H1024B1823A02152 MSP:JSL 06/25/21 #90 A02152
AMENDMENTS TO HOUSE BILL NO. 1024
Sponsor: SENATOR REGAN
Printer's No. 1823
Amend Bill, page 1, lines 14 and 15, by striking out
"confidentiality and public disclosure and for"
Amend Bill, page 1, line 21, by striking out
"grower/processor" and inserting
grower/processors
Amend Bill, page 1, line 23, by inserting after
"requirements;"
in tax on medical marijuana, further providing for Medical
Marijuana Program Fund; in administration, further providing
for temporary regulations; in Medical Marijuana Advisory
Board, further providing for advisory board and for
regulations based on recommendations of advisory board; in
offenses related to medical marijuana, further providing for
disclosure of information prohibited;
Amend Bill, page 1, line 26, by striking out "; and," and
inserting
and providing for research initiative;
Amend Bill, page 1, line 27, by inserting after
"applicability"
; and making a related repeal
Amend Bill, page 2, line 1, by striking out ""caregiver" and"
and inserting
"caregiver,"
Amend Bill, page 2, line 2, by inserting after "care""
and "serious medical condition"
Amend Bill, page 2, line 4, by striking out "a definition"
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and inserting
definitions
Amend Bill, page 2, line 10, by inserting a bracket before
"The"
Amend Bill, page 2, line 10, by striking out the bracket
before "individual"
Amend Bill, page 2, line 10, by striking out "] person"
Amend Bill, page 2, line 12, by inserting after "marijuana."
] The term includes the following entities designated to
deliver medical marijuana:
(1) An individual designated by a patient.
(2) If the patient is under 18 years of age, an
individual under section 506(2).
(3) Individuals designated in writing, for purposes of
section 502, by an organization that provides hospice,
palliative or home health care services and:
(i) are employed by an organization that is licensed
under the act of July 19, 1979 (P.L.130, No.48), known as
the Health Care Facilities Act;
(ii) have significant responsibility for managing
the health care and well-being of a patient; and
(iii) were designated by the organization to provide
care to a patient who has provided authorization for the
designation.
(4) Individuals designated in writing, for purposes of
section 502, by a residential facility, including a long-term
care nursing facility, a skilled nursing facility, an
assisted living facility, a personal care home, an
independent long-term care facility or an intermediate care
facility for individuals with intellectual disabilities that:
(i) are licensed by the department or the Department
of Human Services;
(ii) have significant responsibility for managing
the health care and well-being of the patient; and
(iii) were designated by the residential facility to provide
care to a patient who has provided authorization for the
designation.
Amend Bill, page 2, lines 19 through 22, by striking out all
of said lines and inserting
" Excipients. " Solvents, chemicals or materials reported by a
medical marijuana organization and approved by the department
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for use in the processing of medical marijuana.
* * *
" Harvest batch. " A specifically identified quantity of
medical marijuana plant that is uniform in strain, cultivated
utilizing the same growing practices, harvested at the same time
and at the same location and cured under uniform conditions.
" Harvest lot. " A specifically identified quantity of medical
marijuana plant taken from a harvest batch.
* * *
" Medical marijuana product. " The final form and dosage of
medical marijuana that is grown, processed, produced, sealed,
labeled and tested by a grower/processor and sold to a
dispensary.
* * *
" Process lot. " An amount of a medical marijuana product of
the same type and processed using the same medical marijuana
extract, standard operating procedures and the same or
combination of different harvest lots.
* * *
" Research initiative. " A nonpatient investigation not
subject to Institutional Review Board or Research Approval
Committee approval requirements of a patient-based research
program, project or study, conducted by an academic clinical
research center and its contracted clinical registrant.
* * *
"Serious medical condition." Any of the following:
(1) Cancer, including remission therapy.
(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]
central nervous system (brain-spinal cord) with objective
neurological indication of intractable spasticity and other
associated neuropathies.
(7) Epilepsy.
(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) Sickle cell anemia.
(16) 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].
(17) Autism.
(18) Other conditions that are recommended by the
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advisory board and approved by the secretary under section
1202.
" Synchronous interaction. " A two-way or multiple-way
exchange of information between a patient and a health care
provider that occurs in real time via audio or video
conferencing.
Amend Bill, page 2, line 24, by striking out "302(b),"
Amend Bill, page 2, line 25, by inserting after "(4)"
and (7)
Amend Bill, page 2, lines 26 through 30; page 3, lines 1
through 15; by striking out all of said lines on said pages
Amend Bill, page 6, by inserting between lines 7 and 8
(7) A statement that the applicant:
[(i) Is of good moral character. For purposes of
this subparagraph, an applicant shall include each
financial backer, operator, employee and principal of the
medical marijuana organization.]
(ii) Possesses the ability to obtain in an
expeditious manner the right to use sufficient land,
buildings and other premises and equipment to properly
carry on the activity described in the application and
any proposed location for a facility.
(iii) Is able to maintain effective security and
control to prevent diversion, abuse and other illegal
conduct relating to medical marijuana.
(iv) Is able to comply with all applicable
Commonwealth laws and regulations relating to the
activities in which it intends to engage under this act.
* * *
Amend Bill, page 6, line 26, by inserting a bracket before
"the"
Amend Bill, page 6, line 27, by inserting after "substances:"
] the manufacture, delivery or possession with intent to
manufacture or deliver a controlled substance in violation of
the act of April 14, 1972 (P.L.233, No.64), known as The
Controlled Substance, Drug, Device and Cosmetic Act, or similar
law in any other jurisdiction:
Amend Bill, page 7, lines 1 through 4, by striking out "TO
INDIVIDUALS" in line 1 and all of lines 2 through 4 and
inserting
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to an individual for whom it has been 10 or more years since
the entry of a final disposition of a felony conviction related
to the manufacture, delivery or possession with intent to
manufacture or deliver a controlled substance in violation of
the act of April 14, 1972 (P.L.233, No.64), known as The
Controlled Substance, Drug, Device and Cosmetic Act, or similar
law in any other jurisdiction, or one year since the
individual's release from imprisonment for the felony
conviction, whichever is later.
Amend Bill, page 7, line 9, by striking out "and"
Amend Bill, page 7, line 22, by striking out "advisory board"
and inserting
department
Amend Bill, page 7, line 24, by striking out the comma after
"704" and inserting
and
Amend Bill, page 7, lines 24 and 25, by striking out ",
802(a)(1), 2001.1(A), 2002(A) AND (B) and 2109(a)"
Amend Bill, page 8, line 1, by inserting after "Obtain"
and transport
Amend Bill, page 8, line 3, by inserting after "grow"
and process
Amend Bill, page 8, line 10, by inserting after
"Commonwealth"
to process medical marijuana
Amend Bill, page 8, lines 15 through 30; page 9, lines 1
through 5; by striking out "The department shall" in line 15,
all of lines 16 through 30 on page 8 and all of lines 1 through
5 on page 9 and inserting
(3) Apply solvent-based extraction methods and processes
to medical marijuana plants that have failed a test conducted
by an approved laboratory at harvest, subject to the
following:
(i) The test failure shall be limited to yeast and
mold.
(ii) The extracted material shall be processed into
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a topical form.
(iii) The medical marijuana product must pass a
final processed test under section 704.
(iv) The medical marijuana product shall be labeled
as remediated.
(v) This paragraph shall expire upon the publication
in the Pennsylvania Bulletin of a notice of the
secretary's approval of the recommendations relating to a
research initiative, as prescribed in section 2003.1.
(4) Obtain harvested hemp from a person holding a permit
issued by the Department of Agriculture to grow or cultivate
hemp under the 3 Pa.C.S. Ch. 15 (relating to controlled
plants and noxious weeds) if the hemp received by a
grower/processor is subject to the laboratory testing
requirements of section 704.
(5) Add excipients or hemp or hemp-derived additives
obtained or cultivated in accordance with paragraph (4).
Excipients must be pharmaceutical grade, unless otherwise
approved by the department. In determining whether to approve
an added substance, the department shall consider the
following:
(i) Whether the added substance is permitted by the
United States Food and Drug Administration for use in
food or is Generally Recognized as Safe (GRAS) under
Federal guidelines.
(ii) Whether the added substance constitutes a known
hazard such as diacetyl, CAS number 431-03-8, and
pentanedione, CAS number 600-14-6.
Amend Bill, page 9, lines 14 through 19, by striking out
"the" in line 14 and all of lines 15 through 19 and inserting
a grower/processor shall maintain continuous video
surveillance. A grower/processor is required to retain the
recordings onsite or offsite for a period of no less than 180
days, unless otherwise required for investigative or
litigation purposes.
Amend Bill, page 9, lines 24 through 30; page 10, lines 1
through 13; by striking out the period in line 24, all of lines
25 through 30 on page 9 and all of lines 1 through 13 on page 10
and inserting
and designated by the Secretary of Agriculture in
consultation with the secretary for use by a
grower/processor.
(2) The Secretary of Agriculture shall, within 30 days
of the effective date of this subsection, transmit to the
Legislative Reference Bureau for publication in the
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Pennsylvania Bulletin an initial list of pesticides which may
be used by grower/processors. The list shall be posted on the
department's publicly accessible Internet website and shall
be reviewed and updated by the Secretary of Agriculture, in
consultation with the secretary, at least once annually and
transmitted to the Legislative Reference Bureau for
publication in the Pennsylvania Bulletin.
Amend Bill, page 11, line 7, by striking out the bracket
before the comma after "determine"
Amend Bill, page 11, line 8, by striking out "] of"
Amend Bill, page 11, line 14, by striking out "harvest batch
of"
Amend Bill, page 11, line 14, by inserting after "marijuana"
product derived from a harvest batch
Amend Bill, page 11, line 16, by striking out "a harvest
batch" and inserting
each process lot
Amend Bill, page 11, line 18, by striking out "harvest batch
of"
Amend Bill, page 11, line 18, by inserting after "marijuana"
product
Amend Bill, page 11, line 28, by striking out "REMOTELY" and
inserting
by synchronous interaction
Amend Bill, page 12, line 5, by striking out "REMOTELY" and
inserting
by synchronous interaction
Amend Bill, page 12, by inserting between lines 20 and 21
Section 5. Section 802(a)(1) of the act is amended and the
subsection is amended by adding a paragraph to read:
Amend Bill, page 12, by inserting between lines 26 and 27
(1.1) For the purposes of paragraph (1), a dispensary
shall maintain continuous video surveillance. The dispensary
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is required to retain the recordings onsite or offsite for a
period of no less than 180 days, unless otherwise required
for investigative or litigation purposes.
Amend Bill, page 12, by inserting between lines 27 and 28
Section 6. Sections 902(d), 1107(b), 1201(j)(4), (5) and
(6), 1202, 1307, 2001.1(a) and 2002(a) and (b) of the act are
amended to read:
Section 902. Medical Marijuana Program Fund.
* * *
(d) Repayment of initial funding.--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.]
Section 1107. Temporary regulations.
* * *
(b) Expiration.--[The] Notwithstanding any other provision
of law, the department's authority to adopt temporary
regulations under subsection (a) shall expire [two years after
the effective date of this section] May 31, 2022. Regulations
adopted after this period shall be promulgated as provided by
law.
* * *
Section 1201. Advisory board.
* * *
(j) Duties.--The advisory board shall have the following
duties:
* * *
(4) To issue [two years after the effective date of this
section a written report] written reports to the Governor,
the Senate and the House of Representatives.
(5) The written [report] reports 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 the form 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.
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[(vi) Whether to permit medical marijuana to be
dispensed in dry leaf or plant form, for administration
by vaporization.]
(6) The [final written report] written reports under
this section shall be adopted at a public meeting. The
[report] reports 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 1202. [Regulations based on] Effectuating
recommendations of advisory board.
After receiving [the] a report of the advisory board under
section 1201(j)(4), at the discretion of the secretary, the
department may [promulgate regulations to] effectuate
recommendations made by the advisory board by transmitting a
notice to the Legislative Reference Bureau for publication in
the Pennsylvania Bulletin. The secretary shall [issue notice]
transmit notice to the Legislative Reference Bureau for
publication in the Pennsylvania Bulletin within 12 months of the
receipt of [the] a 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.
Section 1307. Disclosure of information prohibited.
(a) Offense defined.--In addition to any other penalty
provided by law, an employee, financial backer, operator or
principal of any of the following 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:
(1) A medical marijuana organization.
(2) A health care medical marijuana organization or
university participating in a research study under Chapter
19.
(3) A clinical registrant or academic clinical research
center under Chapter 20.
(4) An employee or contractor of the department.
(b) Exception.--Subsection (a) shall not apply where
disclosure is permitted or required by law or by court order.
The department, including an authorized employee, requesting or
obtaining information under this act shall not be subject to any
criminal liability. The immunity provided by this subsection
shall not apply to any employee of the department who knowingly
and willfully discloses prohibited information under this act.
Amend Bill, page 14, lines 2 through 15, by striking out all
of said lines and inserting
(1) The department shall:
(i) Open applications for the approval of up to two
additional academic clinical research centers and issue
approvals to qualified academic clinical research centers
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within 90 days of the effective date of this paragraph.
(ii) Open applications for the approval of up to two
additional clinical registrants within 120 days of the
effective date of this paragraph and issue permits to
qualified clinical registrants within 180 days from the
date when applications are posted.
(2) If the statutory maximum number of approved academic
clinical research centers or approved clinical registrants
are not approved under paragraph (1), the department shall
reopen the application process for the approval of academic
clinical research centers and clinical registrants.
Amend Bill, page 14, line 26, by striking out "LICENSE" and
inserting
permit
Amend Bill, page 15, lines 10 and 11, by striking out ", AND
PROVIDED ALL RIGHTS OF OTHER GROWER/PROCESSOR PERMITTEES, "
Amend Bill, page 15, line 14, by inserting a bracket before
"ONLY"
Amend Bill, page 15, line 14, by inserting a bracket after
"ONLY"
Amend Bill, page 15, by inserting between lines 22 and 23
Section 7. The act is amended by adding a section to read:
Section 2003.1. Research initiative.
(a) Authority.--An academic clinical research center, in
coordination with its contracted clinical registrant, may
conduct a research initiative on the antimicrobial effects of
applying solvent-based extraction methods and processes to
microbial contamination of immature medical marijuana plants,
medical marijuana plants, medical marijuana or medical marijuana
products.
(b) Procedure.--An academic clinical research center shall
submit to the department for approval a completed written
research protocol of the planned research initiative. The
department shall grant approval or denial of the protocol within
15 days of its submissions. The following apply:
(1) The research initiative shall commence no later than
30 days from the date the department issues approval and
shall be completed no later than six months from the start
date of research initiative.
(2) Research initiative findings shall be provided to
the department by the academic clinical research center
within 15 days of the research initiative's conclusion.
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(3) An academic clinical research center and its
contracted clinical registrant shall present research
initiative findings to the advisory board and the board's
research subcommittee for the board's review and
consideration under sections 1201 and 1202. The board shall
issue a written report, with recommendations and findings
regarding the use of solvent-based extraction methods and
processes on microbial contamination by a clinical registrant
or grower/processor. The secretary may approve the board's
recommendation in accordance with section 1202.
(4) Prior to implementing a recommendation of the board
under paragraph (3), as approved by the secretary, a clinical
registrant or grower/processor shall seek approval from the
department for a change in its grower/processor extraction
process. The department shall inspect the site and facility
equipment. Upon approval, the department shall issue a notice
of final approval to implement the process.
Section 8. Section 2109(a) of the act is amended to read:
Amend Bill, page 15, line 30, by striking out all of said
line and inserting
Section 9. The amendment of the definition of "serious
medical condition" in section 103 of the act shall apply
retroactively to May 18, 2016.
Section 10. Repeals are as follows:
(1) The General Assembly declares that the repeal under
paragraph (2) is necessary to effectuate this act.
(2) Section 1736-A.1 of the act of April 9, 1929
(P.L.343, No.176), known as The Fiscal Code, is repealed.
Section 11. This act shall take effect as follows:
(1) The amendment or addition of sections 701(c.1) and
703(8) of the act shall take effect in 180 days.
(2) The remainder of this act shall take effect
immediately.
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