Regular Session 2023-2024 House Bill 2208 P.N. 3078

PRIOR PRINTER'S NOS. 2930, 3014

PRINTER'S NO. 3078

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

AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES,

MAY 8, 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 preliminary

provisions, further providing for definitions; 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

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

a laboratory and operates in conformance with the most recent

version of International Organization for Standardization

ISO/IEC 17011 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 a laboratory's compliance with and

conformance to the relevant standards established by the

International Organization for Standardization, including

ISO/IEC 17025, ESTABLISHED BY EXPERTS 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 a 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

20240HB2208PN3078 - 2 -

<--

the department, in accordance with section 704, to identify,

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.

* * *

"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

free from commercial, financial or other pressures that may

influence the results of the testing and evaluation process.

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:

Section 701. Electronic tracking.

20240HB2208PN3078 - 3 -

<--

* * *

704(l) 704(N) , 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.]

20240HB2208PN3078 - 4 -

<--<--

(a) Application and approval.--The following apply:

(1) An owner or operator of 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) A nonrefundable initial application fee in the

amount of $250 shall be paid by certified check or money

order.

(3) The department may designate the 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. Nothing

in this subsection shall be deemed to require the department

to issue an approval to an independent laboratory.

(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 PURSUANT TO

28 PA. CODE § 1171A.23 (RELATING TO APPROVAL OF LABORATORIES)

PRIOR TO THE EFFECTIVE DATE OF THIS SECTION SHALL BE DEEMED

AN APPROVED LABORATORY UNTIL ITS APPROVAL EXPIRES. A

LABORATORY UNDER THIS PARAGRAPH SHALL BE SUBJECT TO THE

REQUIREMENTS OF THIS ACT.

20240HB2208PN3078 - 5 -

<--

<--<--

<--

(b) Compliance testing.--A grower/processor shall contract

with approved laboratories as required by the department AN

APPROVED LABORATORY to test the medical marijuana produced by

the grower/processor. The following shall apply:

(1) The department shall establish uniform medical

marijuana testing standards and require that the approved

laboratory 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.

(2) 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.

(2) 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.

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.

20240HB2208PN3078 - 6 -

<--

<--<--

(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.

(4) IF A GROWER/PROCESSOR STORES HARVESTED MEDICAL

MARIJUANA FOR A MINIMUM OF SIX MONTHS AFTER HARVEST TESTING

AND BEFORE PROCESSING IT INTO A MEDICAL MARIJUANA PRODUCT,

THE GROWER/PROCESSOR SHALL RETAIN A SAMPLE OF THE UNPROCESSED

MEDICAL MARIJUANA AND REQUEST THAT AN APPROVED LABORATORY

CONDUCT STABILITY TESTING. THE STABILITY TESTING UNDER THIS

PARAGRAPH SHALL OCCUR EVERY SIX MONTHS UNTIL THE UNPROCESSED

MEDICAL MARIJUANA IS PROCESSED INTO MEDICAL MARIJUANA PRODUCT

OR UNTIL IT EXPIRES.

(d) Research and development testing.--An approved

laboratory may collect samples from a grower/processor for

research and development if requested. Test results RESULTS for

research and development TESTING shall be reported to the

department. Testing RESEARCH AND DEVELOPMENT TESTING for

research and development shall not be a replacement for

compliance testing ANY OTHER TESTING REQUIRED UNDER THIS

SECTION .

(e) 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.

(f) Standard operating procedures.--The following shall

20240HB2208PN3078 - 7 -

<--<--

<--

<--<--

<--

apply:

(1) An approved laboratory shall maintain written

standard operating procedures for each of the following:

(i) All sampling and testing procedures, including

compliance testing, stability testing, research and

development testing and quality assurance testing.

(ii) Quality control.

(iii) Any other operation as determined by the

department.

(2) An independent laboratory applying to be an approved

laboratory under subsection (a) shall submit the laboratory's

standard operating procedures to the department as part of

the independent laboratory's application.

(3) An approved laboratory shall, within 30 days of

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 days prior to the modification.

(g) 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. The department may require

the approved laboratory to submit and adhere to a corrective

action plan following an inspection.

(h) Accreditation body.--The department may engage with an

accreditation body to fulfill the requirements under this

section.

(i) Quality assurance testing.--The following shall apply:

(1) The department shall coordinate testing for quality

20240HB2208PN3078 - 8 -

<--

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 issued REQUIRED by an accreditation body as

required 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 PROGRAM.

(5) (6) Nothing shall IN THIS SECTION SHALL BE CONSTRUED

TO prohibit the department from coordinating quality

assurance testing more than once within a calendar year.

(6) (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:

(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,

20240HB2208PN3078 - 9 -

<--<--

<--

<--<--<--

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 for review. The following

shall apply:

(A) The department shall approve or deny a

corrective action plan within 30 days of receipt of

the plan.

(B) 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.

revised corrective action plan within 30 days.

(D) The plan shall be implemented within 30 days

of the approval of the department.

(J) 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

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.

20240HB2208PN3078 - 10 -

<--

(j) (K) 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.

(k) (L) 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

30 days of approval THE TIMELINE DETERMINED by the

department.

(4) Failure to participate in the required quality

assurance 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.

(l) Sanctions.--The department may 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, violation of an order issued under this act or a

regulation promulgated under this act or for conduct or activity

which would have disqualified the approved laboratory from

receiving approval to test medical marijuana.

20240HB2208PN3078 - 11 -

<--

<--<--

<--

<--<--

<--

<--<--

(M) SANCTIONS.--IN ADDITION TO THE PENALTIES PERMITTED UNDER

SUBSECTION (L), THE DEPARTMENT MAY IMPOSE THE FOLLOWING

SANCTIONS:

(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.

(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 WHICH THE APPROVAL TO TEST MEDICAL

MARIJUANA COULD BE REVOKED.

(5) ORDER THE APPROVED LABORATORY TO CEASE AND DESIST

TESTING MEDICAL MARIJUANA.

(m) (N) Testing data and trend analysis.--The following

shall apply:

(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 for the following purposes:

20240HB2208PN3078 - 12 -

<--<--

<--

(i) To conduct trend analysis for laboratory

oversight and compliance.

(ii) To review functionality of testing standards

and methods.

(iii) To ensure compliance of medical marijuana

products.

(iv) To ensure compliance by grower/processors.

(v) To release de-identified data to academic

clinical research centers for research purposes only.

(vi) To compile and aggregate testing information to

post on the department's publicly accessible Internet

website.

(vii) To aid the department in any aspect of its

regulatory efforts, including administrative action.

(n) (O) 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.

(o) (P) State testing laboratory.--The department may

establish and maintain a State testing laboratory. A State

testing laboratory under this section shall be responsible for

all of the following:

(1) Developing and maintaining a medical marijuana

laboratory reference library that contains testing

methodologies, including all of the following:

(i) Potency.

(ii) Homogeneity.

(iii) Detection of contaminants and the quantity of

20240HB2208PN3078 - 13 -

<--<--

those contaminants.

(iv) Solvents.

(2) Establishing standard operating procedures for

sample collection, preparation and analysis of medical

marijuana by approved laboratories.

(3) Conducting proficiency QUALITY ASSURANCE testing of

approved laboratories.

(4) Remediation of RESOLVING problems with approved

laboratories.

(5) Conducting compliance testing and audit testing on

medical marijuana samples analyzed by approved testing

laboratories.

(p) (Q) Materials.--Approved laboratories shall provide

materials to the State testing laboratory reference library.

(q) (R) 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

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:

20240HB2208PN3078 - 14 -

<--<--

<--

<--<--

(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.

known as the Regulatory Review Act.

(iii) Within 90 days of the effective date of this

paragraph, 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 board's 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.

(3) Within 90 days of submitting the temporary

regulations to the Legislative Reference Bureau, the

department shall issue guidance to accompany the temporary

regulations.

Section 3. 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:

* * *

20240HB2208PN3078 - 15 -

<--<--

(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.

(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

20240HB2208PN3078 - 16 -

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.

* * *

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

20240HB2208PN3078 - 17 -