reglab/statecodes huggingface dataset:
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.32 - Training

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Within the time
				specified, the following individuals shall complete a 4-hour training course
				approved by the Department:
(1) A physician
				prior to being included in the practitioner registry under §
										1181a.24 (relating to practitioner
				registration).
(2) A medical
				professional prior to assuming any duties at a dispensary under §
										1161a.25 (relating to licensed
				medical professionals at facility).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1181a - PHYSICIANS AND PRACTITIONERS › Section 1181a.33 - Appeals

Current through Register Vol. 54, No. 28, July 13, 2024
Sections 501-508 of 2 Pa.C.S. (relating to practice and
				  procedure of Commonwealth agencies) and the accompanying regulations, as
				  modified by Chapter 1230a (relating to practice and procedure), apply to all
				  actions of the Department under this chapter constituting an adjudication as
				  defined in
				  2
				  Pa.C.S. §
										101 (relating to
				  definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.22 - Patient and caregiver registry

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				The Department will maintain a patient and caregiver registry.
(b) Patient and caregiver information
				maintained by the Department is confidential and not subject to public
				disclosure, including disclosure under the Right-to-Know Law (65 P.S.
				§§
										67.101-67.3104). Patient and
				caregiver information must include the following:
(1) Information provided in an identification
				card application.
(2) Information
				in a patient certification issued by a practitioner.
(3) Criminal history record check information
				provided as part of an identification card application submitted by a caregiver
				under §
										1191a.27 (relating to criminal
				background checks).
(4) Information
				encoded in the 2D barcode of an identification card.
(5) Information relating to a patient's
				serious medical condition.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.23 - Patients and caregivers generally

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				The qualifications that a patient or caregiver shall meet to be included in the
				patient and caregiver registry and to obtain an identification card or a
				medical marijuana patient authorization letter are continuing
				qualifications.
(b) Except with
				respect to a minor patient as provided in §
									1191a.32 (relating to medical
				marijuana patient authorization letters), the Department may issue an
				identification card to an applicant who meets the qualifications in the act and
				this part.
(c) A minor patient
				shall have a caregiver who is one of the following:
(1) A parent or legal guardian.
(2) An individual designated by a parent or
				legal guardian.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.24 - Medical marijuana cardholder responsibilities

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A medical marijuana cardholder shall
				immediately contact the Department upon the occurrence of any of the following:
(1) A change of the medical marijuana
				cardholder's name or address.
(2)
				The withdrawal of a patient certification by a practitioner under §
										1181a.29 (relating to revocation
				of a patient certification).
(3) A
				decision by a patient or the patient's legal guardian to discontinue the
				services of a caregiver.
(4) A
				decision by a caregiver to no longer serve as a caregiver for a
				patient.
(5) A decision by a
				patient, the patient's legal guardian or a parent on behalf of a patient to
				discontinue obtaining medical treatment from the practitioner who issued the
				patient certification.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.25 - Application for, and issuance or denial of, identification cards

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An applicant
				shall submit an identification card application. The application will be made
				available on the Department's publicly-accessible web site and in hard copy
				upon request.
(b) An identification
				card application submitted by or on behalf of a patient must include the
				following information:
(1) The name, address,
				telephone number, e-mail address, if available, and date of birth of the
				patient.
(2) The patient's
				Pennsylvania driver's license number, a Department of Transportation
				State-issued identification card, if applicable, or other documentation
				acceptable to the Department evidencing the patient's identification and
				residency in this Commonwealth.
(3)
				The name, address and telephone number of the practitioner who issued the
				patient certification.
(4) The
				name, birth date, address, telephone number and e-mail address, if applicable,
				of up to two individuals designated by the applicant to serve as caregivers, if
				applicable.
(5) The patient
				certification issued by the patient's practitioner, which shall be provided by
				the practitioner to the Department under §
										1181a.27(d)(2)
				(relating to issuing patient certifications).
(6) The appropriate fee or proof of financial
				hardship as provided for in §
										1191a.26 (relating to application
				fees).
(7) The signature of the
				applicant and the date signed.
(8)
				A statement that a false statement made in the application is punishable under
				the applicable provisions of 18 Pa.C.S. Chapter 49 (relating to falsification
				and intimidation).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.26 - Application fees

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An applicant
				shall pay no more than one fee of $50 in a 12-month period for an
				identification card with an identification card application.
(b) Notwithstanding subsection (a) the
				following apply:
(1) An applicant shall
				submit a fee of $25 if the Department issues a replacement identification card
				as a result of a lost, stolen, destroyed, defaced or illegible identification
				card.
(2) An applicant shall pay a
				second fee of $50 in the same 12-month period with an identification card
				renewal application.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.27 - Criminal background checks

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An
				individual applying for an identification card to serve as a caregiver, who has
				not previously been approved by the Department to serve as a caregiver, shall
				submit fingerprints to the Pennsylvania State Police, or an authorized agent,
				for the purpose of obtaining a criminal history record check. The Pennsylvania
				State Police, or an authorized agent, will submit the fingerprints to the
				Federal Bureau of Investigation for the purpose of verifying the identity of
				the caregiver and obtaining a current record of any criminal arrests and
				convictions.
(b) The Department may
				only review the criminal history record information received under subsection
				(a) to determine the caregiver's character, fitness and suitability to serve as
				a caregiver under the act and this part.
This section cited in 28 Pa. Code §
											1191a.22 (relating to patient and
					 caregiver registry); 28 Pa. Code §
											1191a.25 (relating to application
					 for, and issuance or denial of, identification cards); and 28 Pa. Code §
											1191a.29 (relating to renewing an
					 identification card).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.28 - Identification cards

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The Department
				will issue an identification card to a patient or caregiver as soon as
				reasonably practicable after approving an identification card
				application.
(b) An identification
				card will contain all of the following information:
(1) The full name of the medical marijuana
				cardholder.
(2) The address of the
				medical marijuana cardholder.
(3) A
				designation of the medical marijuana cardholder as a patient or a
				caregiver.
(4) The date of issuance
				and the date of expiration of the identification card.
(5) A unique identification number for the
				medical marijuana cardholder.
(6) A
				photograph of the medical marijuana cardholder unless the patient or caregiver
				provides the Department with a statement in accordance with subsection
				(c).
(7) A requirement or
				limitation on the patient certification concerning the recommended form of
				medical marijuana products or limitation on the duration of use, if
				applicable.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.29 - Renewing an identification card

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				medical marijuana cardholder shall submit an identification card renewal
				application to the Department no later than 30 days prior to the expiration
				date on the card. The form of the renewal application will be prescribed by the
				Department and will be made available on the Department's publicly-accessible
				web site and in hard copy upon request. If a medical marijuana cardholder's
				patient certification is expired, the cardholder shall obtain a new or updated
				patient certification issued by the patient's practitioner, which will be
				provided by the practitioner to the Department under §
									1181a.27(d)(2)
				(relating to issuing patient certifications).
(b) If the Department denies an
				identification card renewal application or if the Department does not receive a
				complete identification card renewal application by the expiration date on the
				identification card, the identification card will no longer be valid beyond the
				expiration date and the Department may remove a medical marijuana cardholder
				from the patient and caregiver registry.
(c) Section
				1191a.27 (relating to criminal
				background checks) shall not apply to an applicant who has been previously
				approved by the Department to serve as a caregiver.
This section cited in 28 Pa. Code §
											1191a.25 (relating to application
					 for, and issuance or denial of, identification cards).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.30 - Revocation or suspension of identification card

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The Department may revoke or suspend a
				medical marijuana cardholder's identification card upon the occurrence of any
				of the following:
(1) The Department receives
				written notice from a practitioner under §
										1181a.29(a)
				(relating to revocation of a patient certification).
(2) A caregiver notifies the Department in
				writing that the caregiver is no longer acting as a caregiver.
(3) The patient or caregiver has
				intentionally, knowingly or recklessly violated the act or this part. The
				suspension or revocation will be in addition to any criminal or other penalty
				that may apply.
(4) Except for good
				cause shown, a medical marijuana cardholder does not visit a dispensary within
				60 days from the issuance date on an identification card.
(5) A patient notifies the Department in
				writing that the patient has elected to withdraw from participation in the
				Medical Marijuana Program or that the patient has removed or changed a current
				caregiver. If the caregiver is not serving as a caregiver for any other
				patient, the Department will issue a notification to the caregiver that the
				caregiver's identification card is invalid.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.31 - Obtaining medical marijuana products from a dispensary

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A medical marijuana cardholder may only
				obtain medical marijuana products from a dispensary in accordance with §
									1161a.24 (relating to limitations
				on dispensing).
(b) A medical
				marijuana cardholder may only obtain medical marijuana products from a
				dispensary based upon the recommendation in a patient certification that has
				not been revoked under §
									1181a.29 (relating to revocation
				of a patient certification) and that may be accessed by a dispensary through
				the electronic tracking system.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.32 - Medical marijuana patient authorization letters

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The Department will issue a medical
				marijuana patient authorization letter to a minor patient instead of issuing an
				identification card to the minor patient. Upon reaching 18 years of age, a
				minor patient who has been issued a medical marijuana patient authorization
				letter will be entitled to receive an identification card upon application
				under §
									1191a.25 (relating to application
				for, and issuance or denial of, identification cards).
(b) The Department may issue a medical
				marijuana patient authorization letter to an adult patient only when the
				patient's illness or infirmity permanently prevents the patient from visiting a
				dispensary.
(c) A patient who has
				been issued a medical marijuana patient authorization letter by the Department
				under this section shall have all of the rights and obligations of a medical
				marijuana cardholder under this chapter, except that an identification card
				shall be required for entry into a dispensary.
(d) A medical marijuana patient authorization
				letter is subject to the same terms and conditions, including expiration,
				revocation and suspension requirements, as an identification card under this
				chapter.
(e) A patient who has been
				issued a medical marijuana patient authorization letter by the Department under
				this section will not be required to pay an identification card application fee
				or an identification card renewal application fee.
This section cited in 28 Pa. Code §
											1141a.21 (relating to
					 definitions); and 28 Pa. Code §
											1191a.23 (relating to patients and
					 caregivers generally).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1191a - PATIENTS AND CAREGIVERS › Section 1191a.33 - Appeals

Current through Register Vol. 54, No. 28, July 13, 2024
Sections 501-508 of 2 Pa.C.S. (relating to practice and
				  procedure of Commonwealth agencies) and the accompanying regulations, as
				  modified by Chapter 1230a (relating to practice and procedure), apply to all
				  actions of the Department under this chapter constituting an adjudication as
				  defined in
				  2
				  Pa.C.S. §
										101 (relating to
				  definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.22 - Clinical registrants generally

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The qualifications that a clinical
				registrant shall meet to be approved by the Department are continuing
				qualifications.
(b) An applicant
				that has already been issued a grower/ processor permit or a dispensary permit
				by the Department under sections 601-616 of the act (35 P.S. §§
										10231.601-10231.616) who wishes to become an
				approved clinical registrant shall:
(1)
				Submit a request to the Department under §
										1211a.28 (relating to request for
				conversion of an existing permit) with the application for approval of a
				clinical registrant.
(2) Not be
				required to apply for, or be eligible to receive, an additional
				grower/processor permit or dispensary permit under the act, this chapter,
				Chapter 1141a, Chapter 1151a or Chapter 1161a, as applicable.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.23 - Limitation on permits

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An approved
				clinical registrant may not hold more than one grower/processor permit and one
				dispensary permit.
(b) A dispensary
				permit held by an approved clinical registrant for use under this chapter may
				be used to dispense medical marijuana products at no more than six separate
				locations as approved in its application or under §
									1161a.40 (relating to additional
				dispensary locations), each of which shall be dispensing medical marijuana for
				the purpose of conducting research.
(c) An approved clinical registrant may not
				locate more than three of its approved dispensaries in the same medical
				marijuana region or in the same county.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.24 - Capital requirements

Current through Register Vol. 54, No. 28, July 13, 2024
An applicant shall provide all of the following information
				  with its application under §
									1211a.27 (relating to application
				  for approval of a clinical registrant):
(1) An affidavit, on a form prescribed by the
				Department, stating that the applicant has at least $15 million in capital,
				which must include evidence that the applicant meets the capital requirements
				of a medical marijuana organization under §
									1141a.30 (relating to capital
				requirements).
(2) A release
				sufficient to obtain information from a State governmental agency, financial
				institutions, an employer or any other person to verify the requirements of
				paragraph (1). Failure to provide a release will result in the rejection of the
				application for approval of a clinical registrant.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.25 - Certifying ACRCs

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
				qualifications that an ACRC shall meet to be approved by the Department are
				continuing qualifications.
(b) An
				accredited medical school may file an application with the Department to be
				certified as an ACRC using a form prescribed by the Department. The Department
				will publish a notice in the
Pennsylvania Bulletin
announcing
				the availability of the application and the time period during which the
				Department will accept applications.
(c) An application submitted under subsection
				(b) must include all of the following information:
(1) The legal name, address and telephone
				number of the accredited medical school and the name, telephone number and
				professional e-mail address of an individual at the accredited medical school
				who will be the primary contact for the Department during the Department's
				review of the application.
(2) The
				legal name, address and telephone number of the acute care hospital that is
				operated by or partnered with the accredited medical school and the name,
				telephone number and professional e-mail address of an individual at the
				accredited medical school who will be the primary contact for the Department
				during the Department's review of the application.
(3) An affidavit, on a form prescribed by the
				Department, disclosing any payments to the accredited medical school or any of
				its affiliates made by a person with whom the accredited medical school intends
				to enter into a research contract for purposes of operating as an approved
				clinical registrant or by any principal or financial backer of the person, up
				to and including the date of the submission of the application. The affidavit
				must include the amount and purpose of each payment made.
(4) A statement that the accredited medical
				school is currently accredited by the Liaison Committee of Medical Education or
				the Commission on Osteopathic College Accreditation.
(5) A statement that the acute care hospital
				designated by the accredited medical school under paragraph (2) holds a valid
				license from the Department.
(6)
				The Federal and State tax identification numbers of the accredited medical
				school.
(7) A statement that a
				false statement made by the accredited medical school submitting the
				application is punishable under the applicable provisions of 18 Pa.C.S. Chapter
				49 (relating to falsification and intimidation).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.26 - Revocation of a certification of an ACRC

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The certification of an ACRC will be
				revoked by the Department upon the occurrence of any of the following:
(1) The ACRC is no longer accredited by the
				Liaison Committee of Medical Education or the Commission on Osteopathic College
				Accreditation, as applicable.
(2)
				The ACRC no longer operates or is partnered with the acute care hospital listed
				in its application for certification.
(3) The ACRC is no longer located in this
				Commonwealth.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.27 - Application for approval of a clinical registrant

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An applicant shall file an application
				for approval of a clinical registrant with the Department on a form prescribed
				by the Department. The Department will publish a notice in the
Pennsylvania Bulletin
announcing the availability of
				applications and the time period during which the Department will accept
				applications.
(b) An application
				for approval of a clinical registrant submitted under this section must include
				all of the following information:
(1) The
				legal name, address and telephone number of the applicant and the name,
				telephone number and professional e-mail address of an individual who will be
				the primary contact for the Department during the Department's review of the
				application.
(2) The name of the
				ACRC under §
										1211a.25 (relating to certifying
				ACRCs).
(3) The applicant's Federal
				and State tax identification numbers.
(4) An affidavit, on a form prescribed by the
				Department, disclosing any payments made by the applicant, a principal or
				financial backer of the applicant to an ACRC or any affiliates of an ACRC, up
				to and including the date of the submission of the application. The affidavit
				must include the amount and purpose of each payment made.
(5) The name of an institution of higher
				education, if any, that will be participating in an approved research program
				or research study.
(6) An affidavit
				and release under §
										1211a.24 (relating to capital
				requirements).
(7) Evidence that
				the applicant is responsible and capable of successfully operating as an
				approved clinical registrant, including all of the following:
(i) A copy of the research contract between
				the applicant and the ACRC.
(ii) A
				description of the research program or research study the applicant and the
				ACRC intend to conduct.
(iii) A
				statement that the applicant may not engage in the business of selling,
				dispensing or offering to dispense medical marijuana products at an applicant's
				dispensary as a clinical registrant until the clinical registrant's
				grower/processor and dispensary facilities have been inspected and deemed
				operational by the Department.
(8) Except as provided in §
										1211a.28 (relating to request for
				conversion of an existing permit), an application for a grower/processor permit
				under Chapters 1141a and 1151a (relating to general provisions; and growers/
				processors).
(9) Except as provided
				in § 1211a.28, an application for a dispensary permit under Chapter 1141a
				and Chapter 1161a (relating to dispensaries).
(10) A statement that a false statement made
				by the applicant is punishable under the applicable provisions of 18 Pa.C.S.
				Chapter 49 (relating to falsification and intimidation).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.27a - Research contracts

Current through Register Vol. 54, No. 28, July 13, 2024
(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
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
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.28 - Request for conversion of an existing permit

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An applicant holding a grower/processor
				permit or a dispensary permit, or both, under sections 601-616 of the act
				(35
				P.S. §§
										10231.601-10231.616), shall
				submit a request for conversion of an existing permit under this section on a
				form prescribed by the Department when submitting an application for approval
				of a clinical registrant under §
									1211a.27 (relating to application
				for approval of a clinical registrant).
(b) Upon approval of a clinical registrant
				under subsection (a), the clinical registrant shall surrender its grower/
				processor permit or dispensary permit, or both, previously issued under
				sections 601-616 of the act.
(c) A
				grower/processor permit or dispensary permit, or both, surrendered under
				subsection (b) will increase the number of grower/processor permits or
				dispensary permits, as applicable, available to other persons applying for
				permits under sections 601-616 of the act, Chapter 1141a (relating to general
				provisions) and Chapter 1151a or Chapter 1161a (relating to growers/processors;
				and dispensaries), as applicable.
(d) An applicant may include additional
				dispensary locations in its request for conversion of an existing permit or may
				request additional dispensary locations at a later date under §
									1161a.40 (relating to application
				for additional dispensary locations).
This section cited in 28 Pa. Code §
											1211a.22 (relating to clinical
					 registrants generally); and 28 Pa. Code §
											1211a.27 (relating to application
					 for approval of a clinical registrant).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.29 - Practices and procedures of research programs, projects or studies

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Medical
				marijuana dispensed as part of a research program shall be dispensed only in a
				form permitted by the act or this part and only from a dispensary to a patient
				or to a caregiver.
(b) Marijuana
				dispensed under a research project or study may be dispensed, in any form
				deemed medically safe by an IRB, from a clinical registrant dispensary directly
				to an ACRC.
(c) A RAC or IRB shall
				adopt research procedures and shall review and approve each research program in
				accordance with the RAC or IRB established practices and procedures.
(d) An IRB shall review each proposed
				research project or study in accordance with the IRB's practices, procedures
				and protocols.
(e) A RAC or IRB
				shall ensure that each research program, project or study addresses all of the
				following:
(1) Protecting the rights and
				welfare of patients involved ia)(2.1))n research programs conducted under this
				chapter.
(2) Minimizing the risk to
				patients by using procedures that are consistent with sound research design and
				that do not unnecessarily expose patients to risk being performed on subjects
				for diagnosis or treatment purposes.
(3) Determining that the risks to patients
				involved in research programs are reasonable in relation to the anticipated
				benefits (if any) to the patients, and the importance of the knowledge that may
				be expected to result from the research program.
(4) Guaranteeing that informed consent will
				be sought from each prospective patient or the patient's legally authorized
				representative and is properly documented.
(5) Protecting the privacy of every
				patient.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.29a - Research initiative

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An
				ACRC, in coordination with its contracted clinical registrant, may conduct a
				research initiative on the antimicrobial effects of applying solvent-based
				extraction methods and processes to microbial contamination of immature medical
				marijuana plants, medical marijuana plants, medical marijuana or medical
				marijuana products.
(b) An ACRC
				shall submit to the Department for approval a completed written research
				protocol of the planned research initiative. The Department shall grant
				approval or denial of the protocol within 15 days of its submission. The
				following apply:
(1) The research initiative
				shall commence no later than 30 days from the date the Department issues
				approval and shall be completed no later than 6 months from the start date of
				the research initiative.
(2)
				Research initiative findings shall be provided to the Department by the ACRC
				within 15 days of the research initiative's conclusion.
(3) An ACRC and its contracted clinical
				registrant shall present research initiative findings to the Medical Marijuana
				Advisory Board (Board) and the Board's research subcommittee for the Board's
				review and consideration under sections 1201 and 1202 of the act (35 P.S.
				§§
											10231.1201 and
				10231.1202). The Board shall
				issue a written report, with recommendations and findings regarding the use of
				solvent-based extraction methods and processes on microbial contamination by a
				clinical registrant or grower/processor. The secretary may approve the Board's
				recommendation in accordance with section 1202.
(4) Prior to implementing a recommendation of
				the Board under paragraph (3), as approved by the secretary, a clinical
				registrant or grower/processor shall seek approval from the Department for a
				change in its grower/ processor extraction process. The Department shall
				inspect the site and facility equipment. Upon approval, the Department shall
				issue a notice of final approval to implement the process.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.30 - Approval or denial of an application for approval of a clinical registrant

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An applicant
				shall be an approved clinical registrant upon the Department's approval of an
				application under §
									1211a.27 (relating to application
				for approval of a clinical registrant).
(b) The Department may deny the application
				for approval of a clinical registrant if the payments disclosed in the
				affidavit submitted under §
									1211a.27(b)(4)
				violate the prohibition in §
									1211a.34 (relating to
				prohibition).
(c) Before the
				Department denies an application for approval of a clinical registrant under
				subsection (b), the Department will provide the applicant with written notice
				specifying the violation. The applicant may submit to the Department, within 10
				days following receipt of the Department's written notice, a supplemental
				affidavit indicating that the ACRC or its affiliate has refunded to the
				applicant or a principal or financial backer of the applicant that portion of
				payments in violation of § 1211a.34. Upon receipt of the supplemental
				affidavit, the Department may approve the application for approval of a
				clinical registrant. If the applicant fails to provide a supplemental affidavit
				within 10 days of the Department's written notice, the Department will deny the
				application for approval of a clinical registrant.
(c.1) The Department shall not approve an
				applicant for a grower/processor permit if the applicant has previously had a
				contractual relationship with an ACRC whereby the ACRC 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.
(d) An approved
				clinical registrant shall have the same rights and obligations as a medical
				marijuana organization that holds a grower/processor permit or a dispensary
				permit under sections 601-616 of the act (35 P.S. §§
										10231.601-10231.616) and Chapters 1141a,
				1151a and 1161a (relating to general provisions; growers/ processors; and
				dispensaries), as applicable, subject to any modifications or limitations in
				sections 2001-2003 of the act (35 P.S. §§
										10231.2001-10231.2003) and this
				chapter.
(e) A grower/processor
				permit and a dispensary permit issued to an approved clinical registrant will
				expire upon the nonrenewal, revocation or suspension by the Department of the
				approved clinical registrant's approval.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.31 - Renewal of approval of a clinical registrant

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The term of an approval of a clinical
				registrant will coincide with the term of the clinical registrant's grower/
				processor permit and dispensary permit.
(b) An approved clinical registrant shall
				renew its approval as part of the renewal for a grower/processor permit and a
				dispensary permit under §
									1141a.36 (relating to permit
				renewal applications). The renewal application must be on a form prescribed by
				the Department and include all of the following:
(1) A copy of the research
				contract.
(2) A list of the
				approved research programs or research studies that are continuing or, if any
				of them are concluded, the dates they were concluded.
(3) A report of the current status of active
				research programs or research studies being conducted under the research
				contract, including preliminary findings, if applicable, and any expectations
				and projections the approved clinical registrant and the ACRC have for future
				research programs or research studies over the course of the 2 years following
				the date of submission of the report.
(4) A description of proposed research
				programs or research studies covered by the research contract that the approved
				clinical registrant intends to conduct within the next year following
				submission of the renewal application including evidence of IRB approval for
				each research program or research study.
(5) A statement that a false statement made
				by the approved clinical registrant or the ACRC is punishable under the
				applicable provisions of 18 Pa.C.S. Chapter 49 (relating to falsification and
				intimidation).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.32 - Revocation of approval of a clinical registrant

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The approval of a clinical registrant
				will be revoked immediately by the Department upon the occurrence of any of the
				following:
(1) The Department revokes,
				suspends or does not renew the grower/processor permit or dispensary permit
				held by the approved clinical registrant.
(2) Subject to subsection (b), the Department
				revokes the certification of the ACRC listed in the clinical registrant's
				application under §
										1211a.27 (relating to application
				for approval of a clinical registrant).
(3) The research contract between the
				approved clinical registrant and the ACRC expires without being renewed or is
				terminated by either party.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.33 - Dispensing and tracking medical marijuana products

Current through Register Vol. 54, No. 28, July 13, 2024
In addition to the information to be entered in the
				  electronic tracking system under §
									1161a.39 (relating to electronic
				  tracking system) with respect to medical marijuana products dispensed to all
				  patients and caregivers, the dispensary of an approved clinical registrant
				  shall enter information into the electronic tracking system as required by the
				  Department that identifies patients that are enrolled in an approved research
				  program or research study.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.34 - Prohibition

Current through Register Vol. 54, No. 28, July 13, 2024
Except for reasonable remuneration specifically in a research
				  contract for the services to be performed or costs to be incurred by an ACRC,
				  an ACRC may not solicit or accept anything of value from an approved clinical
				  registrant or a principal or financial backer of an approved clinical
				  registrant. Reasonable remuneration may include up-front deposits or other
				  payments to an ACRC under a research contract to defray start-up and ongoing
				  costs of the ACRC in connection with the establishment of the contractual
				  relationship in the research contract. This section does not apply to
				  charitable contributions that are part of a history of giving to an ACRC
				  established 1 year or more prior to the effective date of the act.
This section cited in 28 Pa. Code §
											1211a.30 (relating to approval or
					 denial of an application for approval of a clinical
					 registrant).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.35 - Reporting requirements

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
				Except as provided in subsection (b), an approved clinical registrant shall
				provide a written report of the findings of its research program or research
				study to the Department within 365 days of the completion of an approved
				research program or research study.
(b) In the event the approved clinical
				registrant or its ACRC intends to submit a manuscript of the results of an
				approved research program or research study to a peer-reviewed medical journal
				for publication, the written report required under subsection (a) shall be
				provided to the Department within 30 days following publication.
(c) The Department may post the findings
				received under this section on its publicly-accessible web site and share them
				with other approved clinical registrants, ACRCs or any other person it
				determines would benefit from the findings.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.36 - Sale or exchange

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
				grower/processor of an approved clinical registrant may sell or exchange the
				following items to another grower/processor:
(1) Seeds.
(2) Immature medical marijuana
				plants.
(3) Medical marijuana
				plants.
(4) Medical marijuana
				products.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1211a - CLINICAL REGISTRANTS AND ACADEMIC RESEARCH CENTERS › Section 1211a.37 - Appeals

Current through Register Vol. 54, No. 28, July 13, 2024
Sections 501-508 of 2 Pa.C.S. (relating to practice and
				  procedure of Commonwealth agencies) and its accompanying regulations, as
				  modified by Chapter 1230a (relating to practice and procedure), apply to
				  actions of the Department under this chapter constituting an adjudication as
				  defined in
				  2
				  Pa.C.S. §
										101 (relating to
				  definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1230a - PRACTICE AND PROCEDURE › Subchapter A - PRELIMINARY PROVISIONS › GENERAL › Section 1230a.21 - Scope

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This chapter
					 governs practice and procedure before the Department in medical marijuana
					 appeals and in any action taken by the Office under the act.
(b) This chapter is not applicable to a
					 proceeding to the extent that the applicable statute governing or authorizing
					 the proceeding sets forth inconsistent practice or procedure.
(c) Except when inconsistent with this
					 chapter, 1 Pa. Code Part II (relating to General Rules of Administrative
					 Practice and Procedure) is applicable insofar as it relates to adjudicatory
					 proceedings.
(d) Subsections
					 (a)-(c) supplement 1 Pa. Code §
											31.1 (relating to scope of
					 part).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1230a - PRACTICE AND PROCEDURE › Subchapter A - PRELIMINARY PROVISIONS › GENERAL › Section 1230a.22 - Definitions

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The following
					 words and terms, when used in this chapter, have the following meanings, unless
					 the context clearly indicates otherwise:
Act
-The Medical Marijuana Act
						(35
						P.S. §§
													10231.101-10231.2110).
Clerk
-The Department's Docket Clerk in
						the Office of Legal Counsel.
Department
-The Department of
						Health.
Office
-The Department's Office of
						Medical Marijuana.
Person
-An individual, partnership,
						association, corporation, political subdivision, municipal authority or other
						entity.
(b) Subsection (a)
					 supplements 1 Pa. Code §
											31.3 (relating to
					 definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1230a - PRACTICE AND PROCEDURE › Subchapter A - PRELIMINARY PROVISIONS › GENERAL › Section 1230a.23 - Docket

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The Clerk has
					 the following duties:
(1) Provide information
					 as to practice and procedure before the Department, under this
					 chapter.
(2) Receive and docket
					 pleadings and other documents required by the Department to be filed with the
					 Clerk.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1230a - PRACTICE AND PROCEDURE › Subchapter A - PRELIMINARY PROVISIONS › GENERAL › Section 1230a.24 - Filing generally

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 Pleadings and other documents filed with the Clerk must clearly designate the
					 docket number, if one has been assigned, the application or permit number, if
					 one has been assigned, and a short title identifying the pleading or other
					 document. The identity of the individual or person filing the pleading or other
					 document, including the name, mailing address and status (for example, party or
					 attorney for a party) must appear on the pleading or other document being
					 filed.
(b) If a pleading or other
					 document tendered for filing does not comply with this chapter, does not
					 sufficiently set forth required material or is otherwise deficient, the
					 Department may decline to accept the pleading or other document for filing and
					 may return it without filing, or the Department may accept the pleading or
					 other document for filing and advise the individual or person tendering it of
					 the deficiency and require that the deficiency be corrected within a reasonable
					 period of time.
(c) The Department
					 may require redundant, immaterial, obscene or otherwise inappropriate comments
					 stricken from a pleading or other document before accepting it for
					 filing.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IXa - MEDICAL MARIJUANA › Chapter 1230a - PRACTICE AND PROCEDURE › Subchapter A - PRELIMINARY PROVISIONS › TIME › Section 1230a.25 - Effective date of adjudication, actions or order

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An adjudication, action or order will be
					 effective as of the date of mailing unless otherwise specifically
					 provided.
(b) Subsection (a)
					 supersedes 1 Pa. Code §
											31.14 (relating to effective dates
					 of agency orders).