Provides that medical marihuana may be used as part of the treatment of a patient's condition and removes the "serious" designation of such condition; provides that a practitioner be authorized to prescribe controlled substances in the state and removes the requirement that a physician prescribe such medical marihuana; increases the supply amount of marihuana from thirty to sixty days; allows a designated caregiver facility or designated caregiver facility employee to possess, acquire, deliver, transfer, transport or administer medical marihuana; requires the commissioner of health to establish a medical marihuana research license; establishes a medical marihuana research program; requires the registration of designated caregiver facilities; authorizes the commissioner of health to approve and permit one or more independent laboratories to test medical marihuana; increases the number of dispensing sites of a registered organization from four to eight; and makes related provisions.
STATE OF NEW YORK
________________________________________________________________________
531
2021-2022 Regular Sessions
IN ASSEMBLY(Prefiled)
January 6, 2021
___________
Introduced by M. of A. GOTTFRIED, PEOPLES-STOKES, LUPARDO, ABINANTI,
ASHBY, CARROLL, CRUZ, DICKENS, ENGLEBRIGHT, GLICK, HEVESI,
JEAN-PIERRE, HUNTER, M. MILLER, PAULIN, PICHARDO, REYES, L. ROSENTHAL,
SIMON, SAYEGH, DARLING, FERNANDEZ, RAMOS, FAHY, BRONSON -- read once
and referred to the Committee on Health
AN ACT to amend the public health law, in relation to medical marihuana
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Subdivisions 1, 5, 7 and 12 of section 3360 of the public
2 health law, subdivisions 1, 5, 7 and 12 as added by chapter 90 of the
3 laws of 2014, paragraph (a) of subdivision 7 as amended by chapter 273
4 of the laws of 2018, are amended and three new subdivisions 5-a, 5-b and
5 19 are added to read as follows:
6 1. "Certified medical use" means the acquisition, possession, use, or,
7 transportation of medical marihuana by a certified patient, or the
8 acquisition, possession, delivery, transportation or administration of
9 medical marihuana by a designated caregiver, for use as part of the
10 treatment of the patient's [serious] condition, as authorized in a
11 certification under this title including enabling the patient to toler-
12 ate treatment for the [serious] condition. [A certified medical use does
13 not include smoking.]
14 5. "Designated caregiver" means the individual or caregiver facility
15 designated by a certified patient in a registry application. A certified
16 patient may designate up to two designated caregivers, not counting a
17 designated caregiver facility or designated caregiver facility employee.
18 5-a. "Designated caregiver facility" means an entity that registers
19 with the commissioner to assist one or more certified patients with the
20 acquisition, possession, delivery, transportation or administration of
21 medical marihuana and is: a general hospital or residential health care
22 facility operating under article twenty-eight of this chapter; an adult
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD00363-01-1
A. 531 2
1 care facility operating under title two of article seven of the social
2 services law; a community mental health residence established under
3 section 41.44 of the mental hygiene law; a hospital operating under
4 section 7.17 of the mental hygiene law; a mental hygiene facility oper-
5 ating under article thirty-one of the mental hygiene law; an inpatient
6 or residential treatment program certified under article thirty-two of
7 the mental hygiene law; a residential facility for the care and treat-
8 ment of persons with developmental disabilities operating under article
9 sixteen of the mental hygiene law; a residential treatment facility for
10 children and youth operating under article thirty-one of the mental
11 hygiene law; a public school or private school operating under the
12 education law; a research institution with an internal review board; a
13 medical marihuana research program licensed under section thirty-three
14 hundred sixty-four-a of this title; or any other facility as determined
15 by the commissioner in regulation.
16 5-b. "Designated caregiver facility employee" means an employee of a
17 designated caregiver facility.
18 7. (a) ["Serious condition"] "Condition" means:
19 (i) having one of the following [severe debilitating or life-threaten-
20 ing] conditions: cancer, positive status for human immunodeficiency
21 virus or acquired immune deficiency syndrome, amyotrophic lateral scler-
22 osis, Parkinson's disease, multiple sclerosis, damage to the nervous
23 tissue of the spinal cord with objective neurological indication of
24 intractable spasticity, epilepsy, inflammatory bowel disease, neuropa-
25 thies, Huntington's disease, post-traumatic stress disorder, pain that
26 degrades health and functional capability where the use of medical mari-
27 huana is an alternative to opioid use, substance use disorder,
28 Alzheimer's, muscular dystrophy, dystonia, rheumatoid arthritis, autism,
29 or [as added by the commissioner; and
30 (ii) any of the following conditions where it is clinically associated
31 with, or a complication of, a condition under this paragraph or its
32 treatment: cachexia or wasting syndrome; severe or chronic pain; severe
33 nausea; seizures; severe or persistent muscle spasms; or such conditions
34 as are added by the commissioner.
35 (b) No later than eighteen months from the effective date of this
36 section, the commissioner shall determine whether to add the following
37 serious conditions: Alzheimer's, muscular dystrophy, dystonia, post-
38 traumatic stress disorder and rheumatoid arthritis] any other condition
39 certified by the practitioner.
40 12. "Practitioner" means a practitioner who (i) [is a physician
41 licensed by New York state and practicing within the state,] is author-
42 ized to prescribe controlled substances within the state; (ii) [who] by
43 training or experience is qualified to treat a [serious] condition as
44 defined in subdivision seven of this section; and (iii) [has completed a
45 two to four hour course as determined by the commissioner in regulation
46 and registered with the department; provided however, a registration
47 shall not be denied without cause. Such course may count toward board
48 certification requirements. The commissioner shall consider the inclu-
49 sion of nurse practitioners under this title based upon considerations
50 including access and availability. After such consideration the commis-
51 sioner is authorized to deem nurse practitioners as practitioners under
52 this title] completes, at a minimum, a two hour course as determined by
53 the commissioner. A person's status as a practitioner under this title
54 is deemed to be a "license" for purposes of section thirty-three hundred
55 ninety of this article.
A. 531 3
1 19. "Medical marihuana research program" means a medical marihuana
2 research program licensed under section thirty-three hundred
3 sixty-four-a of this title.
4 § 2. Subdivisions 1, 2, and 9 of section 3361 of the public health
5 law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and
6 subdivision 9 as added by chapter 416 of the laws of 2015, are amended
7 to read as follows:
8 1. A patient certification may only be issued if: (a) a practitioner
9 has been registered with the department to issue a certification as
10 determined by the commissioner; (b) the patient has a [serious] condi-
11 tion, which shall be specified in the patient's health care record; (c)
12 the practitioner by training or experience is qualified to treat the
13 [serious] condition; (d) the patient is under the practitioner's contin-
14 uing care for the [serious] condition; and (e) in the practitioner's
15 professional opinion and review of past treatments, the patient is like-
16 ly to receive therapeutic or palliative benefit from the primary or
17 adjunctive treatment with medical use of marihuana for the [serious]
18 condition.
19 2. The certification shall include (a) the name, date of birth and
20 address of the patient; (b) a statement that the patient has a [serious]
21 condition and the patient is under the practitioner's care for the
22 [serious] condition; (c) a statement attesting that all requirements of
23 subdivision one of this section have been satisfied; (d) the date; and
24 (e) the name, address, federal registration number, telephone number,
25 and the handwritten signature of the certifying practitioner. The
26 commissioner may require by regulation that the certification shall be
27 on a form provided by the department. The practitioner may state in the
28 certification that, in the practitioner's professional opinion, the
29 patient would benefit from medical marihuana only until a specified
30 date. The practitioner may state in the certification that, in the prac-
31 titioner's professional opinion, the patient is terminally ill and that
32 the certification shall not expire until the patient dies.
33 9.(a) A certification may be a special certification if, in addition
34 to the other requirements for a certification, the practitioner certi-
35 fies in the certification that the patient's [serious] condition is
36 progressive and degenerative or that delay in the patient's certified
37 medical use of marihuana poses a serious risk to the patient's life or
38 health.
39 (b) The department shall create the form to be used for a special
40 certification and shall make that form available to be downloaded from
41 the department's website.
42 § 3. Subdivisions 1 and 2 of section 3362 of the public health law, as
43 added by chapter 90 of the laws of 2014, are amended and a new subdivi-
44 sion 3 is added to read as follows:
45 1. The possession, acquisition, use, delivery, transfer, transporta-
46 tion, or administration of medical marihuana by a certified patient or
47 designated caregiver possessing a valid registry identification card,
48 for certified medical use, shall be lawful under this title; provided
49 that:
50 (a) the marihuana that may be possessed by a certified patient shall
51 not exceed a [thirty] sixty day supply of the dosage as determined by
52 the practitioner, consistent with any guidance and regulations issued by
53 the commissioner, provided that during the last seven days of any [thir-
54 ty] sixty day period, the certified patient may also possess up to such
55 amount for the next [thirty] sixty day period;
A. 531 4
1 (b) the marihuana that may be possessed by designated caregivers does
2 not exceed the quantities referred to in paragraph (a) of this subdivi-
3 sion for each certified patient for whom the caregiver possesses a valid
4 registry identification card, up to five certified patients;
5 (c) the marihuana that may be possessed by designated caregiver facil-
6 ities does not exceed the quantities referred to in paragraph (a) of
7 this subdivision for each certified patient under care or treatment of
8 the facility;
9 (d) the form or forms of medical marihuana that may be possessed by
10 the certified patient [or], designated caregiver, or designated caregiv-
11 er facility pursuant to a certification shall be in compliance with any
12 recommendation or limitation by the practitioner as to the form or forms
13 of medical marihuana or dosage for the certified patient in the certif-
14 ication; and
15 [(d)] (e) the medical marihuana shall be kept in the original package
16 in which it was dispensed under subdivision twelve of section thirty-
17 three hundred sixty-four of this title, except for the portion removed
18 for immediate consumption for certified medical use by the certified
19 patient.
20 2. Notwithstanding subdivision one of this section:
21 (a) possession of medical marihuana shall not be lawful under this
22 title if it is smoked, consumed, vaporized, or grown in a public place,
23 regardless of the form of medical marihuana stated in the patient's
24 certification.
25 (b) a [person] certified patient or designated caregiver possessing
26 medical marihuana under this title shall possess his or her registry
27 identification card at all times when in immediate possession of medical
28 marihuana.
29 (c) medical marihuana may not be smoked in any place where tobacco may
30 not be smoked under article thirteen-E of this chapter, regardless of
31 the form of medical marihuana stated in the patient's certification.
32 3. The possession, acquisition, delivery, transfer, transportation, or
33 administration of medical marihuana by a designated caregiver facility
34 or designated caregiver facility employee shall be lawful under this
35 title provided that:
36 (a) the designated caregiver facility registers with the department on
37 a form provided by the commissioner;
38 (b) such possession, acquisition, delivery, transfer, transportation,
39 or administration is on behalf of a certified patient possessing a
40 registry identification card;
41 (c) the designated caregiver facility maintains a copy of the registry
42 identification card of each certified patient for which it possesses,
43 acquires, delivers, transfers, transports, or administers medical mari-
44 huana; and
45 (d) a designated caregiver facility employee shall be identified as an
46 employee when necessary, as provided by the commissioner.
47 § 4. Subdivisions 2, 3, 5, and 11 of section 3363 of the public health
48 law, as added by chapter 90 of the laws of 2014, are amended to read as
49 follows:
50 2. To obtain, amend or renew a registry identification card, a certi-
51 fied patient or designated caregiver shall file a registry application
52 with the department. The registry application or renewal application
53 shall include:
54 (a) in the case of a certified patient:
55 (i) the patient's certification (a new written certification shall be
56 provided with a renewal application);
A. 531 5
1 (ii) the name, address, and date of birth of the patient;
2 (iii) the date of the certification;
3 (iv) if the patient has a registry identification card based on a
4 current valid certification, the registry identification number and
5 expiration date of that registry identification card;
6 (v) the specified date until which the patient would benefit from
7 medical marihuana, if the certification states such a date;
8 (vi) the name, address, federal registration number, and telephone
9 number of the certifying practitioner;
10 (vii) any recommendation or limitation by the practitioner as to the
11 form or forms of medical marihuana or dosage for the certified patient;
12 and
13 (viii) other individual identifying information required by the
14 department;
15 (b) (i) in the case of a certified patient, if the patient designates
16 a designated caregiver, the name, address, and date of birth of the
17 designated caregiver, and other individual identifying information
18 required by the department;
19 (ii) if the designated caregiver is a medical marihuana research
20 program, the name of the organization conducting the research; the
21 address, phone number, and name of the individual leading the research
22 or appropriate designee; and other identifying information required by
23 the department;
24 (c) in the case of a designated caregiver:
25 (i) the name, address, and date of birth of the designated caregiver;
26 (ii) if the designated caregiver has a registry identification card,
27 the registry identification number and expiration date of that registry
28 identification card; and
29 (iii) other individual identifying information required by the depart-
30 ment;
31 (d) a statement that a false statement made in the application is
32 punishable under section 210.45 of the penal law;
33 (e) the date of the application and the signature of the certified
34 patient or designated caregiver, as the case may be; and
35 (f) [a fifty dollar application fee, provided, that the department may
36 waive or reduce the fee in cases of financial hardship; and
37 (g)] any other requirements determined by the commissioner.
38 3. Where a certified patient is under the age of eighteen:
39 (a) The application for a registry identification card shall be made
40 by an appropriate person over twenty-one years of age. The application
41 shall state facts demonstrating that the person is appropriate.
42 (b) The designated caregiver shall be (i) a parent or legal guardian
43 of the certified patient, (ii) a person designated by a parent or legal
44 guardian, [or] (iii) in the case of such a certified patient being cared
45 for by a designated caregiver facility, the designated caregiver facili-
46 ty designated by the parent or legal guardian; or (iv) an appropriate
47 person approved by the department upon a sufficient showing that no
48 parent or legal guardian is appropriate or available.
49 5. No person may be a designated caregiver for more than five certi-
50 fied patients at one time; provided however that this limitation shall
51 not apply to a designated caregiver facility or designated caregiver
52 facility employee.
53 11. A certified patient or designated caregiver who has been issued a
54 registry identification card shall notify the department of any change
55 in his or her name or address or, with respect to the patient, if he or
56 she ceases to have the [serious] condition noted on the certification
A. 531 6
1 within ten days of such change. The certified patient's or designated
2 caregiver's registry identification card shall be deemed invalid and
3 shall be returned promptly to the department.
4 § 5. Subdivisions 3 and 5 of section 3364 of the public health law, as
5 added by chapter 90 of the laws of 2014, are amended and a new subdivi-
6 sion 14 is added to read as follows:
7 3. Each registered organization shall contract with an independent
8 laboratory permitted under section thirty-three hundred sixty-four-c of
9 this title to test the medical marihuana produced by the registered
10 organization. The commissioner shall approve the laboratory and require
11 that the laboratory report testing results in a manner determined by the
12 commissioner. The commissioner is authorized to issue regulation requir-
13 ing the laboratory to perform certain tests and services.
14 5. (a) No registered organization may sell, deliver, distribute or
15 dispense to any certified patient or designated caregiver a quantity of
16 medical marihuana larger than that individual would be allowed to
17 possess under this title.
18 (b) When dispensing medical marihuana to a certified patient or desig-
19 nated caregiver, the registered organization (i) shall not dispense an
20 amount greater than a [thirty] sixty day supply to a certified patient
21 until the certified patient has exhausted all but a seven day supply
22 provided pursuant to a previously issued certification, and (ii) shall
23 verify the information in subparagraph (i) of this paragraph by consult-
24 ing the prescription monitoring program registry under section thirty-
25 three hundred forty-three-a of this article.
26 (c) Medical marihuana dispensed to a certified patient or designated
27 caregiver by a registered organization shall conform to any recommenda-
28 tion or limitation by the practitioner as to the form or forms of
29 medical marihuana or dosage for the certified patient.
30 14. A registered organization may contract with a person or entity to
31 provide facilities, equipment or services that are ancillary to the
32 registered organization's functions or activities under this section
33 (including, but not limited to, shipping, maintenance, construction,
34 repair, and security), but not including any function or activity
35 directly involving the planting, growing, tending, harvesting, process-
36 ing, or packaging of plants; or any other function directly involving
37 manufacturing or retailing of medical marihuana. All laws and regu-
38 lations applicable to such facilities, equipment, or services shall
39 apply to the contract. The registered organization and other parties to
40 the contract shall each be responsible for compliance with such laws and
41 regulations under the contract. The commissioner may make regulations
42 consistent with this title relating to contracts and parties to
43 contracts under this subdivision.
44 § 6. The public health law is amended by adding a new section 3364-a
45 to read as follows:
46 § 3364-a. Medical marihuana research licenses. 1. The commissioner
47 shall establish a medical marihuana research license that permits a
48 licensee to produce, process, purchase, possess, transfer, and sell
49 marihuana, subject to this section, for the following limited research
50 purposes:
51 (a) to test chemical potency and composition levels;
52 (b) to conduct clinical investigations of marihuana-derived products;
53 (c) to conduct research on the efficacy and safety of administering
54 marihuana as part of medical treatment; or
55 (d) to conduct genomic or agricultural research relating to medical
56 marihuana.
A. 531 7
1 2. As part of the application process for a medical marihuana research
2 license, an applicant must submit to the commissioner a description of
3 the research that is intended to be conducted as well as the amount of
4 marihuana to be grown or purchased. The commissioner shall review an
5 applicant's research project and determine whether it meets the require-
6 ments of subdivision one of this section. In addition, the commissioner
7 shall assess the application based on the following criteria:
8 (a) project quality, study design, value, and impact;
9 (b) whether the applicant has the appropriate personnel, expertise,
10 facilities and infrastructure, funding, and (to the extent legally
11 available) approvals relating to human or animal research, in place to
12 successfully conduct the project; and
13 (c) whether the amount of marihuana to be grown or purchased by the
14 applicant is consistent with the project's scope and goals.
15 3. If the commissioner determines that the research project meets the
16 requirements of subdivision one of this section, the commissioner may
17 approve the application. If not, the application shall be denied.
18 4. A medical marihuana research licensee may only sell or transfer
19 marihuana grown or produced within its operation to other medical mari-
20 huana research licensees, or otherwise for purposes of the licensee's
21 research.
22 5. In establishing a medical marihuana research license, the commis-
23 sioner may make regulations on the following:
24 (a) application requirements;
25 (b) license renewal requirements, including whether additional
26 research projects may be added or considered;
27 (c) conditions for license revocation;
28 (d) security measures to ensure marihuana is not diverted to purposes
29 other than research;
30 (e) amount of plants, useable marihuana, marihuana concentrates, or
31 marihuana-infused products a licensee may have on its premises;
32 (f) licensee reporting requirements;
33 (g) conditions under which marihuana grown by licensed medical mari-
34 huana producers and other product types from licensed medical marihuana
35 processors may be donated to medical marihuana research licensees; and
36 (h) any additional requirements deemed necessary by the commissioner.
37 6. A marihuana research license issued under this section shall be
38 issued in the name of the applicant or applicants, specify the location
39 at which the marihuana researcher intends to operate, which shall be
40 within the state, and shall not allow any other person to use the
41 license except as under subdivision four of this section.
42 7. Participation by certified patients in any medical marihuana
43 research program shall be voluntary.
44 8. The application fee for a medical marihuana research license shall
45 be determined by the commissioner on an annual basis.
46 9. Each medical marihuana research licensee shall issue an annual
47 report to the commissioner. The commissioner shall review such report
48 and make a determination as to whether the research project continues to
49 meet the research qualifications under this section.
50 § 7. The public health law is amended by adding a new section 3364-b
51 to read as follows:
52 § 3364-b. Registration of designated caregiver facilities. 1. To
53 obtain, amend or renew a registration as a designated caregiver facili-
54 ty, the facility shall file an application with the commissioner. The
55 application shall include:
56 (a) the facility's full name and address;
A. 531 8
1 (b) operating certificate or license number where appropriate;
2 (c) name, title, and signature of an authorized facility represen-
3 tative;
4 (d) a statement that the facility agrees to secure and ensure proper
5 handling of all medical marihuana products;
6 (e) an acknowledgement that a false statement in the application is
7 punishable under section 210.45 of the penal law; and
8 (f) any other information that may be required by the commissioner.
9 2. Prior to issuing or renewing a designated caregiver facility regis-
10 tration, the commissioner may verify the information submitted by the
11 applicant. The applicant shall provide, at the commissioner's request,
12 such information and documentation, including any consents or authori-
13 zations, that may be necessary for the commissioner to verify the infor-
14 mation.
15 3. The application shall be approved, denied or determined incomplete
16 or inaccurate by the commissioner within thirty days of receipt of the
17 application. If the application is approved, the commissioner shall
18 issue a registration as soon as is reasonably practicable.
19 4. Registrations under this section shall remain valid for two years
20 from the date of issuance.
21 § 8. The public health law is amended by adding a new section 3364-c
22 to read as follows:
23 § 3364-c. Laboratory permits. 1. The commissioner shall approve and
24 permit one or more independent laboratories to test medical marihuana.
25 To be permitted as an independent laboratory under this section, a labo-
26 ratory must apply to the department in a form and manner prescribed by
27 the commissioner and must demonstrate the following to the satisfaction
28 of the commissioner:
29 (a) the owners and directors of the laboratory are of good moral char-
30 acter;
31 (b) the laboratory and its staff have the skills, resources, and
32 expertise needed to accurately and consistently perform all testing
33 required;
34 (c) the laboratory has in place and will maintain adequate policies,
35 procedures, and facility security to ensure proper collection, labeling,
36 accessioning, preparation, analysis, result reporting, disposal, and
37 storage of medical marihuana;
38 (d) the laboratory is physically located in New York state;
39 (e) the laboratory has a certificate of approval as an environmental
40 laboratory issued by the commissioner under title one of article five of
41 this chapter; and
42 (f) the laboratory meets all requirements prescribed by this chapter
43 and the commissioner in regulation.
44 2. The owner of an independent laboratory permitted under this section
45 shall not hold a registration as a registered organization and shall not
46 have any direct or indirect ownership interest in such registered organ-
47 ization. No board member, manager, owner, partner, principal stakehold-
48 er, or member of a registered organization, or such person's immediate
49 family, shall have an interest or voting rights in any independent labo-
50 ratory permittee. No registered organization shall have any direct or
51 indirect ownership interest in such laboratory.
52 3. An independent laboratory shall not be required to be licensed by
53 the federal drug enforcement administration.
54 § 9. Subdivision 9 of section 3365 of the public health law, as added
55 by chapter 90 of the laws of 2014, is amended to read as follows:
A. 531 9
1 9. [The commissioner shall register no more than five] A registered
2 [organizations] organization that [manufacture] manufactures medical
3 marihuana [with] may have no more than [four] eight dispensing sites
4 wholly owned and operated by [such] the registered organization. The
5 commissioner shall ensure that such [registered organizations and]
6 dispensing sites are geographically distributed across the state. The
7 commission [may] shall register additional registered organizations
8 reflecting the demographics of the state.
9 § 10. Subdivision 1 of section 3365-a of the public health law, as
10 added by chapter 416 of the laws of 2015, is amended to read as follows:
11 1. There is hereby established in the department an emergency medical
12 marihuana access program (referred to in this section as the "program")
13 under this section. The purpose of the program is to expedite the avail-
14 ability of medical marihuana to avoid suffering and loss of life, during
15 the period before full implementation of and production under this
16 title, especially in the case of patients whose [serious] condition is
17 progressive and degenerative or is such that delay in the patient's
18 medical use of marihuana poses a serious risk to the patient's life or
19 health. The commissioner shall implement the program as expeditiously as
20 practicable, including by emergency regulation.
21 § 11. Subdivision 1 of section 3369 of the public health law, as added
22 by chapter 90 of the laws of 2014, is amended to read as follows:
23 1. Certified patients, designated caregivers, designated caregiver
24 facilities, designated caregiver facility employees, medical marihuana
25 research program employees, practitioners, registered organizations and
26 the employees of registered organizations shall not be subject to
27 arrest, prosecution, or penalty in any manner, or denied any right or
28 privilege, including but not limited to civil penalty or disciplinary
29 action by a business or occupational or professional licensing board or
30 bureau, solely for the certified medical use or manufacture of marihua-
31 na, or for any other action or conduct in accordance with this title.
32 § 12. Section 3369-d of the public health law, as added by chapter 90
33 of the laws of 2014, is amended to read as follows:
34 § 3369-d. Pricing. [1. Every sale of medical marihuana shall be at the
35 price determined by the commissioner. Every charge made or demanded for
36 medical marihuana not in accordance with the price determined by the
37 commissioner, is prohibited.
38 2. The commissioner is hereby authorized to set the per dose price of
39 each form of medical marihuana sold by any registered organization. In
40 setting the per dose price of each form of medical marihuana, the
41 commissioner shall consider the fixed and variable costs of producing
42 the form of marihuana and any other factor the commissioner, in his or
43 her discretion, deems relevant to determining the per dose price of each
44 form of medical marihuana.] Registered organizations shall submit
45 documentation of any price and change in price per dose for any medical
46 marihuana product to the commissioner within fifteen days of setting or
47 changing the price. Prior approval by the commissioner shall not be
48 required for any price or change of price. However, the commissioner is
49 authorized to modify the price per dose for any medical marihuana prod-
50 uct if necessary to maintain public access to appropriate medication.
51 § 13. This act shall take effect immediately; provided, however, that
52 the amendments to title 5-A of article 33 of the public health law made
53 by sections one, two, three, four, five, six, seven, eight, nine, ten,
54 eleven and twelve of this act shall not affect the repeal of such title
55 and shall be deemed repealed therewith. Effective immediately, the addi-
56 tion, amendment and/or repeal of any rule or regulation necessary for
A. 531 10
1 the implementation of this act on its effective date are authorized to
2 be made and completed on or before such effective date.
