An Act amending the act of April 17, 2016 (P.L.84, No.16), known as the Medical Marijuana Act, in preliminary provisions, further providing for definitions; in practitioners, further providing for practitioner registration; in medical marijuana controls, further providing for electronic tracking and for laboratory; and, in Medical Marijuana Advisory Board, further providing for advisory board.

CORRECTIVE REPRINT
PRIOR PRINTER'S NOS. 12, 372 PRINTER'S NO. 441
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 33
Session of
2025
INTRODUCED BY FRANKEL, PIELLI, GIRAL, KHAN, HILL-EVANS, HOWARD,
SANCHEZ, CIRESI, TWARDZIK AND GREEN, JANUARY 10, 2025
AS REPORTED FROM COMMITTEE ON HEALTH, HOUSE OF REPRESENTATIVES,
AS AMENDED, JANUARY 29, 2025
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
PRACTITIONERS, FURTHER PROVIDING FOR PRACTITIONER
REGISTRATION; in medical marijuana controls, further
providing for electronic tracking and for laboratory; and, in
Medical Marijuana Advisory Board, further providing for
advisory board.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 103 of the act of April 17, 2016 (P.L.84,
No.16), known as the Medical Marijuana Act, is amended by adding
definitions to read:
Section 103. Definitions.
The following words and phrases when used in this act shall
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have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Accreditation body." An organization which meets all of the
following criteria:
(1) Certifies the competency, expertise and integrity of
an independent laboratory and operates in conformance with
standards established by experts for competency, consistent
operations and impartiality of organizations accrediting
assessment bodies as adopted by the department after review.
The department shall transmit notice of the adoption under
this paragraph to the Legislative Reference Bureau for
publication in the next available issue of the Pennsylvania
Bulletin.
(2) Determines an independent laboratory's compliance
with and conformance to the relevant standards established by
exp erts of testing and calibration laboratories as adopted by
the department after review. The department shall transmit
notice of the adoption under this paragraph to the
Legislative Reference Bureau for publication in the next
available issue of the Pennsylvania Bulletin.
(3) Is a signatory to the International Accreditation
Cooperation Mutual Recognition Arrangement for Testing.
(4) Is not affiliated with an independent laboratory
applicant for which it has or will issue a certificate of
accreditation.
(5) Is not affiliated with, owned by, operated by or
financed by a medical marijuana organization.
* * *
"Approved laboratory." An independent laboratory approved by
the department, in accordance with section 704, to identify,
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collect, handle and conduct tests on medical marijuana samples
from a grower/processor, as part of the quality assurance
testing and on medical marijuana samples from the department.
* * *
"Cooperative laboratory." A public or private independent
laboratory that identifies, collects, handles and conducts tests
on medical marijuana samples on behalf of the department. The
term does not include an approved laboratory.
"CORRECTIVE ACTION." AN ACTION TAKEN BY AN APPROVED
LABORATORY TO RESOLVE, AND PREVENT FROM RECURRENCE, A DEFICIENCY
WITH THE LABORATORY OPERATIONS.
* * *
"Independent laboratory." A laboratory that:
(1) Is not owned, operated or affiliated with a medical
marijuana organization.
(2) Does not employ a principal, financial backer,
operator or employee of a medical marijuana organization.
(3) Is recognized by an accreditation body to test and
evaluate products to an established product safety standard
and provide unbiased results.
* * *
"Research and development testing." Testing performed on
behalf of a grower/processor to evaluate the effectiveness of
environmental controls in its cultivation and processing
practices and to enhance medical marijuana crop yields,
resilience and sustainability by developing medical marijuana
with improved traits.
* * *
Section 2. Sections 701(c) and 704 of the act are amended to
read:
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SECTION 2. SECTION 401 OF THE ACT IS AMENDED BY ADDING A
SUBSECTION TO READ:
SECTION 401. PRACTITIONER REGISTRATION.
* * *
(D) DEPARTMENT AUTHORITY.--THE DEPARTMENT MAY PLACE ONE OR
MORE CONDITIONS ON A PRACTITIONER FOR INCLUSION IN THE REGISTRY,
INCLUDING:
(1) A TERM OF PROBATION.
(2) A LIMITATION ON THE NUMBER OF CERTIFICATIONS THE
PRACTITIONER MAY ISSUE WITHIN A SET TIME FRAME. THE TIME
FRAME MAY BE EXTENDED BY THE DEPARTMENT IF THE EXTENSION IS
NECESSARY TO PROTECT THE HEALTH AND SAFETY OF PATIENTS IN THE
PROGRAM.
(3) SUPERVISION BY ANOTHER PRACTITIONER WHO HAS AGREED
TO OVERSEE THE PRACTITIONER FOR A SET TIME FRAME. THE TIME
FRAME MAY BE EXTENDED BY THE DEPARTMENT IF AN EXTENSION IS
NECESSARY TO PROTECT THE HEALTH AND SAFETY OF PATIENTS IN THE
PROGRAM.
(4) REPORTING REQUIREMENTS TO THE DEPARTMENT, INCLUDING
THE SUBMISSION OF DOCUMENTATION NECESSARY FOR THE DEPARTMENT
TO ENSURE THAT THE PRACTITIONER IS COMPLYING WITH THIS ACT
AND ANY CONDITIONS PLACED UPON THE PRACTITIONER.
(5) ANY OTHER CONDITION THAT THE DEPARTMENT DETERMINES
IS NECESSARY TO PROTECT THE HEALTH AND SAFETY OF PATIENTS IN
THE PROGRAM.
SECTION 3. SECTIONS 701(C) AND 704 OF THE ACT ARE AMENDED TO
READ:
Section 701. Electronic tracking.
* * *
(c) Access.--[Information] Except as provided in section
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704(p), information maintained in electronic tracking systems
under subsection (a) shall be confidential and not subject to
the act of February 14, 2008 (P.L.6, No.3), known as the Right-
to-Know Law.
* * *
Section 704. [Laboratory.] Laboratories.
[(a) General testing.--A grower/processor shall contract
with one or more independent laboratories to test the medical
marijuana produced by the grower/processor. The department shall
approve 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 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
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 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.]
(c) Application and approval.--
(1) An independent laboratory may apply, in the form and
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manner prescribed by the department, for approval to test
medical marijuana in accordance with the medical marijuana
program.
(2) A nonrefundable initial application fee in the
amount of $250 shall be paid by certified check or money
order.
(3) The department may issue an approval to an
independent laboratory as an approved laboratory under this
subsection if the department determines that an independent
laboratory is financially and professionally suitable to
conduct testing required under this act.
(4) An approval issued by the department to an
independent laboratory is valid:
(i) For two years from the date of issuance.
(ii) Only for the location specified in the
application and approval notice.
(5) An annual registration fee of $125 shall be paid by
each approved laboratory.
(6) Fees payable under this section shall be deposited
into the fund.
(7) A laboratory approved by the department to test
medical marijuana prior to the effective date of this
paragraph shall be deemed an approved laboratory until its
approval expires. A laboratory under this paragraph shall be
subject to the requirements of this act.
(d) Compliance testing.--
(1) A grower/processor shall contract with an approved
laboratory to test the medical marijuana produced by the
grower/processor.
(2) The department shall establish uniform medical
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marijuana testing standards and require that the approved
laboratories report testing results in a manner as the
department shall determine, including:
(i) Requiring a test at harvest and at final
processing.
(ii) Retesting of failed test results.
(3) Nothing in this section shall be construed to
prevent a grower/processor from engaging one approved
laboratory to complet e all testing required under this
subsection.
(e) Stability testing.--An approved laboratory shall perform
stability testing to ensure the medical marijuana product's
potency and purity. 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 an
approved laboratory from each process lot to perform stability
testing 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.
(3) The stability testing results shall be reported to
the department.
(f) Research and development testing.--An approved
laboratory may collect samples from a grower/processor for
research and development if requested. Results for research and
development testing shall be reported to the department.
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Research and development testing shall not be a replacement for
any other testing required under this section.
(g) Audit testing.--The department, in its sole discretion,
may conduct audit testing of medical marijuana samples collected
from a grower/processor facility and medical marijuana products
found at a dispensary facility using a cooperative laboratory or
approved laboratory to identify, collect, handle and test the
medical marijuana on the department's behalf. ALL SAMPLES TESTED
BY THE DEPARTMENT, BY AN APPROVED LABORATORY OR COOPERATIVE
LABORATORY MUST BE DE-IDENTIFIED AND ANONYMOUS. THE AUDIT
LABORATORY MAY NOT KNOW THE APPROVED LABORATORIES THAT HAVE
TESTED THE SAMPLE, THE GROWER/PROCESSOR OR DISPENSA RY FROM WHICH
THE SAMPLE ORIGINATED AND THE TESTING H ISTORY.
(h) Standard operating procedures.--
(1) An approved laboratory shall maintain written
standard operating procedures for all quality control
sampling and testing procedures, including compliance
testing, stability testing, research and development testing
and quality assurance testing.
(2) An independent laboratory applying to be an approved
laboratory under subsection (c) shall submit the independent
laboratory's standard operating procedures to the department
as part of the independent laboratory's application.
(3) An approved laboratory shall, within 30 days after
the effective date of this paragraph, submit its standard
operating procedures to the department.
(4) An approved laboratory shall notify the department
in writing of any modifications to its standard operating
procedures no less than 30 15 BU SINESS days prior to the
modifi cation IMPLEMENTATION .
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(i) Enforcement procedures.--The department shall conduct
announced or unannounced inspections or investigations to
determine an approved laboratory's compliance with its standard
operating procedures and this act OR A R EGULATION PROMULGATED
UND ER THIS ACT . The department may require the approved
laboratory to submit and adhere to a corrective action plan
following an inspection.
(j) Accreditation body.--The department may engage with an
accreditation body to fulfill the requirements under this
section.
(k) Quality assurance testing.--
(1) The department shall coordinate testing for quality
assurance purposes related to the department and compliance
by each approved laboratory no less than once a year
beginning January 1 after the effective date of this
paragraph.
(2) The quality assurance testing may be announced or
unannounced.
(3) Any fees for conducting tests as part of the quality
assurance testing shall be the responsibility of each
approved laboratory. The fees associated with the cost of the
medical marijuana samples submitted as part of the testing
shall be waived.
(4) A test required by an accreditation body solely to
maintain accreditation shall not fulfill the requirements of
this subsection.
(5) Quality assurance testing shall be conducted using
industry best practices and standards and shall be uniform
among all approved laboratories in the medical marijuana
program.
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(6) Nothing in this section shall be construed to
prohibit the department from coordinating quality assurance
testing more than once within a calendar year.
(7) THE DETERMINATION OF "SATISFACTORY" OR
"UNSATISFACTORY" SHALL BE BASED ON PREESTABLISHED CRITERIA
PROVIDED BY THE DEPARTMENT.
(7) (8) If the department determines that an approved
laboratory's test results are unsatisfactory, the department
shall initiate an investigation which may include the
following:
(i) Additional testing, as needed, to understand the
causes for the anomalies and unanticipated errors.
(ii) A review of the approved laboratory's standard
operating procedures.
(iii) An inspection of the approved laboratory's
facility, transportation vehicles, equipment,
instruments, tools and physical or electronic materials.
(iv) Interviews with the personnel, staff, directors
or other responsible parties of the approved laboratory.
(v) The approved laboratory submitting a corrective
action plan to the department.
(l) Corrective actions.--The following shall apply to a
corrective action plan required by the department:
(1) The department shall approve or deny a corrective
action plan within 30 days of receipt of the plan.
(2) The department may, in its sole discretion, allow
the approved laboratory to submit a revised corrective action
plan based on the reasons for the denial of the plan within
30 days of receipt of the denial.
(3) The department shall approve or deny a revised
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corrective action plan within 30 days of receipt of the plan.
(4) The corrective action plan shall be implemented
within a practicable time frame determined by the department
following approval.
(m) Lawful possession.--The possession of medical marijuana
by an approved laboratory or cooperative laboratory to conduct
compliance testing, stability testing, research and development
testing, audit testing and quality assurance testing shall be
lawful use.
(n) Violations.--In addition to any other requirements under
this act or a regulation promulgated under this act , the
following shall be considered to be violations of this section
and may result in penalties under section 1308(b):
(1) Failure to comply with the department as part of an
inspection or investigation.
(2) Failure to submit a corrective action plan as
required by the department.
(3) Failure to implement a corrective action plan within
the timeline determined by the department.
(4) Failure to participate in th e required quality
assurance OR AUDIT testing.
(5) Failure to produce:
(i) Test results.
(ii) Satisfactory test results as part of the
quality assurance testing.
(6) Fraudulent reporting of laboratory test results.
(o) Sanctions.--In addition to the penalties permitted under
subsection (n), the department may impose the following
sanctions:
(1) Revoke or suspend the approval to test medical
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marijuana of an approved laboratory found to be in violation
of this act or a regulation promulgated under this act.
(2) Revoke or suspend the approval to test medical
marijuana of an approved laboratory found to be in violation
of an order issued under this act or a regulation promulgated
under this act.
(3) Revoke or suspend the approval to test medical
marijuana of an approved laboratory for conduct or activity
which would have disqualified the approved laboratory from
receiving approval to test medical marijuana.
(4) Suspend an approved laboratory pending the outcome
of a hearing in a case in which the approval to test medical
marijuana could be revoked.
(5) Order the approved laboratory to cease and desist
testing medical marijuana.
(1) ORDER THE APPROVED LABORATORY TO CEASE AND DESIST
TESTING MEDICAL MARIJUANA TO PROTECT THE PUBLIC'S HEALTH,
SAFETY AND WELFARE.
(2) REVOKE OR SUSPEND THE APPROVAL TO TEST MEDICAL
MARIJUANA OF AN APPROVED LABORATORY FOR ANY OF THE FOLLOWING
REASONS:
(I) THE APPROVED LABORATORY IS FOUND TO BE IN
VIOLATION OF THIS ACT OR A REGULATION PROMULGATED UNDER
THIS ACT.
(II) THE APPROVED LABORATORY HAS FAILED TO COMPLETE
A CORRECTIVE ACTION PLAN.
(III) FRAUDULENT REPORTING OF LABORATORY TEST
RESULTS.
(IV) FALSIFYING RECORDS AND LABORATORY DATA.
(V) REPEATED FAILURES TO ADHERE TO STANDARD
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OPERATING PROCEDURES.
(p) Testing data and trend analysis.--
(1) An owner or operator of each approved laboratory
shall ensure that the laboratory enters all of the following
testing results into the seed-to-sale tracking system:
(i) Compliance testing.
(ii) Stability testing.
(iii) Research and development testing.
(iv) Quality assurance testing.
(2) The department may utilize the test results entered
by the approved laboratory to:
(i) Conduct trend analysis for laboratory oversight
and compliance.
(ii) Review functionality of testing standards and
methods.
(iii) Ensure compliance of medical marijuana
products.
(iv) Ensure compliance by grower/processors.
(v) Release de-identified data to academic clinical
research centers for research purposes only.
(vi) Compile and aggregate DE-IDENT IFIED testing
information to post on the department's publicly
accessible Internet website.
(vii) Aid the department in any aspect of its
regulatory efforts, including administrative action.
(q) Accreditation.--The department shall determine the scope
of the accreditation an approved laboratory must receive and
maintain. The department shall provide an approved laboratory
reasonable time to receive any additional accreditation beyond
the laboratory's most recent certificate of accreditation.
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(r) State testing laboratory.--The department may establish
and maintain a State testing laboratory. A State testing
laboratory under this section shall be responsible for:
(1) Developing and maintaining a medical marijuana
laboratory reference library that contains testing
methodologies, including:
(i) Potency.
(ii) Homogeneity.
(iii) Detection of contaminants and the quantity of
those contaminants.
(iv) Solvents.
(2) Establishing standard operating procedures for
sample collection, preparation and analysis of medical
marijuana by approved laboratories.
(3) Conducting quality assurance testing of approved
laboratories.
(4) Resolving problems with approved laboratories.
(5) Conducting audit testing on medical marijuana
samples analyzed by approved testing laboratories.
(s) Materials.--Approved laboratories shall provide
materials to the State testing laboratory reference library.
(t) Powers and duties of department.--The department shall:
(1) Hire sufficient staff with the proper expertise to
conduct the requirements of this section.
(2) Within 90 days of the effective date of this
paragraph, promulgate temporary regulations in accordance
with the following:
(i) In order to facilitate the prompt implementation
of this section, the department shall have the authority
to promulgate temporary regulations which shall expire
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not later than two years following the publication of the
temporary regulations in the Pennsylvania Bulletin under
subparagraph (iii) and on the department's publicly
accessible Internet website.
(ii) The department may promulgate temporary
regulations not subject to:
(A) Sections 201, 202, 203, 204 and 205 of the
act of July 31, 1968 (P.L.769, No.240), referred to
as the Commonwealth Documents Law.
(B) Section 204(b) of the act of October 15,
1980 (P.L.950, No.164), known as the Commonwealth
Attorneys Act.
(C) The act of June 25, 1982 (P.L.633, No.181),
known as the Regulatory Review Act.
(iii) Within 90 days of the effective date of this
subsection, the department shall transmit the temporary
regulations to the Legislative Reference Bureau for
publication in the next available issue of the
Pennsylvania Bulletin.
(iv) The department's authority to adopt temporary
regulations under subparagraph (i) shall expire two years
after publication of the temporary regulations.
Regulations adopted after this period shall be
promulgated as provided by law.
(v) The department shall rescind any regulation
promulgated prior to the effective date of this
subsection insofar as the regulation conflicts with a
temporary regulation promulgated by the department under
this subsection.
(3) Within 90 days of submitting the temporary
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regulations to the Legislative Reference Bureau, the
department shall issue guidance to accompany the temporary
regulations.
Section 3 4. Section 1201(b), (d), (e), (g), (h) and (i) of
the act are amended and subsection (a) is amended by adding a
paragraph to read:
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:
* * *
(10) One member appointed by the Governor, who shall
have experience and expertise in laboratory science and shall
not be affiliated with, contracted with, an owner of,
operator of or financed by an approved laboratory or medical
marijuana organization.
(b) Terms.--Except as provided under subsection (g), the
members appointed under subsection (a)(8) [and], (9) and (10)
shall serve a term of four years or until a successor has been
appointed and qualified, but no longer than six months beyond
the four-year period.
* * *
(d) Voting; quorum.--The members under subsection (a)(1),
(2), (3), (4), (5), (6) and (7) shall serve ex officio and all
members shall have voting rights. A majority of the members
shall constitute a quorum for the purpose of organizing the
advisory board, conducting its business and fulfilling its
duties. A vote of the majority of the members present shall be
sufficient for all actions of the advisory board unless the
bylaws require a greater number.
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(e) Attendance.--A member of the advisory board appointed
under subsection (a)(8) [or], (9) or (10) who fails to attend
three consecutive meetings shall forfeit his seat unless the
secretary, upon written request from the member, finds that the
member should be excused from a meeting for good cause. A member
who cannot be physically present may attend meetings via
electronic means, including video conference.
* * *
(g) Initial terms.--The initial terms of members appointed
under subsection (a)(8) [and], (9) and (10) shall be for terms
of one, two, three or four years, the particular term of each
member to be designated by the secretary at the time of
appointment. All other members shall serve for a term of four
years.
(h) Vacancy.--In the event that any member appointed under
subsection (a)(8) [or], (9) or (10) shall die or resign or
otherwise become disqualified during the member's term of
office, a successor shall be appointed in the same way and with
the same qualifications as set forth in this section and shall
hold office for the unexpired term. An appointed member of the
advisory board shall be eligible for reappointment.
(i) Expenses.--A member appointed under subsection (a)(8)
[or], (9) or (10) shall receive the amount of reasonable travel,
hotel and other necessary expenses incurred in the performance
of the duties of the member in accordance with Commonwealth
regulations, but shall receive no other compensation for the
member's service on the board.
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Section 4. This act shall take effect in 90 days.
SECTION 5. THIS ACT SHALL TAKE EFFECT AS FOLLOWS:
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(1) THE ADDITION OF SECTION 401(D) OF THE ACT SHALL TAKE
EFFECT IN 60 DAYS.
(2) THIS SECTION SHALL TAKE EFFECT IMMEDIATELY.
(3) THE REMAINDER OF THIS ACT SHALL TAKE EFFECT IN 90
DAYS.
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