28 Pa. Code § 1211a.27a

Current through Register Vol. 54, No. 45, November 9, 2024

Section 1211a.27a - Research contracts

(a) An applicant for approval as a clinical registrant shall provide, with its application, either an executed agreement or a letter of intent to enter into an agreement, with an ACRC, the effective date of which shall be on or after the effective date of the ACRC certification.

(b) A clinical registrant applicant may submit more than one application, with separate applications identifying distinct ACRCs.

(c) An ACRC may enter into a letter of intent with more than one clinical registrant applicant but may only execute a research contract with one approved clinical registrant.

(d) If more than one applicant for approval as a clinical registrant submits an application that includes a letter of intent with the same ACRC, the Department shall follow the following process in approving the applications:

(1) Determine initially that the CR application meets all of the following qualifications:

(i) Is complete.

(ii) Complies with the act and this part.

(iii) Meets the following minimum scoring requirements in each of the following application sections:

Grower Processor Application	Max Points/Section	MinimumAcceptable Score
8-Operational Timetable	75	31
9-Employee Qualifications, Description of Duties and Training	25	11
10-Security and Surveillance	50	21
11-Transportation of Medical Marijuana	25	11
12-Storage of Medical Marijuana	25	11
13-Packaging and Labeling of Medical Marijuana	25	11
14-Inventory Management	25	11
15-Management and Disposal of Medical Marijuana Waste	25	11
16-Diversion Prevention	50	21
17-Growing Practice	100	41
18-Nutrient and Additive Practices	100	41
19-Processing and Extraction	100	41
20-Sanitation and Safety	25	11
22-Recordkeeping	25	11
24-Business History and Capacity to Operate	75	31
Attachment D: Site and Facility Plan	50	21

Dispensary Application	Max Points/Section	MinimumAcceptable Score
8-Operational Timetable	100	41
9-Employee Qualifications, Description of Duties and Training	50	21
10-Security and Surveillance	100	41
11-Transportation of Medical Marijuana	50	21
12-Storage of Medical Marijuana	75	31
14-Inventory Management	75	31
15-Diversion Prevention	100	41
16-Sanitation and Safety	50	21
17-Recordkeeping	75	31
19-Business History and Capacity to Operate	75	31
Attachment D: Site and Facility Plan	50	21

(2) The Department shall approve clinical registrant applicants that meet the standards of paragraph (1) in the following order:

(i) A clinical registrant applicant that holds a grower/ processor permit and a dispensary permit, both of which are in good standing, and both medical marijuana organizations have been deemed operational by the Department. In applying this preference, the Department will look at the clinical registrant's primary dispensary location only.

(ii) A clinical registrant applicant that holds a grower/ processor permit only that is in good standing and the applicant's medical marijuana organization has been deemed operational by the Department.

(iii) A clinical registrant applicant that holds a dispensary permit only that is in good standing and the applicant's primary dispensary location has been deemed operational by the Department.

(iv) A clinical registrant applicant that holds a grower/ processor permit only that is in good standing, but has not been deemed operational by the Department.

(v) A clinical registrant applicant that holds a dispensary permit only that is in good standing, but has not had its primary location deemed operational by the Department.

(vi) A clinical registrant applicant that is applying for both a grower/processor permit and dispensary permit under this chapter. Awarding of approval to these clinical registrant applications shall be prioritized by ranking the sum of the grower/processor permit and dispensary permit application scores highest to lowest.

28 Pa. Code § 1211a.27a

Adopted by Pennsylvania Bulletin, Vol 53, No. 09. March 4, 2023, effective 3/4/2023