S T A T E O F N E W Y O R K
________________________________________________________________________
531
2021-2022 Regular Sessions
I N A S S E M B L Y
(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:
Section 1. Subdivisions 1, 5, 7 and 12 of section 3360 of the public
health law, subdivisions 1, 5, 7 and 12 as added by chapter 90 of the
laws of 2014, paragraph (a) of subdivision 7 as amended by chapter 273
of the laws of 2018, are amended and three new subdivisions 5-a, 5-b and
19 are added to read as follows:
1. "Certified medical use" means the acquisition, possession, use, or,
transportation of medical marihuana by a certified patient, or the
acquisition, possession, delivery, transportation or administration of
medical marihuana by a designated caregiver, for use as part of the
treatment of the patient's [serious] condition, as authorized in a
certification under this title including enabling the patient to toler-
ate treatment for the [serious] condition. [A certified medical use does
not include smoking.]
5. "Designated caregiver" means the individual OR CAREGIVER FACILITY
designated by a certified patient in a registry application. A certified
patient may designate up to two designated caregivers, NOT COUNTING A
DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER FACILITY EMPLOYEE.
5-A. "DESIGNATED CAREGIVER FACILITY" MEANS AN ENTITY THAT REGISTERS
WITH THE COMMISSIONER TO ASSIST ONE OR MORE CERTIFIED PATIENTS WITH THE
ACQUISITION, POSSESSION, DELIVERY, TRANSPORTATION OR ADMINISTRATION OF
MEDICAL MARIHUANA AND IS: A GENERAL HOSPITAL OR RESIDENTIAL HEALTH CARE
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
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CARE FACILITY OPERATING UNDER TITLE TWO OF ARTICLE SEVEN OF THE SOCIAL
SERVICES LAW; A COMMUNITY MENTAL HEALTH RESIDENCE ESTABLISHED UNDER
SECTION 41.44 OF THE MENTAL HYGIENE LAW; A HOSPITAL OPERATING UNDER
SECTION 7.17 OF THE MENTAL HYGIENE LAW; A MENTAL HYGIENE FACILITY OPER-
ATING UNDER ARTICLE THIRTY-ONE OF THE MENTAL HYGIENE LAW; AN INPATIENT
OR RESIDENTIAL TREATMENT PROGRAM CERTIFIED UNDER ARTICLE THIRTY-TWO OF
THE MENTAL HYGIENE LAW; A RESIDENTIAL FACILITY FOR THE CARE AND TREAT-
MENT OF PERSONS WITH DEVELOPMENTAL DISABILITIES OPERATING UNDER ARTICLE
SIXTEEN OF THE MENTAL HYGIENE LAW; A RESIDENTIAL TREATMENT FACILITY FOR
CHILDREN AND YOUTH OPERATING UNDER ARTICLE THIRTY-ONE OF THE MENTAL
HYGIENE LAW; A PUBLIC SCHOOL OR PRIVATE SCHOOL OPERATING UNDER THE
EDUCATION LAW; A RESEARCH INSTITUTION WITH AN INTERNAL REVIEW BOARD; A
MEDICAL MARIHUANA RESEARCH PROGRAM LICENSED UNDER SECTION THIRTY-THREE
HUNDRED SIXTY-FOUR-A OF THIS TITLE; OR ANY OTHER FACILITY AS DETERMINED
BY THE COMMISSIONER IN REGULATION.
5-B. "DESIGNATED CAREGIVER FACILITY EMPLOYEE" MEANS AN EMPLOYEE OF A
DESIGNATED CAREGIVER FACILITY.
7. (a) ["Serious condition"] "CONDITION" means:
(i) having one of the following [severe debilitating or life-threaten-
ing] conditions: cancer, positive status for human immunodeficiency
virus or acquired immune deficiency syndrome, amyotrophic lateral scler-
osis, 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, neuropa-
thies, Huntington's disease, post-traumatic stress disorder, pain that
degrades health and functional capability where the use of medical mari-
huana is an alternative to opioid use, substance use disorder,
ALZHEIMER'S, MUSCULAR DYSTROPHY, DYSTONIA, RHEUMATOID ARTHRITIS, AUTISM,
or [as added by the commissioner; and
(ii) any of the following conditions where it is clinically associated
with, or a complication of, a condition under this paragraph or its
treatment: cachexia or wasting syndrome; severe or chronic pain; severe
nausea; seizures; severe or persistent muscle spasms; or such conditions
as are added by the commissioner.
(b) No later than eighteen months from the effective date of this
section, the commissioner shall determine whether to add the following
serious conditions: Alzheimer's, muscular dystrophy, dystonia, post-
traumatic stress disorder and rheumatoid arthritis] ANY OTHER CONDITION
CERTIFIED BY THE PRACTITIONER.
12. "Practitioner" means a practitioner who (i) [is a physician
licensed by New York state and practicing within the state,] IS AUTHOR-
IZED TO PRESCRIBE CONTROLLED SUBSTANCES WITHIN THE STATE; (ii) [who] by
training or experience is qualified to treat a [serious] condition as
defined in subdivision seven of this section; and (iii) [has completed a
two to four hour course as determined by the commissioner in regulation
and registered with the department; provided however, a registration
shall not be denied without cause. Such course may count toward board
certification requirements. The commissioner shall consider the inclu-
sion of nurse practitioners under this title based upon considerations
including access and availability. After such consideration the commis-
sioner is authorized to deem nurse practitioners as practitioners under
this title] COMPLETES, AT A MINIMUM, A TWO HOUR COURSE AS DETERMINED BY
THE COMMISSIONER. A PERSON'S STATUS AS A PRACTITIONER UNDER THIS TITLE
IS DEEMED TO BE A "LICENSE" FOR PURPOSES OF SECTION THIRTY-THREE HUNDRED
NINETY OF THIS ARTICLE.
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19. "MEDICAL MARIHUANA RESEARCH PROGRAM" MEANS A MEDICAL MARIHUANA
RESEARCH PROGRAM LICENSED UNDER SECTION THIRTY-THREE HUNDRED
SIXTY-FOUR-A OF THIS TITLE.
§ 2. Subdivisions 1, 2, and 9 of section 3361 of the public health
law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and
subdivision 9 as added by chapter 416 of the laws of 2015, are amended
to read as follows:
1. A patient certification may only be issued if: (a) a practitioner
has been registered with the department to issue a certification as
determined by the commissioner; (b) the patient has a [serious] condi-
tion, which shall be specified in the patient's health care record; (c)
the practitioner by training or experience is qualified to treat the
[serious] condition; (d) the patient is under the practitioner's contin-
uing care for the [serious] condition; and (e) in the practitioner's
professional opinion and review of past treatments, the patient is like-
ly to receive therapeutic or palliative benefit from the primary or
adjunctive treatment with medical use of marihuana for the [serious]
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 [serious]
condition and the patient is under the practitioner's care for the
[serious] 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, federal registration number, telephone number,
and the handwritten signature of the certifying practitioner. The
commissioner 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 marihuana 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.
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 [serious] condition is
progressive and degenerative or that delay in the patient's certified
medical use of marihuana poses a serious 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.
§ 3. Subdivisions 1 and 2 of section 3362 of the public health law, as
added by chapter 90 of the laws of 2014, are amended and a new subdivi-
sion 3 is added to read as follows:
1. The possession, acquisition, use, delivery, transfer, transporta-
tion, or administration of medical marihuana by a certified patient or
designated caregiver possessing a valid registry identification card,
for certified medical use, shall be lawful under this title; provided
that:
(a) the marihuana that may be possessed by a certified patient shall
not exceed a [thirty] SIXTY day supply of the dosage as determined by
the practitioner, consistent with any guidance and regulations issued by
the commissioner, provided that during the last seven days of any [thir-
ty] SIXTY day period, the certified patient may also possess up to such
amount for the next [thirty] SIXTY day period;
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(b) the marihuana that may be possessed by designated caregivers does
not exceed the quantities referred to in paragraph (a) of this subdivi-
sion for each certified patient for whom the caregiver possesses a valid
registry identification card, up to five certified patients;
(c) THE MARIHUANA THAT MAY BE POSSESSED BY DESIGNATED CAREGIVER FACIL-
ITIES DOES NOT EXCEED THE QUANTITIES REFERRED TO IN PARAGRAPH (A) OF
THIS SUBDIVISION FOR EACH CERTIFIED PATIENT UNDER CARE OR TREATMENT OF
THE FACILITY;
(D) the form or forms of medical marihuana that may be possessed by
the certified patient [or], designated caregiver, OR DESIGNATED CAREGIV-
ER FACILITY pursuant to a certification shall be in compliance with any
recommendation or limitation by the practitioner as to the form or forms
of medical marihuana or dosage for the certified patient in the certif-
ication; and
[(d)] (E) the medical marihuana shall be kept in the original package
in which it was dispensed under subdivision twelve of section thirty-
three hundred sixty-four of this title, except for the portion removed
for immediate consumption for certified medical use by the certified
patient.
2. Notwithstanding subdivision one of this section:
(a) possession of medical marihuana shall not be lawful under this
title if it is smoked, consumed, vaporized, or grown in a public place,
regardless of the form of medical marihuana stated in the patient's
certification.
(b) a [person] CERTIFIED PATIENT OR DESIGNATED CAREGIVER possessing
medical marihuana under this title shall possess his or her registry
identification card at all times when in immediate possession of medical
marihuana.
(C) MEDICAL MARIHUANA MAY NOT BE SMOKED IN ANY PLACE WHERE TOBACCO MAY
NOT BE SMOKED UNDER ARTICLE THIRTEEN-E OF THIS CHAPTER, REGARDLESS OF
THE FORM OF MEDICAL MARIHUANA STATED IN THE PATIENT'S CERTIFICATION.
3. THE POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION, OR
ADMINISTRATION OF MEDICAL MARIHUANA BY A DESIGNATED CAREGIVER FACILITY
OR DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL BE LAWFUL UNDER THIS
TITLE PROVIDED THAT:
(A) THE DESIGNATED CAREGIVER FACILITY REGISTERS WITH THE DEPARTMENT ON
A FORM PROVIDED BY THE COMMISSIONER;
(B) SUCH POSSESSION, ACQUISITION, DELIVERY, TRANSFER, TRANSPORTATION,
OR ADMINISTRATION IS ON BEHALF OF A CERTIFIED PATIENT POSSESSING A
REGISTRY IDENTIFICATION CARD;
(C) THE DESIGNATED CAREGIVER FACILITY MAINTAINS A COPY OF THE REGISTRY
IDENTIFICATION CARD OF EACH CERTIFIED PATIENT FOR WHICH IT POSSESSES,
ACQUIRES, DELIVERS, TRANSFERS, TRANSPORTS, OR ADMINISTERS MEDICAL MARI-
HUANA; AND
(D) A DESIGNATED CAREGIVER FACILITY EMPLOYEE SHALL BE IDENTIFIED AS AN
EMPLOYEE WHEN NECESSARY, AS PROVIDED BY THE COMMISSIONER.
§ 4. Subdivisions 2, 3, 5, and 11 of section 3363 of the public health
law, as added by chapter 90 of the laws of 2014, are amended to read as
follows:
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. 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);
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(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 marihuana, if the certification states such a date;
(vi) the name, address, federal registration number, and telephone
number of the certifying practitioner;
(vii) any recommendation or limitation by the practitioner as to the
form or forms of medical marihuana or dosage for the certified patient;
and
(viii) other individual identifying information required by the
department;
(b) (I) in the case of a certified 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;
(II) IF THE DESIGNATED CAREGIVER IS A MEDICAL MARIHUANA RESEARCH
PROGRAM, THE NAME OF THE ORGANIZATION CONDUCTING THE RESEARCH; THE
ADDRESS, PHONE NUMBER, AND NAME OF THE INDIVIDUAL LEADING THE RESEARCH
OR APPROPRIATE DESIGNEE; AND OTHER 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;
(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;
(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 certified
patient or designated caregiver, as the case may be; AND
(f) [a fifty dollar application fee, provided, that the department may
waive or reduce the fee in cases of financial hardship; and
(g)] any other requirements determined by the commissioner.
3. Where a certified patient is under the age of eighteen:
(a) The application for a registry identification card shall be made
by an appropriate person over twenty-one years of age. The application
shall state facts demonstrating that the person is appropriate.
(b) The designated caregiver shall be (i) a parent or legal guardian
of the certified patient, (ii) a person designated by a parent or legal
guardian, [or] (iii) IN THE CASE OF SUCH A CERTIFIED PATIENT BEING CARED
FOR BY A DESIGNATED CAREGIVER FACILITY, THE DESIGNATED CAREGIVER FACILI-
TY DESIGNATED BY THE PARENT OR LEGAL GUARDIAN; OR (IV) an appropriate
person approved by the department upon a sufficient showing that no
parent or legal guardian is appropriate or available.
5. No person may be a designated caregiver for more than five certi-
fied patients at one time; PROVIDED HOWEVER THAT THIS LIMITATION SHALL
NOT APPLY TO A DESIGNATED CAREGIVER FACILITY OR DESIGNATED CAREGIVER
FACILITY EMPLOYEE.
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 [serious] condition noted on the certification
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within ten days of such change. The certified patient's or designated
caregiver's registry identification card shall be deemed invalid and
shall be returned promptly to the department.
§ 5. Subdivisions 3 and 5 of section 3364 of the public health law, as
added by chapter 90 of the laws of 2014, are amended and a new subdivi-
sion 14 is added to read as follows:
3. Each registered organization shall contract with an independent
laboratory PERMITTED UNDER SECTION THIRTY-THREE HUNDRED SIXTY-FOUR-C OF
THIS TITLE to test the medical marihuana produced by the registered
organization. The commissioner shall approve the laboratory and require
that the laboratory report testing results in a manner determined by the
commissioner. The commissioner is authorized to issue regulation requir-
ing the laboratory to perform certain tests and services.
5. (a) No registered organization may sell, deliver, distribute or
dispense to any certified patient or designated caregiver a quantity of
medical marihuana larger than that individual would be allowed to
possess under this title.
(b) When dispensing medical marihuana to a certified patient or desig-
nated caregiver, the registered organization (i) shall not dispense an
amount greater than a [thirty] SIXTY day supply to a certified patient
until the certified patient has exhausted all but a seven day supply
provided pursuant to a previously issued certification, and (ii) shall
verify the information in subparagraph (i) of this paragraph by consult-
ing the prescription monitoring program registry under section thirty-
three hundred forty-three-a of this article.
(c) Medical marihuana dispensed to a certified patient or designated
caregiver by a registered organization shall conform to any recommenda-
tion or limitation by the practitioner as to the form or forms of
medical marihuana or dosage for the certified patient.
14. 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 SECTION
(INCLUDING, BUT NOT LIMITED TO, SHIPPING, MAINTENANCE, CONSTRUCTION,
REPAIR, AND SECURITY), BUT NOT INCLUDING ANY FUNCTION OR ACTIVITY
DIRECTLY INVOLVING THE PLANTING, GROWING, TENDING, HARVESTING, PROCESS-
ING, OR PACKAGING OF PLANTS; OR ANY OTHER FUNCTION DIRECTLY INVOLVING
MANUFACTURING OR RETAILING OF MEDICAL MARIHUANA. ALL LAWS AND REGU-
LATIONS 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 COMMISSIONER MAY MAKE REGULATIONS
CONSISTENT WITH THIS TITLE RELATING TO CONTRACTS AND PARTIES TO
CONTRACTS UNDER THIS SUBDIVISION.
§ 6. The public health law is amended by adding a new section 3364-a
to read as follows:
§ 3364-A. MEDICAL MARIHUANA RESEARCH LICENSES. 1. THE COMMISSIONER
SHALL ESTABLISH A MEDICAL MARIHUANA RESEARCH LICENSE THAT PERMITS A
LICENSEE TO PRODUCE, PROCESS, PURCHASE, POSSESS, TRANSFER, AND SELL
MARIHUANA, SUBJECT TO THIS SECTION, FOR THE FOLLOWING LIMITED RESEARCH
PURPOSES:
(A) TO TEST CHEMICAL POTENCY AND COMPOSITION LEVELS;
(B) TO CONDUCT CLINICAL INVESTIGATIONS OF MARIHUANA-DERIVED PRODUCTS;
(C) TO CONDUCT RESEARCH ON THE EFFICACY AND SAFETY OF ADMINISTERING
MARIHUANA AS PART OF MEDICAL TREATMENT; OR
(D) TO CONDUCT GENOMIC OR AGRICULTURAL RESEARCH RELATING TO MEDICAL
MARIHUANA.
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2. AS PART OF THE APPLICATION PROCESS FOR A MEDICAL MARIHUANA RESEARCH
LICENSE, AN APPLICANT MUST SUBMIT TO THE COMMISSIONER A DESCRIPTION OF
THE RESEARCH THAT IS INTENDED TO BE CONDUCTED AS WELL AS THE AMOUNT OF
MARIHUANA TO BE GROWN OR PURCHASED. THE COMMISSIONER SHALL REVIEW AN
APPLICANT'S RESEARCH PROJECT AND DETERMINE WHETHER IT MEETS THE REQUIRE-
MENTS OF SUBDIVISION ONE OF THIS SECTION. IN ADDITION, THE COMMISSIONER
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 (TO THE EXTENT LEGALLY
AVAILABLE) APPROVALS RELATING TO HUMAN OR ANIMAL RESEARCH, IN PLACE TO
SUCCESSFULLY CONDUCT THE PROJECT; AND
(C) WHETHER THE AMOUNT OF MARIHUANA TO BE GROWN OR PURCHASED BY THE
APPLICANT IS CONSISTENT WITH THE PROJECT'S SCOPE AND GOALS.
3. IF THE COMMISSIONER DETERMINES THAT THE RESEARCH PROJECT MEETS THE
REQUIREMENTS OF SUBDIVISION ONE OF THIS SECTION, THE COMMISSIONER MAY
APPROVE THE APPLICATION. IF NOT, THE APPLICATION SHALL BE DENIED.
4. A MEDICAL MARIHUANA RESEARCH LICENSEE MAY ONLY SELL OR TRANSFER
MARIHUANA GROWN OR PRODUCED WITHIN ITS OPERATION TO OTHER MEDICAL MARI-
HUANA RESEARCH LICENSEES, OR OTHERWISE FOR PURPOSES OF THE LICENSEE'S
RESEARCH.
5. IN ESTABLISHING A MEDICAL MARIHUANA RESEARCH LICENSE, THE COMMIS-
SIONER MAY MAKE REGULATIONS ON THE FOLLOWING:
(A) APPLICATION REQUIREMENTS;
(B) LICENSE RENEWAL REQUIREMENTS, INCLUDING WHETHER ADDITIONAL
RESEARCH PROJECTS MAY BE ADDED OR CONSIDERED;
(C) CONDITIONS FOR LICENSE REVOCATION;
(D) SECURITY MEASURES TO ENSURE MARIHUANA IS NOT DIVERTED TO PURPOSES
OTHER THAN RESEARCH;
(E) AMOUNT OF PLANTS, USEABLE MARIHUANA, MARIHUANA CONCENTRATES, OR
MARIHUANA-INFUSED PRODUCTS A LICENSEE MAY HAVE ON ITS PREMISES;
(F) LICENSEE REPORTING REQUIREMENTS;
(G) CONDITIONS UNDER WHICH MARIHUANA GROWN BY LICENSED MEDICAL MARI-
HUANA PRODUCERS AND OTHER PRODUCT TYPES FROM LICENSED MEDICAL MARIHUANA
PROCESSORS MAY BE DONATED TO MEDICAL MARIHUANA RESEARCH LICENSEES; AND
(H) ANY ADDITIONAL REQUIREMENTS DEEMED NECESSARY BY THE COMMISSIONER.
6. A MARIHUANA RESEARCH LICENSE ISSUED UNDER THIS SECTION SHALL BE
ISSUED IN THE NAME OF THE APPLICANT OR APPLICANTS, SPECIFY THE LOCATION
AT WHICH THE MARIHUANA RESEARCHER INTENDS TO OPERATE, WHICH SHALL BE
WITHIN THE STATE, AND SHALL NOT ALLOW ANY OTHER PERSON TO USE THE
LICENSE EXCEPT AS UNDER SUBDIVISION FOUR OF THIS SECTION.
7. PARTICIPATION BY CERTIFIED PATIENTS IN ANY MEDICAL MARIHUANA
RESEARCH PROGRAM SHALL BE VOLUNTARY.
8. THE APPLICATION FEE FOR A MEDICAL MARIHUANA RESEARCH LICENSE SHALL
BE DETERMINED BY THE COMMISSIONER ON AN ANNUAL BASIS.
9. EACH MEDICAL MARIHUANA RESEARCH LICENSEE SHALL ISSUE AN ANNUAL
REPORT TO THE COMMISSIONER. THE COMMISSIONER SHALL REVIEW SUCH REPORT
AND MAKE A DETERMINATION AS TO WHETHER THE RESEARCH PROJECT CONTINUES TO
MEET THE RESEARCH QUALIFICATIONS UNDER THIS SECTION.
§ 7. The public health law is amended by adding a new section 3364-b
to read as follows:
§ 3364-B. REGISTRATION OF DESIGNATED CAREGIVER FACILITIES. 1. TO
OBTAIN, AMEND OR RENEW A REGISTRATION AS A DESIGNATED CAREGIVER FACILI-
TY, THE FACILITY SHALL FILE AN APPLICATION WITH THE COMMISSIONER. THE
APPLICATION SHALL INCLUDE:
(A) THE FACILITY'S FULL NAME AND ADDRESS;
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(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 MARIHUANA 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 COMMISSIONER.
2. PRIOR TO ISSUING OR RENEWING A DESIGNATED CAREGIVER FACILITY REGIS-
TRATION, THE COMMISSIONER MAY VERIFY THE INFORMATION SUBMITTED BY THE
APPLICANT. THE APPLICANT SHALL PROVIDE, AT THE COMMISSIONER'S REQUEST,
SUCH INFORMATION AND DOCUMENTATION, INCLUDING ANY CONSENTS OR AUTHORI-
ZATIONS, THAT MAY BE NECESSARY FOR THE COMMISSIONER TO VERIFY THE INFOR-
MATION.
3. THE APPLICATION SHALL BE APPROVED, DENIED OR DETERMINED INCOMPLETE
OR INACCURATE BY THE COMMISSIONER WITHIN THIRTY DAYS OF RECEIPT OF THE
APPLICATION. IF THE APPLICATION IS APPROVED, THE COMMISSIONER SHALL
ISSUE A REGISTRATION AS SOON AS IS REASONABLY PRACTICABLE.
4. REGISTRATIONS UNDER THIS SECTION SHALL REMAIN VALID FOR TWO YEARS
FROM THE DATE OF ISSUANCE.
§ 8. The public health law is amended by adding a new section 3364-c
to read as follows:
§ 3364-C. LABORATORY PERMITS. 1. THE COMMISSIONER SHALL APPROVE AND
PERMIT ONE OR MORE INDEPENDENT LABORATORIES TO TEST MEDICAL MARIHUANA.
TO BE PERMITTED AS AN INDEPENDENT LABORATORY UNDER THIS SECTION, A LABO-
RATORY MUST APPLY TO THE DEPARTMENT IN A FORM AND MANNER PRESCRIBED BY
THE COMMISSIONER AND MUST DEMONSTRATE THE FOLLOWING TO THE SATISFACTION
OF THE COMMISSIONER:
(A) THE OWNERS AND DIRECTORS OF THE LABORATORY ARE OF GOOD MORAL CHAR-
ACTER;
(B) THE LABORATORY AND ITS STAFF HAVE THE SKILLS, RESOURCES, AND
EXPERTISE NEEDED TO ACCURATELY AND CONSISTENTLY PERFORM ALL TESTING
REQUIRED;
(C) THE LABORATORY HAS IN PLACE AND WILL MAINTAIN ADEQUATE POLICIES,
PROCEDURES, AND FACILITY SECURITY TO ENSURE PROPER COLLECTION, LABELING,
ACCESSIONING, PREPARATION, ANALYSIS, RESULT REPORTING, DISPOSAL, AND
STORAGE OF MEDICAL MARIHUANA;
(D) THE LABORATORY IS PHYSICALLY LOCATED IN NEW YORK STATE;
(E) THE LABORATORY HAS A CERTIFICATE OF APPROVAL AS AN ENVIRONMENTAL
LABORATORY ISSUED BY THE COMMISSIONER UNDER TITLE ONE OF ARTICLE FIVE OF
THIS CHAPTER; AND
(F) THE LABORATORY MEETS ALL REQUIREMENTS PRESCRIBED BY THIS CHAPTER
AND THE COMMISSIONER IN REGULATION.
2. THE OWNER OF AN INDEPENDENT LABORATORY PERMITTED UNDER THIS SECTION
SHALL NOT HOLD A REGISTRATION AS A REGISTERED ORGANIZATION AND SHALL NOT
HAVE ANY DIRECT OR INDIRECT OWNERSHIP INTEREST IN SUCH REGISTERED ORGAN-
IZATION. NO BOARD MEMBER, MANAGER, OWNER, PARTNER, PRINCIPAL STAKEHOLD-
ER, OR MEMBER OF A REGISTERED ORGANIZATION, OR SUCH PERSON'S IMMEDIATE
FAMILY, SHALL HAVE AN INTEREST OR VOTING RIGHTS IN ANY INDEPENDENT LABO-
RATORY PERMITTEE. NO REGISTERED ORGANIZATION SHALL HAVE ANY DIRECT OR
INDIRECT OWNERSHIP INTEREST IN SUCH LABORATORY.
3. AN INDEPENDENT LABORATORY SHALL NOT BE REQUIRED TO BE LICENSED BY
THE FEDERAL DRUG ENFORCEMENT ADMINISTRATION.
§ 9. Subdivision 9 of section 3365 of the public health law, as added
by chapter 90 of the laws of 2014, is amended to read as follows:
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9. [The commissioner shall register no more than five] A registered
[organizations] ORGANIZATION that [manufacture] MANUFACTURES medical
marihuana [with] MAY HAVE no more than [four] EIGHT dispensing sites
wholly owned and operated by [such] THE registered organization. The
commissioner shall ensure that such [registered organizations and]
dispensing sites are geographically distributed across the state. The
commission [may] SHALL register additional registered organizations
REFLECTING THE DEMOGRAPHICS OF THE STATE.
§ 10. Subdivision 1 of section 3365-a of the public health law, as
added by chapter 416 of the laws of 2015, is amended to read as follows:
1. There is hereby established in the department an emergency medical
marihuana access program (referred to in this section as the "program")
under this section. The purpose of the program is to expedite the avail-
ability of medical marihuana to avoid suffering and loss of life, during
the period before full implementation of and production under this
title, especially in the case of patients whose [serious] condition is
progressive and degenerative or is such that delay in the patient's
medical use of marihuana poses a serious risk to the patient's life or
health. The commissioner shall implement the program as expeditiously as
practicable, including by emergency regulation.
§ 11. Subdivision 1 of section 3369 of the public health law, as added
by chapter 90 of the laws of 2014, is amended to read as follows:
1. Certified patients, designated caregivers, DESIGNATED CAREGIVER
FACILITIES, DESIGNATED CAREGIVER FACILITY EMPLOYEES, MEDICAL MARIHUANA
RESEARCH PROGRAM EMPLOYEES, practitioners, registered organizations and
the employees of registered organizations shall not be subject to
arrest, prosecution, or penalty in any manner, or denied any right or
privilege, including but not limited to civil penalty or disciplinary
action by a business or occupational or professional licensing board or
bureau, solely for the certified medical use or manufacture of marihua-
na, or for any other action or conduct in accordance with this title.
§ 12. Section 3369-d of the public health law, as added by chapter 90
of the laws of 2014, is amended to read as follows:
§ 3369-d. Pricing. [1. Every sale of medical marihuana shall be at the
price determined by the commissioner. Every charge made or demanded for
medical marihuana not in accordance with the price determined by the
commissioner, is prohibited.
2. The commissioner is hereby authorized to set the per dose price of
each form of medical marihuana sold by any registered organization. In
setting the per dose price of each form of medical marihuana, the
commissioner shall consider the fixed and variable costs of producing
the form of marihuana and any other factor the commissioner, in his or
her discretion, deems relevant to determining the per dose price of each
form of medical marihuana.] REGISTERED ORGANIZATIONS SHALL SUBMIT
DOCUMENTATION OF ANY PRICE AND CHANGE IN PRICE PER DOSE FOR ANY MEDICAL
MARIHUANA PRODUCT TO THE COMMISSIONER WITHIN FIFTEEN DAYS OF SETTING OR
CHANGING THE PRICE. PRIOR APPROVAL BY THE COMMISSIONER SHALL NOT BE
REQUIRED FOR ANY PRICE OR CHANGE OF PRICE. HOWEVER, THE COMMISSIONER IS
AUTHORIZED TO MODIFY THE PRICE PER DOSE FOR ANY MEDICAL MARIHUANA PROD-
UCT IF NECESSARY TO MAINTAIN PUBLIC ACCESS TO APPROPRIATE MEDICATION.
§ 13. This act shall take effect immediately; provided, however, that
the amendments to title 5-A of article 33 of the public health law made
by sections one, two, three, four, five, six, seven, eight, nine, ten,
eleven and twelve of this act shall not affect the repeal of such title
and shall be deemed repealed therewith. Effective immediately, the addi-
tion, amendment and/or repeal of any rule or regulation necessary for
A. 531 10
the implementation of this act on its effective date are authorized to
be made and completed on or before such effective date.