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COMMONWEALTH OF PENNSYLVANIA

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28 Pa. Code § 1141.21. Definitions.

§ 1141.21. Definitions.

 The following words and terms, when used in this part, have the following meanings, unless the context clearly indicates otherwise:

   Act—The Medical Marijuana Act (35 P.S. § §  10231.101—10231.2110).

   Adverse event—An injury resulting from the use of medical marijuana dispensed at a dispensary. An injury includes physical harm, mental harm or loss of function.

   Adverse loss—A loss, discrepancy in inventory, diversion or theft of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana, medical marijuana products, funds or other property of a medical marijuana organization.

   Advertising—The publication, dissemination, solicitation or circulation, for a fee, that is visual, oral, written or electronic to induce directly or indirectly an individual to patronize a particular dispensary, laboratory or practitioner, or to purchase particular medical marijuana products.

   Applicant

     (i)   Depending on the context the term may mean either of the following:

       (A)   A person who wishes to submit or submits an application to the Department for a permit to operate as a grower/processor or dispensary, or both, under the act and this part.

       (B)   A patient or a caregiver who submits an identification card application to the Department.

     (ii)   The term includes a legal guardian or a parent who submits an application on behalf of a patient.

     (iii)   The term does not include an individual under 21 years of age unless the Department has determined under section 507(a) of the act (35 P.S. §  10231.507(a)) that the individual should be permitted to serve as a caregiver.

   CBD—Cannabidiol.

   Caregiver—One of the following:

     (i)   An individual designated by a patient to obtain on behalf of a patient, and provide to a patient, a medical marijuana product.

     (ii)   For a minor patient, an individual who meets the requirements in section 506(2) of the act (35 P.S. §  10231.506(2)).

   Certified medical use—The acquisition, possession, use or transportation of medical marijuana products by a patient, or the acquisition, possession, delivery, transportation or administration of medical marijuana products by a caregiver, for use as part of the treatment of the patient’s serious medical condition, as authorized in a patient certification issued under the act, including enabling the patient to tolerate treatment for the serious medical condition.

   Change in control—The acquisition by a person or group of persons acting in concert of a controlling interest in an applicant or permittee either all at one time or over the span of a 12-consecutive-month period.

   Change in ownership—The addition or removal of a principal, operator or financial backer or a change in control of a medical marijuana organization after the Department approves an initial permit application or a permit renewal application.

   Clinical registrant—An entity that:

     (i)   Holds a permit as both a grower/processor and a dispensary.

     (ii)   Has a contractual relationship with an academic clinical research center under which the academic clinical research center or its affiliate provides advice to the entity, regarding, among other areas, patient health and safety, medical applications and dispensing and management of controlled substances.

   Controlled substance—A drug, substance or immediate precursor included in Schedules I—V as listed in section 4 of The Controlled Substance, Drug, Device and Cosmetic Act (35 P.S. §  780-104).

   Controlling interest

     (i)   For a publicly traded company, voting rights that entitle a person to elect or appoint one or more of the members of the board of directors or other governing board or the ownership or beneficial holding of 5% or more of the securities of the publicly traded company.

     (ii)   For a privately held entity, the ownership of any security in the entity.

   Department—The Department of Health of the Commonwealth.

   Disadvantaged business—The term as defined in 74 Pa.C.S. §  303(b) (relating to diverse business participation).

   Dispensary

     (i)   A person who holds a permit issued by the Department to dispense medical marijuana products.

     (ii)   The term does not include a health care medical marijuana organization as defined under sections 1901—1908 of the act (35 P.S. § §  10231.1901—10231.1908).

   Diverse group—A disadvantaged business, minority-owned business, women-owned business, service-disabled veteran-owned small business or veteran-owned small business that has been certified by a third-party certifying organization.

   Diverse participants—The term includes the following:

     (i)   Individuals from diverse racial, ethnic and cultural backgrounds and communities.

     (ii)   Women.

     (iii)   Veterans.

     (iv)   Individuals with disabilities.

   Diversity plan—A strategy that promotes or ensures participation by diverse groups in the management and operation of a medical marijuana organization through contracting and employment opportunities.

   Electronic tracking system—An electronic seed-to-sale system approved by the Department that is utilized by:

     (i)   A grower/processor to log, verify and monitor the receipt, use and sale of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products, the funds received by a grower/processor for the sale of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products to another medical marijuana organization, the disposal of medical marijuana waste and the recall of defective seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products.

     (ii)   A dispensary to log, verify and monitor the receipt of medical marijuana product from a grower/processor, the verification of the validity of an identification card presented by a patient or caregiver, the dispensing of medical marijuana product to a patient or caregiver, the disposal of medical marijuana waste and the recall of defective medical marijuana products.

     (iii)   An approved laboratory to log, verify and monitor the receipt of samples and test samples for testing, the results of tests performed by the approved laboratory, and the disposal of tested and untested samples and test samples.

   Employee—An individual who is hired for a wage, salary, fee or payment to perform work for an applicant or permittee.

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

   Facility—A structure and other appurtenances or improvements where a medical marijuana organization grows and processes or dispenses medical marijuana.

   Family or household member—The term as defined in 23 Pa.C.S. §  6102 (relating to definitions).

   Financial backer—An investor, mortgagee, bondholder, note holder, or other source of equity, capital or other assets other than a financial institution.

   Financial institution—A bank, a National banking association, a bank and trust company, a trust company, a savings and loan association, a building and loan association, a mutual savings bank, a credit union or a savings bank.

   Form of medical marijuana—The characteristics of the medical marijuana recommended or limited for a particular patient, including the method of consumption and any particular dosage, strain, variety and quantity or percentage of medical marijuana or particular active ingredient.

   Fund—The Medical Marijuana Program Fund established in section 902 of the act (35 P.S. §  10231.902).

   Grower/processor

     (i)   A person who holds a permit from the Department under the act to grow and process medical marijuana.

     (ii)   The term does not include a health care medical marijuana organization as defined under sections 1901—1908 of the act.

   Health care medical marijuana organization—A vertically integrated health system approved by the Department to dispense medical marijuana or grow and process medical marijuana, or both, in accordance with a research study under sections 1901—1908 of the act.

   Hydroponic nutrient solution—A mixture of water, minerals and essential nutrients without soil used to grow medical marijuana plants.

   Identification card—A document issued under section 501 of the act (35 P.S. §  10231.501) that authorizes a patient or caregiver to have access to medical marijuana products under the act.

   Immature medical marijuana plant—A rootless, nonflowering part of a medical marijuana plant that is no longer than 12 inches and no wider than 12 inches produced from a cutting, clipping or seedling and that is in a growing container that is no larger than 2 inches wide and 2 inches tall that is sealed on the sides and bottom.

   Immediate family—The term as defined in 4 Pa.C.S. §  1512(b) (relating to financial and employment interests).

   Industrial hemp—The plant Cannabis sativa L., and any part of the plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3% on a dry-weight basis.

   Initial permit application—The document submitted to the Department by an applicant that, if approved, grants a permit to an applicant.

   Laboratory—A place, establishment or institution within this Commonwealth that has been issued a certificate of accreditation.

   Limited access area—Any area on a site or within a facility where:

     (i)   Immature medical marijuana plants or medical marijuana plants are growing or being processed into medical marijuana.

     (ii)   Immature medical marijuana plants, medical marijuana plants, medical marijuana or medical marijuana products are being loaded into or out of transport vehicles.

     (iii)   Seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana or medical marijuana products are packaged for sale or stored.

     (iv)   Medical marijuana waste is processed, stored or destroyed.

     (v)   Surveillance system devices are stored or maintained.

   Marijuana

     (i)   All parts of the plant Cannabis sativa L., whether growing or not, the seeds of that plant and resin extracted from any part of the plant, and every compound, manufacture, salt, derivative, mixture or preparation of the plant, its seeds or resin.

     (ii)   The term does not include industrial hemp.

     (iii)   The term does not include the mature stalks of Cannabis sativa L., fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt or derivative, mixture or preparation of the mature stalks.

   Medical marijuana—Marijuana for certified medical use, limited to the following forms:

     (i)   Pill.

     (ii)   Oil.

     (iii)   Topical forms, including gels, creams or ointments.

     (iv)   A form medically appropriate for administration by vaporization or nebulization, including dry leaf or plant form for administration by vaporization.

     (v)   Tincture.

     (vi)   Liquid.

   Medical marijuana container—A sealed, traceable, food compliant, tamper resistant, tamper evident container used for the purpose of containment of packaged medical marijuana products being transported from a grower/processor to a medical marijuana organization or an approved laboratory.

   Medical marijuana organization

     (i)   A dispensary or a grower/processor.

     (ii)   The term does not include a health care medical marijuana organization under sections 1901—1908 of the act or a clinical registrant under sections 2001—2003 of the act (35 P.S. § §  10231.2001—10231.2003)

   Medical marijuana plant—A plant which is greater than 12 vertical inches in height from where the base of the stalk emerges from the growth medium to the tallest point of the plant, or greater than 12 horizontal inches in width from the end of one branch to the end of another branch.

   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.

   Medical Marijuana Program—The program authorized under the act and implemented by the Department.

   Medical marijuana waste

     (i)   Solid, liquid, semi-solid or contained gaseous materials that are generated by a grower/processor or an approved laboratory.

     (ii)   The term includes:

       (A)   Unused, surplus, returned, recalled, contaminated or expired medical marijuana.

       (B)   Any medical marijuana plant material that is not used in the growing, harvesting or processing of medical marijuana, including flowers, stems, trim, leaves, seeds, dead medical marijuana plants, dead immature medical marijuana plants, unused medical marijuana plant parts, unused immature medical marijuana plant parts or roots.

       (C)   Spent hydroponic nutrient solution.

       (D)   Unused containers for growing immature medical marijuana plants or medical marijuana plants or for use in the growing and processing of medical marijuana.

       (E)   Unused fertilizers and pesticides.

       (F)   Unused excipients.

       (G)   Wastewater.

   Minority-owned business—The term as defined in 74 Pa.C.S. §  303(b).

   Municipal waste—The term as defined in section 103 of the Solid Waste Management Act (35 P.S. §  6018.103).

   Municipality—A city, borough, incorporated town or township.

   Nebulization—The generation of medical marijuana products in the form of fine spray for medicinal inhalation.

   Nutrient—The essential elements and compounds necessary for the growth, metabolism and development of medical marijuana plants.

   Nutrient practice—The use by a grower/processor of essential elements and compounds necessary for the growth, metabolism and development of seeds, immature medical marijuana plants or medical marijuana plants.

   Operational—The time at which the Department determines that a medical marijuana organization is ready, willing and able to properly carry on the activity for which a permit has been issued under this part, including the implementation of an electronic tracking system.

   Operator—An individual who directly oversees or manages the day-to-day business functions for an applicant or permittee and has the ability to direct employee activities onsite and offsite or within a facility for which a permit is sought or has been issued under this part.

   Patient—An individual who:

     (i)   Has a serious medical condition.

     (ii)   Has met the requirements for certification under the act.

     (iii)   Is a resident of this Commonwealth.

   Permit—An authorization issued by the Department to an applicant to conduct activities authorized under the act.

   Permittee—A person who has been issued an authorization to operate as a medical marijuana organization under the act and this part.

   Person—A natural person, corporation, foundation, organization, business trust, estate, limited liability company, licensed corporation, trust, partnership, limited liability partnership, association or other form of legal business entity.

   Practitioner—A physician who is registered with the Department under section 401 of the act (35 P.S. §  10231.401).

   Principal—An officer, director or person who directly or beneficially owns securities of an applicant or permittee, or a person who has a controlling interest in an applicant or permittee or who has the ability to elect the majority of the board of directors of an applicant or permittee or otherwise control an applicant or permittee, other than a financial institution.

   Publicly traded company—A person other than an individual who:

     (i)   Has a class or series of securities registered under the Securities Exchange Act of 1934 (15 U.S.C.A. § §  78a—78pp) or on a foreign stock exchange determined by the Department to have similar listing and reporting requirements to exchanges that are regulated under the Securities Exchange Act of 1934.

     (ii)   Is a registered management company under the Investment Company Act of 1940 (15 U.S.C.A. § §  80a-1—80a-64).

     (iii)   Is subject to the reporting obligations imposed by section 15(d) of the Securities Exchange Act of 1934 (15 U.S.C.A. §  78o(d)) by reason of having filed a registration statement which has become effective under the Securities Act of 1933 (15 U.S.C.A. § §  77a—77aa).

   Security—The term as defined in section 102(t) of the Pennsylvania Securities Act of 1972 (70 P.S. §  1-102(t)).

   Serious medical condition—Any of the following conditions:

     (i)   Cancer, including remission therapy.

     (ii)   Positive status for Human Immunodeficiency Virus or Acquired Immune Deficiency Syndrome.

     (iii)   Amyotrophic lateral sclerosis.

     (iv)   Parkinson’s disease.

     (v)   Multiple sclerosis.

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

     (vii)   Epilepsy.

     (viii)   Inflammatory bowel disease.

     (ix)   Neuropathies.

     (x)   Huntington’s disease.

     (xi)   Crohn’s disease.

     (xii)   Post-traumatic stress disorder.

     (xiii)   Intractable seizures.

     (xiv)   Glaucoma.

     (xv)   Sickle cell anemia.

     (xvi)   Severe chronic or intractable pain of neuropathic origin or severe chronic or intractable pain.

     (xvii)   Autism.

     (xviii)   Neurodegenerative diseases.

     (ixx)   Terminal illness.

     (xx)   Dyskinetic and spastic movement disorders.

     (xxi)   Opioid use disorder for which conventional therapeutic interventions are contraindicated or ineffective, or for which adjunctive therapy is indicated in combination with primary therapeutic interventions.

   Service-disabled—The term as defined in 51 Pa.C.S. §  9601 (relating to definitions).

   Service-disabled veteran-owned small business—The term as defined in 51 Pa.C.S. §  9601.

   Site—The total area contained within the property line boundaries in which a facility is operated by a medical marijuana organization.

   Spent hydroponic nutrient solution—Hydroponic nutrient solution that has been used and can no longer serve the purpose for which it was produced.

   THC—Tetrahydrocannabinol.

   Terminal illness—A condition or disease for which the medical prognosis of life expectancy is approximately 1 year or less if the condition or disease runs its normal course.

   Third-party certifying organization—The term as defined in 74 Pa.C.S. §  303(b).

   Transport vehicle—A vehicle that meets the requirements of the act and is used to transport seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products between medical marijuana organizations or between medical marijuana organizations and an approved laboratory.

   Unit—The weight or volume of total usable medical marijuana products, calculated in metric units.

   Vaporization—The generation of medical marijuana products in the form of vapor for medicinal inhalation.

   Veteran—The term as defined in 51 Pa.C.S. §  9601.

   Veteran-owned small business—The term as defined in 51 Pa.C.S. §  9601.

   Women-owned business—The term as defined in 74 Pa.C.S. §  303(b).

Source

   The temporary provisions of this §  1141.21 amended January 13, 2017, effective January 14, 2017, expire on January 14, 2019, 47 Pa.B. 199; amended May 11, 2018, effective May 17, 2018, expire on May 12, 2020, 48 Pa.B. 2767. Immediately preceding text appears at serial pages (390707) to (390708) and (385907) to (385912).



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