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SENATE AMENDED
PRIOR PRINTER'S NOS. 1059, 1596, 1635
PRINTER'S NO. 1823
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
SENATOR REGAN, LAW AND JUSTICE, IN SENATE, AS AMENDED,
JUNE 15, 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, for storage and transportation and for
laboratory; in dispensaries, further providing for dispensing
to patients and caregivers and for facility requirements; IN
ACADEMIC CLINICAL RESEARCH CENTERS AND CLINICAL REGISTRANTS,
FURTHER PROVIDING FOR ACADEMIC CLINICAL RESEARCH CENTERS AND
FOR CLINICAL REGISTRANTS; and, in miscellaneous provisions,
further providing for applicability.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
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Section 1. The definitions of "caregiver" and "continuing
care" 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:
* * *
"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.
* * *
"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.
* * *
Section 2. Sections 302(b), 303(b)(4), 405, 502(b), 602(a)
(4), 609 AND 614 of the act are amended to read:
Section 302. Confidentiality and public disclosure.
* * *
(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
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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
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
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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
illegal drugs.
Section 602. Permits.
(a) Application.--An application for a grower/processor or
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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
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
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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.
* * *
Section 609. Relocation.
(a) Authorization.--The department may approve an
application from a medical marijuana organization to relocate
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:
(1) Financial backers.
(2) Principals.
(3) Employees.
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(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.
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.
* * *
Section 4. Sections 702, 703(8), 704, 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
grower/processor may do all of the following in accordance with
department regulations:
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(1) Obtain 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 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. 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
remediated.
(5) Add pharmaceutical-grade or food-grade additives to
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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.
(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.
(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.
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(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.
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.
* * *
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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[,
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 and request that a sample be
identified and collected by a laboratory approved under
subsection (a) from a harvest batch to perform stability testing
under the following conditions:
(1) The harvest batch of medical marijuana 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, TO
VERIFY PATIENT CERTIFICATIONS AND TO CONSULT WITH PATIENTS AND
CAREGIVERS AT ALL TIMES DURING THE HOURS THE DISPENSARY IS OPEN
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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, 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.
* * *
(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 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.
* * *
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
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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
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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).
(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 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
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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
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 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.
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