RULES AND REGULATIONS
Title 28—HEALTH AND SAFETY
DEPARTMENT OF HEALTH
[ 28 PA. CODE CHS. 1141 AND 1151 ]
Medical Marijuana; General Provisions; Growers/Processors; Temporary Regulations
[46 Pa.B. 6829]
[Saturday, October 29, 2016]The Department of Health (Department) is publishing temporary regulations in Chapters 1141 and 1151 (relating to general provisions; and growers/processors) to read as set forth in Annex A. The 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 Commonwealth Attorneys Act (71 P.S. §§ 732-204(b) and 732-301(10)). The Department will be periodically publishing temporary regulations regarding various sections of the act.
To implement the Medical Marijuana Program, the Department will periodically publish temporary regulations regarding various sections of the act. The temporary regulations in Chapters 1141 and 1151 are effective upon publication and will expire on October 29, 2018.
Chapters 1141 and 1151 pertain to grower/processors who will grow and process medical marijuana for use in the Medical Marijuana Program. The next set of temporary regulations that the Department anticipates publishing relate to dispensaries and laboratories, followed by temporary regulations relating to academic clinical research centers, practitioners, caregivers and patients.
Interested persons are invited to submit written comments, suggestions or objections regarding the temporary regulations to John J. Collins, Office of Medical Marijuana, Department of Health, Room 628, Health and Welfare Building, 625 Forester Street, Harrisburg, PA 17120, (717) 787-4366, RA-DHMedMarijuana@pa.gov. Persons with a disability who wish to submit comments, suggestions or objections regarding the temporary regulations may do so by using the previous contact information. Speech and/or hearing impaired persons may use V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service (800) 654-5984 (TT). Persons who require an alternative format of this document may contact John J. Collins so that necessary arrangements may be made.
KAREN M. MURPHY, PhD, RN,
SecretaryFiscal Note: 10-199. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 28. HEALTH AND SAFETY
PART IX. MEDICAL MARIJUANA
CHAPTER 1141. GENERAL PROVISIONS Sec.
1141.21. Definitions. 1141.22. Records subject to disclosure; confidentiality. 1141.23. Limitation on number of permits. 1141.24. Medical marijuana regions. 1141.25. General requirements for permits. 1141.26. Privilege and nontransferability. 1141.27. General requirements for application. 1141.28. Fees. 1141.29. Initial permit application. 1141.30. Capital requirements. 1141.31. Background checks. 1141.32. Diversity goals. 1141.33. Review of initial permit applications. 1141.34. Denial of a permit. 1141.35. Notice of denial. 1141.36. Permit renewal applications. 1141.37. Denial of renewal of a permit. 1141.38. Duty to report. 1141.39. Application for approval of a change in ownership of a medical marijuana organization. 1141.40. Application for approval of a change in location of a facility. 1141.41. Application for approval of alteration of a facility. 1141.42. Failure to be operational. 1141.43. Closure of a facility. 1141.44. Insurance requirements. 1141.45. Inspection and investigation. 1141.46. Reports. 1141.47. General penalties and sanctions. 1141.48. Training. 1141.49. Zoning. 1141.50. Advertising by a medical marijuana organization. § 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 or medical marijuana, 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 or to purchase particular medical marijuana.
Applicant—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.
Batch—A specific group of medical marijuana grown from one or more seeds, cuttings or tissue culture material that is harvested at the same time.
CBD—Cannabidiol.
Caregiver—An individual over 21 years of age, or if the patient is under 18 years of age, an individual under section 506(2) of the act (35 P.S. § 10231.506(2)), who is designated by a patient for certified medical use.
Certified medical use—The acquisition, possession, use or transportation of medical marijuana by a patient, or the acquisition, possession, delivery, transportation or administration of medical marijuana by a caregiver, for use as part of the treatment of the patient's serious medical condition, as authorized in a 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.
(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 implemented by a grower/processor to log, verify and monitor the receipt, use and sale of seeds, immature medical marijuana plants or medical marijuana plants, and the funds received by a grower/processor for the sale of medical marijuana to a medical marijuana organization.
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 access to medical marijuana 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 laboratory located in this Commonwealth that is approved by the Department to test medical marijuana for a grower/processor or the Department.
Limited access area—An area within a facility where:
(i) Immature medical marijuana plants or medical marijuana plants are growing or being processed into medical marijuana.
(ii) Medical marijuana is packaged for sale or stored prior to transport to a medical marijuana organization.
(iii) Medical marijuana waste is processed, stored or destroyed.
(iv) Surveillance system devices are stored.
Lot—One of the following that results in medical marijuana being processed for a certified medical use:
(i) The flowers from one or more medical marijuana plants of the same strain which are produced by a continuous process, in a unit of time and a manner that ensures its having uniform character and quality.
(ii) The trim, leaves or other plant matter from one or more medical marijuana plants that has been produced by a continuous process, in a unit of time and manner that ensures its having uniform character and quality.
Marijuana—
(i) The plant, of genus Cannabis sativa L., within the family Cannabaceae, including any part of the plant genus Cannabis, within the family Cannabaceae and the immature plant or seeds of the plant genus Cannabis, within the family Cannabaceae.
(ii) The term does not include industrial hemp.
Medical marijuana—Marijuana for certified medical use as set forth in the act.
Medical marijuana container—A sealed, traceable, food compliant, tamper resistant, tamper evident container used for the purpose of containment of packaged medical marijuana being transported from a grower/processor to a medical marijuana organization or a 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 program—The program authorized under the act and implemented by the Department.
Minority-owned business—The term as defined in 74 Pa.C.S. § 303(b).
Municipality—A city, borough, incorporated town or township.
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 complete 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.
(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 spinal cord with objective neurological indication of intractable spasticity.
(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 in which conventional therapeutic intervention and opiate therapy is contraindicated or ineffective.
(xvii) Autism.
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.
THC—Tetrahydrocannabinol.
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 medical marijuana between medical marijuana organizations or between medical marijuana organizations and a laboratory.
Unit—The weight or volume of total usable medical marijuana in the finished product, calculated in metric units.
Vaporization or nebulization—The generation of medical marijuana in the form of vapor or fine spray 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 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.
(c) An applicant shall mark confidential proprietary information as confidential proprietary information prior to submission to the Department.
§ 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.
§ 1141.24. Medical marijuana regions.
(a) The Department will issue permits to applicants in each of six regions. The regions are as follows:
(1) Region 1—the geographical region comprised of the counties of the Department's Southeast District.
(2) Region 2—the geographical region comprised of the counties of the Department's Northeast District.
(3) Region 3—the geographical region comprised of the counties of the Department's Southcentral District.
(4) Region 4—the geographical region comprised of the counties of the Department's Northcentral District.
(5) Region 5—the geographical region comprised of the counties of the Department's Southwest District.
(6) Region 6—the geographical region comprised of the counties of the Department's Northwest District.
(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 valid only 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 may 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 other person or any other 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.
(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.
(d) An application that is rejected by the Department will be returned to the applicant without further consideration by the Department along with the refund of the initial permit fee.
(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 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.
(b) An applicant for an initial dispensary permit or renewal permit shall pay the following fees by certified check 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.
(c) A medical marijuana organization shall pay a fee of $250 by certified check 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 the initial permit application form electronically through the Department's web site or by mail in an electronic format that is prescribed by the Department.
(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 refund of fees submitted by the applicant with the 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 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 medical marijuana.
(iv) Storage of medical marijuana.
(v) Labeling of medical marijuana.
(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 medical marijuana for potential contamination.
(ix) Recordkeeping.
(x) Preventing unlawful diversion of medical marijuana.
(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 applicant is able to continuously maintain effective security, surveillance and accounting control measures to prevent diversion, abuse and other illegal conduct regarding medical marijuana plants and medical marijuana.
(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 will 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.
(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, and the applicant's compliance with the laws and regulations of the Commonwealth, if applicable, the municipality's zoning requirements, relating to the applicant's proposed site and facility 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 medical marijuana to a facility or a 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 must be 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 shall 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. The Pennsylvania State Police will provide the results of the record checks to the Department.
(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 or 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 information and shall clearly mark this information as confidential.
(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)).
(b) The Department will publish the number of permits to be issued and the location of each permit in the Pennsylvania Bulletin prior 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.
(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) An applicant may request a debriefing from the Department within 30 days from the date of notice of denial. The debriefing will be limited to a discussion of the applicant's permit application.
(c) The applicant may not obtain the names or any other information relating to persons reviewing applications, including a reviewer's individual application reviews.
(d) The applicant may appeal a notice of denial under 2 Pa.C.S. Chapter 5 (relating to practice and procedure).
§ 1141.36. Permit renewal applications.
(a) A medical marijuana organization wishing to renew its permit shall submit 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.
(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) Dispose of any remaining medical marijuana, plant matter, seed or any growing equipment as set forth in § 1151.40 (relating to disposal of medical marijuana).
(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 permittee 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 within 24 hours of becoming aware, of any adverse loss from the permittee's facility or any vehicle transporting medical marijuana to or from the permittee's facility.
(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 medical marijuana 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 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.
(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 by 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 of 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) Not less than 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).
§ 1141.43. Closure of a facility.
(a) A medical marijuana organization shall notify the Department in writing immediately, but in no event less than 60 days prior to the projected date of closure, upon making a determination that it intends to close its facility.
(b) A medical marijuana organization may not accept or purchase seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana, other plant matter, equipment or medical devices or instruments as of the date of notice.
(c) The notice must be accompanied by the medical marijuana organization's written plan for closing the facility which must include the following information:
(1) The projected date of closure.
(2) How it intends to notify in writing, prior to the projected date for closure, any person to which the medical marijuana organization provides medical marijuana or medical marijuana services prior to closure.
(3) How it intends to dispose of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana or other plant matter projected to still be in the facility at the time of the projected closure in accordance with § 1151.40 (relating to disposal of medical marijuana).
(4) How it intends to dispose of equipment or medical devices or instruments used by the medical marijuana organization in its operations at the facility.
(d) A medical marijuana organization may not remove or destroy any seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana, other plant matter, equipment or medical devices or instruments until the Department has approved its plan for closure submitted under subsection (c) and shall comply with all requirements regarding disposal of medical marijuana in § 1151.40.
(e) The Department may enter the site and facility and inspect the medical marijuana organization's vehicles following receipt of a medical marijuana organization's plan of closure to determine whether to approve the medical marijuana organization's closure plan.
(f) If the Department approves the medical marijuana organization's plan to close the facility submitted under this section, the medical marijuana organization shall surrender its permit to the Department on or before the date for closure provided in the plan.
§ 1141.44. Insurance requirements.
(a) A medical marijuana organization shall obtain and maintain an appropriate amount of insurance coverage that insures the site and facility and equipment used in the operation of the facility. An adequate amount of comprehensive liability insurance covering the medical marijuana organization's activities authorized by the permit shall begin on the date the initial permit is issued by the Department and continuing for as long as the medical marijuana organization is operating under the permit.
(b) A medical marijuana organization shall obtain and maintain workers' compensation insurance coverage for employees at the time the medical marijuana organization is determined to be operational by the Department.
§ 1141.45. Inspection and investigation.
(a) The Department may conduct announced or unannounced inspections or investigations to determine the medical marijuana organization's compliance with its permit, the act or this part.
(b) An investigation or inspection may include:
(1) Inspection of a medical marijuana organization's site, facility, vehicles, books, records, papers, documents, data, and other physical or electronic information.
(2) Questioning of employees, principals, operators and financial backers of the medical marijuana organization.
(3) Inspection of a grower/processor facility's equipment, instruments, tools and machinery that are used to grow, process and package medical marijuana, including containers and labels.
(c) The Department and its authorized agents will have free access to review and, if necessary, make copies of books, records, papers, documents, data, or other physical or electronic information that relates to the business of the medical marijuana organization, including financial data, sales data, shipping data, pricing data and employee data.
(d) Failure of a medical marijuana organization to provide the Department and its authorized agents immediate access to any part of a medical marijuana organization's site or facility, requested material, physical or electronic information, or individual as part of an inspection or investigation may result in the imposition of a civil monetary penalty, suspension or revocation of its permit, or an immediate cessation of operations pursuant to a cease and desist order issued by the Department.
(e) The Department and its authorized agents will have free access to any area within a site or facility that is being used to store medical marijuana for testing purposes and are permitted to collect samples for testing at a laboratory.
§ 1141.46. Reports.
(a) A medical marijuana organization shall submit the following reports to the Department, on forms prescribed by the Department, at the end of the first 12-month period following the issuance of a permit, and as of the end of each 3-month period thereafter:
(1) In the case of a grower/processor:
(i) The amount of medical marijuana sold by the grower/precessor during the period for which the report is being submitted.
(ii) The per-dose price of an amount of medical marijuana sold by the grower/processor to a medical marijuana organization in a unit of measurement as determined by the Department.
(2) In the case of a dispensary:
(i) The amount of medical marijuana purchased by the dispensary during the period for which the report is being submitted.
(ii) The per-dose price of medical marijuana purchased by a dispensary in a unit of measurement as determined by the Department.
(iii) The per-dose price of an amount of medical marijuana dispensed to a patient or caregiver by a dispensary as well as the unit of measurement as determined by the Department.
(b) The Department will aggregate the information in the reports submitted by medical marijuana organizations under subsection (a) and post the information on the Department's web site.
(c) The Department may require ongoing reporting of operational and financial information in a form and manner prescribed by the Department.
(d) The Department may require any reports necessary to carry out its responsibilities under the act and this part.
§ 1141.47. General penalties and sanctions.
(a) In addition to any other penalty imposed by law for violations of the act or this part, the Department may take one or more of the following actions:
(1) Suspend or revoke a permit if any of the following occur:
(i) The medical marijuana organization fails to maintain effective control against diversion of medical marijuana from its facility or under its control.
(ii) The medical marijuana organization violates a provision of the act or this part, or an order issued under the act or this part.
(iii) The medical marijuana organization violates a provision of other State or local laws regarding the operation of its facility.
(iv) The medical marijuana organization engages in conduct, or an event occurs, that would have disqualified the medical marijuana organization from being issued a permit or having its permit renewed.
(2) Impose a civil penalty of not more than $10,000 for each violation and an additional penalty of not more than $1,000 for each day of a continuing violation. In determining the amount of each penalty, the Department will take the following into consideration:
(i) The gravity of the violation.
(ii) The potential harm resulting from the violation to patients, caregivers or the general public.
(iii) The willfulness of the violation.
(iv) Previous violations, if any, by the medical marijuana organization being assessed.
(v) The economic benefit to the medical marijuana organization being assessed resulting from the violation.
(3) Suspend or revoke a permit pending the outcome of a hearing if the Department determines that the health, safety or welfare of the public, a patient or a caregiver is at risk.
(4) Order the restitution of funds or property unlawfully obtained or retained by a medical marijuana organization.
(5) Issue a cease and desist order to immediately stop or restrict the operations of a medical marijuana organization conducted under the permit to protect the public's health, safety and welfare. The following apply:
(i) An order may include a requirement that a medical marijuana organization cease or restrict some or all of its operations. In addition, the order may prohibit the use of some or all of the medical marijuana grown, processed or to be sold by the medical marijuana organization.
(ii) An order may be issued by an authorized agent of the Department immediately upon completion of an inspection or investigation if the agent observes or suspects an operational failure or determines that the conditions will likely create a diversion of medical marijuana, contamination of medical marijuana, or a risk to patients or the public.
(iii) An order may include:
(A) An immediate evacuation of the site and facility and the sealing of the entrances to the facility.
(B) A quarantine of some or all of the medical marijuana found at the facility.
(C) The suspension of the sale or shipment of some or all of the medical marijuana found at the facility.
(6) Issue a written warning if the Department determines that either:
(i) The public interest will be adequately served under the circumstances by the issuance of the warning.
(ii) The violation does not threaten the safety or health of a patient, caregiver or the general public, and the medical marijuana organization took immediate action to remedy the violation.
(b) A person who aids, abets, counsels, induces, procures or causes another person to violate the act or this part, or an order issued under the act or this part, shall also be subject to the civil penalties provided under this section.
(c) Before the Department may act under subsection (a) or (b), the Department will provide the medical marijuana organization or other person with written notice specifying the nature of the alleged violation or conduct. The notice will fix a time and place for a hearing. The hearing will be scheduled at least 10 days after the date of the notice. This subsection supersedes 1 Pa. Code §§ 35.102 and 35.121 (relating to hearing calendar; and initiation of hearings).
(d) Notwithstanding subsection (c), for violations of the act or this part, the Department may require a medical marijuana organization to develop and adhere to a plan of correction approved by the Department. The Department will monitor compliance with the plan of correction. Failure to comply with the plan of correction may result in the Department's taking action under applicable provisions of this section as it deems appropriate.
(e) The Department's actions under subsections (a), (b) and (c) are subject to 2 Pa.C.S. Chapter 5, Subchapter A (relating to practice and procedure of Commonwealth agencies).
§ 1141.48. Training.
(a) As required under the act, the following individuals shall complete a 2-hour training course developed by the Department within the times specified:
(1) Each principal of a medical marijuana organization, prior to starting initial operation of a facility.
(2) Each employee of a medical marijuana organization who has direct contact with patients or caregivers or who physically handles medical marijuana, within 90 days after starting work at the facility.
(b) The training course required under subsection (a) must provide the following information:
(1) The provisions of the act and this part relevant to the responsibilities of principals and employees of grower/processors.
(2) Proper handling of medical marijuana.
(3) Proper recordkeeping.
(4) How to prevent and detect the diversion of medical marijuana.
(5) Best practice security procedures.
(6) Best practice safety procedures, including responding to the following:
(i) A medical emergency.
(ii) A fire.
(iii) A chemical spill.
(iv) A threatening event including:
(A) An armed robbery.
(B) A burglary.
(C) A criminal incident.
(c) A medical marijuana organization shall retain the attendance records of its principals and employees and make them available for inspection by the Department and its authorized agents upon request.
(d) The Department will make the 2-hour training course available at no cost to the medical marijuana organization, its principals or employees.
§ 1141.49. Zoning.
(a) A grower/processor shall meet the same municipal zoning and land use requirements as other manufacturing, processing and production facilities that are located in the same zoning district.
(b) A dispensary shall meet the same municipal zoning and land use requirements as other commercial facilities that are located in the same zoning district.
§ 1141.50. Advertising by a medical marijuana organization.
(a) In the advertising and marketing of medical marijuana, a medical marijuana organization shall be consistent with the Federal regulations governing prescription drug advertising and marketing in 21 CFR 202.1 (relating to prescription-drug advertisments).
(b) Promotional, advertising and marketing materials shall be approved by the Department prior to their use.
(c) This part does not apply to information provided by a grower/processor to a dispensary listing various medical marijuana items that the grower/processor is offering for sale to the dispensary.
[Continued on next Web Page]
No part of the information on this site may be reproduced for profit or sold for profit.This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
