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S0003B0889A04284

DMS:CMD 11/19/15

#90

A04284

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE KNOWLES
Printer's No. 889
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Amend Bill, page 8, line 28, by striking out all of said line

Amend Bill, page 8, line 29, by striking out "(16)" and

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4

inserting
(15)

2015/90DMS/SB0003A04284

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Regular Session 2015 - 2016


Amendment A04285 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04286

DMS:CMD 11/19/15

#90

A04286

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE KNOWLES
Printer's No. 889
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Amend Bill, page 8, lines 25 through 27, by striking out all


of lines 25 and 26 and "(14)" in line 27 and inserting
(13)
Amend Bill, page 8, line 28, by striking out "(15)" and
inserting
(14)
Amend Bill, page 8, line 29, by striking out "(16)" and
inserting
(15)

2015/90DMS/SB0003A04286

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Regular Session 2015 - 2016


Amendment A04287 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04288

DMS:CDM 11/19/15

#90

A04288

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE KNOWLES
Printer's No. 889
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Amend Bill, page 2, line 18, by striking out "Expansion of


medical conditions" and inserting
(Reserved)
Amend Bill, page 8, lines 29 and 30, by striking out all of
said lines

Amend Bill, page 13, lines 5 through 7, by striking out "To

implement procedures to allow the expansion of" in line 5, all

of line 6 and "medical cannabis under section 703" in line 7 and

inserting

10
11

(Reserved)
Amend Bill, page 50, lines 10 through 30; page 51, lines 1

12

through 19; by striking out "Expansion of medical conditions."

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in line 10, all of lines 11 through 30 on page 50 and all of

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lines 1 through 19 on page 51 and inserting

15

(Reserved).

2015/90DMS/SB0003A04288

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Regular Session 2015 - 2016


Amendment A04289 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04290 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04291

DMS:JSL 11/19/15

#90

A04291

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE MENTZER
Printer's No. 889
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Amend Bill, page 1, lines 1 and 2, by striking out "the

medical use of cannabis in the Commonwealth of" in line 1 and

all of line 2 and inserting

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Statewide expanded access clinical trials for cannabinoids; and


requiring certain physicians to provide annual reports.

Amend Bill, page 1, lines 4 through 16; pages 2 and 3, lines

1 through 30; page 4, line 1; by striking out all of said lines

on said pages and inserting

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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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Amend Bill, page 4, lines 4 through 30; pages 5 through 68,

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lines 1 through 30; page 69, lines 1 through 27; by striking out

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all of said lines on said pages and inserting

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Section 1. Short title.


This act shall be known and may be cited as the Therapeutic
Cannabinoid Research Act.
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

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make marijuana itself a medicine.


(4) Marijuana contains at least 85 cannabinoids that can
be extracted from marijuana and purified, or synthesized in a
laboratory, and tested in animals in preclinical research to
ensure that they are safe to administer to humans in clinical
trials.
(5) The FDA has approved several expanded access
investigational new drug (IND) applications that enable
investigators to utilize cannabinoids.
(6) The intent of this act is to increase the number of
expanded access IND applications at academic medical centers
in this Commonwealth so as to provide and further test the
medical uses of cannabinoids.
Section 3. 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 medical center." A hospital that operates a
medical residency program for physicians and conducts research
that involves human subjects.
"Approved source." A provider which produces cannabinoids
that:
(1) Have been manufactured and tested in a facility
approved or certified by the Food and Drug Administration or
similar national regulatory agency in the United States or
another country.
(2) Have been tested in animals to demonstrate
preliminary effectiveness and to ensure that it is safe to
administer to humans.
"Investigator." An individual who actually conducts a
clinical investigation and under whose immediate direction a
drug is administered or dispensed to a subject.
"Physician." A person licensed to practice medicine in this
Commonwealth.
"Sponsor." A person, including an individual or
pharmaceutical company, governmental agency, academic
institution, private organization or other organization, who
takes responsibility for and initiates a clinical investigation.
"Sponsor-investigator." An individual who both initiates and
conducts an investigation and under whose immediate direction an
investigational drug is administered or dispensed.
Section 4. Expanded access clinical trials.
(a) Authorization.--Statewide investigational new drug
applications may be established in this Commonwealth, if
submitted by a sponsor or sponsor-investigator and approved by
the Food and Drug Administration, to conduct expanded access
clinical trials using cannabinoids.
(b) Physicians as sponsor-investigators or investigators.--A
physician practicing in an academic medical center in this
Commonwealth shall serve as the sponsor-investigator or
investigator for the clinical trials.

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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.

2015/90DMS/SB0003A04291

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S0003B0889A04294

AJM:CMD 11/19/15

#90

A04294

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE DUSH
Printer's No. 889
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Amend Bill, page 68, line 9, by striking out "(a)


Requirement.--"
Amend Bill, page 68, lines 11 through 30, by striking out all
of said lines

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S0003B0889A04297

AJM:CMD 11/19/15

#90

A04297

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE DUSH
Printer's No. 889
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Amend Bill, page 27, by inserting between lines 4 and 5


(j) Penalty.--Notwithstanding any other provision of law, a
person who is an owner, operator or employee of a medical
cannabis grower and fails to report the loss or theft of medical
cannabis within 24 hours of discovery of the loss or theft
commits a misdemeanor of the first degree.
Amend Bill, page 29, by inserting between lines 17 and 18
(h) Penalty.--Notwithstanding any other provision of law, a
person who is an owner, operator or employee of a medical
cannabis processor and fails to report the loss or theft of
medical cannabis within 24 hours of discovery of the loss or
theft commits a misdemeanor of the first degree.
Amend Bill, page 34, by inserting between lines 2 and 3

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(h) Penalty.--Notwithstanding any other provision of law, a


person who is an owner, operator or employee of a medical
cannabis dispenser and fails to report the loss or theft of
medical cannabis within 24 hours of discovery of the loss or
theft commits a misdemeanor of the first degree.

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Amend Bill, page 41, by inserting between lines 20 and 21

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(e) Penalty.--Notwithstanding any other provision of law, a


person who is an owner, operator or employee of a testing
laboratory and fails to report the loss or theft of medical
cannabis within 24 hours of discovery of the loss or theft
commits a misdemeanor of the first degree.

2015/90AJM/SB0003A04297

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S0003B0889A04302

KMK:JSL 11/19/15

#90

A04302

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
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Amend Bill, page 1, line 1, by striking out "cannabis" and


inserting
cannabidiol

Amend Bill, page 1, lines 3 through 16; pages 2 and 3, lines

1 through 30; page 4, line 1; by striking out all of said lines

on said pages

Amend Bill, page 4, lines 4 through 30; pages 5 through 68,

lines 1 through 30; page 69, lines 1 through 27; by striking out

all of said lines on said pages and inserting

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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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be provided exclusively by a physician.


(b) Source.--A university medical center shall be the sole
authorized source of any recommendation for the use of
cannabidiol, and shall be the sole authorized source to use
cannabidiol in or as a part of the treatment of an individual
diagnosed with a debilitating epileptic condition.
(c) Authority.--A university medical center shall have the
sole authority to determine the use or amount of cannabidiol, if
any, in the treatment of an individual diagnosed with a
debilitating epileptic condition.
(d) Prohibition.--A Commonwealth agency or a political
subdivision of the Commonwealth, including any law enforcement
agency thereof, may not initiate proceedings to remove a child
from the home of a parent based solely upon the parent's or
child's possession or use of cannabidiol as authorized by this
act.
Section 3. Research and development study.
A university medical center participating under this act
shall establish a research and development study purposed to
determine medical uses and benefits of cannabidiol for
individuals with debilitating epileptic conditions.
Section 4. Prosecution for use of cannabidiol.
(a) General rule.--The following shall apply:
(1) A university medical center-affiliated pediatric
training entity, including any authorized physician, nurse,
attendant or agent thereof, shall not be subject to
prosecution for the unlawful possession, use, distribution or
prescription of cannabis under the laws of this Commonwealth
for its activities arising directly out of, or directly
related to, the recommendation for use or the use of
cannabidiol in the treatment of individuals diagnosed with a
debilitating epileptic condition.
(2) A university medical center affiliated pediatric
training entity, including any authorized physician, nurse,
attendant or agent thereof, shall not be subject to
prosecution for the unlawful possession, use or distribution
of cannabis under the laws of this Commonwealth for its
activities arising directly out of, or directly related to,
the department's research and development activities in
pursuit of medical benefits and uses of cannabidiol, as long
as the prescription, treatment or use of cannabidiol is
provided only to individuals diagnosed with a debilitating
epileptic condition.
(b) Affirmative defense.--In a prosecution for the unlawful
possession of cannabis under the laws of this Commonwealth, it
is an affirmative and complete defense to prosecution that the
defendant:
(1) has a debilitating epileptic condition and used or
possessed cannabidiol pursuant to a recommendation of a
physician; or
(2) possesses cannabidiol because he or she is the

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parent of an individual who has a debilitating epileptic


condition and who has a recommendation for the possession and
use of cannabidiol as authorized by a physician, and the
parent's possession of the cannabidiol is on behalf of and
otherwise for the prescribed individual's use only.
Section 5. Construction.
Nothing in this act shall be construed to allow or
accommodate the prescription, testing, medical use or possession
of any other form of cannabis other than that defined under this
act.
Section 6. Effective date.
This act shall take effect in 60 days.

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S0003B0889A04303

KMK:CMD 11/19/15

#90

A04303

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE MENTZER
Printer's No. 889
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Amend Bill, page 52, line 26, by striking out "(A)

USE IN

FOOD.--"
Amend Bill, page 53, lines 2 through 8, by striking out all
of said lines

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S0003B0889A04304

MSP:NLH 11/19/15

#90

A04304

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE KNOWLES
Printer's No. 889
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Amend Bill, page 1, by inserting between lines 6 and 7


CHAPTER 2.
Section
Section
Section
Section
Section
Section
Section

201.
202.
203.
204.
205.
206.
207.

MEDICAL CANNABIS RESEARCH TRIAL


PROGRAM
Department of Health Trial Program.
Definitions.
Health care medical cannabis dispensers.
Research programs.
Medical cannabis research.
Research reports.
Funding.

Amend Bill, page 3, by inserting after line 30


Section 5105.

Expiration.

Amend Bill, page 4, line 1, by striking out "5105" and


inserting
5106
Amend Bill, page 9, by inserting between lines 17 and 18
CHAPTER 2
MEDICAL CANNABIS RESEARCH TRIAL PROGRAM
Section 201. Department of Health Trial Program.
Upon the adoption of regulations as required under this act
and for a five-year period thereafter, the dispensing of medical
cannabis shall only be authorized for patients participating in
research programs as prescribed under this chapter.
Section 202. 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:
"Physician." A medical doctor or doctor of osteopathy as
defined under section 2 of the act of December 20, 1985
(P.L.457, No.112), known as the Medical Practice Act of 1985,
who is board certified in one of the following medical
specializations:
(1) Oncology.
(2) Neurology.

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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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with a disclosure, prepared by the Department of Health,


which includes potential dangers, recognition and correction
of problematic dosage and any other information required by
the board or which the Department of Health deems relevant
for patient safety.
(d) Restrictions for health care medical cannabis
dispensers.--A health care medical cannabis dispenser may not
participate in a research study or dispense medical cannabis if
the health care medical cannabis dispenser has violated
licensure requirements under the Health Care Facilities Act.
Section 204. Research programs.-(a) Establishment.--The Department of Health shall establish
and develop research programs to study the impact of medical
cannabis on disease treatment and symptom management.
(b) Duties.--The following shall apply:
(1) In order for the Commonwealth to engage in research
on medical cannabis, the Department of Health shall:
(i) Review all diagnoses which are cited by a
physician upon the physician's recommendation that the
patient be granted a medical cannabis access card.
(ii) Create a database of all diagnoses and
comorbidities which are cited in the medical cannabis
access card recommendation.
(iii) Upon receipt of 25 or more patients with the
same diagnosis or diagnosis and comorbidities, petition
the United States Food and Drug Administration and the
United States Drug Enforcement Administration for
approval to study the disease and the impact of medical
cannabis on the disease.
(iv) 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 group upon which a vertically
integrated health system and a university within this
Commonwealth may submit a request to participate in the
research group.
(v) Upon approval of the research program by the
United States Food and Drug Administration and the United
States Drug Enforcement Administration, select a
vertically integrated health system to administer the
research program and designate the strain of medical
cannabis which will be used to treat the disease or
disease and comorbidities.
(vi) Notify patients who have been granted medical
cannabis access cards that the patients have been placed
into a research program to study medical cannabis as a
treatment and inform the patients where the patients are
able to secure medical cannabis through a health care
medical cannabis dispenser.
(vii) Automatically assign additional patients with
diagnoses which have reached the threshold under

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subparagraph (iii) to a research project upon receipt of


the certification by the physician.
(2) The Department of Health shall take into
consideration the geographic location of the health care
medical cannabis dispenser when assigning a patient to a
dispenser.
(3) If a vertically integrated health system is not
geographically located within 50 miles of the patient, the
patient may be given the opportunity to opt out of the
research study.
(4) Data collected by the health care medical cannabis
dispenser must be provided to the affiliated university
participating in the research program for analysis.
(5) Reports on the effectiveness of the use of medical
cannabis for the treatment of the disease and all counterindications and noted side effects must be submitted to the
board beginning 180 days after the implementation of the
research program for the specific disease or disease with
comorbidities.
Section 205. Medical cannabis research.
(a) Establishment.--The Department of Health shall establish
a research project for each qualified medical condition which
appears to benefit from the use of medical cannabis as a
treatment option. The research projects approved under the
procedure established under section 204 shall only use
vertically integrated health systems in this Commonwealth and
shall engage universities within this Commonwealth to
participate in the collection, collation, analysis and
conclusive findings of the medical cannabis research projects.
(b) Form and procedure.--The Department of Health shall
establish a form and procedure for universities to administer or
conduct research on medical cannabis. The forms shall include,
at a minimum, the following:
(1) The strain of medical cannabis to be studied.
(2) The disease to be studied.
Section 206. Research reports.
(a) Notification of required data for reports.--The
Department of Health shall notify the vertically integrated
health system and the university participating in the research
project of the data which is required to meet the United States
Food and Drug Administration and the United States Drug
Enforcement Administration's approval for the research project.
(b) Initial report.--The first report, including the data
required under subsection (a), shall be submitted to the
Department of Health and made publicly available within 180 days
of the initiation of the research project.
(c) Annual reporting.--An annual report of the data required
under subsection (a) shall be submitted to the Department of
Health beginning one year after the initiation of the research
project and each year thereafter.
(d) Duties of the Department of Health.--The Department of

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14

Health shall have the duty to do the following:


(1) Compile annual reports from vertically integrated
health systems and universities participating in the research
project and make them publicly available.
(2) Provide the reports to the following:
(i) The chairperson and minority chairperson of the
Public Health and Welfare Committee of the Senate of
Pennsylvania.
(ii) The chairperson and minority chairperson of the
Health Committee of the House of Representatives.
Section 207. Funding.
The funding of studies and the cost of medical cannabis
dispensed pursuant to the studies under this chapter may be paid
from any research fund provided for under this act.

15

Amend Bill, page 69, by inserting between lines 25 and 26

16
17
18

Section 5105. Expiration.


This act shall expire five years and six months after the
effective date of this section.

19
20
21

Amend Bill, page 69, line 26, by striking out "5105" and
inserting
5106

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#90

A04307

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE MENTZER
Printer's No. 889
1
2
3

Amend Bill, page 59, line 6, by striking out "6%" and


inserting
10%

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#90

A04308

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE DIAMOND
Printer's No. 889
1

Amend Bill, page 11, lines 20 through 22 (A04380), by

striking out "Subject to section 1108, no individual dose of" in

line 20 and all of lines 21 and 22 and inserting

(Reserved).

Amend Bill, page 31, lines 25 through 27 (A04380), by

6
7
8

striking out all of said lines


Amend Bill, page 33, lines 40 through 42 (A04380), by
striking out all of said lines

2015/90BIL/SB0003A04308

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Regular Session 2015 - 2016


Amendment A04309 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04310 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04311

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#90

A04311

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE DIAMOND
Printer's No. 889
1
2
3

Amend Bill, page 14, line 25 (A04380), by inserting after


"substances"
within the previous five years

2015/90BIL/SB0003A04311

- 1 -

Regular Session 2015 - 2016


Amendment A04312 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04313 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04314 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04315 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04316 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04317 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04321 to
Senate Bill 3 Printer's Number 889
Request withdrawn

S0003B0889A04322

PWK:EJH 11/19/15

#90

A04322

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE LAWRENCE
Printer's No. 889
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
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19

Amend Bill, page 3, by inserting between lines 27 and 28


Section 5101.1. Federal income tax records.
Amend Bill, page 68, by inserting after line 30
Section 5101.1. Federal income tax records.
(a) Internal Revenue Service Form 8300.--A medical cannabis
dispenser, medical cannabis grower or medical cannabis producer
that files an Internal Revenue Service Form 8300, or its
successor, under the terms and conditions established by the
Internal Revenue Service shall file a duplicate copy with the
State Board of Medical Cannabis Licensing.
(b) Record.--The State Board of Medical Cannabis Licensing
shall maintain a record of each Internal Revenue Service Form
8300 received for a period of not less than five years from the
date of receipt.
(c) Penalty.--Failure to file a duplicate of the Internal
Revenue Service Form 8300 under subsection (a) shall pay a fine
of $1,000 for each form not filed.
(d) Deposit of funds.--Fines collected under subsection (c)
shall be deposited into the account.

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#90

A04323

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE LAWRENCE
Printer's No. 889
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15

Amend Bill, page 3, by inserting between lines 27 and 28


Section 5101.1. Labor organization.
Amend Bill, page 68, by inserting after line 30
Section 5101.1. Labor organization.
(a) Membership.--No medical cannabis employee may be
required to become or remain a member of a labor organization as
a condition of employment or continuation of employment.
(b) The following words and phrases when used in this
section shall have the meanings given to them in this subsection
unless the context clearly indicates otherwise:
"Labor organization." An organization, agency or employee
representation committee, plan or arrangement in which employees
participate and which exists for the purpose of dealing with
employers concerning grievances, labor disputes, wages, rates of
pay, hours of employment or conditions of work.

2015/90PWK/SB0003A04323

- 1 -

Regular Session 2015 - 2016


Amendment A04324 to
Senate Bill 3 Printer's Number 889
Request withdrawn

S0003B0889A04325

PWK:NLH 11/20/15

#90

A04325

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE LAWRENCE
Printer's No. 889
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37

Amend Bill, page 3, by inserting between lines 27 and 28


Section 5101.1.

Financial and employment interests.

Amend Bill, page 68, by inserting after line 30


Section 5101.1. Financial and employment interests.
(a) Financial interests.--Except as may be provided for the
judiciary by rule or order of the Pennsylvania Supreme Court, an
executive-level public employee, public official or party
officer, or an immediate family member thereof, shall not
intentionally or knowingly hold a financial interest in a
medical cannabis dispenser, medical cannabis grower or medical
cannabis processor, or in a holding company, affiliate,
intermediary or subsidiary thereof, while the individual is an
executive-level public employee, public official or party
officer and for one year following termination of the
individual's status as an executive-level public employee,
public official or party officer.
(b) Employment.--Except as may be provided by rule or order
of the Pennsylvania Supreme Court, no executive-level public
employee, public official or party officer, or an immediate
family member thereof, shall be employed by a medical cannabis
dispenser, medical cannabis grower or medical cannabis
processor, or by any holding company, affiliate, intermediary or
subsidiary thereof, while the individual is an executive-level
public employee, public official or party officer and for one
year following termination of the individual's status as an
executive-level public employee, public official or party
officer.
(c) Grading.--An individual who violates this section
commits a misdemeanor and shall, upon conviction, be sentenced
to pay a fine of not more than $1,000 or to imprisonment for not
more than one year, or both.
(d) State Ethics Commission.--The State Ethics Commission
shall do all of the following:
(1) Issue a written determination of whether a person is
subject to subsections (a) or (b) upon the written request of
the person or any other person that may have liability for an
action taken with respect to such person. A person that

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relies in good faith on a determination made under this


paragraph shall not be subject to any penalty for an action
taken, provided that all material facts set forth in the
request for the determination are correct.
(2) Publish a list of all State, county, municipal and
other government positions that meet the definitions of
"public official" as defined under subsection (b) or
"executive-level public employee." The Office of
Administration shall assist the State Ethics Commission in
the development of the list, which shall be published by the
State Ethics Commission in the Pennsylvania Bulletin
biennially and posted by the board on the board's Internet
website. Upon request, each public official shall have a duty
to provide the State Ethics Commission with adequate
information to accurately develop and maintain the list. The
State Ethics Commission may impose a civil penalty under 65
Pa.C.S. 1109(f) (relating to penalties) upon any
individual, including any public official or executive-level
public employee, who fails to cooperate with the State Ethics
Commission under this subsection. A person that relies in
good faith on the list published by the State Ethics
Commission shall not be subject to any penalty for a
violation of this section.
(e) Definitions.--As used in this section, the following
words and phrases shall have the meanings given to them in this
subsection:
"Financial interest." As defined in 4 Pa.C.S. 1512(b)
(relating to financial and employment interests).
"Immediate family." As defined in 4 Pa.C.S. 1512(b).
"Party officer." As defined in 4 Pa.C.S. 1512(b).
"Public official." The term shall include the following:
(1) The Governor, Lieutenant Governor, a member of the
Governor's cabinet, Treasurer, Auditor General and Attorney
General of the Commonwealth.
(2) A member of the Senate or House of Representatives
of the Commonwealth.
(3) An individual elected or appointed to any office of
a county or municipality that directly receives a
distribution of revenue under this part.
(4) An individual elected or appointed to a department,
agency, board, commission, authority or other governmental
body not included in paragraph (1), (2) or (3) that directly
receives a distribution of revenue under this part.
(5) An individual elected or appointed to a department,
agency, board, commission, authority, county, municipality or
other governmental body not included in paragraph (1), (2) or
(3) with discretionary power which may influence or affect
the outcome of an action or decision and who is involved in
the development of regulation or policy relating to a
licensed entity or who is involved in other matters under
this part.

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1
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5

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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#90

A04326

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE PETRARCA
Printer's No. 889
1

Amend Bill, page 31, lines 23 and 24 (A04380), by striking

out ", for administration" in line 23 and "by vaporization" in

line 24

4
5

Amend Bill, page 33, line 39 (A04380), by striking out "for


administration by vaporization"

2015/90LKK/SB0003A04326

- 1 -

Regular Session 2015 - 2016


Amendment A04327 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04328 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04329 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04330

LKK:NLH 11/20/15

#90

A04330

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE M. DALEY
Printer's No. 889
1
2

Amend Bill, page 31, line 3 (A04380), by inserting after


"issue"

within

Amend Bill, page 31, line 27 (A04380), by inserting after

"10%"

6
7
8

or to eliminate a cap on the percentage of


tetrahydrocannabinol that an individual dose of medical cannabis
may contain

9
10

Amend Bill, page 33, line 15 (A04380), by striking out


"Regulations based on recommendations" and inserting

11

Recommendations

12

Amend Bill, page 33, lines 17 through 45 (A04380), by

13

striking out all of said lines and inserting

14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32

(a) Determination of secretary.--Within six months after


receiving the report of the advisory board under section 1106(j)
(4), the secretary shall determine whether to adopt any of the
recommendations contained in the report. Within 30 days after
making the determination, the secretary shall issue a notice to
be published in the Pennsylvania Bulletin stating which
recommendations the secretary will adopt and the recommendations
the secretary will not adopt. The notice shall contain the
specific reasons why the secretary is or is not adopting a
recommendation.
(b) Notice and regulations.--If the secretary's notice under
subsection (a) includes a determination to adopt recommendations
of the advisory board with respect to the matters described in
subparagraphs 1106(j)(5)(vi) or (vii), the recommendations will
be deemed adopted as of the date of publication of the notice
and provisions of the recommendations will be in effect under
this act as of that date as if the provisions were included in
this act. If the secretary's notice under subsection (a)
includes a determination to adopt any other recommendations of

2015/90LKK/SB0003A04330

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1
2
3

the advisory board, the recommendations will be adopted through


the promulgation of regulations within 12 months following the
date of the publication of the notice.

2015/90LKK/SB0003A04330

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Regular Session 2015 - 2016


Amendment A04331 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04332

PWK:BTW 11/20/15

#90

A04332

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE WHEATLEY
Printer's No. 889
1

Amend Bill, page 17, by inserting between lines 10 and 11

2
3

(27) To develop a diversity plan for licensing minority


business owners.

Amend Bill, page 17, line 11, by striking out "(27)" and

5
6
7
8
9

inserting
(28)
Amend Bill, page 17, line 12, by striking out "(28)" and
inserting
(29)

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#90

A04333

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE WHEATLEY
Printer's No. 889
1

Amend Bill, page 5, by inserting between lines 13 and 14

2
3
4
5

"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.

Amend Bill, page 26, line 24, by inserting after "center"

7
8

, unless the medical cannabis grower is located within a


keystone opportunity zone

Amend Bill, page 29, line 8, by inserting after "center"

10
11

, unless the medical cannabis processor is located within


a keystone opportunity zone

12

Amend Bill, page 33, line 14, by inserting after "center"

13
14

, unless the medical cannabis dispenser is located within


a keystone opportunity zone

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S0003B0889A04334

PWK:NLH 11/20/15

#90

A04334

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE WHEATLEY
Printer's No. 889
1

Amend Bill, page 5, by inserting between lines 13 and 14

2
3
4
5

"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.

Amend Bill, page 26, line 24, by inserting after "center"

7
8

, unless the medical cannabis grower is located within a


keystone opportunity zone in a city of the first class

Amend Bill, page 29, line 8, by inserting after "center"

10
11

, unless the medical cannabis processor is located within


a keystone opportunity zone in a city of the first class

12

Amend Bill, page 33, line 14, by inserting after "center"

13
14

, unless the medical cannabis dispenser is located within


a keystone opportunity zone in a city of the first class

2015/90PWK/SB0003A04334

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#90

A04335

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE WHEATLEY
Printer's No. 889
1
2
3
4
5
6
7

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.

2015/90PWK/SB0003A04335

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S0003B0889A04336

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#90

A04336

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE WHEATLEY
Printer's No. 889
1
2
3
4
5
6
7

Amend Bill, page 29, line 8, by striking out the period after
"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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#90

A04337

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE WHEATLEY
Printer's No. 889
1
2
3
4
5
6
7

Amend Bill, page 33, line 14, by striking out the period
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.

2015/90PWK/SB0003A04337

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S0003B0889A04338

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#90

A04338

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE WHEATLEY
Printer's No. 889
1
2
3
4
5
6
7
8
9
10

Amend Bill, page 10, by inserting between lines 20 and 21


(10)

One member appointed by each of the following:


(i) President pro tempore of the Senate.
(ii) Minority Leader of the Senate.
(iii) Speaker of the House of Representatives.
(iv) Minority Leader of the House of
Representatives.
Amend Bill, page 10, line 29, by striking out "Each" and
inserting
Except for subsection (b)(10), each

2015/90PWK/SB0003A04338

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#90

A04340

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE WHEATLEY
Printer's No. 889
1
2
3
4

Amend Bill, page 35, by inserting between lines 20 and 21


(f) Public hearing.--The board shall hold a public hearing
with an opportunity for the public to comment on the location of
the facility for each new applicant under this section.

2015/90PWK/SB0003A04340

- 1 -

Regular Session 2015 - 2016


Amendment A04342 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04343

LKK:NLH 11/20/15

#90

A04343

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE GAINEY
Printer's No. 889
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38

Amend Bill, page 25, by inserting between lines 45 and 46


(A04380)
Section 712. Diversity goals.
(a) Goals.--It is the intent and goal of the General
Assembly that the department promote and ensure diversity and
the participation by diverse groups in the activities authorized
under this act. In order to further this goal, the department
shall adopt and implement policies or guidelines ensuring the
following:
(1) That diverse groups are accorded equal opportunity
in the registration process, either directly as applicants or
registrants or through ownership interests in applicants or
registrants.
(2) That registrants promote the participation of
diverse groups in the registrants' operations by affording
equal access to employment opportunities.
(b) Duties of department.--To facilitate participation by
diverse groups in the activities authorized under this act, the
department shall:
(1) Conduct the necessary and appropriate outreach,
including, if determined appropriate, consulting with other
State agencies, boards and commissions, including the
Department of General Services and the Department of State,
for the purpose of identifying diverse groups capable of
participating in the activities under this act.
(2) Provide sufficient and continuous notice of the
participation opportunities afforded under this act by
publishing notice in the Pennsylvania Bulletin and on the
department's publicly accessible Internet website.
(3) Include in the applications for registration under
this act language to encourage applicants to utilize and give
consideration to diverse groups for contracting or
professional services opportunities.
(4) Designate an employee to oversee the efforts adopted
by registrants to promote the participation of diverse groups
in the activities authorized under this act and comply with
the diversity goals of this section.
(c) Reports.--No later than March 1, 2018, and each March 1

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thereafter, the department shall submit a report to the


chairperson and minority chairperson of the Public Health and
Welfare Committee of the Senate and the chairperson and minority
chairperson of the Health Committee of the House of
Representatives summarizing the participation and utilization of
diverse groups in the activities authorized under this act. The
report shall include:
(1) The participation level, by percentage, of diverse
groups in the activities authorized under this act.
(2) A summary of how diverse groups are utilized by
registrants, including in the provision of goods or services.
(3) Any other information the department deems
appropriate.
(d) Definitions.--The following words and phrases when used
in this section shall have the meanings given to them in this
subsection unless the context clearly indicates otherwise:
"Disadvantaged business." As defined in 74 Pa.C.S. 303(b)
(relating to diverse business participation).
"Diverse group." A disadvantaged business, minority-owned
business, women-owned business, service-disabled veteran-owned
small business or veteran-owned small business that has been
certified by a third-party certifying organization.
"Minority-owned business." As defined in 74 Pa.C.S.
303(b).
"Service-disabled veteran-owned small business." As defined
in 51 Pa.C.S. 9601 (relating to definitions).
"Third-party certifying organization." As defined in 74
Pa.C.S. 303(b).
"Veteran-owned small business." As defined in 51 Pa.C.S.
9601.
"Women-owned business." As defined in 74 Pa.C.S. 303(b).

2015/90LKK/SB0003A04343

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Regular Session 2015 - 2016


Amendment A04344 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04345

LKK:CDM 11/20/15

#90

A04345

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE SCHWEYER
Printer's No. 889
1
2

Amend Bill, page 26, lines 42 and 43 (A04380), by striking


out "no more than" and inserting

at least

Amend Bill, page 26, line 43 (A04380), by inserting after

"15%"

, but not more than 25%,

Amend Bill, page 26, line 43 (A04380), by striking out "may"

8
9
10
11
12

and inserting
shall
Amend Bill, page 26, line 51 (A04380), by inserting after
"waiver"
or reduction

2015/90LKK/SB0003A04345

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Regular Session 2015 - 2016


Amendment A04346 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04347 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04349

PWK:CMD 11/19/15

#90

A04349

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE LAWRENCE
Printer's No. 889
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37

Amend Bill, page 3, by inserting between lines 27 and 28


Section 5101.1. Campaign contributions.
Amend Bill, page 68, by inserting after line 30
Section 5101.1. Campaign contributions.
(a) Contribution restriction.--The following persons shall
be prohibited from contributing any money or in-kind
contribution to a candidate for nomination or election to any
public office in this Commonwealth, to any political party
committee or other political committee in this Commonwealth or
to any group, committee or association organized in support of a
candidate, political party committee or other political
committee in this Commonwealth:
(1) A medical cannabis dispenser.
(2) A medical cannabis grower.
(3) A medical cannabis producer.
(4) A medical cannabis employee.
(5) An affiliate, intermediary, subsidiary or holding
company of a medical cannabis dispenser, medical cannabis
grower or medical cannabis producer.
(6) A person who holds a similar license for the
production or sale of medical cannabis in another
jurisdiction and the affiliates, intermediaries,
subsidiaries, holding companies, principals or key employees
thereof.
(b) Contributions to certain associations and organizations
barred.--The individuals prohibited from making political
contributions under subsection (a) shall not make a political
contribution of money or an in-kind contribution to any
association or organization, including a nonprofit organization,
that has been solicited by, or knowing that the contribution or
a portion thereof will be contributed to, the elected official,
executive-level public employee or candidate for nomination or
election to a public office in this Commonwealth.
(c) Penalties.--The following penalties shall apply to any
medical cannabis grower, medical cannabis employee, medical
cannabis producer or medical cannabis dispenser that violates
subsection (b):

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(1) For the first violation, a fine of $1,000.


(2) For a second violation, a fine of $10,000.
(3) For a third or subsequent violation, a fine of
$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.

2015/90PWK/SB0003A04349

- 2 -

Regular Session 2015 - 2016


Amendment A04351 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04352

KMK:JMT 11/19/15

#90

A04352

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE GODSHALL
Printer's No. 889
1

Amend Bill, page 1, lines 1 through 16; pages 2 and 3, lines

1 through 30; page 4, line 1; by striking out all of said lines

on said pages and inserting

4
5

Providing for the use of investigational drugs, biological


products and devices by terminally ill patients.

Amend Bill, page 4, lines 4 through 30; pages 5 through 68,

lines 1 through 30; page 69, lines 1 through 27; by striking out

all of said lines on said pages and inserting

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Section 1. Short title.


This act shall be known and may be cited as the Right-to-Try
Act.
Section 2. 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:
"Eligible patient." As follows:
(1) A person who has:
(i) a terminal illness, attested to by the patient's
treating physician;
(ii) carefully considered all other treatment
options approved by the United States Food and Drug
Administration;
(iii) been unable to participate in a clinical trial
for the terminal illness that is located within 100 miles
of the patient's home address or has not been accepted to
the clinical trial within one week of completion of the
clinical trial application process;
(iv) received a recommendation from the patient's
treating physician for an investigational drug,
biological product or device;
(v) given written, informed consent for the use of
the investigational drug, biological product or device,
or, if the patient is a minor or lacks the mental
capacity to provide informed consent, a parent or legal

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guardian has given written, informed consent on the


patient's behalf; and
(vi) documentation from the patient's treating
physician that the patient meets the requirements of this
paragraph.
(2) The term does not include a person being treated as
an inpatient in any hospital.
"Hospital." As defined in section 802.1 of the act of July
19, 1979 (P.L.130, No.48), known as the Health Care Facilities
Act.
"Investigational drug, biological product or device." A
drug, biological product or device that has successfully
completed phase one of a clinical trial but has not yet been
approved for general use by the United States Food and Drug
Administration and remains under investigation in a clinical
trial approved by the United States Food and Drug
Administration.
"Physician." As defined in section 2 of the act of December
20, 1985 (P.L.457, No.112), known as the Medical Practice Act of
1985.
"Terminal illness." A disease or condition that, without
life-sustaining procedures, will soon result in death or a state
of permanent unconsciousness from which recovery is unlikely.
"Written, informed consent." A written document signed by
the patient and attested to by the patient's treating physician
and a witness that, at a minimum:
(1) Explains the currently approved products and
treatments for the disease or condition from which the
patient suffers.
(2) Attests to the fact that the patient concurs with
the patient's treating physician in believing that all
currently approved and conventionally recognized treatments
are unlikely to prolong the patient's life.
(3) Clearly identifies the specific proposed
investigational drug, biological product or device that the
patient is seeking to use.
(4) Describes the potentially best and worst outcomes of
using the investigational drug, biological product or device
with a realistic description of the most likely outcome,
including the possibility that new, unanticipated, different
or worse symptoms might result, and that death could be
hastened by the proposed treatment, based on the physician's
knowledge of the proposed treatment in conjunction with an
awareness of the patient's condition.
(5) Makes clear that the patient's health insurer and
provider are not obligated to pay for any care or treatments
consequent to the use of the investigational drug, biological
product or device.
(6) Makes clear that the patient's eligibility for
hospice care may be withdrawn if the patient begins curative
treatment and care may be reinstated if the curative

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treatment ends and the patient meets hospice eligibility


requirements.
(7) Makes clear that in-home health care may be denied
if treatment begins.
(8) States that the patient understands that the patient
is liable for all expenses consequent to the use of the
investigational drug, biological product or device, and that
this liability extends to the patient's estate, unless a
contract between the patient and the manufacturer of the
investigational drug, biological product or device states
otherwise.
Section 3. Access.
(a) General rule.--A manufacturer of an investigational
drug, biological product or device may make available the
manufacturer's investigational drug, biological product or
device to eligible patients in accordance with this act. Access
to investigational drugs shall also include any cannabinoids
which are being investigated by the United States Food and Drug
Administration.
(b) Costs.--A manufacturer may:
(1) Provide an investigational drug, biological product
or device to an eligible patient without receiving
compensation.
(2) Require an eligible patient to pay the costs of, or
the costs associated with, the manufacture of the
investigational drug, biological product or device.
(c) Insurers.--A health insurer may:
(1) In its discretion, provide coverage for the cost of
an investigational drug, biological product or device.
(2) Except as set forth in subsection (d), deny coverage
to an eligible patient from the time the eligible patient
begins use of the investigational drug, biological product or
device through a period not to exceed six months from the
time the investigational drug, biological product or device
is no longer used by the eligible patient.
(d) Limitation.--Coverage may not be denied for a
preexisting condition or in cases where coverage commenced prior
to the time the eligible patient begins use of the
investigational drug, biological product, or device.
Section 4. Unprofessional conduct.
(a) Physician immunity.--No physician who in good faith
recommends or participates in the use of an investigational
drug, biological product or device under this act shall be
subject to criminal or civil liability, nor shall a physician be
found to have committed an act of unprofessional conduct under
the act of October 5, 1978 (P.L.1109, No.261), known as the
Osteopathic Medical Practice Act, or the act of December 20,
1985 (P.L.457, No.112), known as the Medical Practice Act of
1985.
(b) Physician licensure not affected.--Notwithstanding any
other law to the contrary, the State Board of Medicine and the

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State Board of Osteopathic Medicine may not revoke, suspend or


otherwise take any action against an individual holding a
license issued under the Osteopathic Medical Practice Act or the
Medical Practice Act of 1985, based solely on the individual's
recommendations to an eligible patient regarding access to or
treatment with an investigational drug, biological product or
device, as long as the recommendations are consistent with
standards of care set forth by the manufacturer. Any action
against an individual or entity's Medicare certification based
solely on recommendations that a patient have access to an
investigational drug, biological product or device is
prohibited.
Section 5. Protection from prosecution.
In the prosecution for the unlawful possession of cannabis
under the laws of the Commonwealth, it is an affirmative and
complete defense to the prosecution that the individual:
(1) has a terminal illness and is using or possessing
cannabis at the recommendation of a physician to use
cannabis; or
(2) is the parent of a minor child with a terminal
illness and is in possession of cannabis for the benefit of
the minor child who has a recommendation of a physician to
use cannabis.
Section 6. Construction.
Nothing in this act shall be construed as creating a private
cause of action against a manufacturer of an investigational
drug, biological product or device, or against any other person
or entity involved in the care of an eligible patient using an
investigational drug, biological product or device for any
injury suffered by the eligible patient resulting from the
investigational drug, biological product or device, as long as
the manufacturer or other person or entity acted in accordance
with this act, except when the injury results from a failure to
exercise reasonable care.
Section 7. Effective date.
This act shall take effect in 60 days.

2015/90KMK/SB0003A04352

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Regular Session 2015 - 2016


Amendment A04353 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04355

KMK:EJH 11/19/15

#90

A04355

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE WATSON
Printer's No. 889
1

Amend Bill, page 1, line 1, by striking out "cannabis" and

inserting

CBD oil

Amend Bill, page 1, lines 3 through 16; pages 2 and 3, lines

1 through 30; page 4, line 1; by striking out all of said lines

on said pages

Amend Bill, page 4, lines 4 through 30; pages 5 through 68,

lines 1 through 30; page 69, lines 1 through 27; by striking out

all of said lines on said pages and inserting

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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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vertically integrated health system with an affiliation to an


academic clinical research center.
(3) The patient or the patient's parent, guardian or
custodian must execute a hold-harmless agreement that
releases from liability the Commonwealth and any political
subdivision, agency, institution or employee of the
Commonwealth involved in the research, cultivation,
processing, dispensing, prescribing or administration of CBD
oil.
(b) Prohibition.--A Commonwealth agency or a political
subdivision of the Commonwealth, including any law enforcement
agency thereof, may not initiate proceedings to remove a child
from the home based solely upon the possession or use of CBD oil
by the child or parent, guardian or custodian of the child as
authorized under this act.
Section 3. Production or possession of CBD oil for research.
(a) General rule.--Academic clinical research centers are
the only entities authorized to produce or possess cannabidiol
for research.
(b) Compliance.--Production or possession of CBD oil for
research must comply with the provisions of the Controlled
Substances Act (Public Law 91-513, 84 Stat. 1236) relating to
lawful possession of controlled substances, provisions of the
act of September 27, 1961 (P.L.1700, No.699), known as the
Pharmacy Act, relating to record-keeping requirements relative
to the dispensing, use or administration of controlled
substances, and any other applicable State law or regulation.
(c) Permits or waivers.--Academic clinical research centers
may pursue any Federal permits or waivers necessary to conduct
the programs authorized under this act.
Section 4. Prosecution for possession of CBD oil.
(a) General rule.--An employee of the Commonwealth or an
agency, institution or political subdivision of the Commonwealth
involved in the research, cultivation, processing, dispensing,
prescribing or administration of CBD oil shall not be subject to
prosecution for unlawful possession, use, distribution or
prescription of marijuana under the laws of this Commonwealth
for activities arising from, or related to, the use of CBD oil
in the treatment of individuals diagnosed with a debilitating
epileptic condition under this act.
(b) Affirmative defense.--In a prosecution for the unlawful
possession of marijuana under the laws of this Commonwealth, it
is an affirmative and complete defense to prosecution that the
defendant:
(1) suffered from a debilitating epileptic condition or
related illness and the use or possession of CBD oil was
pursuant to the order of a physician as authorized under this
act; or
(2) is the parent, guardian or custodian of an
individual who suffered from a debilitating epileptic
condition or related illness and the use or possession of CBD

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oil was pursuant to the order of a physician as authorized


under this act.
Section 5. Effective date.
This act shall take effect in 60 days.

2015/90KMK/SB0003A04355

- 3 -

Regular Session 2015 - 2016


Amendment A04356 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04359

PWK:JSL 11/20/15

#90

A04359

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE LAWRENCE
Printer's No. 889
1

Amend Bill, page 2, by inserting between lines 50 and 51

(A04380)

Section 2101.1.

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Federal income tax records.

Amend Bill, page 42, by inserting between lines 6 and 7


(A04380)
Section 2101.1. Federal income tax records.
(a) Internal Revenue Service Form 8300.--A medical marijuana
organization that files an Internal Revenue Service Form 8300,
or its successor, under the terms and conditions established by
the Internal Revenue Service shall file a duplicate copy with
the Department of Revenue.
(b) Record.--The Department of Revenue shall maintain a
record of each Internal Revenue Service Form 8300 received for a
period of not less than five years from the date of receipt.
(c) Penalty.--Failure to file a duplicate of the Internal
Revenue Service Form 8300 under subsection (a) shall pay a fine
of $1,000 for each form not filed.
(d) Deposit of funds.--Fines collected under subsection (c)
shall be deposited into the fund.

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S0003B0889A04360

PWK:JSL 11/20/15

#90

A04360

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE LAWRENCE
Printer's No. 889
1

Amend Bill, page 2, by inserting between lines 50 and 51

(A04380)

Section 2101.1.

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Labor organizations.

Amend Bill, page 42, by inserting between lines 6 and 7


(A04380)
Section 2101.1. Labor organizations.
(a) Membership.--No employee of a medical marijuana
organization may be required to become or remain a member of a
labor organization as a condition of employment or continuation
of employment.
(b) The following words and phrases when used in this
section shall have the meanings given to them in this subsection
unless the context clearly indicates otherwise:
"Labor organization." An organization, agency or employee
representation committee, plan or arrangement in which employees
participate and which exists for the purpose of dealing with
employers concerning grievances, labor disputes, wages, rates of
pay, hours of employment or conditions of work.

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S0003B0889A04361

PWK:JSL 11/22/15

#90

A04361

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE LAWRENCE
Printer's No. 889
1

Amend Bill, page 2, by inserting between lines 50 and 51

(A04380)

Section 2101.1.

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Financial and employment interests.

Amend Bill, page 42, by inserting between lines 6 and 7


(A04380)
Section 2101.1. Financial and employment interests.
(a) Financial interests.--Except as may be provided for the
judiciary by rule or order of the Pennsylvania Supreme Court, an
executive-level public employee, public official or party
officer, or an immediate family member thereof, shall not
intentionally or knowingly hold a financial interest in a
medical marijuana organization or in a holding company,
affiliate, intermediary or subsidiary thereof, while the
individual is an executive-level public employee, public
official or party officer and for one year following termination
of the individual's status as an executive-level public
employee, public official or party officer.
(b) Employment.--Except as may be provided by rule or order
of the Pennsylvania Supreme Court, no executive-level public
employee, public official or party officer, or an immediate
family member thereof, shall be employed by a medical marijuana
organization or by any holding company, affiliate, intermediary
or subsidiary thereof, while the individual is an executivelevel public employee, public official or party officer and for
one year following termination of the individual's status as an
executive-level public employee, public official or party
officer.
(c) Grading.--An individual who violates this section
commits a misdemeanor and shall, upon conviction, be sentenced
to pay a fine of not more than $1,000 or to imprisonment for not
more than one year, or both.
(d) State Ethics Commission.--The State Ethics Commission
shall do all of the following:
(1) Issue a written determination of whether a person is
subject to subsections (a) or (b) upon the written request of
the person or any other person that may have liability for an

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action taken with respect to such person. A person that


relies in good faith on a determination made under this
paragraph shall not be subject to any penalty for an action
taken, provided that all material facts set forth in the
request for the determination are correct.
(2) Publish a list of all State, county, municipal and
other government positions that meet the definitions of
"public official" as defined under subsection (b) or
"executive-level public employee." The Office of
Administration shall assist the State Ethics Commission in
the development of the list, which shall be published by the
State Ethics Commission in the Pennsylvania Bulletin
biennially and posted by the board on the board's Internet
website. Upon request, each public official shall have a duty
to provide the State Ethics Commission with adequate
information to accurately develop and maintain the list. The
State Ethics Commission may impose a civil penalty under 65
Pa.C.S. 1109(f) (relating to penalties) upon any
individual, including any public official or executive-level
public employee, who fails to cooperate with the State Ethics
Commission under this subsection. A person that relies in
good faith on the list published by the State Ethics
Commission shall not be subject to any penalty for a
violation of this section.
(e) Definitions.--As used in this section, the following
words and phrases shall have the meanings given to them in this
subsection:
"Financial interest." As defined in 4 Pa.C.S. 1512(b)
(relating to financial and employment interests).
"Immediate family." As defined in 4 Pa.C.S. 1512(b).
"Party officer." As defined in 4 Pa.C.S. 1512(b).
"Public official." The term shall include the following:
(1) The Governor, Lieutenant Governor, a member of the
Governor's cabinet, Treasurer, Auditor General and Attorney
General of the Commonwealth.
(2) A member of the Senate or House of Representatives
of the Commonwealth.
(3) An individual elected or appointed to any office of
a county or municipality that directly receives a
distribution of revenue under this part.
(4) An individual elected or appointed to a department,
agency, board, commission, authority or other governmental
body not included in paragraph (1), (2) or (3) that directly
receives a distribution of revenue under this part.
(5) An individual elected or appointed to a department,
agency, board, commission, authority, county, municipality or
other governmental body not included in paragraph (1), (2) or
(3) with discretionary power which may influence or affect
the outcome of an action or decision and who is involved in
the development of regulation or policy relating to a
licensed entity or who is involved in other matters under

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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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S0003B0889A04362

PWK:JSL 11/22/15

#90

A04362

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE LAWRENCE
Printer's No. 889
1

Amend Bill, page 2, by inserting between lines 50 and 51

(A04380)

Section 2101.1.

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Campaign contributions.

Amend Bill, page 42, by inserting between lines 6 and 7


(A04380)
Section 2101.1. Campaign contributions.
(a) Contribution restriction.--The following persons shall
be prohibited from contributing any money or in-kind
contribution to a candidate for nomination or election to any
public office in this Commonwealth, to any political party
committee or other political committee in this Commonwealth or
to any group, committee or association organized in support of a
candidate, political party committee or other political
committee in this Commonwealth:
(1) A medical marijuana organization.
(2) An affiliate, intermediary, subsidiary or holding
company of a medical marijuana organization.
(3) A person who holds a similar license for the
production or sale of medical marijuana in another
jurisdiction and the affiliates, intermediaries,
subsidiaries, holding companies, principals or key employees
thereof.
(b) Contributions to certain associations and organizations
barred.--The individuals prohibited from making political
contributions under subsection (a) shall not make a political
contribution of money or an in-kind contribution to any
association or organization, including a nonprofit organization,
that has been solicited by, or knowing that the contribution or
a portion thereof will be contributed to, the elected official,
executive-level public employee or candidate for nomination or
election to a public office in this Commonwealth.
(c) Penalties.--The following penalties shall apply to any
medical marijuana organization that violates subsection (b):
(1) For the first violation, a fine of $1,000.
(2) For a second violation, a fine of $10,000.
(3) For a third or subsequent violation, a fine of

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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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S0003B0889A04363

LKK:BTW 11/19/15

#90

A04363

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE DUSH
Printer's No. 889
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Amend Bill, page 3, by inserting between lines 27 and 28


Section 5101.1.

Bond requirement.

Amend Bill, page 68, by inserting after line 30


Section 5101.1. Bond requirement.
(a) Security required.--In addition to any other
requirement, the following persons shall maintain a reserve
account of $2 million in cash or cash equivalent for claims
relating to product liability, injury or loss or theft of
medical cannabis:
(1) Medical cannabis grower.
(2) Medical cannabis processor.
(3) Medical cannabis dispenser.
(4) Health care practitioner who recommends the use of
medical cannabis to a patient.
(5) A patient representative other than a parent or
guardian of a registered patient.
(b) Penalty.--A person who fails to comply with subsection
(a) shall have any license, permit or certificate to operate
under this act suspended until such time as the person complies
with subsection (a).

2015/90LKK/SB0003A04363

- 1 -

Regular Session 2015 - 2016


Amendment A04364 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04365

LKK:BTW 11/19/15

#90

A04365

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
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3

Amend Bill, page 8, line 23, by striking out "HIV/AIDS" and


inserting
(Reserved)

2015/90LKK/SB0003A04365

- 1 -

S0003B0889A04366

KMK:CMD 11/19/15

#90

A04366

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE WATSON
Printer's No. 889
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3

Amend Bill, page 1, line 1, by striking out "cannabis" and


inserting
medical marijuana

Amend Bill, page 1, lines 3 through 16; pages 2 and 3, lines

1 through 30; page 4, line 1; by striking out all of said lines

on said pages

Amend Bill, page 4, lines 4 through 30; pages 5 through 68,

lines 1 through 30; page 69, lines 1 through 27; by striking out

all of said lines on said pages and inserting

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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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to an academic clinical research center.


(3) The patient or the patient's parent, guardian or
custodian must execute a hold-harmless agreement that
releases from liability the Commonwealth and any political
subdivision, agency, institution or employee of the
Commonwealth involved in the research, cultivation,
processing, dispensing, prescribing or administration of
medical marijuana.
(b) Prohibition.--A Commonwealth agency or a political
subdivision of the Commonwealth, including any law enforcement
agency thereof, may not initiate proceedings to remove a child
from the home based solely upon the possession or use of medical
marijuana by the child or parent, guardian or custodian of the
child as authorized under this act.
Section 3. Production or possession of medical marijuana for
research.
(a) General rule.--Academic clinical research centers are
the only entities authorized to produce or possess medical
marijuana for research.
(b) Compliance.--Production or possession of medical
marijuana for research must comply with the provisions of the
Controlled Substances Act (Public Law 91-513, 84 Stat. 1236)
relating to lawful possession of controlled substances,
provisions of the act of September 27, 1961 (P.L.1700, No.699),
known as the Pharmacy Act, relating to record-keeping
requirements relative to the dispensing, use or administration
of controlled substances, and any other applicable State law or
regulation.
(c) Permits or waivers.--Academic clinical research centers
may pursue any Federal permits or waivers necessary to conduct
the programs authorized under this act.
Section 4. Prosecution for possession of medical marijuana.
(a) General rule.--An employee of the Commonwealth or an
agency, institution or political subdivision of the Commonwealth
involved in the research, cultivation, processing, dispensing,
prescribing or administration of medical marijuana shall not be
subject to prosecution for unlawful possession, use,
distribution or prescription of marijuana under the laws of this
Commonwealth for activities arising from, or related to, the use
of medical marijuana in the treatment of individuals diagnosed
with a debilitating epileptic condition under this act.
(b) Affirmative defense.--In a prosecution for the unlawful
possession of marijuana under the laws of this Commonwealth, it
is an affirmative and complete defense to prosecution that the
defendant:
(1) suffered from a debilitating epileptic condition or
related illness and the use or possession of medical
marijuana was pursuant to the order of a physician as
authorized under this act; or
(2) is the parent, guardian or custodian of an
individual who suffered from a debilitating epileptic

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condition or related illness and the use or possession of


medical marijuana was pursuant to the order of a physician as
authorized under this act.
Section 5. Effective date.
This act shall take effect in 60 days.

2015/90KMK/SB0003A04366

- 3 -

Regular Session 2015 - 2016


Amendment A04367 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04368 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04369 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04370

KMK:NLH 11/19/15

#90

A04370

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE STEPHENS
Printer's No. 889
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Amend Bill, page 8, line 21, by striking out the period after
"disorder" and inserting

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so long as the individual is a veteran and the disorder


arose from military service.

Amend Bill, page 8, lines 25 through 27, by striking out all

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of lines 25 and 26 and "(14)" in line 27 and inserting


(13)
Amend Bill, page 8, line 28, by striking out "(15)" and
inserting
(14)
Amend Bill, page 8, line 29, by striking out "(16)" and
inserting
(15)

2015/90KMK/SB0003A04370

- 1 -

Regular Session 2015 - 2016


Amendment A04371 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04372

AJM:CMD 11/19/15

#90

A04372

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE DUSH
Printer's No. 889
1

Amend Bill, page 22, lines 22 and 23, by striking out

"Beginning two years after the effective date of this

subsection," and inserting

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Unless established by this act,


Amend Bill, page 68, line 9, by striking out "(a)
Requirement.--"
Amend Bill, page 68, lines 11 through 30, by striking out all
of said lines

2015/90AJM/SB0003A04372

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S0003B0889A04373

KMK:BTW 11/19/15

#90

A04373

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2

Amend Bill, page 33, lines 15 through 20, by striking out all
of said lines

2015/90KMK/SB0003A04373

- 1 -

Regular Session 2015 - 2016


Amendment A04374 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04375 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04376

DMS:CMD 11/20/15

#90

A04376

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE GAINEY
Printer's No. 889
1

Amend Bill, page 3, by inserting between lines 25 and 26

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CHAPTER 13. ACADEMIC CLINICAL RESEARCH CENTERS


Section 1301. Definitions.
Section 1302. Registration as both grower/processor and
dispensary collaborating with an academic clinical
research center.
Section 1303. Research study.
Section 1304. Regulations.

Amend Bill, page 68, by inserting between lines 5 and 6

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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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Section 1304. 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.

2015/90DMS/SB0003A04376

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S0003B0889A04377

DMS:NLH 11/20/15

#90

A04377

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE GAINEY
Printer's No. 889
1
2

Amend Bill, page 1, line 13 (A04380), by inserting after


"for"

academic clinical research centers and for

Amend Bill, page 2, by inserting between lines 48 and 49

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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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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
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 2003. 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

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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.

2015/90DMS/SB0003A04377

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S0003B0889A04378

AJM:CDM 11/19/15

#90

A04378

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE CORBIN
Printer's No. 889
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Amend Bill, page 31, by inserting between lines 28 and 29


(iv) Indications and usage, dosage and
administration.
(v) Dosage forms and strengths.
(vi) Contraindications.
(vii) Warnings and precautions.
(viii) Adverse reactions.
(ix) Drug interactions.
(x) Use in specific populations.
(xi) Drug abuse and dependence.
(xii) Overdosage.
(xiii) Description.
(xiv) Clinical pharmacology.
(xv) Nonclinical toxicology.
(xvi) Clinical studies.
(xvii) References.
(xviii) How supplied.
(xix) Storage and handling.
(xx) Patient counseling information.
Amend Bill, page 31, line 29, by striking out "(iv)" and
inserting
(xxi)

2015/90AJM/SB0003A04378

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S0003B0889A04380

BIL:JSL 11/20/15

#90

A04380

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE MARSICO
Printer's No. 889
1

Amend Bill, page 1, lines 1 through 16; pages 2 and 3, lines

1 through 30; page 4, line 1; by striking out all of said lines

on said pages and inserting

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Establishing a medical marijuana program; providing for patient


and caregiver certification and for medical marijuana
organization registration; imposing duties on the Department
of Health; providing for a tax on medical marijuana
organization gross receipts; establishing the Medical
Marijuana Program Fund; establishing the Medical Marijuana
Advisory Board; establishing a medical marijuana research
program; imposing duties on the Department of Corrections,
the Department of Education and the Department of Human
Services; and providing for penalties and enforcement.
TABLE OF CONTENTS
Chapter 1. Preliminary Provisions
Section 101. Short title.
Section 102. Declaration of policy.
Section 103. Definitions.
Chapter 3. Program
Section 301. Program established.
Section 302. Practitioner registration.
Section 303. Practitioner restrictions.
Chapter 5. Patient and Caregiver Certification
Section 501. Issuance of certification.
Section 502. Certification form.
Section 503. Lawful use of medical marijuana.
Section 504. Unlawful use of medical marijuana.
Section 505. Identification cards.
Section 506. Process for obtaining or renewing an
identification card.
Section 507. Special conditions.
Section 508. Minors.
Section 509. Caregiver authorization and limitations.
Section 510. Contents of identification card.
Section 511. Suspension.
Section 512. Use of prescription drug monitoring program.
Chapter 7. Medical Marijuana Organizations

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Section
Section
Section
Section
Section
Section
Section
Section
Section
Section
Section
Chapter
Section
Section
Chapter
Section
Section
Section
Section
Section
Section
Section
Section
Section
Chapter
Section
Section
Section
Section
Section
Section
Section
Section
Section
Chapter
Section
Section
Section
Section
Section
Section
Section
Section
Chapter
Section
Section

701. Medical marijuana organizations.


702. Laboratory.
703. Dispensing to patients and caregivers.
704. Pricing.
705. Facility requirements.
706. Registration.
707. Limitations on registrations.
708. Application and issuance of registration.
709. Registration renewals.
710. Suspension or revocation of registration.
711. Privilege not property right.
9. Tax on Medical Marijuana
901. Excise tax on medical marijuana.
902. Medical Marijuana Program Fund.
11. Administration
1101. Governing practice and procedure.
1102. Reports by medical marijuana organizations.
1103. Law enforcement notification.
1104. Evaluation.
1105. Report.
1106. Advisory board.
1107. Regulations.
1108. Regulations based on recommendations of board.
1109. Temporary regulations.
13. Offenses Related to Medical Marijuana
1301. Criminal diversion of medical marijuana by
practitioners.
1302. Criminal diversion of medical marijuana by
medical marijuana organizations.
1303. Criminal retention of medical marijuana.
1304. Criminal diversion of medical marijuana by
patient or caregiver.
1305. Falsification of identification cards.
1306. Adulteration of medical marijuana.
1307. Disclosure of information prohibited.
1308. Additional penalties.
1309. Other restrictions.
19. Research Program
1901. Definitions.
1902. Establishment of medical marijuana research
program.
1903. Medical marijuana research program
administration.
1904. Approval.
1905. Requirements.
1906. Restrictions.
1907. Regulations.
1908. Nonentitlement.
21. Miscellaneous Provisions
2101. Conflict.
2102. Insurers.

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Section
Section
Section
Section
Section
Section
Section
Section

2103.
2104.
2105.
2106.
2107.
2108.
2109.
2110.

Protections for patients and caregivers.


Schools.
Day-care centers.
Medical marijuana from other states.
Zoning.
Notice.
Applicability.
Effective date.

Amend Bill, page 4, lines 4 through 30; pages 5 through 68,

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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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"Certified medical use." The acquisition, possession, use or


transportation of medical marijuana by a patient, or the
acquisition, possession, delivery, transportation or
administration of medical marijuana by a caregiver, for use as
part of the treatment of the patient's serious medical
condition, as authorized in a certification under this act,
including enabling the patient to tolerate treatment for the
serious medical condition.
"Certified registered nurse practitioner." As defined in
section 2 of the act of May 22, 1951 (P.L.317, No.69), known as
The Professional Nursing Law.
"Change in control." The acquisition by a person or group of
persons acting in concert of a controlling interest in an
applicant or registrant either all at one time or over the span
of a 12-consecutive-month period.
"Continuing care." Treating a patient, in the course of
which the practitioner has completed a full assessment of the
patient's medical history and current medical condition,
including an in-person consultation with the patient.
"Controlling interest." As follows:
(1) The term shall mean the following:
(i) For a publicly traded entity, voting rights that
entitle a person to elect or appoint one or more of the
members of the board of directors or other governing
board or the ownership or beneficial holding of 5% or
more of the securities of the publicly traded entity.
(ii) For a privately held entity, the ownership of
any security in the entity.
(2) For purposes of this definition, the term "security"
is as defined in section 102(t) of the act of December 5,
1972 (P.L.1280, No.284), known as the Pennsylvania Securities
Act of 1972.
"Department." The Department of Health of the Commonwealth.
"Dispensary." A person, including a natural person,
corporation, partnership, association, trust or other entity, or
any combination thereof, which is registered by the department
to dispense medical marijuana. The term does not include a
health care medical marijuana organization under Chapter 19.
"Family or household member." As defined in 23 Pa.C.S.
6102 (relating to definitions).
"Financial backer." An investor, mortgagee, bondholder, note
holder or other source of equity of an applicant other than a
financial institution.
"Financial institution." A bank, a national banking
association, a bank and trust company, a trust company, a
savings and loan association, a building and loan association, a
mutual savings bank, a credit union or a savings bank.
"Form of medical marijuana." The characteristics of the
medical marijuana recommended or limited for a particular
patient, including the method of consumption and any particular
dosage, strain, variety and quantity or percentage of medical

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marijuana or particular active ingredient.


"Fund." The Medical Marijuana Program Fund established in
section 902.
"Grower/processor." A person, including a natural person,
corporation, partnership, association, trust or other entity, or
any combination thereof, which is registered by the department
under this act to grow and process medical marijuana. The term
does not include a health care medical marijuana organization
under Chapter 19.
"Identification card." A document issued under section 505
that permits access to medical marijuana under this act.
"Individual dose." A single measure of medical marijuana.
"Medical marijuana." Marijuana for medical use as set forth
in this act.
"Medical marijuana organization." A dispensary or a
grower/processor. The term does not include a health care
medical marijuana organization under Chapter 19.
"Patient." An individual who:
(1) has a serious medical condition;
(2) has met the requirements for certification under
this act; and
(3) is a resident of this Commonwealth.
"Physician assistant." As defined in section 2 of the act of
December 20, 1985 (P.L.457, No.112), known as the Medical
Practice Act of 1985, and section 2 of the act of October 5,
1978 (P.L.1109, No.261), known as the Osteopathic Medical
Practice Act.
"Practitioner." A physician who is registered with the
department under section 302.
"Prescription drug monitoring program." The Achieving Better
Care by Monitoring All Prescriptions Program (ABC-MAP).
"Principal." An officer, director or person who directly
owns a beneficial interest in or ownership of the securities of
an applicant or registrant, a person who has a controlling
interest in an applicant or registrant or who has the ability to
elect the majority of the board of directors of an applicant or
registrant or otherwise control an applicant or registrant,
other than a financial institution.
"Registry." The registry established by the department under
section 301(1).
"Secretary." The Secretary of Health of the Commonwealth.
"Serious medical condition." Any of the following:
(1) Cancer.
(2) Positive status for human immunodeficiency virus or
acquired immune deficiency syndrome.
(3) Amyotrophic lateral sclerosis.
(4) Parkinson's disease.
(5) Multiple sclerosis.
(6) Damage to the nervous tissue of the spinal cord with
objective neurological indication of intractable spasticity.
(7) Epilepsy.

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(8) Inflammatory bowel disease.


(9) Neuropathies.
(10) Huntington's disease.
(11) Crohn's disease.
(12) Post-traumatic stress disorder.
(13) Intractable seizures.
(14) Glaucoma.
(15) Severe chronic or intractable pain of neuropathic
origin or severe chronic or intractable pain in which
conventional therapeutic intervention and opiate therapy is
contraindicated or ineffective.
"Terminally ill." A medical prognosis of life expectancy of
approximately one year or less if the illness runs its normal
course.
CHAPTER 3
PROGRAM
Section 301. Program established.
A medical marijuana program for patients suffering from
serious medical conditions is established. The program shall be
administered by the department. The department shall have the
authority to do all things necessary to fulfill its
responsibilities in implementing this act. At minimum, the
department shall:
(1) Establish and maintain a computerized registry
containing information set forth in this act relating to
patients certified to use medical marijuana, caregivers,
practitioners and medical marijuana organizations, which
shall include identification numbers. The computerized
registry shall include a separate, electronic database to be
used by the department and dispensaries and which contains
the information set forth in section 703(a)(1), (2), (3), (4)
and (5) and such additional information that the department
may require by regulation. The registry and database shall be
capable of providing information in real time. Dispensaries
shall have real-time access to information:
(i) To ensure that medical marijuana is not diverted
or otherwise used for unlawful purposes.
(ii) To establish the authenticity of identification
cards.
(iii) To provide the form of medical marijuana
provided in the certification by the practitioner.
(2) Develop and implement procedures for:
(i) Issuance of identification cards to patients and
caregivers.
(ii) Review and approval of certifications submitted
by practitioners.
(iii) Review of the credentials of practitioners who
submit certifications.
(iv) Review and approval of applications for
identification cards.
(v) Review and approval of applications to become

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registered with the department as a medical marijuana


organization.
(vi) Review and approval of applications of
physicians to become registered with the department as
practitioners.
(3) Develop a four-hour course for physicians regarding
the latest scientific research on medical marijuana,
including the risks and benefits of medical marijuana, and
any other subjects deemed necessary by the department. The
State Board of Medicine and the State Board of Osteopathic
Medicine shall approve continuing education credit for any
physician who successfully completes the course. The State
Board of Pharmacy shall approve continuing education credit
for any pharmacist who successfully completes the course
pursuant to the requirement in section 707(9). The State
Board of Nursing shall approve continuing education credit
for a certified registered nurse practitioner who
successfully completes the course pursuant to the requirement
in section 707(9). The State Board of Medicine and the State
Board of Osteopathic Medicine shall approve continuing
education credit for a physician assistant who successfully
completes the course pursuant to the requirement in section
707(9).
(4) Develop a two-hour course for the principals and
employees of a medical marijuana organization who either come
into contact with patients or caregivers or who physically
handle medical marijuana. Employees must successfully
complete the course no later than 90 days after commencing
employment. Principals must successfully complete the course
prior to commencing initial operation of the medical
marijuana organization. The subject matter of the course
shall encompass the following:
(i) Recognizing unauthorized suspected activity
under this act and the regulations promulgated by the
department, including criminal diversion of medical
marijuana and falsification of identification cards.
(ii) Proper handling of medical marijuana and
recordkeeping.
(iii) Proper reporting of suspected unauthorized
activity, including activities under subparagraph (i), to
law enforcement.
(iv) Any other subject necessary to ensure
compliance with this act and regulations promulgated
under this act, as determined by the department.
(5) Develop a procedure for announced and unannounced
inspections by the department of the facilities for growing,
processing or dispensing or selling medical marijuana, and of
the books, papers and tracking and other systems utilized by
medical marijuana organizations required by this act.
(6) Establish a manner and method to administer research
studies to be operated by vertically integrated health

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systems in order to collect research data on the use of


medical marijuana to treat serious medical conditions in
accordance with Chapter 19.
(7) Establish and maintain public outreach efforts about
this act. The efforts shall include:
(i) A dedicated telephone number regarding medical
marijuana so that patients, caregivers and members of the
public may call to obtain basic information about the
dispensing of medical marijuana under this act.
(ii) A publicly accessible Internet website with
similar information.
(8) Collaborate as necessary, as determined by the
secretary, with other Commonwealth agencies or to contract
with third parties to assist the department in fulfilling its
responsibilities under this act.
(9) Determine the minimum number and type of medical
marijuana to be produced by a grower/processor and dispensed
by a dispensary.
Section 302. Practitioner registration.
(a) Eligibility.--A physician who satisfies the following is
eligible for inclusion in the registry:
(1) The physician applies for registration in the form
and manner required by the department.
(2) The department determines that the physician is, by
training or experience, qualified to treat a serious medical
condition. The physician shall provide documentation of
required credentials, training or experience as required by
the department.
(3) The physician has successfully completed the course
under section 301(3).
(b) Department action.--The department shall review an
application submitted by a physician to determine whether to
include the physician in the registry. The review shall include
information maintained by the Department of State regarding
whether the physician has a valid, unexpired, unrevoked,
unsuspended Pennsylvania license to practice medicine and
whether the physician has been subject to discipline. The review
shall be conducted each time the department reviews
certifications under section 501. If the physician is not the
holder of a valid, unexpired, unrevoked, unsuspended
Pennsylvania license to practice medicine, then the department
shall deny the certification and shall remove the physician from
the registry until such time as the physician holds a valid,
unexpired, unrevoked, unsuspended Pennsylvania license to
practice medicine. A physician who is listed in the registry is
authorized to issue a certification to use medical marijuana.
(c) Practitioner requirements.--A practitioner shall have an
ongoing responsibility, so long as the practitioner remains in
the registry, to immediately notify the department in writing if
the practitioner knows or has reason to know that any of the
following is true with respect to a patient for whom the

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practitioner has issued a certification under this act:


(1) The patient no longer has the serious medical
condition for which the certification was issued.
(2) Medical marijuana would no longer be therapeutic or
palliative.
(3) The patient has died.
Section 303. Practitioner restrictions.
(a) Practices prohibited.--The following apply with respect
to practitioners:
(1) A practitioner may not accept, solicit or offer any
form of remuneration from or to a prospective patient,
patient, prospective caregiver, caregiver or medical
marijuana organization, including an employee, financial
backer or principal, to certify a patient, other than
accepting a fee for service with respect to the examination
of the prospective patient to determine if the prospective
patient should be issued a certification to use medical
marijuana.
(2) A practitioner may not hold a direct or economic
interest in a medical marijuana organization.
(3) A practitioner may not advertise the practitioner's
services as a practitioner who can certify a patient to
receive medical marijuana.
(b) Unprofessional conduct.--A practitioner who violates
subsection (a)(1), (2) or (3) or section 501(f) shall not be
permitted to issue certifications to patients. The practitioner
shall be removed from the registry.
(c) Discipline.--In addition to any other penalty that may
be imposed under this act, a violation of subsection (a)(1), (2)
or (3) or section 501(f) shall be deemed unprofessional conduct
under section 41(8) of the act of December 20, 1985 (P.L.457,
No.112), known as the Medical Practice Act of 1985, or section
15(a)(8) of the act of October 5, 1978 (P.L.1109, No.261), known
as the Osteopathic Medical Practice Act, and shall subject the
practitioner to discipline by the State Board of Medicine or the
State Board of Osteopathic Medicine, as appropriate.
CHAPTER 5
PATIENT AND CAREGIVER CERTIFICATION
Section 501. Issuance of certification.
(a) Conditions for issuance.--A certification to use medical
marijuana may be issued by a practitioner to a patient if all of
the following requirements are met:
(1) The practitioner is authorized, as evidenced by the
practitioner's inclusion in the registry, to issue a
certification.
(2) The patient has a serious medical condition, which
is specified in the patient's health care record.
(3) The practitioner by training or experience is
qualified to treat the patient's serious medical condition.
(4) The patient is under the practitioner's continuing
care for the serious medical condition.

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(5) In the practitioner's professional opinion and


review of past treatments, the practitioner determines the
patient is likely to receive therapeutic or palliative
benefit from the use of medical marijuana.
(b) Contents.--In addition to the information set forth in
subsection (a), the certification shall include:
(1) The name, date of birth and address of the patient.
(2) The specific serious medical condition of the
patient.
(3) A statement by the practitioner that the patient has
a serious medical condition and the patient is under the
practitioner's continuing care for the serious medical
condition.
(4) The date of issuance.
(5) The name, address, telephone number and signature of
the practitioner.
(6) Any requirement or limitation concerning the
appropriate form of medical marijuana.
(7) Information needed for the research program database
under section 1902(b)(2) as determined by the department.
(c) Optional information.--The practitioner may state in the
certification that, in the practitioner's professional opinion:
(1) The patient would benefit from medical marijuana
only until a specified date.
(2) The patient is terminally ill.
(d) Consultation.--A practitioner shall consult the
prescription drug monitoring program prior to issuing or
modifying a certification for the purpose of reviewing the
controlled substance history of a patient.
(e) Duties of practitioner.--The practitioner shall:
(1) Provide the certification to the patient.
(2) Provide a copy of the certification to the
department, which shall place the information in the
registry. The department shall permit electronic submission
of the certification.
(3) File a copy of the certification in the patient's
health care record.
(f) Prohibition.--A practitioner may not issue a
certification for the practitioner's own use or for the use of a
family or household member.
Section 502. Certification form.
The department shall develop a standard certification form,
which shall be available upon request. In addition, the form
shall be available to practitioners electronically. The form
shall include a statement that a false statement made by a
practitioner is punishable under the applicable provisions of 18
Pa.C.S. Ch. 49 (relating to falsification and intimidation).
Section 503. Lawful use of medical marijuana.
(a) General rule.--Notwithstanding any provision of law to
the contrary, certified medical use of medical marijuana as set
forth in this act and regulations promulgated under this act is

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lawful within this Commonwealth.


(b) Limitations.--The lawful use of medical marijuana is
subject to the following limitations:
(1) Medical marijuana may only be administered to a
patient who is certified by a practitioner.
(2) Subject to regulations promulgated under section
1108(3), medical marijuana may only be dispensed to a patient
or caregiver in the following forms:
(i) pill;
(ii) oil;
(iii) topical forms, including gel, creams or
ointments;
(iv) a form medically appropriate for administration
by vaporization or nebulization.
(v) tincture; or
(vi) liquid.
(3) In accordance with section 1108, medical marijuana
may be dispensed to a patient or a caregiver in dry leaf or
plant form.
(4) Subject to section 1108, no individual dose of
medical marijuana may contain more than 10%
tetrahydrocannabinol.
(5) For each patient, possession of medical marijuana by
a patient and a caregiver may not exceed a 30-day supply of
individual doses, consistent with any regulations of the
department, except that, during the last seven days of any
30-day period, a patient may also possess a 30-day supply for
the subsequent 30-day period.
(6) An individual may not act as a caregiver for more
than five patients.
(7) A patient may designate up to two caregivers at any
one time.
(8) The form of medical marijuana that may be possessed
by a patient or caregiver under a certification shall be in
compliance with any requirement or limitation of the
practitioner.
(9) The medical marijuana shall be kept in the original
package in which it was dispensed, except for the portion
removed for immediate use by the patient.
(10) A patient or caregiver shall possess an
identification card whenever the patient or caregiver is in
immediate possession of medical marijuana.
(11) With respect to the packaging of medical marijuana
by growers/processors and dispensing of medical marijuana by
dispensaries, the medical marijuana shall only be identified
by the name of the grower/processor, the name of the
dispensary, the species and the percentage of
tetrahydrocannabinol and cannabidiol.
Section 504. Unlawful use of medical marijuana.
(a) General rule.--Notwithstanding section 503, the use of
medical marijuana as set forth in this section is unlawful and

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shall, in addition to any other penalty provided by law, be


deemed a violation of the act of April 14, 1972 (P.L.233,
No.64), known as The Controlled Substance, Drug, Device and
Cosmetic Act.
(b) Unlawful use described.--Regardless of the form of
medical marijuana stated in the patient's certification, it is
unlawful to:
(1) Smoke medical marijuana.
(2) Incorporate medical marijuana into edible form.
Nothing in this act shall be construed to preclude the
incorporation of medical marijuana into edible form by a
patient or a caregiver in order to aid ingestion of the
medical marijuana by the patient.
(3) Grow medical marijuana unless registered as a
grower/processor or health care medical marijuana
organization under Chapter 19 and acting in compliance with
this act.
Section 505. Identification cards.
(a) Issuance.--Upon review and approval of the certification
issued to a patient by a practitioner, satisfactory review of a
practitioner's medical credentials, satisfactory review of the
prescription drug monitoring program in the case of a caregiver
and satisfactory review of the Federal and Commonwealth criminal
history record information in the case of a caregiver, the
department shall issue an identification card to a patient or
caregiver. The identification card shall permit a patient or
caregiver to access medical marijuana in accordance with this
act.
(b) Expiration.--An identification card shall expire within
one year from the date of issuance, upon the death of the
patient, or as otherwise provided in this section. The
department shall specify the form of application for an
identification card. The department shall provide the form upon
request, and the form shall be available electronically via the
department's publicly accessible Internet website.
(c) Separate cards to be issued.--The department shall issue
separate identification cards for patients and caregivers as
soon as reasonably practicable after receiving a completed
application, unless it determines that the application is
incomplete or factually inaccurate, in which case it shall
promptly notify the applicant.
(d) Change in name or address.--A patient or caregiver who
has been issued an identification card shall notify the
department within 10 days of any change of name or address. In
addition, with respect to the patient, the patient shall notify
the department within 10 days if the patient no longer has the
serious medical condition noted on the certification.
(e) Lost or defaced card.--In the event of a lost, stolen,
destroyed or illegible identification card, the patient or
caregiver shall apply to the department within 10 business days
of discovery of the loss or defacement of the card for a

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replacement card. The application for a replacement card shall


be on a form furnished by the department and accompanied by a
$25 fee. The department may establish higher fees for issuance
of second and subsequent replacement identification cards. The
department may waive or reduce the fee in cases of demonstrated
financial hardship. The department shall issue a replacement
identification card as soon as practicable. The card may contain
a different identification number. A patient or caregiver may
not obtain medical marijuana until the patient receives the
replacement card.
(f) Information to be kept confidential.--The department
shall maintain a confidential list of patients and caregivers to
whom it has issued identification cards. Individual identifying
information obtained by the department, including information
provided by the Pennsylvania State Police pursuant to section
506(b), under this act shall be confidential and exempt from
disclosure, including disclosure under the act of February 14,
2008 (P.L.6, No.3), known as the Right-to-Know Law.
Section 506. Process for obtaining or renewing an
identification card.
(a) Requirements.--The following apply:
(1) To obtain, amend or renew an identification card, a
patient or caregiver shall file an application with the
department.
(2) In the case of a patient, the application shall
include the following:
(i) The patient's certification. A new certification
must be provided with a renewal application.
(ii) The name, address and date of birth of the
patient.
(iii) The date of the certification.
(iv) If the patient has an identification card based
on a current valid certification, the identification
number and expiration date of that identification card.
(v) The specified date until which the patient would
benefit from medical marijuana, if the certification
states such a date.
(vi) The name, address and telephone number of the
certifying practitioner.
(vii) Other information required by the department.
(3) If the patient designates a caregiver, the
application shall include the name, address and date of birth
of the caregiver, and other individual identifying
information required by the department.
(4) In the case of a caregiver, the application shall
include the following:
(i) Federal and Commonwealth criminal history record
information as set forth in subsection (b).
(ii) The name, address and date of birth of the
caregiver.
(iii) If the caregiver has an identification card,

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the identification number and expiration date of the


identification card.
(iv) Other information required by the department.
(5) The application shall be signed and dated by the
patient or caregiver, as appropriate.
(6) The application shall be accompanied by a fee of
$50. The department may waive or reduce the fee in cases of
demonstrated financial hardship.
(7) The department may prescribe any other requirements
for the application.
(b) Requirement.--The following apply:
(1) In each case before approving the application to be
a caregiver, the department shall review the applicant's
Federal and Commonwealth criminal history record information
and the prescription drug monitoring program with respect to
the caregiver to determine if the caregiver has a history of
drug abuse or a history of diversion of controlled substances
or illegal drugs. The department may, within its discretion,
deny an application to become a caregiver if the applicant
has a history of drug abuse or a history of diverting
controlled substances or illegal drugs. The department shall
deny the application to be a caregiver if the applicant has
been convicted of any criminal offense related to sale or
possession of drugs, narcotics or other controlled
substances.
(2) Notwithstanding any provision of law to the contrary
and in order to fulfill the requirements of this subsection,
the Pennsylvania State Police shall, at the request of the
department, provide criminal history background
investigations, which shall include records of criminal
arrests and convictions, no matter where occurring, including
Federal criminal history record information, on applicants
for the position of caregiver. For purposes of approving
applicants to become caregivers, the department shall request
the information set forth in this paragraph for each
applicant who seeks to become a caregiver. The department may
receive and retain information otherwise protected by 18
Pa.C.S. Ch. 91 (relating to criminal history record
information).
(c) Notice.--An application for an identification card shall
include notice that a false statement made in the application is
punishable under the applicable provisions of 18 Pa.C.S. Ch. 49
(relating to falsification and intimidation).
Section 507. Special conditions.
The following apply:
(1) If the practitioner states in the certification
that, in the practitioner's professional opinion, the patient
would benefit from medical marijuana only until a specified
earlier date, then the identification card shall expire on
that date.
(2) If the practitioner reissues a certification which

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terminates a certification on an earlier date, then a


replacement identification card shall be issued with the
earlier expiration date. The original identification card
shall be promptly returned by the patient to the department.
(3) If the certification so provides, the identification
card shall state any requirement or limitation by the
practitioner as to the form of medical marijuana for the
patient.
Section 508. Minors.
If a patient is under 18 years of age, the following apply:
(1) The patient shall have a caregiver.
(2) A caregiver must be one of the following:
(i) A parent or legal guardian of the patient.
(ii) An individual designated by a parent or legal
guardian.
(iii) An appropriate individual approved by the
department upon a sufficient showing that no parent or
legal guardian is appropriate or available.
Section 509. Caregiver authorization and limitations.
(a) Age.--An individual who is under 21 years of age may not
be a caregiver unless a sufficient showing, as determined by the
department, is made to the department that the individual should
be permitted to serve as a caregiver.
(b) Changing caregiver.--If a patient wishes to change or
terminate the designation of the patient's caregiver, for
whatever reason, the patient shall notify the department as soon
as practicable. The department shall issue a notification to the
caregiver that the caregiver's identification card is invalid
and must be promptly returned to the department.
(c) Denial in part.--If an application of a patient
designates an individual as a caregiver who is not authorized to
be a caregiver, that portion of the application shall be denied
by the department. The department shall review the balance of
the application and may approve that portion of it.
Section 510. Contents of identification card.
An identification card shall contain the following:
(1) The name of the patient and the caregiver, as
appropriate. The identification card shall also state whether
the individual is designated as a patient or as a caregiver.
(2) The date of issuance and expiration date.
(3) An identification number for the patient and
caregiver, as appropriate.
(4) A photograph of the individual to whom the
identification card is being issued, whether the individual
is a patient or a caregiver. The method of obtaining the
photograph shall be specified by the department by
regulation. The department shall provide reasonable
accommodation for a patient who is confined to the patient's
home or is in inpatient care due to a serious medical
condition.
(5) Any requirement or limitation set by the

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practitioner as to the form of medical marijuana.


(6) Any other requirements determined by the department,
except the department may not require that an identification
card disclose the patient's serious medical condition.
Section 511. Suspension.
If a patient or caregiver intentionally, knowingly or
recklessly violates any provision of this act as determined by
the department, the identification card of the patient or
caregiver may be suspended or revoked. The suspension or
revocation shall be in addition to any criminal or other penalty
that may apply.
Section 512. Use of prescription drug monitoring program.
(a) Requirement.--A practitioner shall consult the
prescription drug monitoring program each time prior to
authorizing the use of medical marijuana for a patient and each
time prior to changing the form of medical marijuana for a
patient.
(b) Other access by practitioner.--A practitioner may access
the prescription drug monitoring program to:
(1) Determine whether a patient may be under treatment
with a controlled substance by another physician or other
person.
(2) Allow the practitioner to review the patient's
controlled substance history as deemed necessary by the
practitioner.
(3) Provide to the patient, or caregiver on behalf of
the patient if authorized by the patient, a copy of the
patient's controlled substance history.
CHAPTER 7
MEDICAL MARIJUANA ORGANIZATIONS
Section 701. Medical marijuana organizations.
The growing, acquiring, possessing, manufacturing, selling,
delivering, transporting, distributing or dispensing of medical
marijuana by a medical marijuana organization under this act and
in accordance with regulations promulgated by the department
under this act shall be lawful.
Section 702. Laboratory.
A grower/processor shall contract with an independent
laboratory to test the medical marijuana produced by the
grower/processor. The department shall approve the laboratory
and require that the laboratory report testing results in a
manner as the department shall determine, including requiring a
test at harvest and a test at final processing.
Section 703. Dispensing to patients and caregivers.
(a) General rule.--A dispensary may dispense medical
marijuana to a patient or caregiver upon presentation to the
dispensary of a valid identification card for that patient or
caregiver. The dispensary shall provide to the patient or
caregiver a receipt, as appropriate. The receipt shall include
all of the following:
(1) The name, address and identification number of the

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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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the act of December 17, 1968 (P.L.1224, No.387), known as the


Unfair Trade Practices and Consumer Protection Law.
(2) The department shall set the maximum per-dose price
of each form of medical marijuana dispensed by a dispensary.
In setting the maximum per-dose price, the department shall
consider the fixed and variable costs of producing the form
of medical marijuana and any other factor the department
deems relevant to determine the maximum per-dose price.
(3) The department may set the maximum per-dose price of
each form of medical marijuana sold by a grower/processor to
a dispensary.
(4) A grower/processor shall make medical marijuana
available for sale to all dispensaries at the same per-dose
price.
(5) If a grower/processor changes the per-dose price on
any sale of any form of medical marijuana to a dispensary,
the grower/processor shall change the per-dose price for that
form of medical marijuana for all other dispensaries by the
same amount.
Section 705. Facility requirements.
(a) General rule.--The following apply:
(1) A grower/processor may only grow or process medical
marijuana in an indoor, enclosed, secure facility located
within this Commonwealth, as determined by the department.
The facility may include a greenhouse.
(2) A dispensary may only dispense medical marijuana in
an indoor, enclosed, secure facility located within this
Commonwealth, as determined by the department.
(3) A dispensary may not operate on the same site as a
facility used for growing and processing medical marijuana.
(b) Determination.--A grower/processor shall provide
documentation of the quality and safety of the medical marijuana
produced by the grower/processor to the department and to any
patient or caregiver to which the medical marijuana is
dispensed. The documentation shall include the test results
under section 702.
Section 706. Registration.
(a) Registration required.--Upon application, the department
may register the person as:
(1) Both a grower/processor and a dispensary or solely
as a grower/processor.
(2) Both a dispensary and a grower/processor or solely
as a dispensary.
(b) Separate registration.--Separate registration is
required for a grower/processor and for a dispensary, including
when:
(1) A dispensary is registered as a grower/processor.
(2) A grower/processor is registered as a dispensary.
(c) Records.--A grower/processor which is also registered as
a dispensary shall keep separate books and records.
(d) Department to establish regions.--The department shall

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establish no fewer than three regions within this Commonwealth


for the purpose of registering growers/processors and
dispensaries and providing for their locations. The department
shall implement this subsection in a manner which will supply an
adequate amount of medical marijuana to patients and caregivers
in each region. In determining the geographic boundaries of the
regions, the department shall consider the following:
(1) Population.
(2) The number of patients suffering from serious
medical conditions.
(3) The types of serious medical conditions.
(4) Access to public transportation.
(5) Any other factor the department deems relevant.
(e) Notice.--When the boundaries are established, the
department shall publish notice of the determination in the
Pennsylvania Bulletin. The department may adjust the boundaries
as necessary every two years. Notice of any adjustment to the
boundaries shall be published in the Pennsylvania Bulletin.
Section 707. Limitations on registrations.
The following limitations apply to registration of
grower/processors and dispensaries:
(1) The department may not initially register more than
25 growers/processors.
(2) The department may not initially register more than
50 dispensaries. Each dispensary may provide medical
marijuana at no more than three separate locations.
(3) The department may not permit a single person to
hold more than five individual dispensary registrations.
(4) The department may not permit a single person to
hold more than one grower/processor registration.
(5) No more than five grower/processors may be
registered as dispensaries. If the number of
growers/processors is increased pursuant to section 1108(4),
no more than 20% of the total number of growers/processors
may also be registered as dispensaries.
(6) A dispensary may only obtain medical marijuana from
a grower/processor holding a valid registration under this
act.
(7) A grower/processor may only provide medical
marijuana to a dispensary holding a valid registration under
this act.
(8) No marijuana may be dispensed from, obtained from or
transferred to a location outside of this Commonwealth.
(9) A dispensary shall have a physician or a pharmacist
onsite at all times during the hours the dispensary is open
to receive patients and caregivers, except that if a
dispensary has more than one separate location, a physician
assistant or a certified registered nurse practitioner may be
onsite at the other location. A physician, a pharmacist, a
physician assistant or a certified registered nurse
practitioner shall, prior to assuming duties under this

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paragraph, successfully complete the course established in


section 301(3). A physician may not certify patients to
receive medical marijuana or otherwise treat patients at the
dispensary.
(10) A dispensary may sell medical devices and
instruments which are needed to administer medical marijuana
under this act.
Section 708. Application and issuance of registration.
(a) Application for initial registration.--The department
shall register organizations which grow and process or dispense
medical marijuana. The department shall develop a standard
application form, which shall be available upon request. The
department shall provide the application in electronic form,
which shall be available on the department's publicly accessible
Internet website.
(b) Contents of application.--An applicant shall provide the
following information:
(1) A description of the business activities in which
the applicant intends to engage as a medical marijuana
organization.
(2) A statement that the applicant:
(i) Is of good moral character. The applicant shall
submit Federal and Commonwealth criminal history record
information in order to support the assertion of good
moral character. For purposes of this subparagraph an
applicant shall include each financial backer and
principal of the medical marijuana organization.
(ii) Possesses or has the right to use sufficient
land, buildings and other premises and equipment to
properly carry on the activity described in the
application. The information shall be specified in the
application in sufficient detail to allow the department
to verify the information.
(iii) Is able to maintain effective security and
control to prevent diversion, abuse and other illegal
conduct relating to medical marijuana. The statement
shall include a provision which states that in the event
of any loss or theft of medical marijuana the medical
marijuana organization shall notify the Pennsylvania
State Police within 24 hours.
(iv) Is able to comply with all applicable
Commonwealth laws and regulations relating to the
activities in which it intends to engage under the
registration.
(3) The name, address and title of each financial backer
and principal of the applicant. Residential addresses shall
be included for individuals. Each individual or
representative of an entity shall submit an affidavit with
the application setting forth:
(i) Any position of management or ownership during
the preceding 10 years of a controlling interest in any

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other business, located inside or outside this


Commonwealth, manufacturing or distributing controlled
substances.
(ii) Whether the individual or entity has been
convicted of a criminal offense graded higher than a
summary offense.
(iii) Whether the individual or entity has had a
registration or license suspended or revoked in any
administrative or judicial proceeding.
(iv) Any other information the department may
require.
(c) Notice.--The application shall include notice that a
false statement made in the application is punishable under the
applicable provisions of 18 Pa.C.S. Ch. 49 (relating to
falsification and intimidation).
(d) Duty to report.--The applicant is under a continuing
duty to:
(1) Report to the department any change in facts or
circumstances reflected in the application or any newly
discovered or occurring fact or circumstance which is
required to be included in the application, including a
change in control of the medical marijuana organization.
(2) Report to the Pennsylvania State Police, within 24
hours, any loss or theft of medical marijuana from the
facility the applicant is operating.
(3) Submit to inspections, whether announced or
unannounced, by the department of the facilities for growing,
processing, dispensing or selling medical marijuana, or of
the books, papers and tracking or other systems required by
this act.
(e) Granting of registration.--The department shall grant a
registration or amendment to a registration under this section
if the department is satisfied that:
(1) The applicant will be able to maintain effective
control against diversion of medical marijuana.
(2) The applicant will be able to comply with all
applicable laws and regulations of this Commonwealth relating
to the activities in which it intends to engage under the
registration.
(3) The applicant is ready, willing and able to properly
carry on the activity for which a registration is sought.
(4) The applicant possesses or has the right to use
sufficient land, buildings and equipment to properly carry on
the activity described in the application.
(5) It is in the public interest that the registration
be granted. In determining whether the granting of
registration is in the public interest, the department shall
consider whether the number of medical marijuana
organizations in an area will be adequate or excessive.
(6) The applicant and its principals and financial
backers are of good moral character.

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(7) The applicant satisfies any other conditions as


determined by the department.
(f) Additional information.--If the department is not
satisfied that the applicant should be issued a registration,
the department shall notify the applicant in writing of the
factors for which further documentation is required. Within 30
days of the receipt of the notification, the applicant may
submit additional material to the department for consideration.
(g) Fees.--The following apply:
(1) For a grower/processor:
(i) An initial application fee in the amount of
$10,000 shall be paid. The fee is nonrefundable.
(ii) A fee for registration as a grower/processor in
the amount of $200,000 shall be paid. The period of
registration is one year. Applicants shall submit the
registration fee at the time of submission of the
application. The fee shall be returned if the
registration is not granted.
(iii) A renewal fee for registration as a
grower/processor in the amount of $10,000 shall be paid.
The renewal fee shall be returned if the renewal is not
granted.
(iv) Before the granting of the initial
registration, the department shall verify that the
applicant has $2,000,000 in capital, $500,000 of which
must be on deposit with a financial institution.
(v) An application to renew registration shall be
filed with the department not more than six months nor
less than four months prior to expiration.
(vi) All fees shall be paid by certified check or
money order.
(2) For a dispensary:
(i) An initial application fee in the amount of
$5,000 shall be paid. The fee is nonrefundable.
(ii) A fee for registration as a dispensary in the
amount of $30,000 shall be paid. The period of
registration is one year. An applicant shall submit the
registration fee at the time of submission of the
application. The fee shall be returned if the application
is not granted.
(iii) A renewal fee for registration as a dispensary
in the amount of $5,000 shall be paid. The fee shall be
returned if the renewal is not granted.
(iv) There shall be no additional fee for operating
more than one location.
(v) Before the granting of the initial registration,
the department shall verify that the applicant has
$150,000 in capital, which must be on deposit with a
financial institution.
(vi) An application to renew registration shall be
filed with the department not more than six months nor

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less than four months prior to expiration.


(vii) All fees shall be paid by certified check or
money order.
(3) A fee of $250 shall be required when amending the
application to indicate relocation within this Commonwealth
or the addition or deletion of approved activities by the
medical marijuana organization.
(4) Fees payable under this section shall be deposited
into the fund.
(h) Issuance.--A registration issued by the department to a
medical marijuana organization shall be effective only for that
organization and shall specify the following:
(1) The name and address of the medical marijuana
organization.
(2) The land, buildings and facilities that may be used
by the medical marijuana organization.
(3) Any other information the department requires to
assure compliance with this act.
(i) Relocation.--The department may approve an application
from a medical marijuana organization to relocate within this
Commonwealth or to add or delete activities or facilities. The
medical marijuana organization may not relocate or add or delete
activities or facilities unless approved by the department.
(j) Length of registration.--A registration issued by the
department shall be valid for one year from the date of
issuance, except that in order to facilitate registration
renewals, the department may, upon an initial application for
registration, issue registrations that are valid for not more
than one year and eleven months.
(k) Posting.--A dispensary shall post a copy of its
registration in a location within its facility such that it is
easily observable by patients, caregivers, law enforcement
officers and agents of the department.
Section 709. Registration renewals.
(a) The following apply to a renewal of registration:
(1) An applicant is under a continuing duty to report to
the department any change in facts or circumstances reflected
in the application or any newly discovered or occurring fact
or circumstance which is required to be included in the
application.
(2) The application shall include the following
information, prepared in the manner and detail as the
department may require:
(i) Any material change in the information provided
by the medical marijuana organization in an application
or renewal of registration.
(ii) Every known charge or initiated investigation,
pending or concluded during the period of the
registration, by any governmental or administrative
agency with respect to:
(A) each incident or alleged incident involving

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the theft, loss or possible diversion of medical


marijuana grown, processed or dispensed by the
applicant; and
(B) compliance by the applicant with the laws of
this Commonwealth with respect to any substance
listed in section 4 of the act of April 14, 1972
(P.L.233, No.64), known as The Controlled Substance,
Drug, Device and Cosmetic Act.
(b) Granting of renewal.--The department shall renew a
registration unless the department determines that:
(1) The applicant is unlikely to maintain or be able to
maintain effective control against diversion of medical
marijuana.
(2) The applicant is unlikely to comply with all laws of
this Commonwealth applicable to the activities in which it
may engage under the registration.
(c) Nonrenewal decision.--If the department is not satisfied
that the applicant is entitled to a renewal of the registration,
the department shall within a reasonable time serve upon the
applicant or the applicant's attorney of record by registered or
certified mail an order directing the applicant to show cause
why the application for renewal should not be denied. The order
shall specify in detail the way in which the applicant has not
satisfied the department's requirement for renewal. Within 30
days of the order, the applicant may submit additional material
to the department or demand a hearing, or both. If a hearing is
demanded, the department shall fix a date as soon as
practicable.
Section 710. Suspension or revocation of registration.
The department may suspend or revoke registration as a
medical marijuana organization if:
(1) The department has evidence that a medical marijuana
organization has failed to maintain effective control against
diversion of medical marijuana.
(2) The organization violates any provision of this act
or a regulation of the department.
(3) The organization has intentionally, knowingly,
recklessly or negligently failed to comply with applicable
laws of this Commonwealth relating to the activities in which
it engages under the registration.
Section 711. Privilege not property right.
Registration of a medical marijuana organization gives a
medical marijuana organization a privilege to engage in the
specified activity, but registration does not give a property
right.
CHAPTER 9
TAX ON MEDICAL MARIJUANA
Section 901. Tax on medical marijuana.
(a) Tax imposed.--A tax is imposed on the gross receipts of
a grower/processor received from the sale of medical marijuana
by a grower/processor to a dispensary, to be paid by the

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grower/processor, at the rate of 5%. The tax shall be charged


against and be paid by the grower/processor and shall not be
added as a separate charge or line item on any sales slip,
invoice, receipt or other statement or memorandum of the price
paid by a dispensary, patient or caregiver.
(b) Payment of tax and reports.--The tax imposed under
subsection (a) shall be administered in the same manner as the
tax imposed under Article XI of the act of March 4, 1971 (P.L.6,
No.2), known as the Tax Reform Code of 1971, except that
estimated tax payments under section 3003.2 of the Tax Reform
Code of 1971 shall not be required. A grower/processor shall
make quarterly payments under this section for each calendar
quarter at the rate prescribed in subsection (a) on the gross
receipts for the calendar quarter. The tax shall be due and
payable on the 20th day of January, April, July and October for
the preceding calendar quarter on a form prescribed by the
Department of Revenue.
(c) (Reserved).
(d) Deposit of proceeds.--All money received from the tax
imposed under subsection (a) shall be deposited in the fund.
(e) Exemption.--Medical marijuana shall not be subject to
the tax imposed under section 202 of the Tax Reform Code of
1971.
(f) Information.--A grower/processor that sells medical
marijuana shall provide to the Department of Revenue information
required by the department.
Section 902. Medical Marijuana Program Fund.
(a) Fund established.--The Medical Marijuana Program Fund is
established as a special fund in the State Treasury. Money in
the fund is appropriated as set forth in subsection (c). Any
amount unspent at the end of a fiscal year shall be appropriated
to the department for its operations.
(b) Source of funds.--Fees and taxes payable under this act
shall be deposited into the fund. The money deposited into the
fund may only be used for the purposes set forth in this
section. Any interest accrued shall be deposited into the fund.
(c) Use of proceeds.--After any repayment made under
subsection (d), money in the fund is appropriated in accordance
with the following percentages:
(1) To the department, for operations of the department,
including outreach efforts under section 301(7), as required
by this act, 45% of the revenue in the fund. However, no more
than 15% of the amount under this paragraph may be expended
for:
(i) the cost of providing medical marijuana to
patients participating in the research program under
Chapter 19;
(ii) the cost of providing medical marijuana to
patients who demonstrate financial hardship under this
act; and
(iii) the cost associated with the waiver of fees

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for identification cards under sections 505 (e) and


506(a)(6).
(2) To the Department of Drug and Alcohol Programs, for
drug abuse prevention and counseling and treatment services,
10% of the revenue in the fund.
(3) To the department, for further research related to
the safety and use of medical marijuana, including the
research program established under Chapter 19, 30% of the
revenue in the fund. Funding shall be provided for research
into the treatment of those serious medical conditions for
which medical marijuana is available for treatment within
this Commonwealth and for research into the use of medical
marijuana to treat other medical conditions for which medical
marijuana may have legitimate medicinal value.
(4) To the Pennsylvania Commission on Crime and
Delinquency, for distribution to local police departments
which demonstrate a need relating to the enforcement of this
act, as determined by the Pennsylvania Commission on Crime
and Delinquency, 10% of the revenue in the fund.
(5) To the Pennsylvania State Police to fulfill its
duties under this act, 5% of the revenue in the fund.
(d) Repayment of initial appropriation.--The department
shall repay from the fees, taxes and investment earnings of the
fund to the General Fund any money appropriated for the initial
planning, organization and administration by the department with
respect to the establishment of the program at the time of the
original enactment of this act. Repayment shall take place
within a 10-year period commencing one year after the date of
publication in the Pennsylvania Bulletin of the final
regulations described under section 1107.
CHAPTER 11
ADMINISTRATION
Section 1101. Governing practice and procedure.
The department's consideration and resolution of all
applications for registration under Chapter 7, the resolution of
applications for identification cards, the finding of violations
by the department and the imposition of civil penalties and
sanctions shall be conducted in accordance with 2 Pa.C.S.
(relating to administrative law and procedure).
Section 1102. Reports by medical marijuana organizations.
(a) Report required.--A medical marijuana organization shall
periodically file reports related to its activities. The
department shall determine the information required in and the
frequency of filing the reports.
(b) Tracking systems.--Each medical marijuana organization
shall adopt and maintain security, tracking, recordkeeping,
record retention and surveillance systems relating to every
stage of acquiring, possessing, growing, manufacturing, selling,
delivering, transporting, distributing or dispensing medical
marijuana. The department shall specify the type and manner of
security, tracking, recordkeeping, record retention and

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surveillance system required through regulation.


(c) Additional tracking and recall systems.--In addition to
other systems required by subsection (b), the department shall
require that a grower/processor or dispenser implement the
following:
(1) For a grower/processor and a dispensary, real time
inventory tracking.
(2) For a grower/processor, a seed-to-sale tracking
system that tracks medical marijuana from seed or immature
plant stage until the medical marijuana is sold to a
dispensary.
(3) For a dispensary, a system that tracks medical
marijuana from purchase from the grower/processor until the
medical marijuana is dispensed to a patient or caregiver.
(4) For a grower/processor and a dispensary, a daily log
of each day's beginning inventory, acquisitions, sales,
disbursements, disposals and ending inventory.
(5) For a grower/processor and a dispensary, a system
for recall of defective medical marijuana.
(6) For a grower/processor, a system to track the plant
waste resulting from the growth or processing of medical
marijuana.
Section 1103. Law enforcement notification.
Notwithstanding any law to the contrary, the department may
notify any appropriate law enforcement agency of information
relating to any violation or suspected violation of this act.
In addition, the department shall verify to law enforcement
personnel in an appropriate case whether a certification,
registration or an identification card is valid.
Section 1104. Evaluation.
The department may provide for an analysis and evaluation of
the implementation and effectiveness of this act, including
whether the intent and stated policy of the General Assembly
have been achieved. The department may enter into agreements
with one or more persons for the performance of an evaluation of
the implementation and effectiveness of this act.
Section 1105. Report.
(a) Report required.--The department shall submit a written
report under subsection (b) every two years, beginning two years
after the effective date of this section, to the following:
(1) The Governor.
(2) The President pro tempore of the Senate.
(3) The Majority Leader and the Minority Leader of the
Senate.
(4) The Speaker of the House of Representatives.
(5) The Majority Leader and the Minority Leader of the
House of Representatives.
(6) The chairman and minority chairman of the Judiciary
Committee of the Senate.
(7) The chairman and minority chairman of the Public
Health and Welfare Committee of the Senate.

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(8) The chairman and minority chairman of the Judiciary


Committee of the House of Representatives.
(9) The chairman and minority chairman of the Health
Committee of the House of Representatives.
(10) The Attorney General of the Commonwealth.
(b) Contents of report.--The following information shall be
included in the report:
(1) An assessment of the use of medical marijuana as a
result of the enactment of this act.
(2) An assessment of the benefits and risks to patients
using medical marijuana under this act, including adverse
events.
(3) Recommendations for amendments to this act for
reasons of patient safety or to aid the general welfare of
the citizens of this Commonwealth.
Section 1106. Advisory board.
(a) Establishment.--The Medical Marijuana Advisory Board is
established within the department. The advisory board shall
consist of the following members:
(1) The secretary or a designee.
(2) The Commissioner of the Pennsylvania State Police or
a designee.
(3) The chairman of the State Board of Pharmacy or a
designee.
(4) The Commissioner of Professional and Occupational
Affairs or a designee.
(5) The Physician General or a designee.
(6) The president of the Pennsylvania Chiefs of Police
Association or a designee.
(7) The president of the Pennsylvania District Attorneys
Association or a designee.
(8) One member to be appointed by each of the following,
which members shall be knowledgeable and experienced in
issues relating to care and treatment of individuals with a
serious medical condition, geriatric or pediatric medicine or
clinical research:
(i) The Governor.
(ii) The President pro tempore of the Senate.
(iii) The Majority Leader of the Senate.
(iv) The Minority Leader of the Senate.
(v) The Speaker of the House of Representatives.
(vi) The Majority Leader of the House of
Representatives.
(vii) The Minority Leader of the House of
Representatives.
(9) One member appointed by the Governor, who shall be a
patient, a family or household member of a patient or a
patient advocate.
(b) Terms.--Except as provided under subsection (g), the
members appointed under subsection (a)(8) and (9) shall serve a
term of four years or until a successor has been appointed and

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qualified, but no longer than six months beyond the four-year


period.
(c) Chair.--The secretary, or a designee, shall serve as
chair of the advisory board.
(d) Voting; quorum.--The members under subsections (1), (2),
(3), (4), (5), (6) and (7) shall serve ex officio and shall have
voting rights. A majority of the members shall constitute a
quorum for the purpose of organizing the advisory board,
conducting its business and fulfilling its duties. A vote of the
majority of the members present shall be sufficient for all
actions of the advisory board unless the bylaws require a
greater number.
(e) Attendance.--A member of the advisory board appointed
under subsection (a)(8) or (9) who fails to attend three
consecutive meetings shall forfeit his seat unless the
secretary, upon written request from the member, finds that the
member should be excused from a meeting for good cause. A member
who cannot be physically present may attend meetings via
electronic means, including video conference.
(f) Governance.--The advisory board shall have the power to
prescribe, amend and repeal bylaws, rules and regulations
governing the manner in which the business of the advisory board
is conducted and the manner in which the duties granted to it
are fulfilled. The advisory board may delegate supervision of
the administration of advisory board activities to an
administrative secretary and other employees of the department
as the secretary shall appoint.
(g) Initial terms.--The initial terms of members appointed
under subsection (a)(8) and (9) shall be for terms of one, two,
three or four years, the particular term of each member to be
designated by the secretary at the time of appointment. All
other members shall serve for a term of four years.
(h) Vacancy.--In the event that any member appointed under
subsection (a)(8) or (9) shall die or resign or otherwise become
disqualified during the member's term of office, a successor
shall be appointed in the same way and with the same
qualifications as set forth in this section and shall hold
office for the unexpired term. An appointed member of the
advisory board shall be eligible for reappointment.
(i) Expenses.--A member appointed under subsection (a)(8) or
(9) shall receive the amount of reasonable travel, hotel and
other necessary expenses incurred in the performance of the
duties of the member in accordance with Commonwealth
regulations, but shall receive no other compensation for the
member's service on the board.
(j) Duties.--The advisory board shall have the following
duties:
(1) To examine and analyze the statutory and regulatory
law relating to medical marijuana within this Commonwealth.
(2) To examine and analyze the law and events in other
states and the nation with respect to medical marijuana.

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(3) To accept and review written comments from


individuals and organizations about medical marijuana.
(4) To issue three years after the effective date of
this section a written report to the Governor, the Senate and
the House of Representatives.
(5) The written report under paragraph (4) shall include
recommendations and findings as to the following:
(i) Whether to change the types of medical
professionals who can issue certifications to patients.
(ii) Whether to change, add or reduce the types of
medical conditions which qualify as serious medical
conditions under this act.
(iii) Whether to change, add or reduce the form and
manner of consumption of medical marijuana permitted
under this act.
(iv) Whether to change, add or reduce the number of
growers/processors or dispensaries.
(v) How to ensure affordable patient access to
medical marijuana, including whether the department
should set a maximum per-dose price for medical
marijuana.
(vi) Whether to permit medical marijuana to be
dispensed in dry leaf or plant form, for administration
by vaporization.
(vii) Whether to permit an individual dose of
medical marijuana to contain a greater percentage of
tetrahydrocannabinol than 10%.
(6) The final written report under this section shall be
adopted at a public meeting. The report shall be a public
record under the act of February 14, 2008 (P.L.6, No.3),
known as the Right-to-Know Law.
Section 1107. Regulations.
In order to implement the provisions of this act, the
department shall promulgate regulations within 18 months of the
effective date of this section. The regulations shall provide
for the following:
(1) Restricting the advertising and marketing of medical
marijuana, which shall be consistent with the Federal
regulations governing prescription drug advertising and
marketing.
(2) Growing of medical marijuana by grower/processors in
an indoor, enclosed facility. The regulations shall also
specify the manner and method of growing medical marijuana.
(3) The procedure for certification of patients.
(4) A procedure for review and approval of
certifications submitted by practitioners.
(5) A procedure to review the credentials of
practitioners who submit certifications.
(6) A procedure to review and approve applications for
identification cards.
(7) A procedure to review and approve applications to

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become registered with the department as a medical marijuana


organization.
(8) A procedure to renew the registration of a medical
marijuana organization.
(9) The setting of a maximum per-dose price for medical
marijuana by a dispensary.
(10) Additional information required by the department
for certification of patients and applications to become
registered as a medical marijuana organization.
(11) The procedure for waiving or reducing application
fees to be paid by patients and caregivers in the case of
financial hardship.
(12) Additional requirements of identification cards for
patients or caregivers.
(13) The method of transporting, delivering, growing,
processing and selling medical marijuana by a
grower/processor and the method of dispensing of medical
marijuana by a dispensary, including what types of medical
devices and instruments may be sold at a dispensary.
(14) The method for maintaining effective security and
control to prevent diversion and abuse of medical marijuana
by a medical marijuana organization, including specifying the
requirements of the tracking system required by section
1102(b) and (c).
(15) The contents and timing of reports which must be
filed with the department by medical marijuana organizations.
(16) The proper disposal of electronic information by
medical marijuana organizations.
(17) Information required for labeling of medical
marijuana by medical marijuana organizations.
(18) The procedure for practitioners registering with
the department.
(19) The frequency of filing reports by medical
marijuana organizations.
(20) The criteria for designating an appropriate
individual to be a caregiver for a patient under 18 years of
age.
(21) The procedure for obtaining photographs for
identification cards.
(22) The procedure for reporting results of laboratory
testing of medical marijuana.
(23) The procedure for approving laboratories that seek
to test medical marijuana.
(24) The contents of the safety insert.
(25) The procedure for filing receipts generated by
dispensaries with the department.
(26) A schedule for inspections by the department of the
facilities for growing, processing, dispensing or selling
medical marijuana, or of the books, papers and tracking
systems of medical marijuana organizations required by this
act.

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(27) Regulations that the department must promulgate


under section 1903(a), a procedure to select patients for the
research study and any other regulation the department deems
necessary to implement the research program under Chapter 19.
(28) Regulations which ensure a grower/processor only
provides medical marijuana to a dispensary holding a valid
registration and which ensure that a dispensary only procures
medical marijuana from a grower/processor holding a valid
registration, as set forth in section 707(6) and (7).
(29) The determination of the minimum number and the
types of medical marijuana to be produced by a
grower/processor and dispensed by a dispensary.
(30) Any other regulation necessary to implement this
act, as determined by the department.
Section 1108. Regulations based on recommendations of advisory
board.
(a) Recommendations.--After receiving the report of the
advisory board under section 1106(j)(4), at the discretion of
the secretary, the department may promulgate regulations to
effectuate recommendations made by the advisory board. The
secretary shall issue notice in the Pennsylvania Bulletin within
12 months of the receipt of the report of the advisory board.
The notice shall include the recommendations of the advisory
board and shall state the specific reasons for the decision of
the secretary on whether or not to effectuate each
recommendation. The secretary shall consider whether to
promulgate regulations with respect to:
(1) Whether to change the types of medical professionals
who can issue certifications to patients with respect to the
use of medical marijuana under this act.
(2) Whether to change, add or reduce the types of
medical conditions which qualify as serious medical
conditions under this act.
(3) Whether to change, add or reduce the form and manner
of consumption of medical marijuana permitted under this act.
(4) Whether to change, add or reduce the number of
growers/processors or dispensaries.
(5) Whether to permit medical marijuana to be dispensed
in dry leaf or plant form for administration by vaporization.
(6) Whether to permit an individual dose of medical
marijuana to contain a greater percentage of
tetrahydrocannabinol than 10%.
(b) Timing.--Any regulations promulgated under this
paragraph shall be promulgated within 12 months of the receipt
of the report of the advisory board.
Section 1109. Temporary regulations.
(a) Promulgation.--In order to facilitate the prompt
implementation of this act, regulations promulgated by the
department shall be deemed temporary regulations which shall
expire not later than 18 months following the publication of the
temporary regulation. The department may promulgate temporary

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regulations not subject to:


(1) Sections 201, 202, 203, 204 and 205 of the act of
July 31, 1968 (P.L.769, No.240), referred to as the
Commonwealth Documents Law.
(2) The act of June 25, 1982 (P.L.633, No.181), known as
the Regulatory Review Act.
(3) Sections 204(b) and 301(10) of the act of October
15, 1980 (P.L.950, No.164), known as the Commonwealth
Attorneys Act.
(b) Expiration.--The department's authority to adopt
temporary regulations under subsection (a) shall expire 18
months after the effective date of this section. Regulations
adopted after this period shall be promulgated as provided by
law.
(c) Temporary regulations.--The department shall begin
publishing temporary regulations in the Pennsylvania Bulletin no
later than six months from the effective date of this section.
CHAPTER 13
OFFENSES RELATED TO MEDICAL MARIJUANA
Section 1301. Criminal diversion of medical marijuana by
practitioners.
In addition to any other penalty provided by law, a
practitioner commits a misdemeanor of the first degree if the
practitioner intentionally, knowingly or recklessly certifies a
person as being able to lawfully receive medical marijuana or
otherwise provides medical marijuana to a person who is not
lawfully permitted to receive medical marijuana.
Section 1302. Criminal diversion of medical marijuana by
medical marijuana organizations.
In addition to any other penalty provided by law, an employee
or principal of a medical marijuana organization commits a
misdemeanor of the first degree if the person intentionally,
knowingly or recklessly sells, dispenses, trades, delivers or
otherwise provides medical marijuana to a person who is not
lawfully permitted to receive medical marijuana.
Section 1303. Criminal retention of medical marijuana.
In addition to any other penalty provided by law, a patient
or caregiver commits a misdemeanor of the third degree if the
patient or caregiver intentionally, knowingly or recklessly
possesses, stores or maintains an amount of medical marijuana in
excess of the amount legally permitted.
Section 1304. Criminal diversion of medical marijuana by
patient or caregiver.
(a) Offense defined.--In addition to any other penalty
provided by law, a patient or caregiver commits an offense if
the patient or caregiver intentionally, knowingly or recklessly
provides medical marijuana to a person who is not lawfully
permitted to receive medical marijuana.
(b) Grading.--A first offense under this section constitutes
a misdemeanor of the second degree. A second or subsequent
offense constitutes a misdemeanor of the first degree.

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Section 1305. Falsification of identification cards.


(a) Offense defined.--In addition to any other penalty
provided by law, a person commits an offense if, knowing he is
not privileged to hold an identification card, the person:
(1) possesses an identification card and either attempts
to use the card to obtain medical marijuana or obtains
medical marijuana;
(2) possesses an identification card which falsely
identifies the person as being lawfully entitled to receive
medical marijuana and either attempts to use the card to
obtain medical marijuana or obtains medical marijuana; or
(3) possesses an identification card which contains any
false information on the card and the person either attempts
to use the card to obtain medical marijuana or obtains
medical marijuana.
(b) Grading.--A first offense under this section constitutes
a misdemeanor of the second degree. A second or subsequent
offense under this section constitutes a misdemeanor of the
first degree.
Section 1306. Adulteration of medical marijuana.
(a) General rule.--In addition to any other penalty provided
by law, a person commits an offense if the person adulterates,
fortifies, contaminates or changes the character or purity of
medical marijuana from that set forth on the patient's or
caregiver's identification card.
(b) Grading.--A first offense under this section constitutes
a misdemeanor of the second degree. A second or subsequent
offense under this section constitutes a misdemeanor of the
first degree.
Section 1307. Disclosure of information prohibited.
(a) Offense defined.--In addition to any other penalty
provided by law, an employee or principal of a medical marijuana
organization or an employee of the department commits a
misdemeanor of the third degree if the person discloses, except
to authorized persons for official governmental or health care
purposes, any information related to the use of medical
marijuana.
(b) Exception.--Subsection (a) shall not apply where
disclosure is permitted or required by law or by court order.
Section 1308. Additional penalties.
(a) Criminal penalties.--In addition to any other penalty
provided by law, a practitioner, caregiver, patient or employee
or principal of any medical marijuana organization who violates
any of the provisions of this act, other than those specified in
section 1301, 1302, 1303, 1304, 1305, 1306 or 1307, or any
regulation promulgated under this act:
(1) For a first offense, commits a misdemeanor of the
third degree and shall, upon conviction, be sentenced to pay
a fine of not more than $5,000, or to imprisonment for not
more than six months.
(2) For a second or subsequent offense, commits a

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misdemeanor of the third degree and shall, upon conviction,


be sentenced to pay a fine of not more than $10,000, or to
imprisonment for not less than six months or more than one
year, or both.
(b) Civil penalties.--In addition to any other remedy
available to the department, the department may assess a civil
penalty for a violation of this act, a regulation promulgated
under this act or an order issued under this act or regulation
as provided in this subsection. The following shall apply:
(1) The department may assess a penalty of not more than
$10,000 for each violation and an additional penalty of not
more than $1,000 for each day of a continuing violation. In
determining the amount of each penalty, the department shall
take the following factors into consideration:
(i) The gravity of the violation.
(ii) The potential harm resulting from the violation to
patients, caregivers or the general public.
(iii) The willfulness of the violation.
(iv) Previous violations, if any, by the person being
assessed.
(v) The economic benefit to the person being assessed
for failing to comply with the requirements of this act, a
regulation promulgated under this act or an order issued
under this act or regulation.
(2) If the department finds that the violation did not
threaten the safety or health of a patient, caregiver or the
general public and the violator took immediate action to
remedy the violation upon learning of it, the department may
issue a written warning in lieu of assessing a civil penalty.
(3) A person who aids, abets, counsels, induces,
procures or causes another person to violate this act, a
regulation promulgated under this act or an order issued
under this act or regulation shall be subject to the civil
penalties provided under this subsection.
(c) Sanctions.-(1) In addition to the penalties provided in subsection
(b) and any other penalty authorized by law, the department
may impose the following sanctions:
(i) Revoke or suspend the registration of a person
found to be in violation of this act, a regulation
promulgated under this act or an order issued under this
act or regulation.
(ii) Revoke or suspend the registration of a person
for conduct, activity or the occurrence of an event that
would have disqualified the person from receiving the
registration.
(iii) Revoke or suspend the registration of a person
for willfully and knowingly violating or attempting to
violate an order of the department directed to the
person.
(iv) Suspend a registration of a person pending the

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outcome of a hearing in a case in which the registration


could be revoked.
(v) Order restitution of funds or property
unlawfully obtained or retained by a registrant.
(vi) Issue a cease and desist order.
(2) A person who aids, abets, counsels, induces,
procures or causes another person to violate this act shall
be subject to the sanctions provided under this subsection.
(d) Costs of action.--The department may assess against a
person determined to be in violation of this act the costs of
investigation of the violation.
(e) Minor violations.--Nothing in this section shall be
construed to require the assessment of a civil penalty or the
imposition of a sanction for a minor violation of this act if
the department determines that the public interest will be
adequately served under the circumstances by the issuance of a
written warning.
Section 1309. Other restrictions.
This act does not permit any person to engage in and does not
prevent the imposition of any civil, criminal or other penalty
for the following:
(1) Undertaking any task under the influence of medical
marijuana when doing so would constitute negligence,
professional malpractice or professional misconduct.
(2) Possessing or using medical marijuana in a State or
county correctional facility, including a facility owned or
operated or under contract with the Department of Corrections
or the county which houses inmates serving a portion of their
sentences on parole or other community correction program.
Nothing in this paragraph shall be construed to apply to
employees of the facilities set forth in this paragraph. The
Department of Corrections shall adopt a written policy no
later than 18 months from the effective date of this section
regarding the possession and use of medical marijuana by
employees in State correctional facilities. The governing
authority of a county may adopt a resolution no later than 18
months from the effective date of this section regarding the
possession and use of medical marijuana by employees in a
county correctional facility.
(3) Possessing or using medical marijuana in a youth
detention center or other facility which houses children
adjudicated delinquent, including the separate, secure Stateowned facility or unit utilized for sexually violent
delinquent children under 42 Pa.C.S. 6404 (relating to
duration of inpatient commitment and review). As used in this
paragraph, the term "sexually violent delinquent children"
shall have the meaning given to it in 42 Pa.C.S. 6402
(relating to definitions). Nothing in this paragraph shall be
construed to apply to employees of the facilities set forth
in this paragraph.
CHAPTER 19

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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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participate, at the patient's option, in a research study


to study medical marijuana as a treatment; and
(ii) where the patient may secure medical marijuana
through a health care medical marijuana organization at
no cost to the patient in accordance with subsection (c).
(7) If the United States Food and Drug Administration
and the United States Drug Enforcement Administration reject
the proposal for the research study, take all reasonable
steps to collect and collate data on the serious medical
condition and the use of medical marijuana as a treatment for
the serious medical condition and consider submitting an
additional request to the United States Food and Drug
Administration and United States Drug Enforcement
Administration for a research study on the same condition.
(c) Costs.--The cost of the medical marijuana which is
dispensed to patients in accordance with an approved research
study shall be paid for by the fund.
(d) Geographic accessibility.--The department shall take
into consideration the geographic location of the health care
medical marijuana organization when assigning a patient to a
health care medical marijuana organization. The department shall
make an effort to assign a patient to a health care medical
marijuana organization that is located within 50 miles of the
patient's residence.
(e) Data.--Data collected by the health care medical
marijuana organization shall be provided to the university
participating in the research study for analysis.
Section 1903. Medical marijuana research program
administration.
(a) General rule.--The department shall establish a research
study for each serious medical condition. The department shall
engage universities within this Commonwealth to participate in
the collection, collation, analysis and conclusive findings of
the research studies. The department shall, by regulation,
establish the procedure to be used by health care medical
marijuana organizations with respect to:
(1) Real time inventory tracking.
(2) Real time tracking of the medical marijuana
dispensed.
(3) Recall of defective marijuana.
(b) Request for distributions.--The department shall
establish a form and procedure for universities selected to
participate in a research study to request distributions from
the fund to conduct research on medical marijuana, including
administrative costs. These distributions shall also be used to
pay for the cost of the medical marijuana so that it is not
borne by the patient participating in the research study. The
forms shall include, at a minimum, the following:
(1) The form or forms of medical marijuana to be
studied.
(2) The serious medical condition to be studied.

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(c)

Research reports.-(1) A vertically integrated health system shall report


on the effectiveness of the use of medical marijuana for the
treatment of the serious medical condition studied and all
counterindications and noted side effects.
(2) The department shall notify the vertically
integrated health system and the university participating in
the research study of the data which is required to meet the
United States Food and Drug Administration's and the United
States Drug Enforcement Administration's approval for the
research study.
(3) The first report, including the data required under
paragraph (2), shall be submitted to the department and made
publicly available within 180 days of the initiation of a
research study for a specific serious medical condition.
(4) An annual report of the data required under
paragraph (2) shall be submitted to the department beginning
one year after the initiation of a research study for a
specific serious medical condition and each year thereafter.
Section 1904. Approval.
A vertically integrated health system located in this
Commonwealth may petition the department to participate in a
research study to study a serious medical condition under
section 1902. Approval of the vertically integrated health
system as a health care medical marijuana organization by the
department shall authorize access within a region under section
706(d) to medical marijuana for all patients included in an
approved research study.
Section 1905. Requirements.
(a) Dispensing.--A health care medical marijuana
organization that dispenses medical marijuana shall:
(1) Maintain licensure with the department as required
under the act of July 19, 1979 (P.L.130, No.48), known as the
Health Care Facilities Act.
(2) Secure the medical marijuana within the associated
pharmacies of the health care medical marijuana organization
in a manner and method prescribed by the department.
(3) Keep a daily log of the medical marijuana dispensed
and the research study with which the patient and the medical
marijuana are associated. Reports shall be delivered to the
department and the university participating in the research
study 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 marijuana and
treatment options.
(5) Only dispense medical marijuana received from a
grower/processor or a health care medical marijuana
organization that is approved to grow and process medical
marijuana.
(6) Provide all patients or caregivers with the safety

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insert, prepared by the department, which includes potential


dangers, recognition and correction of problematic dosage and
any other information required by the department or which the
department deems relevant for patient safety.
(b) Growing and processing.--A health care medical marijuana
organization that grows and processes medical marijuana shall:
(1) Maintain licensure with the department as required
under the Health Care Facilities Act.
(2) Only make available medical marijuana to health care
medical marijuana organizations that dispense medical
marijuana.
(3) Keep a daily log of medical marijuana intended for
ultimate use by patients participating in a research study.
Section 1906. Restrictions.
A health care medical marijuana organization may not
participate in a research study of any kind, including the
program established under this chapter, or dispense or grow and
process medical marijuana if it has violated its licensure
requirements under the Health Care Facilities Act.
Section 1907. Regulations.
The department shall, by regulation, establish the procedure
to be used by a health care medical marijuana organization that
grows and processes medical marijuana with respect to:
(1) Real time inventory tracking, including a seed-todispensing tracking system that tracks medical marijuana from
seed or immature plant stage until the medical marijuana is
provided to a patient in a research study.
(2) Security, recordkeeping, record retention and
surveillance systems relating to every stage of growing and
processing medical marijuana.
(3) A daily log of each day's beginning inventory,
acquisitions, disbursements, disposals and ending inventory.
(4) A system to recall defective medical marijuana.
(5) A system to track the plant waste resulting from the
growth of medical marijuana.
(6) Testing of medical marijuana by an independent
laboratory to test the medical marijuana produced by the
health care medical marijuana organization, including
requiring a test at harvest and a test at final processing.
(7) Any other procedure deemed necessary by the
department.
Section 1908. Nonentitlement.
Nothing in this chapter shall be construed to create an
entitlement or right of a patient to receive medical marijuana
or to participate in a research study.
CHAPTER 21
MISCELLANEOUS PROVISIONS
Section 2101. Conflict.
The growth, processing, manufacture, acquisition,
transportation, sale, dispensing, distribution, possession and
consumption of medical marijuana permitted under this act shall

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not be deemed to be a violation of the act of April 14, 1972


(P.L.233, No.64), known as The Controlled Substance, Drug,
Device and Cosmetic Act. If a provision of the Controlled
Substance, Drug, Device and Cosmetic Act relating to marijuana
conflicts with a provision of this act, this act shall take
precedence.
Section 2102. Insurers.
Nothing in this act shall be construed to require an insurer
or a health plan, whether paid for by Commonwealth funds or
private funds, to provide coverage for medical marijuana.
Section 2103. Protections for patients and caregivers.
(a) Licensure.--No patient, caregiver, practitioner, medical
marijuana organization, health care medical marijuana
organization or university participating in a research study
under Chapter 19 or an employee, principal or financial backer
of a medical marijuana organization or employee of a health care
medical marijuana organization or an employee of a university
participating in a research study under Chapter 19 shall be
subject to arrest, prosecution or penalty in any manner, or
denied any right or privilege, including civil penalty or
disciplinary action by a Commonwealth licensing board or
commission, solely for lawful use of medical marijuana or
manufacture or sale or dispensing of medical marijuana, or for
any other action taken in accordance with this act.
(b) Employment.-(1) No employer may discharge, threaten, refuse to hire
or otherwise discriminate or retaliate against an employee
regarding an employee's compensation, terms, conditions,
location or privileges solely on the basis of such employee's
status as an individual who is certified to use medical
marijuana.
(2) Nothing in this act shall require an employer to
make any accommodation of the use of medical marijuana on the
property or premises of any place of employment. This act
shall in no way limit an employer's ability to discipline an
employee for being under the influence of medical marijuana
in the workplace or for working while under the influence of
medical marijuana when the employee's conduct falls below the
standard of care normally accepted for that position.
(3) Nothing in this act shall require an employer to
commit any act that would put the employer or any person
acting on its behalf in violation of Federal law.
(c) Custody determination.--The fact that an individual is
certified to use medical marijuana and acting in accordance with
this act shall not by itself be considered by a court in a
custody proceeding. In determining the best interest of a child
with respect to custody, the provisions of 23 Pa.C.S. Ch. 53
(relating to child custody) shall apply.
(d) Disclosure.--Data and information collected by the
department under this act, including copies of identification
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public disclosure under the act of February 14, 2008 (P.L.6,


No.3), known as the Right-to-Know Law. However, an application
to become a medical marijuana organization shall be a public
record under the Right-to-Know Law.
Section 2104. Schools.
The Department of Education shall promulgate regulations
within 18 months of the effective date of this section regarding
the following:
(1) Possession and use of medical marijuana by a student
on the grounds of a preschool, primary school and a secondary
school.
(2) Possession and use of medical marijuana by an
employee of a preschool, primary school and a secondary
school on the grounds of such school.
Section 2105. Day-care centers.
The Department of Human Services shall promulgate regulations
within 18 months of the effective date of this section regarding
the following:
(1) Possession and use of medical marijuana by a child
under the care of a child-care or social service center
licensed or operated by the Department of Human Services.
(2) Possession and use of medical marijuana by an
employee of a child-care or social service center licensed or
operated by the Department of Human Services.
(3) Possession and use of medical marijuana by employees
of a youth development center or other facility which houses
children adjudicated delinquent, including the separate,
secure State-owned facility or unit for sexually violent
children, as set forth in section 1309(3).
Section 2106. Medical marijuana from other states.
(a) General rule.--It is not a violation of this act or the
act of April 14, 1972 (P.L.233, No.64), known as The Controlled
Substance, Drug, Device and Cosmetic Act, if a parent or
guardian of a minor under 18 years of age lawfully obtains
medical marijuana from another state, territory of the United
States or any other country to be administered to the minor.
(b) Expiration.--This section shall expire 730 days after
the effective date of this section.
Section 2107. Zoning.
The following apply:
(1) A grower/processor shall meet the same municipal
zoning and land use requirements as other manufacturing,
processing and production facilities that are located in the
same zoning district.
(2) A dispensary shall meet the same municipal zoning
and land use requirements as other commercial facilities that
are located in the same zoning district.
Section 2108. Notice.
Upon amendment of the Controlled Substances Act (Public Law
91-513, 84 Stat. 1236) removing marijuana from Schedule I of the
Controlled Substances Act, the department shall publish notice

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of the effective date of the amendment in the Pennsylvania


Bulletin.
Section 2109. Applicability.
The provisions of this act with respect to dispensaries shall
not apply beginning 1,095 days from the effective date of an
amendment to the Controlled Substances Act (Public Law 91-513,
84 Stat. 1236) removing marijuana from Schedule I of the
Controlled Substances Act.
Section 2110. Effective date.
This act shall take effect as follows:
(1) The following provisions shall take effect
immediately:
(i) This section.
(ii) Chapter 1.
(iii) Chapter 3.
(iv) Section 704.
(v) Section 711.
(vi) Chapter 9.
(vii) Section 1101.
(viii) Section 1104.
(ix) Section 1105.
(x) Section 1106.
(xi) Section 1107.
(xii) Section 1108.
(xiii) Section 1109.
(xiv) Section 1309.
(xv) Chapter 19.
(xvi) Section 2101.
(xvii) Section 2102.
(xviii) Section 2103.
(xix) Section 2104.
(xx) Section 2105.
(xxi) Section 2106.
(xxii) Section 2108.
(xxiii) Section 2109.
(2) The remainder of this act shall take effect upon the
issuance of temporary regulations by the department under
section 1109(a) or 18 months from the effective date of this
section, whichever is sooner.

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Regular Session 2015 - 2016


Amendment A04382 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04383

DMS:CMD 11/20/15

#90

A04383

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE HEFFLEY
Printer's No. 889
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Amend Bill, page 24, line 24, by striking out "Imposition.--"


and inserting
Fees.--

Amend Bill, page 24, by inserting between lines 29 and 30

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(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.

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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
inserting
(f)
Amend Bill, page 25, line 10, by striking out "(f)" and
inserting
(g)
Amend Bill, page 25, line 15, by striking out "(g)" and
inserting
(h)
Amend Bill, page 26, line 21, by striking out "(h)" and
inserting

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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)
Amend Bill, page 27, line 21, by striking out "(d)" and
inserting
(e)
Amend Bill, page 27, line 25, by striking out "(e)" and
inserting
(f)
Amend Bill, page 27, line 28, by striking out "(f)" and
inserting
(g)
Amend Bill, page 29, line 5, by striking out "(g)" and
inserting
(h)
Amend Bill, page 29, line 27, by striking out "Imposition.--"
and inserting
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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amount of $10,000,000 to cover any potential liability arising


from the licensee's activities under this act.
Amend Bill, page 30, line 2, by striking out "(c)" and
inserting
(d)
Amend Bill, page 30, line 5, by striking out "(d)" and
inserting
(e)
Amend Bill, page 30, line 9, by striking out "(e)" and
inserting
(f)
Amend Bill, page 30, line 12, by striking out "(f)" and
inserting
(g)
Amend Bill, page 33, line 11, by striking out "(g)" and
inserting
(h)

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Amend Bill, page 47, by inserting between lines 22 and 23

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(4) Posts a bond with the department in the amount of


$10,000,000 to cover any potential liability arising from
recommendations made under this act.

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Amend Bill, page 47, line 23, by striking out "(4)" and

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inserting
(5)
Amend Bill, page 47, line 27, by striking out "(5)" and
inserting
(6)
Amend Bill, page 48, line 3, by striking out "(6)" and
inserting
(7)
Amend Bill, page 48, line 6, by striking out "(7)" and
inserting

2015/90DMS/SB0003A04383

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(8)
Amend Bill, page 48, line 11, by striking out "(8)" and
inserting
(9)
Amend Bill, page 48, line 13, by striking out "(9)" and
inserting
(10)

2015/90DMS/SB0003A04383

- 4 -

S0003B0889A04384

DMS:CMD 11/20/15

#90

A04384

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE HEFFLEY
Printer's No. 889
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Amend Bill, page 3, by inserting between lines 28 and 29


Section 5103.

Deposits into General Fund.

Amend Bill, page 3, line 29, by striking out "5103" and


inserting
5104
Amend Bill, page 3, line 30, by striking out "5104" and
inserting
5105
Amend Bill, page 4, line 1, by striking out "5105" and
inserting
5106
Amend Bill, page 69, by inserting between lines 9 and 10

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Section 5103. Deposits into General Fund.


Notwithstanding any other provision to the contrary, all
fees, fines, penalties and revenue accruing to the Commonwealth
from any licensed entity under this act shall be deposited into
the General Fund and annually appropriated to the Department of
Drug and Alcohol Programs.

19

Amend Bill, page 69, line 10, by striking out "5103" and

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inserting
5104
Amend Bill, page 69, line 18, by striking out "5104" and
inserting
5105
Amend Bill, page 69, line 26, by striking out "5105" and
inserting

2015/90DMS/SB0003A04384

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5106

2015/90DMS/SB0003A04384

- 2 -

S0003B0889A04385

AJM:CMD 11/19/15

#90

A04385

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE DUSH
Printer's No. 889
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Amend Bill, page 2, by inserting between lines 14 and 15


Section 513.

Department of Health inspector.

Amend Bill, page 42, by inserting between lines 2 and 3


Section 513. Department of Health inspector.
(a) Health inspector.--The Department of Health shall
establish a program to train new employees, or retrain existing
employees, in health and safety practices related to the
processing and dispensing of medical cannabis.
(b) Onsite inspector.--A Department of Health employee who
has been trained or retrained under subsection (a) shall be on
the premises of a medical cannabis processor or dispenser during
all operating hours to ensure compliance with health and safety
requirements under this act and issue weekly reports to the
board and the Department of Health.
(c) Reimbursement of expenses.--A medical cannabis processor
or dispensary shall enter into an agreement with the Department
of Health to reimburse the department for the salary, benefits
and any reasonable costs or expenses incurred for department
employees under subsection (b).

2015/90AJM/SB0003A04385

- 1 -

Regular Session 2015 - 2016


Amendment A04386 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04387

MSP:JSL 11/20/15

#90

A04387

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE PETRI
Printer's No. 889
1

Amend Bill, page 69, line 27, by striking out "in 60 days."

and inserting

3
4

30 days after the United States Food and Drug Administration


removes the Schedule I classification of cannabis or marijuana.

2015/90MSP/SB0003A04387

- 1 -

S0003B0889A04388

AJM:CMD 11/19/15

#90

A04388

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE PETRI
Printer's No. 889
1

Amend Bill, page 69, line 27, by striking out "in 60 days."

and inserting

3
4

30 days after the Food and Drug Administration removes the


Schedule 1 classification of cannabis or marijuana.

2015/90AJM/SB0003A04388

- 1 -

S0003B0889A04390

KMK:CDM 11/19/15

#90

A04390

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE MURT
Printer's No. 889
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2

Amend Bill, page 8, line 27, by inserting after "DISEASE"


and ulcerative colitis

2015/90KMK/SB0003A04390

- 1 -

S0003B0889A04391

AJM:EJH 11/20/15

#90

A04391

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 1, lines 1 through 16; pages 2 and 3, lines

1 through 30; page 4, line 1; by striking out all of said lines

on said pages and inserting

4
5

Providing for the use of investigational drugs, biological


products and devices by terminally ill patients.

Amend Bill, page 4, lines 4 through 30; pages 5 through 68,

lines 1 through 30; page 69, lines 1 through 27; by striking out

all of said lines on said pages and inserting

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Section 1. Short title.


This act shall be known and may be cited as the Right-to-Try
Act.
Section 2. 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:
"Eligible patient." As follows:
(1) A person who has:
(i) a terminal illness, attested to by the patient's
treating physician;
(ii) carefully considered all other treatment
options approved by the United States Food and Drug
Administration;
(iii) been unable to participate in a clinical trial
for the terminal illness that is located within 100 miles
of the patient's home address or has not been accepted to
the clinical trial within one week of completion of the
clinical trial application process;
(iv) received a recommendation from the patient's
treating physician for an investigational drug,
biological product or device;
(v) given written, informed consent for the use of
the investigational drug, biological product or device
or, if the patient is a minor or lacks the mental
capacity to provide informed consent, a parent or legal

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guardian has given written, informed consent on the


patient's behalf; and
(vi) documentation from the patient's treating
physician that the patient meets the requirements of this
paragraph.
(2) A person with a qualifying medical condition who
seeks to use only an investigational cannabis product.
(3) The term does not include a person being treated as
an inpatient in any hospital.
"Hospital." As defined in section 802.1 of the act of July
19, 1979 (P.L.130, No.48), known as the Health Care Facilities
Act.
"Investigational cannabis product." A pharmaceutical product
which has been approved for study by the United States Food and
Drug Administration, but is not yet approved for general use by
the United States Food and Drug Administration, which contains a
derivative of cannabis.
"Investigational drug, biological product or device." A
drug, biological product or device that has successfully
completed phase one of a clinical trial but has not yet been
approved for general use by the United States Food and Drug
Administration and remains under investigation in a clinical
trial approved by the United States Food and Drug
Administration.
"Physician." As defined in section 2 of the act of December
20, 1985 (P.L.457, No.112), known as the Medical Practice Act of
1985.
"Qualifying medical condition." As follows:
(1) Cancer.
(2) Epilepsy and seizures.
(3) Amyotrophic lateral sclerosis.
(4) Cachexia/wasting syndrome.
(5) Parkinson's disease.
(6) Traumatic brain injury and postconcussion syndrome.
(7) Multiple sclerosis.
(8) Spinocerebellar ataxia (SCA).
(9) HIV/AIDS.
(10) Glaucoma.
"Terminal illness." A disease or condition that, without
life-sustaining procedures, will soon result in death or a state
of permanent unconsciousness from which recovery is unlikely.
"Written, informed consent." A written document signed by
the patient and attested to by the patient's treating physician
and a witness that, at a minimum:
(1) Explains the currently approved products and
treatments for the disease or condition from which the
patient suffers.
(2) Attests to the fact that the patient concurs with
the patient's treating physician in believing that all
currently approved and conventionally recognized treatments
are unlikely to prolong the patient's life.

2015/90AJM/SB0003A04391

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(3) Clearly identifies the specific proposed


investigational drug, biological product or device or
investigational cannabis product that the patient is seeking
to use.
(4) Describes the potentially best and worst outcomes of
using the investigational drug, biological product or device
or investigational cannabis product with a realistic
description of the most likely outcome, including the
possibility that new, unanticipated, different or worse
symptoms might result, and that death could be hastened by
the proposed treatment, based on the physician's knowledge of
the proposed treatment in conjunction with an awareness of
the patient's condition.
(5) Makes clear that the patient's health insurer and
provider are not obligated to pay for any care or treatment
consequent to the use of the investigational drug, biological
product or device or investigational cannabis product.
(6) Makes clear that the patient's eligibility for
hospice care may be withdrawn if the patient begins curative
treatment and care may be reinstated if the curative
treatment ends and the patient meets hospice eligibility
requirements.
(7) Makes clear that in-home health care may be denied
if treatment begins.
(8) States that the patient understands that the patient
is liable for all expenses consequent to the use of the
investigational drug, biological product or device or
investigational cannabis product, and that this liability
extends to the patient's estate, unless a contract between
the patient and the manufacturer of the investigational drug,
biological product or device or investigational cannabis
product states otherwise.
Section 3. Access.
(a) General rule.--A manufacturer of an investigational
drug, biological product or device or investigational cannabis
product may make available the manufacturer's investigational
drug, biological product or device or investigational cannabis
product to eligible patients in accordance with this act.
(b) Costs.--A manufacturer may:
(1) Provide an investigational drug, biological product
or device or investigational cannabis product to an eligible
patient without receiving compensation.
(2) Require an eligible patient to pay the costs of, or
the costs associated with, the manufacture of the
investigational drug, biological product or device or
investigational cannabis product.
(c) Insurers.--A health insurer may:
(1) In its discretion, provide coverage for the cost of
an investigational drug, biological product or device or
investigational cannabis product.
(2) Except as set forth in subsection (d), deny coverage

2015/90AJM/SB0003A04391

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to an eligible patient from the time the eligible patient


begins use of the investigational drug, biological product or
device or investigational cannabis product through a period
not to exceed six months from the time the investigational
drug, biological product or device or investigational
cannabis product is no longer used by the eligible patient.
(d) Limitation.--Coverage may not be denied for a
preexisting condition or in cases where coverage commenced prior
to the time the eligible patient begins use of the
investigational drug, biological product or device or
investigational cannabis product.
Section 4. Unprofessional conduct.
(a) Physician immunity.--No physician who in good faith
recommends or participates in the use of an investigational
drug, biological product or device or investigational cannabis
product under this act shall be subject to criminal or civil
liability, nor shall a physician be found to have committed an
act of unprofessional conduct under the act of October 5, 1978
(P.L.1109, No.261), known as the Osteopathic Medical Practice
Act, or the act of December 20, 1985 (P.L.457, No.112), known as
the Medical Practice Act of 1985.
(b) Physician licensure not affected.--Notwithstanding any
other law to the contrary, the State Board of Medicine and the
State Board of Osteopathic Medicine may not revoke, suspend or
otherwise take any action against an individual holding a
license issued under the Osteopathic Medical Practice Act or the
Medical Practice Act of 1985 based solely on the individual's
recommendations to an eligible patient regarding access to or
treatment with an investigational drug, biological product or
device or investigational cannabis product as long as the
recommendations are consistent with standards of care as set
forth by the manufacturer. Any action against an individual or
entity's Medicare certification based solely on recommendations
that a patient have access to an investigational drug,
biological product or device or investigational cannabis product
is prohibited.
Section 5. Construction.
Nothing in this act shall be construed as creating a private
cause of action against a manufacturer of an investigational
drug, biological product or device or investigational cannabis
product or against any other person or entity involved in the
care of an eligible patient using an investigational drug,
biological product or device or investigational cannabis product
for any injury suffered by the eligible patient resulting from
the investigational drug, biological product or device or
investigational cannabis product as long as the manufacturer or
other person or entity acted in accordance with this act, except
when the injury results from a failure to exercise reasonable
care.
Section 6. Protection from prosecution.
In the prosecution for the unlawful possession of marijuana

2015/90AJM/SB0003A04391

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under the laws of this Commonwealth, it is an affirmative and


complete defense to the prosecution that the individual has a
qualifying illness and is using or possessing marijuana at the
recommendation of a physician to use cannabis or the individual
is the parent of a minor child with a terminal illness and is in
possession of marijuana for the benefit of the minor child who
has a recommendation of a physician to use cannabis.
Section 7. Effective date.
This act shall take effect in 60 days.

2015/90AJM/SB0003A04391

- 5 -

Regular Session 2015 - 2016


Amendment A04392 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04394 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04395 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04396 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04397 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04398 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04399 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04400 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04401 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04402 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04403 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04404 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04405

AJB:JMT 11/20/15

#90

A04405

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 1, lines 1 through 16; pages 2 and 3, lines

1 through 30; page 4, line 1; by striking out all of said lines

on said pages and inserting

4
5
6
7
8
9

Providing for defenses for prosecution of unlawful possession of


marijuana; prohibiting a Commonwealth agency from removing a
child from a parent's custody for possession or use of an
investigational cannabis product; providing immunity from
prosecution for university medical centers and for research
and development study.

10

Amend Bill, page 4, lines 4 through 30; pages 5 through 68,

11

lines 1 through 30; page 69, lines 1 through 27; by striking out

12

all of said lines on said pages and inserting

13
14
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16
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34

Section 1. Short title.


This act shall be known and may be cited as the Possession of
Marijuana Defense Act.
Section 2. 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:
"FDA." The United States Food and Drug Administration.
"Investigational cannabis product." A pharmaceutical product
which has been approved for study by the United States Food and
Drug Administration but has not been approved by the United
States Food and Drug Administration and contains a derivative of
cannabis.
"Physician." An individual who has been licensed by the
State Board of Medicine to practice as a physician in this
Commonwealth.
"Serious medical condition." Cancer, epilepsy, multiple
sclerosis, HIV or AIDS, rheumatoid arthritis or any other
condition for which the United States Food and Drug
Administration has approved an investigational drug trial for an
investigational cannabis product.
"University medical centers." A facility licensed by the

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Department of Health and as a hospital which has an affiliation


with a university medical educational program for the training
and development of health care practitioners.
Section 3. Defenses for prosecution of unlawful possession of
marijuana.
(a) Medical condition defense.--In a prosecution for the
unlawful possession of marijuana under the laws of this
Commonwealth, it is an affirmative and complete defense to the
prosecution that the defendant has a serious medical condition
and used or possessed an investigational cannabis product
pursuant to a recommendation of a physician.
(b) Parental possession defense.--In a prosecution for the
unlawful possession of marijuana under the laws of this
Commonwealth, it is an affirmative and complete defense to the
prosecution that the defendant possessed an investigational
cannabis product because of all of the following:
(1) he or she is the parent of an individual who has a
serious medical condition; and
(2) he or she has a recommendation for the possession
and use of an investigational cannabis product as authorized
by a physician; and
(3) his or her possession of the investigational
cannabis product is on behalf of and otherwise for the
prescribed minor individual's use only.
Section 4. Removal of a child prohibited.
An agency of the Commonwealth or a political subdivision of
the Commonwealth, including any law enforcement agency, may not
initiate proceedings to remove a child from the home of a parent
based solely upon the parent's or child's possession or use of
an investigational cannabis product as authorized under this
act.
Section 5. Method of recommendation for possession or use of
investigational cannabis product.
A recommendation for the possession or use of an
investigational cannabis product as authorized by this act
shall be provided exclusively by a physician for a serious
medical condition. University medical centers shall be the sole
authorized source of any recommendation for the use of an
investigational cannabis product and shall be the sole
authorized source to use an investigational cannabis product in
or as a part of the treatment of an individual diagnosed with a
serious medical condition. A university medical center shall
have the sole authority to determine the use or amount of an
investigational cannabis product, if any, in the treatment of an
individual diagnosed with a serious medical condition.
Section 6. Immunity from prosecution.
A university medical center affiliated pediatric training
entity, including any authorized physician, nurse, attendant or
agent of the university medical center, shall not be subject to
prosecution for the unlawful possession, use, distribution or
prescription of marijuana under the laws of this Commonwealth

2015/90AJB/SB0003A04405

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for its activities arising directly out of or directly related


to any of the following:
(1) The recommendation for use or the use of an
investigational cannabis product in the treatment of
individuals diagnosed with a serious medical condition.
(2) The university medical center's research and
development activities in pursuit of medical benefits and
uses of an investigational cannabis product if the
prescription, treatment or use of an investigational cannabis
product is provided only to individuals diagnosed with a
serious medical condition.
Section 7. Research and development study.
A university medical center that possesses, uses, distributes
or prescribes marijuana in accordance with this act shall
establish a research and development study to determine medical
uses and benefits of an investigational cannabis product for
individuals with serious medical conditions.
Section 8. Construction.
Nothing in this act shall be construed to allow or
accommodate the prescription, testing, medical use or possession
of any form of cannabis except as permitted by this act.
Section 9. Effective date.
This act shall take effect in 60 days.

2015/90AJB/SB0003A04405

- 3 -

Regular Session 2015 - 2016


Amendment A04406 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04409 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04410 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04415 to
Senate Bill 3 Printer's Number 889
This amendment has been cancelled.

Regular Session 2015 - 2016


Amendment A04438 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04441

VDL:JMT 11/20/15

#90

A04441

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE D. COSTA
Printer's No. 889
1

Amend Bill, page 3, lines 6 through 8 (A04380), by striking

out "Notice." in line 6, all of line 7 and "Section 2110." in

line 8

Amend Bill, page 43, lines 48 through 51; page 44, lines 1

through 8 (A04380); by striking out all of said lines on said

pages

7
8
9
10
11

Amend Bill, page 44, line 9 (A04380), by striking out "2110"


and inserting
2108
Amend Bill, page 44, lines 34 and 35 (A04380), by striking
out all of said lines

2015/90VDL/SB0003A04441

- 1 -

Regular Session 2015 - 2016


Amendment A04442 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04445

BIL:CMD 11/20/15

#90

A04445

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE COHEN
Printer's No. 889
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8

Amend Bill, page 8, by inserting between lines 28 and 29


(16)
(17)
(18)
(19)

Ulcerative colitis.
Tourette's disorder.
Sickle cell disease.
Severe psoriasis and psoriatic arthritis.

Amend Bill, page 8, line 29, by striking out "(16)" and


inserting
(20)

2015/90BIL/SB0003A04445

- 1 -

S0003B0889A04446

BIL:CMD 11/20/15

#90

A04446

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE COHEN
Printer's No. 889
1
2
3
4

Amend Bill, page 7, lines 4 and 5, by striking out "The" in


line 4 and all of line 5
Amend Bill, page 55, lines 23 and 24, by striking out all of
said lines

2015/90BIL/SB0003A04446

- 1 -

S0003B0889A04447

DMS:CMD 11/20/15

#90

A04447

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE CORBIN
Printer's No. 889
1

Amend Bill, page 1, lines 1 and 2, by striking out all of

said lines and inserting

3
4
5

Providing for Statewide expanded access clinical trials for


cannabidiol for certain pediatric patients; and requiring
certain physicians to provide annual reports.

Amend Bill, page 1, lines 4 through 16; pages 2 and 3, lines

1 through 30; page 4, line 1; by striking out all of said lines

on said pages and inserting

9
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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.

17

Amend Bill, page 4, lines 4 through 30; pages 5 through 68,

18

lines 1 through 30; page 69, lines 1 through 27; by striking out

19

all of said lines on said pages and inserting

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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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including cannabidiol (CBD), that can be extracted from


marijuana and purified, or synthesized in a laboratory, and
tested in animals in preclinical research to ensure that they
are safe to administer to humans in clinical trials.
(5) The FDA has approved several expanded access
investigational new drug (IND) applications that enable
investigators to:
(i) Administer a purified CBD to children with
refractory epilepsy who do not respond to standard
medications.
(ii) Gather evidence with respect to dosage,
formulation and mode of administration for advanced
clinical trials.
(6) The Dravet Syndrome Foundation, the Epilepsy
Foundation and the American Epilepsy Society support this
type of research.
(7) The intent of this act is to increase the number of
expanded access IND applications at academic medical centers
in this Commonwealth so as to provide and to further test
purified or synthesized CBD in children with rare forms of
epilepsy.
(8) If further testing shows CBD is effective, and the
FDA approves it, physicians will be able to prescribe CBD to
all children in the nation who suffer from intractable
epilepsy.
Section 3. 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 medical center." A hospital that operates a
medical residency program for physicians and conducts research
that involves human subjects.
"Approved source." A provider which produces cannabidiol
that:
(1) Has been manufactured and tested in a facility
approved or certified by the Food and Drug Administration or
similar national regulatory agency in the United States or
another country.
(2) Has been tested in animals to demonstrate
preliminary effectiveness and to ensure that it is safe to
administer to humans.
"Cannabidiol." A finished preparation containing, of its
total cannabinoid content, at least 98% cannabidiol and no more
than .30% tetrahydrocannabinol that has been extracted from
marijuana or synthesized in a laboratory.
"Investigator." An individual who actually conducts a
clinical investigation and under whose immediate direction a
drug is administered or dispensed to a subject.
"Pediatric patients with severe forms of epilepsy." Children
who are younger than 21 years of age, suffer from refractory
epilepsy and do not respond to standard medications.

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"Physician." A person licensed to practice medicine in this


Commonwealth.
"Sponsor." A person, including an individual or
pharmaceutical company, governmental agency, academic
institution, private organization or other organization, who
takes responsibility for and initiates a clinical investigation.
"Sponsor-investigator." An individual who both initiates and
conducts an investigation and under whose immediate direction an
investigational drug is administered or dispensed.
Section 4. Expanded access clinical trials.
(a) Authorization.--A Statewide investigational new drug
application may be established in this Commonwealth, if
submitted by a sponsor or sponsor-investigator and approved by
the Food and Drug Administration, to conduct expanded access
clinical trials using cannabidiol on pediatric patients with
severe forms of epilepsy.
(b) Physicians as sponsor-investigators or investigators.--A
physician who is a board-certified neurologist practicing in an
academic medical center in this Commonwealth and treating
pediatric patients with severe forms of epilepsy shall serve as
the sponsor-investigator or investigator for the clinical
trials.
(c) Subinvestigators.--A physician, acting as a sponsorinvestigator or investigator, may include subinvestigators who
are board-certified neurologists who practice in an academic
medical center in this Commonwealth and treat pediatric patients
with severe forms of epilepsy.
(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 cannabidiol.
(a) General rule.--Expanded access clinical trials conducted
pursuant to a Statewide investigational new drug application
established pursuant to this act shall only utilize cannabidiol
that is:
(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 cannabidiol.--The sponsor, sponsorinvestigator or investigator and any subinvestigator may receive
cannabidiol 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 cannabidiol pursuant to this

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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.

2015/90DMS/SB0003A04447

- 4 -

S0003B0889A04450

PWK:JMT 11/20/15

#90

A04450

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE D. COSTA
Printer's No. 889
1

Amend Bill, page 14, lines 16 through 25 (A04380), by

striking out "to determine if the caregiver has a history of" in

line 16 and all of lines 17 through 25 and inserting

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. The department may, in its discretion, deny an application


to be a caregiver if the prescription drug monitoring program
indicates that the applicant has a history of drug abuse within
the five-year period immediately preceding the submission of the
application. The department shall deny an application to be a
caregiver if the criminal history record information indicates
that the applicant plead guilty to or has been convicted of a
felony under the act of April 14, 1972 (P.L.233, No.64), known
as The Controlled Substance, Drug, Device and Cosmetic Act, or
under a similar law in another state or at the Federal level
within the five-year period immediately preceding the submission
of the application.

2015/90PWK/SB0003A04450

- 1 -

Regular Session 2015 - 2016


Amendment A04492 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04508

MSP:NLH 11/24/15

#90

A04508

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE KNOWLES
Printer's No. 889
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Amend Bill, page 1, by inserting between lines 6 and 7


CHAPTER 2.
Section
Section
Section
Section
Section
Section
Section

201.
202.
203.
204.
205.
206.
207.

MEDICAL CANNABIS RESEARCH TRIAL


PROGRAM
Department of Health Trial Program.
Definitions.
Health care medical cannabis dispensers.
Research programs.
Medical cannabis research.
Research reports.
Funding.

Amend Bill, page 3, by inserting after line 30


Section 5105.

Expiration.

Amend Bill, page 4, line 1, by striking out "5105" and


inserting
5106
Amend Bill, page 9, by inserting between lines 17 and 18
CHAPTER 2
MEDICAL CANNABIS RESEARCH TRIAL PROGRAM
Section 201. Department of Health Trial Program.
Upon the adoption of regulations as required under this act
and for a five-year period thereafter, the dispensing of medical
cannabis shall only be authorized for patients participating in
research programs as prescribed under this chapter.
Section 202. 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:
"Physician." A medical doctor or doctor of osteopathy as
defined under section 2 of the act of December 20, 1985
(P.L.457, No.112), known as the Medical Practice Act of 1985,
who is board certified in one of the following medical
specializations:
(1) Oncology.
(2) Neurology.

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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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with a disclosure, prepared by the Department of Health,


which includes potential dangers, recognition and correction
of problematic dosage and any other information which the
Department of Health deems relevant for patient safety.
(d) Restrictions for health care medical cannabis
dispensers.--A health care medical cannabis dispenser may not
participate in a research study or dispense medical cannabis if
the health care medical cannabis dispenser has violated
licensure requirements under the Health Care Facilities Act.
Section 204. Research programs.-(a) Establishment.--The Department of Health shall establish
and develop research programs to study the impact of medical
cannabis on disease treatment and symptom management.
(b) Duties.--The following shall apply:
(1) In order for the Commonwealth to engage in research
on medical cannabis, the Department of Health shall:
(i) Review all diagnoses which are cited by a
physician upon the physician's recommendation that the
patient be granted a medical cannabis access card.
(ii) Create a database of all diagnoses and
comorbidities which are cited in the medical cannabis
access card recommendation.
(iii) Upon receipt of 25 or more patients with the
same diagnosis or diagnosis and comorbidities, petition
the United States Food and Drug Administration and the
United States Drug Enforcement Administration for
approval to study the disease and the impact of medical
cannabis on the disease.
(iv) 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 group upon which a vertically
integrated health system and a university within this
Commonwealth may submit a request to participate in the
research group.
(v) Upon approval of the research program by the
United States Food and Drug Administration and the United
States Drug Enforcement Administration, select a
vertically integrated health system to administer the
research program and designate the strain of medical
cannabis which will be used to treat the disease or
disease and comorbidities.
(vi) Notify patients who have been granted medical
cannabis access cards that the patients have been placed
into a research program to study medical cannabis as a
treatment and inform the patients where the patients are
able to secure medical cannabis through a health care
medical cannabis dispenser.
(vii) Automatically assign additional patients with
diagnoses which have reached the threshold under
subparagraph (iii) to a research project upon receipt of

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the certification by the physician.


(2) The Department of Health shall take into
consideration the geographic location of the health care
medical cannabis dispenser when assigning a patient to a
dispenser.
(3) If a vertically integrated health system is not
geographically located within 50 miles of the patient, the
patient may be given the opportunity to opt out of the
research study.
(4) Data collected by the health care medical cannabis
dispenser must be provided to the affiliated university
participating in the research program for analysis.
(5) Reports on the effectiveness of the use of medical
cannabis for the treatment of the disease and all counterindications and noted side effects must be submitted to the
Department of Health beginning 180 days after the
implementation of the research program for the specific
disease or disease with comorbidities.
Section 205. Medical cannabis research.
(a) Establishment.--The Department of Health shall establish
a research project for each qualified medical condition which
appears to benefit from the use of medical cannabis as a
treatment option. The research projects approved under the
procedure established under section 204 shall only use
vertically integrated health systems in this Commonwealth and
shall engage universities within this Commonwealth to
participate in the collection, collation, analysis and
conclusive findings of the medical cannabis research projects.
(b) Form and procedure.--The Department of Health shall
establish a form and procedure for universities to administer or
conduct research on medical cannabis. The forms shall include,
at a minimum, the following:
(1) The strain of medical cannabis to be studied.
(2) The disease to be studied.
Section 206. Research reports.
(a) Notification of required data for reports.--The
Department of Health shall notify the vertically integrated
health system and the university participating in the research
project of the data which is required to meet the United States
Food and Drug Administration and the United States Drug
Enforcement Administration's approval for the research project.
(b) Initial report.--The first report, including the data
required under subsection (a), shall be submitted to the
Department of Health and made publicly available within 180 days
of the initiation of the research project.
(c) Annual reporting.--An annual report of the data required
under subsection (a) shall be submitted to the Department of
Health beginning one year after the initiation of the research
project and each year thereafter.
(d) Duties of the Department of Health.--The Department of
Health shall have the duty to do the following:

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(1) Compile annual reports from vertically integrated


health systems and universities participating in the research
project and make them publicly available.
(2) Provide the reports to the following:
(i) The chairperson and minority chairperson of the
Public Health and Welfare Committee of the Senate of
Pennsylvania.
(ii) The chairperson and minority chairperson of the
Health Committee of the House of Representatives.
Section 207. Funding.
The funding of studies and the cost of medical cannabis
dispensed pursuant to the studies under this chapter may be paid
from any research fund provided for under this act.

14

Amend Bill, page 69, by inserting between lines 25 and 26

15
16
17

Section 5105. Expiration.


This act shall expire five years and six months after the
effective date of this section.

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19
20

Amend Bill, page 69, line 26, by striking out "5105" and
inserting
5106

2015/90MSP/SB0003A04508

- 5 -

Regular Session 2015 - 2016


Amendment A04509 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04524

BIL:CMD 11/25/15

#90

A04524

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE MARSICO
Printer's No. 889
1
2

Amend Bill, page 20, line 42 (A04380), by inserting after


"No"

3
4
5

medical
Amend Bill, page 21, line 10 (A04380), by striking out "shall
register organizations which" and inserting

is authorized to register eligible applicants to

Amend Bill, page 25, line 35 (A04380), by inserting after

"The"

9
10
11
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13
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medical marijuana
Amend Bill, page 25, line 37 (A04380), by inserting after
"The"
medical marijuana
Amend Bill, page 39, line 40 (A04380), by inserting after
"defective"
medical

2015/90BIL/SB0003A04524

- 1 -

S0003B0889A04558

BIL:BTW 11/30/15

#90

A04558

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE LAWRENCE
Printer's No. 889
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Amend Bill, page 13, by inserting between lines 18 and 19


(A04380)
(g) Notice.--The department shall, upon issuance of an
identification card to a patient or caregiver 15 years of age or
older, include a written notification with the following
language:
IMPORTANT NOTICE ABOUT MEDICAL MARIJUANA
AND OPERATING A MOTOR VEHICLE
Before starting a medical marijuana regimen, talk to your
doctor or health care practitioner about how medical marijuana
may impact your ability to safely operate a motor vehicle.
Under Pennsylvania law, even a small amount of marijuana in your
blood could result in conviction for DUI (Driving Under the
Influence), also called Impaired Driving or Drugged Driving.
Conviction for DUI can result in serious penalties, including
fines, jail and losing your driver's license for a period of
time. If you have any questions about how the DUI law could
potentially impact you, contact your attorney for legal advice.

2015/90BIL/SB0003A04558

- 1 -

Regular Session 2015 - 2016


Amendment A04576 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04577 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04578 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04579 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04580 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04581 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04582

BIL:JMT 11/30/15

#90

A04582

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE MARSICO
Printer's No. 889
1
2

Amend Bill, page 20, by inserting between lines 43 and 44


(A04380)

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(8.1) In accordance with regulations promulgated by the


department:
(i) To initially grow medical marijuana, a
grower/processor may obtain seed and plant material from
outside this Commonwealth.
(ii) To grow medical marijuana, a grower/processor
may obtain seed and plant material from another
grower/processor within this Commonwealth.

11

Amend Bill, page 33, by inserting between lines 12 and 13

12

(A04380)

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18

(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.
(ii) From another grower/processor within this
Commonwealth to grow medical marijuana.

19

Amend Bill, page 33, line 13 (A04380), by striking out "(30)"

20
21

and inserting
(31)

2015/90BIL/SB0003A04582

- 1 -

Regular Session 2015 - 2016


Amendment A04583 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04584

BIL:JMT 11/30/15

#90

A04584

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE MARSICO
Printer's No. 889
1
2

Amend Bill, page 20, line 42 (A04380), by inserting after


"No"

3
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5

medical
Amend Bill, page 20, by inserting between lines 43 and 44
(A04380)

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9
10
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12
13

(8.1) In accordance with regulations promulgated by the


department:
(i) To initially grow medical marijuana, a
grower/processor may obtain seed and plant material from
outside this Commonwealth.
(ii) To grow medical marijuana, a grower/processor
may obtain seed and plant material from another
grower/processor within this Commonwealth.

14

Amend Bill, page 21, line 10 (A04380), by striking out "shall

15

register organizations which" and inserting

16

is authorized to register eligible applicants to

17

Amend Bill, page 25, line 35 (A04380), by inserting after

18

"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.

2015/90BIL/SB0003A04584

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(ii) From another grower/processor within this


Commonwealth to grow medical marijuana.
Amend Bill, page 33, line 13 (A04380), by striking out "(30)"
and inserting
(31)
Amend Bill, page 39, line 40 (A04380), by inserting after
"defective"
medical

2015/90BIL/SB0003A04584

- 2 -

Regular Session 2015 - 2016


Amendment A04585 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04586 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04587 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04592

KMK:CMD 11/30/15

#90

A04592

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE PETRARCA
Printer's No. 889
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2

Amend Bill, page 26, lines 42 and 43 (A04380), by striking


out "However, no more than 15%" and inserting

Fifteen percent

Amend Bill, page 26, line 43 (A04380), by striking out "may"

and inserting

shall

Amend Bill, page 31, line 3 (A04380), by striking out "three"

8
9

and inserting
two

2015/90KMK/SB0003A04592

- 1 -

S0003B0889A04597

KMK:CMD 12/01/15

#90

A04597

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE PETRARCA
Printer's No. 889
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Amend Bill, page 14, line 25 (A04380), by inserting after


"substances"
within the last five years
Amend Bill, page 26, lines 42 and 43 (A04380), by striking
out "However, no more than 15%" and inserting
Fifteen percent
Amend Bill, page 26, line 43 (A04380), by striking out "may"
and inserting
shall
Amend Bill, page 31, line 3 (A04380), by striking out "three"
and inserting
two

2015/90KMK/SB0003A04597

- 1 -

S0003B0889A04608

KMK:JMT 12/02/15

#90

A04608

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
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Amend Bill, page 49, by inserting between lines 14 and 15

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(8) Complete an assessment or provide follow up care


through electronic means, including, but not limited to, the
telephone or the Internet if the health care practitioner is
going to provide the certification as required under section
701. Health care practitioners who provide such care shall be
deemed to have violated professional standards and shall be
subject to penalty by the appropriate licensing board of the
Commonwealth.

2015/90KMK/SB0003A04608

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S0003B0889A04609

KMK:JMT 12/02/15

#90

A04609

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
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14
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Amend Bill, page 2, by inserting between lines 14 and 15


Section 513.

Testing of medical cannabis.

Amend Bill, page 42, by inserting between lines 2 and 3


Section 513. Testing of medical cannabis.
The Department of Health and the Department of Agriculture
shall promulgate rules and regulations necessary to facilitate
the testing of medical cannabis in testing laboratories. The
testing shall include, but not be limited to, the presence of:
(1) pesticides;
(2) mold;
(3) mildew;
(4) e-coli;
(5) salmonella; and
(6) any other foreign substance that is not naturally
found in cannabis.

2015/90KMK/SB0003A04609

- 1 -

S0003B0889A04610

KMK:JMT 12/02/15

#90

A04610

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2
3

Amend Bill, page 29, line 19, by striking out "130" and
inserting
five

2015/90KMK/SB0003A04610

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S0003B0889A04611

KMK:JMT 12/02/15

#90

A04611

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
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Amend Bill, page 55, by inserting between lines 24 and 25


(5) Any registered patient who is party to a selfregulatory organization, including, but not limited to, the
National Collegiate Athletic Association (NCAA), the National
Football League (NFL), the National Hockey League (NHL),
Major League Baseball (MLB), the National Basketball
Association (NBA), the Women's National Basketball
Association (WNBA), the Professional Golfers' Association
(PGA), the United States Soccer Federation (USSF), the Ladies
Professional Golf Association (LPGA) and the United States
Tennis Association (USTA) and is subject to random drug
testing for which cannabis is prohibited is not permitted to
use his or her status as a registered patient as a defense to
any judicial or disciplinary actions instituted by the selfregulatory organization.

2015/90KMK/SB0003A04611

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S0003B0889A04612

KMK:JMT 12/02/15

#90

A04612

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
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Amend Bill, page 55, by inserting between lines 24 and 25


(5) An employer of any of the following may prohibit the
use of medical cannabis by its employees at all times, even
if the employee has received a medical access card:
(i) an individual who operates a vehicle of mass
transportation, including a bus or plane;
(ii) an individual who operates a vehicle of public
transportation;
(iii) an individual who works with minors in his or
her ordinary course of business; or
(iv) an individual who works for a public utility
company, including a nuclear power plant.

2015/90KMK/SB0003A04612

- 1 -

S0003B0889A04613

KMK:EJH 12/02/15

#90

A04613

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
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Amend Bill, page 55, by inserting between lines 24 and 25


(5) An individual may not claim intoxication due to
medical cannabis or marijuana as a defense in an impairment
of contracts cause of action.
(6) An employer of any of the following may prohibit the
use of medical cannabis by its employees at all times, even
if the employee has received a medical access card:
(i) an individual who operates a vehicle of mass
transportation, including a bus or plane;
(ii) an individual who operates a vehicle of public
transportation;
(iii) an individual who works with minors in his or
her ordinary course of business; or
(iv) an individual who works for a public utility
company, including a nuclear power plant.

2015/90KMK/SB0003A04613

- 1 -

S0003B0889A04614

KMK:EJH 12/02/15

#90

A04614

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 55, by inserting between lines 24 and 25

2
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(5) An individual may not claim intoxication due to


medical cannabis or marijuana as a defense in an impairment
of contracts cause of action.

2015/90KMK/SB0003A04614

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S0003B0889A04615

KMK:EJH 12/02/15

#90

A04615

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 8, line 12, by striking out "Any of the

following:" and inserting

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Any of the following medical conditions that have been


diagnosed by both the health care practitioner who has issued
the certification for the patient under section 701(d) and has
been concurred by one other licensed physician by acknowledgment
in writing that, based on his or her separate personal medical
examination of the patient and in his or her medical judgment,
the patient has the medical condition:

2015/90KMK/SB0003A04615

- 1 -

Regular Session 2015 - 2016


Amendment A04616 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04618 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04619 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04620 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04621 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04622 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04623 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04624 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04633

AJB:BTW 12/02/15

#90

A04633

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE EVANKOVICH
Printer's No. 889
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Amend Bill, page 55, by inserting between lines 13 and 14


(v) Chemicals which require a permit issued by the
Federal Government or a state government or an agency of
the Federal Government or a state government.
(vi) High voltage electricity or any other public
utility.
Amend Bill, page 55, line 14, by striking out "(v)" and
inserting
(vii)

10

Amend Bill, page 55, by inserting between lines 24 and 25

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(5) A registered patient may not perform any employment


duties at heights or in confined spaces, including, but not
limited to, mining while under the influence of medical
cannabis.
(6) A registered patient may be prohibited by an
employer from performing any task which the employer deems
life threatening, to either the employee or any of the
employees of the employer, while under the influence of
medical cannabis. The prohibition shall not be deemed an
adverse employment decision even if the prohibition results
in financial harm for the registered patient.
(7) A registered patient may be prohibited by an
employer from performing any duty which could result in a
public health or safety risk while under the influence of
medical cannabis. The prohibition shall not be deemed an
adverse employment decision even if the prohibition results
in financial harm for the registered patient.

2015/90AJB/SB0003A04633

- 1 -

Regular Session 2015 - 2016


Amendment A04634 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04635

AJB:CDM 12/02/15

#90

A04635

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE MURT
Printer's No. 889
1
2
3
4
5

Amend Bill, page 8, by inserting between lines 28 and 29


(16)

Chiari malformation.

Amend Bill, page 8, line 29, by striking out "(16)" and


inserting
(17)

2015/90AJB/SB0003A04635

- 1 -

Regular Session 2015 - 2016


Amendment A04636 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04638

AJB:EJH 12/02/15

#90

A04638

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 10, line 29, by striking out "Each" and

inserting

3
4

In addition to the qualifications specified under section


310, each

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Amend Bill, page 24, by inserting between lines 16 and 17


Section 310. Qualifications and restrictions of the board.
(a) Qualification and restrictions.--The qualifications and
restrictions of members of the board shall be as follows:
(1) Each member at the time of appointment shall be at
least 25 years of age and shall have been a resident of this
Commonwealth for a period of at least one year immediately
preceding appointment. Each member shall continue to remain a
resident of this Commonwealth during the term of membership
on the board.
(2) Except for ex officio members, no person shall be
appointed a member of the board or be employed by or be an
independent contractor of the board if that person is a
public official or party officer as defined 4 Pa.C.S. 1512
(relating to financial and employment interests) in this
Commonwealth or any of its political subdivisions.
(3) Each member, employee and independent contractor of
the board shall sign an agreement not to disclose
confidential information.
(4) No member, employee or independent contractor of the
board or other agency having regulatory authority over the
board shall be employed, hold any office or position or be
engaged in any activity which is incompatible with the
position, employment or contract.
(5) No member shall be paid or receive any fee or other
compensation for any activity related to the duties or
authority of the board other than salary and expenses
provided by law.
(6) No member, employee or independent contractor of the
board shall participate in a hearing, proceeding or other
matter in which the member, employee or independent
contractor, or the immediate family of the member, employee
or independent contractor, has a financial interest in the

2015/90AJB/SB0003A04638

- 1 -

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subject matter of the hearing or proceeding or other interest


that could be substantially affected by the outcome of the
hearing or proceeding without first fully disclosing the
nature of the interest to the board and other persons
participating in the hearing or proceeding. The board shall
determine if the interest is a disqualifying interest that
requires the disqualification or nonparticipation of an
employee or independent contractor. For purposes of this
paragraph, the term "immediate family" shall mean spouse,
parent, brother, sister or child.
(7) At the time of appointment and annually thereafter,
each member shall disclose the existence of any financial
interest in any applicant, medical cannabis grower, processor
or dispenser and in an affiliate, intermediary, subsidiary or
holding company thereof held by the member or known to be
held by the member's immediate family. The disclosure
statement shall be filed with the chairperson of the board
and the Governor and shall be open to inspection by the
public at the office of the board during the normal business
hours of the board for the duration of the member's term and
for two years after the member leaves office. For purposes of
this paragraph, the term "immediate family" shall mean
spouse, parent, brother, sister or child.
(8) Prior to being sworn as a member, an appointee and
the appointee'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 appointee or
known to be held by the appointee's immediate family. For the
duration of the member's term and for two years thereafter,
the member and the member's immediate family may not acquire
a financial interest in any applicant, medical cannabis
grower, processor or dispenser or in an affiliate,
intermediary, subsidiary or holding company of any applicant,
medical cannabis grower, processor or dispenser. For purposes
of this paragraph, the term "immediate family" shall mean
spouse and any minor or unemancipated child.
(9) Prior to entering into employment or a contract with
the board and annually thereafter, an employee or independent
contractor shall disclose the existence of 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. The
disclosure statement shall be filed with the board and shall
be open to inspection by the public at the office of the
board during the normal business hours of the board and for
two years after termination of employment or a contract with
the board. For purposes of this paragraph, the term
"immediate family" shall mean spouse, parent, brother, sister

2015/90AJB/SB0003A04638

- 2 -

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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

2015/90AJB/SB0003A04638

- 3 -

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a member shall be designated pursuant to subsection (e) to


serve the remainder of the ex officio member's term.
(15) The following shall apply to an employee of the
board whose duties substantially involve licensing,
enforcement, development of law, promulgation of regulations
or development of policy, relating to medical cannabis under
this chapter or who has other discretionary authority which
may affect or influence the outcome of an action, proceeding
or decision under this part, including the executive
director, bureau directors and attorneys:
(i) The individual may not, for a period of two
years following termination of employment, accept
employment with or be retained by any applicant, medical
cannabis grower, processor or dispenser or by any
affiliate, intermediary, subsidiary or holding company of
an applicant, medical cannabis grower, processor or
dispenser.
(ii) The individual may not, for a period of two
years following termination of employment, appear before
the board in a hearing or proceeding or participate in
activity on behalf of any applicant, medical cannabis
grower, processor or dispenser or on behalf of any
affiliate, intermediary, subsidiary or holding company of
any applicant, medical cannabis grower, processor or
dispenser.
(iii) Any applicant, medical cannabis grower,
processor or dispenser or affiliate, intermediary,
subsidiary or holding company of any applicant, medical
cannabis grower, processor or dispenser may not, until
the expiration of two years following termination of
employment, employ or retain the individual. Violation of
this subparagraph shall result in termination of the
individual's employment and subject the violator to
section 904.
(iv) A prospective employee who, upon employment,
would be subject to this paragraph must, as a condition
of employment, sign an affidavit that the prospective
employee will not violate subparagraph (i) or (ii). If
the prospective employee fails to sign the affidavit, the
board shall rescind any offer of employment and shall not
employ the individual.
(16) The following shall apply to an entity involved in
consultation relating to licensing, enforcement, development
of law, promulgation of regulations or development of policy,
relating to medical cannabis under this chapter:
(i) The person may not, for a period of two years
following termination of the contract with the board, be
retained by any applicant, medical cannabis grower,
processor or dispenser or any affiliate, intermediary,
subsidiary or holding company of a applicant, medical
cannabis grower, processor or dispenser.

2015/90AJB/SB0003A04638

- 4 -

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(ii) The person may not, for a period of two years


following termination of the contract with the board,
appear before the board in a hearing or proceeding or
participate in activity on behalf of any applicant, or
applicant, medical cannabis grower, processor or
dispenser on behalf of an affiliate, intermediary,
subsidiary or holding company of any applicant,
applicant, medical cannabis grower, processor or
dispenser.
(iii) Any applicant, medical cannabis grower,
processor or dispenser or an affiliate, intermediary,
subsidiary or holding company of any applicant, medical
cannabis grower, processor or dispenser may not, until
the expiration of two years following termination of the
contract with the board, employ or retain the person. A
knowing violation of this subparagraph shall result in
termination of the person's employment and subject the
violator to section 904.
(iv) Each contract between the board and an
independent contractor which involves the duties set
forth in this paragraph shall contain a provision
requiring the independent contractor to sign an affidavit
that the independent contractor will not violate
subparagraph (i) or (ii). If the independent contractor
fails to sign the affidavit, the board shall not enter
into the contract.
(v) An independent contractor shall require a
prospective employee whose employment would involve the
duties set forth in this paragraph to sign an affidavit
that the prospective employee will not violate
subparagraph (i) or (ii). If the prospective employee
fails to sign the affidavit, the independent contractor
shall rescind any offer of employment and shall not
employ the individual.
(17) If a member of the board violates any provision of
this section, the Governor may remove the person from the
board. A member removed under this paragraph shall, for a
period of five years following removal, be prohibited from
future appointment to the board and shall be prohibited from
applying for a license, permit or other authorization under
this chapter.
(b) Definitions.--As used in this section, the term
"financial interest" shall mean the ownership, property,
leasehold or other beneficial interest in an entity.
Section 311. Liability.
Members shall not be personally liable for any of the
following:
(1) Obligations of the board.
(2) Actions which were within the scope of their office
and made in good faith.

2015/90AJB/SB0003A04638

- 5 -

Regular Session 2015 - 2016


Amendment A04639 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04640

AJB:CDM 12/02/15

#90

A04640

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2
3
4
5
6
7
8
9
10
11

Amend Bill, page 47, by inserting between lines 10 and 11


(o) Prohibitions.--The Department of Health shall not issue
a medical cannabis access card to any patient who has:
(1) a prior felony drug conviction for any illegal or
illicit substance within the last five years;
(2) been prohibited from contact with any illegal or
intoxicating substance as a condition of probation or parole;
or
(3) as a condition of bail, as set by a court of
competent jurisdiction, been prohibited from using an illegal
or intoxicating substance.

2015/90AJB/SB0003A04640

- 1 -

Regular Session 2015 - 2016


Amendment A04641 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04642

AJB:JMT 12/02/15

#90

A04642

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2

Amend Bill, page 7, line 5, by inserting after "vaporization"


or vaporization

Amend Bill, page 52, line 26, by striking out "(A)"

Amend Bill, page 53, lines 2 through 8, by striking out all

of said lines

Amend Bill, page 55, line 24, by inserting after "cannabis"

7
8

or utilize a vaporizer to ingest or inhale medical


cannabis

2015/90AJB/SB0003A04642

- 1 -

Regular Session 2015 - 2016


Amendment A04643 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04644

AJB:JMT 12/02/15

#90

A04644

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 4, line 1, by striking out "Effective date"

and inserting

Expiration

4
5
6
7
8
9
10
11

Amend Bill, page 4, by inserting between lines 1 and 2


Section 5106.

Effective date.

Amend Bill, page 69, by inserting between lines 25 and 26


Section 5105. Expiration.
This act shall expire July 1, 2018.
Amend Bill, page 69, line 26, by striking out "5105" and
inserting
5106

2015/90AJB/SB0003A04644

- 1 -

Regular Session 2015 - 2016


Amendment A04645 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04646

AJB:CDM 12/02/15

#90

A04646

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2
3
4
5
6
7
8
9

Amend Bill, page 2, by inserting between lines 14 and 15


Section 513.

Applicant prohibitions.

Amend Bill, page 42, by inserting between lines 2 and 3


Section 513. Applicant prohibitions.
An individual applying for a license as a medical cannabis
grower, processor, dispenser, cannabis employee, patient or
patient designee shall be prohibited from obtaining a license if
the individual has a prior drug felony conviction for any
illegal or illicit substance within the last five years.

2015/90AJB/SB0003A04646

- 1 -

Regular Session 2015 - 2016


Amendment A04647 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04648

LKK:JMT 12/02/15

#90

A04648

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2
3
4
5
6

Amend Bill, page 3, by inserting after line 30


Section 5105.

Expiration.

Amend Bill, page 4, line 1, by striking out "5105" and


inserting
5106
Amend Bill, page 69, by inserting between lines 25 and 26

7
8
9
10

Section 5105. Expiration.


This act shall expire four years from the effective date of
this section unless reenacted prior to the expiration of this
act.

11

Amend Bill, page 69, line 26, by striking out "5105" and

12
13

inserting
5106

2015/90LKK/SB0003A04648

- 1 -

Regular Session 2015 - 2016


Amendment A04649 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04650

AJB:JMT 12/02/15

#90

A04650

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2
3
4
5
6
7

Amend Bill, page 47, by inserting between lines 10 and 11


(o) Prohibitions.--The Department of Health shall not issue
a medical cannabis access card to any patient who is prohibited
from contact with any illegal or intoxicating substance as a
condition of probation or parole or who, as a condition of bail,
as set by a court of competent jurisdiction, is prohibited from
using an illegal or intoxicating substance.

2015/90AJB/SB0003A04650

- 1 -

S0003B0889A04651

LKK:JMT 12/02/15

#90

A04651

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2
3
4
5

Amend Bill, page 3, by inserting after line 30


Section 5105.

Expiration.

Amend Bill, page 4, line 1, by striking out "5105" and


inserting
5106

Amend Bill, page 69, by inserting between lines 25 and 26

7
8
9

Section 5105. Expiration.


This act shall expire five years from the effective date of
this section unless reenacted prior to that date.

10
11
12

Amend Bill, page 69, line 26, by striking out "5105" and
inserting
5106

2015/90LKK/SB0003A04651

- 1 -

Regular Session 2015 - 2016


Amendment A04652 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04653 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04654

LKK:JMT 12/02/15

#90

A04654

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2
3
4
5
6
7
8
9
10
11
12
13
14

Amend Bill, page 3, by inserting after line 30


Section 5105.

Severability.

Amend Bill, page 4, line 1, by striking out "5105" and


inserting
5106
Amend Bill, page 69, by inserting between lines 25 and 26
Section 5105. Severability.
If any provision of this act or the application thereof to
any person or circumstance is held invalid, the invalidity shall
affect other provisions or applications of the act and to this
end the provisions of this act are declared to be nonseverable.
Amend Bill, page 69, line 26, by striking out "5105" and
inserting
5106

2015/90LKK/SB0003A04654

- 1 -

Regular Session 2015 - 2016


Amendment A04655 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04656

LKK:CDM 12/02/15

#90

A04656

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 5, line 30, by striking out all of said line

2015/90LKK/SB0003A04656

- 1 -

S0003B0889A04657

AJB:BTW 12/02/15

#90

A04657

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2
3
4
5
6
7
8
9
10
11
12
13
14

Amend Bill, page 3, by inserting after line 30


Section 5105.

Nonseverability.

Amend Bill, page 4, line 1, by striking out "5105" and


inserting
5106
Amend Bill, page 69, by inserting between lines 25 and 26
Section 5105. Nonseverability.
The provisions of this act are nonseverable. If any provision
of this act or its application to any person or circumstance is
held invalid, the remaining provisions or applications of this
act are void.
Amend Bill, page 69, line 26, by striking out "5105" and
inserting
5106

2015/90AJB/SB0003A04657

- 1 -

Regular Session 2015 - 2016


Amendment A04658 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04659

LKK:JSL 12/02/15

#90

A04659

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2
3
4
5
6

Amend Bill, page 7, line 5, by inserting after "vaporization"


or vaporization
Amend Bill, page 52, line 26, by striking out "(A)

USE IN

FOOD.--"
Amend Bill, page 53, lines 2 through 8, by striking out all
of said lines

2015/90LKK/SB0003A04659

- 1 -

Regular Session 2015 - 2016


Amendment A04660 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04661 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04662

LKK:EJH 12/02/15

#90

A04662

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2

Amend Bill, page 33, lines 15 through 20, by striking out all
of said lines

2015/90LKK/SB0003A04662

- 1 -

Regular Session 2015 - 2016


Amendment A04663 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04664

LKK:CDM 12/02/15

#90

A04664

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 43, lines 24 through 30; page 44, lines 1

through 7; by striking out all of lines 24 through 30 on page

43, all of lines 1 through 6 and "(m)" in line 7 on page 44 and

inserting

5
6
7
8

(l)
Amend Bill, page 46, line 21, by striking out "(n)" and
inserting
(m)

2015/90LKK/SB0003A04664

- 1 -

S0003B0889A04665

AJB:EJH 12/02/15

#90

A04665

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 1, lines 1 and 2, by striking out "the

medical use of cannabis in the Commonwealth of" in line 1 and

all of line 2 and inserting

4
5

Statewide expanded access clinical trials for cannabinoids; and


requiring certain physicians to provide annual reports.

Amend Bill, page 1, lines 4 through 16; pages 2 and 3, lines

1 through 30; page 4, line 1; by striking out all of said lines

on said pages and inserting

9
10
11
12
13
14
15
16

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

Amend Bill, page 4, lines 4 through 30; pages 5 through 68,

18

lines 1 through 30; page 69, lines 1 through 27; by striking out

19

all of said lines on said pages and inserting

20
21
22
23
24
25
26
27
28
29
30
31
32

Section 1. Short title.


This act shall be known and may be cited as the Therapeutic
Cannabinoid Research Act.
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

2015/90AJB/SB0003A04665

- 1 -

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make marijuana itself a medicine.


(4) Marijuana contains at least 85 cannabinoids that can
be extracted from marijuana and purified, or synthesized in a
laboratory, and tested in animals in preclinical research to
ensure that they are safe to administer to humans in clinical
trials.
(5) The FDA has approved several expanded access
investigational new drug (IND) applications that enable
investigators to utilize cannabinoids.
(6) The intent of this act is to increase the number of
expanded access IND applications at academic medical centers
in this Commonwealth so as to provide and further test the
medical uses of cannabinoids.
(7) Additionally, there are already FDA-approved drugs
made from cannabinoids for which individuals who may benefit
from the drugs have significantly limited access in this
Commonwealth.
(8) It is further the intent of this act to allow access
to those FDA-approved cannabinoids to more individuals with
qualifying medical conditions.
Section 3. 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 medical center." A hospital that operates a
medical residency program for physicians and conducts research
that involves human subjects.
"Approved source." A provider which produces cannabinoids
that:
(1) Have been manufactured and tested in a facility
approved or certified by the Food and Drug Administration or
similar national regulatory agency in the United States or
another country.
(2) Have been tested in animals to demonstrate
preliminary effectiveness and to ensure that it is safe to
administer to humans.
"Investigator." An individual who actually conducts a
clinical investigation and under whose immediate direction a
drug is administered or dispensed to a subject.
"Qualifying medical condition." One of the following
diseases diagnosed by a physician:
(1) Cancer, or complications as a direct result of
cancer.
(2) HIV/AIDS.
(3) Wasting syndrome.
(4) Multiple sclerosis.
(5) Intractable epilepsy.
"Physician." A person licensed to practice medicine in this
Commonwealth.
"Sponsor." A person, including an individual or
pharmaceutical company, governmental agency, academic

2015/90AJB/SB0003A04665

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institution, private organization or other organization, who


takes responsibility for and initiates a clinical investigation.
"Sponsor-investigator." An individual who both initiates and
conducts an investigation and under whose immediate direction an
investigational drug is administered or dispensed.
Section 4. Expanded access clinical trials.
(a) Authorization.--Statewide investigational new drug
applications may be established in this Commonwealth, if
submitted by a sponsor or sponsor-investigator and approved by
the Food and Drug Administration, to conduct expanded access
clinical trials using cannabinoids for individuals with a
qualifying medical condition.
(b) Physicians as sponsor-investigators or investigators.--A
physician practicing in an academic medical center in this
Commonwealth shall serve as the sponsor-investigator or
investigator for the clinical trials.
(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, even if the condition is
not specified in an investigational new drug application.
(3) Subject to oversight by the Food and Drug
Administration.
(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

2015/90AJB/SB0003A04665

- 3 -

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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.

2015/90AJB/SB0003A04665

- 4 -

Regular Session 2015 - 2016


Amendment A04666 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

Regular Session 2015 - 2016


Amendment A04667 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04668

LKK:EJH 12/02/15

#90

A04668

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 68, lines 11 through 24, by striking out

"Temporary regulations.--In order to facilitate the" in line 11,

all of lines 12 through 23 and "(c)" in line 24

4
5
6

Amend Bill, page 68, line 28, by striking out "(d)" and
inserting
(c)

2015/90LKK/SB0003A04668

- 1 -

Regular Session 2015 - 2016


Amendment A04669 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04670

LKK:EJH 12/02/15

#90

A04670

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 56, line 29, by striking out "second" and

inserting

first

4
5
6
7
8
9
10

Amend Bill, page 57, line 3, by striking out "third" and


inserting
second
Amend Bill, page 57, line 5, by striking out "misdemeanor"
and inserting
felony
Amend Bill, page 57, line 6, by striking out "first" and

11

inserting

12

third

13
14
15

Amend Bill, page 57, line 9, by striking out "third" and


inserting
second

2015/90LKK/SB0003A04670

- 1 -

Regular Session 2015 - 2016


Amendment A04671 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04672

LKK:CDM 12/02/15

#90

A04672

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE EVANKOVICH
Printer's No. 889
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25

Amend Bill, page 55, by inserting between lines 13 and 14


(v) Chemicals which require a permit issued by a
Federal or state government, or agency thereof.
(vi) High voltage electricity or any other public
utility.
Amend Bill, page 55, line 14, by striking out "(v)" and
inserting
(vii)
Amend Bill, page 55, by inserting between lines 24 and 25
(5) A registered patient may not perform any employment
duties at heights or in confined spaces, including mining,
while under the influence of medical cannabis.
(6) A registered patient may be prohibited by an
employer from performing any task which the employer deems
life-threatening, to either the employee or any of the
employees of the employer, while under the influence of
medical cannabis. This prohibition may not be deemed an
adverse employment decision even if the prohibition results
in financial harm for the registered patient.
(7) A registered patient may be prohibited by an
employer from performing any duty which could result in a
public health or safety risk while under the influence of
medical cannabis. This prohibition may not be deemed an
adverse employment decision even if the prohibition results
in financial harm for the registered patient.

2015/90LKK/SB0003A04672

- 1 -

Regular Session 2015 - 2016


Amendment A04673 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04674

LKK:JMT 12/02/15

#90

A04674

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 53, line 11, by inserting after "program"

2
3
4
5
6

insurer of any type, including a workers' compensation payer


or insurer, a self insured workers' compensation employer, the
State Workers Insurance Fund, the Uninsured Employers Guaranty
Fund, a private liability insurer or self insurer of any type,
including a motor vehicle, property or general liability carrier

Amend Bill, page 54, line 18, by inserting after "individual"

8
9
10
11
12

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

13

through 3; by striking out all of said lines on said pages and

14

inserting

15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33

(i) Nothing in this act shall require an employer to


make any accommodation for the use of medical marijuana
on the property or premises of any place of employment.
This act shall in no way limit the ability of an employer
do any of the following if the employer has reason to
believe that being under the influence of medical
marijuana could cause an employee's conduct to fall below
the standard of care normally accepted for the employee's
position:
(A) Prohibit an employee from being under the
influence of medical marijuana in the workplace.
(B) Prohibit an employee from working while
under the influence of medical marijuana.
(C) Requiring employees or job applicants to
disclose a prescription for or use of medical
marijuana.
(ii) This act shall in no way limit an employer's
ability to discipline an employee for violating a
workplace policy under subparagraph (i).

2015/90LKK/SB0003A04674

- 1 -

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(iii) This act shall in no way limit an employer's


ability to drug test employees or job applicants.
(iv) Nothing in this act shall require an employer
to commit any act that would put the employer or any
person acting on an employer's behalf in violation of
Federal law or at risk of losing a federal contract or
federal funding.
(6) No workers' compensation benefits shall be paid for
an accident or injury caused by or contributed to by medical
marijuana use in violation of the prescribed dosage,
treatment regimen or workplace policy under paragraph (5)(i).
(7) The following shall apply to unemployment
compensation:
(i) An employer shall be granted relief from charges
if a former employee is granted unemployment compensation
benefits because the employer could not accommodate the
employee's lawful use of medical marijuana.
(ii) An employee whose separation from employment
was caused by any of the following shall be deemed to
have committed willful misconduct and therefore is
ineligible for unemployment compensation benefits:
(A) Medical marijuana use that violates the
prescribed dosage, treatment regimen or workplace
policy under paragraph (5)(i).
(B) Refusal to submit to a test requested by an
employer to determine whether the employee is under
the influence of marijuana and therefore in violation
of paragraph (5)(i).

2015/90LKK/SB0003A04674

- 2 -

Regular Session 2015 - 2016


Amendment A04675 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04676

LKK:EJH 12/02/15

#90

A04676

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1
2
3

Amend Bill, page 43, line 10, by striking out "two years" and
inserting
one year

2015/90LKK/SB0003A04676

- 1 -

Regular Session 2015 - 2016


Amendment A04677 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04678

LKK:JSL 12/02/15

#90

A04678

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 35, by inserting between lines 18 and 19

2
3
4
5
6

(e) Criminal history.--The board shall deny an application


under this section if the applicant has been convicted of any
offense above a summary offense or of a violation of the act of
April 14, 1972 (P.L.233, No.64), known as The Controlled
Substance, Drug, Device and Cosmetic Act.

7
8
9

Amend Bill, page 35, line 19, by striking out "(e)" and
inserting
(f)

2015/90LKK/SB0003A04678

- 1 -

Regular Session 2015 - 2016


Amendment A04679 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04680

LKK:EJH 12/02/15

#90

A04680

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
1

Amend Bill, page 2, line 18, by striking out all of said line

Amend Bill, page 2, line 19, by striking out "704" and

3
4
5
6
7
8
9
10
11
12
13

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
Amend Bill, page 2, line 22, by striking out "707" and
inserting
706

14

Amend Bill, page 8, lines 29 and 30, by striking out "(16)

15

condition authorized by the department under" in line 29 and all

16

of line 30

17
18
19
20
21
22
23

Amend Bill, page 13, lines 5 through 8, by striking out all


of lines 5 through 7 and "(6)" in line 8 and inserting
(5)
Amend Bill, page 13, line 10, by striking out "(7)" and
inserting
(6)
Amend Bill, page 13, line 14, by striking out "(8)" and

2015/90LKK/SB0003A04680

- 1 -

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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)
Amend Bill, page 15, line 13, by striking out "(16)" and
inserting
(15)
Amend Bill, page 15, line 16, by striking out "(17)" and
inserting
(16)
Amend Bill, page 15, line 20, by striking out "(18)" and
inserting

2015/90LKK/SB0003A04680

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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)
Amend Bill, page 17, line 12, by striking out "(28)" and
inserting
(27)

2015/90LKK/SB0003A04680

- 3 -

1
2
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11

Amend Bill, page 50, lines 10 through 30; page 51, lines 1
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

2015/90LKK/SB0003A04680

- 4 -

Regular Session 2015 - 2016


Amendment A04681 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A04683

SFR:BTW 12/02/15

#90

A04683

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04380)


Sponsor: REPRESENTATIVE WATSON
Printer's No. 889
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Amend Bill, page 1, line 13 (A04380), by inserting after


"for"

academic clinical research centers and for

Amend Bill, page 2, by inserting between lines 48 and 49

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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

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(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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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
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 2003. 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

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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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S0003B0889A04978

DMS:NLH 12/09/15

#90

A04978

AMENDMENTS TO SENATE BILL NO. 3


Sponsor: REPRESENTATIVE DUSH
Printer's No. 889
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Amend Bill, page 2, by inserting between lines 14 and 15


Section 513.

Onsite alarm system.

Amend Bill, page 42, by inserting between lines 2 and 3


Section 513. Onsite alarm system.
In addition to any other requirement of this act, an onsite
alarm system shall be installed and maintained at any location
where the growing, producing, processing, distributing or
dispensing of medical marijuana, medical cannabis or any
cannabinoid takes place. The onsite alarm system shall be
installed and maintained in accordance with requirements
established by the Pennsylvania State Police.

2015/90DMS/SB0003A04978

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Regular Session 2015 - 2016


Amendment A04979 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

S0003B0889A05021

DMS:CMD 12/10/15

#90

A05021

AMENDMENTS TO SENATE BILL NO. 3 (As amended by A04385)


Sponsor: REPRESENTATIVE DUSH
Printer's No. 889
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Amend Bill, page 1, by inserting after line 19 (A04385)


(d)

Online alarm system.-(1) In addition to any other requirement of this


section, an onsite alarm system shall be installed and
maintained at any location where the growing, producing,
processing, distributing or dispensing of medical marijuana,
medical cannabis or any cannabinoid takes place. The onsite
alarm system shall be installed and maintained in accordance
with requirements established by the Pennsylvania State
Police.
(2) A Department of Health employee who has been trained
or retrained under subsection (a) shall be physically present
at the location during the hours of operation and shall
participate in the onsite alarm activation and deactivation
procedure upon the daily opening and closing of the location.
(3) A daily log of the activation and deactivation of
the onsite alarm by the onsite inspector shall be maintained.

2015/90DMS/SB0003A05021

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Regular Session 2015 - 2016


Amendment A05024 to
Senate Bill 3 Printer's Number 889
LRB Awaiting Notification of Amendment to be Affected

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