Legislative Bill Drafting Commission 11129-03-9 S. -------Senate -------- IN SENATE--Introduced by Sen --read twice and ordered printed, and when printed to be committed to the Committee on -------- A. Assembly -------IN ASSEMBLY--Introduced by M. of A. with M. of A. as co-sponsors --read once and referred to the Committee on *PUBHEALA* (Relates to medical marihuana) -------Pub Heal. medical marihuana 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 Assembly, do enact as follows: ______________________________ IN SENATE____________________________________________________ Senate introducer's signature The senators whose names are circled below wish to join me in the sponsorship of this proposal: s15 Addabbo s02 Flanagan s09 Kaminsky s25 Montgomery s52 Akshar s55 Funke s07 Kaplan s20 Myrie s23 Savino s32 Sepulveda s46 Amedore s59 Gallivan s26 Kavanagh s58 O'Mara s41 Serino s50 Antonacci s05 Gaughran s63 Kennedy s62 Ortt s29 Serrano s36 Bailey s12 Gianaris s28 Krueger s21 Parker s51 Seward s30 Benjamin s22 Gounardes s24 Lanza s19 Persaud s39 Skoufis s34 Biaggi s47 Griffo s01 LaValle s13 Ramos s16 Stavisky s04 Boyle s40 Harckham s45 Little s61 Ranzenhofer s35 Stewart- s44 Breslin s54 Helming s11 Liu s48 Ritchie Cousins s08 Brooks s27 Hoylman s03 Martinez s33 Rivera s49 Tedisco s38 Carlucci s31 Jackson s53 May s56 Robach s06 Thomas s14 Comrie s60 Jacobs s37 Mayer s18 Salazar s57 s17 Felder s43 Jordan s42 Metzger s10 Sanders IN ASSEMBLY__________________________________________________ Assembly introducer's signature The Members of the Assembly whose names are circled below wish to join me in the multi-sponsorship of this proposal: a049 Abbate a072 De La Rosa a029 Hyndman a144 Norris a090 Sayegh a092 Abinanti a034 DenDekker a104 Jacobson a069 O'Donnell a140 Schimminger a084 Arroyo a003 DeStefano a097 Jaffee a051 Ortiz a099 Schmitt a107 Ashby a070 Dickens a011 Jean-Pierre a091 Otis a076 Seawright a035 Aubry a054 Dilan a135 Johns a132 Palmesano a052 Simon a120 Barclay a081 Dinowitz a115 Jones a002 Palumbo a036 Simotas a030 Barnwell a147 DiPietro a077 Joyner a088 Paulin a005 Smith a106 Barrett a016 D'Urso a040 Kim a141 Peoples- a060 Barron a048 Eichenstein a131 Kolb a082 Benedetto a004 Englebright a105 Lalor a058 Perry a042 Bichotte a074 Epstein a013 Lavine a023 Pheffer a079 Blake a109 Fahy a134 Lawrence Stokes Amato a118 Smullen a022 Solages a114 Stec a110 Steck a010 Stern a117 Blankenbush a061 Fall a050 Lentol a086 Pichardo a127 Stirpe a098 Brabenec a125 Lifton a089 Pretlow a102 Tague a080 Fernandez a026 Braunstein a126 Finch a009 LiPetri a073 Quart a071 Taylor a138 Bronson a008 Fitzpatrick a123 Lupardo a019 Ra a001 Thiele a093 Buchwald a124 Friend a129 Magnarelli a012 Raia a031 Titus a142 Burke a046 Frontus a064 Malliotakis a006 Ramos a033 Vanel a119 Buttenschon a095 Galef a130 Manktelow a018 Raynor a116 Walczyk a094 Byrne a137 Gantt a108 McDonald a062 Reilly a133 Byrnes a007 Garbarino a014 McDonough a087 Reyes a143 Wallace a103 Cahill a148 Giglio a146 McMahon a043 Richardson a112 Walsh a044 Carroll a066 Glick a017 Mikulin a078 Rivera a041 Weinstein a047 Colton a150 Goodell a101 Miller, B. a068 Rodriguez a024 Weprin a032 Cook a075 Gottfried a038 Miller, M. G. a136 Romeo a085 Crespo a021 Griffin a020 Miller, M. L. a027 Rosenthal, D. a113 Woerner a122 Crouch a100 Gunther a015 Montesano a067 Rosenthal, L. a056 Wright a039 Cruz a139 Hawley a145 Morinello a025 Rozic a063 Cusick a083 Heastie a057 Mosley a149 Ryan a045 Cymbrowitz a028 Hevesi a065 Niou a121 Salka a053 Davila a128 Hunter a037 Nolan a111 Santabarbara a055 Walker a059 Williams a096 Zebrowski 1) Single House Bill (introduced and printed separately in either or both houses). Uni-Bill (introduced simultaneously in both houses and printed as one bill. Senate and Assembly introducer sign the same copy of the bill). 2) Circle names of co-sponsors and return to introduction clerk with 2 signed copies of bill and 4 copies of memorandum in support (single house); or 4 signed copies of bill and 8 copies of memorandum in support (uni-bill). LBDC 03/11/19 04/17/19 1 Section 2 1. 11129-03-9 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 3 laws 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 of 90 of the 2014, paragraph (a) of subdivision 7 as amended by chapter 273 1. "Certified medical use" means the acquisition, possession, use, or, 7 transportation of medical marihuana 8 acquisition, 9 medical marihuana by a designated caregiver, for certified patient, or the delivery, transportation or administration of [serious] condition, as part of the 11 certification under this title including enabling the patient to 12 ate treatment for the [serious] condition. [A certified medical use does 13 not include smoking.] "Designated patient's use treatment 5. the a 10 14 of possession, by as authorized in a toler- 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 23 ________________________________________________________________________ care facility operating under title two of article seven of the social 24 ________________________________________________________________________ services law; a community mental health residence established under 25 ________________________________________________________________________ section 41.44 of the mental hygiene law; a hospital operating under 26 ________________________________________________________________________ section 7.17 of the mental hygiene law; a mental hygiene facility oper- 27 ________________________________________________________________________ ating under article thirty-one of the mental hygiene law; an inpatient 28 ________________________________________________________________________ or residential treatment program certified under article thirty-two of 04/17/19 3 11129-03-9 1 ________________________________________________________________________ the mental hygiene law; a residential facility for the care and treat- 2 ________________________________________________________________________ ment of persons with developmental disabilities operating under article 3 ________________________________________________________________________ sixteen of the mental hygiene law; a residential treatment facility for 4 ________________________________________________________________________ children and youth operating under article thirty-one of the mental 5 ________________________________________________________________________ hygiene law; a public school or private school operating under the 6 ________________________________________________________________________ education law; a research institution with an internal review board; a 7 ________________________________________________________________________ medical marihuana research program licensed under section thirty-three 8 ________________________________________________________________________ hundred sixty-four-a of this title; or any other facility as determined 9 __________________________________ by the commissioner in regulation. 10 11 ______________________________________________________________________ 5-b. "Designated caregiver facility employee" means an employee of a ______________________________ designated caregiver facility. 12 7. (a) ["Serious condition"] ___________ "Condition" means: 13 (i) having one of the following [severe debilitating or life-threaten- 14 ing] 15 virus or acquired immune deficiency syndrome, amyotrophic lateral scler- 16 osis, Parkinson's disease, multiple sclerosis, 17 tissue 18 intractable spasticity, epilepsy, inflammatory bowel 19 thies, 20 degrades health and functional capability where the use of medical mari- 21 huana 22 ________________________________________________________________________ Alzheimer's, muscular dystrophy, dystonia, rheumatoid arthritis, autism, 23 or [as added by the commissioner; and 24 conditions: of the cancer, spinal Huntington's is an positive cord status for human immunodeficiency damage to the nervous with objective neurological indication of disease, neuropa- disease, post-traumatic stress disorder, pain that alternative to opioid use, substance use disorder, (ii) any of the following conditions where it is clinically associated 25 with, or a complication of, a condition under this paragraph or its 26 treatment: cachexia or wasting syndrome; severe or chronic pain; 27 nausea; seizures; severe or persistent muscle spasms; or such conditions 28 as are added by the commissioner. severe 04/17/19 1 (b) 4 No later than eighteen 11129-03-9 months from the effective date of this 2 section, the commissioner shall determine whether to add 3 serious 4 traumatic stress disorder and rheumatoid arthritis] ____________________ any other condition 5 _____________________________ certified by the practitioner. 6 12. conditions: "Practitioner" Alzheimer's, means a muscular practitioner the following dystrophy, dystonia, post- who (i) [is a physician 7 licensed by New York state and practicing within the state,] ___________ is author- 8 __________________________________________________________ ized to prescribe controlled substances within the state; (ii) [who] by 9 training or experience is qualified to treat a [serious] condition as 10 defined in subdivision seven of this section; and (iii) [has completed a 11 two 12 and registered with the department; 13 shall 14 certification requirements. The commissioner shall consider 15 sion 16 including access and availability. After such consideration the 17 sioner 18 this title] ____________________________________________________________ completes, at a minimum, a two hour course as determined by 19 ________________________________________________________________________ the commissioner. A person's status as a practitioner under this title 20 ________________________________________________________________________ is deemed to be a "license" for purposes of section thirty-three hundred 21 ______________________ ninety of this article. to four hour course as determined by the commissioner in regulation not of be provided however, a registration denied without cause. Such course may count toward board the inclu- nurse practitioners under this title based upon considerations commis- is authorized to deem nurse practitioners as practitioners under 22 ______________________________________________________________________ 19. "Medical marihuana research program" means a medical marihuana 23 ________________________________________________________________________ research program licensed under section thirty-three hundred 24 ___________________________ sixty-four-a of this title. 25 § 2. Subdivisions 1, 2, and 9 of section 3361 of the public health 26 law, subdivisions 1 and 2 as added by chapter 90 of the laws of 2014 and 27 subdivision 28 to read as follows: 9 as added by chapter 416 of the laws of 2015, are amended 04/17/19 1 5 11129-03-9 1. A patient certification may only be issued if: (a) been registered with the a practitioner 2 has department to issue a certification as 3 determined by the commissioner; (b) the patient has a 4 tion, 5 the 6 [serious] condition; (d) the patient is under the practitioner's contin- 7 uing care for the [serious] condition; and 8 professional opinion and review of past treatments, the patient is like- 9 ly practitioner receive by training therapeutic or experience is qualified to treat the or adjunctive treatment with medical use of 11 condition. The certification shall (e) in the practitioner's palliative benefit from the primary or 10 2. condi- which shall be specified in the patient's health care record; (c) to 12 [serious] marihuana for the [serious] include (a) the name, date of birth and 13 address of the patient; (b) a statement that the patient has a [serious] 14 condition and the patient is 15 [serious] 16 subdivision one of this section have been satisfied; (d) the 17 (e) 18 and the 19 commissioner 20 on a form provided by the department. The practitioner may state in 21 certification 22 patient would benefit from medical 23 date. The practitioner may state in the certification that, in the prac- 24 titioner's 25 the certification shall not expire until the patient dies. 26 9.(a) A certification may be a special certification if, the practitioner's care for the condition; (c) a statement attesting that all requirements of the the under name, date; and address, federal registration number, telephone number, handwritten may signature of the certifying practitioner. The require by regulation that the certification shall be that, in the practitioner's marihuana the professional opinion, the only until a specified professional opinion, the patient is terminally ill and that 27 to 28 fies in the certification that in addition other requirements for a certification, the practitioner certithe patient's [serious] condition is 04/17/19 6 and 1 progressive 2 medical use of marihuana poses a serious risk to the patient's 3 health. 4 (b) The degenerative 11129-03-9 department shall or that delay in the patient's certified create certification and shall make that form available to be 6 the department's website. added 9 sion 3 is added to read as follows: from by chapter 90 of the laws of 2014, are amended and a new subdivi- 1. The possession, acquisition, use, delivery, 11 tion, 12 designated caregiver possessing a valid 13 for 14 that: 15 downloaded § 3. Subdivisions 1 and 2 of section 3362 of the public health law, as 8 10 or the form to be used for a special 5 7 life or transfer, transporta- administration of medical marihuana by a certified patient or certified medical registry identification use, shall be lawful under this title; provided (a) the marihuana that may be possessed by a certified shall not 17 the practitioner, consistent with any guidance and regulations issued by 18 the commissioner, provided that during the last seven days of any [thir- 19 ty] _____ sixty day period, the certified patient may also possess up to 20 amount for the next [thirty] _____ sixty day period; (b) a patient 16 21 exceed card, [thirty] _____ sixty day supply of the dosage as determined by such the marihuana that may be possessed by designated caregivers does 22 not exceed the quantities referred to in paragraph (a) of this subdivi- 23 sion for each certified patient for whom the caregiver possesses a valid 24 registry identification card, up to five certified patients; 25 ______________________________________________________________________ (c) the marihuana that may be possessed by designated caregiver facil- 26 ________________________________________________________________________ ities does not exceed the quantities referred to in paragraph (a) of 27 ________________________________________________________________________ this subdivision for each certified patient under care or treatment of 28 _____________ the facility; 04/17/19 7 11129-03-9 1 [(c)] ___ (d) the form or forms of medical marihuana that may be possessed 2 by the certified patient [or], _ designated caregiver, _____________________ or designated care- 3 _______________ giver facility 4 any recommendation or limitation by the practitioner as to the 5 forms 6 certification; and 7 of pursuant to a certification shall be in compliance with medical 8 in 9 three hundred sixty-four of this title, except for the 10 for 11 patient. it immediate consumption for 13 (a) possession of medical marihuana shall not 14 title 15 regardless of the form of medical 16 certification. portion removed certified medical use by the certified 2. Notwithstanding subdivision one of this section: (b) package was dispensed under subdivision twelve of section thirty- 12 17 or marihuana or dosage for the certified patient in the [(d)] ___ (e) the medical marihuana shall be kept in the original which form be lawful under this if it is smoked, consumed, vaporized, or grown in a public place, a [person] marihuana stated in the patient's _________________________________________ certified patient or designated caregiver possessing 18 medical marihuana under this title shall possess his or her registry 19 identification card at all times when in immediate possession of medical 20 marihuana. 21 ______________________________________________________________________ (c) medical marihuana may not be smoked in any place where tobacco may 22 ________________________________________________________________________ not be smoked under article thirteen-E of this chapter, regardless of 23 ____________________________________________________________________ the form of medical marihuana stated in the patient's certification. 24 ______________________________________________________________________ 3. The possession, acquisition, delivery, transfer, transportation, or 25 ________________________________________________________________________ administration of medical marihuana by a designated caregiver facility 26 ________________________________________________________________________ or designated caregiver facility employee shall be lawful under this 27 ____________________ title provided that: 04/17/19 1 2 8 11129-03-9 ______________________________________________________________________ (a) the designated caregiver facility registers with the department on ____________________________________ a form provided by the commissioner; 3 ______________________________________________________________________ (b) such possession, acquisition, delivery, transfer, transportation, 4 ________________________________________________________________________ or administration is on behalf of a certified patient possessing a 5 _____________________________ registry identification card; 6 ______________________________________________________________________ (c) the designated caregiver facility maintains a copy of the registry 7 ________________________________________________________________________ identification card of each certified patient for which it possesses, 8 ________________________________________________________________________ acquires, delivers, transfers, transports, or administers medical mari- 9 __________ huana; and 10 11 12 ______________________________________________________________________ (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 13 law, 14 follows: 15 as added by chapter 90 of the laws of 2014, are amended to read as 2. To obtain, amend or renew a registry identification card, a 16 fied patient 17 with the department. The registry 18 shall include: or designated caregiver shall file a registry application application 19 (a) in the case of a certified patient: 20 (i) 21 or renewal application the patient's certification (a new written certification shall be provided with a renewal application); 22 (ii) the name, address, and date of birth of the patient; 23 (iii) the date of the certification; 24 (iv) if the patient has a registry certification, the 26 expiration date of that registry identification card; (v) the specified date until which registry card current 28 valid identification 25 27 certi- the based on a identification number and patient would medical marihuana, if the certification states such a date; benefit from 04/17/19 1 2 (vi) 9 the name, address, 11129-03-9 federal registration number, and telephone number of the certifying practitioner; 3 (vii) any recommendation or limitation by the practitioner as to the 4 form or forms of medical marihuana or dosage for the certified 5 and 6 (viii) 7 department; 8 9 other individual identifying information required (b) ___ (i) in the case of a certified patient, if the patient a designated caregiver, caregiver, the 10 designated and 11 required by the department; name, other patient; by the designates address, and date of birth of the individual identifying information 12 ______________________________________________________________________ (ii) if the designated caregiver is a medical marihuana research 13 ________________________________________________________________________ program, the name of the organization conducting the research; the 14 ________________________________________________________________________ address, phone number, and name of the individual leading the research 15 ________________________________________________________________________ or appropriate designee; and other identifying information required by 16 _______________ the department; 17 (c) in the case of a designated caregiver: 18 (i) the name, address, and date of birth of the designated caregiver; 19 (ii) if the designated caregiver has a registry identification card, 20 the registry identification number and expiration date of that 21 identification card; and 22 (iii) other individual identifying information required by the depart- 23 ment; 24 (d) 25 26 27 registry 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 patient or designated caregiver, as the case may be; ___ and the certified 04/17/19 1 2 10 11129-03-9 (f) [a fifty dollar application fee, provided, that the department may waive or reduce the fee in cases of financial hardship; and 3 (g)] any other requirements determined by the commissioner. 4 3. Where a certified patient is under the age of eighteen: 5 (a) The application for a registry identification card shall be made 6 by an appropriate person over twenty-one years of age. 7 shall state facts demonstrating that the person is appropriate. 8 9 (b) The The application designated caregiver shall be (i) a parent or legal guardian of the certified patient, (ii) a person designated by a parent or legal 10 guardian, [or] (iii) ___________________________________________________ in the case of such a certified patient being cared 11 ________________________________________________________________________ for by a designated caregiver facility, the designated caregiver facili- 12 _________________________________________________________ ty designated by the parent or legal guardian; or (iv) an appropriate 13 person approved by the department upon 14 parent or legal guardian is appropriate or available. 15 5. No a sufficient showing that no person may be a designated caregiver for more than five certi- 16 fied patients at one time; _______________________________________________ provided however that this limitation shall 17 ________________________________________________________________________ not apply to a designated caregiver facility or designated caregiver 18 _________________ facility employee. 19 11. A certified patient or designated caregiver who has been issued 20 registry 21 in his or her name or address or, with respect to the patient, if he 22 she 23 within ten days of such change. The certified 24 caregiver's 25 shall be returned promptly to the department. 26 identification ceases to a card shall notify the department of any change or have the [serious] condition noted on the certification registry identification card patient's or designated shall be deemed invalid and § 5. Subdivisions 3 and 5 of section 3364 of the public health law, as 27 added by chapter 90 of the laws of 2014, are amended and a new 28 sion 14 is added to read as follows: subdivi- 04/17/19 1 3. 11 Each registered organization 11129-03-9 shall contract with an independent 2 laboratory _____________________________________________________________ permitted under section thirty-three hundred sixty-four-c of 3 _____________ this chapter 4 organization. The commissioner shall approve the laboratory and 5 that the laboratory report testing results in a manner determined by the 6 commissioner. The commissioner is authorized to issue regulation requir- 7 ing the laboratory to perform certain tests and services. 8 9 5. (a) No to test the medical marihuana produced by the registered registered organization may sell, deliver, distribute or dispense to any certified patient or designated caregiver a quantity 10 medical 11 possess under this title. 12 require marihuana larger than that individual would of be allowed to (b) When dispensing medical marihuana to a certified patient or desig- 13 nated caregiver, the registered organization (i) shall not 14 amount 15 until the certified patient has exhausted all but 16 provided 17 verify the information in subparagraph (i) of this paragraph by consult- 18 ing the prescription monitoring program registry under 19 three hundred forty-three-a of this article. 20 (c) greater a seven day supply to a previously issued certification, and (ii) shall section thirty- marihuana dispensed to a certified patient or designated 21 caregiver by a registered organization shall conform to any 22 tion 23 medical marihuana or dosage for the certified patient. or an than a [thirty] _____ sixty day supply to a certified patient pursuant Medical dispense limitation by the practitioner as recommenda- to the form or forms of 24 ______________________________________________________________________ 14. A registered organization may contract with a person or entity to 25 ________________________________________________________________________ provide facilities, equipment or services that are ancillary to the 26 ________________________________________________________________________ registered organization's functions or activities under this section 27 ________________________________________________________________________ (including, but not limited to, shipping, maintenance, construction, 28 ________________________________________________________________________ repair, and security). All laws and regulations applicable to such 04/17/19 12 11129-03-9 1 ________________________________________________________________________ facilities, equipment, or services shall apply to the contract. The 2 ________________________________________________________________________ registered organization and other parties to the contract shall each be 3 ________________________________________________________________________ responsible for compliance with such laws and regulations under the 4 ________________________________________________________________________ contract. The commissioner may make regulations consistent with this 5 ________________________________________________________________________ title relating to contracts and parties to contracts under this subdivi- 6 _____ sion. 7 8 § 6. The public health law is amended by adding a new section 3364-a to read as follows: 9 ______________________________________________________________________ § 3364-a. Medical marihuana research licenses. 1. The commissioner 10 ________________________________________________________________________ shall establish a medical marihuana research license that permits a 11 ________________________________________________________________________ licensee to produce, process, purchase, possess, transfer, and sell 12 ________________________________________________________________________ marihuana, subject to this section, for the following limited research 13 _________ purposes: 14 ____________________________________________________ (a) to test chemical potency and composition levels; 15 _____________________________________________________________________ (b) to conduct clinical investigations of marihuana-derived products; 16 ______________________________________________________________________ (c) to conduct research on the efficacy and safety of administering 17 18 19 __________________________________________ marihuana as part of medical treatment; or ______________________________________________________________________ (d) to conduct genomic or agricultural research relating to medical __________ marihuana. 20 ______________________________________________________________________ 2. As part of the application process for a medical marihuana research 21 ________________________________________________________________________ license, an applicant must submit to the commissioner a description of 22 ________________________________________________________________________ the research that is intended to be conducted as well as the amount of 23 ________________________________________________________________________ marihuana to be grown or purchased. The commissioner shall review an 24 ________________________________________________________________________ applicant's research project and determine whether it meets the require- 25 ________________________________________________________________________ ments of subdivision one of this section. In addition, the commissioner 26 _____________________________________________________________ shall assess the application based on the following criteria: 27 _____________________________________________________ (a) project quality, study design, value, and impact; 04/17/19 13 11129-03-9 1 ______________________________________________________________________ (b) whether the applicant has the appropriate personnel, expertise, 2 ________________________________________________________________________ facilities and infrastructure, funding, and (to the extent legally 3 ________________________________________________________________________ available) approvals relating to human or animal research, in place to 4 _____________________________________ successfully conduct the project; and 5 6 ______________________________________________________________________ (c) whether the amount of marihuana to be grown or purchased by the ___________________________________________________________ applicant is consistent with the project's scope and goals. 7 ______________________________________________________________________ 3. If the commissioner determines that the research project meets the 8 ________________________________________________________________________ requirements of subdivision one of this section, the commissioner may 9 _________________________________________________________________ approve the application. If not, the application shall be denied. 10 ______________________________________________________________________ 4. A medical marihuana research licensee may only sell or transfer 11 ________________________________________________________________________ marihuana grown or produced within its operation to other medical mari- 12 ________________________________________________________________________ huana research licensees, or otherwise for purposes of the licensee's 13 _________ research. 14 15 ______________________________________________________________________ 5. In establishing a medical marihuana research license, the commis_____________________________________________ sioner may make regulations on the following: 16 _____________________________ (a) application requirements; 17 ______________________________________________________________________ (b) license renewal requirements, including whether additional 18 _____________________________________________ research projects may be added or considered; 19 ______________________________________ (c) conditions for license revocation; 20 ______________________________________________________________________ (d) security measures to ensure marihuana is not diverted to purposes 21 22 23 ____________________ other than research; ______________________________________________________________________ (e) amount of plants, useable marihuana, marihuana concentrates, or _______________________________________________________________ marihuana-infused products a licensee may have on its premises; 24 ____________________________________ (f) licensee reporting requirements; 25 ______________________________________________________________________ (g) conditions under which marihuana grown by licensed medical mari- 26 ________________________________________________________________________ huana producers and other product types from licensed medical marihuana 27 ______________________________________________________________________ processors may be donated to medical marihuana research licensees; and 28 _____________________________________________________________________ (h) any additional requirements deemed necessary by the commissioner. 04/17/19 14 11129-03-9 1 ______________________________________________________________________ 6. A marihuana research license issued under this section shall be 2 ________________________________________________________________________ issued in the name of the applicant or applicants, specify the location 3 ________________________________________________________________________ at which the marihuana researcher intends to operate, which shall be 4 ________________________________________________________________________ within the state, and shall not allow any other person to use the 5 _________________________________________________________ license except as under subdivision four of this section. 6 7 8 9 ______________________________________________________________________ 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. 10 ______________________________________________________________________ 9. Each medical marihuana research licensee shall issue an annual 11 ________________________________________________________________________ report to the commissioner. The commissioner shall review such report 12 ________________________________________________________________________ and make a determination as to whether the research project continues to 13 ____________________________________________________ meet the research qualifications under this section. 14 15 § 7. The public health law is amended by adding a new section 3364-b to read as follows: 16 ______________________________________________________________________ § 3364-b. Registration of designated caregiver facilities. 1. To 17 ________________________________________________________________________ obtain, amend or renew a registration as a designated caregiver facili- 18 ________________________________________________________________________ ty, the facility shall file an application with the commissioner. The 19 __________________________ application shall include: 20 _________________________________________ (a) the facility's full name and address; 21 ______________________________________________________________ (b) operating certificate or license number where appropriate; 22 ______________________________________________________________________ (c) name, title, and signature of an authorized facility represen- 23 24 25 26 27 28 _______ 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. 04/17/19 15 11129-03-9 1 ______________________________________________________________________ 2. Prior to issuing or renewing a designated caregiver facility regis- 2 ________________________________________________________________________ tration, the commissioner may verify the information submitted by the 3 ________________________________________________________________________ applicant. The applicant shall provide, at the commissioner's request, 4 ________________________________________________________________________ such information and documentation, including any consents or authori- 5 ________________________________________________________________________ zations, that may be necessary for the commissioner to verify the infor- 6 _______ mation. 7 ______________________________________________________________________ 3. The application shall be approved, denied or determined incomplete 8 ________________________________________________________________________ or inaccurate by the commissioner within thirty days of receipt of the 9 ________________________________________________________________________ application. If the application is approved, the commissioner shall 10 11 12 13 14 __________________________________________________________ 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: 15 ______________________________________________________________________ § 3364-c. Laboratory permits. 1. The commissioner shall approve and 16 ________________________________________________________________________ permit one or more independent laboratories to test medical marihuana. 17 ________________________________________________________________________ To be permitted as an independent laboratory under this section, a labo- 18 ________________________________________________________________________ ratory must apply to the department in a form and manner prescribed by 19 ________________________________________________________________________ the commissioner and must demonstrate the following to the satisfaction 20 ____________________ of the commissioner: 21 22 ______________________________________________________________________ (a) the owners and directors of the laboratory are of good moral char______ acter; 23 ______________________________________________________________________ (b) the laboratory and its staff have the skills, resources, and 24 ________________________________________________________________________ expertise needed to accurately and consistently perform all testing 25 _________ required; 26 ______________________________________________________________________ (c) the laboratory has in place and will maintain adequate policies, 27 ________________________________________________________________________ procedures, and facility security to ensure proper collection, labeling, 04/17/19 16 11129-03-9 1 ________________________________________________________________________ accessioning, preparation, analysis, result reporting, disposal, and 2 _____________________________ storage of medical marihuana; 3 ___________________________________________________________ (d) the laboratory is physically located in New York state; 4 ______________________________________________________________________ (e) the laboratory has a certificate of approval as an environmental 5 ________________________________________________________________________ laboratory issued by the commissioner under title one of article five of 6 _________________ this chapter; and 7 8 ______________________________________________________________________ (f) the laboratory meets all requirements prescribed by this chapter ___________________________________ and the commissioner in regulation. 9 ______________________________________________________________________ 2. The owner of an independent laboratory permitted under this section 10 ________________________________________________________________________ shall not hold a registration as a registered organization and shall not 11 ________________________________________________________________________ have any direct or indirect ownership interest in such registered organ- 12 ________________________________________________________________________ ization. No board member, manager, owner, partner, principal stakehold- 13 ________________________________________________________________________ er, or member of a registered organization, or such person's immediate 14 ________________________________________________________________________ family, shall have an interest or voting rights in any independent labo- 15 ________________________________________________________________________ ratory permittee. No registered organization shall have any direct or 16 _______________________________________________ indirect ownership interest in such laboratory. 17 18 ______________________________________________________________________ 3. An independent laboratory shall not be required to be licensed by ____________________________________________ the federal drug enforcement administration. 19 § 9. Subdivision 9 of section 3365 of the public health law, as 20 by chapter 90 of the laws of 2014, is amended to read as follows: 21 9. [The commissioner added shall register no more than five] _ A registered 22 [organizations] ____________ organization that 23 marihuana no more than [four] _____ eight dispensing sites 24 wholly owned and operated by [such] 25 commissioner 26 dispensing sites are geographically distributed across 27 commission 28 ________________________________________ reflecting the demographics of the state. [with] _________ may have shall [may] ensure _____ shall that register [manufacture] ___ the such ____________ manufactures registered organization. [registered additional medical The organizations and] the state. The registered organizations 04/17/19 1 2 3 17 11129-03-9 § 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 4 marihuana access program (referred to in this section as the 5 under this section. The purpose of the program is to expedite the avail- 6 ability of medical marihuana to avoid suffering and loss of life, during 7 the 8 title, especially in the case of patients whose [serious] 9 progressive period before and full implementation degenerative or is of "program") and production under this condition is such that delay in the patient's 10 medical use of marihuana poses a serious risk to the patient's 11 health. The commissioner shall implement the program as expeditiously as 12 practicable, including by emergency regulation. 13 14 15 life or § 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 16 ________________________________________________________________________ facilities, designated caregiver facility employees, medical marihuana 17 ____________________________ research program employees, practitioners, registered organizations and 18 the employees of 19 arrest, 20 privilege, including but not limited to civil 21 action 22 bureau, solely for the certified medical use or manufacture of 23 na, or for any other action or conduct in accordance with this title. 24 25 26 27 § registered prosecution, or organizations shall not be subject to penalty in any manner, or denied any right or penalty or disciplinary by a business or occupational or professional licensing board or marihua- 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 04/17/19 18 1 medical 2 commissioner, is prohibited. 3 2. marihuana not in 11129-03-9 accordance with the price determined by the The commissioner is hereby authorized to set the per dose price of 4 each form of medical marihuana sold by any registered 5 setting 6 commissioner shall consider the fixed and variable 7 the 8 her discretion, deems relevant to determining the per dose price of each 9 form the form of per dose price of each organization. In form of medical marihuana, the costs of producing of marihuana and any other factor the commissioner, in his or medical marihuana.] ________________________________________ Registered organizations shall submit 10 ________________________________________________________________________ documentation of any price and change in price per dose for any medical 11 ________________________________________________________________________ marihuana product to the commissioner within fifteen days of setting or 12 ________________________________________________________________________ changing the price. Prior approval by the commissioner shall not be 13 ________________________________________________________________________ required for any price or change of price. However, the commissioner is 14 ________________________________________________________________________ authorized to modify the price per dose for any medical marihuana prod- 15 _____________________________________________________________________ uct if necessary to maintain public access to appropriate medication. 16 § 13. This act shall take effect immediately; provided, however, that 17 the amendments to title 5-A of article 33 of the public health law made 18 by sections one, two, three, four, five, six, seven, eight, 19 eleven 20 and shall be deemed repealed therewith. Effective immediately, the addi- 21 tion, amendment and/or repeal of any rule or 22 the 23 be made and completed on or before such effective date. nine, ten, and twelve of this act shall not affect the repeal of such title regulation necessary for implementation of this act on its effective date are authorized to