PRINTER'S NO. 924
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
835
Session of
2023
INTRODUCED BY REGAN AND BREWSTER, JUNE 20, 2023
REFERRED TO LAW AND JUSTICE, JUNE 20, 2023
AN ACT
Amending the act of April 17, 2016 (P.L.84, No.16), entitled "An
act 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 academic clinical research
centers and for penalties and enforcement," in preliminary
provisions, further providing for definitions; in program,
further providing for program established, for
confidentiality and public disclosure, for lawful use of
medical marijuana and for unlawful use of medical marijuana;
in practitioners, further providing for practitioner
registration, for practitioner restrictions, for issuance of
certification and for duration; in patients, further
providing for identification cards, for verification and for
contents of identification card; in medical marijuana
organizations, further providing for granting of permit, for
relocation and for limitations on permits; in medical
marijuana controls, further providing for electronic
tracking, for grower/processors, for storage and
transportation, for laboratory and for prices and providing
for recalls; in dispensaries, further providing for
dispensing to patients and caregivers and for facility
requirements; in tax on medical marijuana, further providing
for Medical Marijuana Program Fund; in Medical Marijuana
Advisory Board, further providing for advisory board; in
research program, further providing for establishment of
medical marijuana research program, for medical marijuana
research program administration and for approval; in academic
clinical research centers and clinical registrants, further
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
providing for legislative findings and declaration of policy,
for definitions and for clinical registrants and providing
for termination of contract; and, in miscellaneous
provisions, further providing for applicability.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The definitions of "certified medical use,"
"excipients," "harvest batch," "harvest lot," "patient,"
"process lot" and "serious medical condition" in section 103 of
the act of April 17, 2016 (P.L.84, No.16), known as the Medical
Marijuana Act, are amended and the section is amended by adding
a definition to read:
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:
* * *
"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] by the patient as authorized in a
certification under this act.
* * *
"Excipients." Solvents, chemicals or materials reported by a
medical marijuana organization [and approved by] to the
department for use in the processing of medical marijuana.
* * *
["Harvest batch." A specifically identified quantity of
20230SB0835PN0924 - 2 -
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
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.]
* * *
"Office." The Office of Medical Marijuana within the
department.
"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.
* * *
"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].
* * *
["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 central nervous
system (brain-spinal cord) with objective neurological
indication of intractable spasticity and other associated
neuropathies.
20230SB0835PN0924 - 3 -
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
(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.
(17) Autism.
(18) Other conditions that are recommended by the
advisory board and approved by the secretary under section
1202.]
* * *
Section 2. Section 301(a) introductory paragraph, (4)(v),
(9), (13) and (14) of the act are amended, the subsection is
amended by adding a paragraph and the section is amended by
adding a subsection to read:
Section 301. Program established.
(a) Establishment.--A medical marijuana program for patients
suffering from [serious] medical conditions is established. The
program shall be implemented and administered by the department.
The department shall:
* * *
(4) Establish and maintain an electronic database to
include activities and information relating to medical
marijuana organizations, certifications and identification
cards issued, practitioner registration and electronic
20230SB0835PN0924 - 4 -
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
tracking of all medical marijuana as required under this act
to include:
* * *
(v) [The] Two-way communication between the database
and the tracking system under section 701 [must include
information under section 801(a) and any other
information required by the department to be used by the
department and dispensaries to enable a dispensary to
lawfully provide medical marijuana. The tracking system
and database shall be capable of providing information in
real time. The database shall be capable of receiving
information from a dispensary regarding the disbursement
of medical marijuana to patients and caregivers. This
information shall be immediately accessible to the
department and other dispensaries to inhibit diversion
and ensure compliance with this act.] with immediate
access by the department and dispensaries to information,
including all of the following:
(A) Receipts as required under section 801(a)
and (c).
(B) Supply and form of medical marijuana
limitations requiring verification by dispensaries
under section 801(g).
(C) Any other information required by the
department to be used by the department and
dispensaries to enable a dispensary to lawfully
provide medical marijuana or to inhibit diversion and
ensure compliance with this act.
* * *
(9) Establish a program to authorize the use of medical
20230SB0835PN0924 - 5 -
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
marijuana to conduct medical research relating to the use of
medical marijuana to treat [serious] medical conditions,
including the collection of data and the provision of
research grants.
* * *
(13) Develop recordkeeping requirements for all books,
papers, any electronic database or tracking system data and
other information of a medical marijuana organization.
Information shall be retained for a minimum period of [four
years] 180 days unless otherwise provided by the department.
[(14) Restrict the advertising and marketing of medical
marijuana, which shall be consistent with the Federal
regulations governing prescription drug advertising and
marketing.]
(15) Define and publish within 30 days of the effective
date of this paragraph guidelines for and monitor the
advertising and marketing of medical marijuana in accordance
with the following:
(i) Medical marijuana organizations must follow the
guidelines.
(ii) Advertising or marketing materials produced by
or for a medical marijuana organization shall:
(A) Not require preapproval by the department.
(B) Be free of names, colors and images that
would be attractive to individuals under 21 years of
age.
(C) Only be placed where the audience is
reasonably expected to be 21 years of age or older.
(D) Comply with local ordinances pertaining to
signs and advertising.
20230SB0835PN0924 - 6 -
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
(iii) Permitted activities shall include the
development of and ability to provide and sell medical
marijuana organization branded materials.
* * *
(c) Office of Medical Marijuana.--The department shall
establish an Office of Medical Marijuana in accordance with the
following:
(1) The office shall oversee the Medical Marijuana
Program.
(2) A full-time director of the office shall be
appointed by the Governor, subject to the consent of a
majority of the members elected to the Senate.
Section 2.1. Section 302(a)(5) of the act is amended and the
section is amended by adding a subsection to read:
Section 302. Confidentiality and public disclosure.
(a) Patient information.--The department shall maintain a
confidential list of patients and caregivers to whom it has
issued identification cards. All information obtained by the
department relating to patients, caregivers and other applicants
shall be confidential and not subject to public disclosure,
including disclosure under the act of February 14, 2008 (P.L.6,
No.3), known as the Right-to-Know Law, including:
* * *
(5) Information relating to the patient's [serious]
medical condition.
* * *
(c) Administration.--Nothing in this section shall preclude
aggregation of de-identified data for research purposes,
operational key performance measures or sharing of the data for
the sole purpose of administering services to patients through a
20230SB0835PN0924 - 7 -
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
service provider who is contractually obligated to not use the
data for anything other than services provided to a medical
marijuana organization.
Section 3. Section 303(b)(2), (3) and (8) of the act are
amended and the subsection is amended by adding paragraphs to
read:
Section 303. Lawful use of medical marijuana.
* * *
(b) Requirements.--The lawful use of medical marijuana is
subject to the following:
* * *
(2) [Subject to regulations promulgated under this act,
medical] Medical marijuana may only be dispensed to a patient
or caregiver in the following forms:
[(i) pill;
(ii) oil;
(iii) topical forms, including gels, creams or
ointments;
(iv) a form medically appropriate for administration
by vaporization or nebulization, excluding dry leaf or
plant form until dry leaf or plant forms become
acceptable under regulations adopted under section 1202;
(v) tincture; or
(vi) liquid.
(3) Unless otherwise provided in regulations adopted by
the department under section 1202, medical marijuana may not
be dispensed to a patient or a caregiver in dry leaf or plant
form.]
(i) Infused edible forms meant to be chewed,
dissolved, taken sublingually or swallowed. This includes
20230SB0835PN0924 - 8 -
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
oil, tincture, capsules, tablets, gummies, liquids,
including beverages, and other ingestible forms.
(ii) Infused nonedible forms, including gels,
creams, patches and ointments.
(iii) Forms for administration by inhalation,
vaporization or nebulization, including flower and plant
materials.
* * *
(8) Products packaged by a grower/processor or sold by a
dispensary shall [only] be identified by the name of the
grower/processor, the name of the dispensary, the form and
species of medical marijuana, the percentage of
tetrahydrocannabinol and cannabinol contained in the product
and any other labeling [required by the department.] deemed
necessary by the medical marijuana organization.
(9) Grower/processors and dispensaries may source and
sell ancillary devices used to administer medical marijuana.
(10) The department shall publish guidelines for
packaging and labeling of medical marijuana. Preapproval of
packaging and labels by the department shall not be required.
All packaging shall be childproof and free of names, colors
and images that would be attractive to individuals under 21
years of age and packaging that will be in contact with the
medical marijuana must be food grade.
Section 4. Sections 304(b), 401(a) and (c), 402(a), 403(a)
(2) and (3) and (b), 405, 501(c), (d), (e) and (h), 503.1, 508,
603(d) and 609(a) of the act are amended to read:
Section 304. Unlawful use of medical marijuana.
* * *
(b) Unlawful use described.--It is unlawful to:
20230SB0835PN0924 - 9 -
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
[(1) Smoke medical marijuana.
(2) Except as provided under subsection (c), incorporate
medical marijuana into edible form.]
(3) Grow medical marijuana unless the grower/processor
has received a permit from the department under this act.
(4) Grow or dispense medical marijuana unless authorized
as a health care medical marijuana organization under Chapter
19.
(5) Dispense medical marijuana unless the dispensary has
received a permit from the department under this act.
* * *
Section 401. Practitioner registration.
(a) Eligibility.--A physician included in the registry is
authorized to issue certifications to patients to use medical
marijuana. To be eligible for inclusion in the registry a
physician must:
(1) [A physician must apply] Apply for registration in
the form and manner required by the department.
(2) [The department must determine that the physician
is, by] By training or experience, be qualified to treat [a
serious medical condition] medical conditions. The physician
shall provide documentation of credentials, training or
experience as required by the department.
(3) [The physician must have] Have successfully
completed the course under section 301(a)(6).
* * *
(c) Practitioner requirements.--A practitioner included in
the registry shall have an ongoing responsibility to immediately
notify the department in writing if [the practitioner knows or
has reason to know that any of the following is true with
20230SB0835PN0924 - 10 -
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
respect to a patient for whom the practitioner has issued a
certification:
(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.]:
(1) The practitioner chooses to no longer certify an
individual.
(2) A patient for whom the practitioner issued a
certification has died.
Section 402. 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.]
* * *
Section 403. Issuance of certification.
20230SB0835PN0924 - 11 -
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
(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:
* * *
(2) The practitioner has determined that the patient has
a [serious] medical condition and has included the condition
in the patient's health care record.
(3) The patient is under the practitioner's continuing
care [for the serious medical condition].
* * *
(b) Contents.--The certification shall include:
(1) The patient's name, date of birth and address.
(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 and limitation on the
duration of use, if applicable, including whether the patient
is terminally ill.
* * *
Section 405. Duration.
Receipt of medical marijuana by a patient or caregiver from
[a dispensary] dispensaries may not exceed a 90-day supply. [of
individual doses. During the last seven days of any 30-day
20230SB0835PN0924 - 12 -
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
period during the term of the identification card, a patient may
obtain and possess a 90-day supply for the subsequent 30-day
period. Additional 90-day supplies may be provided in accordance
with this section for the duration of the authorized period of
the identification card unless a shorter period is indicated on
the certification.]
Section 501. Identification cards.
* * *
(c) Application.--A patient or a caregiver [may apply, in]
applying for an issuance of an identification card shall apply
in a form and manner prescribed by the department[, for issuance
or renewal of an identification card]. A caregiver must submit a
separate application for issuance [or renewal]. Each application
must include:
(1) The name, address and date of birth of the patient.
(2) The name, address and date of birth of a caregiver.
(3) The certification issued by the practitioner.
(4) The name, address and telephone number of the
practitioner and documentation from the practitioner that all
of the requirements of section 403(a) have been met.
(5) A one time $50 processing fee. The department may
waive or reduce the fee if the applicant demonstrates
financial hardship.
(6) The signature of the applicant and date signed.
(7) Other information required by the department.
(d) Forms.--Application [and renewal] forms shall be
available on the department's publicly accessible Internet
website.
(e) Expiration.--An identification card of a patient or
caregiver shall not expire [within one year from the date of
20230SB0835PN0924 - 13 -
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
issuance, upon the death of the patient, or as otherwise
provided in this section].
* * *
(h) 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, the patient shall notify the department within 10 days
if the patient no longer has the serious medical condition noted
on the certification.]
Section 503.1. Verification.
The department shall verify the information in a patient or
caregiver's application [and on any renewal form].
Section 508. Contents of identification card.
An identification card shall contain the following:
(1) The name of the caregiver or the patient, 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 or
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.
[(5) Any requirement or limitation set by the
practitioner as to the form of medical marijuana.]
(6) Any other requirements determined by the department,
20230SB0835PN0924 - 14 -
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
except the department may not require that an identification
card disclose the patient's [serious] medical condition.
Section 603. Granting of permit.
* * *
(d) Regions.--The department shall establish a minimum of
three regions within this Commonwealth for the purpose of
granting permits to grower/processors and dispensaries and
enforcing this act. The department shall approve permits for
grower/processors and dispensaries in a manner which will
provide an adequate amount of medical marijuana to patients and
caregivers in all areas of this Commonwealth. The department
shall consider the following when issuing a permit:
(1) Regional 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.
Section 609. Relocation.
(a) Authorization.--The department may approve an
application from a medical marijuana organization to relocate
within [this Commonwealth or] the same permitted region as
established in section 603(d) to add or delete activities or
facilities.
* * *
Section 5. Section 616(3) and (4) of the act are amended and
the section is amended by adding paragraphs to read:
Section 616. Limitations on permits.
The following limitations apply to approval of permits for
grower/processors and dispensaries:
20230SB0835PN0924 - 15 -
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
* * *
(3) The department may not issue more than five
individual dispensary permits to one [person] entity.
(4) The department may not issue more than one
individual grower/processor permit to one [person] entity.
* * *
(8) After the initial issuance of permits, any
additional dispensary permits shall be awarded using the
competitive process and shall be issued in underserved
regions based upon patient distance to the nearest dispensary
and in counties without a dispensary permit as of the
effective date of this paragraph.
(9) If Federal or State law permits the sale of adult
use marijuana, e ach medical marijuana organization shall be
automatically issued a permit for growing/processing or
dispensing, based on the existing permit or permits, of both
medical and adult use marijuana products.
Section 6. Section 701(d) of the act is amended to read:
Section 701. Electronic tracking.
* * *
(d) Reports.--Within one year of the issuance of the first
permit to a grower/processor or dispensary, and every three
months thereafter in a form and manner prescribed by the
department, the following information shall be provided to the
department, which shall compile the information and post it on
the department's publicly accessible Internet website:
(1) The amount of medical marijuana sold in units by a
grower/processor during each three-month period.
(2) The [price] wholesale price by unit of amounts of
medical marijuana sold by grower/processors [as determined by
20230SB0835PN0924 - 16 -
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
the department].
(3) The amount of medical marijuana purchased in units
by each dispensary in this Commonwealth.
(4) The [cost of amounts] wholesale price by unit of
medical marijuana [to] received in each dispensary in amounts
as determined by the department.
(5) The total amount and dollar value of medical
marijuana sold by each dispensary in the three-month period.
Section 7. Section 702(a)(1), (3) and (5) and (b)(2) of the
act are amended and subsection (a) is amended by adding
paragraphs to read:
Section 702. Grower/processors.
(a) Authorization.--Subject to subsection (b), a
grower/processor may do all of the following in accordance with
department regulations:
(1) Obtain and transport seed and immature plant
material from outside this Commonwealth [during at least one
30-day period per year as designated by the department] to
grow and process medical marijuana.
* * *
[(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
a topical form.
(iii) The medical marijuana product must pass a
final processed test under section 704.
20230SB0835PN0924 - 17 -
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
(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.]
(3.1) Obtain industrial hemp-derived cannabidiol and
other cannabinoids from any commercial source within or from
outside of this Commonwealth.
* * *
(5) [Add] Produce medical marijuana products using
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] or food grade,
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], with residual limitations not to exceed
Federal guidelines for the subsequent dosage form under
the United States Pharmacopeia and the National
Formulary, and not a known hazard, including diacetyl,
CAS number 431-03-8, and pentanedione, CAS number 600-14-
6.
(6) Produce and sell medical marijuana products without
limitation or prior approval if the product:
(i) Is in compliance with paragraph (5).
20230SB0835PN0924 - 18 -
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
(ii) Has all ingredients listed on the packaging.
(iii) Is in a form authorized by this act.
(b) Limitations.--
* * *
(2) For the purpose of paragraph (1), 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] 60 days, unless
otherwise required for investigative or litigation purposes.
* * *
Section 8. Sections 703(3), 704 and 705 of the act are
amended to read:
Section 703. Storage and transportation.
The department shall develop regulations relating to the
storage and transportation of medical marijuana among
grower/processors, testing laboratories and dispensaries which
ensure adequate security to guard against in-transit losses. The
tracking system developed by the department shall include all
transportation and storage of medical marijuana. The regulations
shall provide for the following:
* * *
[(3) Security systems that include a numbered seal on
the trailer.]
* * *
Section 704. Laboratory.
(a) [General testing] Contracting.--A grower/processor shall
contract with one or more independent laboratories to test the
medical marijuana produced by the grower/processor.
(a.1) Approved laboratories.--The department shall approve a
laboratory under this subsection and require that the laboratory
20230SB0835PN0924 - 19 -
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
report testing results [in a manner as the department shall
determine, including requiring a test at harvest and a test at
final processing] within the State tracking system. The
possession by a laboratory of medical marijuana shall be a
lawful use.
(a.2) Samples.--
(1) A grower/processor shall submit a sample of final
products utilizing a statistically relevant sample for the
size of the batch to a contracted laboratory for testing.
(2) The batch size shall not be limited.
(3) Products may not be transferred for sale to a
dispensary without a passing test result.
(b) [Stability testing.--A laboratory shall perform
stability testing to ensure the medical marijuana product's
potency and purity.] Testing.--A grower/processor shall retain a
sample from each medical marijuana product [derived from a
harvest batch and request that a sample be identified and
collected by a laboratory approved under subsection (a) from
each process lot to perform stability testing] tested for sale
and submit the stability sample to a contracted laboratory to
perform stability testing to ensure the medical marijuana
product's potency and purity under the following conditions:
(1) The medical marijuana product is still in inventory
at a dispensary in this Commonwealth as determined by the
seed-to-sale system.
(2) The stability testing is done at six-month intervals
for the duration of the expiration date period as listed on
the medical marijuana product [and once within six months of
the expiration date].
Section 705. Prices.
20230SB0835PN0924 - 20 -
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
The department and the Department of Revenue shall monitor
the price of medical marijuana sold by grower/processors and by
dispensaries, including a [per-dose] unit price. If the
department and the Department of Revenue determine that the
prices are unreasonable or excessive, the department may
implement a cap on the price of medical marijuana being sold for
a period of six months. The cap may be amended during the six-
month period. If the department and the Department of Revenue
determine that the prices become unreasonable or excessive
following the expiration of a six-month cap, additional caps may
be imposed for periods not to exceed six months.
Section 9. The act is amended by adding a section to read:
Section 706. Recalls.
(a) Public health or safety.--A grower/processor shall
develop and implement a recall process and shall regularly
evaluate the products marketed by the grower/processor for
quality issues and defects that may impact public health or
safety and determine if a recall is necessary.
(b) Process.--Each grower/processor shall have a process for
recalls that includes all the following:
(1) How to assess the need for the recall.
(2) A plan of action while conducting a recall.
(3) How to address the depth of the recall.
(4) Whether public warnings should be issued.
(5) A plan to extend the effectiveness checks for the
recall.
(c) Definitions.--As used in this section, the following
words and phrases shall have the meanings given to them in this
subsection unless the context clearly indicates otherwise:
"Recall." A voluntary action by a grower/processor to remove
20230SB0835PN0924 - 21 -
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
a marketed product that is considered to be a risk to the public
health or safety.
Section 10. Sections 801(b), (d), (e), (f) and (h)
introductory paragraph, 802(a), 902(c)(3), 1201(a)(8) and (j)(5)
(i) and (ii), 1902(a) and (b), 1903, 1904 and 2000(a)(1) of the
act are amended to read:
Section 801. Dispensing to patients and caregivers.
* * *
(b) Requirements.--[A dispensary shall have a physician or a
pharmacist available, either in person or by synchronous
interaction, to verify patient certifications and to consult
with patients and caregivers at all times during the hours the
dispensary is open to receive patients and caregivers. If a
dispensary has more than one separate location, a physician
assistant or a certified registered nurse practitioner may
verify patient certifications and consult with patients and
caregivers, either in person or by synchronous interaction, at
each of the other locations in lieu of the physician or
pharmacist. A physician, a pharmacist, a physician assistant or
a certified registered nurse practitioner shall, prior to
assuming duties under this paragraph, successfully complete the
course established in section 301(a)(6). A physician may not
issue a certification to authorize patients to receive medical
marijuana or otherwise treat patients at the dispensary.] The
following shall apply:
(1) A dispensary shall verify patient certification upon
entry into the dispensary. The verification may be performed
by a pharmacy technician, certified medical assistant or
certified nurse aide with supervision of a physician or
pharmacist.
20230SB0835PN0924 - 22 -
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
(2) A dispensary shall have a physician or a pharmacist
available, either in person or by synchronous interaction, to
supervise verification of patient certifications and to
consult with patients and caregivers at all times during the
hours the dispensary is open to receive patients and
caregivers.
(3) If a dispensary has more than one location:
(i) A physician assistant or certified registered
nurse practitioner may verify patient certifications and
consult with patients and caregivers, either in person or
by synchronous interaction, at each of the other
locations in lieu of the physician or pharmacist.
(ii) The dispensary shall maintain a minimum of a
one-to-one medical professional-to-location ratio except
for brief periods of time that may include lunch breaks,
bathroom breaks, unexpected emergencies and unexpected
time off, during which the dispensary is permitted to
have a medical professional cover no more than two
locations at one time, and the dispensary may be required
to show a documented customer service process that
prevents excessive wait times for patient consultation.
For purposes of this subparagraph, the term "medical
professional" shall mean a physician, pharmacist,
physician assistant or certified registered nurse
practitioner.
(4) A physician, pharmacist, physician assistant,
certified registered nurse practitioner, pharmacy
technician, certified medical assistant or certified
nurse aide shall, prior to assuming duties under this
subsection, successfully complete the course established
20230SB0835PN0924 - 23 -
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
in section 301(a)(6).
(5) A physician may not issue a certification to
authorize patients to receive medical marijuana or
otherwise treat patients at the dispensary.
* * *
(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] a 90-day supply of individual doses; 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 90-day supply until the patient has exhausted all but a
seven-day supply provided pursuant to a previously issued
certification until additional certification is presented under
section 405.]
(f) Verification.--Prior to dispensing medical marijuana to
a patient or caregiver, the dispensary shall verify any
discrepancy of the information in [subsections (e) and]
subsection (g) by consulting or receiving communication to the
dispensary tracking system under section 701(a)(2) which
connects to the electronic tracking system included in the
department's electronic database established under section
301(a)(4)(v) [and the dispensary tracking system under section
701(a)(2)].
* * *
(h) Safety insert.--When a dispensary dispenses medical
marijuana to a patient or caregiver for the first time, the
dispensary shall provide to that patient or caregiver, as
20230SB0835PN0924 - 24 -
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
appropriate, a safety insert and the insert shall be available
to a patient upon request at any subsequent visit. The insert
shall be developed and approved by the department. The insert
shall provide the following information:
* * *
Section 802. Facility requirements.
(a) General rule.--
(1) A dispensary may dispense medical marijuana in an
indoor, enclosed, secure facility located within this
Commonwealth or in accordance with a curbside delivery
protocol as determined by the department.
(1.1) For the purposes of paragraph (1), a dispensary
shall maintain continuous video surveillance. If the
dispensary has more than one location, continuous video
surveillance may be performed on-site at the dispensary
location or remotely from a centralized security location if
the dispensary has a protocol and communication channel for
the centralized security location to communicate with each
dispensary location. The dispensary is required to retain the
recordings onsite or offsite for a period of no less than
[180] 60 days, unless otherwise required for investigative or
litigation purposes.
(2) A dispensary may not operate on the same site as a
facility used for growing and processing medical marijuana.
(3) A dispensary may not be located within 1,000 feet of
the property line of a public, private or parochial school or
a day-care center.
(4) A dispensary may sell medical devices and
instruments which are needed to administer medical marijuana
and the dispensary's brand logo products under this act
20230SB0835PN0924 - 25 -
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
without prior approval of the department if the dispensary
conforms with the advertising guidelines in section 301(a)
(15).
(5) A dispensary may sell services [approved by the
department] related to the use of medical marijuana.
* * *
Section 902. Medical Marijuana Program Fund.
* * *
(c) Use of proceeds.--After any repayment made under
subsection (d), money in the fund is appropriated in accordance
with the following percentages:
* * *
(3) To the department, for further research related to
the 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. Money shall be used to
subsidize the cost of, or provide, medical marijuana to
patients participating in the program. However, money in the
fund may not be expended on activity under Chapter 20.
* * *
Section 1201. Advisory board.
(a) Establishment.--The Medical Marijuana Advisory Board is
established within the department. The advisory board shall
consist of the following members:
* * *
20230SB0835PN0924 - 26 -
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
(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.
* * *
(j) Duties.--The advisory board shall have the following
duties:
* * *
(5) The written 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.]
* * *
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
20230SB0835PN0924 - 27 -
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
medical marijuana on the treatment and symptom management of
[serious] medical conditions. The program shall not include a
clinical registrant or academic clinical research center under
Chapter 20.
(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
20230SB0835PN0924 - 28 -
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
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
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.
* * *
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
20230SB0835PN0924 - 29 -
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
dispensed.
(3) Recall of defective medical 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.
(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
20230SB0835PN0924 - 30 -
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
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 1903. 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
603(d) to medical marijuana for all patients included in an
approved research study.
Section 2000. Legislative findings and declaration of policy.
(a) Legislative findings.--It is determined and declared as
a matter of legislative finding:
(1) Patients suffering from [serious] medical conditions
deserve the benefit of research conducted in conjunction with
the Commonwealth's medical schools to determine whether
medical marijuana will improve their conditions or symptoms.
* * *
Section 11. Section 2001 of the act is amended by adding a
definition to read:
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:
* * *
"Accredited medical school." An institution within this
Commonwealth that is accredited by the Liaison Committee of
Medical Education or the Commission on Osteopathic College
20230SB0835PN0924 - 31 -
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
Accreditation or has gained pre-accreditation or provisional
accreditation so that the institution is authorized to enroll
students and is affiliated with an accredited institution of
higher education within this Commonwealth.
* * *
Section 12. Section 2002 of the act is amended by adding a
subsection to read:
Section 2002. Clinical registrants.
* * *
(c) Automatic permits.--If Federal or State law permits the
sale of adult use marijuana, each clinical registrant shall be
automatically issued permits for growing/processing and
dispensing, based on existing permits, of medical and adult use
marijuana.
Section 13. The act is amended by adding a section to read:
Section 2005. Termination of contract.
If an academic clinical research center does not renew or
terminates a contract with a clinical registrant, the clinical
registrant shall retain the grower/processor and dispensary
permits and shall be permitted to continue to operate its
grower/processor facility and all dispensaries if the facility
and dispensaries were operating for a minimum of two years prior
to the nonrenewal or termination of the clinical registrant's
contract with the academic clinical research center.
Section 14. Section 2109 of the act is amended by adding a
subsection to read:
Section 2109. Applicability.
* * *
(c) Required regulations.--If new temporary or permanent
regulations are required to implement changes made to this act,
20230SB0835PN0924 - 32 -
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
the existing regulations issued by the department will remain in
effect until the revised regulations are issued. The department
shall transmit notice of the new or revised temporary or
permanent regulations to the Legislative Reference Bureau for
publication in the next available issue of the Pennsylvania
Bulletin within 60 days of the effective date of this
subsection.
Section 15. This act shall take effect in 30 days.
20230SB0835PN0924 - 33 -
1
2
3
4
5
6
7
8