Escolar Documentos
Profissional Documentos
Cultura Documentos
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Section
Section
Section
Section
Section
Section
Section
Section
1.
2.
3.
4.
5.
6.
7.
8.
Short title.
Legislative findings and intent.
Definitions.
Expanded access clinical trials.
Requirements for cannabinoids.
Duty to provide annual report.
Construction.
Effective date.
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(c) Subinvestigators.--A physician, acting as a sponsorinvestigator or investigator, may include subinvestigators who
are physicians practicing in an academic medical center in this
Commonwealth.
(d) Compliance with rules and regulations.--The sponsor,
sponsor-investigator or investigator, and all subinvestigators,
shall adhere to the rules and regulations established by the
relevant institutional review board for each participating
academic medical center and by the Food and Drug Administration,
Drug Enforcement Administration, National Institute on Drug
Abuse, Department of Health and the State Board of Pharmacy,
where applicable.
Section 5. Requirements for cannabinoids.
(a) General rule.--Expanded access clinical trials conducted
pursuant to a Statewide investigational new drug application
established pursuant to this act shall only utilize cannabinoids
that are:
(1) From an approved source.
(2) Authorized by the Food and Drug Administration to be
used for treatment of a condition specified in an
investigational new drug application.
(b) Source of cannabinoids.--The sponsor, sponsorinvestigator or investigator, and any subinvestigator, may
receive cannabinoids directly from an approved source or
authorized distributor for an approved source for use in the
expanded access clinical trials.
(c) Oversight and enforcement.--The ordering, receipt,
handling, storage and dispensing of cannabinoids pursuant to
this act shall be subject to oversight and enforcement by the
State Board of Pharmacy.
Section 6. Duty to provide annual report.
The sponsor or sponsor-investigator in the Statewide
investigational new drug application established pursuant to
this act shall annually provide a report on the results of the
expanded access clinical trials to the chairpersons of the
Committee on Public Health and Welfare of the Senate and
Committee on Health of the House of Representatives. The report
shall redact the names of patients and may redact the names of
physicians, if desired. The information in the report may be
derived from reports required by and submitted to the Food and
Drug Administration, if appropriate.
Section 7. Construction.
Nothing in this act shall be construed to authorize the
cultivating or processing of marijuana, cannabis or hemp by any
individual or entity in this Commonwealth for any purpose.
Section 8. Effective date.
This act shall take effect in 60 days.
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Section 1. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Cannabidiol." A nonpsychoactive cannabinoid found in the
plant cannabis sativa L. or any other preparation thereof that
is essentially free from plant material and has a THC level of
no more than 0.5%.
"Debilitating epileptic condition." Epilepsy or another
neurological disorder, or the treatment of epilepsy or another
neurological disorder, that, as diagnosed by a board-certified
neurologist, produces serious, debilitating or life-threatening
seizures.
"Department." The Department of Health of the Commonwealth.
"Physician." An individual who has been licensed by the
State Board of Medicine and who is a board certified
neurologist.
"University medical center." A facility licensed by the
department as a hospital which has an affiliation with a
university medical educational program for the training and
development of health care practitioners.
Section 2. Permitted possession or use of cannabidiol.
(a) General rule.--A recommendation for the possession or
use of cannabidiol for a debilitating epileptic condition shall
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USE IN
FOOD.--"
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201.
202.
203.
204.
205.
206.
207.
Expiration.
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(3) Endocrinology.
(4) Rheumatology.
(5) Gastroenterology.
(6) Internal medicine.
(7) Any other board certified specialist designated by
the board.
"Vertically integrated health system." A health delivery
system in which the complete spectrum of care, including primary
and specialty care, hospitalization and pharmaceutical care, is
provided within a single organization and is affiliated with a
university authorized to grant medical degrees under the laws of
this Commonwealth.
Section 203. Health care medical cannabis dispensers.
(a) Limitation during trial program.--During the period
described under section 201, only a vertically integrated health
system shall be eligible to dispense medical cannabis in this
Commonwealth.
(b) Licensing.-(1) A health care facility that is part of a vertically
integrated health system seeking to dispense medical cannabis
must be licensed under the act of July 19, 1979 (P.L.130,
No.48), known as the Health Care Facilities Act.
(2) Once a health care facility that is part of a
vertically integrated health system is licensed under the
Health Care Facilities Act, the health care facility must
petition the Department of Health to participate in a
research project to study a debilitating medical condition
under section 204. The Department of Health shall qualify the
vertically integrated health system as a health care medical
cannabis dispenser, which will allow for access within the
health care region for all patients included in an approved
research project.
(c) Requirements for health care medical cannabis
dispensers.--A health care medical cannabis dispenser must:
(1) Maintain an appropriate license with the Department
of Health as required under the Health Care Facilities Act.
(2) Secure the medical cannabis within the associated
pharmacies of the health care medical cannabis dispenser in a
manner and method prescribed by the Department of Health.
(3) Keep a daily log of the medical cannabis dispensed
and the research study with which the patient and the medical
cannabis are associated. Reports must be delivered to the
Department of Health and the associated academic research
facility on a weekly basis.
(4) Report to the Pennsylvania Health Care Cost
Containment Council the utilization rates of those patients
participating in the research of medical cannabis and disease
treatment options.
(5) Only dispense medical cannabis received from a
licensed medical cannabis processor in this Commonwealth.
(6) Provide all patients, or patient representatives,
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inserting
5106
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within
"10%"
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Recommendations
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(28)
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inserting
(29)
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Amend Bill, page 26, line 24, by striking out the period
after "center" and inserting
, unless the medical cannabis grower is located within a
keystone opportunity zone, as defined in section 103 of the
act of October 6, 1998 (P.L.705, No.92), known as the
Keystone Opportunity Zone, Keystone Opportunity Expansion
Zone and Keystone Opportunity Improvement Zone Act.
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"center" and inserting
, unless the medical cannabis processor is located within
a keystone opportunity zone, as defined in section 103 of the
act of October 6, 1998 (P.L.705, No.92), known as the
Keystone Opportunity Zone, Keystone Opportunity Expansion
Zone and Keystone Opportunity Improvement Zone Act.
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after "center" and inserting
, unless the medical cannabis dispenser is located within
a keystone opportunity zone, as defined in section 103 of the
act of October 6, 1998 (P.L.705, No.92), known as the
Keystone Opportunity Zone, Keystone Opportunity Expansion
Zone and Keystone Opportunity Improvement Zone Act.
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at least
"15%"
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and inserting
shall
Amend Bill, page 26, line 51 (A04380), by inserting after
"waiver"
or reduction
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inserting
CBD oil
on said pages
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Section 1. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Academic clinical research center." An accredited medical
school within this Commonwealth which operates an acute care
hospital licensed within this Commonwealth.
"CBD oil." Processed cannabis plant extract, oil or resin
that contains more than 15% cannabidiol, or a dilution of the
resin that contains at least 50 milligrams of cannabidiol per
milliliter, but not more than 0.5% of tetrahydrocannabinol.
"Vertically integrated health system." A health delivery
system in which the complete spectrum of care, including primary
and specialty care, hospitalization and pharmaceutical care, is
provided within a single organization.
Section 2. Administration of CBD.
(a) General rule.--The following shall apply:
(1) CBD oil may only be obtained on the order of a
physician who is licensed to practice in this Commonwealth
and administered to a patient by or under the direction or
supervision of a physician at an academic clinical research
center.
(2) The CBD oil must be obtained from or tested by an
academic clinical research center and dispensed by a
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Section 2101.1.
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Section 2101.1.
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Labor organizations.
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Section 2101.1.
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this part.
The term does not include a member of a school board or an
individual who held an uncompensated office with a governmental
body prior to January 1, 2016, and who no longer holds the
office as of January 1, 2016. The term includes a member of an
advisory board or commission.
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Section 2101.1.
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Campaign contributions.
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$25,000.
(4) A second or subsequent violation that occurs more
than five years after the previous violation shall be treated
as a first offense.
(d) Deposit of funds.--Fines under this section shall be
deposited into the account.
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Bond requirement.
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on said pages
lines 1 through 30; page 69, lines 1 through 27; by striking out
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Section 1. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Academic clinical research center." An accredited medical
school within this Commonwealth which operates an acute care
hospital licensed within this Commonwealth.
"Medical marijuana." Marijuana cultivated, manufactured,
possessed, distributed, dispensed, obtained or administered in
accordance with this act for a serious medical condition.
"Vertically integrated health system." A health delivery
system in which the complete spectrum of care, including primary
and specialty care, hospitalization and pharmaceutical care, is
provided within a single organization.
Section 2. Administration of medical marijuana.
(a) General rule.--The following shall apply:
(1) Medical marijuana may only be obtained on the order
of a physician who is licensed to practice in this
Commonwealth and administered to a patient by or under the
direction or supervision of a physician at an academic
clinical research center.
(2) The medical marijuana must be obtained from or
tested by an academic clinical research center and dispensed
by a vertically integrated health system with an affiliation
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CHAPTER 13
ACADEMIC CLINICAL RESEARCH CENTERS
Section 1301. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Academic clinical research center." An accredited medical
school within this Commonwealth that operates an acute care
hospital licensed within this Commonwealth.
"Registrant." A medical cannabis grower, medical cannabis
processor and medical cannabis dispenser registered under this
chapter.
Section 1302. Registration as both grower/processor and
dispensary collaborating with an academic clinical
research center.
Notwithstanding the limitations in sections 706 and 707, the
department may register up to eight medical cannabis growers,
medical cannabis processors and medical cannabis dispensaries
that have a contractual relationship with an academic clinical
research center under which the academic clinical research
center or its affiliate provides advice to medical cannabis
growers, medical cannabis processors and medical cannabis
dispensers regarding, among other areas, patient health and
safety, medical applications and dispensing and management of
controlled substances. Each medical cannabis grower, medical
cannabis processor and medical cannabis dispenser may provide
medical marijuana at not more than six separate locations. The
total number of locations authorized to dispense medical
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marijuana under this section shall not exceed 48. The following
apply with respect to this category of registrant:
(1) The registrant must hold:
(i) a medical cannabis grower or medical cannabis
processor license; and
(ii) a medical cannabis dispenser license in order
to be registered by the department under this section.
(2) The registrant must pay the fees for a medical
cannabis grower, medical cannabis processor and medical
cannabis dispenser under section 708.
(3) The registrant must register as a medical cannabis
grower, medical cannabis processor and medical cannabis
dispenser, and the department shall verify that registrant
has a minimum of $15,000,000 in capital. This requirement is
in addition to the requirements of section 708, except that
section 708(g) shall not apply.
(4) The registrant must comply with all other
requirements of this act regarding growing, processing and
dispensing medical marijuana.
Section 1303. Research study.
Notwithstanding any provision of this act to the contrary,
the department may, upon application, approve the dispensing of
medical marijuana by a registrant to its academic clinical
research center for the purpose of conducting a research study.
The department shall develop the application and standards for
approval of such dispensing by the registrant. The following
apply to the research study:
(1) The registrant shall disclose the following
information to the department in its application:
(i) The reason for the research project, including
the reason for the trial.
(ii) The strain of medical marijuana to be used and
the strength of the medical marijuana to be used in the
research study.
(iii) The anticipated duration of the study.
(iv) Evidence of approval of the trial by accredited
institutional review board, including any other required
regulatory approvals.
(v) Other information required by the department,
except that the department may not require disclosure of
any information that would infringe upon the academic
clinical research center's exclusive right to
intellectual property.
(2) The academic clinical research center shall provide
its findings to the department within 365 days of the
conclusion of the research study or within 365 days of
publication of the results of the research study in a peerreviewed medical journal, whichever is later.
(3) The department shall allow the exchange of medical
marijuana seed between registrants for the conduct of
research.
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(A04380)
Chapter 20. Academic Clinical Research Centers
Section 2001. Definitions.
Section 2002. Registration as both grower/processor and
dispensary collaborating with an academic clinical
research center.
Section 2003. Research study.
Section 2004. Regulations.
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CHAPTER 20
ACADEMIC CLINICAL RESEARCH CENTERS
Section 2001. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Academic clinical research center." An accredited medical
school within this Commonwealth that operates an acute care
hospital licensed within this Commonwealth.
"Registrant." A medical cannabis grower, medical cannabis
processor and medical cannabis dispenser registered under this
chapter.
Section 2002. Registration as both grower/processor and
dispensary collaborating with an academic clinical
research center.
Notwithstanding the limitations in sections 706 and 707, the
department may register up to eight medical cannabis growers,
medical cannabis processors and medical cannabis dispensaries
that have a contractual relationship with an academic clinical
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intellectual property.
(2) The academic clinical research center shall provide
its findings to the department within 365 days of the
conclusion of the research study or within 365 days of
publication of the results of the research study in a peerreviewed medical journal, whichever is later.
(3) The department shall allow the exchange of medical
marijuana seed between registrants for the conduct of
research.
Section 2004. Regulations.
The department shall promulgate regulations in order to
implement the provisions of this chapter within 30 days of the
effective date of this section.
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CHAPTER 1
PRELIMINARY PROVISIONS
Section 101. Short title.
This act shall be known and may be cited as the Medical
Marijuana Act.
Section 102. Declaration of policy.
The General Assembly finds and declares as follows:
(1) Scientific evidence suggests that medical marijuana
is one potential therapy that may mitigate suffering in some
patients and also enhance quality of life.
(2) The Commonwealth is committed to patient safety.
Carefully regulating the program which allows access to
medical marijuana will enhance patient safety while research
into its effectiveness continues.
(3) It is the intent of the General Assembly to:
(i) Provide a program of access to medical marijuana
which balances the need of patients to have access to the
latest treatments with the need to promote patient
safety.
(ii) Provide a safe and effective method of delivery
of medical marijuana to patients.
(iii) Promote high quality research into the
effectiveness and utility of medical marijuana.
(4) It is the further intention of the General Assembly
that any Commonwealth-based program to provide access to
medical marijuana serve as a temporary measure, pending
Federal approval of and access to medical marijuana through
traditional medical and pharmaceutical avenues.
Section 103. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Advisory board." The advisory board established under
section 1106.
"Caregiver." The individual designated by a patient or, if
the patient is under 18 years of age, an individual under
section 508(2), to deliver medical marijuana.
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dispensary.
(2) The name and identification number of the patient
and caregiver.
(3) The date the medical marijuana was dispensed.
(4) Any requirement or limitation by the practitioner as
to the form of medical marijuana for the patient.
(5) The form and the quantity of medical marijuana
dispensed.
(b) Record retention.--The dispensary shall retain the
following for six years:
(1) A copy of the patient's or caregiver's
identification card, as appropriate.
(2) The receipt, which may be retained in electronic
form.
(c) Filing with department.--Prior to dispensing medical
marijuana to a patient or caregiver, the dispensary shall file
the receipt information with the department by electronic means
on a real-time basis as the department shall require. The
department shall immediately enter the information into the
separate, electronic database established under section 301(1)
for use by the department and dispensaries to inhibit diversion
and other unlawful use of medical marijuana. When filing receipt
and certification information electronically under this
subsection, the dispensary shall dispose of any electronically
recorded prescription certification information as provided by
regulation.
(d) Limitations.--No dispensary may dispense to a patient or
caregiver:
(1) a quantity of medical marijuana greater than that
which the patient or caregiver is permitted to possess under
the certification; or
(2) a form of medical marijuana prohibited by this act.
(e) Supply.--When dispensing medical marijuana to a patient
or caregiver, the dispensary may not dispense an amount greater
than a 30-day supply until the patient has exhausted all but a
seven-day supply provided pursuant to a previously issued
certification.
(f) Verification.--Prior to dispensing medical marijuana to
a patient or caregiver, the dispensary shall verify the
information in subsections (e) and (g) by consulting the
database established under section 301(1).
(g) Form of medical marijuana.--Medical marijuana dispensed
to a patient or caregiver by a dispensary shall conform to any
requirement or limitation set by the practitioner as to the form
of medical marijuana for the patient.
(h) Safety insert.--When a dispensary dispenses medical
marijuana to a patient or caregiver, the organization shall
provide to that patient or caregiver, as appropriate, a safety
insert. The insert shall be developed and approved by the
department. The insert shall provide the following information:
(1) Lawful methods for administering medical marijuana
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in individual doses.
(2) Any potential dangers stemming from the use of
medical marijuana.
(3) How to recognize what may be problematic usage of
medical marijuana and how to obtain appropriate services or
treatment for problematic usage.
(4) How to prevent or deter the misuse of medical
marijuana by minors or others.
(5) Any other information as determined by the
department.
(i) Sealed and labeled package.--Medical marijuana shall be
dispensed by a dispensary to a patient or caregiver in a sealed
and properly labeled package. The labeling shall contain the
following:
(1) The information required to be included in the
receipt provided to the patient or caregiver, as appropriate,
by the dispensary.
(2) The packaging date.
(3) Any applicable date by which the medical marijuana
should be used.
(4) A warning stating:
"This product is for medicinal use only. Women should not
consume during pregnancy or while breastfeeding except on the
advice of the practitioner who issued the certification and
in the case of breastfeeding, the infant's pediatrician. This
product might impair the ability to drive or operate heavy
machinery. Keep out of reach of children."
(5) The amount of individual doses contained within the
package and the species and percentage of
tetrahydrocannabinol and cannabidiol.
(6) A warning that the medical marijuana must be kept in
the original container in which it was dispensed.
(7) A warning that unauthorized use is unlawful and will
subject the person to criminal penalties.
(8) Any other information required by the department.
(j) Convictions prohibited.--The following individuals may
not hold volunteer positions or positions with remuneration in
or be affiliated with a medical marijuana organization in any
way if the individual has been convicted of any criminal offense
related to the sale or possession of illegal drugs, narcotics or
controlled substances:
(1) Financial backers.
(2) Principals.
(3) Employees.
Section 704. Pricing.
The following apply:
(1) Each sale of medical marijuana by a dispensary shall
not exceed the maximum price determined by the department
through regulation. A charge made or demanded for medical
marijuana by a dispensary which exceeds the maximum price
determined by the department is deemed to be a violation of
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RESEARCH PROGRAM
Section 1901. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Health care medical marijuana organization." A vertically
integrated health system approved by the department to dispense
medical marijuana or grow and process medical marijuana, or
both, in accordance with a research study under this chapter.
"Vertically integrated health system." A health delivery
system licensed under the act of July 19, 1979 (P.L.130, No.48),
known as the Health Care Facilities Act, in which the complete
spectrum of care, including primary and specialty care,
hospitalization and pharmaceutical care, is provided within a
single organization.
Section 1902. Establishment of medical marijuana research
program.
(a) Program to be established.--The department shall
establish and develop a research program to study the impact of
medical marijuana on the treatment and symptom management of
serious medical conditions.
(b) Department duties.--The department shall:
(1) Review all serious medical conditions which are
cited by a practitioner upon the practitioner's certification
that a patient be granted an identification card.
(2) Create a database of all serious medical conditions,
including comorbidities, which are cited by practitioners in
the certifications of patients. The database shall also
include the form of medical marijuana certified to treat each
serious medical condition.
(3) When the database contains 25 or more patients with
the same serious medical condition, petition the United
States Food and Drug Administration and the United States
Drug Enforcement Administration for approval to study the
condition and the impact of medical marijuana on the
condition.
(4) Concurrent with the request to the United States
Food and Drug Administration and United States Drug
Enforcement Administration, publicly announce the formation
of a research study to which a vertically integrated health
system and a university within this Commonwealth may submit a
request to participate.
(5) Upon approval of a research study by the United
States Food and Drug Administration and the United States
Drug Enforcement Administration, select a vertically
integrated health system or systems to conduct the research
study and designate the form or forms of medical marijuana
which will be used to treat the serious medical condition.
(6) Notify a patient who has been issued an
identification card:
(i) that the patient has been selected to
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(c)
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Amend Bill, page 24, line 30, by striking out "(c)" and
inserting
(d)
Amend Bill, page 25, line 3, by striking out "(d)" and
inserting
(e)
Amend Bill, page 25, line 7, by striking out "(e)" and
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(f)
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(i)
Amend Bill, page 27, line 2, by striking out "(i)" and
inserting
(j)
Amend Bill, page 27, line 12, by striking out "Imposition.--"
and inserting
Fees.-Amend Bill, page 27, by inserting between lines 17 and 18
(c) Bond.--At the time of license issuance, the board shall
require the licensee to post a bond with the department in the
amount of $10,000,000 to cover any potential liability arising
from the licensee's activities under this act.
Amend Bill, page 27, line 18, by striking out "(c)" and
inserting
(d)
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Fees.-Amend Bill, page 30, by inserting between lines 1 and 2
(c) Bond.--At the time of license issuance, the board shall
require the licensee to post a bond with the department in the
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(5)
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(8)
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(10)
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5104
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Ulcerative colitis.
Tourette's disorder.
Sickle cell disease.
Severe psoriasis and psoriatic arthritis.
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Section
Section
Section
Section
Section
Section
Section
Section
1.
2.
3.
4.
5.
6.
7.
8.
Scope.
Legislative findings and intent.
Definitions.
Expanded access clinical trials.
Requirements for cannabidiol.
Duty to provide annual report.
Construction.
Effective date.
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Section 1. Scope.
This chapter relates to therapeutic cannabidiol research.
Section 2. Legislative findings and intent.
The General Assembly finds and declares that:
(1) Pennsylvania's citizens with severe or lifethreatening diseases or conditions may not be able to access
critical medications that are still in clinical trials.
(2) The Food and Drug Administration (FDA) has
established Expanded Access Programs to allow limited,
supervised access to such medications.
(3) While certain of its unique chemicals called
cannabinoids may become approved medicines, this does not
make marijuana itself a medicine.
(4) Marijuana contains at least 85 cannabinoids,
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201.
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207.
Expiration.
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(3) Endocrinology.
(4) Rheumatology.
(5) Gastroenterology.
(6) Internal medicine.
(7) Any other board certified specialist designated by
the Department of Health.
"Vertically integrated health system." A health delivery
system in which the complete spectrum of care, including primary
and specialty care, hospitalization and pharmaceutical care, is
provided within a single organization and is affiliated with a
university authorized to grant medical degrees under the laws of
this Commonwealth.
Section 203. Health care medical cannabis dispensers.
(a) Limitation during trial program.--During the period
described under section 201, only a vertically integrated health
system shall be eligible to dispense medical cannabis in this
Commonwealth.
(b) Licensing.-(1) A health care facility that is part of a vertically
integrated health system seeking to dispense medical cannabis
must be licensed under the act of July 19, 1979 (P.L.130,
No.48), known as the Health Care Facilities Act.
(2) Once a health care facility that is part of a
vertically integrated health system is licensed under the
Health Care Facilities Act, the health care facility must
petition the Department of Health to participate in a
research project to study a debilitating medical condition
under section 204. The Department of Health shall qualify the
vertically integrated health system as a health care medical
cannabis dispenser, which will allow for access within the
health care region for all patients included in an approved
research project.
(c) Requirements for health care medical cannabis
dispensers.--A health care medical cannabis dispenser must:
(1) Maintain an appropriate license with the Department
of Health as required under the Health Care Facilities Act.
(2) Secure the medical cannabis within the associated
pharmacies of the health care medical cannabis dispenser in a
manner and method prescribed by the Department of Health.
(3) Keep a daily log of the medical cannabis dispensed
and the research study with which the patient and the medical
cannabis are associated. Reports must be delivered to the
Department of Health and the associated academic research
facility on a weekly basis.
(4) Report to the Pennsylvania Health Care Cost
Containment Council the utilization rates of those patients
participating in the research of medical cannabis and disease
treatment options.
(5) Only dispense medical cannabis received from a
licensed medical cannabis processor in this Commonwealth.
(6) Provide all patients, or patient representatives,
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medical
Amend Bill, page 21, line 10 (A04380), by striking out "shall
register organizations which" and inserting
"The"
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medical marijuana
Amend Bill, page 25, line 37 (A04380), by inserting after
"The"
medical marijuana
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"defective"
medical
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and inserting
(31)
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medical
Amend Bill, page 20, by inserting between lines 43 and 44
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"The"
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medical marijuana
Amend Bill, page 25, line 37 (A04380), by inserting after
"The"
medical marijuana
Amend Bill, page 33, by inserting between lines 12 and 13
(A04380)
(30) Regulations which set forth the procedure for a
grower/processor to obtain seed and plant material:
(i) From outside this Commonwealth to initially grow
medical marijuana.
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and inserting
shall
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and inserting
two
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inserting
five
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Chiari malformation.
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Amend Bill, page 10, line 29, by striking out "Each" and
inserting
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or child.
(10) Prior to entering into employment or contracting
with the board, an employee or independent contractor and the
employee's or independent contractor's immediate family shall
divest any financial interest in any applicant, medical
cannabis grower, processor or dispenser, and in an affiliate,
intermediary, subsidiary or holding company thereof, owned or
held by the employee or independent contractor or known to be
held by the immediate family of the employee or independent
contractor. For the duration of the employee's employment
with the board or the independent contractor's contract with
the board and for two years thereafter, the employee or
independent contractor and the immediate family thereof shall
not acquire, by purchase, gift, exchange or otherwise, any
financial interest in any applicant, medical cannabis grower,
processor or dispenser and in any affiliate, intermediary,
subsidiary or holding company thereof. For purposes of this
paragraph, the term "immediate family" shall mean spouse,
parent, brother, sister or child.
(11) No member, employee or independent contractor of
the board may directly or indirectly solicit, request,
suggest or recommend to any applicant, medical cannabis
grower, processor or dispenser, or an affiliate,
intermediary, subsidiary or holding company thereof or to any
principal, employee, independent contractor or agent thereof,
the appointment or employment of any person in any capacity
by the applicant, medical cannabis grower, processor or
dispenser, or an affiliate, intermediary, subsidiary or
holding company thereof for a period of two years from the
termination of term of office, employment or contract with
the board.
(12) No member may accept employment with any medical
cannabis grower, processor or dispenser, or an affiliate,
intermediary, subsidiary or holding company thereof, for a
period of two years from the termination of term of office.
(13) No former member may appear before the board in any
hearing or proceeding or participate in any other activity on
behalf of any applicant, medical cannabis grower, processor
or dispenser, or an affiliate, intermediary, subsidiary or
holding company of an applicant or medical cannabis grower,
processor or dispenser for a period of two years from the
termination of term of office.
(14) A member who has been convicted during his term in
any domestic or foreign jurisdiction of a felony, infamous
crime or controlled substances offense shall, upon
conviction, be automatically removed from the board and shall
be ineligible to become a member in the future. If an ex
officio member is convicted during his term in any domestic
or foreign jurisdiction of a felony, infamous crime or
controlled substances offense, the ex officio member shall,
upon conviction, be automatically removed from the board and
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and inserting
Expiration
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Effective date.
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Applicant prohibitions.
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Expiration.
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Amend Bill, page 69, line 26, by striking out "5105" and
12
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inserting
5106
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Expiration.
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inserting
5106
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Severability.
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Nonseverability.
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USE IN
FOOD.--"
Amend Bill, page 53, lines 2 through 8, by striking out all
of said lines
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of said lines
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(l)
Amend Bill, page 46, line 21, by striking out "(n)" and
inserting
(m)
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Section
Section
Section
Section
Section
Section
Section
Section
1.
2.
3.
4.
5.
6.
7.
8.
Short title.
Legislative findings and intent.
Definitions.
Expanded access clinical trials.
Requirements for cannabinoids.
Duty to provide annual report.
Construction.
Effective date.
17
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Amend Bill, page 68, line 28, by striking out "(d)" and
inserting
(c)
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Amend Bill, page 56, line 29, by striking out "second" and
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first
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inserting
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solely
Amend Bill, page 54, line 19, by striking out "The" and
inserting
However, the
Amend Bill, page 54, lines 20 through 30; page 55, lines 1
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Amend Bill, page 43, line 10, by striking out "two years" and
inserting
one year
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Amend Bill, page 35, line 19, by striking out "(e)" and
inserting
(f)
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Amend Bill, page 2, line 18, by striking out all of said line
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inserting
703
Amend Bill, page 2, line 20, by striking out "705" and
inserting
704
Amend Bill, page 2, line 21, by striking out "706" and
inserting
705
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inserting
706
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inserting
(7)
Amend Bill, page 13, line 17, by striking out "(9)" and
inserting
(8)
Amend Bill, page 13, line 20, by striking out "(10)" and
inserting
(9)
Amend Bill, page 13, line 22, by striking out "(11)" and
inserting
(10)
Amend Bill, page 13, line 24, by striking out "(12)" and
inserting
(11)
Amend Bill, page 13, line 27, by striking out "(13)" and
inserting
(12)
Amend Bill, page 14, line 1, by striking out "(14)" and
inserting
(13)
Amend Bill, page 14, line 19, by striking out "(15)" and
inserting
(14)
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inserting
(15)
Amend Bill, page 15, line 16, by striking out "(17)" and
inserting
(16)
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inserting
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(17)
Amend Bill, page 15, line 24, by striking out "(19)" and
inserting
(18)
Amend Bill, page 15, line 26, by striking out "(20)" and
inserting
(19)
Amend Bill, page 15, line 29, by striking out "(21)" and
inserting
(20)
Amend Bill, page 16, line 1, by striking out "(22)" and
inserting
(21)
Amend Bill, page 16, line 3, by striking out "(23)" and
inserting
(22)
Amend Bill, page 17, line 2, by striking out "(24)" and
inserting
(23)
Amend Bill, page 17, line 5, by striking out "(25)" and
inserting
(24)
Amend Bill, page 17, line 9, by striking out "(26)" and
inserting
(25)
Amend Bill, page 17, line 11, by striking out "(27)" and
inserting
(26)
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inserting
(27)
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through 19; by striking out all of said lines on said pages
Amend Bill, page 51, line 20, by striking out "704" and
inserting
703
Amend Bill, page 52, line 21, by striking out "705" and
inserting
704
Amend Bill, page 53, line 9, by striking out "706" and
inserting
705
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(A04380)
Chapter 20. Academic Clinical Research Centers
Section 2001. Definitions.
Section 2002. Registration as both grower/processor and
dispensary collaborating with an academic clinical
research center.
Section 2003. Research study.
Section 2004. Regulations.
Amend Bill, page 41, by inserting between lines 45 and 46
14
(A04380)
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CHAPTER 20
ACADEMIC CLINICAL RESEARCH CENTERS
Section 2001. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Academic clinical research center." An accredited medical
school within this Commonwealth that operates an acute care
hospital licensed within this Commonwealth.
"Registrant." A medical cannabis grower, medical cannabis
processor and medical cannabis dispenser registered under this
chapter.
Section 2002. Registration as both grower/processor and
dispensary collaborating with an academic clinical
research center.
Notwithstanding the limitations in sections 706 and 707, the
department may register up to eight medical cannabis growers,
medical cannabis processors and medical cannabis dispensaries
that have a contractual relationship with an academic clinical
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intellectual property.
(2) The academic clinical research center shall provide
its findings to the department within 365 days of the
conclusion of the research study or within 365 days of
publication of the results of the research study in a peerreviewed medical journal, whichever is later.
(3) The department shall allow the exchange of medical
marijuana seed between registrants for the conduct of
research.
Section 2004. Regulations.
The department shall promulgate regulations in order to
implement the provisions of this chapter within 30 days of the
effective date of this section.
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