Following up from its August 10th news release, the New York State Department of Health has published proposed regulations to the New York State Register today that detail some substantial changes ahead for the program (see pages 5-7). The proposed rules are subject to a 30-day public comment period before they can be be adopted.

The state will now permit new forms of products, like capsules, chewable tablets and lozenges. Additionally, advertising restrictions were reduced, with registered organizations now permitted to use lighting with their signage for dispensaries, which no longer are limited to black and white. Even with the changes, the program, which currently serves 28,077 certified patients, has room for further improvement, according to Jeremy Unruh, General Counsel at PharmaCann.

New York recently added five new registered organizations, bring the total to ten, including Citiva Medical, Columbia Care, Etain, Fiorella Pharmaceuticals, MedMen, NYCANNA, PalliaTech NY, PharmaCann, Valley Agriceuticals and Vireo Health. Publicly-traded iAnthus Capital Holdings (CSE: IAN) (OTC: ITHUF) recently announced a pending acquisition of Citiva. MedMen acquired Bloomfield Industries earlier this year.

Here is the complete text of the proposed rules:

Substance of revised rule (Full text is posted at the following State

website: https://regs.health.ny.gov/regulations/proposed-rule-making):

Pursuant to the authority vested in the Commissioner of Health by Section

3369-a of the Public Health Law (PHL), Part 1004 of Title 10 (Health) of

the Official Compilation of Codes, Rules and Regulations of the State of

New York, and pursuant to Section 502 of the PHL, Subpart 55-2 of Title

10, are amended, to be effective upon publication of a Notice of Adoption

in the New York State Register, to read as follows:

§ 1004.1 Practitioner registration. Section 1004.1(a) and (b) are

amended to align with the statute, which requires practitioners to complete

a two to four-hour course and register with the department before certifying

patients for medical marihuana.

§ 1004.2 Practitioner issuance of certification. Section 1004.2(a) is

amended to clarify the department’s expectation that practitioners adhere

to new section 1004.2(e) which details the statutory requirement to consult

the Prescription Monitoring Program Registry. Section 1004.2(a) is further

amended to require registered practitioners to indicate on patient

certifications whether a patient is temporarily residing in New York State

for the purpose of receiving care and treatment from the practitioner.

§ 1004.3 Application for registration as a certified patient. Section

1004.3(b) is amended to clarify that New York State residents must show

proof of residency. Section 1004.3(b) is amended to remove the requirement

that applicants include a statement in their application if they are

temporarily residing in New York State for purposes of receiving care and

treatment in in the state, as this requirement will now be documented by

the certifying practitioner.

§ 1004.4 Designated caregiver registration. Section 1004.4(b) is

amended to indicate that acceptable proof of residence for a caregiver

includes a New York State non-driver identification card.

§ 1004.5 Application for initial registration as a registered organization.

Section 1004.5(b) is amended to clarify the requirement to submit a prepared

financial statement upon initial application for designation as a

registered organization.

§ 1004.6 Consideration of registered organization applications. Section

1004.6(a) is amended to allow forms of payment other than a certified

check. Section 1004.6(e) is amended to clarify that a registered organization’s

registration may be amended instead of the application for

registration.

§ 1004.10 Registered organizations; general requirements. Section

1004.10(a) is amended to include a process in which the department will

provide a statement of findings to a registered organization, and that the

registered organization must respond and implement a plan of correction

to address any deficiencies identified by the department. Section

1004.10(a) is also amended to allow manufacturing materials to be submitted

to the department upon request and to reduce sample retention duration

from two years to thirty days after the date of expiration. Further, this

section is amended to clarify that registered organizations must notify the

department of adverse events and other incidents within 24 hours and

must inventory and maintain records of medical marihuana products or

by-products which are disposed. Section 1004.10(a) is also amended to

account for records that may need to be maintained for a time period other

than five years and to require registered organizations to post a registration

certificate in a conspicuous location on the premises of each manufacturing

and dispensing facility site. Section 1004.10(b) is amended to clarify

criminal history requirements for registered organization managers or

employees.

§ 1004.11 Manufacturing requirements for approved medical marihuana

product(s). Section 1004.11(a)(2) is amended to update the allowable

range of THC and CBD concentration per dose and brand for potency testing

purposes, and is amended to remove the term “extraction” from the

definition of a brand. Section 1004.11(c) is modified to remove the prohibition

on the use of unprocessed whole flower, to coincide with amendments

to section 1004.11(g) and the allowable forms of administration.

Section 1004.11(c) is also amended to clarify reporting requirements for

other cannabinoid components at >0.1%. Section 1004.11(e) is amended

to update the allowable range of THC and CBD concentration per dose

and brand for potency testing purposes and is updated to clarify that the

New York State Department of Environmental Conservation is the authority

which registers acceptable pesticides. In addition, section 1004.11(e) is

modified to add a requirement that registered organizations shall ensure

continual environmental monitoring of harvested plant material awaiting

additional processing. Section 1004.11(g) is modified to allow registered organizations to produce medical marihuana products in new forms of

administration. Section 1004.11(h) is amended to allow registered

organizations to break the seal of an approved medical marihuana product

for internal quality control testing or destruction. Section 1004.11(k) is

amended to clarify labeling requirements related to stability studies. Section

1004.11(m) is amended to clarify stability testing requirements and to

account for initial stability testing limitations. Section 1004.11(n) is

amended to make clear that registered organizations may not use any cannabinoid

preparation not produced by a registered organization in an approved

manufacturing facility.

§ 1004.12 Requirements for dispensing facilities. Section 1004.12(a) is

amended to clarify that medical marihuana products may not be dispensed

or handled unless an individual with an active New York State pharmacist

license is on the premises and supervising. Section 1004.12(a) is further

revised to clarify that dispensing facility pharmacists must complete a four

hour course approved by the commissioner pursuant to section 1004.1(b).

Section 1004.12(b) is amended to allow dispensing facilities to sell additional

items. Section 1004.12(d) is stricken to allow food or beverages to

be consumed on the premises of a dispensing facility. Section 1004.12(f)

is changed to section 1004.12(d) and new section 1004.12(d) is amended

to include a requirement that the Prescription Monitoring Program (PMP)

Registry be consulted prior to dispensing approved medical marihuana

products. Section 1004.12(g) is changed to section 1004.12(e) and new

section 1004.12(e) is amended to clarify dispensing facility access

restrictions. Section 1004.12(h) is changed to section 1004.12(f) and new

section 1004.12(f) is revised to clarify that labels shall include the expiration

date of the product once opened. Section 1004.12(m) is changed to

section 1004.12(k) and new section 1004.12(k) is modified to clarify the

documentation requirements for dispensing facilities that accept returns of

approved medical marihuana products and to ensure secure storage until

returned products can be properly disposed.

§ 1004.13 Security requirements for manufacturing and dispensing

facilities. Section 1004.13(a) is revised to clarify that production and

harvesting are included in the definition of manufacturing and a video

surveillance requirement is also added to the disposal process. Section

1004.13(a)(8) is amended to allow registered organizations to use an

automatic voice dialer, digital dialer or other acceptable industry standard

equivalent. Section 1004.13(c) removes the requirement that a back-up

alarm system needs to be provided by a different company than the primary

alarm. Section 1004.13(g) reduces the frequency of alarm system

testing that must be conducted by the registered organization. Section

1004.13(h) addresses visitors at the manufacturing facility. Section

1004.13(i) is amended to clarify the requirements for storage of marihuana.

Section 1004.13(j) is amended to clarify that registered organizations must

store medical marihuana in such a manner as to protect against physical,

chemical and microbial contamination and deterioration. Sections

1004.13(n)-(p) are modified to remove the requirement that registered

organizations only transport approved medical marihuana products from a

manufacturing facility to dispensing facilities.

§ 1004.14 Laboratory testing requirements for medical marihuana. Section

1004.14(b) is amended to add the requirement that no immediate family

members of a board member, officer, manager, owner, partner, principal

stakeholder or member of a registered organization shall have an interest

or voting rights in the lab performing testing on medical marihuana. Section

1004.14(c) is amended to clarify final product testing sample

requirements. Section 1004.14(d) is modified to clarify that registered

organizations may test final products that have been packaged. Section

1004.14(e) is amended to add the requirement that sampling methodologies

must be approved by the department. Section 1004.14(g) is amended

to clarify the list of contaminants for which testing must occur and to

clarify that pesticides include herbicides and fungicides. Section

1004.14(h) is amended to clarify stability testing requirements for open

and unopened products. Section 1004.14(i) is added to include a disposal

requirement for laboratories. Section 1004.14(j) is added to include a

requirement for laboratories to return medical marihuana products deemed

unsuitable for testing to the registered organization.

§ 1004.16 Medical Marihuana marketing and advertising by registered

organizations. Section 1004.16(a) is amended to remove the requirement

that only a single black and white sign may be allowed on the external

structures of a registered organization. Section 1004.16(a) is also amended

to remove the restriction that external signs not be illuminated. Section

1004.16(m) is amended to clarify that registered organizations may educate

practitioners about medical marihuana brands or devices offered by

the registered organization.

§ 1004.20 Proper disposal of medical marihuana products by patients or

designated caregivers. Section 1004.20 is amended to allow patients and

caregivers to return approved medical marihuana products to the dispensing

facility from which they were purchased or any dispensing facility associated

with the registered organization. Section 1004.20(b) is also

amended to clarify that the New York State Department of Environmental

Conservation provides guidance on proper drug disposal.

§ 1004.21 General prohibitions. Section 1004.21(d) is amended to allow

physicians, nurse practitioners and physician assistants, employed by

registered organizations, to counsel certified patients and designated

caregivers on medical marihuana product use, administration and risks.

§ 1004.24 Registered Organizations disposal of medical marihuana.

Section 1004.24 is added to provide guidance on acceptable processes for

disposing of medical marihuana products and by-products.

§ 55-2.15 Requirements for laboratories performing testing for medical

marihuana. Section 55-2.15(b) is amended to correct the agency name and

to include a disposal requirement for laboratories. Section 55-2.15(c) is

also amended to include a disposal requirement for laboratories.

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