PRIOR PRINTER'S NO. 224
PRINTER'S NO. 793
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
SENATOR FOLMER, STATE GOVERNMENT, AS AMENDED, APRIL 21, 2015
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.
Section 308. Financing.
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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. Expansion of medical conditions.
Section 703. Medical use permitted.
Section 704. Health insurance.
Section 705. 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.
CHAPTER 11. MEDICAL CANNABIS SURCHARGE
Section 1101. Definitions.
Section 1102. Incidence and rate of surcharge.
Section 1103. Limitation of surcharge.
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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. Appropriations.
Section 5103. Applicability of other statutes.
Section 5104. Repeals.
Section 5105. Effective date.
TABLE OF CONTENTS
CHAPTER 1. PRELIMINARY PROVISIONS
SECTION 101. SHORT TITLE.
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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.
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.
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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.
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.
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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.
SECTION 5104. REPEALS.
SECTION 5105. 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
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licensed entity.
"Department." The Department of State of the Commonwealth.
"Health care facility." A facility that provides health care
to patients. The term includes:
(1) A hospital, as defined under the act of July 19,
1979 (P.L.130, No.48), known as the Health Care Facilities
Act.
(2) A clinic operated by the hospital.
(3) An ambulatory or surgical facility.
(4) A long-term care nursing facility.
(5) A cancer treatment center.
(6) A hospice care facility.
"Health care practitioner." An individual 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, who is authorized to
prescribe Schedule III drugs under the act of April 14, 1972
(P.L.233, No.64), known as The Controlled Substance, Drug,
Device and Cosmetic Act. The term shall not include an
individual licensed under the act of May 1, 1933 (P.L.216,
No.76), known as The Dental Law.
"Medical cannabis." 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.
The term includes extracted oil, edible products, ointments and
tinctures.
"Medical cannabis access card." A document issued by the
Department of Health to authorize a patient or patient
representative to purchase and possess medical cannabis in this
Commonwealth.
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"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 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
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
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term does not include the smoking or vaporization of cannabis.
"Occupation permit." A permit issued by the board
authorizing an individual to be employed as a medical cannabis
employee.
"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
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
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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,
including treatment:
(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) A condition authorized by the department under
section 702.
"Testing laboratory." A clinical laboratory or testing
facility located within this Commonwealth, certified by the
board under section 511.
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,
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processing, delivery or dispensing of medical cannabis unless
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 Public Welfare or a designee who is
an employee of the Department of Public Welfare.
(4) Two public members.
(5) One member representing hospitals.
(6) Two members who are medical doctors representing
specialties which utilize medical cannabis to treat patients.
(7) Two members who are registered nurses.
(8) 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
public member shall be appointed by the Governor with the advice
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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)(4) through (8),
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.
(g) Chairperson.--The board shall annually select a
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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
12months 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
under section 511.
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(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 702.
(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 inspection and
oversight 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 utilization of any prescription
monitoring program established by the Commonwealth by a
health care practitioner to review a patient's pharmaceutical
history.
(13) To develop a system to ensure medical cannabis
dispensers are able to verify medical cannabis access cards.
(14) To establish a medical cannabis registry to ensure
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adequate availability of different strains and concentrations
of medical cannabis.
(15) To develop regular inspection schedules,unannounced
inspections, procedures and other enforcement measures to
regulate all medical cannabis growers, processors and
dispensers.
(16) To inspect, at any time, premises occupied or used
for the production, preparation, testing, packaging,
processing, storage, sale, distribution and transport of
medical cannabis.
(17) To develop standards and requirements for the
implementation, use and maintenance of security systems.
(18) To submit annually to the department an estimate of
financial requirements of the board, including
administrative, legal and other expenses.
(19) To develop a system for mandatory and voluntary
recall of defective products or medical cannabis.
(20) To develop an inventory tracking system to be used
by all licensees and certified laboratories.
(21) 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.
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(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) instructions to keep the product in the
package;
(D) warnings related to use, including pregnancy
and medical conditions;
(E) warnings to keep medical cannabis out of
children's reach;
(F) other warnings deemed appropriate by the
board;
(G) recommended dosages;
(H) appropriate methods to administer medical
cannabis for authorized diseases; and
(22) To provide for the form and content of the
authority given to a registered patient by a health care
provider to obtain medical cannabis.
(23) To consult information published by the American
Herbal Pharmacopeia, in the promulgation of regulations.
(24) To enforce regulations under this act.
(25) To submit an annual report to the Secretary of the
Senate and the Chief Clerk of the House of Representatives.
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 disciplinary and licensing matters before
the board in order to investigate an alleged violation in
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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.
(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
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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 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
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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
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
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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
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.
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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.
(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
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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(21) so that the projected revenues will meet or exceed
projected expenditures.
(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(21) 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(21),
for all examinations, registrations, certificates, licensures or
applications permitted by this act or a regulation under this
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act.
(f) Civil penalties.--All civil penalties shall be deposited
into the account.
(g) 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.
(h) 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.
(i) 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
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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.
(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
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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.
(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.
(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
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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
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, edible
products, 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.
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(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:
(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
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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.
(12) Maintain daily records of all sales and other
activities as required by the board.
(13) Comply with the regulations of the Department of
Agriculture relating to food safety when manufacturing edible
products.
(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 cannabis from anyone other than a licensed
medical cannabis grower.
(4) Obtain 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
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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
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 a system to verify medical cannabis access
cards.
(2) Submit to preoperational and postoperational
announced and unannounced inspections by the board and the
department.
(3) Maintain a daily log of all medical cannabis
purchased and dispensed. The log shall include:
(i) The name of the registered patient or a patient
representative that holds the medical cannabis access
card.
(ii) The amount of medical cannabis dispensed.
(iii) The date of each dispensing to the cardholder.
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(4) Provide reports as required by the board relating to
amounts dispensed.
(5) Maintain an enclosed, secure physical premises that
meets the regulations of the board. Medical cannabis may not
be visible from the entryway to an individual who is not an
occupation-permitted employee, owner or operator of the
licensed premises.
(6) Dispense no more than a 30-day supply of the dosage
recommended by the health care practitioner unless the
registered patient receives a waiver from the department
authorizing a larger amount. A new 30-day supply may be
dispensed during the seven days prior to the end of the 30-
day period under this paragraph.
(7) Only accept authorizations from a health care
practitioner for no more than the 30-day supply periods.
Thereafter, a new authorization 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.
(10) Sell only medical cannabis that has received
approval from the certified laboratory.
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(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 with
qualifications required 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 a plant and product monitoring system, container
tracking system, staffing plan and security plan.
(16) Perform a weekly physical inventory of all medical
cannabis and medical cannabis products.
(17) Obtain medical cannabis only from a medical
cannabis processor.
(18) Notify law enforcement within 24 hours of a loss or
theft of medical cannabis.
(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.
(2) Be located in a residential dwelling or an area
zoned for residential use.
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(3) Obtain 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 cannabis on its
property.
(6) Sell products which contain nicotine or alcohol.
(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
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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
corporations and unincorporated associations).
(vii) Any other information required by the board.
(2) Consent to the conduct of a background investigation
by the board, the scope of which shall be determined by the
board consistent with this act. Consent shall include a
release signed by each person subject to the investigation of
information required to complete the investigation.
(c) Refusal.--A refusal to provide the information required
under this section or to consent to a background investigation
shall result in the immediate denial of a license.
(d) Character requirements.--Each application for a grower,
processor or dispenser license shall include information,
documentation and assurance required to establish by clear and
convincing evidence that the applicant is a person of good
character, honesty and integrity, has appropriate financial
suitability and is eligible and suitable to be an owner or
operator. Information shall include information pertaining to
associates during the 10-year period immediately preceding the
filing date of the application.
(e) Privilege.--The issuance or renewal of a license under
this section shall be a revocable privilege.
Section 505. Licensing of owner or operator.
(a) License required.--Each owner or operator of an
applicant for licensure under this act must obtain an owner or
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operator license from the board. An owner or operator may only
have an interest in the activity under this act for which
licensure is sought.
(b) Application.--An owner or operator license application
shall be in a form prescribed by the board and shall include the
following:
(1) Verification of status as an owner or operator from
a medical cannabis dispenser, grower or processor.
(2) A description of responsibilities as an owner or
operator.
(3) Each release necessary to obtain information from
governmental agencies, employers and other organizations.
(4) Fingerprints, which shall be submitted to the
Pennsylvania State Police. The Pennsylvania State Police
shall submit fingerprint data to and receive national
criminal history record information from the Federal Bureau
of Investigation for use in investigating an applicant for an
owner or operator license.
(5) A photograph that meets the standards of the
Commonwealth Photo Imaging Network.
(6) Details relating to a similar license, permit or
other authorization obtained in another jurisdiction.
(7) Any additional information required by the board.
(c) Issuance.--Following review of the application and the
background investigation, the board may issue an owner or
operator license if the applicant has proven by clear and
convincing evidence that the applicant is a person of good
character, honesty and integrity and is eligible and suitable to
be licensed as an owner or operator.
(d) Nontransferability.--A license issued under this section
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shall be nontransferable.
(e) Owner or operator.--An individual who receives an owner
or operator license need not obtain an occupation permit.
(f) Waiver.--The board may waive licensure requirements for
an owner of securities in a publicly traded corporation if the
board determines that the holder of the securities is not
significantly involved in the activities of the applicant.
Section 506. Occupation permit for medical cannabis employees
and certain patient representatives.
(a) Permit required.--Each medical cannabis employee, and
each patient representative who is not a parent or guardian of a
patient, shall obtain an occupation permit from the board.
(b) Application.--An occupation permit application shall be
in a form prescribed by the board and shall include the
following:
(1) Verification of one of the following:
(i) The status as a medical cannabis employee or
potential medical cannabis employer from a medical
cannabis grower, processor or dispenser.
(ii) From a health care facility that the patient
representative is an employee designated to purchase,
possess, transport, deliver and properly administer
medical cannabis to a patient with a medical cannabis
access card who is unable to obtain the medical cannabis.
(2) A description of employment responsibilities.
(3) Each release necessary to obtain information from
governmental agencies, employers and other organizations.
(4) Fingerprints, which shall be submitted to the
Pennsylvania State Police. The Pennsylvania State Police
shall submit fingerprint data to and receive national
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criminal history record information from the Federal Bureau
of Investigation for use in investigating an applicant for an
occupation permit.
(5) A photograph that meets the standards of the
Commonwealth Photo Imaging Network.
(6) Details relating to a similar license, permit or
other authorization obtained in another jurisdiction.
(7) Any additional information required by the board.
(c) Issuance.--Following review of the application and the
background investigation, the board may issue an occupation
permit if the applicant has proven by clear and convincing
evidence that the applicant is a person of good character,
honesty and integrity and is eligible and suitable to be an
occupation permit holder.
(d) Nontransferability.--An occupation permit issued under
this section shall be nontransferable.
(e) Privilege.--The issuance or renewal of a permit under
this section shall be a revocable privilege.
Section 507. Change in ownership.
The following apply to notification and approval:
(1) A medical cannabis grower, processor or dispenser
must notify the board upon becoming aware of a proposed or
contemplated change of ownership or control of the licensee.
The new owner must pay the licensing fee required under this
chapter.
(2) The purchaser of the assets of a medical cannabis
grower, processor or dispenser must independently qualify for
a license in accordance with this act and must pay the
license fee required under this chapter.
(3) If the ownership of the operation of a licensed
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grower, processor or dispenser or its affiliate is changed,
the new owner must pay the annual renewal fee for each
applicable license.
Section 508. Location.
(a) General rule.--Except as otherwise provided under this
act, each grower, processor and dispenser license shall be valid
for the specific physical location within the municipality and
county for which it was originally granted. A person may not
distribute medical cannabis from a location other than a
licensed facility.
(b) Zoning.--The following shall apply:
(1) The growing of medical cannabis shall be classified
as a normal agricultural operation as defined under section 2
of the act of June 10, 1982 (P.L.454, No.133), referred to as
the Right-to-Farm Law.
(2) Facilities for the manufacturing, preparation and
production of medical cannabis shall meet the same municipal
zoning and land use requirements as other manufacturing,
preparation and production facilities.
(3) Facilities for the dispensing of medical cannabis
shall meet the same municipal zoning and land use
requirements as other commercial facilities.
(c) Petition.--An applicant or holder of a license under
this act may petition the board to relocate its facility. In
determining whether to grant a petition to relocate, the board
shall do all of the following:
(1) Evaluate the proposed new location and the reason
for relocation.
(2) Evaluate community support and compliance with local
ordinances.
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