Signed by Governor Tom Wolf

Vote Smart's Synopsis:

Vote to concur with senate amendments and pass a bill that amends marijuana laws to make it easier to remove yeast or mold contaminants.

Highlights:

• Defines “caregiver” as the person designated by a patient or, if the patient is under 18 years of age, an individual under section 506(2), to deliver medical marijuana, including the following entities designated to deliver medical marijuna (Sec. 1):

• An individual designated by a patient;

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

• Individuals designated in writing, for the purposes of section 502, by an organization that provides hospice, palliative, or home health care services and 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, as well as have significant responsibility for managing the health care and well-being of a patient and were designated by the organization to provide care to a patient who has provided authorization for the designation; and

• Individuals designated in writing, for the 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 are licensed by the department or the department of human services, have significant responsibility for managing the health care and well-being of the patient, and were designated by the residential facility to provide care to a patient who has provided authorization for the designation.

• Defines “continuing care” as 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 a consultation with the patient (Sec. 1).

• Defines “excipients” as solvents, chemicals or materials reported by a medical marijuana organization and approved by the department for the use in the processing of medical marijuana (Sec. 1).

• Defines “harvest batch” as a specifically identified quantity of a 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, and  “harvest lot” as a specifically identified quantity of medical marijuana plant taken from a harvest batch (Sec. 1).

• Defines “medical marijuana product” as 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 (Sec. 1).

• Defines “process lot” as 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 (Sec. 1).

• Defines “research initiative” as 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 (Sec. 1).

• Defines “serious medical condition” to include any of the following (Sec. 1):

• Cancer, including remission therapy;

• Positive status for human immunodeficiency virus or acquired immune deficiency syndrome;

• Amyotrophic lateral sclerosis;

• Parkinson’s disease;

• Multiple sclerosis;

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

• Epilepsy;

• Inflammatory bowel disease;

• Neuropathies; 

• Huntington’s disease;

• Crohn’s disease;

• Post-traumatic stress disorder;

• Intractable seizures;

• Glaucoma;

• Sickle cell anemia;

• Severe chronic or intractable pain of neurological origin or severe chronic or intractable pain in which conventional therapeutic intervention and opiate therapy is contraindicated or ineffective;

• Autism;

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

• Defines “synchronous interaction” as 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 (Sec. 1).

• Requires that no individual may act as a caregiver for more than 5 patients (Sec. 303).

• Establishes that a receipt of medical marijuana by a patient or caregiver from a dispensary may not exceed a 90-day supply of individual doses with the following specifications (Sec. 405):

• During the last 7 days of any 30-day period during the term of the identification card, a patient may obtain and possess a 90-day supply for the subsequent 30-day period; and

• Additional 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.

• Establishes that a caregiver who has not been previously approved by the department under this section is to submit fingerprints for the purpose of obtaining criminal history record checks, and the Pennsylvania State Police or its authorized agent is to 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 (Sec. 502).

• Specifies that 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 and may not be subject to the limitations under 18 Pa.C.S. § 9121(b) (2) (Sec. 502).

• Establishes that the department is to 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 and if the applicant has a history of drug abuse or of diverting controlled substances or illegal drugs (Sec. 502).

• Requires that an application for a grower/processor or dispensary permit to grow, process or dispense medical marijuana is to be in a form and manner prescribed by the department and include the following (Sec. 602):

• A criminal history record check where medical marijuana organizations applying for a permit submit fingerprints of principals, financial backers, operators and employees to the Pennsylvania State Police to determine their character, fitness and suitability to serve as a principal, financial backer, operator and employee under this act; and

• 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.

• Requires a statement that the applicant for a grower/processor or dispensary permit to grow, process or dispense medical marijuana adheres to the following (Sec. 602):

• That the financial backer, operator, employee, and principal of the medical marijuana organization is of good moral character;

• 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;

• Is able to maintain effective security and control to prevent diversion, abuse and other illegal conduct relating to medical marijuana; and 

• Is able to comply with all applicable commonwealth laws and regulations relating to the activities in which it intends to engage under this act.

• Establishes that the department may approve an application from a medical marijuana organization to relocate within this Commonwealth or to add or delete activities or facilities (Sec. 609).

• Specifies that the following individuals may not hold volunteer positions or positions with remuneration in or be affiliated with a medical marijuana organization in any way if the individual has been convicted of any felony criminal offense related to 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 (Sec. 614):

• Financial backers;

• Principals;

• Employees.

• Specifies that the aforementioned provision does 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 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, or one year since the individual’s release from imprisonment for the felony conviction, whichever is later (Sec. 614).

• Establishes that the department or the department's contracted seed-to-sale vendor is to 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 and that the vendor provides 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 (Sec. 701).

• Requires that a grower/processor do all of the following in accordance with department regulations:

• 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 grow and process medical marijuana;

• Obtain seed and plant material from another grower/processor within this Commonwealth to grow medical marijuana;

• Obtain and transport bulk postharvest medical marijuana plant material—including 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—from another grower/processor within this Commonwealth to process medical marijuana. 

• Specifies that apply solvent-based extraction methods and processes to medical marijuana plants that have failed a test conducted by an approved laboratory at harvest are subject to the following (Sec. 702):

• The test failure is limited to yeast and mold;

• The extracted material is to be processed into a topical form;

• The medical marijuana product must pass a final processed test under section 704;

• The medical marijuana product is to be labeled as remediated; 

• This paragraph will 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.

• Establishes that add excipients or hemp or hemp-derived additives are to be obtained or cultivated in accordance with paragraph 4 and that excipients must be pharmaceutical grace, unless otherwise approved by the department. In determining whether to approve an added substance, the department is to consider the following (Sec. 702):

• Whether the added substance is permitted by the United States Food and Drug Administration for use in food or is generally recognized as safe under federal guidelines; and 

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

• Establishes that a grower/processor may only grow, store, harvest or process medical marijuana in an indoor, enclosed, secure facility which (Sec. 702):

• Includes electronic locking systems, electronic surveillance and other features required by the department; and

• Is located within this Commonwealth.

• Requires that a grower/processor is to maintain continuous video surveillance and retain the recordings onsite or offsite for a period of no less than 180 days, unless otherwise required for investigative or litigation purposes (Sec. 702).

• Specifies that the following apply to pesticides (Sec. 702):

• 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 

• The Secretary of Agriculture is to, 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 are posted on the Department’s publicly accessible internet website and is 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—which may be used by growers/processors.

• Specifies that the department is to 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, including all transportation and storage of medical marijuana. The regulations shall provide for the following (Sec. 702):

• Requirements to utilize any electronic tracking system required by the department, which 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.

• Establishes that a grower/processor is to contract with one or more independent laboratories to test the medical marijuana produced by the grower/processor and the department is to approve a laboratory under this subsection and require that the laboratory report testing results in a manner as the department is to determine including requiring a test at harvest and a test at final processing (Sec. 704).

• Establishes that a laboratory is to perform stability testing to ensure the medical marijuana product's potency and purity and that a grower/processor is to 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 (Sec. 704):

• The medical marijuana product is still in inventory at a dispensary in this Commonwealth as determined by the seed-to-sale system; and 

• 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.

• Establishes that a dispensary is to have a physician or a pharmacist available, either in person or remotely 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(Sec. 801).

• Specifies that when dispensing medical marijuana to a patient or caregiver, the dispensary may not dispense an amount greater than a 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 (Sec. 801).

• Establishes that a dispensary may 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 (Sec. 802).

• Specifies that notwithstanding any other provision of law, the department’s authority to adopt temporary regulations under subsection (A) is to expire May 31, 2022 and regulations adopted after this period are to be promulgated as provided by law (Sec. 1107).

• Establishes that the advisory board is to have the following duties (Sec. 1201):

• To issue written reports to the Governor, the Senate and the House of Representatives that include recommendations and findings as to the following:

• Whether to change the types of medical professionals who can issue certifications to patients;

• Whether to change, add or reduce the types of medical conditions which quality as serious medical conditions under this act;

• Whether to change the form of medical marijuana permitted under this act;

• How to ensure affordable patient access to medical marijuana

• The written reports under this section are to be adopted at a public meeting; and 

• The reports are to be a public record under the Act of February 14, 2008 (P.L.6, NO.3), known as the Right-to-Know Law.

• Establishes that 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 oto authorized persons for official governmental or health care purposes, any information related to the use of medical marijuana (Sec. 1307):

• A medical marijuana organization;

• A health care medical marijuana organization or university participating in a research study under chapter 19;

• A clinical registrant or academic clinical research center under chapter 20; and

• An employee or contractor of the department. 

• Specifies that the department, including an authorized employee, requesting or obtaining information under this act is not to be subject to any criminal liability; however, this immunity does not apply to any employee of the department who knowingly and willfully discloses prohibited information under this act (Sec. 1307). 

Full Bill Text