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§ 10231.2002. Clinical registrants

Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 35 P.S. Health and SafetyEffective: June 30, 2021

Purdon's Pennsylvania Statutes and Consolidated Statutes
Title 35 P.S. Health and Safety (Refs & Annos)
Chapter 64. Medical Marijuana Act (Refs & Annos)
Chapter 20. Academic Clinical Research Centers and Clinical Registrants (Refs & Annos)
Effective: June 30, 2021
35 P.S. § 10231.2002
§ 10231.2002. Clinical registrants
Currentness
(a) Approval.--The department may approve up to 10 clinical registrants. Each clinical registrant may provide medical marijuana at not more than six separate locations. The total number of locations authorized to dispense medical marijuana under this section shall not exceed 60. The grower/processor and dispensary permits issued to clinical registrants approved under this section shall be in addition to the 25 grower/processor and 50 dispensary permits issued by the department in accordance with section 616(1) and (2).1 The limitations relating to number and location in sections 616(1) and (2) and 603(d)2 do not apply. A clinical registrant may not hold more than one grower/processor and one dispensary permit. Once the department approves an entity as a clinical registrant, the entity shall comply with this chapter. The following shall apply:
(1) The department shall:
(i) Open applications for the approval of up to two additional academic clinical research centers and issue approvals to qualified academic clinical research centers within 90 days of the effective date of this paragraph.
(ii) Open applications for the approval of up to two additional clinical registrants within 120 days of the effective date of this paragraph and issue permits to qualified clinical registrants within 180 days from the date when applications are posted.
(2) If the statutory maximum number of approved academic clinical research centers or approved clinical registrants are not approved under paragraph (1), the department shall reopen the application process for the approval of academic clinical research centers and clinical registrants.
(b) Requirements.--The following shall apply to clinical registrants:
(1) An entity seeking approval as a clinical registrant shall submit an application to the department in such form and manner as the department prescribes. The department shall ensure that the applicant meets the requirements of this act before approving the application to become a clinical registrant.
(2) An entity may be issued a permit as a grower/processor or dispensary before seeking approval as a clinical registrant. An entity may also apply for a permit as a grower/processor or a dispensary at the same time the entity seeks approval from the department as a clinical registrant.
(3) An entity seeking approval as a clinical registrant that does not already hold a permit as a grower/processor or a dispensary shall submit the applications required under Chapter 6.3 In reviewing an application, the department shall ensure that the entity meets all of the requirements for the issuance of a grower/processor permit or a dispensary permit, as applicable.
(4) When the department issues a permit as a grower/processor or a dispensary to an entity seeking approval as a clinical registrant, the issuance shall not be construed to reduce the number of permits for growers/processors and dispensaries authorized under section 616(1) and (2).
(i) The department shall not approve an applicant for a grower/processor permit if the applicant has previously had a contractual relationship with an academic clinical research center whereby the academic clinical research center or its affiliate provided advice to the applicant regarding, among other areas, patient health and safety, medical applications and dispensing and management of controlled substances and the applicant subsequently sold or assigned for profit to another entity their responsibility under the contractual relationship.
(ii) (Reserved).
(5) Except as provided in section 607(1)(vi) and (2)(vi),4 an entity seeking approval as a clinical registrant must pay the fees and meet all other requirements under this act for obtaining a permit as a grower/processor and a dispensary.
Upon approval of the department, a clinical registrant shall be issued a grower/processor permit and a dispensary permit and shall be a medical marijuana organization. As a medical marijuana organization, a clinical registrant must comply with all the provisions of this act relating to medical marijuana organizations except as otherwise provided in this chapter.
(6) The clinical registrant must have a minimum of $15,000,000 in capital. The department shall verify the capital requirement.
(7) The clinical registrant shall have all of the same rights as a grower/processor permittee and must comply with all other requirements of this act regarding growing, processing and dispensing medical marijuana.
(8) A grower/processor facility owned by a clinical registrant may sell its medical marijuana products to all dispensary facilities. The facility may sell seeds, medical marijuana plants and medical marijuana products to, or exchange seeds, medical marijuana plants and medical marijuana products with, any other grower/processor facility holding a permit under Chapter 6 or this chapter.
(9) A clinical registrant may petition the department, on a form prescribed by the department, for approval to sell certain of the medical marijuana products grown and processed by its grower/processor facility to other medical marijuana organizations holding dispensary permits under Chapter 6. The petition must be accompanied by a written report of the clinical registrant's research findings with respect to the medical marijuana products which are the subject of the petition. The department shall approve the petition if it has been demonstrated that the medical marijuana products have a practical effect on patients which changes a recommendation within the medical field as indicated in the report submitted by the clinical registrant.
(10) A dispensary owned by a clinical registrant may dispense medical marijuana products to a patient or caregiver who presents a valid identification card to an employee who is authorized to dispense medical marijuana products at a dispensary location operated by the clinical registrant, regardless of whether the patient is a participant in a research study or program.

Credits

2016, April 17, P.L. 84, No. 16, § 2002, effective in 30 days [May 17, 2016]. Amended 2018, June 22, P.L. 322, No. 43, § 5, imd. effective; 2021, June 30, P.L. 210, No. 44, § 6, imd. effective.

Footnotes

1
35 P.S. § 10231.616.
2
35 P.S. § 10231.603.
3
35 P.S. § 10231.601 et seq.
4
35 P.S. § 10231.607.
35 P.S. § 10231.2002, PA ST 35 P.S. § 10231.2002
Current through Act 10 of the 2024 Regular Session. Some statute sections may be more current, see credits for details.
End of Document