The New York State Senate

 
                     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

 A. 531                              2
 
 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.

 A. 531                              3
 
   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;

 A. 531                              4
 
   (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);

 A. 531                              5
 
   (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

 A. 531                              6
 
 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.

 A. 531                              7

   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;

 A. 531                              8
 
   (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

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 the  implementation of this act on its effective date are authorized  to
 be made and completed on or before such effective date.