Bill Text: NY A08569 | 2021-2022 | General Assembly | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Relates to medical use of psilocybin.
Spectrum: Partisan Bill (Democrat 13-0)
Status: (Introduced - Dead) 2022-04-29 - print number 8569a [A08569 Detail]
Download: New_York-2021-A08569-Introduced.html
Bill Title: Relates to medical use of psilocybin.
Spectrum: Partisan Bill (Democrat 13-0)
Status: (Introduced - Dead) 2022-04-29 - print number 8569a [A08569 Detail]
Download: New_York-2021-A08569-Introduced.html
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. LBD11894-04-1A. 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 primaryA. 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 provideA. 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 issueA. 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 byA. 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 titleA. 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 maintenanceA. 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 applicableA. 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 penalA. 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.
