HOUSE AMENDED
PRIOR PRINTER'S NOS. 224, 793, 840,
889
PRINTER'S NO. 1609
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
3
Session of
2015
INTRODUCED BY FOLMER, LEACH, TEPLITZ, WILEY, BLAKE, FONTANA,
YUDICHAK, SCARNATI, BOSCOLA, YAW, ARGALL, SMITH, COSTA,
FARNESE, WAGNER, BARTOLOTTA, WILLIAMS, TARTAGLIONE,
VULAKOVICH, WHITE, SCHWANK, RAFFERTY, STEFANO, WOZNIAK,
McGARRIGLE, BROWNE AND DINNIMAN, JANUARY 26, 2015
AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES,
MARCH 15, 2016
AN ACT
Providing for the medical use of cannabis in the Commonwealth of
Pennsylvania.
TABLE OF CONTENTS
CHAPTER 1. PRELIMINARY PROVISIONS
Section 101. Short title.
Section 102. Definitions.
CHAPTER 3. STATE BOARD OF MEDICAL CANNABIS
LICENSING AND ADMINISTRATIVE PROCEDURE
Section 301. License.
Section 302. State Board of Medical Cannabis Licensing.
Section 303. Powers and duties of board.
Section 304. Subpoena power.
Section 305. Hearing examiners.
Section 306. Civil penalties.
Section 307. Confidentiality.
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Section 308. Financing.
CHAPTER 5. LICENSING
Section 501. Medical cannabis growers.
Section 502. Medical cannabis processors.
Section 503. Medical cannabis dispensers.
Section 504. Applications.
Section 505. Licensing of owner or operator.
Section 506. Occupation permit for medical cannabis employees
and certain patient representatives.
Section 507. Change in ownership.
Section 508. Location.
Section 509. Storage and transportation.
Section 510. Disposal and donation.
Section 511. Testing laboratories.
Section 512. Licensee prohibitions.
CHAPTER 7. MEDICAL CANNABIS ACCESS
Section 701. Medical cannabis access card.
Section 702. Health care practitioners.
Section 703. Expansion of medical conditions.
Section 704. Medical use permitted.
Section 705. Authorized use.
Section 706. Health insurance.
Section 707. Sovereign immunity.
CHAPTER 9. PROTECTION, PROHIBITIONS,
ENFORCEMENT AND PENALTIES
Section 901. Civil discrimination protection.
Section 902. Prohibitions and use.
Section 903. Unlawful activities.
Section 904. Criminal penalties and fines.
Section 905. Daily log access.
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Section 906. Law enforcement.
CHAPTER 11. MEDICAL CANNABIS SURCHARGE
Section 1101. Definitions.
Section 1102. Incidence and rate of surcharge.
Section 1103. Limitation of surcharge.
Section 1104. Remittance of surcharge to department.
Section 1105. Procedures for claiming refund.
Section 1106. Sales or possession of medical cannabis when
surcharge not paid.
Section 1107. Assessment.
Section 1108. Failure to file return.
Section 1109. False or fraudulent return.
Section 1110. Extension of limitation period.
Section 1111. Failure to furnish information, returning false
information or failure to permit inspection.
Section 1112. Records of shipments and receipts of medical
cannabis required.
Section 1113. Licensing of medical cannabis purveyors.
Section 1114. License fees and issuance and display of license.
Section 1115. Electronic filing.
Section 1116. Expiration of license.
Section 1117. Administration powers and duties.
Section 1118. Sales without license.
Section 1119. Violations and penalties.
Section 1120. Property rights.
Section 1121. Information exchange.
CHAPTER 51. MISCELLANEOUS PROVISIONS
Section 5101. Regulations.
Section 5102. Appropriation.
Section 5103. Applicability of other statutes.
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Section 5104. Repeals.
Section 5105. Effective date.
ESTABLISHING A MEDICAL MARIJUANA PROGRAM; PROVIDING FOR PATIENT
AND CAREGIVER CERTIFICATION AND FOR MEDICAL MARIJUANA
ORGANIZATION REGISTRATION; IMPOSING DUTIES ON THE DEPARTMENT
OF HEALTH; PROVIDING FOR A TAX ON MEDICAL MARIJUANA
ORGANIZATION GROSS RECEIPTS; ESTABLISHING THE MEDICAL
MARIJUANA PROGRAM FUND; ESTABLISHING THE MEDICAL MARIJUANA
ADVISORY BOARD; ESTABLISHING A MEDICAL MARIJUANA RESEARCH
PROGRAM; IMPOSING DUTIES ON THE DEPARTMENT OF CORRECTIONS,
THE DEPARTMENT OF EDUCATION AND THE DEPARTMENT OF HUMAN
SERVICES; AND PROVIDING FOR ACADEMIC CLINICAL RESEARCH
CENTERS AND FOR PENALTIES AND ENFORCEMENT.
TABLE OF CONTENTS
CHAPTER 1. PRELIMINARY PROVISIONS
SECTION 101. SHORT TITLE.
SECTION 102. DECLARATION OF POLICY.
SECTION 103. DEFINITIONS.
CHAPTER 3. PROGRAM
SECTION 301. PROGRAM ESTABLISHED.
SECTION 301.1. CONFIDENTIALITY AND PUBLIC DISCLOSURE.
SECTION 302. PRACTITIONER REGISTRATION.
SECTION 303. PRACTITIONER RESTRICTIONS.
CHAPTER 5. PATIENT AND CAREGIVER CERTIFICATION
SECTION 501. ISSUANCE OF CERTIFICATION.
SECTION 502. CERTIFICATION FORM.
SECTION 503. LAWFUL USE OF MEDICAL MARIJUANA.
SECTION 504. UNLAWFUL USE OF MEDICAL MARIJUANA.
SECTION 505. IDENTIFICATION CARDS.
SECTION 506. PROCESS FOR OBTAINING OR RENEWING AN
IDENTIFICATION CARD.
SECTION 507. SPECIAL CONDITIONS.
SECTION 508. MINORS.
SECTION 509. CAREGIVER AUTHORIZATION AND LIMITATIONS.
SECTION 510. CONTENTS OF IDENTIFICATION CARD.
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SECTION 511. SUSPENSION.
SECTION 512. USE OF PRESCRIPTION DRUG MONITORING PROGRAM.
SECTION 513. PROHIBITIONS.
CHAPTER 7. MEDICAL MARIJUANA ORGANIZATIONS
SECTION 701. MEDICAL MARIJUANA ORGANIZATIONS.
SECTION 702. LABORATORY.
SECTION 703. DISPENSING TO PATIENTS AND CAREGIVERS.
SECTION 704. PRICING.
SECTION 705. FACILITY REQUIREMENTS.
SECTION 706. REGISTRATION.
SECTION 707. LIMITATIONS ON REGISTRATIONS.
SECTION 708. APPLICATION AND ISSUANCE OF REGISTRATION.
SECTION 709. REGISTRATION RENEWALS.
SECTION 710. SUSPENSION OR REVOCATION OF REGISTRATION.
SECTION 711. PRIVILEGE NOT PROPERTY RIGHT.
SECTION 712. DIVERSITY GOALS.
CHAPTER 9. TAX ON MEDICAL MARIJUANA
SECTION 901. EXCISE TAX ON MEDICAL MARIJUANA.
SECTION 902. MEDICAL MARIJUANA PROGRAM FUND.
CHAPTER 11. ADMINISTRATION
SECTION 1101. GOVERNING PRACTICE AND PROCEDURE.
SECTION 1102. REPORTS BY MEDICAL MARIJUANA ORGANIZATIONS.
SECTION 1103. LAW ENFORCEMENT NOTIFICATION.
SECTION 1104. EVALUATION.
SECTION 1105. REPORT.
SECTION 1106. ADVISORY BOARD.
SECTION 1107. REGULATIONS.
SECTION 1108. REGULATIONS BASED ON RECOMMENDATIONS OF BOARD.
SECTION 1109. TEMPORARY REGULATIONS.
CHAPTER 13. OFFENSES RELATED TO MEDICAL MARIJUANA
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SECTION 1301. CRIMINAL DIVERSION OF MEDICAL MARIJUANA BY
PRACTITIONERS.
SECTION 1302. CRIMINAL DIVERSION OF MEDICAL MARIJUANA BY
MEDICAL MARIJUANA ORGANIZATIONS.
SECTION 1303. CRIMINAL RETENTION OF MEDICAL MARIJUANA.
SECTION 1304. CRIMINAL DIVERSION OF MEDICAL MARIJUANA BY
PATIENT OR CAREGIVER.
SECTION 1305. FALSIFICATION OF IDENTIFICATION CARDS.
SECTION 1306. ADULTERATION OF MEDICAL MARIJUANA.
SECTION 1307. DISCLOSURE OF INFORMATION PROHIBITED.
SECTION 1308. ADDITIONAL PENALTIES.
SECTION 1309. OTHER RESTRICTIONS.
CHAPTER 19. RESEARCH PROGRAM
SECTION 1901. DEFINITIONS.
SECTION 1902. ESTABLISHMENT OF MEDICAL MARIJUANA RESEARCH
PROGRAM.
SECTION 1903. MEDICAL MARIJUANA RESEARCH PROGRAM
ADMINISTRATION.
SECTION 1904. APPROVAL.
SECTION 1905. REQUIREMENTS.
SECTION 1906. RESTRICTIONS.
SECTION 1907. REGULATIONS.
SECTION 1908. NONENTITLEMENT.
CHAPTER 20. ACADEMIC CLINICAL RESEARCH CENTERS
SECTION 2001. DEFINITIONS.
SECTION 2002. REGISTRATION AS BOTH GROWER/PROCESSOR AND
DISPENSARY COLLABORATING WITH AN ACADEMIC CLINICAL
RESEARCH CENTER.
SECTION 2003. RESEARCH STUDY.
CHAPTER 21. MISCELLANEOUS PROVISIONS
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SECTION 2101. CONFLICT.
SECTION 2101.1. FINANCIAL AND EMPLOYMENT INTERESTS.
SECTION 2102. INSURERS.
SECTION 2103. PROTECTIONS FOR PATIENTS AND CAREGIVERS.
SECTION 2104. SCHOOLS.
SECTION 2105. DAY-CARE CENTERS.
SECTION 2106. MEDICAL MARIJUANA FROM OTHER STATES.
SECTION 2107. ZONING.
SECTION 2108. NOTICE.
SECTION 2109. APPLICABILITY.
SECTION 2110. EFFECTIVE DATE.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
CHAPTER 1
PRELIMINARY PROVISIONS
Section 101. Short title.
This act shall be known and may be cited as the Medical
Cannabis Act.
Section 102. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Account." The Professional Licensure Augmentation Account
established under and used in accordance with the act of July 1,
1978 (P.L.700, No.124), known as the Bureau of Professional and
Occupational Affairs Fee Act.
"Board." The State Board of Medical Cannabis Licensing.
"Change in control." The acquisition by a person or group of
persons acting in concert of at least 20% of an interest in a
licensed entity.
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"Department." Except as provided in section 1101, the
Department of State of the Commonwealth.
"Health care facility." A facility that provides health care
to patients. The term includes:
(1) Any of the following, as defined under section 802.1
of the act of July 19, 1979 (P.L.130, No.48), known as the
Health Care Facilities Act:
(i) A health care facility.
(ii) An ambulatory surgical facility.
(iii) A long-term care nursing facility.
(iv) A hospice.
(2) A clinic operated by a hospital.
(3) A cancer treatment center.
"Health care practitioner." Any of the following:
(1) A medical doctor or a doctor of osteopathy, as
defined under section 2 of the act of December 20, 1985
(P.L.457, No.112), known as the Medical Practice Act of 1985.
(2) A certified registered nurse practitioner as defined
in section 2(12) of the act of May 22, 1951 (P.L.317, No.69),
known as The Professional Nursing Law, when acting in
collaboration with a physician as set forth in a written
agreement.
"Medical cannabis." As follows:
(1) Plants containing cannabidiol, tetrahydrocannabinol
or delta-9-tetrahydrocannabinol acid or any part of a
cannabis plant, including cannabis processed by extracting
oil from the plant, intended for medical purposes.
(2) The term includes any of the following made from
plants under paragraph (1):
(i) Oils.
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(ii) Ointments.
(iii) Tinctures.
(iv) Liquids.
(v) Gels.
(vi) Pills.
(vii) Similar substances.
"Medical cannabis access card." A document issued by the
Department of Health that authorizes a patient or patient
representative to purchase and possess medical cannabis in this
Commonwealth.
"Medical cannabis dispenser." A for-profit or nonprofit
entity licensed under section 503 to dispense medical cannabis.
"Medical cannabis employee." An individual who is eligible
to receive an occupation permit by meeting one of the following:
(1) An individual who meets all of the following:
(i) Is employed by a medical cannabis grower,
medical cannabis processor, medical cannabis dispenser or
certified laboratory with the authority to make a
discretionary decision relating to the growing,
processing, dispensing or testing of medical cannabis,
including a manager, supervisor or an individual who
directly handles or controls medical cannabis.
(ii) Is responsible for tracking the amount and
transportation of medical cannabis.
(2) Any other employee position designated by the board.
"Medical cannabis grower." A for-profit or nonprofit entity
licensed under section 501 that grows or cultivates cannabis for
distribution to authorized medical cannabis processors and
medical cannabis dispensers in accordance with this act.
"Medical cannabis processor." A for-profit or nonprofit
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entity licensed under section 502 authorized to purchase medical
cannabis from a medical cannabis grower for the purpose of
processing the medical cannabis for distribution to a medical
cannabis dispenser in accordance with this act.
"Medical cannabis strains." The three types of pure cannabis
utilized for medical purposes. The term includes cannabis
sativa, cannabis indica and the hybrid created by the
combination of both cannabis sativa and cannabis indica.
"Medical use." The acquisition, possession or use of medical
cannabis by a registered patient or patient representative. The
term does not include the smoking of cannabis.
"Occupation permit." A permit issued by the board
authorizing an individual to be employed as a medical cannabis
employee or patient representative.
"Owner or operator." Any of the following:
(1) An officer or director of the medical cannabis
grower, processor or dispenser licensed under section 505.
(2) A person who directly holds a beneficial interest in
or has a controlling interest in an applicant or licensee.
(3) A person who has the ability to elect a majority of
the board of directors of a licensee or to otherwise control
a licensee.
"Patient." An individual who has an established
practitioner-patient relationship and has been diagnosed with a
qualified medical condition.
"Patient representative." Any of the following:
(1) A parent or guardian of a registered patient.
(2) An individual who:
(i) is at least 18 years of age; and
(ii) receives a medical cannabis access card which
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authorizes:
(A) purchase, possession, transport and transfer
of medical cannabis from a medical cannabis
dispenser; and
(B) proper administration of the medical
cannabis to a registered patient in accordance with
the recommendation of the registered patient's health
care practitioner.
"Practitioner-patient relationship." The relationship
established between a patient and health care practitioner
following an assessment of the patient's medical history and
current condition and the conduct of a personal examination.
"Qualified medical condition." Any of the following:
(1) Cancer.
(2) Epilepsy and seizures.
(3) Amyotrophic lateral sclerosis.
(4) Cachexia/wasting syndrome.
(5) Parkinson's disease.
(6) Traumatic brain injury and postconcussion syndrome.
(7) Multiple sclerosis.
(8) Spinocerebellara Ataxia (SCA).
(9) Posttraumatic stress disorder.
(10) Severe fibromyalgia.
(11) HIV/AIDS.
(12) Glaucoma.
(13) Chronic or intractable pain where other methods of
treatment no longer have therapeutic or palliative benefit.
(14) Crohn's disease.
(15) Diabetes.
(16) A condition authorized by the department under
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section 703.
"Testing laboratory." A clinical laboratory or testing
facility located within this Commonwealth, certified by the
board under section 511.
"Tracking system." An electronic system established by the
department to monitor the activities of a person that grows,
processes, dispenses, transports or tests medical cannabis or is
determined by the department to be engaged in an activity
regulated under this act.
"Verification system." An electronic system established and
maintained by the Department of Health that allows the
Department of Health, the Bureau of Professional and
Occupational Affairs, licensed dispensers and law enforcement to
verify the issuance of a medical cannabis access card to an
individual.
"Written certification." A document dated and signed by a
health care practitioner that meets the requirements under
section 702(c).
CHAPTER 3
STATE BOARD OF MEDICAL CANNABIS
LICENSING AND ADMINISTRATIVE PROCEDURE
Section 301. License.
(a) Medical cannabis.--A person may not conduct an activity
related to the growing, processing or dispensing of medical
cannabis or operating a testing laboratory unless the person is
licensed or certified by the board under this act.
(b) Employee.--A licensed medical cannabis grower, medical
cannabis processor or a medical cannabis dispenser may not
employ an individual to directly participate in the growing,
processing, delivery or dispensing of medical cannabis unless
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the individual receives an occupation permit from the board
under this act.
Section 302. State Board of Medical Cannabis Licensing.
(a) Establishment.--There is hereby established the State
Board of Medical Cannabis Licensing within the department.
(b) Composition.--The board shall consist of the following:
(1) The Secretary of Health or a designee who is an
employee of the Department of Health.
(2) Commissioner of Professional and Occupational
Affairs or a designee who is an employee of the Bureau of
Professional and Occupational Affairs.
(3) The Secretary of Human Services or a designee who is
an employee of the Department of Human Services.
(4) Two public members.
(5) One medical doctor who is an expert in the field of
pediatrics.
(6) Two members who are medical doctors representing
specialties which utilize medical cannabis to treat patients.
(7) The Physician General.
(8) Two members who are registered nurses.
(9) A licensed pharmacist.
(c) Meetings.--The board shall meet within 30 days of
confirmation of the members and shall:
(1) Establish procedures to operate the board.
(2) Develop applications and other forms for licensure
and occupation permits and enforcement of this act and
certifications for testing laboratories.
(3) Promulgate regulations, as necessary, to implement
and enforce this act.
(d) Appointment and qualifications.--Each professional and
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public member shall be appointed by the Governor with the advice
and consent of a majority of the Senate. Each member must comply
with all of the following:
(1) Be a citizen of the United States and a resident of
this Commonwealth.
(2) Not hold any other public office during the term on
the board.
(e) Terms.--
(1) A member under subsection (b)(1), (2) or (3) shall
serve ex officio.
(2) For a member under subsection (b), the following
apply:
(i) Initial appointments shall be as follows:
(A) Three members shall serve for a term of four
years.
(B) Three members shall serve for a term of
three years.
(C) Two members shall serve for a term of two
years.
(ii) Each subsequent term shall be for four years or
until a successor has been appointed and qualified, which
may not be longer than six months beyond the four-year
period.
(iii) A member may not serve more than two
consecutive terms.
(f) Quorum.--A majority of the members of the board shall
constitute a quorum. Each member must be physically in
attendance to be counted as part of a quorum or to vote on an
issue. A majority of the members present shall be necessary for
a vote to be considered binding.
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(g) Chairperson.--The board shall annually select a
chairperson from the members of the board.
(h) Expenses.--With the exception of ex officio members,
each member of the board shall receive $100 per diem when
attending to the work of the board. A member shall also receive
the amount of reasonable travel, hotel and other necessary
expenses incurred in the performance of the member's duties in
accordance with Commonwealth regulations.
(i) Forfeiture.--A member who fails to attend three
consecutive meetings shall forfeit the member's seat unless the
chairman, upon written request from the member, finds that the
member should be excused because of illness or death of a family
member.
(j) Frequency of meetings.--The board shall meet at least
once per month for the first 12 months, including and after the
initial meeting required by section 302(c). After the first 12
months following the establishment of the board, the board shall
meet at least six times a year and may meet at additional times
as necessary to conduct the business of the board.
Section 303. Powers and duties of board.
The board shall have the following powers and duties:
(1) To provide for and regulate the licensing of the
following:
(i) A medical cannabis grower under section 501.
(ii) A medical cannabis processor under section 502.
(iii) A medical cannabis dispenser under section
503.
(2) To issue occupation permits to medical cannabis
employees.
(3) To issue certifications to testing laboratories
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under section 511.
(4) To issue, deny, renew, reinstate or refuse to renew,
suspend and revoke licenses, certifications of testing
laboratories and occupation permits in accordance with this
act.
(5) To implement procedures to allow the expansion of
qualified medical conditions for which a patient may obtain
medical cannabis under section 703.
(6) To administer and enforce the provisions of this
act.
(7) To investigate and conduct background checks for
each application for a license or occupation permit to
determine the fitness and eligibility of a person applying
for a license or occupation permit.
(8) To establish fees for application and renewal of
licenses and occupation permits and the due dates for all
fees.
(9) To charge for services related to the enforcement
and administration of this act. Billings shall be submitted
at least quarterly and all charges shall be itemized.
(10) To keep minutes and records of each transaction and
proceeding.
(11) To provide standards for the appearance of
dispensers to ensure a professional atmosphere.
(12) To require site plans, including streets, property
lines, buildings, security features and access to water
sources.
(13) To require utilization of any prescription
monitoring program established by the Commonwealth by a
health care practitioner to review a patient's pharmaceutical
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history.
(14) To establish an electronic verification system that
can be accessed by health care practitioners, the Department
of Health, patients, the Bureau of Professional and
Occupational Affairs, law enforcement personnel and other
individuals designated by the board to verify individual
medical cannabis access cards and determine whether the
identification number corresponds with a current, valid
registry identification card and that the cardholder is a
registered qualifying patient or a patient representative.
The verification system:
(i) Must be available on a 24-hour basis for the
verification of medical cannabis access cards.
(ii) May only disclose the validity of the card,
whether the cardholder is a qualified patient or a
patient representative and the registry identification
number of the patient.
(iii) Must determine whether a medical cannabis
access card has been suspended or revoked.
(15) To establish an electronic tracking system to be
used by the department to track the growing, processing,
transporting, dispensing and delivery of all medical cannabis
products between growers, processors, laboratories, transport
entities, dispensers and other persons engaged in activities
regulated under this act. The electronic tracking system must
include:
(i) Date, time, quantity and price of each sale of
medical cannabis to a qualified patient or patient
representative.
(ii) Each daily record of plants and products grown
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and possessed by a licensee, including date of harvest,
batch number, origin and strain, number of seeds or
cuttings planted, chemical additives, disposal and other
information required by the board.
(iii) Each sale, transport and other activity as
deemed necessary by the department.
(iv) Records of transport to and from testing
laboratories and the results of testing.
(v) An inventory control system, including each
day's beginning inventory, acquisitions, harvests, sales,
disbursements, disposals and ending inventory.
Information must be added to the electronic tracking
system under this paragraph on a daily basis.
(16) To establish a medical cannabis registry to ensure
adequate availability of different strains and concentrations
of medical cannabis.
(17) To develop regular inspection schedules,unannounced
inspections, procedures and other enforcement measures to
regulate all medical cannabis growers, processors, dispensers
and testing laboratories.
(18) To inspect, at any time, premises occupied or used
for the production, preparation, testing, packaging,
processing, storage, sale, distribution and transport of
medical cannabis.
(19) To develop standards and requirements for the
implementation, use and maintenance of security systems.
(20) To submit annually to the department an estimate of
financial requirements of the board, including
administrative, legal and other expenses.
(21) To develop a system for mandatory and voluntary
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recall of defective products or medical cannabis.
(22) To develop standards for creation and maintenance
of qualifying patient records.
(23) To promulgate regulations to implement this act,
including:
(i) The receipt of medical cannabis for study and
research of the health benefits of medical cannabis by
accredited research institutions, universities and
colleges in this Commonwealth.
(ii) Determination of required quality and safe
clinical strength of medical cannabis.
(iii) Print advertising and marketing of medical
cannabis.
(iv) Containers, tracking and testing.
(v) Packaging and labeling by licensed growers,
licensed processors and licensed dispensers. Regulations
under this subparagraph shall require labeling to
specify:
(A) date of packaging;
(B) use-by date;
(C) cultivation site;
(D) instructions to keep the product in the
package;
(E) warnings related to use, including pregnancy
and medical conditions;
(F) warnings to keep medical cannabis out of
children's reach;
(G) other warnings deemed appropriate by the
board;
(H) recommended dosages; and
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(I) appropriate methods to administer medical
cannabis for authorized diseases.
(24) To provide for the form and content of the
authority given to a registered patient by a health care
practitioner to obtain medical cannabis.
(25) To adopt requirements relating to the amount of
tetrahydrocannabinol authorized for each product and the
tetrahydrocannabinol's application to the appropriate
qualified medical condition.
(26) To consult information published by the American
Herbal Pharmacopeia, in the promulgation of regulations.
(27) To enforce regulations under this act.
(28) To establish record retention policies for persons
regulated under this act.
Section 304. Subpoena power.
The General Counsel of the Commonwealth, or the General
Counsel's designee, shall have the power to issue a subpoena on
behalf of the board in enforcement, disciplinary and licensing
matters before the board in order to investigate an alleged
violation in accordance with the following:
(1) The power shall not apply to patient records without
order of a court of competent jurisdiction showing that the
records are reasonably necessary for the conduct of an
investigation.
(2) The court may impose limitations on the scope of a
subpoena as necessary to prevent unnecessary intrusion into
patient confidential information.
(3) The attorney representing the Commonwealth in a
disciplinary matter before the board may apply to
Commonwealth Court to enforce the subpoenas.
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(4) Nothing in this section shall be construed to excuse
a person from producing documents and records as requested by
the board under any other provision of law.
Section 305. Hearing examiners.
(a) Appointment.--The Commissioner of Professional and
Occupational Affairs, after consultation with the board, shall
appoint hearing examiners as necessary to conduct hearings in
disciplinary matters before the board.
(b) Regulation.--Regulations promulgated by the board shall
include the procedural rules to be followed by hearing examiners
under this act. Each proceeding shall be conducted in accordance
with 2 Pa.C.S. (relating to administrative law and procedure).
(c) Powers.--A hearing examiner shall have the following
powers:
(1) To conduct hearings.
(2) To issue subpoenas requiring:
(i) The attendance and testimony of individuals.
(ii) The production of pertinent records or other
papers by persons whom the examiner believes have
information relevant to matters pending before the
examiner.
(3) To issue decisions.
Section 306. Civil penalties.
(a) Authorization.--The board shall adopt a schedule of
civil penalties for operating without a current, registered,
unsuspended and unrevoked license, certificate or occupation
permit and for violations of this act. The schedule shall be
published in the Pennsylvania Bulletin.
(b) Imposition.--An agent of the board may issue citations
and impose penalties for a violation of this chapter. A citation
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or a penalty may be appealed to a hearing examiner or the board
pursuant to regulations promulgated by the board. If the matter
is initially referred to a hearing examiner, the board shall
render a decision on an exception to the decision of the hearing
examiner or on any applications for review under 2 Pa.C.S.
(relating to administrative law and procedure).
(c) Board sanction.--
(1) In addition to any other penalty authorized by law,
the board may impose the following sanctions:
(i) Revocation of the license, permit or certificate
of a person convicted of a criminal offense or violation
of this act or regulations of the board which would
disqualify the holder from growing, processing or
dispensing medical cannabis.
(ii) Revocation of the license of a person for
willfully and knowingly violating or attempting to
violate an order of the board directed to the person.
(iii) Revocation of an occupation permit or
certificate of a person for willfully and knowingly
violating or attempting to violate an order of the board
directed to the person.
(iv) Suspension of the license, permit or
certificate of a person pending the outcome of a hearing
in a case in which a license, occupation permit or
certification revocation could result.
(v) Suspension of the license of a licensed grower,
processor or dispenser for a violation or attempt to
violate any provisions of this act.
(vi) Assessment of an administrative penalty as
necessary to address misconduct and deter future
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violations.
(vii) Ordering of restitution of funds or property
unlawfully obtained or retained by a licensee.
(viii) Entrance of a cease and desist order which
specifies the conduct which is to be discontinued,
altered or implemented by the licensee.
(2) If the board refuses to issue or renew a license,
certificate or occupation permit or imposes a penalty under
paragraph (1), the board shall provide the applicant,
licensee, certificate holder or permit holder with written
notification of the decision, including a statement of the
reasons for the decision by certified mail within five
business days of the decision of the board. The applicant,
licensee, certificate holder or permittee shall have the
right to appeal the decision in accordance with 2 Pa.C.S.
Chs. 5 (relating to practice and procedure) and 7 (relating
to judicial review).
(3) A person who aids, abets, counsels, induces,
procures or causes another person to violate this act shall
be subject to all sanctions and penalties provided under this
subsection.
(d) Additional powers.--In addition to the penalties under
subsections (b) and (c), the board shall have the power to do
the following:
(1) Levy a civil penalty of not more than $25,000 for a
violation of this act.
(2) Impose a civil penalty of up to $15,000 per
violation if a person aids and abets the unlicensed growing,
processing, distribution or dispensing of medical cannabis.
The penalty may not be levied against a person solely as a
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consequence of that person being a registered patient of the
unlicensed person.
(3) Assess against a respondent determined to be in
violation of this act the costs of investigation underlying
that disciplinary action. The cost of investigation shall not
include costs incurred by the board after the filing of
formal actions or disciplinary charges against a respondent.
(e) Judgment.--A civil penalty imposed under this section
shall be a judgment in favor of the board upon the person or
property of the person upon whom the civil penalty is imposed.
The Attorney General shall be responsible for enforcing the
judgments in courts of competent jurisdiction in accordance with
the provisions of 42 Pa.C.S. (relating to judiciary and judicial
procedure).
Section 307. Confidentiality.
(a) General rule.--Investigative records of the board,
including prosecutorial memos and transcripts of deposition on
behalf of the board or concerning a licensure-related complaint
filed with the department, shall be confidential and privileged.
The following shall apply:
(1) No person who has investigated or has access to or
custody of documents, materials or information which is
confidential and privileged under this section may be
required to testify in a judicial or administrative
proceeding without the written consent of the board unless
directed to do so by a court of competent jurisdiction.
(2) This subsection shall not preclude or limit
introduction of the contents of an investigative file or
related witness testimony in a hearing or proceeding before
the board.
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(3) This section shall not apply to a letter or other
document to a licensee, occupation permittee or certificate
holder that discloses the final outcome of an investigation
or to a final adjudication or order of the board.
(b) Disclosure permitted.--Except as provided in subsection
(a), this section shall not prevent disclosure of documents,
materials or information pertaining to the status of a license,
certificate or occupation permit or the sharing of information
with law enforcement officials or similar regulatory boards in
other jurisdictions. A violation of this section shall subject
an employee or agent of the board to administrative discipline,
including discharge, suspension or other formal or appropriate
disciplinary action.
(c) Affidavit.--Each employee or agent of the board must
execute a confidentiality affidavit which provides that
documents, materials or information in subsection (a) obtained
by the employee or agent shall be considered confidential and
may be disclosed only as permitted under this section.
(d) Waiver.--The board may not require an applicant to waive
any confidentiality under this section as a condition for the
approval of a license or other action of the board.
Section 308. Financing.
(a) Setting of fees.--Beginning two years after the
effective date of this subsection, all fees required under this
act shall be fixed by the board by regulation. If revenue raised
by fees, fines and civil penalties imposed under this act are
not sufficient to meet expenditures over a two-year period, the
board shall increase those fees by regulation under section
303(23) so that the projected revenues will meet or exceed
projected expenditures.
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(b) Renewal fees.--Beginning two years after the effective
date of this subsection, all renewal fees shall be deposited
into the account.
(c) Inadequate fees.--If the Bureau of Professional and
Occupational Affairs determines that the fees established by the
board under subsection (a) are inadequate to meet the minimum
enforcement efforts required by this act, then the bureau, after
consultation with the board, shall increase the fees by
regulation under section 303(23) in an amount that adequate
revenues are raised to meet the required enforcement effort.
(d) Disposition.--Fees, fines and civil penalties imposed
and collected under this act shall be for the exclusive use of
the board in carrying out this act and shall be annually
appropriated from the account for that purpose. This subsection
shall not apply to an initial license fee.
(e) Charging of fees.--The board may charge a reasonable
fee, as set by the board by regulation under section 303(23),
for all examinations, enforcement activities, registrations,
certificates, audits, licensures or applications permitted by
this act or a regulation under this act.
(f) Civil penalties.--All civil penalties shall be deposited
into the account.
Section 309. Records and reports.
(a) Records.--Each record of activities required under this
act must be retained for a period of at least two years unless
otherwise required by the board.
(b) Reports to department.--The board shall submit annually
to the department an estimate of the financial requirements of
the board for its administrative, investigative, legal and
miscellaneous expenses.
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(c) Reports to the Appropriations Committee of the Senate
and the Appropriations Committee of the House of
Representatives.--The board shall submit annually to the
Appropriations Committee of the Senate and the Appropriations
Committee of the House of Representatives, 15 days after the
Governor has submitted his budget to the General Assembly, a
copy of the budget request for the upcoming fiscal year which
the board previously submitted to the department.
(d) Reports to other legislative committees.--The board
shall submit annually a report to the Consumer Protection and
Professional Licensure Committee of the Senate and to the
Professional Licensure Committee of the House of Representatives
containing a description of the types of complaints received,
status of cases, board action which has been taken and the
length of time from the initial complaint to final board
resolution. The report shall also include a statement of the
numbers and types of licenses granted.
CHAPTER 5
LICENSING
Section 501. Medical cannabis growers.
(a) Licensing.--The board shall license not more than 65
medical cannabis growers to supply medical cannabis for
distribution to medical cannabis processors and medical cannabis
dispensers under this act.
(b) Imposition.--At the time of license issuance, the board
shall impose a licensing fee in the amount of $50,000. The board
shall impose an initial $5,000 annual renewal fee for each year
immediately following the year the license was issued. Renewal
fees shall thereafter be subject to adjustment under section
308.
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(c) Term.--Upon payment of the fee under subsection (b), a
grower's license shall be in effect unless suspended, revoked or
not renewed by the board for good cause.
(d) Update.--A licensee under this section must notify the
board of a change relating to the status of its license or other
information contained in its application and other information
filed with the board.
(e) Deposit.--The licensure fee under subsection (b) shall
be deposited into the General Fund. Renewal fees under
subsection (b) shall be deposited into the account.
(f) Restriction.--There shall be no restriction on specific
strains of medical cannabis that may be grown under this act.
Use of genetically modified organisms or an organism whose
genetic material has been altered using genetic engineering may
not be used in the cultivation of medical cannabis.
(g) Requirements.--A medical cannabis grower shall:
(1) Only grow medical cannabis using conventional
growing methods approved by the board in consultation with
the Department of Agriculture.
(2) Submit to preoperational and postoperational
announced and unannounced inspections by the board or the
department.
(3) Grow cannabis only in an indoor, enclosed, secure
facility.
(4) Conduct quality testing utilizing a testing
laboratory certified by the board prior to the sale of
medical cannabis and submit to random testing of medical
cannabis conducted by the board.
(5) Package and label medical cannabis products in
accordance with regulations of the board.
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(6) Only sell, transport or deliver medical cannabis to
a medical cannabis processor, certified laboratory or medical
cannabis dispenser.
(7) Provide information relating to the enclosed, secure
facility where medical cannabis will be grown, harvested or
stored, including electronic locking systems, limited access
areas, secure storage and disposal procedures, electronic
surveillance and other features required by the board.
(8) Provide a cultivation, inventory and packaging plan
and procedures for the oversight of the cultivation area,
including a plant monitoring system, container tracking
system and staffing plan.
(9) Maintain daily records of plants, sales and other
activities, as required by the board.
(10) Perform a weekly physical inventory of all plants
and containers.
(11) Notify law enforcement within 24 hours of any loss
or theft of medical cannabis and record the loss or theft in
the electronic tracking system.
(12) Utilize any electronic tracking system required by
the board.
(h) Prohibitions.--A medical cannabis grower may not do any
of the following:
(1) Be located within 1,000 feet of the property line of
a public, private or parochial school or a day-care center.
(2) Be located in a residential dwelling or an area
zoned for residential use.
(3) Acquire cannabis from outside this Commonwealth or
otherwise in violation of regulations of the board.
(4) Permit an individual to consume cannabis on its
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property.
(5) Advertise medical cannabis on radio or television.
(i) Exchange.--The board shall promulgate regulations for
the exchange of medical cannabis seed and plant materials
between growers.
Section 502. Medical cannabis processors.
(a) Licensing.--The board shall license not more than 65
medical cannabis processors to process medical cannabis into
oil-based medical cannabis products, including oil, ointments
and tinctures. The licensees shall be geographically dispersed
throughout this Commonwealth to allow access to processed
medical cannabis by medical cannabis dispensers.
(b) Imposition.--At the time of license issuance, the board
shall impose a licensing fee in the amount of $50,000. The board
shall impose an initial $5,000 annual renewal fee for each year
immediately following the year the license was issued. Renewal
fees shall be subject to adjustment and deposit under section
308.
(c) Term.--Upon payment of the fee under subsection (b), a
processor's license shall be in effect unless suspended, revoked
or not renewed by the board for good cause.
(d) Update.--A licensee under this section must notify the
board of a change relating to the status of its license or other
information contained in its application and other information
filed with the board.
(e) Deposit.--The license fee under subsection (b) shall be
deposited into the General Fund. Renewal fees shall be deposited
into the account.
(f) Requirements.--A medical cannabis processor shall do all
of the following:
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(1) Only use extraction and processing methods approved
by the board.
(2) Submit to preoperational and postoperational
announced and unannounced inspections by the board and the
department.
(3) Conduct quality testing utilizing a certified
testing laboratory approved by the board prior to delivery to
a dispenser and submit to random testing conducted by the
board.
(4) Only sell, transport or deliver medical cannabis to
a testing laboratory or to a medical cannabis dispenser.
(5) Conduct processing activity in a board-approved
facility that is indoor, enclosed and secure, and includes an
electronic locking system, a limited access area, secure
storage and disposal procedures, electronic surveillance and
other features required by the board.
(6) Provide information relating to the facility and
features under paragraph (5).
(7) Provide a processing, inventory and packaging plan
and procedures for the oversight of the processing facility,
including a plant and product monitoring system, container
tracking system and staffing plan.
(8) Perform a weekly physical inventory of all plants,
containers and processing materials.
(9) Maintain a daily log of access to medical cannabis
received and products shipped.
(10) Only sell medical cannabis approved by a certified
laboratory to a licensed medical cannabis dispenser.
(11) Notify law enforcement within 24 hours of a loss or
theft of medical cannabis and record the loss or theft in the
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electronic tracking system.
(12) Maintain daily records of all sales and other
activities as required by the board.
(13) Utilize any electronic tracking system required by
the board.
(g) Prohibitions.--A medical cannabis processor may not do
any of the following:
(1) Be located within 1,000 feet of the property line of
a public, private or parochial school or a day-care center.
(2) Be located in a residential dwelling or an area
zoned for residential use.
(3) Acquire medical cannabis from anyone other than a
licensed medical cannabis grower.
(4) Obtain medical cannabis from outside this
Commonwealth.
(5) Process cannabis for any purpose except to provide
medical cannabis to a licensed medical cannabis dispenser.
(6) Advertise medical cannabis on radio or television.
Section 503. Medical cannabis dispensers.
(a) Licensing.--The board shall license not more than 130
medical cannabis dispensers to accept medical cannabis access
cards and dispense medical cannabis to a registered patient or
patient representative in accordance with the instructions of a
health care practitioner. The licensees shall be geographically
dispersed throughout this Commonwealth to allow all registered
patients reasonable proximity and access to medical cannabis by
a medical cannabis dispenser.
(b) Imposition.--At the time of license issuance, the board
shall impose a licensing fee in the amount of $50,000. The board
shall impose an initial $5,000 annual renewal fee for each year
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immediately following the year the license was issued. Renewal
fees shall be subject to adjustment under section 308.
(c) Term.--Upon payment of the fee under subsection (b), a
dispenser's license shall be in effect unless suspended, revoked
or not renewed by the board for good cause.
(d) Update.--A licensee under this section must notify the
board of a change relating to the status of its license,
operation or other information contained in its application and
other information filed with the board.
(e) Deposit.--The license fee under subsection (b) shall be
deposited into the General Fund. Renewal fees shall be deposited
into the account.
(f) Requirements.--A medical cannabis dispenser shall do all
of the following:
(1) Maintain an ongoing connection with the Department
of Health's individual verification system to verify medical
cannabis access cards.
(2) Submit to preoperational and postoperational
announced and unannounced inspections by the board and the
department.
(3) Prior to dispensing medical cannabis, access the
verification system to ensure that the individual seeking to
purchase medical cannabis holds a medical cannabis access
card in effect at the time of purchase.
(4) Maintain a daily log of all medical cannabis sold
and dispensed. The log shall include:
(i) The name of the registered patient or patient
representative that holds the medical cannabis access
card.
(ii) The amount and dosage of the medical cannabis
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recommended by the physician.
(iii) The qualified medical condition of the
patient.
(iv) The amount of medical cannabis dispensed.
(v) The date and time of each dispensing to the
cardholder.
(vi) The dispensary agent's registry number.
(vii) The signature and date of the patient or
patient representative.
(5) Provide reports as required by the board relating to
amounts dispensed.
(6) Dispense no more than 2.5 ounces of medical cannabis
to a patient, directly or via a patient representative, in a
14-day period unless the qualifying patient has a quantity
waiver from the Department of Health.
(7) Only accept written certifications from a health
care practitioner for no more than the 28-day supply periods.
Thereafter, a new written certification from the health care
practitioner shall be required.
(8) Comply with recommendations of the health care
practitioner as to strain, dosage and amount of medical
cannabis dispensed.
(9) Provide all registered patients and patient
representatives with a safety insert developed by the
Department of Health which includes:
(i) Methods for administering medical cannabis.
(ii) Potential dangers.
(iii) Recognition and correction of problematic
dosage.
(iv) Other information required by the department.
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(10) Sell only medical cannabis that has received
approval from a testing laboratory.
(11) Maintain an electronic security system, including
all of the following:
(i) Electronic surveillance.
(ii) An electronic locking system.
(iii) A locked door or barrier between the entry and
a limited access area for patients, storage, disposal and
other processes.
(12) Provide for the supervision of the dispensing of
medical cannabis at all times by an individual. The board
shall determine the qualifications required to supervise the
dispensing which may include individuals with health care,
educational, pharmaceutical, management or other education or
training as determined by the board.
(13) Display appropriate signage as required by the
board.
(14) Provide the proposed address of the enclosed,
secure facility where medical cannabis will be dispensed.
(15) Provide an inventory and packaging plan and
procedures for the oversight of the dispensing facility,
including compliance with the inventory control system
developed under section 303(15), staffing plan and security
plan.
(16) Appoint a physician to function as a medical
director to serve on site or who is able to be contacted. The
medical director must:
(i) Provide training to dispensary employees.
(ii) Develop patient education.
(iii) Develop a policy for refusing to dispense
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medical cannabis to an individual who appears to be
impaired or abusing medical cannabis.
(17) Perform a weekly physical inventory of all medical
cannabis and medical cannabis products.
(18) Obtain medical cannabis only from a medical
cannabis processor.
(19) Notify law enforcement within 24 hours of a loss or
theft of medical cannabis and record the loss or theft in the
electronic tracking system.
(20) Utilize any electronic tracking system required by
the board.
(g) Prohibitions.--A medical cannabis dispenser may not do
any of the following:
(1) Be located within 1,000 feet of the property line of
a public, private or parochial school or a day-care center.
The board may adjust or waive the prohibition under this
paragraph if it is shown by clear and convincing evidence
that the adjustment or waiver is necessary to provide
adequate access to patients. An adjustment or waiver must
include any additional security, physical plant or other
conditions necessary to protect children.
(2) Be located in a residential dwelling or an area
zoned for residential use.
(3) Obtain medical cannabis from outside this
Commonwealth.
(4) Sell medical cannabis for any purpose except to a
registered patient or a patient representative.
(5) Permit an individual to consume medical cannabis on
its property.
(6) Sell products which contain nicotine or alcohol.
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(7) Sell medical cannabis over the Internet or to a
person not physically present at its location.
(8) Advertise medical cannabis on radio or television.
Section 504. Applications.
(a) Application.--An application for a grower, processor or
dispenser license must be submitted on a form and in a manner as
required by the board. In reviewing an application, the board
shall confirm that all applicable fees have been paid.
(b) Information.--An applicant for a grower, processor or
dispenser license under this act must do all of the following:
(1) Disclose the following information:
(i) Each arrest and citation for a nontraffic
summary offense of the applicant.
(ii) The name, address and photograph of the
applicant and each principal and the principal's position
within the corporation or organization.
(iii) Any financial information required by the
board.
(iv) The proposed location of the growing,
processing or dispensing operation.
(v) The details of each loan obtained to finance the
growing, processing or dispensing operation.
(vi) The details of any civil judgment against the
applicant or the applicant's owners or operators relating
to:
(A) security regulation laws of the Federal
Government;
(B) laws relating to the regulation of
pharmaceuticals; or
(C) laws under 15 Pa.C.S. (relating to
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