Allow Medical Psilocybin Use

Section 1. This act shall be known and may be cited as the "medical psilocybin act".

§ 2. Article 33 of the public health law is amended by adding a new title 5-B to read as follows:

TITLE V-B

MEDICAL PSILOCYBIN ACT Section 3369-aa. Definitions.

3369-bb. Medical use of psilocybin program.

3369-cc. Registry identification cards.

3369-dd. Exemption from criminal and civil penalties for

possession and medical use of psilocybin.

3369-ee. Prohibitions, restrictions and limitations on the use

of psilocybin.

3369-ff. Recordkeeping.

3369-gg. Labelling; warnings.

3369-hh. Safety and testing requirements.

3369-ii. Violations.

3369-jj. Reporting.

3369-kk. Protections for the medical use of psilocybin.

§ 3369-aa. Definitions. As used in this title:

1. "Designated caregiver" means the individual designated by a qualified patient in a registry application. A qualified patient may designate up to two caregivers;

EXPLANATION--Matter in italics (underscored) is new; matter in brackets

[ ] is old law to be omitted.

LBD03342-02-6

2. "Licensed healthcare provider" means a person who: (a) is licensed as a physician, a psychologist or a nurse practitioner under title eight of the education law; and (b) has completed a two to four hour course as determined by the commissioner in regulations; provided however, a registration shall not be denied without cause. Such course may count toward board certification requirements. To be a licensed healthcare provider under this title, such licensed professional's authorized scope of practice does not need to, but may include, medical diagnosis or treatment of a qualifying health condition or the prescription of medications;

3. "Licensed producer" means a person or business enterprise, including a sole proprietorship, partnership, corporation, limited liability company, or other business enterprise, who or which has a license from the department pursuant to this title to grow and harvest or prepare psilocybin from psilocybin-producing mushrooms, including to compound, convert, process or manufacture psilocybin products directly or indirectly from psilocybin mushrooms, to package or repackage or label or relabel the products, and to transport and deliver psilocybin and psilocybin products;

4. "Permitted medical use" means the quantity of psilocybin, dosing parameters, method of administration, setting, and whether supervised use is required, for an individual qualified patient as determined by a licensed healthcare provider as part of an individualized treatment plan;

5. "Psilocybin" means the naturally occurring psychedelic compound 4-phosphoryloxy-N,N-dimethyltryptamine, also known as 4-PO-DMT, and its pharmacologically active metabolite psilocin, 4-hydroxy-N,N-dimethyltryptamine, found in certain mushrooms, but does not include synthetic or synthetic analogs of psilocybin;

6. "Qualified patient" means a patient whose licensed healthcare provider has judged to be a medically appropriate candidate for the use of medical psilocybin based on being diagnosed with a qualifying condition;

7. "Qualifying condition" includes:

(a) major treatment-resistant depression;

(b) post-traumatic stress disorder;

(c) substance use disorders;

(d) end-of-life care;

(e) cluster headaches; and

(f) other conditions approved by the department;

8. "Qualified supervisor" means an individual who meets training and qualification standards established by the department and is authorized by the department to supervise the use of psilocybin by qualified patients. A qualified supervisor need not be a licensed healthcare provider; and

9. "Supervised use" means the administration of psilocybin in the presence of a licensed healthcare provider, a licensed healthcare provider's authorized staff, or a qualified supervisor.

§ 3369-bb. Medical use of psilocybin program. 1. The "medical use of psilocybin program" or "the program" is hereby created within the department. In developing the program, the department shall establish:

(a) procedures for the issuance, renewal, suspension, and revocation of licenses, registrations, or permits necessary for the implementation and operation of the program;

(b) appropriate requirements for licensed producers, licensed healthcare providers and qualified patients;

(c) criteria and a process for licensure and registration of psilocybin producers;

(d) necessary initial and ongoing training for licensed producers, licensed healthcare providers and qualified supervisors;

(e) appropriate qualifications, education and training standards for qualified supervisors;

(f) treatment protocols, including patient selection criteria, medical service standards, dosage standards and approved settings for administration of psilocybin to qualified patients;

(g) requirements and standards for supervised use that are focused on safety and efficacy;

(h) safety protocols for producing psilocybin from mushrooms, transporting, storing, handling and dispensing psilocybin to qualified patients, licensed healthcare providers, qualified supervisors, or other individuals authorized by the department;

(i) registry identification systems for patients and designated caregivers;

(j) other best practices for licensed producers, licensed healthcare providers and qualified supervisors;

(k) requirements for data collection to evaluate the program and the use of best practices by licensed producers, licensed healthcare providers, and qualified supervisors; and

(l) other requirements, restrictions and limitations deemed necessary by the department.

2. The department shall require that either the qualified patient or the licensed healthcare provider who is recommending psilocybin and treating such patient be a New York state resident.

3. The department shall monitor licensed producers, licensed healthcare providers, and qualified supervisors to ensure compliance with the provisions of this title and the rules and regulations promulgated therefor.

4. The department shall consult with the department of mental hygiene in developing best practices, including best settings for administration of psilocybin. Subject to the regulations of the department, a licensed healthcare provider or qualified supervisor shall determine the appropriate setting on a case-by-case basis for qualified patients.

5. The department shall develop and require labels warning consumers of any potential impact on human health resulting from the consumption of psilocybin products that shall be affixed to those products when sold, if such labels are deemed warranted by the department and may establish standardized and/or uniform packaging and labeling requirements for medical use psilocybin products.

6. Psilocybin shall be dispensed in a sealed and properly labeled package. The labeling shall contain: (a) the information required to be included in the receipt provided to the qualified patient by the licensed producer; (b) the packaging date; (c) any applicable date by which the psilocybin should be used; (d) the amount of individual doses contained within; (e) usage instructions; and (f) a warning that the psilocybin must be kept in the original container in which it was dispensed except for the portion removed for immediate consumption.

7. Other than as set forth in subdivision eight of this section, a licensed producer may, in accordance with a qualified patient's permitted medical use, transport and deliver psilocybin to: (a) a qualified patient; (b) a licensed healthcare provider; (c) a qualified supervisor; or (d) an authorized designated caregiver.

8. Psilocybin intended for supervised use as required by the qualified patient's permitted medical use shall only be delivered directly to a licensed healthcare provider, a licensed healthcare provider's authorized staff, or to a qualified supervisor.

9. (a) No licensed producer may sell, deliver, distribute or dispense a quantity of psilocybin larger than, or in a manner inconsistent with, a qualified patient's permitted medical use as allowed under this title.

(b) When dispensing psilocybin to a qualified patient, the licensed producer shall not dispense an amount greater than a thirty day supply of the dosage as determined by the licensed healthcare provider, consistent with the qualified patient's permitted medical use, or, if not specified by the licensed healthcare provider, by the department through regulation, which may include qualifying condition-specific standards for dosing, administration, setting, and supervised use.

§ 3369-cc. Registry identification cards. 1. Upon a determination of qualification of a patient by a licensed healthcare provider to participate in the program under this title, the department shall issue a registry identification card for such qualified patient. A registry identification card shall expire as provided in this section. The department may specify a form for a registry application, in which case the department shall provide 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 qualified patient shall file a registry application with the department. The registry application or renewal application shall include:

(a) (i) the licensed healthcare provider's determination of the patient's qualification under this title;

(ii) the name, address, and date of birth of the patient;

(iii) the date of the qualification;

(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 psilocybin use, if the certification states such a date;

(vi) the name, address, federal registration number, if any, and telephone number of the licensed healthcare provider;

(vii) any recommendation or limitation by the provider as to the form or forms of psilocybin or dosage for the qualified patient and whether or not supervised use is required; and

(viii) other individual identifying information required by the department;

(b) in the case of a qualified patient, if the 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;

(c) in the case of a designated caregiver:

(i) the name, address, and date of birth of the designated caregiver; and

(ii) if the designated caregiver has a registry identification card, the registry identification number and expiration date of that registry identification card;

(d) a statement that a false statement made in the application is punishable under section 210.45 of the penal law;

(e) the date of the application and the signature of the qualified patient; and

(f) any other requirements determined by the commissioner.

3. A registry identification card shall:

(a) contain the name of the qualified patient or the designated caregiver;

(b) contain the date of issuance and expiration date of the registry identification card;

(c) contain a registry identification number for the qualified patient or the designated caregiver, and a registry identification number;

(d) contain a photograph of the individual to whom the registry identification card is being issued, which shall be obtained by the department in a manner specified by the commissioner in regulations; provided, however, that if the department requires qualified patients to submit photographs for this purpose, there shall be a reasonable accommodation of qualified patients who are confined to their homes due to their medical conditions and may therefore have difficulty procuring photographs;

(e) be a secure document as determined by the department;

(f) plainly state any recommendation or limitation by the licensed healthcare provider as to the form or forms of psilocybin or dosage for the qualified patient; and

(g) any other requirements determined by the commissioner.

4. The department shall maintain a confidential list of the persons to whom it has issued registry identification cards. Individual identifying information obtained by the department under this title shall be confidential and exempt from disclosure under article six of the public officers law. Notwithstanding this subdivision, the department may notify any appropriate law enforcement agency of information relating to any violation or suspected violation of this title.

5. The department shall verify to law enforcement personnel in an appropriate case whether a registry identification card is valid.

6. If a qualified patient willfully violates any provision of this title as determined by the department, their registry identification card may be suspended or revoked, in addition to any other penalty that may apply.