STATE OF NEW YORK ________________________________________________________________________ 3775 2025-2026 Regular Sessions IN ASSEMBLY January 30, 2025 ___________ 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. Lawful medical use. 7 3369-cc. Certification of facilitators. 8 3369-dd. Evaluation; research programs; report by department. 9 3369-ee. Relation to other laws. 10 3369-ff. Protections for the medical use of psilocybin. 11 3369-gg. Regulations. 12 3369-hh. Psilocybin assisted therapy grant program. 13 3369-ii. Naturally grown medical psilocybin pilot. 14 3369-jj. Psilocybin assisted therapy advisory board. 15 § 3369-aa. Definitions. For the purposes of this title, the following 16 terms shall have the following meanings: 17 1. "Psilocybin" means a naturally occurring psychedelic prodrug 18 compound produced by fungi, including but not limited to members of the 19 genus Psilocybe. Such term shall include psilocin, the substance into 20 which psilocybin is converted in the human body. 21 2. "Caring for" means treating a patient, in the course of which the 22 practitioner has completed a full assessment of the patient's medical 23 history and current medical condition. EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD01848-01-5
A. 3775 2 1 3. "Certified medical use" includes use of medical psilocybin for a 2 patient to treat or alleviate a patient's medical condition or symptoms 3 associated with the patient's medical condition. 4 4. "License" means a written authorization as provided under this 5 title permitting persons to engage in a specified activity authorized 6 pursuant to this title. 7 5. "Licensee" means an individual or an entity who has been granted a 8 license under this title. 9 6. "Medical psilocybin" means psilocybin intended for a certified 10 medical use, as determined by the department. 11 7. "Facilitator" means a mental health counselor, psychoanalyst, 12 psychologist, physician, physician assistant, registered professional 13 nurse, clinical nurse specialist, nurse practitioner, occupational ther- 14 apist, occupational therapy assistant, licensed clinical social worker, 15 or an individual with evidence of prior experience and knowledge in the 16 field of psychedelic assisted therapy who has completed all requirements 17 under section thirty-three hundred sixty-nine-cc of this title. 18 § 3369-bb. Lawful medical use. The use of medical psilocybin by a 19 patient for certified medical use, shall be lawful under this title 20 provided that: 21 1. The psilocybin used by a patient shall have occurred in a clinical 22 setting, including but not limited to, a facilitator's office or a 23 hospital, under the supervision of a facilitator certified pursuant to 24 section thirty-three hundred sixty-nine-cc of this title. Patients who 25 are unable to travel may receive psilocybin treatment in the home. The 26 course developed to certify facilitators by the department shall include 27 regulations and recommendations for creating appropriate settings for 28 psilocybin treatment; 29 2. Facilitators shall receive psilocybin to use through the naturally 30 grown medical psilocybin pilot, pursuant to section thirty-three hundred 31 sixty-nine-ii of this title. Facilitators who are able to access any 32 forthcoming Federal Food and Drug Administration approved synthetic 33 psilocybin products or MDMA shall be permitted to do so. 34 § 3369-cc. Certification of facilitators. Prior to facilitating a 35 psilocybin session, a facilitator shall complete a course as determined 36 by the department in regulation. 37 § 3369-dd. Evaluation; research programs; report by department. 1. 38 The department may provide for the analysis and evaluation of the opera- 39 tion of this title. The department may enter into agreements with one or 40 more persons, not-for-profit corporations, universities or other organ- 41 izations, for the performance of an evaluation of the implementation and 42 effectiveness of this title. 43 2. The department may develop, seek any necessary federal approval 44 for, and carry out research programs relating to medical use of psilocy- 45 bin. Participation in any such research program shall be voluntary on 46 the part of facilitators, patients, and designated caregivers. 47 3. 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 medical use of psilocybin under this title and make appro- 50 priate recommendations. 51 § 3369-ee. Relation to other laws. 1. The provisions of this title 52 shall apply, except that where a provision of this title conflicts with 53 another provision of this chapter, this title shall apply. 54 2. For the purposes of this title, medical psilocybin shall not be 55 deemed to be a "drug" for purposes of article one hundred thirty-seven 56 of the education law.
A. 3775 3 1 § 3369-ff. Protections for the medical use of psilocybin. 1. Patients 2 and practitioners and facilitators shall not be subject to arrest, pros- 3 ecution, or penalty in any manner, or denied any right or privilege, 4 including but not limited to civil penalty or disciplinary action by a 5 business or occupational or professional licensing board or bureau, 6 solely for the certified medical use of psilocybin or for any other 7 action or conduct in accordance with this title. 8 2. This subdivision shall not bar the enforcement of a policy prohib- 9 iting an employee from performing such employee's employment duties 10 while impaired by a controlled substance. This subdivision shall not 11 require any person or entity to do any act that would put the person or 12 entity in direct violation of federal law or cause it to lose a federal 13 contract or funding. 14 3. The fact that a person is a patient and/or acting in accordance 15 with this title, shall not be a consideration in a proceeding pursuant 16 to applicable sections of the domestic relations law, the social 17 services law and the family court act. 18 4. (a) Certification forms and any patient information contained with- 19 in a database shall be deemed exempt from public disclosure under 20 sections eighty-seven and eighty-nine of the public officers law. Upon 21 specific request by a patient to the department, the department shall 22 verify the requesting patient's status as a valid patient to the 23 patient's school or employer or other designated party, to ensure 24 compliance with the protections afforded by this section. 25 (b) The name, contact information, and other information relating to 26 facilitators registered with the department under this title shall be 27 public information and shall be maintained on the department's website 28 accessible to the public in searchable form. However, if a facilitator 29 notifies the department in writing that such facilitator does not want 30 such facilitator's name and other information disclosed, that 31 facilitator's name and other information shall thereafter not be public 32 information or maintained on the department's website, unless the faci- 33 litator cancels the request. 34 5. A person currently under parole, probation or other state or local 35 supervision, or released on bail awaiting trial may not be punished or 36 otherwise penalized for conduct allowed under this title. 37 § 3369-gg. Regulations. The department shall promulgate regulations to 38 implement this title. 39 § 3369-hh. Psilocybin assisted therapy grant program. 1. The depart- 40 ment shall establish a psilocybin assisted therapy grant program within 41 the amount in the psilocybin and MDMA assisted therapy grant program 42 fund established under section ninety-seven-uuuu of the state finance 43 law. Such grant program shall provide veterans, first responders, 44 retired first responders, and low-income individuals, with the funding 45 necessary to receive psilocybin and/or MDMA assisted therapy. Funding 46 may be initially applied toward an expanded access program approved by 47 the federal food and drug administration pursuant to 21 CFR 312 or other 48 psilocybin and/or MDMA therapies available pursuant to this title. Such 49 grant program shall be terminated upon the approval of psilocybin and/or 50 MDMA for medical use by the federal drug enforcement administration, or 51 any successor agency. 52 2. The department shall promulgate any necessary rules and regulations 53 for the application and distribution of any funds pursuant to this 54 section. 55 § 3369-ii. Naturally grown medical psilocybin pilot. The department of 56 agriculture and markets shall establish and oversee the implementation
A. 3775 4 1 of a pilot program for psilocybin-containing mushrooms to be grown in 2 the state. The department shall promulgate all necessary rules and 3 regulations, regarding medical, therapeutic, or supported use of 4 naturally grown psilocybin mushrooms. The department, in conjunction 5 with the department of environmental conservation, shall establish and 6 implement a process for approval, governing the safe production of 7 psilocybin, including, but not limited to, environmental and energy 8 standards and restrictions on the use of pesticides. The department 9 shall make a good faith effort to work with the federal Department of 10 Justice and Drug Enforcement Agency to receive public health research 11 exemption from the Controlled Substances Act under section 872 (e) or 12 any similar provision. Accredited universities and colleges within the 13 state may apply to the department to participate in pilot cultivation, 14 treatment, and research programs. 15 § 3369-jj. Psilocybin assisted therapy advisory board. 1. The psilocy- 16 bin assisted therapy advisory board or "advisory board" is established 17 within the department to advise and issue recommendations on the use of 18 medical psilocybin in the state of New York. 19 2. (a) The advisory board shall consist of thirteen voting appointed 20 members, along with the following members serving as non-voting ex-offi- 21 cio members: (i) the commissioner, or the commissioner's designee; and 22 (ii) a representative from the department who is familiar with public 23 health programs and public health activities in the state. 24 (b) The governor shall have seven appointments, at least one of which 25 shall be a member of a federally recognized Native American tribe, the 26 temporary president of the senate and the speaker of the assembly shall 27 each have three appointments to the board. Advisory board members shall 28 have statewide geographic representation that is balanced and diverse in 29 its composition. Appointed members shall have an expertise in public and 30 behavioral health, substance use disorder treatment, psilocybin-assisted 31 therapy research, MDMA-assisted therapy research and/or clinical prac- 32 tice, trauma and mental health, access to care in underserved communi- 33 ties, veteran mental health care, and harm reduction. 34 3. The members shall be appointed to the advisory board to each serve 35 four-year terms and in the event of a vacancy, the vacancy shall be 36 filled in the manner of the original appointment for the remainder of 37 the term. The appointed members and representatives shall receive no 38 compensation for their services but shall be allowed their actual and 39 necessary expenses incurred in the performance of their duties as board 40 members. 41 4. The chairperson of the advisory board and the vice chairperson 42 shall be elected from among the members of the advisory board by the 43 members of such advisory board. The vice chairperson shall represent the 44 advisory board in the absence of the chairperson at all official advi- 45 sory board functions. 46 5. The advisory board shall enact and from time to time may amend 47 bylaws or rules in relation to its meetings and the transaction of its 48 business. The board may also establish committees and subcommittees 49 necessary for the operation of the board. The advisory board is 50 expected to work with established religious, cultural and community- 51 based psilocybin groups and cultivators on recommendations to the 52 department regarding guidelines for safe and effective services, safety 53 standards, industry best practices, code of professional conduct, educa- 54 tion, training, and examination for facilitators, production, and long 55 term strategic plans for service. A majority of the total number of 56 voting members which the board would have were there no vacancies, shall
A. 3775 5 1 constitute a quorum and shall be required for the board to conduct busi- 2 ness. All meetings of the advisory board shall be conducted in accord- 3 ance with the provisions of article seven of the public officers law. 4 6. (a) Within the first two years of the establishment of the advisory 5 board, the board shall meet at least once every calendar month at a time 6 and place determined by the chairperson or a majority of the voting 7 members of the board. After the first two years, the advisory board 8 shall meet at least once every calendar quarter at a time and place 9 determined by the chairperson or a majority of the voting members of the 10 board. The advisory board may also meet at other times and places speci- 11 fied by the call of the chairperson or of a majority of the voting 12 members of the board. 13 (b) After the first year of the program's implementation, there shall 14 be: (i) a program audit incorporating patient feedback; and (ii) a 15 state and independent review of efficacy, efficiency, cost, and equity. 16 The audit will include consideration of whether and how to expand psilo- 17 cybin access, provided that the pilot program results are successful. 18 7. The advisory board shall have the following duties: 19 (a) Provide advice to the department regarding the provisions of this 20 title and make recommendations on available medical, psychological, 21 scientific studies, research and other information relating to the safe- 22 ty and efficacy of psilocybin in treating mental health conditions, 23 including but not limited to addiction, depression, anxiety disorders 24 and end-of-life psychological distress. 25 (b) Make recommendations to the department on the requirements, spec- 26 ifications and guidelines for providing psilocybin services to a client. 27 (c) Make recommendations to the department on public health and safety 28 standards and industry best practices under this title. 29 (d) Develop a long-term strategic plan for ensuring that psilocybin 30 services will become and remain a safe, accessible and affordable thera- 31 peutic option for all persons eighteen years of age and older in the 32 state for whom psilocybin services may be appropriate. 33 (e) Monitor and study federal laws, regulations and policies regarding 34 psilocybin. 35 (f) Advise on and helping develop public awareness and education 36 campaigns. 37 § 2. The state finance law is amended by adding a new section 97-uuuu 38 to read as follows: 39 § 97-uuuu. Psilocybin and MDMA assisted therapy grant program fund. 1. 40 There is hereby established in the joint custody of the commissioner of 41 health and the comptroller a fund to be known as the "psilocybin and 42 MDMA assisted therapy grant program fund". 43 2. The fund shall consist of all monies appropriated for its purpose, 44 and all monies required by this section or any other provision of law to 45 be paid into or credited to such fund. The fund shall not contain any 46 monies which are not intended for the fund. 47 3. Monies shall be payable from the fund on the audit and warrant of 48 the state comptroller on vouchers approved and certified by the commis- 49 sioner of health. 50 § 3. The sum of five million dollars ($5,000,000), or so much thereof 51 as may be necessary, is hereby appropriated to the psilocybin and MDMA 52 assisted therapy or P.A.T grant program fund, established under section 53 97-uuuu of the state finance law, out of any moneys in the state treas- 54 ury in the general fund, not otherwise appropriated, and made immediate- 55 ly available, for the purpose of carrying out the provisions of this 56 act. Such moneys shall be payable on the audit and warrant of the comp-
A. 3775 6 1 troller on vouchers certified or approved by the commissioner of health 2 in the manner prescribed by law. 3 § 4. This act shall take effect immediately.