HB 33 — 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.

PRINTER'S NO.   12

                     THE GENERAL ASSEMBLY OF PENNSYLVANIA



                         HOUSE BILL
                         No. 33
                                               Session of
                                                 2025

     INTRODUCED BY FRANKEL, PIELLI, GIRAL, KHAN, HILL-EVANS, HOWARD,
        SANCHEZ AND CIRESI, JANUARY 10, 2025

     REFERRED TO COMMITTEE ON HEALTH, JANUARY 10, 2025


                                    AN ACT
 1   Amending the act of April 17, 2016 (P.L.84, No.16), entitled "An
 2      act establishing a medical marijuana program; providing for
 3      patient and caregiver certification and for medical marijuana
 4      organization registration; imposing duties on the Department
 5      of Health; providing for a tax on medical marijuana
 6      organization gross receipts; establishing the Medical
 7      Marijuana Program Fund; establishing the Medical Marijuana
 8      Advisory Board; establishing a medical marijuana research
 9      program; imposing duties on the Department of Corrections,
10      the Department of Education and the Department of Human
11      Services; and providing for academic clinical research
12      centers and for penalties and enforcement," in preliminary
13      provisions, further providing for definitions; in medical
14      marijuana controls, further providing for electronic tracking
15      and for laboratory; and, in Medical Marijuana Advisory Board,
16      further providing for advisory board.
17      The General Assembly of the Commonwealth of Pennsylvania
18   hereby enacts as follows:
19      Section 1.    Section 103 of the act of April 17, 2016 (P.L.84,
20   No.16), known as the Medical Marijuana Act, is amended by adding
21   definitions to read:
22   Section 103.    Definitions.
23      The following words and phrases when used in this act shall
24   have the meanings given to them in this section unless the
25   context clearly indicates otherwise:
 1      "Accreditation body."    An organization which meets all of the
 2   following criteria:
 3          (1)     Certifies the competency, expertise and integrity of
 4      an independent laboratory and operates in conformance with
 5      standards established by experts for competency, consistent
 6      operations and impartiality of organizations accrediting
 7      assessment bodies as adopted by the department after review.
 8      The department shall transmit notice of the adoption under
 9      this paragraph to the Legislative Reference Bureau for
10      publication in the next available issue of the Pennsylvania
11      Bulletin.
12          (2)     Determines an independent laboratory's compliance
13      with and conformance to the relevant standards established by
14      experts of testing and calibration laboratories as adopted by
15      the department after review. The department shall transmit
16      notice of the adoption under this paragraph to the
17      Legislative Reference Bureau for publication in the next
18      available issue of the Pennsylvania Bulletin.
19          (3)     Is a signatory to the International Accreditation
20      Cooperation Mutual Recognition Arrangement for Testing.
21          (4)     Is not affiliated with an independent laboratory
22      applicant for which it has or will issue a certificate of
23      accreditation.
24          (5)     Is not affiliated with, owned by, operated by or
25      financed by a medical marijuana organization.
26      * * *
27      "Approved laboratory."    An independent laboratory approved by
28   the department, in accordance with section 704, to identify,
29   collect, handle and conduct tests on medical marijuana samples
30   from a grower/processor, as part of the quality assurance

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 1   testing and on medical marijuana samples from the department.
 2      * * *
 3      "Cooperative laboratory."    A public or private independent
 4   laboratory that identifies, collects, handles and conducts tests
 5   on medical marijuana samples on behalf of the department. The
 6   term does not include an approved laboratory.
 7      * * *
 8      "Independent laboratory."    A laboratory that:
 9            (1)   Is not owned, operated or affiliated with a medical
10      marijuana organization.
11            (2)   Does not employ a principal, financial backer,
12      operator or employee of a medical marijuana organization.
13            (3)   Is recognized by an accreditation body to test and
14      evaluate products to an established product safety standard
15      and provide unbiased results.
16      * * *
17      "Research and development testing."    Testing performed on
18   behalf of a grower/processor to evaluate the effectiveness of
19   environmental controls in its cultivation and processing
20   practices and to enhance medical marijuana crop yields,
21   resilience and sustainability by developing medical marijuana
22   with improved traits.
23      * * *
24      Section 2.    Sections 701(c) and 704 of the act are amended to
25   read:
26   Section 701.    Electronic tracking.
27      * * *
28      (c)   Access.--[Information] Except as provided in section
29   704(p), information maintained in electronic tracking systems
30   under subsection (a) shall be confidential and not subject to

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 1   the act of February 14, 2008 (P.L.6, No.3), known as the Right-
 2   to-Know Law.
 3      * * *
 4   Section 704.     [Laboratory.] Laboratories.
 5      [(a)    General testing.--A grower/processor shall contract
 6   with one or more independent laboratories to test the medical
 7   marijuana produced by the grower/processor. The department shall
 8   approve a laboratory under this subsection and require that the
 9   laboratory report testing results in a manner as the department
10   shall determine, including requiring a test at harvest and a
11   test at final processing. The possession by a laboratory of
12   medical marijuana shall be a lawful use.
13      (b)    Stability testing.--A laboratory shall perform stability
14   testing to ensure the medical marijuana product's potency and
15   purity. A grower/processor shall retain a sample from each
16   medical marijuana product derived from a harvest batch and
17   request that a sample be identified and collected by a
18   laboratory approved under subsection (a) from each process lot
19   to perform stability testing under the following conditions:
20             (1)   The medical marijuana product is still in inventory
21      at a dispensary in this Commonwealth as determined by the
22      seed-to-sale system.
23             (2)   The stability testing is done at six-month intervals
24      for the duration of the expiration date period as listed on
25      the medical marijuana product and once within six months of
26      the expiration date.]
27      (c)    Application and approval.--
28             (1)   An independent laboratory may apply, in the form and
29      manner prescribed by the department, for approval to test
30      medical marijuana in accordance with the medical marijuana

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 1    program.
 2          (2)   A nonrefundable initial application fee in the
 3    amount of $250 shall be paid by certified check or money
 4    order.
 5          (3)   The department may issue an approval to an
 6    independent laboratory as an approved laboratory under this
 7    subsection if the department determines that an independent
 8    laboratory is financially and professionally suitable to
 9    conduct testing required under this act.
10          (4)   An approval issued by the department to an
11    independent laboratory is valid:
12                (i)    For two years from the date of issuance.
13                (ii)    Only for the location specified in the
14          application and approval notice.
15          (5)   An annual registration fee of $125 shall be paid by
16    each approved laboratory.
17          (6)   Fees payable under this section shall be deposited
18    into the fund.
19          (7)   A laboratory approved by the department to test
20    medical marijuana prior to the effective date of this
21    paragraph shall be deemed an approved laboratory until its
22    approval expires. A laboratory under this paragraph shall be
23    subject to the requirements of this act.
24    (d)   Compliance testing.--
25          (1)   A grower/processor shall contract with an approved
26    laboratory to test the medical marijuana produced by the
27    grower/processor.
28          (2)   The department shall establish uniform medical
29    marijuana testing standards and require that the approved
30    laboratories report testing results in a manner as the

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 1      department shall determine, including:
 2                  (i)    Requiring a test at harvest and at final
 3            processing.
 4                  (ii)    Retesting of failed test results.
 5            (3)   Nothing in this section shall be construed to
 6      prevent a grower/processor from engaging one approved
 7      laboratory to complete all testing required under this
 8      subsection.
 9      (e)   Stability testing.--An approved laboratory shall perform
10   stability testing to ensure the medical marijuana product's
11   potency and purity. A grower/processor shall retain a sample
12   from each medical marijuana product derived from a harvest batch
13   and request that a sample be identified and collected by an
14   approved laboratory from each process lot to perform stability
15   testing under the following conditions:
16            (1)   The medical marijuana product is still in inventory
17      at a dispensary in this Commonwealth as determined by the
18      seed-to-sale system.
19            (2)   The stability testing is done at six-month intervals
20      for the duration of the expiration date period as listed on
21      the medical marijuana product and once within six months of
22      the expiration date.
23            (3)   The stability testing results shall be reported to
24      the department.
25      (f)   Research and development testing.--An approved
26   laboratory may collect samples from a grower/processor for
27   research and development if requested. Results for research and
28   development testing shall be reported to the department.
29   Research and development testing shall not be a replacement for
30   any other testing required under this section.

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 1      (g)   Audit testing.--The department, in its sole discretion,
 2   may conduct audit testing of medical marijuana samples collected
 3   from a grower/processor facility and medical marijuana products
 4   found at a dispensary facility using a cooperative laboratory or
 5   approved laboratory to identify, collect, handle and test the
 6   medical marijuana on the department's behalf.
 7      (h)   Standard operating procedures.--
 8            (1)   An approved laboratory shall maintain written
 9      standard operating procedures for all quality control
10      sampling and testing procedures, including compliance
11      testing, stability testing, research and development testing
12      and quality assurance testing.
13            (2)   An independent laboratory applying to be an approved
14      laboratory under subsection (c) shall submit the independent
15      laboratory's standard operating procedures to the department
16      as part of the independent laboratory's application.
17            (3)   An approved laboratory shall, within 30 days after
18      the effective date of this paragraph, submit its standard
19      operating procedures to the department.
20            (4)   An approved laboratory shall notify the department
21      in writing of any modifications to its standard operating
22      procedures no less than 30 days prior to the modification.
23      (i)   Enforcement procedures.--The department shall conduct
24   announced or unannounced inspections or investigations to
25   determine an approved laboratory's compliance with its standard
26   operating procedures and this act. The department may require
27   the approved laboratory to submit and adhere to a corrective
28   action plan following an inspection.
29      (j)   Accreditation body.--The department may engage with an
30   accreditation body to fulfill the requirements under this

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 1   section.
 2      (k)     Quality assurance testing.--
 3            (1)   The department shall coordinate testing for quality
 4      assurance purposes related to the department and compliance
 5      by each approved laboratory no less than once a year
 6      beginning January 1 after the effective date of this
 7      paragraph.
 8            (2)   The quality assurance testing may be announced or
 9      unannounced.
10            (3)   Any fees for conducting tests as part of the quality
11      assurance testing shall be the responsibility of each
12      approved laboratory. The fees associated with the cost of the
13      medical marijuana samples submitted as part of the testing
14      shall be waived.
15            (4)   A test required by an accreditation body solely to
16      maintain accreditation shall not fulfill the requirements of
17      this subsection.
18            (5)   Quality assurance testing shall be conducted using
19      industry best practices and standards and shall be uniform
20      among all approved laboratories in the medical marijuana
21      program.
22            (6)   Nothing in this section shall be construed to
23      prohibit the department from coordinating quality assurance
24      testing more than once within a calendar year.
25            (7)   If the department determines that an approved
26      laboratory's test results are unsatisfactory, the department
27      shall initiate an investigation which may include the
28      following:
29                  (i)   Additional testing, as needed, to understand the
30            causes for the anomalies and unanticipated errors.

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 1                  (ii)    A review of the approved laboratory's standard
 2            operating procedures.
 3                  (iii)   An inspection of the approved laboratory's
 4            facility, transportation vehicles, equipment,
 5            instruments, tools and physical or electronic materials.
 6                  (iv)    Interviews with the personnel, staff, directors
 7            or other responsible parties of the approved laboratory.
 8                  (v)    The approved laboratory submitting a corrective
 9            action plan to the department.
10      (l)   Corrective actions.--The following shall apply to a
11   corrective action plan required by the department:
12            (1)   The department shall approve or deny a corrective
13      action plan within 30 days of receipt of the plan.
14            (2)   The department may, in its sole discretion, allow
15      the approved laboratory to submit a revised corrective action
16      plan based on the reasons for the denial of the plan within
17      30 days of receipt of the denial.
18            (3)   The department shall approve or deny a revised
19      corrective action plan within 30 days of receipt of the plan.
20            (4)   The corrective action plan shall be implemented
21      within a practicable time frame determined by the department
22      following approval.
23      (m)   Lawful possession.--The possession of medical marijuana
24   by an approved laboratory or cooperative laboratory to conduct
25   compliance testing, stability testing, research and development
26   testing, audit testing and quality assurance testing shall be
27   lawful use.
28      (n)   Violations.--In addition to any other requirements under
29   this act or a regulation promulgated under this act, the
30   following shall be considered to be violations of this section

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 1   and may result in penalties under section 1308(b):
 2            (1)   Failure to comply with the department as part of an
 3      inspection or investigation.
 4            (2)   Failure to submit a corrective action plan as
 5      required by the department.
 6            (3)   Failure to implement a corrective action plan within
 7      the timeline determined by the department.
 8            (4)   Failure to participate in the required quality
 9      assurance testing.
10            (5)   Failure to produce:
11                  (i)    Test results.
12                  (ii)    Satisfactory test results as part of the
13            quality assurance testing.
14            (6)   Fraudulent reporting of laboratory test results.
15      (o)   Sanctions.--In addition to the penalties permitted under
16   subsection (n), the department may impose the following
17   sanctions:
18            (1)   Revoke or suspend the approval to test medical
19      marijuana of an approved laboratory found to be in violation
20      of this act or a regulation promulgated under this act.
21            (2)   Revoke or suspend the approval to test medical
22      marijuana of an approved laboratory found to be in violation
23      of an order issued under this act or a regulation promulgated
24      under this act.
25            (3)   Revoke or suspend the approval to test medical
26      marijuana of an approved laboratory for conduct or activity
27      which would have disqualified the approved laboratory from
28      receiving approval to test medical marijuana.
29            (4)   Suspend an approved laboratory pending the outcome
30      of a hearing in a case in which the approval to test medical

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 1      marijuana could be revoked.
 2            (5)   Order the approved laboratory to cease and desist
 3      testing medical marijuana.
 4      (p)   Testing data and trend analysis.--
 5            (1)   An owner or operator of each approved laboratory
 6      shall ensure that the laboratory enters all of the following
 7      testing results into the seed-to-sale tracking system:
 8                  (i)    Compliance testing.
 9                  (ii)    Stability testing.
10                  (iii)    Research and development testing.
11                  (iv)    Quality assurance testing.
12            (2)   The department may utilize the test results entered
13      by the approved laboratory to:
14                  (i)    Conduct trend analysis for laboratory oversight
15            and compliance.
16                  (ii)    Review functionality of testing standards and
17            methods.
18                  (iii)    Ensure compliance of medical marijuana
19            products.
20                  (iv)    Ensure compliance by grower/processors.
21                  (v)    Release de-identified data to academic clinical
22            research centers for research purposes only.
23                  (vi)    Compile and aggregate testing information to
24            post on the department's publicly accessible Internet
25            website.
26                  (vii)    Aid the department in any aspect of its
27            regulatory efforts, including administrative action.
28      (q)   Accreditation.--The department shall determine the scope
29   of the accreditation an approved laboratory must receive and
30   maintain. The department shall provide an approved laboratory

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 1   reasonable time to receive any additional accreditation beyond
 2   the laboratory's most recent certificate of accreditation.
 3      (r)   State testing laboratory.--The department may establish
 4   and maintain a State testing laboratory. A State testing
 5   laboratory under this section shall be responsible for:
 6            (1)   Developing and maintaining a medical marijuana
 7      laboratory reference library that contains testing
 8      methodologies, including:
 9                  (i)    Potency.
10                  (ii)    Homogeneity.
11                  (iii)    Detection of contaminants and the quantity of
12            those contaminants.
13                  (iv)    Solvents.
14            (2)   Establishing standard operating procedures for
15      sample collection, preparation and analysis of medical
16      marijuana by approved laboratories.
17            (3)   Conducting quality assurance testing of approved
18      laboratories.
19            (4)   Resolving problems with approved laboratories.
20            (5)   Conducting audit testing on medical marijuana
21      samples analyzed by approved testing laboratories.
22      (s)   Materials.--Approved laboratories shall provide
23   materials to the State testing laboratory reference library.
24      (t)   Powers and duties of department.--The department shall:
25            (1)   Hire sufficient staff with the proper expertise to
26      conduct the requirements of this section.
27            (2)   Within 90 days of the effective date of this
28      paragraph, promulgate temporary regulations in accordance
29      with the following:
30                  (i)    In order to facilitate the prompt implementation

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 1        of this section, the department shall have the authority
 2        to promulgate temporary regulations which shall expire
 3        not later than two years following the publication of the
 4        temporary regulations in the Pennsylvania Bulletin under
 5        subparagraph (iii) and on the department's publicly
 6        accessible Internet website.
 7             (ii)    The department may promulgate temporary
 8        regulations not subject to:
 9                    (A)   Sections 201, 202, 203, 204 and 205 of the
10             act of July 31, 1968 (P.L.769, No.240), referred to
11             as the Commonwealth Documents Law.
12                    (B)   Section 204(b) of the act of October 15,
13             1980 (P.L.950, No.164), known as the Commonwealth
14             Attorneys Act.
15                    (C)   The act of June 25, 1982 (P.L.633, No.181),
16             known as the Regulatory Review Act.
17             (iii)    Within 90 days of the effective date of this
18        subsection, the department shall transmit the temporary
19        regulations to the Legislative Reference Bureau for
20        publication in the next available issue of the
21        Pennsylvania Bulletin.
22             (iv)    The department's authority to adopt temporary
23        regulations under subparagraph (i) shall expire two years
24        after publication of the temporary regulations.
25        Regulations adopted after this period shall be
26        promulgated as provided by law.
27             (v)    The department shall rescind any regulation
28        promulgated prior to the effective date of this
29        subsection insofar as the regulation conflicts with a
30        temporary regulation promulgated by the department under

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 1            this subsection.
 2            (3)    Within 90 days of submitting the temporary
 3      regulations to the Legislative Reference Bureau, the
 4      department shall issue guidance to accompany the temporary
 5      regulations.
 6      Section 3.     Section 1201(b), (d), (e), (g), (h) and (i) of
 7   the act are amended and subsection (a) is amended by adding a
 8   paragraph to read:
 9   Section 1201.     Advisory board.
10      (a)   Establishment.--The Medical Marijuana Advisory Board is
11   established within the department. The advisory board shall
12   consist of the following members:
13            * * *
14            (10)    One member appointed by the Governor, who shall
15      have experience and expertise in laboratory science and shall
16      not be affiliated with, contracted with, an owner of,
17      operator of or financed by an approved laboratory or medical
18      marijuana organization.
19      (b)   Terms.--Except as provided under subsection (g), the
20   members appointed under subsection (a)(8) [and], (9) and (10)
21   shall serve a term of four years or until a successor has been
22   appointed and qualified, but no longer than six months beyond
23   the four-year period.
24      * * *
25      (d)   Voting; quorum.--The members under subsection (a)(1),
26   (2), (3), (4), (5), (6) and (7) shall serve ex officio and all
27   members shall have voting rights. A majority of the members
28   shall constitute a quorum for the purpose of organizing the
29   advisory board, conducting its business and fulfilling its
30   duties. A vote of the majority of the members present shall be

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 1   sufficient for all actions of the advisory board unless the
 2   bylaws require a greater number.
 3      (e)   Attendance.--A member of the advisory board appointed
 4   under subsection (a)(8) [or], (9) or (10) who fails to attend
 5   three consecutive meetings shall forfeit his seat unless the
 6   secretary, upon written request from the member, finds that the
 7   member should be excused from a meeting for good cause. A member
 8   who cannot be physically present may attend meetings via
 9   electronic means, including video conference.
10      * * *
11      (g)   Initial terms.--The initial terms of members appointed
12   under subsection (a)(8) [and], (9) and (10) shall be for terms
13   of one, two, three or four years, the particular term of each
14   member to be designated by the secretary at the time of
15   appointment. All other members shall serve for a term of four
16   years.
17      (h)   Vacancy.--In the event that any member appointed under
18   subsection (a)(8) [or], (9) or (10) shall die or resign or
19   otherwise become disqualified during the member's term of
20   office, a successor shall be appointed in the same way and with
21   the same qualifications as set forth in this section and shall
22   hold office for the unexpired term. An appointed member of the
23   advisory board shall be eligible for reappointment.
24      (i)   Expenses.--A member appointed under subsection (a)(8)
25   [or], (9) or (10) shall receive the amount of reasonable travel,
26   hotel and other necessary expenses incurred in the performance
27   of the duties of the member in accordance with Commonwealth
28   regulations, but shall receive no other compensation for the
29   member's service on the board.
30      * * *

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1     Section 4.    This act shall take effect in 90 days.




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