SENATE AMENDED
PRIOR PRINTER'S NOS. 1059, 1596, 1635,
1823
PRINTER'S NO. 1936
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
1024
Session of
2021
INTRODUCED BY SCHEMEL, BURGOS, POLINCHOCK, RAPP, RYAN,
ZIMMERMAN, WHEATLEY, SHUSTERMAN, FRANKEL, COX, GUZMAN AND
GAINEY, MARCH 26, 2021
AS AMENDED ON THIRD CONSIDERATION, IN SENATE, JUNE 25, 2021
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 confidentiality and public disclosure
and for lawful use of medical marijuana; in practitioners,
further providing for duration; in patients, further
providing for caregivers; in medical marijuana organizations,
further providing for permits, for relocation and for
convictions prohibited; in medical marijuana controls,
further providing for electronic tracking, for
grower/processor GROWER/PROCESSORS, for storage and
transportation and for laboratory; 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
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;
IN ACADEMIC CLINICAL RESEARCH CENTERS AND CLINICAL
<--
<--
<--<--
<--
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
REGISTRANTS, FURTHER PROVIDING FOR ACADEMIC CLINICAL RESEARCH
CENTERS AND FOR CLINICAL REGISTRANTS; and, AND PROVIDING FOR
RESEARCH INITIATIVE; in miscellaneous provisions, further
providing for applicability; AND MAKING A RELATED REPEAL.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The definitions of "caregiver" and "CAREGIVER,"
"continuing care" 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 DEFINITIONS 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:
* * *
"Caregiver." [The [individual] person designated by a
patient or, if the patient is under 18 years of age, an
individual under section 506(2), to deliver medical 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
20210HB1024PN1936 - 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
(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.
* * *
"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] a consultation with the patient.
* * *
"Person." Any natural person, corporation, foundation,
organization, business trust, estate, limited liability company,
licensed corporation, trust, partnership, limited liability
partnership, association or other form of legal business entity.
" EXCIPIENTS. " SOLVENTS, CHEMICALS OR MATERIALS REPORTED BY A
MEDICAL MARIJUANA ORGANIZATION AND APPROVED BY THE DEPARTMENT
FOR USE IN THE PROCESSING OF MEDICAL MARIJUANA.
* * *
20210HB1024PN1936 - 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
" 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.
20210HB1024PN1936 - 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
(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
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.
* * *
Section 2. Sections 302(b), 303(b)(4), 405, 502(b), 602(a)
(4) AND (7), 609 AND 614 of the act are amended to read:
Section 302. Confidentiality and public disclosure.
* * *
20210HB1024PN1936 - 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
(b) Public information.--The following records are public
records and shall be subject to the Right-to-Know Law:
(1) Applications for permits submitted by medical
marijuana organizations.
(2) The names, business addresses and medical
credentials of practitioners authorized to provide
certifications to patients to enable them to obtain and use
medical marijuana in this Commonwealth. All other
practitioner registration information shall be confidential
and exempt from public disclosure under the Right-to-Know
Law.
(3) Information relating to penalties or other
disciplinary actions taken against a medical marijuana
organization or practitioner by the department for violation
of this act.
(4) The names of the individuals retained by the
department to review applications submitted by a medical
marijuana organization seeking a permit.
Section 303. Lawful use of medical marijuana.
* * *
(b) Requirements.--The lawful use of medical marijuana is
subject to the following:
* * *
[(4) An individual may not act as a caregiver for more
than five patients.]
* * *
Section 405. Duration.
Receipt of medical marijuana by a patient or caregiver from a
dispensary may not exceed a [30-day] 90-day supply of individual
doses. During the last seven days of any 30-day period during
20210HB1024PN1936 - 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
the term of the identification card, a patient may obtain and
possess a [30-day] 90-day supply for the subsequent 30-day
period. Additional [30-day] 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 502. Caregivers.
* * *
(b) Criminal history.--A caregiver who has not been
previously approved by the department under this section shall
submit fingerprints for the purpose of obtaining criminal
history record checks, and the Pennsylvania State Police or its
authorized agent shall submit the fingerprints to the Federal
Bureau of Investigation for the purpose of verifying the
identity of the applicant and obtaining a current record of any
criminal arrests and convictions. Any criminal history record
information relating to a caregiver obtained under this section
by the department may be interpreted and used by the department
only to determine the applicant's character, fitness and
suitability to serve as a caregiver under this act. The criminal
history record information provided under this subsection may
not be subject to the limitations under 18 Pa.C.S. § 9121(b) (2)
(relating to general regulations). The department shall also
review the prescription drug monitoring program relating to the
caregiver. The department shall deny the application of a
caregiver who has been convicted of a criminal offense that
occurred within the past five years relating to the sale or
possession of drugs, narcotics or controlled substances. The
department may deny an application if the applicant has a
history of drug abuse or of diverting controlled substances or
20210HB1024PN1936 - 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
illegal drugs.
Section 602. Permits.
(a) Application.--An application for a grower/processor or
dispensary permit to grow, process or dispense medical marijuana
shall be in a form and manner prescribed by the department and
shall include:
* * *
(4) A criminal history record check. Medical marijuana
organizations applying for a permit shall submit fingerprints
of principals, financial backers, operators and employees to
the Pennsylvania State Police for the purpose of obtaining
criminal history record checks and the Pennsylvania State
Police or its authorized agent shall submit the fingerprints
to the Federal Bureau of Investigation for the purpose of
verifying the identity of the principals, financial backers,
operators and employees and obtaining a current record of any
criminal arrests and convictions. Any criminal history record
information relating to principals, financial backers,
operators and employees obtained under this section by the
department may be interpreted and used by the department only
to determine the principal's, financial backer's, operator's
and employee's character, fitness and suitability to serve as
a principal, financial backer, operator and employee under
this act. The criminal history record information provided
under this subsection may not be subject to the limitations
under 18 Pa.C.S. § 9121(b)(2) (relating to general
regulations). AFTER SUBMISSION OF REQUIRED DOCUMENTATION TO
THE DEPARTMENT, MEDICAL MARIJUANA ORGANIZATIONS MAY ALLOW
EMPLOYEES TO WORK IN A SUPERVISED CAPACITY UNTIL THE
DEPARTMENT FORMALLY APPROVES THE EMPLOYEE'S AFFILIATION WITH
20210HB1024PN1936 - 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
THE MEDICAL MARIJUANA ORGANIZATION. ANY EMPLOYEE WHO THE
DEPARTMENT DETERMINES TO BE UNABLE TO MEET THE AFFILIATION
REQUIREMENTS UNDER SECTION 614 SHALL BE TERMINATED BY THE
MEDICAL MARIJUANA ORGANIZATION IMMEDIATELY. This paragraph
shall not apply to an owner of securities in a publicly
traded corporation or an owner of 5% or less in a privately
held business entity if the department determines that the
owner of the securities is not substantially involved in the
activities of the medical marijuana organization.
* * *
(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.
* * *
Section 609. Relocation.
(a) Authorization.--The department may approve an
application from a medical marijuana organization to relocate
20210HB1024PN1936 - 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
within this Commonwealth or to add or delete activities or
facilities.
(b) Designations.--Notwithstanding the provisions of
subsection (a), a dispensary may interchange the designation of
a primary, secondary or tertiary location at any time, including
the period before a location becomes operational, by providing
written notice to the department at least 14 days before the
change in designation. A change in designation under this
subsection may not be subject to approval by the department.
Section 614. Convictions prohibited.
(A) PROHIBITIONS.--The following individuals may not hold
volunteer positions or positions with remuneration in or be
affiliated with a medical marijuana organization, including a
clinical registrant under Chapter 20, in any way if the
individual has been convicted of any felony criminal offense
related to [the sale or possession of illegal drugs, narcotics
or controlled 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:
(1) Financial backers.
(2) Principals.
(3) Employees.
(B) EXCLUSION.--THIS SECTION SHALL NOT APPLY TO INDIVIDUALS
WHO HAVE BEEN CONVICTED OF A NONVIOLENT FELONY OFFENSE IF AT
LEAST 10 YEARS HAVE PASSED SINCE THE SATISFACTORY DISPOSITION OF
THE INDIVIDUAL'S MOST RECENT FELONY SENTENCE. 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,
20210HB1024PN1936 - 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
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.
Section 3. Section 701 of the act is amended by adding a
subsection to read:
Section 701. Electronic tracking.
* * *
(c.1) Application programming interface.--The department and
or the department's contracted seed-to-sale vendor shall allow
two-way communication , AUTOMATION and application-programming
interface of a medical marijuana organization's ENTERPRISE
RESOURCE PLANNING, inventory, accounting and point-of-sale
software with the software of the department or the department's
contracted seed-to-sale vendor. The department or the
department's contracted seed-to-sale vendor shall provide for
the development and use of a seed-to-sale cannabis tracking
system, which shall include a secure application program
interface capable of accessing all data required to be
transmitted to the advisory board to ensure compliance with the
operational reporting requirements established under this act
and the regulations of the advisory board DEPARTMENT .
* * *
Section 4. Sections 702, 703(8), 704, AND 801(e) 801(B) AND
(E), 802(a)(1), 2001.1(A), 2002(A) AND (B) and 2109(a) of the
act are amended to read:
Section 702. Grower/processors.
(a) Authorization.--Subject to subsection (b), a
20210HB1024PN1936 - 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
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
[initially] grow AND PROCESS medical marijuana.
(2) Obtain seed and plant material from another
grower/processor within this Commonwealth to grow medical
marijuana.
(2.1) Obtain AND TRANSPORT BULK postharvest MEDICAL
MARIJUANA plant material from another grower/processor within
this Commonwealth TO PROCESS MEDICAL MARIJUANA . As used in
this paragraph, the term "postharvest plant material"
includes all unfinished plant and plant-derived material,
whether fresh, dried, partially dried, frozen or partially
frozen, oil, concentrate or similar byproducts derived OR
PROCESSED from medical marijuana OR MEDICAL MARIJUANA PLANTS .
The department shall establish a process to implement the
provisions of this paragraph within 60 days of the effective
date of this paragraph.
(3) Remediate MICROBIAL contamination to seeds, immature
medical marijuana plants, medical marijuana plants, medical
marijuana flower or AND medical marijuana products at any
time before final processing, after a failed test or in
preparing a medical marijuana product for independent
laboratory testing AFTER A FAILED TEST BY AN INDEPENDENT
LABORATORY .
(4) Release a medical marijuana product after
independent laboratory testing concludes the MICROBIAL
contamination to the medical marijuana product has been
20210HB1024PN1936 - 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
remediated.
(5) Add pharmaceutical-grade or food-grade additives to
medical marijuana, including hemp or hemp-derived
ingredients. Hemp or hemp-derived ingredients under this
paragraph shall be obtained from an entity that has an
appropriate permit from the Department of Agriculture of the
Commonwealth.
(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.
(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
20210HB1024PN1936 - 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
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.
(b) Limitations.--
(1) A grower/processor may only grow, store, harvest or
process medical marijuana in an indoor, enclosed, secure
facility which:
(i) includes electronic locking systems, electronic
surveillance and other features required by the
department; and
(ii) is located within this Commonwealth.
(2) [(Reserved).] For the purpose of paragraph (1), the
department shall permit video surveillance with video
recordings triggered via motion sensors. A grower/processor
that utilizes the video surveillance authorized under this
paragraph shall retain the video recordings for a period of
no less than 90 days. 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.
20210HB1024PN1936 - 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
(c) Pesticides.--The following shall apply:
(1) A grower/processor may use a pesticide that is
registered by the Department of Agriculture under the act of
March 1, 1974 (P.L.90, No.24), known as the Pennsylvania
Pesticide Control Act of 1973 .
(2) Notwithstanding any provision of the Pennsylvania
Pesticide Control Act of 1973 or any other State law or
regulation, the Secretary of Agriculture shall establish
procedures and operate a periodic process under which
pesticides are reviewed, approved and registered for use in
the cultivation of medical marijuana.
(3) The procedures established by the Secretary of
Agriculture under paragraph (2) shall be consistent with the
Pennsylvania Pesticide Control Act of 1973 and the Federal
Insecticide, Fungicide, and Rodenticide Act (61 Stat. 163, 7
U.S.C. § 136 et seq.)
(4) The Secretary of Agriculture may register pesticides
approved for use in the cultivation of medical marijuana by
other states or jurisdictions if the Secretary of Agriculture
determines that the pesticide registration and approval
requirements of another state or jurisdiction are
comprehensive, thorough and provide similar safeguards and
protections as those required under the Pennsylvania
Pesticide Control Act of 1973. 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
PENNSYLVANIA BULLETIN AN INITIAL LIST OF PESTICIDES WHICH MAY
20210HB1024PN1936 - 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
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.
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:
* * *
(8) Requirements to utilize any electronic tracking
system required by the department, which shall allow for the
two-way communication , AUTOMATION and application-programming
interface between a medical marijuana organization's
ENTERPRISE RESOURCE PLANNING, inventory, accounting and
point-of-sale software and the software of the department or
the department's vendor.
* * *
Section 704. Laboratory.
(a) General testing.--A grower/processor shall contract with
[an independent laboratory] one or more independent laboratories
to test the medical marijuana produced by the grower/processor.
The department shall approve [the] a laboratory under this
subsection and require that the laboratory report testing
results in a manner as the department shall determine[,
20210HB1024PN1936 - 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
including requiring a test at harvest and] of a test at final
processing. The possession by a laboratory of medical marijuana
shall be a lawful use.
(b) Stability testing.--A laboratory shall perform stability
testing to ensure the medical marijuana product's potency and
purity. A grower/processor shall retain a sample from each
harvest batch of 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 a
harvest batch EACH PROCESS LOT to perform stability testing
under the following conditions:
(1) The harvest batch of 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 801. Dispensing to patients and caregivers.
* * *
(B) REQUIREMENTS.--A DISPENSARY SHALL HAVE A PHYSICIAN OR A
PHARMACIST [ONSITE] AVAILABLE, EITHER IN PERSON OR REMOTELY 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 [BE
ONSITE AT] VERIFY PATIENT CERTIFICATIONS AND CONSULT WITH
PATIENTS AND CAREGIVERS, EITHER IN PERSON OR REMOTELY BY
SYNCHRONOUS INTERACTION, AT EACH OF THE OTHER LOCATIONS IN LIEU
20210HB1024PN1936 - 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
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.
* * *
(e) Supply.--When dispensing medical marijuana to a patient
or caregiver, the dispensary may not dispense an amount greater
than a [30-day] 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.
* * *
SECTION 5. SECTION 802(A)(1) OF THE ACT IS AMENDED AND THE
SUBSECTION IS AMENDED BY ADDING A PARAGRAPH TO READ:
Section 802. Facility requirements.
(a) General rule.--
(1) A dispensary may [only] 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. THE DISPENSARY
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.
* * *
SECTION 6. SECTIONS 902(D), 1107(B), 1201(J)(4), (5) AND
20210HB1024PN1936 - 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
(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.
20210HB1024PN1936 - 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
(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.
[(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]
20210HB1024PN1936 - 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
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.
SECTION 2001.1. ACADEMIC CLINICAL RESEARCH CENTERS.
(A) GENERAL RULE.--AN ACADEMIC CLINICAL RESEARCH CENTER MUST
BE APPROVED AND CERTIFIED BY THE DEPARTMENT BEFORE THE ACADEMIC
20210HB1024PN1936 - 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
CLINICAL RESEARCH CENTER MAY CONTRACT WITH A CLINICAL
REGISTRANT. AN ACADEMIC CLINICAL RESEARCH CENTER SHALL ONLY
CONTRACT WITH ONE CLINICAL REGISTRANT. THE ACCREDITED MEDICAL
SCHOOL THAT IS SEEKING APPROVAL AND CERTIFICATION FROM THE
DEPARTMENT AS AN ACADEMIC CLINICAL RESEARCH CENTER MUST PROVIDE
ALL INFORMATION REQUIRED BY THE DEPARTMENT, INCLUDING
INFORMATION FOR THE INDIVIDUAL WHO WILL BE THE PRIMARY CONTACT
FOR THE ACADEMIC CLINICAL RESEARCH CENTER DURING THE
DEPARTMENT'S REVIEW OF THE APPLICATION. THE ACCREDITED MEDICAL
SCHOOL MUST ALSO PROVIDE ALL INFORMATION REQUIRED BY THE
DEPARTMENT FOR ANY LICENSED ACUTE CARE HOSPITAL THAT THE
ACCREDITED MEDICAL SCHOOL WILL OPERATE OR PARTNER WITH DURING
THE TIME THAT IT MAY BE APPROVED AND CERTIFIED AS AN ACADEMIC
CLINICAL RESEARCH CENTER BY THE DEPARTMENT.
* * *
SECTION 2002. CLINICAL REGISTRANTS.
(A) APPROVAL.--THE DEPARTMENT MAY APPROVE UP TO [EIGHT] TEN
CLINICAL REGISTRANTS. EACH CLINICAL REGISTRANT 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] 60. THE
GROWER/PROCESSOR AND DISPENSARY PERMITS ISSUED TO CLINICAL
REGISTRANTS APPROVED UNDER THIS SECTION SHALL BE IN ADDITION TO
THE 25 GROWER/PROCESSOR AND 50 DISPENSARY PERMITS ISSUED BY THE
DEPARTMENT IN ACCORDANCE WITH SECTION 616(1) AND (2). THE
LIMITATIONS RELATING TO NUMBER AND LOCATION IN SECTIONS 616(1)
AND (2) AND 603(D) DO NOT APPLY. A CLINICAL REGISTRANT MAY NOT
HOLD MORE THAN ONE GROWER/PROCESSOR AND ONE DISPENSARY PERMIT.
ONCE THE DEPARTMENT APPROVES [THE] AN ENTITY AS A CLINICAL
REGISTRANT, THE ENTITY SHALL COMPLY WITH THIS CHAPTER. THE
20210HB1024PN1936 - 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
FOLLOWING SHALL APPLY:
(1) THE DEPARTMENT SHALL OPEN APPLICATIONS FOR
ADDITIONAL ACADEMIC CLINICAL RESEARCH CLINICS AND ISSUE
APPROVALS TO QUALIFIED ACADEMIC CLINICAL RESEARCH CLINICS
WITHIN 90 DAYS OF PASSAGE AND SHALL OPEN APPLICATIONS FOR
ADDITIONAL CLINICAL REGISTRANTS WITHIN 120 DAYS OF PASSAGE
AND ISSUE APPROVALS OR PERMITS TO QUALIFIED CLINICAL
REGISTRANTS WITHIN 180 DAYS OF PASSAGE. IF THE STATUTORY
MAXIMUM NUMBERS OF ACADEMIC CLINICAL RESEARCH CLINICS AND
CLINICAL REGISTRANTS ARE NOT APPROVED WITHIN 180 DAYS OF THE
PASSAGE, THE DEPARTMENT WILL REOPEN THE APPLICATION PROCESS
FOR ACADEMIC CLINICAL RESEARCH CLINICS AND CLINICAL
REGISTRANTS , IF AN ACADEMIC CLINICAL RESEARCH CENTER REQUESTS
IT TO DO SO.
(2) (RESERVED).
(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
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.
20210HB1024PN1936 - 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
(B) REQUIREMENTS.--THE FOLLOWING SHALL APPLY TO CLINICAL
REGISTRANTS:
* * *
(4) WHEN THE DEPARTMENT ISSUES A PERMIT AS A
GROWER/PROCESSOR OR A DISPENSARY TO AN ENTITY SEEKING
APPROVAL AS A CLINICAL REGISTRANT, THE ISSUANCE SHALL NOT BE
CONSTRUED TO REDUCE THE NUMBER OF PERMITS FOR
GROWERS/PROCESSORS AND DISPENSARIES AUTHORIZED UNDER SECTION
616(1) AND (2).
(I) THE DEPARTMENT SHALL NOT APPROVE AN APPLICANT
FOR A GROWER/PROCESSOR LICENSE PERMIT IF THE APPLICANT
HAS PREVIOUSLY HAD A CONTRACTUAL RELATIONSHIP WITH AN
ACADEMIC CLINICAL RESEARCH CENTER WHEREBY THE ACADEMIC
CLINICAL RESEARCH CENTER OR ITS AFFILIATE PROVIDED ADVICE
TO THE APPLICANT REGARDING, AMONG OTHER AREAS, PATIENT
HEALTH AND SAFETY, MEDICAL APPLICATIONS AND DISPENSING
AND MANAGEMENT OF CONTROLLED SUBSTANCES AND THE APPLICANT
SUBSEQUENTLY SOLD OR ASSIGNED FOR PROFIT TO ANOTHER
ENTITY THEIR RESPONSIBILITY UNDER THE CONTRACTUAL
RELATIONSHIP.
(II) (RESERVED).
* * *
(7) THE CLINICAL REGISTRANT SHALL HAVE ALL OF THE SAME
RIGHTS AS A GROWER/PROCESSOR PERMITTEE AND MUST COMPLY WITH
ALL OTHER REQUIREMENTS, AND PROVIDED ALL RIGHTS OF OTHER
GROWER/PROCESSOR PERMITTEES, OF THIS ACT REGARDING GROWING,
PROCESSING AND DISPENSING MEDICAL MARIJUANA.
(8) A GROWER/PROCESSOR FACILITY OWNED BY A CLINICAL
REGISTRANT MAY SELL ITS MEDICAL MARIJUANA PRODUCTS [ONLY] TO
[THE CLINICAL REGISTRANT'S DISPENSARY FACILITIES AND THE] ALL
20210HB1024PN1936 - 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
DISPENSARY FACILITIES [OF OTHER CLINICAL REGISTRANTS]. THE
FACILITY MAY SELL SEEDS, MEDICAL MARIJUANA PLANTS AND MEDICAL
MARIJUANA PRODUCTS TO, OR EXCHANGE SEEDS, MEDICAL MARIJUANA
PLANTS AND MEDICAL MARIJUANA PRODUCTS WITH, ANY OTHER
GROWER/PROCESSOR FACILITY HOLDING A PERMIT UNDER CHAPTER 6 OR
THIS CHAPTER.
* * *
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.
(3) AN ACADEMIC CLINICAL RESEARCH CENTER AND ITS
CONTRACTED CLINICAL REGISTRANT SHALL PRESENT RESEARCH
20210HB1024PN1936 - 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
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:
Section 2109. Applicability.
[(a) Dispensaries.--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 5. This act shall take effect in 60 days.
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.
20210HB1024PN1936 - 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
(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.
20210HB1024PN1936 - 27 -
1
2
3
4
5
6
7