RULES AND REGULATIONS
Title 28—HEALTH AND SAFETY
DEPARTMENT OF HEALTH
[ 28 PA. CODE CH. 1211 ]
Medical Marijuana; Research Contracts; Amended Temporary Regulations
[48 Pa.B. 7778]
[Saturday, December 22, 2018]The Department of Health (Department) is publishing amended temporary regulations in Chapter 1211 (relating to clinical registrants and academic clinical research centers—temporary regulations) to read as set forth in Annex A. These amended temporary regulations are published under the Medical Marijuana Act (act) (35 P.S. §§ 10231.101—10231.2110). Section 2004 of the act (35 P.S. § 10231.2004) specifically allows the Department to promulgate temporary regulations relating solely to sections 2000—2004 of the act (35 P.S. §§ 10231.2000—10231.2004), regarding academic clinical research centers and clinical registrants, that are not subject to sections 201—205 of the act of July 31, 1968 (P.L. 769, No. 240) (45 P.S. §§ 1201—1205), known as the Commonwealth Documents Law, the Regulatory Review Act (71 P.S. §§ 745.1—745.14) and sections 204(b) and 301(10) of the Commonwealth Attorneys Act (71 P.S. §§ 732-204(b) and 732-301(10)).
Chapter 1211 pertains to clinical registrants and academic clinical research centers in this Commonwealth who wish to participate in the Medical Marijuana Program. The particular section being added allows for academic clinical research centers to enter into letters of agreement with more than one potential clinical registrant for the purpose of applying for approval as a clinical registrant. By including language in the temporary regulation specifically allowing for more than one letter of intent, the Department hopes to broaden the field of applicants, therefore ultimately being able to approve the highest quality clinical registrants and assuring that the most robust research will occur. Section 1211.27a will expire on December 22, 2020.
Interested persons are invited to submit written comments, suggestions or objections regarding these amended temporary regulations to John J. Collins, Office of Medical Marijuana, Department of Health, Room 628, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120, (717) 547-3047, RA-DHMedMarijuana@pa.gov. Persons with a disability who wish to submit comments, suggestions or objections regarding these amended temporary regulations or who require an alternative format of these amended temporary regulations (for example, large print, audiotape or Braille) may do so by using the previous contact information. For speech and/or hearing impaired persons, call the Pennsylvania AT&T Relay Service at (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).
RACHEL L. LEVINE, MD,
Secretary(Editor's Note: Title 28 of the Pennsylvania Code is amended by adding a temporary regulation in § 1211.27a and amending the temporary regulation in § 1211.21 to read as set forth in Annex A.)
Fiscal Note: 10-218. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 28. HEALTH AND SAFETY
PART IX. MEDICAL MARIJUANA
CHAPTER 1211. CLINICAL REGISTRANTS AND ACADEMIC CLINICAL RESEARCH CENTERS—TEMPORARY REGULATIONS § 1211.21. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * Research contract—A written agreement between an approved clinical registrant and a certified ACRC that contains the responsibilities and duties of each party with respect to the research program or research study that the approved clinical registrant and the certified ACRC intend to conduct under this chapter and under which the certified ACRC will provide medical advice to the approved clinical registrant regarding, among other areas, patient health and safety, medical applications, and dispensing and management of controlled substances. This term shall include a letter of intent to enter into an agreement for purposes of a clinical registrant application.
* * * * * § 1211.27a. 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 a certified 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 certified ACRCs.
(c) A certified 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 certified ACRC, the Department shall follow the following process in approving the applications:
(1) Determine initially that the CR application meets the following qualifications:
(i) Is complete;
(ii) Complies with the Act and the Department's temporary regulations, and
(iii) Meets the following minimum scoring requirements in each of the following application sections:
Grower Processor Application Max Points/
Section
Minimum
Acceptable
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
Minimum
Acceptable
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.
[Pa.B. Doc. No. 18-1971. Filed for public inspection December 21, 2018, 9:00 a.m.]
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