RULES AND REGULATIONS
Title 28—HEALTH AND SAFETY
DEPARTMENT OF HEALTH
[ 28 PA. CODE CHS. 1141 AND 1151 ]
Medical Marijuana; General Provisions; Growers/Processors; Amended Temporary Regulations
[48 Pa.B. 2767]
[Saturday, May 12, 2018]The Department of Health (Department) is publishing amended temporary regulations in Chapters 1141 and 1151 (relating to general provisions—temporary regulations; and growers/processors—temporary regulations) to read as set forth in Annex A. These amended temporary regulations are published under the Medical Marijuana Act (act) (35 P.S. §§ 10231.101—10231.2110). Section 1107 of the act (35 P.S. § 10231.1107) specifically provides that, to facilitate the prompt implementation of the act, the Department may promulgate temporary regulations that are not subject to sections 201—205 of the act of July 31, 1968 (P.L. 769, No. 240) (45 P.S. §§ 1201—1205), known as the Commonwealth Documents Law, the Regulatory Review Act (71 P.S. §§ 745.1—745.14) and sections 204(b) and 301(10) of the Commonwealth Attorneys Act (71 P.S. §§ 732-204(b) and 732-301(10)).
To implement the Medical Marijuana Program, the Department periodically published temporary regulations regarding various sections of the act. Chapter 1141 sets forth the general requirements for the Medical Marijuana Program. Chapter 1151 sets forth the requirements for an entity to become permitted and operate as a grower/processor under the act.
The Department is amending the existing temporary regulations in Chapters 1141 and 1151 for the sake of consistency, and to take into account the need for changes that have arisen as each new set of temporary regulations has been implemented by the Department. Under section 1202 of the act (35 P.S. § 10231.1202), the Department is also amending the existing temporary regulations to effectuate the recommendations made by the Medical Marijuana Advisory Board (Board). After consideration of the Board's report, the Secretary of Health decided to implement the Board's recommendations through the promulgation of temporary regulations.
These amended temporary regulations in Chapters 1141 and 1151 will become effective May 17, 2018, and will expire on May 12, 2020.
Interested persons are invited to submit written comments, suggestions or objections regarding these amended temporary regulations to John J. Collins, Office of Medical Marijuana, Department of Health, Room 628, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120, (717) 547-3047, RA-DHMedMarijuana@pa.gov.
Persons with a disability who wish to submit comments, suggestions or objections regarding these amended temporary regulations or who require an alternative format of these amended temporary regulations (for example, large print, audiotape, Braille) may do so by using the previous contact information, or for speech and/or hearing impaired persons, call the Pennsylvania AT&T Relay Service at (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).
RACHEL L. LEVINE, MD,
Secretary(Editor's Note: Title 28 of the Pennsylvania Code is amended by adding temporary regulations in §§ 1141.52 and 1151.45 and amending the temporary regulations in §§ 1141.21—1141.51 and 1151.21—1151.44 to read as set forth in Annex A.)
Fiscal Note: 10-210. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 28. HEALTH AND SAFETY
PART IX. MEDICAL MARIJUANA
CHAPTER 1141. GENERAL PROVISIONS—
TEMPORARY REGULATIONS§ 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).
§ 1141.22. Records subject to disclosure; confidentiality.
(a) The following records are public records and are subject to disclosure under the Right-to-Know Law (65 P.S. §§ 67.101—67.3104):
(1) An application submitted under the act, except to the extent that the application contains any of the information listed in subsection (b).
(2) The name, business address and medical credentials of a practitioner.
(3) Information regarding penalties or other disciplinary actions taken against a permittee by the Department for a violation of the act.
(b) The following information is considered confidential, is not subject to the Right-to-Know Law and will not otherwise be released to a person unless pursuant to court order:
(1) Information in the possession of the Department or any of its contractors regarding a practitioner's registration information that is not listed as a public record under subsection (a).
(2) The name or other personal identifying information of a patient or caregiver who applies for or is issued an identification card.
(3) Individual identifying information concerning a patient or caregiver, or both.
(4) A patient certification issued by a practitioner.
(5) Any information on an identification card.
(6) Information provided by the Pennsylvania State Police regarding a caregiver, including criminal history record information, as set forth in § 1141.31 (relating to background checks).
(7) Information regarding a patient's serious medical condition.
(8) Other information regarding a patient, caregiver, practitioner or medical marijuana organization not listed in subsection (a) that falls within an exception to the Right-to-Know Law, or is otherwise considered to be confidential proprietary information by other law.
(9) Information regarding the physical features of, and security measures installed in, a facility.
(10) Information maintained in the electronic tracking system of a grower/processor, an approved laboratory and a dispensary.
(11) The names and any other information relating to persons reviewing permit applications, including a reviewer's individual permit application reviews and notes.
(12) Information relating to an applicant's diversity plan that is marked confidential proprietary or trade secret.
(c) An applicant shall mark confidential proprietary information as confidential proprietary or trade secret information, as defined in section 102 of the Right-to-Know Law (65 P.S. § 67.102), prior to submission of a permit application to the Department.
(d) An applicant's failure to redact confidential proprietary or trade secret information in its submitted permit application will result in disclosure to the public of the confidential proprietary or trade secret information in response to a Right-to-Know Law request.
(e) An applicant is responsible for defending its own redactions in any administrative or court proceeding, including any appeals. Any information not adequately defended by the applicant may result in full disclosure of the information in un-redacted form.
§ 1141.23. Limitation on number of permits.
Notwithstanding section 2002 of the act (35 P.S. § 10231.2002), the following limitations apply regarding the number of permits to be issued under this part:
(1) The Department will not initially issue permits to more than 25 applicants for grower/processor permits. The following apply:
(i) The Department will not issue more than one individual grower/processor permit to one person.
(ii) The Department will not issue an individual dispensary permit to more than five individual grower/processors.
(2) The Department will not initially issue permits to more than 50 applicants for dispensary permits. The following apply:
(i) The Department will not issue more than five individual dispensary permits to one person.
(ii) A dispensary permit may be used to provide medical marijuana at no more than three separate locations as approved by the Department.
(3) In accordance with section 1202(j)(5)(iv) of the act (35 P.S. § 10231.1202(j)(5)(iv)), the Department may issue permits in addition to those in paragraphs (1) and (2) if necessary as the Medical Marijuana Program expands, including to comply with an order of court. No more than 20% of the total number of growers/processors may also be issued permits as dispensaries.
§ 1141.24. Medical marijuana regions.
(a) The Department will issue permits to applicants in each of six medical marijuana regions. The six medical marijuana regions are as follows:
(1) Region 1—The geographical region comprised of the counties of the Department's Southeast District, which includes Berks, Bucks, Chester, Delaware, Lancaster, Montgomery, Philadelphia and Schuylkill.
(2) Region 2—The geographical region comprised of the counties of the Department's Northeast District, which includes Carbon, Lackawanna, Lehigh, Luzerne, Monroe, Northampton, Pike, Susquehanna, Wayne and Wyoming.
(3) Region 3—The geographical region comprised of the counties of the Department's Southcentral District, which includes Adams, Bedford, Blair, Cumberland, Dauphin, Franklin, Fulton, Huntingdon, Juniata, Lebanon, Mifflin, Perry and York.
(4) Region 4—The geographical region comprised of the counties of the Department's Northcentral District, which includes Bradford, Centre, Clinton, Columbia, Lycoming, Montour, Northumberland, Potter, Snyder, Sullivan, Tioga and Union.
(5) Region 5—The geographical region comprised of the counties of the Department's Southwest District, which includes Allegheny, Armstrong, Beaver, Butler, Cambria, Fayette, Greene, Indiana, Somerset, Washington and Westmoreland.
(6) Region 6—The geographical region comprised of the counties of the Department's Northwest District, which includes Cameron, Clarion, Clearfield, Crawford, Elk, Erie, Forest, Jefferson, Lawrence, McKean, Mercer, Venango and Warren.
(b) The Department will consider the following factors about each region in its determination to grant or deny an initial permit to an applicant:
(1) Regional population.
(2) The number of patients suffering from a serious medical condition.
(3) The types of serious medical conditions in the region.
(4) Access to public transportation.
(5) The health care needs of rural and urban areas.
(6) Areas with recognized need for economic development.
(c) The publication of this section in the Pennsylvania Bulletin is deemed to be the notice of the establishment of the regions required under section 604 of the act (35 P.S. § 10231.604). The Department may change the number or boundaries of the regions every 2 years upon publication of notice of the adjustment in the Pennsylvania Bulletin.
§ 1141.25. General requirements for permits.
(a) The Department may issue a permit to an applicant only for the specific location identified in the applicant's application, by name and address. A permit will specify that the applicant is authorized to begin the process necessary to become operational. A permit is only valid for the person named in the permit and only for the location specified in the permit.
(b) The medical marijuana organization shall conspicuously post its permit in a location within its facility that is visible to the Department or its authorized agents and law enforcement.
(c) A permit will not be issued to a medical marijuana organization for use in a personal residence or any other location where the Department or its authorized agents or law enforcement would have limited access.
(d) A permit will not be issued to a medical marijuana organization for a site or facility located on lands owned by the United States or the Commonwealth.
(e) A permit is valid for 1 year from the date of issuance.
§ 1141.26. Privilege and nontransferability.
(a) The issuance or renewal of a permit to a medical marijuana organization is a revocable privilege.
(b) A permit issued under this part is not transferable to any person or any location.
§ 1141.27. General requirements for application.
(a) The types of applications to be submitted to the Department under this part include:
(1) An initial permit application.
(2) A permit renewal application.
(3) An application for approval of a change in ownership of a medical marijuana organization authorized by a permit.
(4) An application for approval of a change of location of a facility authorized by a permit.
(5) An application for approval of alteration of a facility authorized by a permit.
(6) An application for additional dispensary locations.
(7) An application for approval of a laboratory.
(b) By submitting an application to the Department, an applicant consents to any investigation, to the extent deemed appropriate by the Department, of the applicant's ability to meet the requirements under the act applicable to the application.
(c) An application is not complete and will be rejected by the Department unless:
(1) The payment of the applicable application fee in § 1141.28 (relating to fees) is submitted with the application.
(2) The applicant and its principals and other persons affiliated with the applicant identified by the Department are current in all tax obligations due and owing to the Commonwealth. An applicant, as part of the application, shall provide tax clearance certificates issued by the Department of Revenue and the Department of Labor and Industry for the applicant and its principals and other persons affiliated with the applicant identified by the Department verifying that the applicant does not have outstanding tax obligations to the Commonwealth. The Department may consider the application to be complete if the applicant states on a form prescribed by the Department of Revenue or the Department of Labor and Industry that tax clearance certificates have been requested at the time the application was submitted to the Department.
(3) All required information for each section of the application, including attachments and any supplemental information required by the Department, is submitted to the Department.
(4) Nothing in this subsection requires the Department to request additional or supplemental information from an applicant.
(d) An application that is rejected by the Department as incomplete will be returned to the applicant without further consideration by the Department and the initial permit fee will be refunded.
(e) An application submitted under this part must contain the following statement signed by the applicant:
A false statement made in this application is punishable under the applicable provisions of 18 Pa.C.S. Ch. 49 (relating to falsification and intimidation).
§ 1141.28. Fees.
(a) An applicant for an initial grower/processor permit or renewal permit shall pay the following fees by certified check or money order to the Department:
(1) Initial permit application fee—$10,000. The initial permit application fee shall be submitted with the initial permit application and is nonrefundable, except as provided in § 1141.29(a)(3) (relating to initial permit application).
(2) Initial permit fee—$200,000. The initial permit fee shall be submitted with the initial permit application and will be refunded if the initial permit is not granted.
(3) Permit renewal fee—$10,000. The permit renewal fee shall be submitted with a renewal application and will be refunded if the renewal permit is not granted.
(4) An initial permit fee refund will be issued to the business named by the applicant in the permit application, in care of the primary contact provided by the applicant, and mailed to the primary contact's mailing address provided by the applicant.
(b) An applicant for an initial dispensary permit or renewal permit shall pay the following fees by certified check or money order to the Department:
(1) Initial permit application fee—$5,000. The initial permit application fee shall be submitted with the initial permit application and is nonrefundable, except as otherwise provided in this part.
(2) Initial permit fee—$30,000 for each dispensary location. The initial permit fee shall be submitted with the initial permit application and will be refunded if the initial permit is not granted.
(3) Permit renewal fee—$5,000. The permit renewal fee shall be submitted with a renewal application and will be refunded if the renewal permit is not granted.
(4) An initial permit fee refund will be issued to the business named by the applicant in the permit application, in care of the primary contact provided by the applicant, and mailed to the primary contact's mailing address provided by the applicant.
(c) A medical marijuana organization shall pay a fee of $250 by certified check or money order to the Department with the submission of the following:
(1) An application for approval of a change in ownership of a medical marijuana organization.
(2) An application for approval of a change of location of a facility authorized by a permit.
(3) An application for approval of alteration of a facility authorized by a permit.
§ 1141.29. Initial permit application.
(a) The Department will publish in the Pennsylvania Bulletin notice of initial permit application availability and the time frame during which initial permit applications will be accepted.
(1) An applicant shall only use the initial permit application form prescribed by the Department on its web site.
(2) An applicant shall submit an initial permit application using the form posted on the Department's web site together with a version that is redacted in accordance with the Right-to-Know Law (65 P.S. §§ 67.101—67.3104), as set out in § 1141.22 (relating to records subject to disclosure; confidentiality), by mail in an electronic format that is prescribed by the Department in the initial permit application instructions.
(3) An initial permit application received from an applicant after the time frame during which the Department is accepting applications will be rejected by the Department and returned to the applicant without further consideration along with the initial permit application fee and initial permit fee submitted by the applicant with the permit application.
(b) In addition to the requirements in § 1141.27 (relating to general requirements for application), the applicant shall provide the Department with the following information in the initial permit application:
(1) The legal name of the applicant.
(2) Certified copies of the applicant's organizational documents, if applicable, and, if the applicant was not organized in this Commonwealth, evidence that it is authorized to conduct business in this Commonwealth.
(3) The physical address of the applicant's proposed site and facility, including the following, as applicable:
(i) Evidence of the applicant's clear legal title to or option to purchase the proposed site and the facility.
(ii) A fully-executed copy of the applicant's unexpired lease for the proposed site and facility that includes the consent by the property owner to the use by the applicant of that site and facility on the proposed site for, at a minimum, the term of the initial permit.
(iii) Other evidence satisfactory to the Department that shows the applicant has the authority to use the proposed site and facility as a site and facility for, at a minimum, the term of the permit.
(4) Evidence that the applicant is or will be in compliance with the municipality's zoning requirements.
(5) The following apply to the proposed facility:
(i) If the facility is in existence at the time the initial permit application is submitted to the Department, the applicant shall submit plans and specifications drawn to scale for the interior of the facility.
(ii) If the facility is in existence at the time the initial permit application is submitted to the Department, and the applicant intends to make alterations to the facility, the applicant shall submit renovation plans and specifications for the interior and exterior of the facility to be altered.
(iii) If the facility is not in existence at the time the initial permit application is submitted to the Department, the applicant shall submit a plot plan that shows the proposed location of the facility and an architect's drawing of the facility, including a detailed drawing, to scale, of the interior of the facility.
(6) The name, residential address, date of birth, title and short version of a curriculum vitae of each principal, operator, financial backer and employee of the applicant, or of any person holding an interest in the applicant's proposed site or facility, including:
(i) A verification of identity that is satisfactory to the Department.
(ii) Evidence of good moral character and reputation of each principal, operator, financial backer or employee.
(iii) A copy of a criminal history records check for each individual performed in accordance with § 1141.31 (relating to background checks). This subparagraph does not apply to an applicant who is an owner of securities in a publicly traded company if the Department determines that the owner of the securities is not substantially involved in the activities of the applicant.
(iv) An affidavit from each principal or operator of the applicant setting forth the following:
(A) Any position of management or ownership held during the 10 years preceding the filing date of the initial permit application of a controlling interest in any other business in this Commonwealth or any other jurisdiction involving the manufacturing or distribution of medical marijuana, medical marijuana products or a controlled substance.
(B) Whether the principal, operator or financial backer has been convicted of a criminal offense graded higher than a summary offense.
(7) If a principal, operator or financial backer is a corporation or limited liability company:
(i) The names, residential addresses, titles and short version of a curricula vitae of each principal of the corporation or limited liability company.
(ii) A certified copy of the filed articles of incorporation of the corporation or filed certificate of organization of the limited liability company.
(iii) Unless the corporation or limited liability company is a publicly traded company, the names and mailing addresses of all persons owning securities in the corporation or membership interests in the limited liability company.
(8) If a principal, operator or financial backer is a general partnership, limited partnership, limited liability partnership or limited liability limited partnership:
(i) The names, residential addresses, titles and short version of a curricula vitae of each partner and general partner of a general partnership, limited partnership, limited liability partnership or limited liability limited partnership, and if any of the partners is a corporation or a limited liability company, the names, residential addresses, titles and short version of a curricula vitae of each principal of that corporation or limited liability company.
(ii) A certified copy of its filed certificate of limited partnership or other formation document, if applicable.
(iii) A certified copy of its partnership agreement.
(iv) Unless the entity is a publicly traded company, the names and mailing addresses of each of its partners.
(9) Evidence that the applicant is responsible and capable of successfully establishing and operating a facility, including the following:
(i) Demonstrated experience, if any, running a for-profit or nonprofit organization or other business within this Commonwealth or any other jurisdiction and the nature of the business conducted by the organization.
(ii) History relating to a similar license, permit or other authorization in other jurisdictions, including provisional licenses, suspensions, revocations or disciplinary actions, including civil monetary penalties or warnings.
(iii) History of response to sanctions, disciplinary actions or civil monetary penalties imposed relating to any similar license, permit or other authorization in another jurisdiction, and the plans of correction or other responses made to those actions.
(iv) Evidence that the applicant and its principals and other persons affiliated with the applicant identified by the Department is in compliance with all the laws of the Commonwealth regarding the payment of State taxes as shown on the tax clearance certificates issued by the Department of Revenue and the Department of Labor and Industry under § 1141.27.
(v) Evidence of any criminal action under the laws of the Commonwealth or any other state, the United States or a military, territorial or tribal authority, graded higher than a summary offense, against a principal, operator, financial backer or employee, or which involved the possession, transportation or sale of illegal drugs, or which related to the provision of marijuana for medical purposes, including any action against an organization providing marijuana for medical purposes in which those individuals either owned shares of stock or served as executives, and which resulted in a conviction, guilty plea or plea of nolo contendere, or an admission of sufficient facts.
(vi) Evidence of any civil or administrative action under the laws of the Commonwealth or any other state, the United States or a military, territorial or tribal authority relating to a principal, operator, financial backer or employee of the applicant's profession, or occupation or fraudulent practices, including fraudulent billing practices.
(vii) Evidence of any attempt by the applicant to obtain a registration, license, permit or other authorization to operate a medical marijuana organization in any jurisdiction by fraud, misrepresentation or the submission of false information.
(viii) A statement that the applicant shall provide evidence of workers' compensation insurance if the applicant is issued a permit and the facility is determined to be operational by the Department.
(10) A description of the duties, responsibilities and roles of each principal, operator, financial backer and employee.
(11) A timetable outlining the steps the applicant will take to become operational.
(12) A summary of the intended plan of operation that describes, at a minimum, how the applicant's proposed business operations will comply with the act and this part relating to:
(i) Security.
(ii) Employee qualifications and training.
(iii) Transportation of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products.
(iv) Storage of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products.
(v) With respect to an application for a grower/processor permit, labeling of medical marijuana products.
(vi) Inventory management.
(vii) With respect to a grower/processor's facility, nutrient practice.
(viii) With respect to a grower/processor's facility, quality control and testing of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products for potential contamination.
(ix) Recordkeeping.
(x) Preventing unlawful diversion of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products.
(xi) With respect to a grower/processor's facility, growing of medical marijuana, including a detailed summary of policies and procedures for its growth.
(xii) Establishment, implementation and monitoring of diversity goals under § 1141.32 (relating to diversity goals).
(13) The relevant financial information in § 1141.30 (relating to capital requirements).
(14) Statements that:
(i) The applicant and each principal, operator, financial backer and employee are of good moral character.
(ii) The applicant possesses the ability to obtain in an expeditious manner the right to use the proposed site and facility, including equipment, to properly perform the activity described in the initial permit application.
(iii) The grower/processor permit applicant is able to continuously maintain effective security, surveillance and accounting control measures to prevent diversion, abuse and other illegal conduct regarding seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products. The dispensary permit applicant is able to continuously maintain effective security, surveillance and accounting control measures to prevent diversion, abuse and other illegal conduct regarding medical marijuana products.
(iv) The applicant is able to continuously comply with all applicable laws of the Commonwealth, the act, this part, and the terms and conditions of the initial permit.
(15) The applicant shall provide the Department with releases sufficient to obtain information from a governmental agency, financial institutions, an employer or any other person. Failure to provide these releases will result in the rejection of the initial permit application.
(16) Other information required by the Department.
(c) If the Department determines that an initial permit application is complete but lacking sufficient information upon which to make a determination, the Department may notify the applicant in writing of the factors that require additional information and documentation. An applicant has 30 days from the mailing date of the notice to provide the requested information and documentation to the Department. An applicant's failure to provide the requested information to the Department by the deadline may be grounds for denial of the issuance of a permit. Nothing in this subsection requires the Department to request additional or supplemental information from an applicant.
(d) At the discretion of the Department, the Department may extend the deadline in subsection (c) for up to an additional 15 days.
(e) The Department may conduct an inspection to determine the appropriateness of a proposed site and facility, the applicant's operational status, the applicant's compliance with the laws and regulations of the Commonwealth, the municipality's zoning requirements relating to the applicant's proposed site and facility, if applicable, and its use as outlined in the permit application. The Department may do the following:
(1) Interview principals, operators, financial backers and employees, including physicians, pharmacists, physician assistants and certified registered nurse practitioners, engaged and to be engaged in the applicant's operations for the purpose of verifying the information contained in the initial permit application.
(2) Inspect transport vehicles that are or will be utilized in the transportation of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana or medical marijuana products to a facility or an approved laboratory.
§ 1141.30. Capital requirements.
(a) An applicant for a grower/processor permit shall provide an affidavit that the applicant has at least $2 million in capital, $500,000 of which is on deposit with one or more financial institutions.
(b) An applicant for a dispensary permit shall provide an affidavit that the applicant has at least $150,000 on deposit with one or more financial institutions.
(c) The affidavit will be in a form prescribed by the Department.
(d) An applicant shall submit with the initial permit application a signed release allowing the Department to contact each financial institution listed in the application to verify the requirements of subsection (a) or (b).
§ 1141.31. Background checks.
(a) To provide the criminal history record check required under § 1141.29 (relating to initial permit application), an applicant shall submit fingerprints of its principals, financial backers, operators and employees to the Pennsylvania State Police. The Pennsylvania State Police or its authorized agent will submit the fingerprints to the Federal Bureau of Investigation for the purpose of verifying the identity of the individuals whose fingerprints have been submitted and obtaining a current record of criminal arrests and convictions.
(b) The Department may only use criminal history background check information obtained under this section to determine the character, fitness and suitability to serve in the designated capacity of the principal, financial backer, operator and employee.
(c) This section does not apply to an owner of securities in a publicly traded company if the Department determines that the owner is not substantially involved in the activities of the medical marijuana organization.
(d) A financial backer, principal or employee may not hold a volunteer position, position for remuneration or otherwise be affiliated with a medical marijuana organization or a clinical registrant if the individual has been convicted of a criminal offense relating to the sale or possession of illegal drugs, narcotics or controlled substances.
§ 1141.32. Diversity goals.
(a) In accordance with section 615 of the act (35 P.S. § 10231.615), this section establishes the procedures for promoting and ensuring the involvement of diverse participants and diverse groups in the activities permitted by the act and this part.
(b) In furtherance of the policy in section 615 of the act, the Department will:
(1) Allocate appropriate staff of the Department to assist medical marijuana organizations in fostering the involvement of diverse participants and diverse groups in their operations.
(2) Provide enhanced publicity of permitting opportunities and information to assist diverse participants and diverse groups in learning how to apply for permits to be issued under the act and this part.
(3) Compile, maintain and make available to medical marijuana organizations lists of diverse participants and diverse groups for the purpose of encouraging medical marijuana organizations to provide employment and contracting opportunities consistent with the act.
(c) Each medical marijuana organization shall include in its permit application a diversity plan that establishes a goal of equal opportunity and access in employment and contracting by the medical marijuana organization. The Department will determine whether the stated goals in the diversity plan are reasonable and represent a good faith effort to meet the diversity goals of section 615(a) of the act.
(d) A medical marijuana organization may demonstrate achievement of its diversity goals by employing diverse participants and transacting business with diverse groups.
(e) The list of diverse groups that are verified by the Department of General Services, Bureau of Diversity, Inclusion and Small Business Opportunities may be used by a medical marijuana organization to establish the eligibility of a diverse group for purposes of this section.
(f) As part of each application to renew a permit submitted to the Department, a medical marijuana organization shall include information of its efforts to meet the diversity goals of the act and the effectiveness of its diversity plan. The report must include information regarding the following, as applicable:
(1) Representation of diverse participants in the medical marijuana organization's workforce.
(2) Efforts to reach out to and recruit diverse participants for employment, including for executive and managerial positions.
(3) Employee retention efforts.
(4) A list of all contracts entered into or transactions conducted by the medical marijuana organization for goods or services with diverse groups.
(g) A medical marijuana organization may request that any proprietary information submitted to the Department under this section be treated as confidential proprietary information and shall clearly mark this information as confidential proprietary information or trade secret under the Right-to-Know Law (65 P.S. §§ 67.101—67.3104) as set forth in § 1141.22 (relating to records subject to disclosure; confidentiality).
(h) The Department will review the diversity plan and provide the medical marijuana organization with advice regarding activities that should be undertaken by the medical marijuana organization to improve its efforts to encourage and promote participation by diverse participants and diverse groups to comply with the diversity goals of the act. The Department may consult with the Department of General Services, Bureau of Diversity, Inclusion and Small Business Opportunities in the review of diversity plans and the reports submitted by medical marijuana organizations under this section.
§ 1141.33. Review of initial permit applications.
(a) The Department will review initial permit applications submitted by applicants according to the criteria in section 603(a.1) of the act (35 P.S. § 10231.603(a.1)) and the factors in § 1141.24(b) (relating to medical marijuana regions).
(b) The Department will publish the number of permits to be issued and the location of each permit in the Pennsylvania Bulletin before to the time the initial permit applications are made available for submission.
§ 1141.34. Denial of a permit.
The Department may deny the issuance of a permit for any of the following reasons:
(1) Failure or refusal to submit information or documentation requested by the Department during the review process. Nothing in this paragraph requires the Department to request additional or supplemental information from an applicant.
(2) Misrepresentation by an applicant of fact, or failure to disclose a material fact to the Department during the review process.
(3) The results of the criminal history record check received by the Department under § 1141.31 (relating to background checks) for a principal, financial backer, operator or employee of the applicant indicates that the individual has been convicted of a criminal offense relating to the sale or possession of illegal drugs, narcotics or controlled substances and, following notification by the Department, the applicant fails or refuses to provide the Department with evidence satisfactory to the Department that the individual is no longer associated with the applicant in this capacity.
(4) Failure to meet the capital funding requirements identified in an affidavit by the applicant or a determination by the Department that the capital funding identified by the applicant is unverifiable.
(5) The applicant denies the Department or its authorized agents access to any place where a permitted activity is proposed to take place or fails to produce any book, paper, record, document, data or other information when requested by the Department.
(6) The applicant's medical marijuana license, permit or other authorization in another state or jurisdiction was, is or has been suspended or revoked or the applicant was otherwise disciplined.
(7) The applicant's plan of operation does not demonstrate, to the satisfaction of the Department, that the applicant is qualified for a permit.
(8) The Department determines, in its sole discretion, that the applicant has not met the criteria under § 1141.33 (relating to review of initial permit applications).
(9) The Department determines, in its sole discretion, that the issuance of the permit will not be in the best interest of the welfare, health or safety of the citizens of this Commonwealth.
§ 1141.35. Notice of denial.
(a) The Department will provide written notice of denial to an applicant.
(b) The applicant may appeal a notice of denial under 2 Pa.C.S. Chapter 5, Subchapter A (relating to practice and procedure of Commonwealth agencies) and its accompanying regulations, as modified by Chapter 1230 (relating to practice and procedure—temporary regulations).
§ 1141.36. Permit renewal applications.
(a) A medical marijuana organization wishing to renew its permit shall submit to the Department a permit renewal application not more than 6 months, nor less than 4 months, prior to the current permit's expiration.
(b) A medical marijuana organization shall submit the applicable fee in § 1141.28 (relating to fees) with the permit renewal application.
(c) A medical marijuana organization shall include the following in the permit renewal application:
(1) Information regarding any charge, or any initiated, pending or concluded investigation, during the period of the initial permit or prior renewal period, by any governmental or administrative agency with respect to:
(i) Any incident involving the theft, loss or possible diversion of medical marijuana by the medical marijuana organization or from the medical marijuana organization's facility.
(ii) Compliance by the medical marijuana organization with the laws of the Commonwealth with respect to any substance in section 4 of The Controlled Substance, Drug, Device and Cosmetic Act (35 P.S. § 780-104).
(2) Information concerning the medical marijuana organization's ability to carry on the activity for which the permit was issued, including medical marijuana product shortages or wait lists occurring during the 12 months prior to the date the renewal permit application was submitted.
(3) The medical marijuana organization's history of compliance with the act and this part.
(d) If the Department determines that a permit renewal application is complete but lacking sufficient information upon which to make a determination, the Department will notify the medical marijuana organization in writing of the factors that require additional information and documentation. The medical marijuana organization shall have 30 days from the mailing date of the notice to provide the requested information and documentation to the Department. A medical marijuana organization's failure to provide the requested information to the Department by the deadline may be grounds for denial of the permit renewal application. Nothing in this subsection requires the Department to request additional or supplemental information from an applicant.
(e) The Department may conduct an onsite inspection of the medical marijuana organization's site and facility to determine an applicant's continuing compliance with the act and this part.
§ 1141.37. Denial of renewal of a permit.
(a) The Department will deny the renewal of a permit if the Department determines:
(1) The medical marijuana organization has not or is unlikely to be able to continuously maintain effective control against diversion of medical marijuana at its facility.
(2) The medical marijuana organization falsified any part of the permit renewal application or any other application submitted to the Department under this part.
(3) The medical marijuana organization is unlikely to comply with all Commonwealth and local laws applicable to the activities in which it may engage under the permit, if renewed.
(b) An existing permit is immediately invalid upon expiration if the medical marijuana organization has not filed a permit renewal application in accordance with § 1141.36 (relating to permit renewal applications) and remitted the required fees in accordance with § 1141.28 (relating to fees).
(c) Except as provided in subsection (e), a medical marijuana organization may not operate if its permit is not renewed prior to expiration.
(d) If the Department denies renewal of the permit or if the medical marijuana organization fails to submit a permit renewal application and permit renewal fee as required under § 1141.28, the medical marijuana organization shall do the following upon the expiration of the permit:
(1) Cease all operations authorized by the permit.
(2) In the case of a grower/processor, dispose of any remaining seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana, medical marijuana products, plant matter or any growing equipment as set forth in § 1151.40 (relating to management and disposal of medical marijuana waste).
(3) In the case of a dispensary, return the medical marijuana products to the grower/processor where the medical marijuana products originated.
(e) If a medical marijuana organization submits a permit renewal application and permit renewal fee to the Department as required under § 1141.28, the Department may administratively extend the existing permit from the date the existing permit expires until the Department can complete its permit renewal application review.
§ 1141.38. Duty to report.
(a) During the application process, or at any time during the permit period if a permit is issued, an applicant or medical marijuana organization shall notify the Department:
(1) In writing of any change in facts or circumstances reflected in the initial permit application or any permit renewal application submitted to the Department, or any newly discovered or occurring fact or circumstance which would have been included in the application if known at the time the application was submitted.
(2) In writing of any proposed modification of its plan of operation at least 30 days prior to the proposed modification.
(3) Immediately upon becoming aware, and State and local law enforcement immediately upon becoming aware, of any adverse loss from a facility operated by the medical marijuana organization or any vehicle transporting seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana or medical marijuana products to or from a facility operated by the medical marijuana organization.
(b) If the change in information involves a change in control of the medical marijuana organization, the medical marijuana organization shall surrender its existing permit to the Department, unless the medical marijuana organization submits an application for approval of a change in ownership of a medical marijuana organization in accordance with § 1141.39 (relating to application for approval of a change in ownership of a medical marijuana organization).
(c) If the change in information involves a change in any of the activities on the medical marijuana organization site, including any of the following, the medical marijuana organization shall surrender its existing permit to the Department and take action as required under § 1141.43 (relating to closure of a facility):
(1) Discontinuance of operations.
(2) Removal of all seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products from the sites and locations by State or Federal authority.
§ 1141.39. Application for approval of a change in ownership of a medical marijuana organization.
(a) In the event of an impending change in ownership involving a change in control of a medical marijuana organization from the ownership listed in the initial permit application or a permit renewal application, the medical marijuana organization shall submit an application for approval of a change in ownership, on a form prescribed by the Department, to the Department together with the fee required under § 1141.28 (relating to fees).
(b) The Department, in its sole discretion, may permit the medical marijuana organization to incorporate by reference all of the information in the medical marijuana organization's initial permit application, and any previously submitted permit renewal application, into the application for approval of a change in ownership.
(c) A medical marijuana organization's application for approval of a change in ownership will not be considered complete by the Department until all portions of the application are completed and the appropriate application fee under § 1141.28 is submitted. The Department may reject an incomplete application.
(d) For each individual that is part of the proposed change in ownership, the medical marijuana organization shall include all of the information required under § 1141.29 (relating to initial permit application) for the individuals listed in those capacities in the medical marijuana organization's initial permit application or any previously submitted permit renewal application.
(e) If the Department determines that an application for approval of a change in ownership is lacking sufficient information upon which to make a determination, the Department will notify the medical marijuana organization in writing of the factors that require additional information and documentation. The medical marijuana organization shall have 30 days from the mailing date of the notice to provide the requested information and documentation to the Department. A medical marijuana organization's failure to provide the requested information to the Department by the deadline may be grounds for denial of approval for the requested change in ownership. Nothing in this subsection requires the Department to request additional or supplemental information from a medical marijuana organization.
(f) A change in ownership of a medical marijuana organization that occurs without the Department's prior written approval of the change as provided in this section is a violation of the act and this part.
§ 1141.40. Application for approval of a change in location of a facility.
(a) A medical marijuana organization wishing to change the location of a site or facility authorized under a permit issued to the medical marijuana organization shall submit an application for approval of a change in location to the Department together with the fee required under § 1141.28 (relating to fees).
(b) A change in location of a facility authorized under a permit may not occur until the Department approves the change, in writing, under this section.
(c) The medical marijuana organization shall submit an application for approval of a change in location on a form prescribed by the Department.
(d) An application for approval of a change in location must include the reason for requesting the change and other information about the new location as the Department may require.
(e) The Department will issue a new permit to the medical marijuana organization for the new location if the request is approved.
(f) Within 180 days of the issuance by the Department of a new permit under subsection (e), the medical marijuana organization shall change the location of its operation to the new location designated in the new permit. Simultaneously with the completion of the move, the medical marijuana organization shall cease to operate at the former location and surrender its existing permit to the Department. The following apply:
(1) At no time may a medical marijuana organization operate or exercise any of the privileges granted under the permit in both locations.
(2) At the discretion of the Department, the Department may extend the 180-day deadline for relocation for up to an additional 90 days.
(3) Once the new facility is determined to be operational by the Department, the medical marijuana organization may resume operations under the new permit at the new location.
(g) The Department will not approve a change of location that is outside the boundaries of the region for which the initial permit was issued.
§ 1141.41. Application for approval of alteration of a facility.
(a) Except as provided in subsection (b), after the issuance of a permit, a medical marijuana organization may not make a physical change, alteration or modification to the facility that materially or substantially alters the facility or its usage as listed in the plot plans originally approved by the Department.
(b) A medical marijuana organization wishing to make any of the following alterations to the facility for which its permit was issued shall submit an application for approval of alteration of a facility, on a form prescribed by the Department, to the Department together with the fee required under § 1141.28 (relating to fees):
(1) An increase or decrease in the total square footage of the facility.
(2) The sealing off, creation of or relocation of a common entryway, doorway, passage or other means of public ingress or egress when the common entryway, doorway or passage alters or changes limited access areas.
(3) Any of the following made to enhance activities authorized under the permit:
(i) Additional electric fixtures or lighting equipment.
(ii) The lowering of a ceiling.
(iii) Electrical modifications that require inspection by the local municipality.
§ 1141.42. Failure to be operational.
(a) Within 6 months from the date of issuance of a permit, a medical marijuana organization shall notify the Department, on a form prescribed by the Department, that it is operational.
(b) After the Department receives the notification in subsection (a), the Department will inspect the facility to determine if the medical marijuana organization is operational to the satisfaction of the Department.
(c) If the medical marijuana organization has not met the operational timetable in the initial permit application to the satisfaction of the Department at the time of the inspection conducted under subsection (b), the Department will notify the medical marijuana organization of the deficiencies. Within 30 days of receiving the Department's notice, the medical marijuana organization shall submit to the Department for approval a plan of correction that sets forth the medical marijuana organization's timeline and a date certain, which may not extend beyond 90 days following the date the Department approves the plan of correction, for correcting the deficiencies.
(d) If the medical marijuana organization does not comply with its plan of correction as approved by the Department within 90 days following the Department's approval, the Department may revoke or suspend the medical marijuana organization's permit under § 1141.47 (relating to general penalties and sanctions).
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