2021 Pennsylvania Consolidated & Unconsolidated Statutes
Act 44 - MEDICAL MARIJUANA ACT - OMNIBUS AMENDMENTS

Session of 2021

No. 2021-44

 

HB 1024

 

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 program, further providing for lawful use of medical marijuana; in practitioners, further providing for duration; in patients, further providing for caregivers; in medical marijuana organizations, further providing for permits, for relocation and for convictions prohibited; in medical marijuana controls, further providing for electronic tracking, for grower/processors, for storage and transportation and for laboratory; in dispensaries, further providing for dispensing to patients and caregivers and for facility requirements; in tax on medical marijuana, further providing for Medical Marijuana Program Fund; in administration, further providing for temporary regulations; in Medical Marijuana Advisory Board, further providing for advisory board and for regulations based on recommendations of advisory board; in offenses related to medical marijuana, further providing for disclosure of information prohibited; in academic clinical research centers and clinical registrants, further providing for academic clinical research centers and for clinical registrants and providing for research initiative; in miscellaneous provisions, further providing for applicability; and making a related repeal.

 

The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows:

 

Section 1.  The definitions of "caregiver," "continuing care" and "serious medical condition" in section 103 of the act of April 17, 2016 (P.L.84, No.16), known as the Medical Marijuana Act, are amended and the section 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:

* * *

"Caregiver."  [The individual designated by a patient or, if the patient is under 18 years of age, an individual under section 506(2), to deliver medical marijuana.] The term includes the following entities designated to deliver medical marijuana:

(1)  An individual designated by a patient.

(2)  If the patient is under 18 years of age, an individual under section 506(2).

(3)  Individuals designated in writing, for purposes of section 502, by an organization that provides hospice, palliative or home health care services and:

(i)  are employed by an organization that is licensed under the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act;

(ii)  have significant responsibility for managing the health care and well-being of a patient; and

(iii)  were designated by the organization to provide care to a patient who has provided authorization for the designation.

(4)  Individuals designated in writing, for purposes of section 502, by a residential facility, including a long-term care nursing facility, a skilled nursing facility, an assisted living facility, a personal care home, an independent long-term care facility or an intermediate care facility for individuals with intellectual disabilities that:

(i)  are licensed by the department or the Department of Human Services;

(ii)  have significant responsibility for managing the health care and well-being of the patient; and

(iii)  were designated by the residential facility to provide care to a patient who has provided authorization for the designation.

* * *

"Continuing care."  Treating a patient, in the course of which the practitioner has completed a full assessment of the patient's medical history and current medical condition, including [an in-person] a consultation with the patient.

* * *

"Excipients."  Solvents, chemicals or materials reported by a medical marijuana organization and approved by the department for use in the processing of medical marijuana.

* * *

"Harvest batch."  A specifically identified quantity of medical marijuana plant that is uniform in strain, cultivated utilizing the same growing practices, harvested at the same time and at the same location and cured under uniform conditions.

"Harvest lot."  A specifically identified quantity of medical marijuana plant taken from a harvest batch.

* * *

"Medical marijuana product."  The final form and dosage of medical marijuana that is grown, processed, produced, sealed, labeled and tested by a grower/processor and sold to a dispensary.

* * *

"Process lot."  An amount of a medical marijuana product of the same type and processed using the same medical marijuana extract, standard operating procedures and the same or combination of different harvest lots.

* * *

"Research initiative."  A nonpatient investigation not subject to Institutional Review Board or Research Approval Committee approval requirements of a patient-based research program, project or study, conducted by an academic clinical research center and its contracted clinical registrant.

* * *

"Serious medical condition."  Any of the following:

(1)  Cancer, including remission therapy.

(2)  Positive status for human immunodeficiency virus or acquired immune deficiency syndrome.

(3)  Amyotrophic lateral sclerosis.

(4)  Parkinson's disease.

(5)  Multiple sclerosis.

(6)  Damage to the nervous tissue of the [spinal cord] central nervous system (brain-spinal cord) with objective neurological indication of intractable spasticity and other associated neuropathies.

(7)  Epilepsy.

(8)  Inflammatory bowel disease.

(9)  Neuropathies.

(10)  Huntington's disease.

(11)  Crohn's disease.

(12)  Post-traumatic stress disorder.

(13)  Intractable seizures.

(14)  Glaucoma.

(15)  Sickle cell anemia.

(16)  Severe chronic or intractable pain of neuropathic origin or severe chronic or intractable pain [in which conventional therapeutic intervention and opiate therapy is contraindicated or ineffective].

(17)  Autism.

(18)  Other conditions that are recommended by the advisory board and approved by the secretary under section 1202.

"Synchronous interaction."  A two-way or multiple-way exchange of information between a patient and a health care provider that occurs in real time via audio or video conferencing.

* * *

Section 2.  Sections 303(b)(4), 405, 502(b), 602(a)(4) and (7), 609 AND 614 of the act are amended to read:

Section 303.  Lawful use of medical marijuana.

* * *

(b)  Requirements.--The lawful use of medical marijuana is subject to the following:

* * *

[(4)  An individual may not act as a caregiver for more than five patients.]

* * *

Section 405.  Duration.

Receipt of medical marijuana by a patient or caregiver from a dispensary may not exceed a [30-day] 90-day supply of individual doses. During the last seven days of any 30-day period during the term of the identification card, a patient may obtain and possess a [30-day] 90-day supply for the subsequent 30-day period. Additional [30-day] 90-day supplies may be provided in accordance with this section for the duration of the authorized period of the identification card unless a shorter period is indicated on the certification.

Section 502.  Caregivers.

* * *

(b)  Criminal history.--A caregiver who has not been previously approved by the department under this section shall submit fingerprints for the purpose of obtaining criminal history record checks, and the Pennsylvania State Police or its authorized agent shall submit the fingerprints to the Federal Bureau of Investigation for the purpose of verifying the identity of the applicant and obtaining a current record of any criminal arrests and convictions. Any criminal history record information relating to a caregiver obtained under this section by the department may be interpreted and used by the department only to determine the applicant's character, fitness and suitability to serve as a caregiver under this act. The criminal history record information provided under this subsection may not be subject to the limitations under 18 Pa.C.S. § 9121(b)(2) (relating to general regulations). The department shall also review the prescription drug monitoring program relating to the caregiver. The department shall deny the application of a caregiver who has been convicted of a criminal offense that occurred within the past five years relating to the sale or possession of drugs, narcotics or controlled substances. The department may deny an application if the applicant has a history of drug abuse or of diverting controlled substances or illegal drugs.

Section 602.  Permits.

(a)  Application.--An application for a grower/processor or dispensary permit to grow, process or dispense medical marijuana shall be in a form and manner prescribed by the department and shall include:

* * *

(4)  A criminal history record check. Medical marijuana organizations applying for a permit shall submit fingerprints of principals, financial backers, operators and employees to the Pennsylvania State Police for the purpose of obtaining criminal history record checks and the Pennsylvania State Police or its authorized agent shall submit the fingerprints to the Federal Bureau of Investigation for the purpose of verifying the identity of the principals, financial backers, operators and employees and obtaining a current record of any criminal arrests and convictions. Any criminal history record information relating to principals, financial backers, operators and employees obtained under this section by the department may be interpreted and used by the department only to determine the principal's, financial backer's, operator's and employee's character, fitness and suitability to serve as a principal, financial backer, operator and employee under this act. The criminal history record information provided under this subsection may not be subject to the limitations under 18 Pa.C.S. § 9121(b)(2) (relating to general regulations). After submission of required documentation to the department, medical marijuana organizations may allow employees to work in a supervised capacity until the department formally approves the employee's affiliation with the medical marijuana organization. Any employee who the department determines to be unable to meet the affiliation requirements under section 614 shall be terminated by the medical marijuana organization immediately. This paragraph shall not apply to an owner of securities in a publicly traded corporation or an owner of 5% or less in a privately held business entity if the department determines that the owner of the securities is not substantially involved in the activities of the medical marijuana organization.

* * *

(7)  A statement that the applicant:

[(i)  Is of good moral character. For purposes of this subparagraph, an applicant shall include each financial backer, operator, employee and principal of the medical marijuana organization.]

(ii)  Possesses the ability to obtain in an expeditious manner the right to use sufficient land, buildings and other premises and equipment to properly carry on the activity described in the application and any proposed location for a facility.

(iii)  Is able to maintain effective security and control to prevent diversion, abuse and other illegal conduct relating to medical marijuana.

(iv)  Is able to comply with all applicable Commonwealth laws and regulations relating to the activities in which it intends to engage under this act.

* * *

Section 609.  Relocation.

(a)  Authorization.--The department may approve an application from a medical marijuana organization to relocate within this Commonwealth or to add or delete activities or facilities.

(b)  Designations.--Notwithstanding the provisions of subsection (a), a dispensary may interchange the designation of a primary, secondary or tertiary location at any time, including  the period before a location becomes operational, by providing written notice to the department at least 14 days before the change in designation. A change in designation under this subsection may not be subject to approval by the department.

Section 614.  Convictions prohibited.

(a)  Prohibitions.--The following individuals may not hold volunteer positions or positions with remuneration in or be affiliated with a medical marijuana organization, including a clinical registrant under Chapter 20, in any way if the individual has been convicted of any felony criminal offense related to [the sale or possession of illegal drugs, narcotics or controlled substances:] the manufacture, delivery or possession with intent to manufacture or deliver a controlled substance in violation of the act of April 14, 1972 (P.L.233, No.64), known as The Controlled Substance, Drug, Device and Cosmetic Act, or similar law in any other jurisdiction:

(1)  Financial backers.

(2)  Principals.

(3)  Employees.

(b)  Exclusion.--This section shall not apply to an individual for whom it has been 10 or more years since the entry of a final disposition of a felony conviction related to the manufacture, delivery or possession with intent to manufacture or deliver a controlled substance in violation of The Controlled Substance, Drug, Device and Cosmetic Act, or similar law in any other jurisdiction, or one year since the individual's release from imprisonment for the felony conviction, whichever is later.

Section 3.  Section 701 of the act is amended by adding a subsection to read:

Section 701.  Electronic tracking.

* * *

(c.1)  Application programming interface.--The department or the department's contracted seed-to-sale vendor shall allow two-way communication, automation and application-programming interface of a medical marijuana organization's enterprise resource planning, inventory, accounting and point-of-sale software with the software of the department or the department's contracted seed-to-sale vendor. The department or the department's contracted seed-to-sale vendor shall provide for the development and use of a seed-to-sale cannabis tracking system, which shall include a secure application program interface capable of accessing all data required to be transmitted to the advisory board to ensure compliance with the operational reporting requirements established under this act and the regulations of the department.

* * *

Section 4.  Sections 702, 703(8), 704 and 801(b) and (e) of the act are amended to read:

Section 702.  Grower/processors.

(a)  Authorization.--Subject to subsection (b), a grower/processor may do all of the following in accordance with department regulations:

(1)  Obtain and transport seed and immature plant material from outside this Commonwealth during at least one 30-day period per year as designated by the department to [initially] grow and process medical marijuana.

(2)  Obtain seed and plant material from another grower/processor within this Commonwealth to grow medical marijuana.

(2.1)  Obtain and transport bulk postharvest medical marijuana plant material from another grower/processor within this Commonwealth to process medical marijuana. As used in this paragraph, the term "postharvest plant material" includes all unfinished plant and plant-derived material, whether fresh, dried, partially dried, frozen or partially frozen, oil, concentrate or similar byproducts derived or processed from medical marijuana or medical marijuana plants.

(3)  Apply solvent-based extraction methods and processes to medical marijuana plants that have failed a test conducted by an approved laboratory at harvest, subject to the following:

(i)  The test failure shall be limited to yeast and mold.

(ii)  The extracted material shall be processed into a topical form.

(iii)  The medical marijuana product must pass a final processed test under section 704.

(iv)  The medical marijuana product shall be labeled as remediated.

(v)  This paragraph shall expire upon the publication in the Pennsylvania Bulletin of a notice of the secretary's approval of the recommendations relating to a research initiative, as prescribed in section 2003.1.

(4)  Obtain harvested hemp from a person holding a permit issued by the Department of Agriculture to grow or cultivate hemp under the 3 Pa.C.S. Ch. 15 (relating to controlled plants and noxious weeds) if the hemp received by a grower/processor is subject to the laboratory testing requirements of section 704.

(5)  Add excipients or hemp or hemp-derived additives obtained or cultivated in accordance with paragraph (4). Excipients must be pharmaceutical grade, unless otherwise approved by the department. In determining whether to approve an added substance, the department shall consider the following:

(i)  Whether the added substance is permitted by the United States Food and Drug Administration for use in food or is Generally Recognized as Safe (GRAS) under Federal guidelines.

(ii)  Whether the added substance constitutes a known hazard such as diacetyl, CAS number 431-03-8, and pentanedione, CAS number 600-14-6.

(b)  Limitations.--

(1)  A grower/processor may only grow, store, harvest or process medical marijuana in an indoor, enclosed, secure facility which:

(i)  includes electronic locking systems, electronic surveillance and other features required by the department; and

(ii)  is located within this Commonwealth.

(2)  [(Reserved).] For the purpose of paragraph (1), a grower/processor shall maintain continuous video surveillance. A grower/processor is required to retain the recordings onsite or offsite for a period of no less than 180 days, unless otherwise required for investigative or litigation purposes.

(c)  Pesticides.--The following shall apply:

(1)  A grower/processor may use a pesticide that is registered by the Department of Agriculture under the act of March 1, 1974 (P.L.90, No.24), known as the Pennsylvania Pesticide Control Act of 1973, and designated by the Secretary of Agriculture in consultation with the secretary for use by a grower/processor.

(2)  The Secretary of Agriculture shall, within 30 days of the effective date of this subsection, transmit to the Legislative Reference Bureau for publication in the Pennsylvania Bulletin an initial list of pesticides which may be used by grower/processors. The list shall be posted on the department's publicly accessible Internet website and shall be reviewed and updated by the Secretary of Agriculture, in consultation with the secretary, at least once annually and transmitted to the Legislative Reference Bureau for publication in the Pennsylvania Bulletin.

Section 703.  Storage and transportation.

The department shall develop regulations relating to the storage and transportation of medical marijuana among grower/processors, testing laboratories and dispensaries which ensure adequate security to guard against in-transit losses. The tracking system developed by the department shall include all transportation and storage of medical marijuana. The regulations shall provide for the following:

* * *

(8)  Requirements to utilize any electronic tracking system required by the department[.], which shall allow for the two-way communication, automation and application-programming interface between a medical marijuana organization's enterprise resource planning, inventory, accounting and point-of-sale software and the software of the department or the department's vendor.

* * *

Section 704.  Laboratory.

(a)  General testing.--A grower/processor shall contract with [an independent laboratory] one or more independent laboratories to test the medical marijuana produced by the grower/processor. The department shall approve [the] 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.

Section 801.  Dispensing to patients and caregivers.

* * *

(b)  Requirements.--A dispensary shall have a physician or a pharmacist [onsite] available, either in person or by synchronous interaction, to verify patient certifications and to consult with patients and caregivers at all times during the hours the dispensary is open to receive patients and caregivers. If a dispensary has more than one separate location, a physician assistant or a certified registered nurse practitioner may [be onsite at] verify patient certifications and consult with patients and caregivers, either in person or by synchronous interaction, at each of the other locations in lieu of the physician or pharmacist. A physician, a pharmacist, a physician assistant or a certified registered nurse practitioner shall, prior to assuming duties under this paragraph, successfully complete the course established in section 301(a)(6). A physician may not issue a certification to authorize patients to receive medical marijuana or otherwise treat patients at the dispensary.

* * *

(e)  Supply.--When dispensing medical marijuana to a patient or caregiver, the dispensary may not dispense an amount greater than a [30-day] 90-day supply until the patient has exhausted all but a seven-day supply provided pursuant to a previously issued certification until additional certification is presented under section 405.

* * *

Section 5.  Section 802(a)(1) of the act is amended and the subsection is amended by adding a paragraph to read:

Section 802.  Facility requirements.

(a)  General rule.--

(1)  A dispensary may [only] dispense medical marijuana in an indoor, enclosed, secure facility located within this Commonwealth[,] or in accordance with a curbside delivery protocol as determined by the department.

(1.1)  For the purposes of paragraph (1), a dispensary shall maintain continuous video surveillance. The dispensary is required to retain the recordings onsite or offsite for a period of no less than 180 days, unless otherwise required for investigative or litigation purposes.

* * *

Section 6.  Sections 902(d), 1107(b), 1201(j)(4), (5) and (6), 1202, 1307, 2001.1(a) and 2002(a) and (b)(4), (7) and (8) of the act are amended to read:

Section 902.  Medical Marijuana Program Fund.

* * *

(d)  Repayment of initial funding.--The department shall repay from the fees, taxes and investment earnings of the fund to the General Fund any money appropriated for the initial planning, organization and administration by the department with respect to the establishment of the program at the time of the original enactment of this act. [Repayment shall take place within a 10-year period commencing one year after the date of publication in the Pennsylvania Bulletin of the final regulations.]

Section 1107.  Temporary regulations.

* * *

(b)  Expiration.--[The] Notwithstanding any other provision of law, the department's authority to adopt temporary regulations under subsection (a) shall expire [two years after the effective date of this section] May 31, 2022. Regulations adopted after this period shall be promulgated as provided by law.

* * *

Section 1201.  Advisory board.

* * *

(j)  Duties.--The advisory board shall have the following duties:

* * *

(4)  To issue [two years after the effective date of this section a written report] written reports to the Governor, the Senate and the House of Representatives.

(5)  The written [report] 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 medical conditions which qualify as serious medical conditions under this act.

(iii)  Whether to change the form of medical marijuana permitted under this act.

[(iv)  Whether to change, add or reduce the number of growers/processors or dispensaries.]

(v)  How to ensure affordable patient access to medical marijuana.

[(vi)  Whether to permit medical marijuana to be dispensed in dry leaf or plant form, for administration by vaporization.]

(6)  The [final written report] written reports under this section shall be adopted at a public meeting. The [report] 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 1202.  [Regulations based on] Effectuating recommendations of advisory board.

After receiving [the] a report of the advisory board under section 1201(j)(4), at the discretion of the secretary, the department may [promulgate regulations to] effectuate recommendations made by the advisory board by transmitting a notice to the Legislative Reference Bureau for publication in the Pennsylvania Bulletin. The secretary shall [issue notice] transmit notice to the Legislative Reference Bureau for publication in the Pennsylvania Bulletin within 12 months of the receipt of [the] a report of the advisory board. The notice shall include the recommendations of the advisory board and shall state the specific reasons for the decision of the secretary on whether or not to effectuate each recommendation.

Section 1307.  Disclosure of information prohibited.

(a)  Offense defined.--In addition to any other penalty provided by law, an employee, financial backer, operator or principal of any of the following commits a misdemeanor of the third degree if the person discloses, except to authorized persons for official governmental or health care purposes, any information related to the use of medical marijuana:

(1)  A medical marijuana organization.

(2)  A health care medical marijuana organization or university participating in a research study under Chapter 19.

(3)  A clinical registrant or academic clinical research center under Chapter 20.

(4)  An employee or contractor of the department.

(b)  Exception.--Subsection (a) shall not apply where disclosure is permitted or required by law or by court order. The department, including an authorized employee, requesting or obtaining information under this act shall not be subject to any criminal liability. The immunity provided by this subsection shall not apply to any employee of the department who knowingly and willfully discloses prohibited information under this act.

Section 2001.1.  Academic clinical research centers.

(a)  General rule.--An academic clinical research center must be approved and certified by the department before the academic clinical research center may contract with a clinical registrant. An academic clinical research center shall only contract with one clinical registrant. The accredited medical school that is seeking approval and certification from the department as an academic clinical research center must provide all information required by the department, including information for the individual who will be the primary contact for the academic clinical research center during the department's review of the application. The accredited medical school must also provide all information required by the department for any licensed acute care hospital that the accredited medical school will operate or partner with during the time that it may be approved and certified as an academic clinical research center by the department.

* * *

Section 2002.  Clinical registrants.

(a)  Approval.--The department may approve up to [eight] 10 clinical registrants. Each clinical registrant may provide medical marijuana at not more than six separate locations. The total number of locations authorized to dispense medical marijuana under this section shall not exceed [48] 60. The grower/processor and dispensary permits issued to clinical registrants approved under this section shall be in addition to the 25 grower/processor and 50 dispensary permits issued by the department in accordance with section 616(1) and (2). The limitations relating to number and location in sections 616(1) and (2) and 603(d) do not apply. A clinical registrant may not hold more than one grower/processor and one dispensary permit. Once the department approves [the] an entity as a clinical registrant, the entity shall comply with this chapter. The following shall apply:

(1)  The department shall:

(i)  Open applications for the approval of up to two additional academic clinical research centers and issue approvals to qualified academic clinical research centers within 90 days of the effective date of this paragraph.

(ii)  Open applications for the approval of up to two additional clinical registrants within 120 days of the effective date of this paragraph and issue permits to qualified clinical registrants within 180 days from the date when applications are posted.

(2)  If the statutory maximum number of approved academic clinical research centers or approved clinical registrants are not approved under paragraph (1), the department shall reopen the application process for the approval of academic clinical research centers and clinical registrants.

(b)  Requirements.--The following shall apply to clinical registrants:

* * *

(4)  When the department issues a permit as a grower/processor or a dispensary to an entity seeking approval as a clinical registrant, the issuance shall not be construed to reduce the number of permits for growers/processors and dispensaries authorized under section 616(1) and (2).

(i)  The department shall not approve an applicant for a grower/processor permit if the applicant has previously had a contractual relationship with an academic clinical research center whereby the academic clinical research center or its affiliate provided advice to the applicant regarding, among other areas, patient health and safety, medical applications and dispensing and management of controlled substances and the applicant subsequently sold or assigned for profit to another entity their responsibility under the contractual relationship.

(ii)  (Reserved).

* * *

(7)  The clinical registrant shall have all of the same rights as a grower/processor permittee and must comply with all other requirements of this act regarding growing, processing and dispensing medical marijuana.

(8)  A grower/processor facility owned by a clinical registrant may sell its medical marijuana products [only] to [the clinical registrant's dispensary facilities and the] all dispensary facilities [of other clinical registrants]. The facility may sell seeds, medical marijuana plants and medical marijuana products to, or exchange seeds, medical marijuana plants and medical marijuana products with, any other grower/processor facility holding a permit under Chapter 6 or this chapter.

* * *

Section 7.  The act is amended by adding a section to read:

Section 2003.1.  Research initiative.

(a)  Authority.--An academic clinical research center, in coordination with its contracted clinical registrant, may conduct a research initiative on the antimicrobial effects of applying solvent-based extraction methods and processes to microbial contamination of immature medical marijuana plants, medical marijuana plants, medical marijuana or medical marijuana products.

(b)  Procedure.--An academic clinical research center shall submit to the department for approval a completed written research protocol of the planned research initiative. The department shall grant approval or denial of the protocol within 15 days of its submissions. The following apply:

(1)  The research initiative shall commence no later than 30 days from the date the department issues approval and shall be completed no later than six months from the start date of the research initiative.

(2)  Research initiative findings shall be provided to the department by the academic clinical research center within 15 days of the research initiative's conclusion.

(3)  An academic clinical research center and its contracted clinical registrant shall present research initiative findings to the advisory board and the board's research subcommittee for the board's review and consideration under sections 1201 and 1202. The board shall issue a written report, with recommendations and findings regarding the use of solvent-based extraction methods and processes on microbial contamination by a clinical registrant or grower/processor. The secretary may approve the board's recommendation in accordance with section 1202.

(4)  Prior to implementing a recommendation of the board under paragraph (3), as approved by the secretary, a clinical registrant or grower/processor shall seek approval from the department for a change in its grower/processor extraction process. The department shall inspect the site and facility equipment. Upon approval, the department shall issue a notice of final approval to implement the process.

Section 8.  Section 2109(a) of the act is amended to read:

Section 2109.  Applicability.

[(a)  Dispensaries.--The provisions of this act with respect to dispensaries shall not apply beginning 1,095 days from the effective date of an amendment to the Controlled Substances Act (Public Law 91-513, 84 Stat. 1236) removing marijuana from Schedule I of the Controlled Substances Act.]

* * *

Section 9.  The amendment of the definition of "serious medical condition" in section 103 of the act shall apply retroactively to May 18, 2016.

Section 10.  Repeals are as follows:

(1)  The General Assembly declares that the repeal under paragraph (2) is necessary to effectuate this act.

(2)  Section 1736-A.1 of the act of April 9, 1929 (P.L.343, No.176), known as The Fiscal Code, is repealed.

Section 11.  This act shall take effect as follows:

(1)  The amendment or addition of sections 701(c.1) and 703(8) of the act shall take effect in 180 days.

(2)  The remainder of this act shall take effect immediately.

 

APPROVED--The 30th day of June, A.D. 2021.

 

TOM WOLF

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