Regular Session 2023-2024 House Bill 2208 P.N. 3014

PRIOR PRINTER'S NO. 2930

PRINTER'S NO. 3014

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 REPORTED FROM COMMITTEE ON HEALTH, HOUSE OF REPRESENTATIVES,

AS AMENDED, APRIL 30, 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. 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 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

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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. 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.

(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.

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(ii) Quality control.

(iii) All sampling and testing procedures, including

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

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prescribed in 28 Pa. Code Ch. 1171a (relating to

laboratories).

(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.

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(iii) The department may enter the approved testing

laboratory for further investigation and shall issue its

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.

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(2) Establishing standard operating procedures for

sample collection, preparation and analysis of medical

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.

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(3) The chairman of the State Board of Pharmacy or a

designee.

(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)

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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.

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

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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.

(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

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professionals who can issue certifications to patients.

(ii) Whether to change, add or reduce the types of

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.

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 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

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CONFORMANCE TO THE RELEVANT STANDARDS ESTABLISHED BY THE

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, INCLUDING

ISO/IEC 17025, 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

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

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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.

* * *

SECTION 2. SECTIONS 701(C) AND 704 OF THE ACT ARE AMENDED TO

READ:

SECTION 701. ELECTRONIC TRACKING.

* * *

704(L), 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:

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(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.]

(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 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

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INTO THE FUND.

(B) COMPLIANCE TESTING.--A GROWER/PROCESSOR SHALL CONTRACT

WITH APPROVED LABORATORIES AS REQUIRED BY THE DEPARTMENT 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 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.

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

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THE EXPIRATION DATE.

(3) THE STABILITY TESTING RESULTS SHALL BE REPORTED TO

THE DEPARTMENT.

(D) RESEARCH AND DEVELOPMENT TESTING.--AN APPROVED

LABORATORY MAY COLLECT SAMPLES FROM A GROWER/PROCESSOR FOR

RESEARCH AND DEVELOPMENT IF REQUESTED. TEST RESULTS FOR RESEARCH

AND DEVELOPMENT SHALL BE REPORTED TO THE DEPARTMENT. TESTING FOR

RESEARCH AND DEVELOPMENT SHALL NOT BE A REPLACEMENT FOR

COMPLIANCE TESTING.

(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

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 THE

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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

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 BY AN ACCREDITATION BODY AS REQUIRED

SOLELY TO MAINTAIN ACCREDITATION SHALL NOT FULFILL THE

REQUIREMENTS OF THIS SUBSECTION.

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(5) NOTHING SHALL PROHIBIT THE DEPARTMENT FROM

COORDINATING QUALITY ASSURANCE TESTING MORE THAN ONCE WITHIN

A CALENDAR YEAR.

(6) 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 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.

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(J) LAWFUL POSSESSION.--THE POSSESSION OF MEDICAL MARIJUANA

BY AN APPROVED LABORATORY OR COOPERATIVE LABORATORY TO CONDUCT

COMPLIANCE TESTING, STABILITY TESTING, AUDIT TESTING AND QUALITY

ASSURANCE TESTING SHALL BE LAWFUL USE.

(K) VIOLATIONS.--IN ADDITION TO ANY OTHER REQUIREMENTS, 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 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.

(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.

(M) 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

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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:

(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) 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) 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:

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(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

THOSE CONTAMINANTS.

(IV) SOLVENTS.

(2) ESTABLISHING STANDARD OPERATING PROCEDURES FOR

SAMPLE COLLECTION, PREPARATION AND ANALYSIS OF MEDICAL

MARIJUANA BY APPROVED LABORATORIES.

(3) CONDUCTING PROFICIENCY TESTING OF APPROVED

LABORATORIES.

(4) REMEDIATION OF PROBLEMS WITH APPROVED LABORATORIES.

(5) CONDUCTING COMPLIANCE TESTING AND AUDIT TESTING ON

MEDICAL MARIJUANA SAMPLES ANALYZED BY APPROVED TESTING

LABORATORIES.

(P) MATERIALS.--APPROVED LABORATORIES SHALL PROVIDE

MATERIALS TO THE STATE TESTING LABORATORY REFERENCE LIBRARY.

(Q) 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

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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.

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 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.

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(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.

(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.

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* * *

(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.

* * *

SECTION 4. THIS ACT SHALL TAKE EFFECT IN 90 DAYS.

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