A. 8569 2
1. "PSILOCYBIN" MEANS A NATURALLY OCCURRING PSYCHEDELIC PRODRUG
COMPOUND PRODUCED BY FUNGI, INCLUDING BUT NOT LIMITED TO MEMBERS OF THE
GENUS PSILOCYBE. SUCH TERM SHALL INCLUDE PSILOCIN, THE SUBSTANCE INTO
WHICH PSILOCYBIN IS CONVERTED IN THE HUMAN BODY.
2. "PSILOCYBIN PRODUCT" MEANS PSILOCYBIN, CONCENTRATED PSILOCYBIN, AND
PSILOCYBIN-INFUSED PRODUCTS FOR USE BY A CERTIFIED PATIENT.
3. "PSILOCYBIN-INFUSED PRODUCTS" MEANS PRODUCTS THAT HAVE BEEN MANU-
FACTURED AND CONTAIN EITHER PSILOCYBIN OR CONCENTRATED PSILOCYBIN AND
OTHER INGREDIENTS THAT ARE INTENDED FOR USE OR CONSUMPTION.
4. "CARING FOR" MEANS TREATING A PATIENT, IN THE COURSE OF WHICH THE
PRACTITIONER HAS COMPLETED A FULL ASSESSMENT OF THE PATIENT'S MEDICAL
HISTORY AND CURRENT MEDICAL CONDITION.
5. "CERTIFIED MEDICAL USE" INCLUDES THE ACQUISITION, CULTIVATION,
MANUFACTURE, DELIVERY, HARVEST, POSSESSION, PREPARATION, TRANSFER,
TRANSPORTATION, OR USE OF MEDICAL PSILOCYBIN FOR A CERTIFIED PATIENT, OR
PARAPHERNALIA RELATING TO THE ADMINISTRATION OF PSILOCYBIN TO TREAT OR
ALLEVIATE A CERTIFIED PATIENT'S MEDICAL CONDITION OR SYMPTOMS ASSOCIATED
WITH THE PATIENT'S MEDICAL CONDITION.
6. "CERTIFIED PATIENT" MEANS A PATIENT WHO IS A RESIDENT OF NEW YORK
STATE OR RECEIVING CARE AND TREATMENT IN NEW YORK STATE AS DETERMINED BY
THE BOARD IN REGULATION, AND IS CERTIFIED UNDER THIS CHAPTER.
7. "CONDITION" MEANS HAVING ONE OF THE FOLLOWING CONDITIONS: CANCER,
POSITIVE STATUS FOR HUMAN IMMUNODEFICIENCY VIRUS OR ACQUIRED IMMUNE
DEFICIENCY SYNDROME, AMYOTROPHIC LATERAL SCLEROSIS, PARKINSON'S DISEASE,
MULTIPLE SCLEROSIS, DAMAGE TO THE NERVOUS TISSUE OF THE SPINAL CORD WITH
OBJECTIVE NEUROLOGICAL INDICATION OF INTRACTABLE SPASTICITY, EPILEPSY,
INFLAMMATORY BOWEL DISEASE, NEUROPATHIES, HUNTINGTON'S DISEASE, POST-
TRAUMATIC STRESS DISORDER, PAIN THAT DEGRADES HEALTH AND FUNCTIONAL
CAPABILITY WHERE THE USE OF MEDICAL CANNABIS IS AN ALTERNATIVE TO OPIOID
USE, SUBSTANCE USE DISORDER, ALZHEIMER'S, MUSCULAR DYSTROPHY, DYSTONIA,
RHEUMATOID ARTHRITIS, AUTISM OR ANY OTHER CONDITION CERTIFIED BY THE
PRACTITIONER.
8. "CULTIVATION" MEANS GROWING, CLONING, HARVESTING, DRYING, CURING,
GRADING, AND TRIMMING OF PSILOCYBIN PLANTS FOR SALE TO CERTAIN OTHER
CATEGORIES OF PSILOCYBIN LICENSE- AND PERMIT-HOLDERS.
9. "PSILOCYBIN SERVICE CENTER" MEANS A FACILITY THAT REGISTERS WITH
THE DEPARTMENT TO ASSIST ONE OR MORE CERTIFIED PATIENTS WITH THE
PURCHASE, ACQUISITION, POSSESSION, USE OR ADMINISTRATION OF MEDICAL
PSILOCYBIN.
10. "DESIGNATED CAREGIVER" MEANS AN INDIVIDUAL DESIGNATED BY A CERTI-
FIED PATIENT IN A REGISTRY APPLICATION. A CERTIFIED PATIENT MAY DESIG-
NATE UP TO FIVE DESIGNATED CAREGIVERS NOT COUNTING DESIGNATED CAREGIVER
FACILITIES OR DESIGNATED CAREGIVER FACILITIES' EMPLOYEES.
11. "PSILOCYBIN SERVICES" MEANS SERVICES PROVIDED TO A CERTIFIED
PATIENT BEFORE, DURING AND AFTER THE PATIENT'S CONSUMPTION OF A PSILOCY-
BIN PRODUCT, INCLUDING A PREPARATION SESSION AND INTEGRATION SESSION.
12. "PSILOCYBIN SERVICE CENTER EMPLOYEE" MEANS AN EMPLOYEE OF A PSILO-
CYBIN SERVICE CENTER.
13. "FORM OF MEDICAL PSILOCYBIN" MEANS CHARACTERISTICS OF THE MEDICAL
PSILOCYBIN RECOMMENDED OR LIMITED FOR A PARTICULAR CERTIFIED PATIENT,
INCLUDING THE METHOD OF CONSUMPTION AND ANY PARTICULAR STRAIN, VARIETY,
AND QUANTITY OR PERCENTAGE OF PSILOCYBIN OR PARTICULAR ACTIVE INGREDI-
ENT, OR WHOLE PSILOCYBIN.
14. "LABORATORY TESTING FACILITY" MEANS ANY INDEPENDENT LABORATORY
CAPABLE OF TESTING PSILOCYBIN AND PSILOCYBIN PRODUCTS FOR MEDICAL-USE.
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15. "LICENSE" MEANS A WRITTEN AUTHORIZATION AS PROVIDED UNDER THIS
TITLE PERMITTING PERSONS TO ENGAGE IN A SPECIFIED ACTIVITY AUTHORIZED
PURSUANT TO THIS TITLE.
16. "LICENSEE" MEANS AN INDIVIDUAL OR AN ENTITY WHO HAS BEEN GRANTED A
LICENSE UNDER THIS TITLE.
17. "MEDICAL PSILOCYBIN" MEANS PSILOCYBIN AS DEFINED IN THIS SECTION,
INTENDED FOR A CERTIFIED MEDICAL USE, AS DETERMINED BY THE DEPARTMENT.
18. "PACKAGE" MEANS ANY CONTAINER OR RECEPTACLE USED FOR HOLDING
PSILOCYBIN OR PSILOCYBIN PRODUCTS.
19. "PRACTITIONER" MEANS A PRACTITIONER WHO IS LICENSED, REGISTERED OR
CERTIFIED BY NEW YORK STATE TO PRESCRIBE CONTROLLED SUBSTANCES WITHIN
THE STATE. NOTHING IN THIS TITLE SHALL BE INTERPRETED SO AS TO GIVE ANY
SUCH PERSON AUTHORITY TO ACT OUTSIDE THEIR SCOPE OF PRACTICE AS DEFINED
BY TITLE EIGHT OF THE EDUCATION LAW. ADDITIONALLY, NOTHING IN THIS TITLE
SHALL BE INTERPRETED TO ALLOW ANY UNLICENSED, UNREGISTERED, OR UNCERTI-
FIED PERSON TO ACT IN A MANNER THAT WOULD REQUIRE A LICENSE, REGISTRA-
TION, OR CERTIFICATION PURSUANT TO TITLE EIGHT OF THE EDUCATION LAW.
20. "PROCESSOR" MEANS A LICENSEE THAT EXTRACTS CONCENTRATED PSILOCYBIN
AND/OR COMPOUNDS, BLENDS, EXTRACTS, INFUSES, OR OTHERWISE MANUFACTURES
CONCENTRATED PSILOCYBIN OR PSILOCYBIN PRODUCTS, BUT NOT THE CULTIVATION
OF THE PSILOCYBIN CONTAINED IN THE PSILOCYBIN PRODUCT.
21. "REGISTERED ORGANIZATION" MEANS AN ORGANIZATION REGISTERED UNDER
THIS TITLE.
22. "REGISTRY APPLICATION" MEANS AN APPLICATION PROPERLY COMPLETED AND
FILED WITH THE DEPARTMENT BY A CERTIFIED PATIENT UNDER THIS TITLE.
23. "REGISTRY IDENTIFICATION CARD" MEANS A DOCUMENT THAT IDENTIFIES A
CERTIFIED PATIENT OR DESIGNATED CAREGIVER, AS PROVIDED UNDER THIS TITLE.
24. "PSILOCYBIN SERVICE CENTER OPERATOR" MEANS A PERSON OR ENTITY THAT
OPERATES A PSILOCYBIN SERVICE CENTER.
25. "PSILOCYBIN SERVICE FACILITATOR" MEANS A PERSON OR ENTITY THAT IS
LICENSED IN ACCORDANCE WITH THIS TITLE TO ADMINISTER PSILOCYBIN
SERVICES.
26. "SMALL BUSINESS" MEANS SMALL BUSINESS AS DEFINED IN SECTION ONE
HUNDRED THIRTY-ONE OF THE ECONOMIC DEVELOPMENT LAW AND SHALL APPLY FOR
PURPOSES OF THIS CHAPTER WHERE ANY INCONSISTENCIES EXIST.
27. "TERMINALLY ILL" MEANS AN INDIVIDUAL HAS A MEDICAL PROGNOSIS THAT
THE INDIVIDUAL'S LIFE EXPECTANCY IS APPROXIMATELY ONE YEAR OR LESS IF
THE ILLNESS RUNS ITS NORMAL COURSE.
28. "WAREHOUSE" MEANS AND INCLUDES A PLACE IN WHICH PSILOCYBIN
PRODUCTS ARE SECURELY HOUSED OR STORED.
29. "WHOLESALE" MEANS TO SOLICIT OR RECEIVE AN ORDER FOR, TO KEEP OR
EXPOSE FOR SALE, AND TO KEEP WITH INTENT TO SELL, MADE BY ANY LICENSED
PERSON, WHETHER PRINCIPAL, PROPRIETOR, AGENT, OR EMPLOYEE OF ANY MEDI-
CAL-USE PSILOCYBIN OR PSILOCYBIN PRODUCT, FOR PURPOSES OF RESALE.
30. "ADMINISTRATION SESSION" MEANS A SESSION HELD AT A PSILOCYBIN
SERVICE CENTER AT WHICH A CERTIFIED PATIENT PURCHASES, CONSUMES AND
EXPERIENCES THE EFFECTS OF A PSILOCYBIN PRODUCT UNDER THE SUPERVISION OF
A PSILOCYBIN SERVICE FACILITATOR.
31. "INTEGRATION SESSION" MEANS A MEETING BETWEEN A CERTIFIED PATIENT
AND A PSILOCYBIN SERVICE FACILITATOR THAT MAY OCCUR AFTER THE PATIENT
COMPLETES AN ADMINISTRATION SESSION.
32. "PREPARATION SESSION" MEANS A MEETING BETWEEN A CERTIFIED PATIENT
AND A PSILOCYBIN SERVICE FACILITATOR THAT MUST OCCUR BEFORE SUCH PATIENT
PARTICIPATES IN AN ADMINISTRATION SESSION.
33. "PREMISES" MEANS ALL PUBLIC AND PRIVATE ENCLOSED AREAS, AS WELL AS
AREAS OUTSIDE OF A BUILDING AT A LOCATION, OTHER THAN A PERSON'S PRIMARY
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RESIDENCE, THAT ARE USED FOR ACTIVITIES PERMITTED UNDER THIS TITLE,
INCLUDING MANUFACTURING PSILOCYBIN PRODUCTS, OPERATING A PSILOCYBIN
SERVICE CENTER OR PROVIDING PSILOCYBIN SERVICES TO CERTIFIED PATIENTS.
SUCH DEFINITION SHALL INCLUDE OFFICES, KITCHENS, REST ROOMS AND STORE-
ROOMS.
§ 3369-BB. CERTIFICATION OF PATIENTS. 1. A PATIENT CERTIFICATION MAY
ONLY BE ISSUED IF:
(A) THE PATIENT HAS A CONDITION, WHICH SHALL BE SPECIFIED IN THE
PATIENT'S HEALTH CARE RECORD;
(B) THE PRACTITIONER BY TRAINING OR EXPERIENCE IS QUALIFIED TO TREAT
THE CONDITION;
(C) THE PATIENT IS UNDER THE PRACTITIONER'S CONTINUING CARE FOR THE
CONDITION; AND
(D) IN THE PRACTITIONER'S PROFESSIONAL OPINION AND REVIEW OF PAST
TREATMENTS, THE PATIENT IS LIKELY TO RECEIVE THERAPEUTIC OR PALLIATIVE
BENEFIT FROM THE PRIMARY OR ADJUNCTIVE TREATMENT WITH MEDICAL USE OF
PSILOCYBIN FOR THE CONDITION.
2. THE CERTIFICATION SHALL INCLUDE: (A) THE NAME, DATE OF BIRTH AND
ADDRESS OF THE PATIENT; (B) A STATEMENT THAT THE PATIENT HAS A CONDITION
AND THE PATIENT IS UNDER THE PRACTITIONER'S CARE FOR THE CONDITION; (C)
A STATEMENT ATTESTING THAT ALL REQUIREMENTS OF SUBDIVISION ONE OF THIS
SECTION HAVE BEEN SATISFIED; (D) THE DATE; AND (E) THE NAME, ADDRESS,
TELEPHONE NUMBER, AND THE SIGNATURE OF THE CERTIFYING PRACTITIONER. THE
DEPARTMENT MAY REQUIRE BY REGULATION THAT THE CERTIFICATION SHALL BE ON
A FORM PROVIDED BY THE DEPARTMENT. THE PRACTITIONER MAY STATE IN THE
CERTIFICATION THAT, IN THE PRACTITIONER'S PROFESSIONAL OPINION, THE
PATIENT WOULD BENEFIT FROM MEDICAL PSILOCYBIN ONLY UNTIL A SPECIFIED
DATE. THE PRACTITIONER MAY STATE IN THE CERTIFICATION THAT, IN THE PRAC-
TITIONER'S PROFESSIONAL OPINION, THE PATIENT IS TERMINALLY ILL AND THAT
THE CERTIFICATION SHALL NOT EXPIRE UNTIL THE PATIENT DIES.
3. IN MAKING A CERTIFICATION, THE PRACTITIONER MAY CONSIDER THE FORM
OF MEDICAL PSILOCYBIN THE PATIENT SHOULD CONSUME, INCLUDING THE METHOD
OF CONSUMPTION AND ANY PARTICULAR STRAIN, VARIETY, AND QUANTITY OR
PERCENTAGE OF PSILOCYBIN OR PARTICULAR ACTIVE INGREDIENT, AND APPROPRI-
ATE DOSAGE. THE PRACTITIONER MAY STATE IN THE CERTIFICATION ANY RECOM-
MENDATION OR LIMITATION THE PRACTITIONER MAKES, IN HIS OR HER PROFES-
SIONAL OPINION, CONCERNING THE APPROPRIATE FORM OR FORMS OF MEDICAL
PSILOCYBIN AND DOSAGE.
4. EVERY PRACTITIONER SHALL CONSULT THE PRESCRIPTION MONITORING
PROGRAM REGISTRY PRIOR TO MAKING OR ISSUING A CERTIFICATION, FOR THE
PURPOSE OF REVIEWING A PATIENT'S CONTROLLED SUBSTANCE HISTORY. FOR
PURPOSES OF THIS SECTION, A PRACTITIONER MAY AUTHORIZE A DESIGNEE TO
CONSULT THE PRESCRIPTION MONITORING PROGRAM REGISTRY ON HIS OR HER
BEHALF, PROVIDED THAT SUCH DESIGNATION IS IN ACCORDANCE WITH SECTION
THIRTY-THREE HUNDRED FORTY-THREE-A OF THIS ARTICLE.
5. THE PRACTITIONER SHALL GIVE THE CERTIFICATION TO THE CERTIFIED
PATIENT AND PLACE A COPY IN THE PATIENT'S HEALTH CARE RECORD.
6. NO PRACTITIONER SHALL ISSUE A CERTIFICATION UNDER THIS SECTION FOR
THEMSELVES.
7. A REGISTRY IDENTIFICATION CARD BASED ON A CERTIFICATION SHALL
EXPIRE ONE YEAR AFTER THE DATE THE CERTIFICATION IS SIGNED BY THE PRAC-
TITIONER, EXCEPT AS PROVIDED FOR IN SUBDIVISION EIGHT OF THIS SECTION.
8. (A) IF THE PRACTITIONER STATES IN THE CERTIFICATION THAT, IN THE
PRACTITIONER'S PROFESSIONAL OPINION, THE PATIENT WOULD BENEFIT FROM
MEDICAL PSILOCYBIN ONLY UNTIL A SPECIFIED EARLIER DATE, THEN THE REGIS-
TRY IDENTIFICATION CARD SHALL EXPIRE ON THAT DATE; (B) IF THE PRACTI-
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TIONER STATES IN THE CERTIFICATION THAT IN THE PRACTITIONER'S PROFES-
SIONAL OPINION THE PATIENT IS TERMINALLY ILL AND THAT THE CERTIFICATION
SHALL NOT EXPIRE UNTIL THE PATIENT DIES, THEN THE REGISTRY IDENTIFICA-
TION CARD SHALL STATE THAT THE PATIENT IS TERMINALLY ILL AND THAT THE
REGISTRATION CARD SHALL NOT EXPIRE UNTIL THE PATIENT DIES; (C) IF THE
PRACTITIONER RE-ISSUES THE CERTIFICATION TO TERMINATE THE CERTIFICATION
ON AN EARLIER DATE, THEN THE REGISTRY IDENTIFICATION CARD SHALL EXPIRE
ON THAT DATE AND SHALL BE PROMPTLY DESTROYED BY THE CERTIFIED PATIENT;
(D) IF THE CERTIFICATION SO PROVIDES, THE REGISTRY IDENTIFICATION CARD
SHALL STATE ANY RECOMMENDATION OR LIMITATION BY THE PRACTITIONER AS TO
THE FORM OR FORMS OF MEDICAL PSILOCYBIN OR DOSAGE FOR THE CERTIFIED
PATIENT; AND (E) THE DEPARTMENT SHALL MAKE REGULATIONS TO IMPLEMENT THIS
SUBDIVISION.
9. (A) A CERTIFICATION MAY BE A SPECIAL CERTIFICATION IF, IN ADDITION
TO THE OTHER REQUIREMENTS FOR A CERTIFICATION, THE PRACTITIONER CERTI-
FIES IN THE CERTIFICATION THAT THE PATIENT'S CONDITION IS PROGRESSIVE
AND DEGENERATIVE OR THAT DELAY IN THE PATIENT'S CERTIFIED MEDICAL USE OF
PSILOCYBIN POSES A RISK TO THE PATIENT'S LIFE OR HEALTH.
(B) THE DEPARTMENT SHALL CREATE THE FORM TO BE USED FOR A SPECIAL
CERTIFICATION AND SHALL MAKE THAT FORM AVAILABLE TO BE DOWNLOADED FROM
THE DEPARTMENT'S WEBSITE.
10. PRIOR TO ISSUING A CERTIFICATION A PRACTITIONER MUST COMPLETE, AT
A MINIMUM, A TWO-HOUR COURSE AS DETERMINED BY THE DEPARTMENT IN REGU-
LATION. FOR THE PURPOSES OF THIS TITLE A PERSON'S STATUS AS A PRACTI-
TIONER IS DEEMED TO BE A "LICENSE" FOR THE PURPOSES OF SECTION THIRTY-
THREE HUNDRED NINETY OF THIS ARTICLE AND SHALL BE SUBJECT TO THE SAME
REVOCATION PROCESS.
§ 3369-CC. LAWFUL MEDICAL USE. THE PURCHASE, POSSESSION, ACQUISITION,
USE, DELIVERY, TRANSFER, TRANSPORTATION, OR ADMINISTRATION OF MEDICAL
PSILOCYBIN BY A CERTIFIED PATIENT, DESIGNATED CAREGIVER, REGISTERED
ORGANIZATION OR THE EMPLOYEES OF A PSILOCYBIN SERVICE CENTER, FOR CERTI-
FIED MEDICAL USE, SHALL BE LAWFUL UNDER THIS TITLE PROVIDED THAT:
1. THE PSILOCYBIN PURCHASED, POSSESSED, ACQUIRED OR USED BY A CERTI-
FIED PATIENT SHALL HAVE OCCURRED AT A PSILOCYBIN SERVICE CENTER UNDER
THE SUPERVISION OF A PSILOCYBIN SERVICE FACILITATOR;
2. THE PSILOCYBIN THAT MAY BE POSSESSED BY A CERTIFIED PATIENT SHALL
NOT EXCEED THE DOSAGE DETERMINED BY THE PRACTITIONER, CONSISTENT WITH
ANY GUIDANCE AND REGULATIONS ISSUED BY THE DEPARTMENT;
3. THE FORM OR FORMS OF MEDICAL PSILOCYBIN THAT MAY BE PURCHASED,
POSSESSED, ACQUIRED OR USED BY THE CERTIFIED PATIENT PURSUANT TO A
CERTIFICATION SHALL BE IN COMPLIANCE WITH ANY RECOMMENDATION OR LIMITA-
TION BY THE PRACTITIONER AS TO THE FORM OR FORMS OF MEDICAL PSILOCYBIN
OR DOSAGE FOR THE CERTIFIED PATIENT IN THE CERTIFICATION; AND
4. THE MEDICAL PSILOCYBIN SHALL BE KEPT IN THE ORIGINAL PACKAGE IN
WHICH IT WAS DISPENSED UNDER THIS TITLE, EXCEPT FOR THE PORTION REMOVED
FOR IMMEDIATE CONSUMPTION FOR CERTIFIED MEDICAL USE BY THE CERTIFIED
PATIENT.
§ 3369-DD. REGISTRY IDENTIFICATION CARDS. 1. UPON APPROVAL OF THE
CERTIFICATION, THE DEPARTMENT SHALL ISSUE REGISTRY IDENTIFICATION CARDS
FOR CERTIFIED PATIENTS AND DESIGNATED CAREGIVERS. A REGISTRY IDENTIFICA-
TION CARD SHALL EXPIRE AS PROVIDED IN THIS TITLE OR AS OTHERWISE
PROVIDED IN THIS SECTION. THE DEPARTMENT SHALL BEGIN ISSUING REGISTRY
IDENTIFICATION CARDS AS SOON AS PRACTICABLE AFTER THE CERTIFICATIONS
REQUIRED BY THIS TITLE ARE GRANTED. THE DEPARTMENT MAY SPECIFY A FORM
FOR A REGISTRY APPLICATION, IN WHICH CASE THE DEPARTMENT SHALL PROVIDE
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THE FORM ON REQUEST, REPRODUCTIONS OF THE FORM MAY BE USED, AND THE FORM
SHALL BE AVAILABLE FOR DOWNLOADING FROM THE DEPARTMENT'S WEBSITE.
2. TO OBTAIN, AMEND OR RENEW A REGISTRY IDENTIFICATION CARD, A CERTI-
FIED PATIENT OR DESIGNATED CAREGIVER SHALL FILE A REGISTRY APPLICATION
WITH THE DEPARTMENT, UNLESS OTHERWISE EXEMPTED BY THE DEPARTMENT IN
REGULATION. THE REGISTRY APPLICATION OR RENEWAL APPLICATION SHALL
INCLUDE:
(A) IN THE CASE OF A CERTIFIED PATIENT:
(I) THE PATIENT'S CERTIFICATION, A NEW WRITTEN CERTIFICATION SHALL BE
PROVIDED WITH A RENEWAL APPLICATION IF REQUIRED BY THE DEPARTMENT;
(II) THE NAME, ADDRESS, AND DATE OF BIRTH OF THE PATIENT;
(III) THE DATE OF THE CERTIFICATION;
(IV) IF THE PATIENT HAS A REGISTRY IDENTIFICATION CARD BASED ON A
CURRENT VALID CERTIFICATION, THE REGISTRY IDENTIFICATION NUMBER AND
EXPIRATION DATE OF THAT REGISTRY IDENTIFICATION CARD;
(V) THE SPECIFIED DATE UNTIL WHICH THE PATIENT WOULD BENEFIT FROM
MEDICAL PSILOCYBIN, IF THE CERTIFICATION STATES SUCH A DATE;
(VI) THE NAME, ADDRESS, AND TELEPHONE NUMBER OF THE CERTIFYING PRACTI-
TIONER;
(VII) ANY RECOMMENDATION OR LIMITATION BY THE PRACTITIONER AS TO THE
FORM OR FORMS OF MEDICAL PSILOCYBIN OR DOSAGE FOR THE CERTIFIED PATIENT;
(VIII) IF THE CERTIFIED PATIENT DESIGNATES A DESIGNATED CAREGIVER, THE
NAME, ADDRESS, AND DATE OF BIRTH OF THE DESIGNATED CAREGIVER, AND OTHER
INDIVIDUAL IDENTIFYING INFORMATION REQUIRED BY THE DEPARTMENT; AND
(IX) OTHER INDIVIDUAL IDENTIFYING INFORMATION REQUIRED BY THE DEPART-
MENT;
(B) IN THE CASE OF A DESIGNATED CAREGIVER:
(I) THE NAME, ADDRESS, AND DATE OF BIRTH OF THE DESIGNATED CAREGIVER;
(II) IF THE DESIGNATED CAREGIVER HAS A REGISTRY IDENTIFICATION CARD,
THE REGISTRY IDENTIFICATION NUMBER AND EXPIRATION DATE OF THAT REGISTRY
IDENTIFICATION CARD; AND
(III) OTHER INDIVIDUAL IDENTIFYING INFORMATION REQUIRED BY THE DEPART-
MENT;
(C) A STATEMENT THAT A FALSE STATEMENT MADE IN THE APPLICATION IS
PUNISHABLE UNDER SECTION 210.45 OF THE PENAL LAW;
(D) THE DATE OF THE APPLICATION AND THE SIGNATURE OF THE CERTIFIED
PATIENT OR DESIGNATED CAREGIVER, AS THE CASE MAY BE; AND
(E) ANY OTHER REQUIREMENTS DETERMINED BY THE DEPARTMENT.
3. WHERE A CERTIFIED PATIENT IS UNDER THE AGE OF EIGHTEEN OR OTHERWISE
INCAPABLE OF CONSENT, THE APPLICATION FOR A REGISTRY IDENTIFICATION CARD
SHALL BE MADE BY THE PERSON RESPONSIBLE FOR MAKING HEALTH CARE DECISIONS
FOR THE PATIENT. SUCH DESIGNATED CAREGIVER SHALL BE: (A) A PARENT OR
LEGAL GUARDIAN OF THE CERTIFIED PATIENT; (B) A PERSON DESIGNATED BY A
PARENT OR LEGAL GUARDIAN; OR (C) AN APPROPRIATE PERSON APPROVED BY THE
DEPARTMENT UPON A SUFFICIENT SHOWING THAT NO PARENT OR LEGAL GUARDIAN IS
APPROPRIATE OR AVAILABLE.
4. NO PERSON MAY BE A DESIGNATED CAREGIVER IF THE PERSON IS UNDER
TWENTY-ONE YEARS OF AGE UNLESS A SUFFICIENT SHOWING IS MADE TO THE
DEPARTMENT THAT THE PERSON SHOULD BE PERMITTED TO SERVE AS A DESIGNATED
CAREGIVER. THE REQUIREMENTS FOR SUCH A SHOWING SHALL BE DETERMINED BY
THE DEPARTMENT.
5. NO PERSON MAY BE A DESIGNATED CAREGIVER FOR MORE THAN FOUR CERTI-
FIED PATIENTS AT ONE TIME.
6. IF A CERTIFIED PATIENT WISHES TO CHANGE OR TERMINATE HIS OR HER
DESIGNATED CAREGIVER, FOR WHATEVER REASON, THE CERTIFIED PATIENT SHALL
NOTIFY THE DEPARTMENT AS SOON AS PRACTICABLE. THE DEPARTMENT SHALL ISSUE
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A NOTIFICATION TO THE DESIGNATED CAREGIVER THAT THEIR REGISTRATION CARD
IS INVALID AND MUST BE PROMPTLY DESTROYED. THE NEWLY DESIGNATED CAREGIV-
ER MUST COMPLY WITH ALL REQUIREMENTS SET FORTH IN THIS SECTION.
7. IF THE CERTIFICATION SO PROVIDES, THE REGISTRY IDENTIFICATION CARD
SHALL CONTAIN ANY RECOMMENDATION OR LIMITATION BY THE PRACTITIONER AS TO
THE FORM OR FORMS OF MEDICAL PSILOCYBIN OR DOSAGE FOR THE CERTIFIED
PATIENT.
8. THE DEPARTMENT SHALL ISSUE SEPARATE REGISTRY IDENTIFICATION CARDS
FOR CERTIFIED PATIENTS AND DESIGNATED CAREGIVERS AS SOON AS REASONABLY
PRACTICABLE AFTER RECEIVING A COMPLETE APPLICATION UNDER THIS SECTION,
UNLESS IT DETERMINES THAT THE APPLICATION IS INCOMPLETE OR FACTUALLY
INACCURATE, IN WHICH CASE IT SHALL PROMPTLY NOTIFY THE APPLICANT.
9. IF THE APPLICATION OF A CERTIFIED PATIENT DESIGNATES AN INDIVIDUAL
AS A DESIGNATED CAREGIVER WHO IS NOT AUTHORIZED TO BE A DESIGNATED CARE-
GIVER, THAT PORTION OF THE APPLICATION SHALL BE DENIED BY THE DEPARTMENT
BUT THAT SHALL NOT AFFECT THE APPROVAL OF THE BALANCE OF THE APPLICA-
TION.
10. A REGISTRY IDENTIFICATION CARD SHALL:
(A) CONTAIN THE NAME OF THE CERTIFIED PATIENT OR THE DESIGNATED CARE-
GIVER AS THE CASE MAY BE;
(B) CONTAIN THE DATE OF ISSUANCE AND EXPIRATION DATE OF THE REGISTRY
IDENTIFICATION CARD;
(C) CONTAIN A REGISTRY IDENTIFICATION NUMBER FOR THE CERTIFIED PATIENT
OR DESIGNATED CAREGIVER, AS THE CASE MAY BE AND A REGISTRY IDENTIFICA-
TION NUMBER;
(D) CONTAIN A PHOTOGRAPH OF THE INDIVIDUAL TO WHOM THE REGISTRY IDEN-
TIFICATION CARD IS BEING ISSUED, WHICH SHALL BE OBTAINED BY THE DEPART-
MENT IN A MANNER SPECIFIED BY THE DEPARTMENT IN REGULATIONS; PROVIDED,
HOWEVER, THAT IF THE DEPARTMENT REQUIRES CERTIFIED PATIENTS TO SUBMIT
PHOTOGRAPHS FOR THIS PURPOSE, THERE SHALL BE A REASONABLE ACCOMMODATION
OF CERTIFIED PATIENTS WHO ARE CONFINED TO THEIR HOMES DUE TO THEIR
MEDICAL CONDITIONS AND MAY THEREFORE HAVE DIFFICULTY PROCURING PHOTO-
GRAPHS;
(E) BE A SECURE DOCUMENT AS DETERMINED BY THE DEPARTMENT;
(F) PLAINLY STATE ANY RECOMMENDATION OR LIMITATION BY THE PRACTITIONER
AS TO THE FORM OR FORMS OF MEDICAL PSILOCYBIN OR DOSAGE FOR THE CERTI-
FIED PATIENT; AND
(G) ANY OTHER REQUIREMENTS DETERMINED BY THE DEPARTMENT.
11. A CERTIFIED PATIENT OR DESIGNATED CAREGIVER WHO HAS BEEN ISSUED A
REGISTRY IDENTIFICATION CARD SHALL NOTIFY THE DEPARTMENT OF ANY CHANGE
IN HIS OR HER NAME OR ADDRESS OR, WITH RESPECT TO THE PATIENT, IF HE OR
SHE CEASES TO HAVE THE CONDITION NOTED ON THE CERTIFICATION WITHIN TEN
DAYS OF SUCH CHANGE. THE CERTIFIED PATIENT'S OR DESIGNATED CAREGIVER'S
REGISTRY IDENTIFICATION CARD SHALL BE DEEMED INVALID AND SHALL BE
PROMPTLY DESTROYED.
12. IF A CERTIFIED PATIENT OR DESIGNATED CAREGIVER LOSES HIS OR HER
REGISTRY IDENTIFICATION CARD, HE OR SHE SHALL NOTIFY THE DEPARTMENT
WITHIN TEN DAYS OF LOSING THE CARD. THE DEPARTMENT SHALL ISSUE A NEW
REGISTRY IDENTIFICATION CARD AS SOON AS PRACTICABLE, WHICH MAY CONTAIN A
NEW REGISTRY IDENTIFICATION NUMBER, TO THE CERTIFIED PATIENT OR DESIG-
NATED CAREGIVER, AS THE CASE MAY BE.
13. THE DEPARTMENT SHALL MAINTAIN A CONFIDENTIAL LIST OF THE PERSONS
TO WHOM IT HAS ISSUED REGISTRY IDENTIFICATION CARDS. INDIVIDUAL IDENTI-
FYING INFORMATION OBTAINED BY THE DEPARTMENT UNDER THIS TITLE SHALL BE
CONFIDENTIAL AND EXEMPT FROM DISCLOSURE UNDER ARTICLE SIX OF THE PUBLIC
OFFICERS LAW.
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14. THE DEPARTMENT SHALL VERIFY TO LAW ENFORCEMENT PERSONNEL IN AN
APPROPRIATE CASE WHETHER A REGISTRY IDENTIFICATION CARD IS VALID AND ANY
OTHER RELEVANT INFORMATION NECESSARY TO PROTECT PATIENTS' RIGHTS TO
MEDICAL PSILOCYBIN BY CONFIRMING COMPLIANCE WITH THIS TITLE.
15. IF A CERTIFIED PATIENT OR DESIGNATED CAREGIVER WILLFULLY VIOLATES
ANY PROVISION OF THIS TITLE AS DETERMINED BY THE DEPARTMENT, HIS OR HER
CERTIFICATION AND REGISTRY IDENTIFICATION CARD MAY BE SUSPENDED OR
REVOKED. THIS IS IN ADDITION TO ANY OTHER PENALTY THAT MAY APPLY.
16. THE DEPARTMENT SHALL MAKE REGULATIONS FOR SPECIAL CERTIFICATIONS,
WHICH SHALL INCLUDE EXPEDITED PROCEDURES AND WHICH MAY REQUIRE THE
APPLICANT TO SUBMIT ADDITIONAL DOCUMENTATION ESTABLISHING THE CLINICAL
BASIS FOR THE SPECIAL CERTIFICATION. IF THE DEPARTMENT HAS NOT ESTAB-
LISHED AND MADE AVAILABLE A FORM FOR A REGISTRY APPLICATION OR RENEWAL
APPLICATION, THEN IN THE CASE OF A SPECIAL CERTIFICATION, A REGISTRY
APPLICATION OR RENEWAL APPLICATION THAT OTHERWISE CONFORMS WITH THE
REQUIREMENTS OF THIS SECTION SHALL NOT REQUIRE THE USE OF A FORM.
§ 3369-EE. REGISTRATION AS A PSILOCYBIN SERVICE CENTER. 1. TO OBTAIN,
AMEND OR RENEW A REGISTRATION AS A PSILOCYBIN SERVICE CENTER, THE FACIL-
ITY SHALL FILE A REGISTRY APPLICATION WITH THE DEPARTMENT. THE REGISTRY
APPLICATION OR RENEWAL APPLICATION SHALL INCLUDE:
(A) THE FACILITY'S FULL NAME AND ADDRESS;
(B) OPERATING CERTIFICATE OR LICENSE NUMBER WHERE APPROPRIATE;
(C) NAME, TITLE, AND SIGNATURE OF AN AUTHORIZED FACILITY REPRESEN-
TATIVE;
(D) A STATEMENT THAT THE FACILITY AGREES TO SECURE AND ENSURE PROPER
HANDLING OF ALL MEDICAL PSILOCYBIN PRODUCTS;
(E) AN ACKNOWLEDGEMENT THAT A FALSE STATEMENT IN THE APPLICATION IS
PUNISHABLE UNDER SECTION 210.45 OF THE PENAL LAW; AND
(F) ANY OTHER INFORMATION THAT MAY BE REQUIRED BY THE DEPARTMENT.
2. PRIOR TO ISSUING OR RENEWING A PSILOCYBIN SERVICE CENTER REGISTRA-
TION, THE DEPARTMENT MAY VERIFY THE INFORMATION SUBMITTED BY THE APPLI-
CANT. THE APPLICANT SHALL PROVIDE, AT THE DEPARTMENT'S REQUEST, SUCH
INFORMATION AND DOCUMENTATION, INCLUDING ANY CONSENTS OR AUTHORIZATIONS
THAT MAY BE NECESSARY FOR THE DEPARTMENT TO VERIFY THE INFORMATION.
3. THE DEPARTMENT SHALL APPROVE, DENY OR DETERMINE INCOMPLETE OR INAC-
CURATE AN INITIAL OR RENEWAL APPLICATION WITHIN THIRTY DAYS OF RECEIPT
OF THE APPLICATION. IF THE APPLICATION IS APPROVED WITHIN THE THIRTY-DAY
PERIOD, THE DEPARTMENT SHALL ISSUE A REGISTRATION AS SOON AS IS REASON-
ABLY PRACTICABLE.
4. AN APPLICANT SHALL HAVE THIRTY DAYS FROM THE DATE OF A NOTIFICATION
OF AN INCOMPLETE OR FACTUALLY INACCURATE APPLICATION TO SUBMIT THE MATE-
RIALS REQUIRED TO COMPLETE, REVISE OR SUBSTANTIATE INFORMATION IN THE
APPLICATION. IF THE APPLICANT FAILS TO SUBMIT THE REQUIRED MATERIALS
WITHIN SUCH THIRTY-DAY TIME PERIOD, THE APPLICATION SHALL BE DENIED BY
THE DEPARTMENT.
5. THE APPLICANT SHALL BE UNDER A CONTINUING DUTY TO REPORT TO THE
DEPARTMENT ANY CHANGE IN FACTS OR CIRCUMSTANCES REFLECTED IN THE APPLI-
CATION OR ANY NEWLY DISCOVERED OR OCCURRING FACT OR CIRCUMSTANCE WHICH
IS REQUIRED TO BE INCLUDED IN THE APPLICATION.
6. (A) THE DEPARTMENT SHALL GRANT A REGISTRATION OR AMENDMENT TO A
REGISTRATION UNDER THIS SECTION IF IT IS SATISFIED THAT:
(I) THE APPLICANT WILL BE ABLE TO MAINTAIN EFFECTIVE CONTROL AGAINST
DIVERSION OF PSILOCYBIN;
(II) THE APPLICANT WILL BE ABLE TO COMPLY WITH ALL APPLICABLE STATE
LAWS;
A. 8569 9
(III) THE APPLICANT AND ITS OFFICERS ARE READY, WILLING AND ABLE TO
PROPERLY CARRY ON THE ACTIVITIES FOR WHICH A REGISTRATION IS SOUGHT;
(IV) THE APPLICANT POSSESSES OR HAS THE RIGHT TO USE SUFFICIENT LAND,
BUILDINGS AND EQUIPMENT TO PROPERLY CARRY ON THE ACTIVITY DESCRIBED IN
THE APPLICATION;
(V) IT IS IN THE PUBLIC INTEREST THAT SUCH REGISTRATION BE GRANTED,
INCLUDING BUT NOT LIMITED TO:
(A) WHETHER THE NUMBER OF PSILOCYBIN SERVICE CENTERS IN AN AREA WILL
BE ADEQUATE OR EXCESSIVE TO REASONABLY SERVE THE AREA;
(B) WHETHER THE PSILOCYBIN SERVICE CENTER IS A MINORITY- AND/OR
WOMEN-OWNED BUSINESS ENTERPRISE, A SERVICE-DISABLED VETERAN-OWNED BUSI-
NESS, OR FROM COMMUNITIES DISPROPORTIONALLY IMPACTED BY THE ENFORCEMENT
OF PSILOCYBIN PROHIBITION;
(C) WHETHER THE PSILOCYBIN SERVICE CENTER PROVIDES EDUCATION AND
OUTREACH TO PRACTITIONERS;
(D) WHETHER THE PSILOCYBIN SERVICE CENTER PROMOTES THE RESEARCH AND
DEVELOPMENT OF MEDICAL PSILOCYBIN AND PATIENT OUTREACH;
(E) THE AFFORDABILITY OF MEDICAL PSILOCYBIN PRODUCTS OFFERED BY THE
PSILOCYBIN SERVICE CENTER;
(F) WHETHER THE PSILOCYBIN SERVICE CENTER IS CULTURALLY, LINGUIS-
TICALLY, AND MEDICALLY COMPETENT TO PROVIDE SERVICES TO UNSERVED AND
UNDERSERVED AREAS; AND
(G) WHETHER THE PSILOCYBIN SERVICE CENTER PROMOTES RACIAL, ETHNIC, AND
GENDER DIVERSITY IN ITS WORKFORCE;
(VI) THE APPLICANT AND ITS MANAGING OFFICERS ARE OF GOOD MORAL CHARAC-
TER;
(VII) THE APPLICANT HAS ENTERED INTO A LABOR PEACE AGREEMENT WITH A
BONA FIDE LABOR ORGANIZATION THAT IS ACTIVELY ENGAGED IN REPRESENTING OR
ATTEMPTING TO REPRESENT THE APPLICANT'S EMPLOYEES; AND THE MAINTENANCE
OF SUCH A LABOR PEACE AGREEMENT SHALL BE AN ONGOING MATERIAL CONDITION
OF REGISTRATION; AND
(VIII) THE APPLICANT SATISFIES ANY OTHER CONDITIONS AS DETERMINED BY
THE DEPARTMENT.
(B) IF THE DEPARTMENT IS NOT SATISFIED THAT THE APPLICANT SHOULD BE
ISSUED A REGISTRATION, THE DEPARTMENT SHALL NOTIFY THE APPLICANT IN
WRITING OF THOSE FACTORS UPON WHICH FURTHER EVIDENCE IS REQUIRED. WITHIN
THIRTY DAYS OF THE RECEIPT OF SUCH NOTIFICATION, THE APPLICANT MAY
SUBMIT ADDITIONAL MATERIAL TO THE DEPARTMENT OR DEMAND A HEARING, OR
BOTH.
(C) THE FEE FOR A REGISTRATION UNDER THIS SECTION SHALL BE AN AMOUNT
DETERMINED BY THE DEPARTMENT IN REGULATIONS; PROVIDED, HOWEVER, IF THE
REGISTRATION IS ISSUED FOR A PERIOD GREATER THAN TWO YEARS THE FEE SHALL
BE INCREASED, PRO RATA, FOR EACH ADDITIONAL MONTH OF VALIDITY.
(D) REGISTRATIONS ISSUED UNDER THIS SECTION SHALL BE EFFECTIVE ONLY
FOR THE PSILOCYBIN SERVICE CENTER AND SHALL SPECIFY:
(I) THE NAME AND ADDRESS OF THE PSILOCYBIN SERVICE CENTER;
(II) WHICH ACTIVITIES OF A PSILOCYBIN SERVICE CENTER ARE PERMITTED BY
THE REGISTRATION;
(III) THE LAND, BUILDINGS AND FACILITIES THAT MAY BE USED FOR THE
PERMITTED ACTIVITIES OF THE PSILOCYBIN SERVICE CENTER; AND
(IV) SUCH OTHER INFORMATION AS THE DEPARTMENT SHALL REASONABLY PROVIDE
TO ENSURE COMPLIANCE WITH THIS TITLE.
(E) UPON APPLICATION OF A PSILOCYBIN SERVICE CENTER, A REGISTRATION
MAY BE AMENDED TO ALLOW THE PSILOCYBIN SERVICE CENTER TO RELOCATE WITHIN
THE STATE OR TO ADD OR DELETE PERMITTED PSILOCYBIN SERVICE CENTER ACTIV-
ITIES OR FACILITIES. THE FEE FOR SUCH AMENDMENT SHALL BE DETERMINED BY
A. 8569 10
THE DEPARTMENT IN REGULATION AND BE BASED OFF THE ADMINISTRATIVE BURDEN
TO PROCESS AND REVIEW THE AMENDMENT BY THE DEPARTMENT, PROVIDED NO FEE
SHALL BE GREATER THAN TWO THOUSAND DOLLARS.
7. REGISTRATIONS ISSUED UNDER THIS SECTION SHALL REMAIN VALID FOR TWO
YEARS FROM THE DATE OF ISSUANCE, EXCEPT THAT IN ORDER TO FACILITATE THE
RENEWALS OF SUCH REGISTRATIONS, THE DEPARTMENT MAY UPON THE INITIAL
APPLICATION FOR A REGISTRATION, ISSUE SOME REGISTRATIONS WHICH MAY
REMAIN VALID FOR A PERIOD OF TIME GREATER THAN TWO YEARS BUT NOT EXCEED-
ING AN ADDITIONAL ELEVEN MONTHS.
8. (A) AN APPLICATION FOR THE RENEWAL OF ANY REGISTRATION ISSUED UNDER
THIS SECTION SHALL BE FILED WITH THE DEPARTMENT NOT MORE THAN SIX MONTHS
NOR LESS THAN FOUR MONTHS PRIOR TO THE EXPIRATION THEREOF. A LATE-FILED
APPLICATION FOR THE RENEWAL OF A REGISTRATION MAY, IN THE DISCRETION OF
THE DEPARTMENT, BE TREATED AS AN APPLICATION FOR AN INITIAL LICENSE.
(B) THE APPLICATION FOR RENEWAL SHALL INCLUDE SUCH INFORMATION
PREPARED IN THE MANNER AND DETAIL AS THE DEPARTMENT MAY REQUIRE, INCLUD-
ING BUT NOT LIMITED TO:
(I) ANY MATERIAL CHANGE IN THE CIRCUMSTANCES OR FACTORS LISTED IN
SUBDIVISION ONE OF THIS SECTION; AND
(II) EVERY KNOWN CHARGE OR INVESTIGATION, PENDING OR CONCLUDED DURING
THE PERIOD OF THE REGISTRATION, BY ANY GOVERNMENTAL OR ADMINISTRATIVE
AGENCY WITH RESPECT TO:
(A) EACH INCIDENT OR ALLEGED INCIDENT INVOLVING THE THEFT, LOSS, OR
POSSIBLE DIVERSION OF MEDICAL PSILOCYBIN MANUFACTURED OR DISTRIBUTED BY
THE APPLICANT; AND
(B) COMPLIANCE BY THE APPLICANT WITH THE LAWS OF THE STATE WITH
RESPECT TO THE DISTRIBUTION OR SALE OF MEDICAL PSILOCYBIN, WHERE APPLI-
CABLE.
(C) AN APPLICANT FOR RENEWAL SHALL BE UNDER A CONTINUING DUTY TO
REPORT TO THE DEPARTMENT ANY CHANGE IN FACTS OR CIRCUMSTANCES REFLECTED
IN THE APPLICATION OR ANY NEWLY DISCOVERED OR OCCURRING FACT OR CIRCUM-
STANCE WHICH IS REQUIRED TO BE INCLUDED IN THE APPLICATION AND TO OBTAIN
APPROVAL PRIOR TO ANY MATERIAL CHANGE IN MANAGEMENT, INTEREST OR OWNER-
SHIP.
(D) IF THE DEPARTMENT IS NOT SATISFIED THAT THE PSILOCYBIN SERVICE
CENTER APPLICANT IS ENTITLED TO A RENEWAL OF THE REGISTRATION, THE
DEPARTMENT SHALL WITHIN A REASONABLY PRACTICABLE TIME AS DETERMINED BY
THE COMMISSIONER, SERVE UPON THE PSILOCYBIN SERVICE CENTER OR ITS ATTOR-
NEY OF RECORD IN PERSON OR BY REGISTERED OR CERTIFIED MAIL AN ORDER
DIRECTING THE PSILOCYBIN SERVICE CENTER TO SHOW CAUSE WHY ITS APPLICA-
TION FOR RENEWAL SHOULD NOT BE DENIED. THE ORDER SHALL SPECIFY IN DETAIL
THE RESPECTS IN WHICH THE APPLICANT HAS NOT SATISFIED THE DEPARTMENT
THAT THE REGISTRATION SHOULD BE RENEWED.
(E) WITHIN A REASONABLY PRACTICABLE TIME AS DETERMINED BY THE DEPART-
MENT OF SUCH ORDER, THE APPLICANT MAY SUBMIT ADDITIONAL MATERIAL TO THE
DEPARTMENT OR DEMAND A HEARING OR BOTH; IF A HEARING IS DEMANDED THE
DEPARTMENT SHALL FIX A DATE AS SOON AS REASONABLY PRACTICABLE.
9. (A) THE DEPARTMENT SHALL RENEW A REGISTRATION UNLESS IT DETERMINES
AND FINDS THAT:
(I) THE APPLICANT IS UNLIKELY TO MAINTAIN OR BE ABLE TO MAINTAIN
EFFECTIVE CONTROL AGAINST DIVERSION;
(II) THE APPLICANT IS UNLIKELY TO COMPLY WITH ALL STATE LAWS APPLICA-
BLE TO THE ACTIVITIES IN WHICH IT MAY ENGAGE UNDER THE REGISTRATION;
(III) IT IS NOT IN THE PUBLIC INTEREST TO RENEW THE REGISTRATION
BECAUSE THE NUMBER OF PSILOCYBIN SERVICE CENTERS IN AN AREA IS EXCESSIVE
TO REASONABLY SERVE THE AREA;
A. 8569 11
(IV) THE APPLICANT HAS EITHER VIOLATED OR TERMINATED ITS LABOR PEACE
AGREEMENT; OR
(V) THE APPLICANT HAS SUBSTANTIVELY VIOLATED THE LAWS OF ANOTHER
JURISDICTION, IN WHICH IT OPERATES OR HAVE OPERATED A PSILOCYBIN LICENSE
OR REGISTRATION, RELATED TO THE OPERATION OF A PSILOCYBIN BUSINESS.
(B) FOR PURPOSES OF THIS SECTION, PROOF THAT A PSILOCYBIN SERVICE
CENTER, DURING THE PERIOD OF ITS REGISTRATION, HAS FAILED TO MAINTAIN
EFFECTIVE CONTROL AGAINST DIVERSION, VIOLATED ANY PROVISION OF THIS
TITLE, OR HAS KNOWINGLY OR NEGLIGENTLY FAILED TO COMPLY WITH APPLICABLE
STATE LAWS RELATING TO THE ACTIVITIES IN WHICH IT ENGAGES UNDER THE
REGISTRATION, MAY CONSTITUTE GROUNDS FOR SUSPENSION, TERMINATION OR
LIMITATION OF THE PSILOCYBIN SERVICE CENTER'S REGISTRATION OR AS DETER-
MINED BY THE DEPARTMENT. THE PSILOCYBIN SERVICE CENTER SHALL ALSO BE
UNDER A CONTINUING DUTY TO REPORT TO THE DEPARTMENT ANY MATERIAL CHANGE
IN FACTS OR CIRCUMSTANCES TO THE INFORMATION PROVIDED IN THE PSILOCYBIN
SERVICE CENTER'S APPLICATION.
10. THE DEPARTMENT MAY SUSPEND OR TERMINATE THE REGISTRATION OF A
PSILOCYBIN SERVICE CENTER, ON GROUNDS AND USING PROCEDURES UNDER THIS
TITLE RELATING TO A LICENSE, TO THE EXTENT CONSISTENT WITH THIS TITLE.
THE DEPARTMENT SHALL SUSPEND OR TERMINATE THE REGISTRATION IN THE EVENT
THAT A PSILOCYBIN SERVICE CENTER VIOLATES OR TERMINATES THE APPLICABLE
LABOR PEACE AGREEMENT. CONDUCT IN COMPLIANCE WITH THIS TITLE WHICH MAY
VIOLATE CONFLICTING FEDERAL LAW, SHALL NOT BE GROUNDS TO SUSPEND OR
TERMINATE A REGISTRATION.
11. IN COORDINATION WITH THE CHIEF EQUITY OFFICER, THE DEPARTMENT
SHALL REGISTER ADDITIONAL REGISTERED PSILOCYBIN SERVICE CENTERS TO
PROVIDE SERVICES TO UNSERVED AND UNDERSERVED AREAS OF THE STATE. SUCH
ADDITIONAL REGISTERED PSILOCYBIN SERVICE CENTERS SHALL BE REFLECTIVE OF
THE DEMOGRAPHICS OF THE STATE, BE REPRESENTATIVE OF COMMUNITIES DISPRO-
PORTIONATELY IMPACTED BY PSILOCYBIN PROHIBITION, AND BE CULTURALLY,
LINGUISTICALLY, AND MEDICALLY COMPETENT TO SERVE UNSERVED AND UNDER-
SERVED AREAS OF THE STATE. THE DEPARTMENT SHALL ACTIVELY PROMOTE RACIAL,
ETHNIC, AND GENDER DIVERSITY WHEN REGISTERING ADDITIONAL REGISTERED
PSILOCYBIN SERVICE CENTERS.
§ 3369-FF. REGISTERED ORGANIZATIONS. 1. A REGISTERED ORGANIZATION
SHALL BE A FOR-PROFIT BUSINESS ENTITY OR NOT-FOR-PROFIT CORPORATION
ORGANIZED FOR THE PURPOSE OF ACQUIRING, POSSESSING, MANUFACTURING, SELL-
ING, DELIVERING, TRANSPORTING, DISTRIBUTING OR DISPENSING PSILOCYBIN TO
PSILOCYBIN SERVICE CENTERS FOR CERTIFIED MEDICAL USE.
2. THE ACQUIRING, POSSESSION, MANUFACTURE, SALE, DELIVERY, TRANSPORT-
ING, DISTRIBUTING OR DISPENSING OF MEDICAL PSILOCYBIN BY A REGISTERED
ORGANIZATION UNDER THIS TITLE IN ACCORDANCE WITH ITS REGISTRATION UNDER
THIS TITLE OR A RENEWAL THEREOF SHALL BE LAWFUL UNDER THIS TITLE.
3. EACH REGISTERED ORGANIZATION SHALL CONTRACT WITH AN INDEPENDENT
LABORATORY PERMITTED BY THE DEPARTMENT TO TEST THE MEDICAL PSILOCYBIN
PRODUCED BY THE REGISTERED ORGANIZATION. THE DEPARTMENT SHALL APPROVE
THE LABORATORIES USED BY THE REGISTERED ORGANIZATION, INCLUDING SAMPLING
AND TESTING PROTOCOLS AND STANDARDS USED BY THE LABORATORIES, AND MAY
REQUIRE THAT THE REGISTERED ORGANIZATION USE A PARTICULAR TESTING LABO-
RATORY. THE DEPARTMENT IS AUTHORIZED TO ISSUE REGULATIONS REQUIRING THE
LABORATORY TO PERFORM CERTAIN TESTS AND SERVICES.
4. (A) A REGISTERED ORGANIZATION MAY LAWFULLY, IN GOOD FAITH, SELL,
DELIVER, DISTRIBUTE OR DISPENSE MEDICAL PSILOCYBIN TO A PSILOCYBIN
SERVICE CENTER REGISTERED PURSUANT TO THIS TITLE FOR USE BY A CERTIFIED
PATIENT.
A. 8569 12
(B) THE PROPRIETOR OF A REGISTERED ORGANIZATION SHALL FILE OR CAUSE TO
BE FILED ANY RECEIPT AND CERTIFICATION INFORMATION WITH THE DEPARTMENT
BY ELECTRONIC MEANS ON A REAL-TIME BASIS AS THE DEPARTMENT SHALL REQUIRE
BY REGULATION. WHEN FILING RECEIPT AND CERTIFICATION INFORMATION ELEC-
TRONICALLY PURSUANT TO THIS PARAGRAPH, THE PROPRIETOR OF THE REGISTERED
ORGANIZATION SHALL DISPOSE OF ANY ELECTRONICALLY RECORDED PRESCRIPTION
INFORMATION IN SUCH MANNER AS THE DEPARTMENT SHALL BY REGULATION
REQUIRE.
5. NO REGISTERED ORGANIZATION MAY SELL, DELIVER, DISTRIBUTE OR
DISPENSE MEDICAL PSILOCYBIN DIRECTLY TO A CERTIFIED PATIENT OR DESIG-
NATED CAREGIVER.
6. WHEN A REGISTERED ORGANIZATION SELLS, DELIVERS, DISTRIBUTES OR
DISPENSES MEDICAL PSILOCYBIN TO A PSILOCYBIN SERVICE CENTER, IT SHALL
PROVIDE TO THAT FACILITY A SAFETY INSERT, DEVELOPED BY THE REGISTERED
ORGANIZATION SUBJECT TO REGULATIONS ISSUED BY THE DEPARTMENT AND
INCLUDE, BUT NOT BE LIMITED TO, INFORMATION ON:
(A) METHODS FOR ADMINISTERING MEDICAL PSILOCYBIN;
(B) ANY POTENTIAL DANGERS STEMMING FROM THE USE OF MEDICAL PSILOCYBIN;
(C) HOW TO RECOGNIZE WHAT MAY BE PROBLEMATIC USAGE OF MEDICAL PSILOCY-
BIN AND OBTAIN APPROPRIATE SERVICES OR TREATMENT FOR PROBLEMATIC USAGE;
AND
(D) OTHER INFORMATION AS DETERMINED BY THE DEPARTMENT.
7. REGISTERED ORGANIZATIONS SHALL NOT BE MANAGED BY OR EMPLOY ANYONE
WHO HAS BEEN CONVICTED WITHIN THREE YEARS OF THE DATE OF HIRE, OF ANY
FELONY RELATED TO THE FUNCTIONS OR DUTIES OF OPERATING A BUSINESS,
EXCEPT THAT IF THE DEPARTMENT DETERMINES THAT THE MANAGER OR EMPLOYEE IS
OTHERWISE SUITABLE TO BE HIRED, AND HIRING THE MANAGER OR EMPLOYEE WOULD
NOT COMPROMISE PUBLIC SAFETY, THE DEPARTMENT SHALL CONDUCT A THOROUGH
REVIEW OF THE NATURE OF THE CRIME, CONVICTION, CIRCUMSTANCES, AND
EVIDENCE OF REHABILITATION OF THE MANAGER OR EMPLOYEE, AND SHALL EVALU-
ATE THE SUITABILITY OF THE MANAGER OR EMPLOYEE BASED ON THE EVIDENCE
FOUND THROUGH THE REVIEW. IN DETERMINING WHICH OFFENSES ARE SUBSTANTIAL-
LY RELATED TO THE FUNCTIONS OR DUTIES OF OPERATING A BUSINESS, THE
DEPARTMENT SHALL INCLUDE, BUT NOT BE LIMITED TO, THE FOLLOWING:
(A) A FELONY CONVICTION INVOLVING FRAUD, MONEY LAUNDERING, FORGERY AND
OTHER UNLAWFUL CONDUCT RELATED TO OWNING AND OPERATING A BUSINESS; AND
(B) A FELONY CONVICTION FOR HIRING, EMPLOYING OR USING A MINOR IN
TRANSPORTING, CARRYING, SELLING, GIVING AWAY, PREPARING FOR SALE, OR
PEDDLING, ANY CONTROLLED SUBSTANCE, OR SELLING, OFFERING TO SELL,
FURNISHING, OFFERING TO FURNISH, ADMINISTERING, OR GIVING ANY CONTROLLED
SUBSTANCE TO A MINOR.
A FELONY CONVICTION FOR THE SALE OR POSSESSION OF DRUGS, NARCOTICS, OR
CONTROLLED SUBSTANCES IS NOT SUBSTANTIALLY RELATED. THIS SUBDIVISION
SHALL ONLY APPLY TO MANAGERS OR EMPLOYEES WHO COME INTO CONTACT WITH OR
HANDLE MEDICAL PSILOCYBIN.
8. MANUFACTURING OF MEDICAL PSILOCYBIN BY A REGISTERED ORGANIZATION
SHALL ONLY BE DONE IN A SECURE FACILITY LOCATED IN NEW YORK STATE, WHICH
MAY INCLUDE A GREENHOUSE. THE DEPARTMENT SHALL PROMULGATE REGULATIONS
ESTABLISHING REQUIREMENTS FOR SUCH FACILITIES.
9. DISPENSING OF MEDICAL PSILOCYBIN BY A REGISTERED ORGANIZATION SHALL
ONLY BE DONE IN AN INDOOR, ENCLOSED, SECURE FACILITY LOCATED IN NEW YORK
STATE. THE DEPARTMENT SHALL PROMULGATE REGULATIONS ESTABLISHING REQUIRE-
MENTS FOR SUCH FACILITIES.
10. A REGISTERED ORGANIZATION MAY CONTRACT WITH A PERSON OR ENTITY TO
PROVIDE FACILITIES, EQUIPMENT OR SERVICES THAT ARE ANCILLARY TO THE
REGISTERED ORGANIZATION'S FUNCTIONS OR ACTIVITIES UNDER THIS TITLE
A. 8569 13
INCLUDING, BUT NOT LIMITED TO, SHIPPING, MAINTENANCE, CONSTRUCTION,
REPAIR, AND SECURITY, PROVIDED THAT THE PERSON OR ENTITY SHALL NOT
PERFORM ANY FUNCTION OR ACTIVITY DIRECTLY INVOLVING THE PLANTING, GROW-
ING, TENDING, HARVESTING, PROCESSING, OR PACKAGING OF PSILOCYBIN PLANTS,
MEDICAL PSILOCYBIN, OR MEDICAL PSILOCYBIN PRODUCTS BEING PRODUCED BY THE
REGISTERED ORGANIZATION; OR ANY OTHER FUNCTION DIRECTLY INVOLVING MANU-
FACTURING OR RETAILING OF MEDICAL PSILOCYBIN. ALL LAWS AND REGULATIONS
APPLICABLE TO SUCH FACILITIES, EQUIPMENT, OR SERVICES SHALL APPLY TO THE
CONTRACT. THE REGISTERED ORGANIZATION AND OTHER PARTIES TO THE CONTRACT
SHALL EACH BE RESPONSIBLE FOR COMPLIANCE WITH SUCH LAWS AND REGULATIONS
UNDER THE CONTRACT. THE DEPARTMENT MAY MAKE REGULATIONS CONSISTENT WITH
THIS TITLE RELATING TO CONTRACTS AND PARTIES TO CONTRACTS UNDER THIS
SUBDIVISION.
11. A REGISTERED ORGANIZATION SHALL, BASED ON THE FINDINGS OF AN INDE-
PENDENT LABORATORY, PROVIDE DOCUMENTATION OF THE QUALITY, SAFETY AND
CLINICAL STRENGTH OF THE MEDICAL PSILOCYBIN MANUFACTURED OR DISPENSED BY
THE REGISTERED ORGANIZATION TO THE DEPARTMENT AND TO ANY PSILOCYBIN
SERVICE CENTER TO WHICH THE MEDICAL PSILOCYBIN IS SOLD OR DISPENSED.
12. MEDICAL PSILOCYBIN SHALL BE DISPENSED TO A PSILOCYBIN SERVICE
CENTER IN A SEALED AND PROPERLY LABELED PACKAGE. THE LABELING SHALL
CONTAIN: (A) THE PACKAGING DATE; (B) ANY APPLICABLE DATE BY WHICH THE
MEDICAL PSILOCYBIN SHOULD BE USED; (C) A WARNING STATING, "THIS PRODUCT
IS FOR MEDICINAL USE ONLY. WOMEN SHOULD NOT CONSUME DURING PREGNANCY OR
WHILE BREASTFEEDING EXCEPT ON THE ADVICE OF THE CERTIFYING HEALTH CARE
PRACTITIONER, AND IN THE CASE OF BREASTFEEDING MOTHERS, INCLUDING THE
INFANT'S PEDIATRICIAN. THIS PRODUCT MIGHT IMPAIR THE ABILITY TO DRIVE.
KEEP OUT OF REACH OF CHILDREN."; (D) THE AMOUNT OF INDIVIDUAL DOSES
CONTAINED WITHIN; AND (E) A WARNING THAT THE MEDICAL PSILOCYBIN MUST BE
KEPT IN THE ORIGINAL CONTAINER IN WHICH IT WAS DISPENSED.
13. THE DEPARTMENT IS AUTHORIZED TO MAKE RULES AND REGULATIONS
RESTRICTING THE ADVERTISING AND MARKETING OF MEDICAL PSILOCYBIN.
14. A REGISTERED ORGANIZATION SHALL OPERATE IN ACCORDANCE WITH MINIMUM
OPERATING AND RECORDKEEPING REQUIREMENTS DETERMINED BY THE DEPARTMENT IN
REGULATION.
§ 3369-GG. REGISTERING OF REGISTERED ORGANIZATIONS. 1. (A) AN APPLI-
CANT FOR REGISTRATION AS A REGISTERED ORGANIZATION UNDER SECTION THIR-
TY-THREE HUNDRED SIXTY-NINE-FF OF THIS TITLE SHALL INCLUDE SUCH INFORMA-
TION PREPARED IN SUCH MANNER AND DETAIL AS THE DEPARTMENT MAY REQUIRE,
INCLUDING BUT NOT LIMITED TO:
(I) A DESCRIPTION OF THE ACTIVITIES IN WHICH IT INTENDS TO ENGAGE AS A
REGISTERED ORGANIZATION;
(II) THAT THE APPLICANT:
(A) IS OF GOOD MORAL CHARACTER;
(B) POSSESSES OR HAS THE RIGHT TO USE SUFFICIENT LAND, BUILDINGS, AND
OTHER PREMISES, WHICH SHALL BE SPECIFIED IN THE APPLICATION, AND EQUIP-
MENT TO PROPERLY CARRY ON THE ACTIVITY DESCRIBED IN THE APPLICATION, OR
IN THE ALTERNATIVE POSTS A BOND OF NOT LESS THAN TWO MILLION DOLLARS;
(C) IS ABLE TO MAINTAIN EFFECTIVE SECURITY AND CONTROL TO PREVENT
DIVERSION, ABUSE, AND OTHER ILLEGAL CONDUCT RELATING TO THE PSILOCYBIN;
AND
(D) IS ABLE TO COMPLY WITH ALL APPLICABLE STATE LAWS AND REGULATIONS
RELATING TO THE ACTIVITIES IN WHICH IT INTENDS TO ENGAGE UNDER THE
REGISTRATION;
(III) THAT THE APPLICANT HAS ENTERED INTO A LABOR PEACE AGREEMENT WITH
A BONA FIDE LABOR ORGANIZATION THAT IS ACTIVELY ENGAGED IN REPRESENTING
OR ATTEMPTING TO REPRESENT THE APPLICANT'S EMPLOYEES AND THE MAINTENANCE
A. 8569 14
OF SUCH A LABOR PEACE AGREEMENT SHALL BE AN ONGOING MATERIAL CONDITION
OF CERTIFICATION;
(IV) THE APPLICANT'S STATUS AS A FOR-PROFIT BUSINESS ENTITY OR NOT-
FOR-PROFIT CORPORATION; AND
(V) THE APPLICATION SHALL INCLUDE THE NAME, RESIDENCE ADDRESS AND
TITLE OF EACH OF THE OFFICERS AND DIRECTORS AND THE NAME AND RESIDENCE
ADDRESS OF ANY PERSON OR ENTITY THAT IS A MEMBER OF THE APPLICANT. EACH
SUCH PERSON, IF AN INDIVIDUAL, OR LAWFUL REPRESENTATIVE IF A LEGAL ENTI-
TY, SHALL SUBMIT AN AFFIDAVIT WITH THE APPLICATION SETTING FORTH:
(A) ANY POSITION OF MANAGEMENT, INTEREST OR OWNERSHIP DURING THE
PRECEDING TEN YEARS OF A TEN PER CENTUM OR GREATER INTEREST IN ANY OTHER
PSILOCYBIN BUSINESS, OR APPLICANT, LOCATED IN OR OUTSIDE THIS STATE,
MANUFACTURING OR DISTRIBUTING DRUGS INCLUDING INDIRECT MANAGEMENT,
INTEREST, OR OWNERSHIP OF PARENT COMPANIES, SUBSIDIARIES, OR AFFILIATES;
(B) WHETHER SUCH PERSON OR ANY SUCH BUSINESS HAS BEEN CONVICTED OF A
FELONY OR HAD A REGISTRATION OR LICENSE SUSPENDED OR REVOKED IN ANY
ADMINISTRATIVE OR JUDICIAL PROCEEDING, AND IF APPLICABLE, THE HISTORY OF
VIOLATIONS OR ADMINISTRATIVE PENALTIES WITH RESPECT TO ANY LICENSE TO
CULTIVATE, MANUFACTURE, DISTRIBUTE OR SELL MEDICAL PSILOCYBIN; AND
(C) SUCH OTHER INFORMATION AS THE DEPARTMENT MAY REASONABLY REQUIRE.
2. THE APPLICANT SHALL BE UNDER A CONTINUING DUTY TO REPORT TO THE
DEPARTMENT ANY CHANGE IN FACTS OR CIRCUMSTANCES REFLECTED IN THE APPLI-
CATION OR ANY NEWLY DISCOVERED OR OCCURRING FACT OR CIRCUMSTANCE WHICH
IS REQUIRED TO BE INCLUDED IN THE APPLICATION.
3. (A) THE DEPARTMENT SHALL GRANT A REGISTRATION OR AMENDMENT TO A
REGISTRATION UNDER THIS SECTION IF THEY ARE SATISFIED THAT:
(I) THE APPLICANT WILL BE ABLE TO MAINTAIN EFFECTIVE CONTROL AGAINST
DIVERSION OF PSILOCYBIN;
(II) THE APPLICANT WILL BE ABLE TO COMPLY WITH ALL APPLICABLE STATE
LAWS;
(III) THE APPLICANT AND ITS OFFICERS ARE READY, WILLING AND ABLE TO
PROPERLY CARRY ON THE MANUFACTURING OR DISTRIBUTING ACTIVITY FOR WHICH A
REGISTRATION IS SOUGHT;
(IV) THE APPLICANT POSSESSES OR HAS THE RIGHT TO USE SUFFICIENT LAND,
BUILDINGS AND EQUIPMENT TO PROPERLY CARRY ON THE ACTIVITY DESCRIBED IN
THE APPLICATION;
(V) IT IS IN THE PUBLIC INTEREST THAT SUCH REGISTRATION BE GRANTED,
INCLUDING BUT NOT LIMITED TO:
(A) WHETHER THE NUMBER OF REGISTERED ORGANIZATIONS IN AN AREA WILL BE
ADEQUATE OR EXCESSIVE TO REASONABLY SERVE THE AREA;
(B) WHETHER THE REGISTERED ORGANIZATION IS A MINORITY AND/OR WOMAN
OWNED BUSINESS ENTERPRISE, A SERVICE-DISABLED VETERAN-OWNED BUSINESS, OR
FROM COMMUNITIES DISPROPORTIONALLY IMPACTED BY THE ENFORCEMENT OF PSILO-
CYBIN PROHIBITION;
(C) WHETHER THE REGISTERED ORGANIZATION PROVIDES EDUCATION AND
OUTREACH TO PRACTITIONERS;
(D) WHETHER THE REGISTERED ORGANIZATION PROMOTES THE RESEARCH AND
DEVELOPMENT OF MEDICAL PSILOCYBIN AND PATIENT OUTREACH;
(E) THE AFFORDABILITY OF MEDICAL PSILOCYBIN PRODUCTS OFFERED BY THE
REGISTERED ORGANIZATION;
(F) WHETHER THE REGISTERED ORGANIZATION IS CULTURALLY, LINGUISTICALLY,
AND MEDICALLY COMPETENT TO PROVIDE SERVICES TO UNSERVED AND UNDERSERVED
AREAS; AND
(G) WHETHER THE REGISTERED ORGANIZATION PROMOTES RACIAL, ETHNIC, AND
GENDER DIVERSITY IN THEIR WORKFORCE;
A. 8569 15
(VI) THE APPLICANT AND ITS MANAGING OFFICERS ARE OF GOOD MORAL CHARAC-
TER;
(VII) THE APPLICANT HAS ENTERED INTO A LABOR PEACE AGREEMENT WITH A
BONA FIDE LABOR ORGANIZATION THAT IS ACTIVELY ENGAGED IN REPRESENTING OR
ATTEMPTING TO REPRESENT THE APPLICANT'S EMPLOYEES; AND THE MAINTENANCE
OF SUCH A LABOR PEACE AGREEMENT SHALL BE AN ONGOING MATERIAL CONDITION
OF REGISTRATION; AND
(VIII) THE APPLICANT SATISFIES ANY OTHER CONDITIONS AS DETERMINED BY
THE DEPARTMENT.
(B) IF THE DEPARTMENT IS NOT SATISFIED THAT THE APPLICANT SHOULD BE
ISSUED A REGISTRATION, THE DEPARTMENT SHALL NOTIFY THE APPLICANT IN
WRITING OF THOSE FACTORS UPON WHICH FURTHER EVIDENCE IS REQUIRED. WITHIN
THIRTY DAYS OF THE RECEIPT OF SUCH NOTIFICATION, THE APPLICANT MAY
SUBMIT ADDITIONAL MATERIAL TO THE DEPARTMENT OR DEMAND A HEARING, OR
BOTH.
(C) THE FEE FOR A REGISTRATION UNDER THIS SECTION SHALL BE AN AMOUNT
DETERMINED BY THE DEPARTMENT IN REGULATIONS; PROVIDED, HOWEVER, IF THE
REGISTRATION IS ISSUED FOR A PERIOD GREATER THAN TWO YEARS THE FEE SHALL
BE INCREASED, PRO RATA, FOR EACH ADDITIONAL MONTH OF VALIDITY.
(D) REGISTRATIONS ISSUED UNDER THIS SECTION SHALL BE EFFECTIVE ONLY
FOR THE REGISTERED ORGANIZATION AND SHALL SPECIFY:
(I) THE NAME AND ADDRESS OF THE REGISTERED ORGANIZATION;
(II) WHICH ACTIVITIES OF A REGISTERED ORGANIZATION ARE PERMITTED BY
THE REGISTRATION;
(III) THE LAND, BUILDINGS AND FACILITIES THAT MAY BE USED FOR THE
PERMITTED ACTIVITIES OF THE REGISTERED ORGANIZATION; AND
(IV) SUCH OTHER INFORMATION AS THE DEPARTMENT SHALL REASONABLY PROVIDE
TO ASSURE COMPLIANCE WITH THIS TITLE.
(E) UPON APPLICATION OF A REGISTERED ORGANIZATION, A REGISTRATION MAY
BE AMENDED TO ALLOW THE REGISTERED ORGANIZATION TO RELOCATE WITHIN THE
STATE OR TO ADD OR DELETE PERMITTED REGISTERED ORGANIZATION ACTIVITIES
OR FACILITIES. THE FEE FOR SUCH AMENDMENT SHALL BE DETERMINED BY THE
DEPARTMENT IN REGULATION AND BE BASED OFF THE ADMINISTRATIVE BURDEN TO
PROCESS AND REVIEW THE AMENDMENT BY THE DEPARTMENT, PROVIDED NO FEE
SHALL BE GREATER THAN TWO THOUSAND DOLLARS.
4. A REGISTRATION ISSUED UNDER THIS SECTION SHALL BE VALID FOR TWO
YEARS FROM THE DATE OF ISSUE, EXCEPT THAT IN ORDER TO FACILITATE THE
RENEWALS OF SUCH REGISTRATIONS, THE DEPARTMENT MAY UPON THE INITIAL
APPLICATION FOR A REGISTRATION, ISSUE SOME REGISTRATIONS WHICH MAY
REMAIN VALID FOR A PERIOD OF TIME GREATER THAN TWO YEARS BUT NOT EXCEED-
ING AN ADDITIONAL ELEVEN MONTHS.
5. (A) AN APPLICATION FOR THE RENEWAL OF ANY REGISTRATION ISSUED UNDER
THIS SECTION SHALL BE FILED WITH THE DEPARTMENT NOT MORE THAN SIX MONTHS
NOR LESS THAN FOUR MONTHS PRIOR TO THE EXPIRATION THEREOF. A LATE-FILED
APPLICATION FOR THE RENEWAL OF A REGISTRATION MAY, IN THE DISCRETION OF
THE DEPARTMENT, BE TREATED AS AN APPLICATION FOR AN INITIAL LICENSE.
(B) THE APPLICATION FOR RENEWAL SHALL INCLUDE SUCH INFORMATION
PREPARED IN THE MANNER AND DETAIL AS THE DEPARTMENT MAY REQUIRE, INCLUD-
ING BUT NOT LIMITED TO:
(I) ANY MATERIAL CHANGE IN THE CIRCUMSTANCES OR FACTORS LISTED IN
SUBDIVISION ONE OF THIS SECTION; AND
(II) EVERY KNOWN CHARGE OR INVESTIGATION, PENDING OR CONCLUDED DURING
THE PERIOD OF THE REGISTRATION, BY ANY GOVERNMENTAL OR ADMINISTRATIVE
AGENCY WITH RESPECT TO:
A. 8569 16
(A) EACH INCIDENT OR ALLEGED INCIDENT INVOLVING THE THEFT, LOSS, OR
POSSIBLE DIVERSION OF MEDICAL PSILOCYBIN MANUFACTURED OR DISTRIBUTED BY
THE APPLICANT; AND
(B) COMPLIANCE BY THE APPLICANT WITH THE LAWS OF THE STATE WITH
RESPECT TO THE CULTIVATION, MANUFACTURE, DISTRIBUTION, OR SALE OF
MEDICAL PSILOCYBIN OR ADULT-USE PSILOCYBIN, WHERE APPLICABLE.
(C) AN APPLICANT FOR RENEWAL SHALL BE UNDER A CONTINUING DUTY TO
REPORT TO THE DEPARTMENT ANY CHANGE IN FACTS OR CIRCUMSTANCES REFLECTED
IN THE APPLICATION OR ANY NEWLY DISCOVERED OR OCCURRING FACT OR CIRCUM-
STANCE WHICH IS REQUIRED TO BE INCLUDED IN THE APPLICATION AND TO OBTAIN
APPROVAL PRIOR TO ANY MATERIAL CHANGE IN MANAGEMENT, INTEREST OR OWNER-
SHIP.
(D) IF THE DEPARTMENT IS NOT SATISFIED THAT THE REGISTERED ORGANIZA-
TION APPLICANT IS ENTITLED TO A RENEWAL OF THE REGISTRATION, THE DEPART-
MENT SHALL WITHIN A REASONABLY PRACTICABLE TIME AS DETERMINED BY THE
EXECUTIVE DIRECTOR, SERVE UPON THE REGISTERED ORGANIZATION OR ITS ATTOR-
NEY OF RECORD IN PERSON OR BY REGISTERED OR CERTIFIED MAIL AN ORDER
DIRECTING THE REGISTERED ORGANIZATION TO SHOW CAUSE WHY ITS APPLICATION
FOR RENEWAL SHOULD NOT BE DENIED. THE ORDER SHALL SPECIFY IN DETAIL THE
RESPECTS IN WHICH THE APPLICANT HAS NOT SATISFIED THE DEPARTMENT THAT
THE REGISTRATION SHOULD BE RENEWED.
(E) WITHIN A REASONABLY PRACTICABLE TIME AS DETERMINED BY THE DEPART-
MENT OF SUCH ORDER, THE APPLICANT MAY SUBMIT ADDITIONAL MATERIAL TO THE
DEPARTMENT OR DEMAND A HEARING OR BOTH; IF A HEARING IS DEMANDED THE
DEPARTMENT SHALL FIX A DATE AS SOON AS REASONABLY PRACTICABLE.
6. (A) THE DEPARTMENT SHALL RENEW A REGISTRATION UNLESS IT DETERMINES
AND FINDS THAT:
(I) THE APPLICANT IS UNLIKELY TO MAINTAIN OR BE ABLE TO MAINTAIN
EFFECTIVE CONTROL AGAINST DIVERSION;
(II) THE APPLICANT IS UNLIKELY TO COMPLY WITH ALL STATE LAWS APPLICA-
BLE TO THE ACTIVITIES IN WHICH IT MAY ENGAGE UNDER THE REGISTRATION;
(III) IT IS NOT IN THE PUBLIC INTEREST TO RENEW THE REGISTRATION
BECAUSE THE NUMBER OF REGISTERED ORGANIZATIONS IN AN AREA IS EXCESSIVE
TO REASONABLY SERVE THE AREA;
(IV) THE APPLICANT HAS EITHER VIOLATED OR TERMINATED ITS LABOR PEACE
AGREEMENT; OR
(V) THE APPLICANT HAS SUBSTANTIVELY VIOLATED THE LAWS OF ANOTHER
JURISDICTION, IN WHICH THEY OPERATE OR HAVE OPERATED A PSILOCYBIN
LICENSE OR REGISTRATION, RELATED TO THE OPERATION OF A PSILOCYBIN BUSI-
NESS.
(B) FOR PURPOSES OF THIS SECTION, PROOF THAT A REGISTERED ORGANIZA-
TION, DURING THE PERIOD OF ITS REGISTRATION, HAS FAILED TO MAINTAIN
EFFECTIVE CONTROL AGAINST DIVERSION, VIOLATES ANY PROVISION OF THIS
TITLE, OR HAS KNOWINGLY OR NEGLIGENTLY FAILED TO COMPLY WITH APPLICABLE
STATE LAWS RELATING TO THE ACTIVITIES IN WHICH IT ENGAGES UNDER THE
REGISTRATION, MAY CONSTITUTE GROUNDS FOR SUSPENSION, TERMINATION OR
LIMITATION OF THE REGISTERED ORGANIZATION'S REGISTRATION OR AS DETER-
MINED BY THE DEPARTMENT. THE REGISTERED ORGANIZATION SHALL ALSO BE UNDER
A CONTINUING DUTY TO REPORT TO THE DEPARTMENT ANY MATERIAL CHANGE OR
FACT OR CIRCUMSTANCE TO THE INFORMATION PROVIDED IN THE REGISTERED
ORGANIZATION'S APPLICATION.
7. THE DEPARTMENT MAY SUSPEND OR TERMINATE THE REGISTRATION OF A
REGISTERED ORGANIZATION, ON GROUNDS AND USING PROCEDURES UNDER THIS
TITLE RELATING TO A LICENSE, TO THE EXTENT CONSISTENT WITH THIS TITLE.
THE DEPARTMENT SHALL SUSPEND OR TERMINATE THE REGISTRATION IN THE EVENT
THAT A REGISTERED ORGANIZATION VIOLATES OR TERMINATES THE APPLICABLE
A. 8569 17
LABOR PEACE AGREEMENT. CONDUCT IN COMPLIANCE WITH THIS TITLE WHICH MAY
VIOLATE CONFLICTING FEDERAL LAW, SHALL NOT BE GROUNDS TO SUSPEND OR
TERMINATE A REGISTRATION.
8. A REGISTERED ORGANIZATION THAT MANUFACTURES MEDICAL PSILOCYBIN MAY
HAVE NO MORE THAN FOUR SITES WHOLLY OWNED AND OPERATED BY SUCH REGIS-
TERED ORGANIZATION. SUCH REGISTERED ORGANIZATION MAY HAVE AN ADDITIONAL
FOUR SITES; PROVIDED, HOWEVER, THAT THE FIRST TWO ADDITIONAL SITES SHALL
BE LOCATED IN UNDERSERVED OR UNSERVED GEOGRAPHIC LOCATIONS, AS DETER-
MINED BY THE DEPARTMENT. THE DEPARTMENT SHALL ENSURE THAT SUCH REGIS-
TERED ORGANIZATIONS AND SITES ARE GEOGRAPHICALLY DISTRIBUTED ACROSS THE
STATE AND THAT THEIR OWNERSHIP REFLECTS THE DEMOGRAPHICS OF THE STATE.
9. IN COORDINATION WITH THE CHIEF EQUITY OFFICER THE DEPARTMENT SHALL
REGISTER ADDITIONAL REGISTERED ORGANIZATIONS TO PROVIDE SERVICES TO
UNSERVED AND UNDERSERVED AREAS OF THE STATE. SUCH ADDITIONAL REGISTERED
ORGANIZATIONS SHALL BE REFLECTIVE OF THE DEMOGRAPHICS OF THE STATE, BE
REPRESENTATIVE OF COMMUNITIES DISPROPORTIONATELY IMPACTED BY PSILOCYBIN
PROHIBITION, AND BE CULTURALLY, LINGUISTICALLY, AND MEDICALLY COMPETENT
TO SERVE UNSERVED AND UNDERSERVED AREAS OF THE STATE. THE DEPARTMENT
SHALL ACTIVELY PROMOTE RACIAL, ETHNIC, AND GENDER DIVERSITY WHEN REGIS-
TERING ADDITIONAL REGISTERED ORGANIZATIONS.
§ 3369-HH. REPORTS OF REGISTERED ORGANIZATIONS. 1. THE DEPARTMENT
SHALL, BY REGULATION, REQUIRE EACH REGISTERED ORGANIZATION TO FILE
REPORTS BY THE REGISTERED ORGANIZATION DURING A PARTICULAR PERIOD. THE
DEPARTMENT SHALL DETERMINE THE INFORMATION TO BE REPORTED AND THE FORMS,
TIME, AND MANNER OF THE REPORTING.
2. THE DEPARTMENT SHALL, BY REGULATION, REQUIRE EACH REGISTERED ORGAN-
IZATION TO ADOPT AND MAINTAIN SECURITY, TRACKING, RECORDKEEPING, RECORD
RETENTION AND SURVEILLANCE SYSTEMS, RELATING TO ALL MEDICAL PSILOCYBIN
AT EVERY STAGE OF ACQUIRING, POSSESSION, MANUFACTURE, SALE, DELIVERY,
TRANSPORTING, DISTRIBUTING, OR DISPENSING BY THE REGISTERED ORGANIZA-
TION, SUBJECT TO REGULATIONS OF THE DEPARTMENT.
§ 3369-II. EVALUATION; RESEARCH PROGRAMS; REPORT BY DEPARTMENT. 1.
THE DEPARTMENT MAY PROVIDE FOR THE ANALYSIS AND EVALUATION OF THE OPERA-
TION OF THIS TITLE. THE DEPARTMENT MAY ENTER INTO AGREEMENTS WITH ONE OR
MORE PERSONS, NOT-FOR-PROFIT CORPORATIONS OR OTHER ORGANIZATIONS, FOR
THE PERFORMANCE OF AN EVALUATION OF THE IMPLEMENTATION AND EFFECTIVENESS
OF THIS TITLE.
2. THE DEPARTMENT MAY DEVELOP, SEEK ANY NECESSARY FEDERAL APPROVAL
FOR, AND CARRY OUT RESEARCH PROGRAMS RELATING TO MEDICAL USE OF PSILOCY-
BIN. PARTICIPATION IN ANY SUCH RESEARCH PROGRAM SHALL BE VOLUNTARY ON
THE PART OF PRACTITIONERS, PATIENTS, AND DESIGNATED CAREGIVERS.
3. THE DEPARTMENT SHALL REPORT EVERY TWO YEARS, BEGINNING TWO YEARS
AFTER THE EFFECTIVE DATE OF THIS TITLE, TO THE GOVERNOR AND THE LEGISLA-
TURE ON THE MEDICAL USE OF PSILOCYBIN UNDER THIS TITLE AND MAKE APPRO-
PRIATE RECOMMENDATIONS.
§ 3369-JJ. PSILOCYBIN RESEARCH LICENSE. 1. THE DEPARTMENT SHALL ESTAB-
LISH A PSILOCYBIN RESEARCH LICENSE THAT PERMITS A LICENSEE TO PRODUCE,
PROCESS, PURCHASE AND/OR POSSESS PSILOCYBIN FOR THE FOLLOWING LIMITED
RESEARCH PURPOSES:
(A) TO TEST CHEMICAL POTENCY AND COMPOSITION LEVELS;
(B) TO CONDUCT CLINICAL INVESTIGATIONS OF PSILOCYBIN-DERIVED DRUG
PRODUCTS;
(C) TO CONDUCT RESEARCH ON THE EFFICACY AND SAFETY OF ADMINISTERING
PSILOCYBIN AS PART OF MEDICAL TREATMENT; AND
(D) TO CONDUCT GENOMIC OR AGRICULTURAL RESEARCH.
A. 8569 18
2. AS PART OF THE APPLICATION PROCESS FOR A PSILOCYBIN RESEARCH
LICENSE, AN APPLICANT MUST SUBMIT TO THE DEPARTMENT A DESCRIPTION OF THE
RESEARCH THAT IS INTENDED TO BE CONDUCTED AS WELL AS THE AMOUNT OF
PSILOCYBIN TO BE GROWN OR PURCHASED. THE DEPARTMENT SHALL REVIEW AN
APPLICANT'S RESEARCH PROJECT AND DETERMINE WHETHER IT MEETS THE REQUIRE-
MENTS OF SUBDIVISION ONE OF THIS SECTION. IN ADDITION, THE DEPARTMENT
SHALL ASSESS THE APPLICATION BASED ON THE FOLLOWING CRITERIA:
(A) PROJECT QUALITY, STUDY DESIGN, VALUE, AND IMPACT;
(B) WHETHER THE APPLICANT HAS THE APPROPRIATE PERSONNEL, EXPERTISE,
FACILITIES AND INFRASTRUCTURE, FUNDING, AND HUMAN, ANIMAL, OR OTHER
APPROVALS IN PLACE TO SUCCESSFULLY CONDUCT THE PROJECT; AND
(C) WHETHER THE AMOUNT OF PSILOCYBIN TO BE GROWN OR PURCHASED BY THE
APPLICANT IS CONSISTENT WITH THE PROJECT'S SCOPE AND GOALS. IF THE
DEPARTMENT DETERMINES THAT THE RESEARCH PROJECT DOES NOT MEET THE
REQUIREMENTS OF SUBDIVISION ONE OF THIS SECTION, THE APPLICATION MUST BE
DENIED.
3. A PSILOCYBIN RESEARCH LICENSEE MAY ONLY SELL PSILOCYBIN GROWN OR
WITHIN ITS OPERATION TO OTHER PSILOCYBIN RESEARCH LICENSEES. THE DEPART-
MENT MAY REVOKE A PSILOCYBIN RESEARCH LICENSE FOR VIOLATIONS OF THIS
SECTION.
4. A PSILOCYBIN RESEARCH LICENSEE MAY CONTRACT WITH AN INSTITUTION OF
HIGHER EDUCATION, INCLUDING BUT NOT LIMITED TO A HOSPITAL WITHIN THE
STATE UNIVERSITY OF NEW YORK, TO PERFORM RESEARCH IN CONJUNCTION WITH
SUCH INSTITUTION. ALL RESEARCH PROJECTS, ENTERED INTO UNDER THIS SECTION
MUST BE APPROVED BY THE DEPARTMENT AND MEET THE REQUIREMENTS OF SUBDIVI-
SION ONE OF THIS SECTION.
5. IN ESTABLISHING A PSILOCYBIN RESEARCH LICENSE, THE DEPARTMENT MAY
ADOPT REGULATIONS ON THE FOLLOWING:
(A) APPLICATION REQUIREMENTS;
(B) PSILOCYBIN RESEARCH LICENSE RENEWAL REQUIREMENTS, INCLUDING WHETH-
ER ADDITIONAL RESEARCH PROJECTS MAY BE ADDED OR CONSIDERED;
(C) CONDITIONS FOR LICENSE REVOCATION;
(D) SECURITY MEASURES TO ENSURE PSILOCYBIN IS NOT DIVERTED TO PURPOSES
OTHER THAN RESEARCH;
(E) AMOUNT OF PLANTS, USEABLE PSILOCYBIN, PSILOCYBIN CONCENTRATES, OR
PSILOCYBIN-INFUSED PRODUCTS A LICENSEE MAY HAVE ON ITS PREMISES;
(F) LICENSEE REPORTING REQUIREMENTS;
(G) CONDITIONS UNDER WHICH PSILOCYBIN GROWN BY LICENSED PSILOCYBIN
PRODUCERS AND OTHER PRODUCT TYPES FROM LICENSED PSILOCYBIN PROCESSORS
MAY BE DONATED TO PSILOCYBIN RESEARCH LICENSEES; AND
(H) ANY ADDITIONAL REQUIREMENTS DEEMED NECESSARY BY THE DEPARTMENT.
6. A PSILOCYBIN RESEARCH LICENSE ISSUED PURSUANT TO THIS SECTION MUST
BE ISSUED IN THE NAME OF THE APPLICANT AND SPECIFY THE LOCATION AT WHICH
THE PSILOCYBIN RESEARCHER INTENDS TO OPERATE, WHICH MUST BE WITHIN THE
STATE OF NEW YORK.
7. THE APPLICATION FEE FOR A PSILOCYBIN RESEARCH LICENSE SHALL BE
DETERMINED BY THE DEPARTMENT ON AN ANNUAL BASIS AND MAY BE BASED ON THE
SIZE, SCOPE AND DURATION OF THE RESEARCH PROPOSED.
8. EACH PSILOCYBIN RESEARCH LICENSEE SHALL ISSUE AN ANNUAL REPORT TO
THE DEPARTMENT. THE DEPARTMENT SHALL REVIEW SUCH REPORT AND MAKE A
DETERMINATION AS TO WHETHER THE RESEARCH PROJECT CONTINUES TO MEET THE
RESEARCH QUALIFICATIONS UNDER THIS SECTION.
§ 3369-KK. RELATION TO OTHER LAWS. 1. THE PROVISIONS OF THIS TITLE
SHALL APPLY, EXCEPT THAT WHERE A PROVISION OF THIS TITLE CONFLICTS WITH
ANOTHER PROVISION OF THIS CHAPTER, THIS TITLE SHALL APPLY.
A. 8569 19
2. MEDICAL PSILOCYBIN SHALL NOT BE DEEMED TO BE A "DRUG" FOR PURPOSES
OF ARTICLE ONE HUNDRED THIRTY-SEVEN OF THE EDUCATION LAW.
§ 3369-LL. PSILOCYBIN SERVICE FACILITATOR LICENSE REQUIREMENTS. 1. AN
APPLICANT FOR A PSILOCYBIN SERVICE FACILITATOR LICENSE SHALL MEET THE
FOLLOWING REQUIREMENTS:
(A) HAVE A HIGH SCHOOL DIPLOMA OR EQUIVALENT EDUCATION;
(B) ANY ADDITIONAL EDUCATION OR TRAINING REQUIREMENTS ESTABLISHED BY
THE DEPARTMENT, EXCEPT THAT THE DEPARTMENT SHALL NOT REQUIRE A DEGREE
FROM AN INSTITUTION OF HIGHER EDUCATION;
(C) ANY EXAMINATION REQUIREMENTS ESTABLISHED BY THE DEPARTMENT, EXCEPT
THAT THE DEPARTMENT MAY PROVIDE FOR WAIVERS OF EXAMINATION REQUIREMENTS
IN CASES IT DEEMS APPROPRIATE. THE DEPARTMENT SHALL OFFER ANY REQUIRED
EXAMINATION AT LEAST TWICE ANNUALLY. THE DEPARTMENT MAY APPOINT A PERSON
TO CONDUCT OR SUPERVISE EXAMINATIONS OF APPLICANTS. AN APPLICANT MAY
RETAKE ANY FAILED SECTION OF THE EXAMINATION IN ACCORDANCE WITH RULES
ADOPTED BY THE DEPARTMENT; AND
(D) ANY OTHER TRAINING, EDUCATION, SKILL OR FITNESS REQUIREMENTS
ADOPTED BY THE DEPARTMENT, SUCH AS:
(I) FACILITATION SKILLS THAT ARE AFFIRMING, NONJUDGMENTAL AND NONDI-
RECTIVE; AND
(II) SUPPORT SKILLS FOR CLIENTS DURING AN ADMINISTRATION SESSION,
INCLUDING SPECIALIZED SKILLS RELATING TO CLIENT SAFETY AND CLIENTS WHO
MAY HAVE MENTAL HEALTH CONDITIONS, ABILITY TO ESTABLISH A PROPER ENVI-
RONMENT IN WHICH PSILOCYBIN SERVICES OCCUR AND SOCIAL AND CULTURAL
SKILLS.
2. THE DEPARTMENT SHALL ESTABLISH A PROCESS TO APPROVE TRAINING COURS-
ES FOR PSILOCYBIN SERVICE FACILITATORS. TO OBTAIN APPROVAL OF A COURSE,
THE PERSON PROVIDING THE COURSE SHALL SUBMIT AN OUTLINE OF INSTRUCTION
TO THE DEPARTMENT AND TO THE DEPARTMENT OF EDUCATION THAT INCLUDES THE
COURSE TOPICS, TOTAL HOURS OF INSTRUCTION, HOURS OF LECTURES IN THEORY
AND HOURS OF INSTRUCTION IN APPLICATION OF PRACTICAL SKILLS.
3. THE DEPARTMENT SHALL ESTABLISH A CODE OF PROFESSIONAL CONDUCT,
INCLUDING A CODE OF ETHICS, FOR PSILOCYBIN SERVICE FACILITATORS. THE
DEPARTMENT SHALL ESTABLISH STANDARDS OF PRACTICE AND PROFESSIONAL
RESPONSIBILITY FOR PSILOCYBIN SERVICE FACILITATORS.
4. A PSILOCYBIN SERVICE FACILITATOR LICENSEE MAY ENGAGE IN THE FOLLOW-
ING ACTIVITIES IN ACCORDANCE WITH RULES ADOPTED BY THE DEPARTMENT:
(A) DELIVER PSILOCYBIN PRODUCTS TO PREMISES FOR WHICH A LICENSE HAS
BEEN ISSUED UNDER THIS TITLE;
(B) RECEIVE PSILOCYBIN PRODUCTS FROM A REGISTERED ORGANIZATION OR
ANOTHER PSILOCYBIN SERVICE CENTER LICENSEE; AND
(C) SELL PSILOCYBIN PRODUCTS TO A CERTIFIED PATIENT ON THE PREMISES
FOR WHICH THE LICENSE HAS BEEN ISSUED.
§ 3369-MM. PROTECTIONS FOR THE MEDICAL USE OF PSILOCYBIN. 1. CERTI-
FIED PATIENTS, DESIGNATED CAREGIVERS, PSILOCYBIN SERVICE CENTERS AND
EMPLOYEES OF PSILOCYBIN SERVICE CENTERS, PRACTITIONERS, REGISTERED
ORGANIZATIONS AND THE EMPLOYEES OF REGISTERED ORGANIZATIONS, AND PSILO-
CYBIN RESEARCHERS SHALL NOT BE SUBJECT TO ARREST, PROSECUTION, OR PENAL-
TY IN ANY MANNER, OR DENIED ANY RIGHT OR PRIVILEGE, INCLUDING BUT NOT
LIMITED TO CIVIL PENALTY OR DISCIPLINARY ACTION BY A BUSINESS OR OCCUPA-
TIONAL OR PROFESSIONAL LICENSING BOARD OR BUREAU, SOLELY FOR THE CERTI-
FIED MEDICAL USE OR MANUFACTURE OF PSILOCYBIN, OR FOR ANY OTHER ACTION
OR CONDUCT IN ACCORDANCE WITH THIS TITLE.
2. BEING A CERTIFIED PATIENT SHALL BE DEEMED TO BE HAVING A "DISABILI-
TY" UNDER ARTICLE FIFTEEN OF THE EXECUTIVE LAW, SECTION FORTY-C OF THE
CIVIL RIGHTS LAW AND SECTIONS 240.00, 485.00, AND 485.05 OF THE PENAL
A. 8569 20
LAW. THIS SUBDIVISION SHALL NOT BAR THE ENFORCEMENT OF A POLICY PROHIB-
ITING AN EMPLOYEE FROM PERFORMING HIS OR HER EMPLOYMENT DUTIES WHILE
IMPAIRED BY A CONTROLLED SUBSTANCE. THIS SUBDIVISION SHALL NOT REQUIRE
ANY PERSON OR ENTITY TO DO ANY ACT THAT WOULD PUT THE PERSON OR ENTITY
IN DIRECT VIOLATION OF FEDERAL LAW OR CAUSE IT TO LOSE A FEDERAL
CONTRACT OR FUNDING.
3. THE FACT THAT A PERSON IS A CERTIFIED PATIENT AND/OR ACTING IN
ACCORDANCE WITH THIS TITLE, SHALL NOT BE A CONSIDERATION IN A PROCEEDING
PURSUANT TO APPLICABLE SECTIONS OF THE DOMESTIC RELATIONS LAW, THE
SOCIAL SERVICES LAW AND THE FAMILY COURT ACT.
4. (A) CERTIFICATION APPLICATIONS, CERTIFICATION FORMS, ANY CERTIFIED
PATIENT INFORMATION CONTAINED WITHIN A DATABASE, AND COPIES OF REGISTRY
IDENTIFICATION CARDS SHALL BE DEEMED EXEMPT FROM PUBLIC DISCLOSURE UNDER
SECTIONS EIGHTY-SEVEN AND EIGHTY-NINE OF THE PUBLIC OFFICERS LAW. UPON
SPECIFIC REQUEST BY A CERTIFIED PATIENT TO THE DEPARTMENT, THE DEPART-
MENT SHALL VERIFY THE REQUESTING PATIENT'S STATUS AS A VALID CERTIFIED
PATIENT TO THE PATIENT'S SCHOOL OR EMPLOYER OR OTHER DESIGNATED PARTY,
TO ENSURE COMPLIANCE WITH THE PROTECTIONS AFFORDED BY THIS SECTION.
(B) THE NAME, CONTACT INFORMATION, AND OTHER INFORMATION RELATING TO
PRACTITIONERS REGISTERED WITH THE DEPARTMENT UNDER THIS TITLE SHALL BE
PUBLIC INFORMATION AND SHALL BE MAINTAINED ON THE DEPARTMENT'S WEBSITE
ACCESSIBLE TO THE PUBLIC IN SEARCHABLE FORM. HOWEVER, IF A PRACTITIONER
NOTIFIES THE DEPARTMENT IN WRITING THAT HE OR SHE DOES NOT WANT HIS OR
HER NAME AND OTHER INFORMATION DISCLOSED, THAT PRACTITIONER'S NAME AND
OTHER INFORMATION SHALL THEREAFTER NOT BE PUBLIC INFORMATION OR MAIN-
TAINED ON THE DEPARTMENT'S WEBSITE, UNLESS THE PRACTITIONER CANCELS THE
REQUEST.
5. A PERSON CURRENTLY UNDER PAROLE, PROBATION OR OTHER STATE OR LOCAL
SUPERVISION, OR RELEASED ON BAIL AWAITING TRIAL MAY NOT BE PUNISHED OR
OTHERWISE PENALIZED FOR CONDUCT ALLOWED UNDER THIS TITLE.
6. EMPLOYEES WHO USE MEDICAL PSILOCYBIN SHALL BE AFFORDED THE SAME
RIGHTS, PROCEDURES AND PROTECTIONS THAT ARE AVAILABLE AND APPLICABLE TO
INJURED WORKERS UNDER THE WORKERS' COMPENSATION LAW, OR ANY RULES OR
REGULATIONS PROMULGATED THEREUNDER, WHEN SUCH INJURED WORKERS ARE
PRESCRIBED MEDICATIONS THAT MAY PROHIBIT, RESTRICT, OR REQUIRE THE
MODIFICATION OF THE PERFORMANCE OF THEIR DUTIES.
§ 3369-NN. REGULATIONS. THE DEPARTMENT SHALL PROMULGATE REGULATIONS TO
IMPLEMENT THIS TITLE.
§ 3369-OO. SUSPEND; TERMINATE. BASED UPON THE RECOMMENDATION OF THE
DEPARTMENT, EXECUTIVE DIRECTOR AND/OR THE SUPERINTENDENT OF STATE POLICE
THAT THERE IS A RISK TO THE PUBLIC HEALTH OR SAFETY, THE GOVERNOR MAY
IMMEDIATELY SUSPEND OR TERMINATE ALL LICENSES ISSUED TO REGISTERED
ORGANIZATIONS.
§ 3369-PP. PRICING. REGISTERED ORGANIZATIONS SHALL SUBMIT DOCUMENTA-
TION TO THE EXECUTIVE DIRECTOR OF ANY CHANGE IN PRICING PER DOSE FOR ANY
MEDICAL PSILOCYBIN PRODUCT WITHIN FIFTEEN DAYS OF SUCH CHANGE. PRIOR
APPROVAL BY THE EXECUTIVE DIRECTOR SHALL NOT BE REQUIRED FOR ANY SUCH
CHANGE; PROVIDED HOWEVER THAT THE DEPARTMENT IS AUTHORIZED TO MODIFY THE
PRICE PER DOSE FOR ANY MEDICAL PSILOCYBIN PRODUCT IF NECESSARY TO MAIN-
TAIN PUBLIC ACCESS TO APPROPRIATE MEDICATION.
§ 3369-QQ. PSILOCYBIN SERVICES GRANT PROGRAM. THE DEPARTMENT SHALL
ESTABLISH A PROGRAM OF AWARDED GRANTS WITHIN THE AMOUNT IN THE PSILOCY-
BIN SERVICES GRANT PROGRAM FUND ESTABLISHED UNDER SECTION NINETY-SEVEN-
UUUU OF THE STATE FINANCE LAW FOR VETERANS AND FIRST RESPONDERS TO
RECEIVE MONETARY ASSISTANCE FOR PSILOCYBIN SERVICES PURSUANT TO THIS
TITLE. THE DEPARTMENT SHALL PROMULGATE ANY NECESSARY RULES AND REGU-
A. 8569 21
LATIONS FOR THE APPLICATION AND DISTRIBUTION OF ANY FUNDS PURSUANT TO
THIS SECTION.
§ 3369-RR. PSILOCYBIN SERVICES ADVISORY BOARD. 1. THE PSILOCYBIN
SERVICES ADVISORY BOARD OR "ADVISORY BOARD" IS ESTABLISHED WITHIN THE
DEPARTMENT TO ADVISE AND ISSUE RECOMMENDATIONS ON THE USE OF MEDICAL
PSILOCYBIN IN THE STATE OF NEW YORK.
2. (A) THE ADVISORY BOARD SHALL CONSIST OF FOURTEEN VOTING APPOINTED
MEMBERS, ALONG WITH THE FOLLOWING MEMBERS SERVING AS NON-VOTING EX-OFFI-
CIO MEMBERS: (I) THE COMMISSIONER, OR HIS OR HER DESIGNEE; AND (II) A
REPRESENTATIVE FROM THE DEPARTMENT WHO IS FAMILIAR WITH PUBLIC HEALTH
PROGRAMS AND PUBLIC HEALTH ACTIVITIES IN THE STATE.
(B) THE GOVERNOR SHALL HAVE EIGHT APPOINTMENTS, THE TEMPORARY PRESI-
DENT OF THE SENATE AND THE SPEAKER OF THE ASSEMBLY SHALL EACH HAVE THREE
APPOINTMENTS TO THE BOARD. ADVISORY BOARD MEMBERS SHALL HAVE STATEWIDE
GEOGRAPHIC REPRESENTATION THAT IS BALANCED AND DIVERSE IN ITS COMPOSI-
TION. APPOINTED MEMBERS SHALL HAVE AN EXPERTISE IN PUBLIC AND BEHAVIORAL
HEALTH, SUBSTANCE USE DISORDER TREATMENT, EFFECTIVE REHABILITATIVE
TREATMENT FOR ADULTS AND JUVENILES, HOMELESSNESS AND HOUSING, ECONOMIC
DEVELOPMENT, ENVIRONMENTAL CONSERVATION, JOB TRAINING AND PLACEMENT,
CRIMINAL JUSTICE, AND DRUG POLICY. FURTHER, THE ADVISORY BOARD SHALL
INCLUDE RESIDENTS FROM COMMUNITIES MOST IMPACTED BY PSILOCYBIN PROHIBI-
TION, PEOPLE WITH PRIOR DRUG CONVICTIONS, THE FORMERLY INCARCERATED, AND
REPRESENTATIVES FROM THE FARMING INDUSTRY, PSILOCYBIN INDUSTRY, AND
ORGANIZATIONS SERVING COMMUNITIES IMPACTED BY PAST FEDERAL AND STATE
DRUG POLICIES.
3. THE MEMBERS SHALL BE APPOINTED TO THE ADVISORY BOARD TO EACH SERVE
FOUR-YEAR TERMS AND IN THE EVENT OF A VACANCY, THE VACANCY SHALL BE
FILLED IN THE MANNER OF THE ORIGINAL APPOINTMENT FOR THE REMAINDER OF
THE TERM. THE APPOINTED MEMBERS AND REPRESENTATIVES SHALL RECEIVE NO
COMPENSATION FOR THEIR SERVICES BUT SHALL BE ALLOWED THEIR ACTUAL AND
NECESSARY EXPENSES INCURRED IN THE PERFORMANCE OF THEIR DUTIES AS BOARD
MEMBERS.
4. THE CHAIRPERSON OF THE ADVISORY BOARD AND THE VICE CHAIRPERSON
SHALL BE ELECTED FROM AMONG THE MEMBERS OF THE ADVISORY BOARD BY THE
MEMBERS OF SUCH ADVISORY BOARD. THE VICE CHAIRPERSON SHALL REPRESENT THE
ADVISORY BOARD IN THE ABSENCE OF THE CHAIRPERSON AT ALL OFFICIAL ADVI-
SORY BOARD FUNCTIONS.
5. THE ADVISORY BOARD SHALL ENACT AND FROM TIME TO TIME MAY AMEND
BYLAWS OR RULES IN RELATION TO ITS MEETINGS AND THE TRANSACTION OF ITS
BUSINESS. THE BOARD MAY ALSO ESTABLISH COMMITTEES AND SUBCOMMITTEES
NECESSARY FOR THE OPERATION OF THE BOARD. A MAJORITY OF THE TOTAL NUMBER
OF VOTING MEMBERS WHICH THE BOARD WOULD HAVE WERE THERE NO VACANCIES,
SHALL CONSTITUTE A QUORUM AND SHALL BE REQUIRED FOR THE BOARD TO CONDUCT
BUSINESS. ALL MEETINGS OF THE ADVISORY BOARD SHALL BE CONDUCTED IN
ACCORDANCE WITH THE PROVISIONS OF ARTICLE SEVEN OF THE PUBLIC OFFICERS
LAW.
6. WITHIN THE FIRST TWO YEARS OF THE ESTABLISHMENT OF THE ADVISORY
BOARD, THE BOARD SHALL MEET AT LEAST ONCE EVERY TWO CALENDAR MONTHS AT A
TIME AND PLACE DETERMINED BY THE CHAIRPERSON OR A MAJORITY OF THE VOTING
MEMBERS OF THE BOARD. AFTER THE FIRST TWO YEARS, THE ADVISORY BOARD
SHALL MEET AT LEAST ONCE EVERY CALENDAR QUARTER AT A TIME AND PLACE
DETERMINED BY THE CHAIRPERSON OR A MAJORITY OF THE VOTING MEMBERS OF THE
BOARD. THE ADVISORY BOARD MAY ALSO MEET AT OTHER TIMES AND PLACES SPECI-
FIED BY THE CALL OF THE CHAIRPERSON OR OF A MAJORITY OF THE VOTING
MEMBERS OF THE BOARD.
7. THE ADVISORY BOARD SHALL HAVE THE FOLLOWING DUTIES:
A. 8569 22
(A) PROVIDE ADVICE TO THE DEPARTMENT REGARDING THE PROVISIONS OF THIS
TITLE AND MAKE RECOMMENDATIONS ON AVAILABLE MEDICAL, PSYCHOLOGICAL,
SCIENTIFIC STUDIES, RESEARCH AND OTHER INFORMATION RELATING TO THE SAFE-
TY AND EFFICACY OF PSILOCYBIN IN TREATING MENTAL HEALTH CONDITIONS,
INCLUDING BUT NOT LIMITED TO ADDICTION, DEPRESSION, ANXIETY DISORDERS
AND END-OF-LIFE PSYCHOLOGICAL DISTRESS.
(B) MAKE RECOMMENDATIONS TO THE DEPARTMENT ON THE REQUIREMENTS, SPEC-
IFICATIONS AND GUIDELINES FOR PROVIDING PSILOCYBIN SERVICES TO A CLIENT,
INCLUDING:
(I) THE REQUIREMENTS, SPECIFICATIONS AND GUIDELINES FOR HOLDING AND
VERIFYING THE COMPLETION OF A PREPARATION SESSION, AN ADMINISTRATION
SESSION AND AN INTEGRATION SESSION; AND
(II) THE CONTENTS OF THE CERTIFIED PATIENT INFORMATION FORM THAT A
CERTIFIED PATIENT MUST COMPLETE AND SIGN BEFORE THE PATIENT PARTICIPATES
IN AN ADMINISTRATION SESSION, GIVING PARTICULAR CONSIDERATION TO:
(A) THE INFORMATION THAT SHOULD BE SOLICITED FROM THE PATIENT TO
DETERMINE WHETHER SUCH PATIENT SHOULD PARTICIPATE IN THE ADMINISTRATION
SESSION, INCLUDING INFORMATION THAT MAY IDENTIFY RISK FACTORS AND
CONTRAINDICATIONS;
(B) THE INFORMATION THAT SHOULD BE SOLICITED FROM THE PATIENT TO
ASSIST THE PSILOCYBIN SERVICE CENTER OPERATOR AND THE PSILOCYBIN SERVICE
FACILITATOR IN MEETING ANY PUBLIC HEALTH AND SAFETY STANDARDS AND INDUS-
TRY BEST PRACTICES DURING THE ADMINISTRATION SESSION; AND
(C) THE HEALTH AND SAFETY WARNINGS AND OTHER DISCLOSURES THAT SHOULD
BE MADE TO THE PATIENT BEFORE SUCH PATIENT PARTICIPATES IN THE ADMINIS-
TRATION SESSION.
(C) MAKE RECOMMENDATIONS TO THE DEPARTMENT ON PUBLIC HEALTH AND SAFETY
STANDARDS AND INDUSTRY BEST PRACTICES FOR EACH TYPE OF LICENSEE UNDER
THIS TITLE.
(D) MAKE RECOMMENDATIONS TO THE DEPARTMENT ON THE FORMULATION OF A
CODE OF PROFESSIONAL CONDUCT FOR PSILOCYBIN SERVICE FACILITATORS, GIVING
PARTICULAR CONSIDERATION TO A CODE OF ETHICS.
(E) MAKE RECOMMENDATIONS TO THE DEPARTMENT ON THE EDUCATION AND TRAIN-
ING THAT PSILOCYBIN SERVICE FACILITATORS MUST COMPLETE, INCLUDING BUT
NOT LIMITED TO WHETHER SUCH EDUCATION AND TRAINING SHOULD BE AVAILABLE
THROUGH ONLINE RESOURCES. GIVING PARTICULAR CONSIDERATION TO:
(I) FACILITATION SKILLS THAT ARE AFFIRMING, NON-JUDGMENTAL AND NON-DI-
RECTIVE;
(II) SUPPORT SKILLS FOR CLIENTS DURING AN ADMINISTRATION SESSION,
INCLUDING SPECIALIZED SKILLS FOR CLIENT SAFETY AND CLIENTS WHO MAY HAVE
A MENTAL HEALTH CONDITION;
(III) THE ENVIRONMENT IN WHICH PSILOCYBIN SERVICES SHOULD OCCUR; AND
(IV) SOCIAL AND CULTURAL CONSIDERATIONS.
(F) MAKE RECOMMENDATIONS TO THE DEPARTMENT ON THE EXAMINATIONS THAT
PSILOCYBIN SERVICE FACILITATORS MUST PASS.
(G) MAKE RECOMMENDATIONS TO THE DEPARTMENT ON PUBLIC HEALTH AND SAFE-
TY STANDARDS AND INDUSTRY BEST PRACTICES FOR HOLDING AND COMPLETING AN
ADMINISTRATION SESSION, INCLUDING:
(I) WHETHER GROUP ADMINISTRATION SESSIONS SHOULD BE AVAILABLE;
(II) WHETHER CERTIFIED PATIENTS SHOULD BE ABLE TO ACCESS COMMON OR
OUTSIDE AREAS ON THE PREMISES OF THE PSILOCYBIN SERVICE CENTER AT WHICH
THE ADMINISTRATION SESSION IS HELD;
(III) THE CIRCUMSTANCES UNDER WHICH AN ADMINISTRATION SESSION IS
CONSIDERED COMPLETE; AND
(IV) THE TRANSPORTATION NEEDS OF THE CLIENT AFTER THE COMPLETION OF
THE ADMINISTRATION SESSION.
A. 8569 23
(H) IN CONSULTATION WITH THE DEPARTMENT OF AGRICULTURE AND MARKETS AND
THE DEPARTMENT OF ENVIRONMENTAL CONSERVATION, PROMULGATE NECESSARY RULES
AND REGULATIONS GOVERNING THE SAFE PRODUCTION OF PSILOCYBIN, INCLUDING
ENVIRONMENTAL AND ENERGY STANDARDS AND RESTRICTIONS ON THE USE OF PESTI-
CIDES AND BEST PRACTICES FOR WATER AND ENERGY CONSERVATION.
(I) DEVELOP A LONG-TERM STRATEGIC PLAN FOR ENSURING THAT PSILOCYBIN
SERVICES WILL BECOME AND REMAIN A SAFE, ACCESSIBLE AND AFFORDABLE THERA-
PEUTIC OPTION FOR ALL PERSONS TWENTY-ONE YEARS OF AGE AND OLDER IN THE
STATE FOR WHOM PSILOCYBIN SERVICES MAY BE APPROPRIATE.
(J) MONITOR AND STUDY FEDERAL LAWS, REGULATIONS AND POLICIES REGARDING
PSILOCYBIN.
§ 2. The state finance law is amended by adding a new section 97-uuuu
to read as follows:
§ 97-UUUU. PSILOCYBIN SERVICES GRANT PROGRAM FUND. 1. THERE IS HEREBY
ESTABLISHED IN THE JOINT CUSTODY OF THE COMMISSIONER OF HEALTH AND THE
COMPTROLLER A FUND TO BE KNOWN AS THE "PSILOCYBIN SERVICES GRANT PROGRAM
FUND".
2. THE FUND SHALL CONSIST OF ALL MONIES APPROPRIATED FOR ITS PURPOSE,
AND ALL MONIES REQUIRED BY THIS SECTION OR ANY OTHER PROVISION OF LAW TO
BE PAID INTO OR CREDITED TO SUCH FUND. THE FUND SHALL NOT CONTAIN ANY
MONIES WHICH ARE NOT INTENDED FOR THE FUND.
3. MONIES OF THE FUND, WHEN ALLOCATED, SHALL BE AVAILABLE PURSUANT TO
SECTION THIRTY-THREE HUNDRED SIXTY-NINE-QQ OF THE PUBLIC HEALTH LAW.
4. MONIES SHALL BE PAYABLE FROM THE FUND ON THE AUDIT AND WARRANT OF
THE STATE COMPTROLLER ON VOUCHERS APPROVED AND CERTIFIED BY THE COMMIS-
SIONER OF HEALTH.
§ 3. The sum of two million dollars ($2,000,000), or so much thereof
as may be necessary, is hereby appropriated to the department of health
out of any moneys in the state treasury in the general fund to the cred-
it of the psilocybin services grant program, not otherwise appropriated,
and made immediately available, for the purpose of carrying out the
provisions of this act. Such moneys shall be payable on the audit and
warrant of the comptroller on vouchers certified or approved by the
commissioner of health in the manner prescribed by law.
§ 4. This act shall take effect on the ninetieth day after it shall
have become a law.