PRINTER'S NO. 2930
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2208
Session of
2024
INTRODUCED BY FRANKEL, MADDEN, HILL-EVANS, HADDOCK, PARKER,
SANCHEZ, KHAN, MAYES, CONKLIN AND OTTEN, APRIL 15, 2024
REFERRED TO COMMITTEE ON HEALTH, APRIL 15, 2024
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 medical
marijuana controls, further providing 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 704 of the act of April 17, 2016 (P.L.84,
No.16), known as the Medical Marijuana Act, is amended to read:
Section 704. Laboratory.
(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
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laboratory report testing results in a manner as the department
shall determine, including requiring a test at harvest and a
test at final processing. A grower/processor may engage a single
approved laboratory to perform both the harvest lot and finished
product testing or a grower/processor may engage more than one
approved laboratory to complete the harvest testing and final
product testing. 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) Standard operating procedures.--
(1) An approved testing laboratory shall maintain
written standard operating procedures for each of the
following:
(i) C onfirmation of the validity of results of
testing.
(ii) Quality control.
(iii) All sampling and testing procedures, including
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required safety tests.
(iv) Any other operation as determined by the
department.
(2) A laboratory applying for approval as a testing
laboratory shall submit its standard operating procedures to
the department as part of the laboratory's application.
(3) An approved testing laboratory shall submit its
standard operating procedures to the department at the
following time periods:
(i) for laboratories approved prior to the effective
date of this paragraph, within 30 days of the effective
date of this paragraph;
(ii) at each renewal of approval; and
(iii) within 30 days of a substantial change to the
standard operating procedures.
(4) The department shall enter and conduct a reasonable
inspection of an approved testing laboratory to ensure
adherence to the standard operating procedures at least
annually. The following shall apply:
(i) If the inspection results in the department
identifying gaps in the standard operating procedure, the
department shall submit its findings to the approved
testing laboratory.
(ii) Failure to adhere to corrective actions within
a reasonable time shall constitute a violation of this
act and may result in penalties under section 1308(b) or
(c). Nothing shall limit the department's ability to
suspend or revoke an approval issued to a laboratory as
prescribed in 28 Pa. Code Ch. 1171a (relating to
laboratories).
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(5) The department may engage with an independent
accreditation body to fulfill the requirements under this
subsection.
(d) Validity of results testing.--
(1) The department, in coordination with the Bureau of
Laboratories, shall ensure that approved testing
laboratories' results are valid no less than once a year
beginning on January 1 after the effective date of this
paragraph. The following apply:
(i) The department shall require approved testing
laboratories to participate in an established method used
to determine validity of results.
(ii) The department may engage an accredited
proficiency testing provider to fulfill subparagraph (i).
(iii) Nothing shall prohibit the department from
ensuring validity of results more than once within a
calendar year.
(iv) A test issued by an accredited proficiency
testing provider as required solely to maintain
accreditation shall not fulfill the requirements of this
subparagraph.
(2) If the results from an approved testing laboratory
are found to be invalid, the following actions shall be taken
by the department:
(i) A review of the approved testing laboratory's
standard operating procedures.
(ii) Additional testing, as needed, to understand
the cause for the anomalies and unanticipated errors.
(iii) The department may enter the approved testing
laboratory for further investigation and shall issue its
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findings. The department may engage with an independent
accreditation body to fulfill the requirements under this
subparagraph.
(3) Failure to participate or failure to adhere to
corrective actions shall constitute a violation of this act
and may result in penalties under section 1308(b) or (c).
Nothing shall limit the department's ability to suspend or
revoke an approval issued to a laboratory as prescribed in 28
Pa. Code Ch. 1171a.
(e) Trend analysis.--The department may utilize the seed-to-
sale tracking system to conduct trend analysis for laboratory
oversight.
(f) Accreditation.--The department shall determine the scope
of 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.
(g) State testing laboratory.--The department may establish
and maintain a State testing laboratory. A State testing
laboratory under this subsection shall be responsible for:
(1) Developing and maintaining a medical marijuana
laboratory reference library that contains testing
methodologies in the areas of:
(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
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marijuana by approved testing laboratories.
(3) Conducting proficiency testing of approved testing
laboratories.
(4) Remediation of problems with approved testing
laboratories.
(5) Conducting compliance testing on medical marijuana
samples analyzed by approved testing laboratories.
(h) Materials.--Approved testing laboratories shall provide
materials to the State testing laboratory reference library.
(i) Memorandum of understanding.--The department may enter
into a memorandum of understanding with the Department of
Agriculture to test medical marijuana at an existing State-run
laboratory if doing so would be a more economic and efficient
alternative to establishing a State testing laboratory under
subsection (g).
(j) Powers and duties of department.--The department shall:
(1) Hire sufficient staff with the proper expertise to
conduct the requirements of this act.
(2) Promulgate regulations to facilitate the
implementation of this act and oversight of laboratories.
Section 2. Section 1201 of the act is amended 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:
(1) The secretary or a designee.
(2) The Commissioner of the Pennsylvania State Police or
a designee.
(3) The chairman of the State Board of Pharmacy or a
designee.
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(4) The Commissioner of Professional and Occupational
Affairs or a designee.
(5) The Physician General or a designee.
(6) The president of the Pennsylvania Chiefs of Police
Association or a designee.
(7) The president of the Pennsylvania District Attorneys
Association or a designee.
(8) One member to be appointed by each of the following,
which members shall be knowledgeable and experienced in
issues relating to care and treatment of individuals with a
serious medical condition, geriatric or pediatric medicine or
clinical research:
(i) The Governor.
(ii) The President pro tempore of the Senate.
(iii) The Majority Leader of the Senate.
(iv) The Minority Leader of the Senate.
(v) The Speaker of the House of Representatives.
(vi) The Majority Leader of the House of
Representatives.
(vii) The Minority Leader of the House of
Representatives.
(9) One member appointed by the Governor, who shall be a
patient, a family or household member of a patient or a
patient advocate.
(10) One member appointed by the Governor, who shall
have experience and expertise in laboratory science.
(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
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the four-year period.
(c) Chair.--The secretary, or a designee, shall serve as
chair of the advisory board.
(d) Voting; quorum.--The members under subsection (a)(1),
(2), (3), (4), (5), (6) and (7) shall serve ex officio and 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.
(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.
(f) Governance.--The advisory board shall have the power to
prescribe, amend and repeal bylaws, rules and regulations
governing the manner in which the business of the advisory board
is conducted and the manner in which the duties granted to it
are fulfilled. The advisory board may delegate supervision of
the administration of advisory board activities to an
administrative secretary and other employees of the department
as the secretary shall appoint.
(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
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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.
(j) Duties.--The advisory board shall have the following
duties:
(1) To examine and analyze the statutory and regulatory
law relating to medical marijuana within this Commonwealth.
(2) To examine and analyze the law and events in other
states and the nation with respect to medical marijuana.
(3) To accept and review written comments from
individuals and organizations about medical marijuana.
(4) To issue written reports to the Governor, the Senate
and the House of Representatives.
(5) The written reports under paragraph (4) shall
include recommendations and findings as to the following:
(i) Whether to change the types of medical
professionals who can issue certifications to patients.
(ii) Whether to change, add or reduce the types of
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medical conditions which qualify as serious medical
conditions under this act.
(iii) Whether to change the form of medical
marijuana permitted under this act.
(v) How to ensure affordable patient access to
medical marijuana.
(6) The written reports under this section shall be
adopted at a public meeting. The 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 3. This act shall take effect in 90 days.
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