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PRIOR PRINTER'S NO.
CORRECTIVE REPRINT PRIOR PRINTER'S NOS.
12 PRINTER'S NO.
12, 372 PRINTER'S NO.
372 THE GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL Session of 2025 No.
441 THE GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL Session of 2025 No.
establishing a medical marijuana research program;
establishing a medical marijuana research the Department of Education and the Department of Humanns, Services;
imposing duties on the Department of Corrections, the Department of Education and the Department of Human centers and for penalties and enforcement," in preliminary provisions, further providing for definitions;
and providing for academic clinical research centers and for penalties and enforcement," in preliminary provisions, further providing for definitions;
* * * "Approved laboratory." An independent laboratory approved by the department, in accordance with section 704, to identify, 20250HB0033PN0372 - 2 - 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.
* * * "Approved laboratory." An independent laboratory approved by the department, in accordance with section 704, to identify, 20250HB0033PN0441 - 2 - 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.
* * * "Independent laboratory." A laboratory that:
"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:
SECTION 2.
20250HB0033PN0441 - 3 - SECTION 2.
20250HB0033PN0372 - 3 - * * * (D) DEPARTMENT AUTHORITY.--THE DEPARTMENT MAY PLACE ONE OR MORE CONDITIONS ON A PRACTITIONER FOR INCLUSION IN THE REGISTRY, INCLUDING:
* * * (D) DEPARTMENT AUTHORITY.--THE DEPARTMENT MAY PLACE ONE OR MORE CONDITIONS ON A PRACTITIONER FOR INCLUSION IN THE REGISTRY, INCLUDING:
* * * (c) Access.--[Information] Except as provided in section 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- 20250HB0033PN0372 - 4 - to-Know Law.
* * * (c) Access.--[Information] Except as provided in section 20250HB0033PN0441 - 4 - 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.
(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 manner prescribed by the department, for approval to test medical marijuana in accordance with the medical marijuana program.
(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 20250HB0033PN0441 - 5 - manner prescribed by the department, for approval to test medical marijuana in accordance with the medical marijuana program.
20250HB0033PN0372 - 5 - (2) A nonrefundable initial application fee in the amount of $250 shall be paid by certified check or money order.
(2) A nonrefundable initial application fee in the amount of $250 shall be paid by certified check or money order.
(2) The department shall establish uniform medical marijuana testing standards and require that the approved laboratories report testing results in a manner as the department shall determine, including:
(2) The department shall establish uniform medical 20250HB0033PN0441 - 6 - marijuana testing standards and require that the approved laboratories report testing results in a manner as the department shall determine, including:
20250HB0033PN0372 - 6 - (i) Requiring a test at harvest and at final processing.
(i) Requiring a test at harvest and at final processing.
Research and development testing shall not be a replacement for any other testing required under this section.
20250HB0033PN0441 - 7 - 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, 20250HB0033PN0372 - 7 - 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.
(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.
(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.
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 DISPENSARY FROM WHICH ◄ THE SAMPLE ORIGINATED AND THE TESTING HISTORY.
◄ (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.
(4) An approved laboratory shall notify the department in writing of any modifications to its standard operating procedures no less than 30 days prior to the modification.
(4) An approved laboratory shall notify the department in writing of any modifications to its standard operating procedures no less than 30 15 BUSINESS days prior to the ◄ modification IMPLEMENTATION.
(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.
◄ 20250HB0033PN0441 - 8 - (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 REGULATION PROMULGATED ◄ UNDER THIS ACT.
The department may require the approved laboratory to submit and adhere to a corrective action plan following an inspection.
The department may require the approved ◄ laboratory to submit and adhere to a corrective action plan following an inspection.
20250HB0033PN0372 - 8 - (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.
(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.
(6) Nothing in this section shall be construed to prohibit the department from coordinating quality assurance testing more than once within a calendar year.
20250HB0033PN0441 - 9 - (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) If the department determines that an approved laboratory's test results are unsatisfactory, the department shall initiate an investigation which may include the following:
(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:
(ii) A review of the approved laboratory's standard 20250HB0033PN0372 - 9 - operating procedures.
(ii) A review of the approved laboratory's standard operating procedures.
(3) The department shall approve or deny a revised corrective action plan within 30 days of receipt of the plan.
(3) The department shall approve or deny a revised 20250HB0033PN0441 - 10 - corrective action plan within 30 days of receipt of the plan.
20250HB0033PN0372 - 10 - (1) Failure to comply with the department as part of an inspection or investigation.
(1) Failure to comply with the department as part of an inspection or investigation.
(4) Failure to participate in the required quality assurance testing.
(4) Failure to participate in the required quality ◄ assurance OR AUDIT testing.
(5) Failure to produce:
◄ (5) Failure to produce:
(1) Revoke or suspend the approval to test medical marijuana of an approved laboratory found to be in violation of this act or a regulation promulgated under this act.
(1) Revoke or suspend the approval to test medical ◄ 20250HB0033PN0441 - 11 - 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.
◄ (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.
◄ (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.
◄ (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.
20250HB0033PN0372 - 11 - (5) Order the approved laboratory to cease and desist testing medical marijuana.
◄ (5) Order the approved laboratory to cease and desist ◄ testing medical marijuana.
(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:
◄ (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.
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◄ (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 ◄ 20250HB0033PN0441 - 12 - 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:
(vi) Compile and aggregate testing information to post on the department's publicly accessible Internet website.
(vi) Compile and aggregate DE-IDENTIFIED testing ◄ information to post on the department's publicly accessible Internet website.
The department shall provide an approved laboratory reasonable time to receive any additional accreditation beyond 20250HB0033PN0372 - 12 - the laboratory's most recent certificate of accreditation.
The department shall provide an approved laboratory reasonable time to receive any additional accreditation beyond the laboratory's most recent certificate of accreditation.
(r) State testing laboratory.--The department may establish and maintain a State testing laboratory.
20250HB0033PN0441 - 13 - (r) State testing laboratory.--The department may establish and maintain a State testing laboratory.
(i) In order to facilitate the prompt implementation of this section, the department shall have the authority 20250HB0033PN0372 - 13 - to promulgate temporary regulations which shall expire 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.
(i) In order to facilitate the prompt implementation of this section, the department shall have the authority to promulgate temporary regulations which shall expire 20250HB0033PN0441 - 14 - 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.
20250HB0033PN0372 - 14 - (3) Within 90 days of submitting the temporary regulations to the Legislative Reference Bureau, the department shall issue guidance to accompany the temporary regulations.
(3) Within 90 days of submitting the temporary 20250HB0033PN0441 - 15 - regulations to the Legislative Reference Bureau, the department shall issue guidance to accompany the temporary regulations.
A vote of the majority of the members present shall be sufficient for all actions of the advisory board unless the 20250HB0033PN0372 - 15 - bylaws require a greater number.
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.
20250HB0033PN0441 - 16 - (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.
<-- 20250HB0033PN0372 - 16 - SECTION 5.
<-- SECTION 5.
<-- (1) THE ADDITION OF SECTION 401(D) OF THE ACT SHALL TAKE EFFECT IN 60 DAYS.
<-- 20250HB0033PN0441 - 17 - (1) THE ADDITION OF SECTION 401(D) OF THE ACT SHALL TAKE EFFECT IN 60 DAYS.
20250HB0033PN0372 - 17 -
20250HB0033PN0441 - 18 -
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