a  finding  of  actual
    29  threat  to  the  health  or  welfare  of  a  child based on all relevant
    30  factors;
    31    (ii) be the basis to restrict parenting  time  with  a  child  without
    32  finding  that  the  parenting time would endanger such child's emotional
    33  development; or
    34    (iii) be the basis to  deny  eligibility  for  any  public  assistance
    35  program, unless required by federal law.
    36    9.  (a)  Information contained in any database created as part of this
    37  title shall be deemed  exempt  from  public  disclosure  under  sections
    38  eighty-seven and eighty-nine of the public officers law.
    39    (b)  The  name, contact information, and other information relating to
    40  support services providers registered with  the  department  under  this
    41  title shall be public information and shall be maintained on the depart-
    42  ment's  website and accessible to the public in searchable form.  Howev-
    43  er, if a support services provider notifies the  department  in  writing
    44  that  such  support services provider does not want such provider's name
    45  and other information disclosed, such support services  provider's  name
    46  and  other  information  shall  thereafter  not be public information or
    47  maintained on the department of education's website, unless the  support
    48  services provider cancels the request.
    49    §  3369-hh.  Regulated  psilocybin  advisory  board.  1. The regulated
    50  psilocybin advisory board or "advisory board" is established within  the
    51  department  to  advise  and  issue  recommendations  on the adult use of
    52  psilocybin and all programs under this title in the state of New York.
    53    2. The advisory board  shall  consist  of  thirteen  voting  appointed
    54  members, along with the following members serving as non-voting ex-offi-
    55  cio  members:  (a) the commissioner, or their designee; and (b) a repre-

        A. 10375                           11
     1  sentative from  the  department  who  is  familiar  with  public  health
     2  programs and public health activities in the state.
     3    3.  The  governor shall have seven appointments, at least one of which
     4  shall be a member of a  federal  or  state  recognized  Native  American
     5  tribe,  the  temporary  president  of  the senate and the speaker of the
     6  assembly shall each have three appointments to the board. Advisory board
     7  members shall have statewide geographic representation that is  balanced
     8  and  diverse  in its composition. Appointed members shall have an exper-
     9  tise in agriculture and mycology, public and behavioral health, psilocy-
    10  bin-assisted therapy research, mental health (including PTSD, depression
    11  and anxiety), substance use disorders, pain management, access  to  care
    12  in  underserved communities, veteran health care, policy or legal exper-
    13  tise related to psilocybin, pharmacology, or  harm  reduction  and  risk
    14  reduction training.
    15    4.  The members shall be appointed to the advisory board to each serve
    16  four-year terms and in the event of a  vacancy,  the  vacancy  shall  be
    17  filled  in  the  manner of the original appointment for the remainder of
    18  the term. The appointed members and  representatives  shall  receive  no
    19  compensation  for  their  services but shall be allowed their actual and
    20  necessary expenses incurred in the performance of their duties as  board
    21  members.
    22    5.  The  chairperson  of  the  advisory board and the vice chairperson
    23  shall be elected from among the members of the  advisory  board  by  the
    24  members of such advisory board. The vice chairperson shall represent the
    25  advisory  board  in the absence of the chairperson at all official advi-
    26  sory board functions.
    27    6. The advisory board shall enact, and from time to  time  may  amend,
    28  bylaws  or  rules in relation to its meetings and the transaction of its
    29  business. The board may  also  establish  committees  and  subcommittees
    30  necessary  for the operation of the board. The advisory board shall work
    31  with established  religious,  cultural  and  community-based  psilocybin
    32  groups  and  cultivators  on recommendations to the department regarding
    33  guidelines for safe and effective services, safety  standards,  industry
    34  best  practices,  code of professional conduct, education, training, and
    35  examination for support services providers,  production,  and  long-term
    36  strategic  plans  for  service. A majority of the total number of voting
    37  members which the board  would  have  were  there  no  vacancies,  shall
    38  constitute a quorum and shall be required for the board to conduct busi-
    39  ness.  All  meetings of the advisory board shall be conducted in accord-
    40  ance with the provisions of article seven of the public officers law.
    41    (a) Within the first two years of the establishment  of  the  advisory
    42  board, the board shall meet at least once every calendar month at a time
    43  and  place  determined  by  the  chairperson or a majority of the voting
    44  members of the board. After the first  two  years,  the  advisory  board
    45  shall  meet  at  least  once  every calendar quarter at a time and place
    46  determined by the chairperson or a majority of the voting members of the
    47  board. The advisory board may also meet at other times and places speci-
    48  fied by the call of the chairperson or  of  a  majority  of  the  voting
    49  members of the board.
    50    (b)  After the first year of the implementation of the programs, there
    51  shall be: (i) a program audit incorporating permit holder optional feed-
    52  back through the reporting program; and (ii)  a  state  and  independent
    53  review of efficacy, efficiency, cost, and equity. The audit will include
    54  consideration  of whether and how to expand psilocybin access, including
    55  additional certifications and licenses relating to use of psilocybin  in

        A. 10375                           12
     1  connection  with  qualifying  health  conditions and psilocybin assisted
     2  therapy.
     3    7. The advisory board shall have the following duties:
     4    (a)  Provide advice to the department regarding the provisions of this
     5  title and make  recommendations  on  available  medical,  psychological,
     6  scientific studies, research and other information relating to the safe-
     7  ty of use of psilocybin.
     8    (b)  Determine  exclusion  criteria to preclude issuance of psilocybin
     9  permits.
    10    (c) Make recommendations to the department on the requirements,  spec-
    11  ifications,  and  guidelines  for providing support services to a permit
    12  holder.
    13    (d) Make recommendations to the department on public health and safety
    14  standards and industry best practices under this title.
    15    (e) Develop a long-term strategic plan for  ensuring  that  psilocybin
    16  services  in  the  state  will  become and remain a safe, accessible and
    17  affordable therapeutic option,  including  in  therapeutic  and  medical
    18  treatments,  for  all  persons  eighteen years of age and older for whom
    19  psilocybin services may be appropriate.
    20    (f) Monitor and study federal laws, regulations and policies regarding
    21  psilocybin.
    22    § 3369-ii. Taxation of psilocybin regulated activities.   1.  Notwith-
    23  standing  any  laws to the contrary, persons or business enterprises who
    24  collect any amounts of monies under this title, including but not limit-
    25  ed  to  for  support  services,  remuneration  for  psilocybin  properly
    26  distributed  by  a  licensed  cultivator, and fees for courses, shall be
    27  taxed as income under state law.
    28    2. Any expenses incurred in any business operated in  accordance  with
    29  this title shall be treated as tax-deductible under state law.
    30    3.  Proceeds  and  fees  under this title shall be used to support the
    31  costs of the department towards administration and other costs  relating
    32  to  programs pursuant to this title, including but not limited to public
    33  education and risks of using psilocybin.
    34    4. The department shall issue regulations to implement and impose  the
    35  tax.
    36    § 2. This act shall take effect immediately.
Go to top