S0003B0889A05835 BIL:BTW 02/04/16 #90 A05835
AMENDMENTS TO SENATE BILL NO. 3
Sponsor: REPRESENTATIVE MARSICO
Printer's No. 889
Amend Bill, page 1, lines 1 through 16; pages 2 and 3, lines
1 through 30; page 4, line 1; by striking out all of said lines
on said pages and inserting
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 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 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.
Section 511. Suspension.
Section 512. Use of prescription drug monitoring program.
Chapter 7. Medical Marijuana Organizations
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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.
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
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 21. Miscellaneous Provisions
Section 2101. Conflict.
Section 2102. Insurers.
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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.
Amend Bill, page 4, lines 4 through 30; pages 5 through 68,
lines 1 through 30; page 69, lines 1 through 27; by striking out
all of said lines on said pages and inserting
CHAPTER 1
PRELIMINARY PROVISIONS
Section 101. Short title.
This act shall be known and may be cited as the Medical
Marijuana Act.
Section 102. Declaration of policy.
The General Assembly finds and declares as follows:
(1) Scientific evidence suggests that medical marijuana
is one potential therapy that may mitigate suffering in some
patients and also enhance quality of life.
(2) The Commonwealth is committed to patient safety.
Carefully regulating the program which allows access to
medical marijuana will enhance patient safety while research
into its effectiveness continues.
(3) It is the intent of the General Assembly to:
(i) Provide a program of access to medical marijuana
which balances the need of patients to have access to the
latest treatments with the need to promote patient
safety.
(ii) Provide a safe and effective method of delivery
of medical marijuana to patients.
(iii) Promote high quality research into the
effectiveness and utility of medical marijuana.
(4) It is the further intention of the General Assembly
that any Commonwealth-based program to provide access to
medical marijuana serve as a temporary measure, pending
Federal approval of and access to medical marijuana through
traditional medical and pharmaceutical avenues.
Section 103. 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:
"Advisory board." The advisory board established under
section 1106.
"Caregiver." The individual designated by a patient or, if
the patient is under 18 years of age, an individual under
section 508(2), to deliver medical marijuana.
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"Certified medical use." The acquisition, possession, use or
transportation of medical marijuana by a patient, or the
acquisition, possession, delivery, transportation or
administration of medical marijuana by a caregiver, for use as
part of the treatment of the patient's serious medical
condition, as authorized in a certification under this act,
including enabling the patient to tolerate treatment for the
serious medical condition.
"Certified registered nurse practitioner." As defined in
section 2 of the act of May 22, 1951 (P.L.317, No.69), known as
The Professional Nursing Law.
"Change in control." The acquisition by a person or group of
persons acting in concert of a controlling interest in an
applicant or registrant either all at one time or over the span
of a 12-consecutive-month period.
"Continuing care." Treating a patient, in the course of
which the practitioner has completed a full assessment of the
patient's medical history and current medical condition,
including an in-person consultation with the patient.
"Controlling interest." As follows:
(1) The term shall mean the following:
(i) For a publicly traded entity, voting rights that
entitle a person to elect or appoint one or more of the
members of the board of directors or other governing
board or the ownership or beneficial holding of 5% or
more of the securities of the publicly traded entity.
(ii) For a privately held entity, the ownership of
any security in the entity.
(2) For purposes of this definition, the term "security"
is as defined in section 102(t) of the act of December 5,
1972 (P.L.1280, No.284), known as the Pennsylvania Securities
Act of 1972.
"Department." The Department of Health of the Commonwealth.
"Dispensary." A person, including a natural person,
corporation, partnership, association, trust or other entity, or
any combination thereof, which is registered by the department
to dispense medical marijuana. The term does not include a
health care medical marijuana organization under Chapter 19.
"Family or household member." As defined in 23 Pa.C.S. §
6102 (relating to definitions).
"Financial backer." An investor, mortgagee, bondholder, note
holder or other source of equity of an applicant other than a
financial institution.
"Financial institution." A bank, a national banking
association, a bank and trust company, a trust company, a
savings and loan association, a building and loan association, a
mutual savings bank, a credit union or a savings bank.
"Form of medical marijuana." The characteristics of the
medical marijuana recommended or limited for a particular
patient, including the method of consumption and any particular
dosage, strain, variety and quantity or percentage of medical
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marijuana or particular active ingredient.
"Fund." The Medical Marijuana Program Fund established in
section 902.
"Grower/processor." A person, including a natural person,
corporation, partnership, association, trust or other entity, or
any combination thereof, which is registered by the department
under this act to grow and process medical marijuana. The term
does not include a health care medical marijuana organization
under Chapter 19.
"Identification card." A document issued under section 505
that permits access to medical marijuana under this act.
"Individual dose." A single measure of medical marijuana.
"Medical marijuana." Marijuana for medical use as set forth
in this act.
"Medical marijuana organization." A dispensary or a
grower/processor. The term does not include a health care
medical marijuana organization under Chapter 19.
"Patient." An individual who:
(1) has a serious medical condition;
(2) has met the requirements for certification under
this act; and
(3) is a resident of this Commonwealth.
"Physician assistant." As defined in section 2 of the act of
December 20, 1985 (P.L.457, No.112), known as the Medical
Practice Act of 1985, and section 2 of the act of October 5,
1978 (P.L.1109, No.261), known as the Osteopathic Medical
Practice Act.
"Practitioner." A physician who is registered with the
department under section 302.
"Prescription drug monitoring program." The Achieving Better
Care by Monitoring All Prescriptions Program (ABC-MAP).
"Principal." An officer, director or person who directly
owns a beneficial interest in or ownership of the securities of
an applicant or registrant, a person who has a controlling
interest in an applicant or registrant or who has the ability to
elect the majority of the board of directors of an applicant or
registrant or otherwise control an applicant or registrant,
other than a financial institution.
"Registry." The registry established by the department under
section 301(1).
"Secretary." The Secretary of Health of the Commonwealth.
"Serious medical condition." Any of the following:
(1) Cancer.
(2) Positive status for human immunodeficiency virus or
acquired immune deficiency syndrome.
(3) Amyotrophic lateral sclerosis.
(4) Parkinson's disease.
(5) Multiple sclerosis.
(6) Damage to the nervous tissue of the spinal cord with
objective neurological indication of intractable spasticity.
(7) Epilepsy.
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(8) Inflammatory bowel disease.
(9) Neuropathies.
(10) Huntington's disease.
(11) Crohn's disease.
(12) Post-traumatic stress disorder.
(13) Intractable seizures.
(14) Glaucoma.
(15) Severe chronic or intractable pain of neuropathic
origin or severe chronic or intractable pain in which
conventional therapeutic intervention and opiate therapy is
contraindicated or ineffective.
"Terminally ill." A medical prognosis of life expectancy of
approximately one year or less if the illness runs its normal
course.
CHAPTER 3
PROGRAM
Section 301. Program established.
A medical marijuana program for patients suffering from
serious medical conditions is established. The program shall be
administered by the department. The department shall have the
authority to do all things necessary to fulfill its
responsibilities in implementing this act. At minimum, the
department shall:
(1) Establish and maintain a computerized registry
containing information set forth in this act relating to
patients certified to use medical marijuana, caregivers,
practitioners and medical marijuana organizations, which
shall include identification numbers. The computerized
registry shall include a separate, electronic database to be
used by the department and dispensaries and which contains
the information set forth in section 703(a)(1), (2), (3), (4)
and (5) and such additional information that the department
may require by regulation. The registry and database shall be
capable of providing information in real time. Dispensaries
shall have real-time access to information:
(i) To ensure that medical marijuana is not diverted
or otherwise used for unlawful purposes.
(ii) To establish the authenticity of identification
cards.
(iii) To provide the form of medical marijuana
provided in the certification by the practitioner.
(2) Develop and implement procedures for:
(i) Issuance of identification cards to patients and
caregivers.
(ii) Review and approval of certifications submitted
by practitioners.
(iii) Review of the credentials of practitioners who
submit certifications.
(iv) Review and approval of applications for
identification cards.
(v) Review and approval of applications to become
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registered with the department as a medical marijuana
organization.
(vi) Review and approval of applications of
physicians to become registered with the department as
practitioners.
(3) Develop a four-hour course for physicians regarding
the latest scientific research on medical marijuana,
including the risks and benefits of medical marijuana, and
any other subjects deemed necessary by the department. The
State Board of Medicine and the State Board of Osteopathic
Medicine shall approve continuing education credit for any
physician who successfully completes the course. The State
Board of Pharmacy shall approve continuing education credit
for any pharmacist who successfully completes the course
pursuant to the requirement in section 707(9). The State
Board of Nursing shall approve continuing education credit
for a certified registered nurse practitioner who
successfully completes the course pursuant to the requirement
in section 707(9). The State Board of Medicine and the State
Board of Osteopathic Medicine shall approve continuing
education credit for a physician assistant who successfully
completes the course pursuant to the requirement in section
707(9).
(4) Develop a two-hour course for the principals and
employees of a medical marijuana organization who either come
into contact with patients or caregivers or who physically
handle medical marijuana. Employees must successfully
complete the course no later than 90 days after commencing
employment. Principals must successfully complete the course
prior to commencing initial operation of the medical
marijuana organization. The subject matter of the course
shall encompass the following:
(i) Recognizing unauthorized suspected activity
under this act and the regulations promulgated by the
department, including criminal diversion of medical
marijuana and falsification of identification cards.
(ii) Proper handling of medical marijuana and
recordkeeping.
(iii) Proper reporting of suspected unauthorized
activity, including activities under subparagraph (i), to
law enforcement.
(iv) Any other subject necessary to ensure
compliance with this act and regulations promulgated
under this act, as determined by the department.
(5) Develop a procedure for announced and unannounced
inspections by the department of the facilities for growing,
processing or dispensing or selling medical marijuana, and of
the books, papers and tracking and other systems utilized by
medical marijuana organizations required by this act.
(6) Establish a manner and method to administer research
studies to be operated by vertically integrated health
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systems in order to collect research data on the use of
medical marijuana to treat serious medical conditions in
accordance with Chapter 19.
(7) Establish and maintain public outreach efforts about
this act. The efforts shall include:
(i) A dedicated telephone number regarding medical
marijuana so that patients, caregivers and members of the
public may call to obtain basic information about the
dispensing of medical marijuana under this act.
(ii) A publicly accessible Internet website with
similar information.
(8) Collaborate as necessary, as determined by the
secretary, with other Commonwealth agencies or to contract
with third parties to assist the department in fulfilling its
responsibilities under this act.
(9) Determine the minimum number and type of medical
marijuana to be produced by a grower/processor and dispensed
by a dispensary.
Section 302. Practitioner registration.
(a) Eligibility.--A physician who satisfies the following is
eligible for inclusion in the registry:
(1) The physician applies for registration in the form
and manner required by the department.
(2) The department determines that the physician is, by
training or experience, qualified to treat a serious medical
condition. The physician shall provide documentation of
required credentials, training or experience as required by
the department.
(3) The physician has successfully completed the course
under section 301(3).
(b) Department action.--The department shall review an
application submitted by a physician to determine whether to
include the physician in the registry. The review shall include
information maintained by the Department of State regarding
whether the physician has a valid, unexpired, unrevoked,
unsuspended Pennsylvania license to practice medicine and
whether the physician has been subject to discipline. The review
shall be conducted each time the department reviews
certifications under section 501. If the physician is not the
holder of a valid, unexpired, unrevoked, unsuspended
Pennsylvania license to practice medicine, then the department
shall deny the certification and shall remove the physician from
the registry until such time as the physician holds a valid,
unexpired, unrevoked, unsuspended Pennsylvania license to
practice medicine. A physician who is listed in the registry is
authorized to issue a certification to use medical marijuana.
(c) Practitioner requirements.--A practitioner shall have an
ongoing responsibility, so long as the practitioner remains in
the registry, to immediately notify the department in writing if
the practitioner knows or has reason to know that any of the
following is true with respect to a patient for whom the
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practitioner has issued a certification under this act:
(1) The patient no longer has the serious medical
condition for which the certification was issued.
(2) Medical marijuana would no longer be therapeutic or
palliative.
(3) The patient has died.
Section 303. Practitioner restrictions.
(a) Practices prohibited.--The following apply with respect
to practitioners:
(1) A practitioner may not accept, solicit or offer any
form of remuneration from or to a prospective patient,
patient, prospective caregiver, caregiver or medical
marijuana organization, including an employee, financial
backer or principal, to certify a patient, other than
accepting a fee for service with respect to the examination
of the prospective patient to determine if the prospective
patient should be issued a certification to use medical
marijuana.
(2) A practitioner may not hold a direct or economic
interest in a medical marijuana organization.
(3) A practitioner may not advertise the practitioner's
services as a practitioner who can certify a patient to
receive medical marijuana.
(b) Unprofessional conduct.--A practitioner who violates
subsection (a)(1), (2) or (3) or section 501(f) shall not be
permitted to issue certifications to patients. The practitioner
shall be removed from the registry.
(c) Discipline.--In addition to any other penalty that may
be imposed under this act, a violation of subsection (a)(1), (2)
or (3) or section 501(f) shall be deemed unprofessional conduct
under section 41(8) of the act of December 20, 1985 (P.L.457,
No.112), known as the Medical Practice Act of 1985, or section
15(a)(8) of the act of October 5, 1978 (P.L.1109, No.261), known
as the Osteopathic Medical Practice Act, and shall subject the
practitioner to discipline by the State Board of Medicine or the
State Board of Osteopathic Medicine, as appropriate.
CHAPTER 5
PATIENT AND CAREGIVER CERTIFICATION
Section 501. Issuance of certification.
(a) Conditions for issuance.--A certification to use medical
marijuana may be issued by a practitioner to a patient if all of
the following requirements are met:
(1) The practitioner is authorized, as evidenced by the
practitioner's inclusion in the registry, to issue a
certification.
(2) The patient has a serious medical condition, which
is specified in the patient's health care record.
(3) The practitioner by training or experience is
qualified to treat the patient's serious medical condition.
(4) The patient is under the practitioner's continuing
care for the serious medical condition.
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(5) In the practitioner's professional opinion and
review of past treatments, the practitioner determines the
patient is likely to receive therapeutic or palliative
benefit from the use of medical marijuana.
(b) Contents.--In addition to the information set forth in
subsection (a), the certification shall include:
(1) The name, date of birth and address of the patient.
(2) The specific serious medical condition of the
patient.
(3) A statement by the practitioner that the patient has
a serious medical condition and the patient is under the
practitioner's continuing care for the serious medical
condition.
(4) The date of issuance.
(5) The name, address, telephone number and signature of
the practitioner.
(6) Any requirement or limitation concerning the
appropriate form of medical marijuana.
(7) Information needed for the research program database
under section 1902(b)(2) as determined by the department.
(c) Optional information.--The practitioner may state in the
certification that, in the practitioner's professional opinion:
(1) The patient would benefit from medical marijuana
only until a specified date.
(2) The patient is terminally ill.
(d) Consultation.--A practitioner shall consult the
prescription drug monitoring program prior to issuing or
modifying a certification for the purpose of reviewing the
controlled substance history of a patient.
(e) Duties of practitioner.--The practitioner shall:
(1) Provide the certification to the patient.
(2) Provide a copy of the certification to the
department, which shall place the information in the
registry. The department shall permit electronic submission
of the certification.
(3) File a copy of the certification in the patient's
health care record.
(f) Prohibition.--A practitioner may not issue a
certification for the practitioner's own use or for the use of a
family or household member.
Section 502. Certification form.
The department shall develop a standard certification form,
which shall be available upon request. In addition, the form
shall be available to practitioners electronically. The form
shall include a statement that a false statement made by a
practitioner is punishable under the applicable provisions of 18
Pa.C.S. Ch. 49 (relating to falsification and intimidation).
Section 503. Lawful use of medical marijuana.
(a) General rule.--Notwithstanding any provision of law to
the contrary, certified medical use of medical marijuana as set
forth in this act and regulations promulgated under this act is
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lawful within this Commonwealth.
(b) Limitations.--The lawful use of medical marijuana is
subject to the following limitations:
(1) Medical marijuana may only be administered to a
patient who is certified by a practitioner.
(2) Subject to regulations promulgated under section
1108(3), medical marijuana may only be dispensed to a patient
or caregiver in the following forms:
(i) pill;
(ii) oil;
(iii) topical forms, including gel, creams or
ointments;
(iv) a form medically appropriate for administration
by vaporization or nebulization.
(v) tincture; or
(vi) liquid.
(3) In accordance with section 1108, medical marijuana
may be dispensed to a patient or a caregiver in dry leaf or
plant form.
(4) Subject to section 1108, no individual dose of
medical marijuana may contain more than 10%
tetrahydrocannabinol.
(5) For each patient, possession of medical marijuana by
a patient and a caregiver may not exceed a 30-day supply of
individual doses, consistent with any regulations of the
department, except that, during the last seven days of any
30-day period, a patient may also possess a 30-day supply for
the subsequent 30-day period.
(6) An individual may not act as a caregiver for more
than five patients.
(7) A patient may designate up to two caregivers at any
one time.
(8) The form of medical marijuana that may be possessed
by a patient or caregiver under a certification shall be in
compliance with any requirement or limitation of the
practitioner.
(9) The medical marijuana shall be kept in the original
package in which it was dispensed, except for the portion
removed for immediate use by the patient.
(10) A patient or caregiver shall possess an
identification card whenever the patient or caregiver is in
immediate possession of medical marijuana.
(11) With respect to the packaging of medical marijuana
by growers/processors and dispensing of medical marijuana by
dispensaries, the medical marijuana shall only be identified
by the name of the grower/processor, the name of the
dispensary, the species and the percentage of
tetrahydrocannabinol and cannabidiol.
Section 504. Unlawful use of medical marijuana.
(a) General rule.--Notwithstanding section 503, the use of
medical marijuana as set forth in this section is unlawful and
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shall, in addition to any other penalty provided by law, be
deemed a violation of the act of April 14, 1972 (P.L.233,
No.64), known as The Controlled Substance, Drug, Device and
Cosmetic Act.
(b) Unlawful use described.--Regardless of the form of
medical marijuana stated in the patient's certification, it is
unlawful to:
(1) Smoke medical marijuana.
(2) Incorporate medical marijuana into edible form.
Nothing in this act shall be construed to preclude the
incorporation of medical marijuana into edible form by a
patient or a caregiver in order to aid ingestion of the
medical marijuana by the patient.
(3) Grow medical marijuana unless registered as a
grower/processor or health care medical marijuana
organization under Chapter 19 and acting in compliance with
this act.
Section 505. Identification cards.
(a) Issuance.--Upon review and approval of the certification
issued to a patient by a practitioner, satisfactory review of a
practitioner's medical credentials, satisfactory review of the
prescription drug monitoring program in the case of a caregiver
and satisfactory review of the Federal and Commonwealth criminal
history record information in the case of a caregiver, the
department shall issue an identification card to a patient or
caregiver. The identification card shall permit a patient or
caregiver to access medical marijuana in accordance with this
act.
(b) Expiration.--An identification card shall expire within
one year from the date of issuance, upon the death of the
patient, or as otherwise provided in this section. The
department shall specify the form of application for an
identification card. The department shall provide the form upon
request, and the form shall be available electronically via the
department's publicly accessible Internet website.
(c) Separate cards to be issued.--The department shall issue
separate identification cards for patients and caregivers as
soon as reasonably practicable after receiving a completed
application, unless it determines that the application is
incomplete or factually inaccurate, in which case it shall
promptly notify the applicant.
(d) Change in name or address.--A patient or caregiver who
has been issued an identification card shall notify the
department within 10 days of any change of name or address. In
addition, with respect to the patient, the patient shall notify
the department within 10 days if the patient no longer has the
serious medical condition noted on the certification.
(e) Lost or defaced card.--In the event of a lost, stolen,
destroyed or illegible identification card, the patient or
caregiver shall apply to the department within 10 business days
of discovery of the loss or defacement of the card for a
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replacement card. The application for a replacement card shall
be on a form furnished by the department and accompanied by a
$25 fee. The department may establish higher fees for issuance
of second and subsequent replacement identification cards. The
department may waive or reduce the fee in cases of demonstrated
financial hardship. The department shall issue a replacement
identification card as soon as practicable. The card may contain
a different identification number. A patient or caregiver may
not obtain medical marijuana until the patient receives the
replacement card.
(f) Information to be kept confidential.--The department
shall maintain a confidential list of patients and caregivers to
whom it has issued identification cards. Individual identifying
information obtained by the department, including information
provided by the Pennsylvania State Police pursuant to section
506(b), under this act shall be confidential and exempt from
disclosure, including disclosure under the act of February 14,
2008 (P.L.6, No.3), known as the Right-to-Know Law.
Section 506. Process for obtaining or renewing an
identification card.
(a) Requirements.--The following apply:
(1) To obtain, amend or renew an identification card, a
patient or caregiver shall file an application with the
department.
(2) In the case of a patient, the application shall
include the following:
(i) The patient's certification. A new certification
must be provided with a renewal application.
(ii) The name, address and date of birth of the
patient.
(iii) The date of the certification.
(iv) If the patient has an identification card based
on a current valid certification, the identification
number and expiration date of that identification card.
(v) The specified date until which the patient would
benefit from medical marijuana, if the certification
states such a date.
(vi) The name, address and telephone number of the
certifying practitioner.
(vii) Other information required by the department.
(3) If the patient designates a caregiver, the
application shall include the name, address and date of birth
of the caregiver, and other individual identifying
information required by the department.
(4) In the case of a caregiver, the application shall
include the following:
(i) Federal and Commonwealth criminal history record
information as set forth in subsection (b).
(ii) The name, address and date of birth of the
caregiver.
(iii) If the caregiver has an identification card,
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the identification number and expiration date of the
identification card.
(iv) Other information required by the department.
(5) The application shall be signed and dated by the
patient or caregiver, as appropriate.
(6) The application shall be accompanied by a fee of
$50. The department may waive or reduce the fee in cases of
demonstrated financial hardship.
(7) The department may prescribe any other requirements
for the application.
(b) Requirement.--The following apply:
(1) In each case before approving the application to be
a caregiver, the department shall review the applicant's
Federal and Commonwealth criminal history record information
and the prescription drug monitoring program with respect to
the caregiver to determine if the caregiver has a history of
drug abuse or a history of diversion of controlled substances
or illegal drugs. The department may, within its discretion,
deny an application to become a caregiver if the applicant
has a history of drug abuse or a history of diverting
controlled substances or illegal drugs. The department shall
deny the application to be a caregiver if the applicant has
been convicted of any criminal offense related to sale or
possession of drugs, narcotics or other controlled
substances.
(2) Notwithstanding any provision of law to the contrary
and in order to fulfill the requirements of this subsection,
the Pennsylvania State Police shall, at the request of the
department, provide criminal history background
investigations, which shall include records of criminal
arrests and convictions, no matter where occurring, including
Federal criminal history record information, on applicants
for the position of caregiver. For purposes of approving
applicants to become caregivers, the department shall request
the information set forth in this paragraph for each
applicant who seeks to become a caregiver. The department may
receive and retain information otherwise protected by 18
Pa.C.S. Ch. 91 (relating to criminal history record
information).
(c) Notice.--An application for an identification card shall
include notice that a false statement made in the application is
punishable under the applicable provisions of 18 Pa.C.S. Ch. 49
(relating to falsification and intimidation).
Section 507. Special conditions.
The following apply:
(1) If the practitioner states in the certification
that, in the practitioner's professional opinion, the patient
would benefit from medical marijuana only until a specified
earlier date, then the identification card shall expire on
that date.
(2) If the practitioner reissues a certification which
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terminates a certification on an earlier date, then a
replacement identification card shall be issued with the
earlier expiration date. The original identification card
shall be promptly returned by the patient to the department.
(3) If the certification so provides, the identification
card shall state any requirement or limitation by the
practitioner as to the form of medical marijuana for the
patient.
Section 508. Minors.
If a patient is under 18 years of age, the following apply:
(1) The patient shall have a caregiver.
(2) A caregiver must be one of the following:
(i) A parent or legal guardian of the patient.
(ii) An individual designated by a parent or legal
guardian.
(iii) An appropriate individual approved by the
department upon a sufficient showing that no parent or
legal guardian is appropriate or available.
Section 509. Caregiver authorization and limitations.
(a) Age.--An individual who is under 21 years of age may not
be a caregiver unless a sufficient showing, as determined by the
department, is made to the department that the individual should
be permitted to serve as a caregiver.
(b) Changing caregiver.--If a patient wishes to change or
terminate the designation of the patient's caregiver, for
whatever reason, the patient shall notify the department as soon
as practicable. The department shall issue a notification to the
caregiver that the caregiver's identification card is invalid
and must be promptly returned to the department.
(c) Denial in part.--If an application of a patient
designates an individual as a caregiver who is not authorized to
be a caregiver, that portion of the application shall be denied
by the department. The department shall review the balance of
the application and may approve that portion of it.
Section 510. Contents of identification card.
An identification card shall contain the following:
(1) The name of the patient and the caregiver, as
appropriate. The identification card shall also state whether
the individual is designated as a patient or as a caregiver.
(2) The date of issuance and expiration date.
(3) An identification number for the patient and
caregiver, as appropriate.
(4) A photograph of the individual to whom the
identification card is being issued, whether the individual
is a patient or a caregiver. The method of obtaining the
photograph shall be specified by the department by
regulation. The department shall provide reasonable
accommodation for a patient who is confined to the patient's
home or is in inpatient care due to a serious medical
condition.
(5) Any requirement or limitation set by the
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practitioner as to the form of medical marijuana.
(6) Any other requirements determined by the department,
except the department may not require that an identification
card disclose the patient's serious medical condition.
Section 511. Suspension.
If a patient or caregiver intentionally, knowingly or
recklessly violates any provision of this act as determined by
the department, the identification card of the patient or
caregiver may be suspended or revoked. The suspension or
revocation shall be in addition to any criminal or other penalty
that may apply.
Section 512. Use of prescription drug monitoring program.
(a) Requirement.--A practitioner shall consult the
prescription drug monitoring program each time prior to
authorizing the use of medical marijuana for a patient and each
time prior to changing the form of medical marijuana for a
patient.
(b) Other access by practitioner.--A practitioner may access
the prescription drug monitoring program to:
(1) Determine whether a patient may be under treatment
with a controlled substance by another physician or other
person.
(2) Allow the practitioner to review the patient's
controlled substance history as deemed necessary by the
practitioner.
(3) Provide to the patient, or caregiver on behalf of
the patient if authorized by the patient, a copy of the
patient's controlled substance history.
CHAPTER 7
MEDICAL MARIJUANA ORGANIZATIONS
Section 701. Medical marijuana organizations.
The growing, acquiring, possessing, manufacturing, selling,
delivering, transporting, distributing or dispensing of medical
marijuana by a medical marijuana organization under this act and
in accordance with regulations promulgated by the department
under this act shall be lawful.
Section 702. Laboratory.
A grower/processor shall contract with an independent
laboratory to test the medical marijuana produced by the
grower/processor. The department shall approve the laboratory
and require that the laboratory report testing results in a
manner as the department shall determine, including requiring a
test at harvest and a test at final processing.
Section 703. Dispensing to patients and caregivers.
(a) General rule.--A dispensary may dispense medical
marijuana to a patient or caregiver upon presentation to the
dispensary of a valid identification card for that patient or
caregiver. The dispensary shall provide to the patient or
caregiver a receipt, as appropriate. The receipt shall include
all of the following:
(1) The name, address and identification number of the
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dispensary.
(2) The name and identification number of the patient
and caregiver.
(3) The date the medical marijuana was dispensed.
(4) Any requirement or limitation by the practitioner as
to the form of medical marijuana for the patient.
(5) The form and the quantity of medical marijuana
dispensed.
(b) Record retention.--The dispensary shall retain the
following for six years:
(1) A copy of the patient's or caregiver's
identification card, as appropriate.
(2) The receipt, which may be retained in electronic
form.
(c) Filing with department.--Prior to dispensing medical
marijuana to a patient or caregiver, the dispensary shall file
the receipt information with the department by electronic means
on a real-time basis as the department shall require. The
department shall immediately enter the information into the
separate, electronic database established under section 301(1)
for use by the department and dispensaries to inhibit diversion
and other unlawful use of medical marijuana. When filing receipt
and certification information electronically under this
subsection, the dispensary shall dispose of any electronically
recorded prescription certification information as provided by
regulation.
(d) Limitations.--No dispensary may dispense to a patient or
caregiver:
(1) a quantity of medical marijuana greater than that
which the patient or caregiver is permitted to possess under
the certification; or
(2) a form of medical marijuana prohibited by this act.
(e) Supply.--When dispensing medical marijuana to a patient
or caregiver, the dispensary may not dispense an amount greater
than a 30-day supply until the patient has exhausted all but a
seven-day supply provided pursuant to a previously issued
certification.
(f) Verification.--Prior to dispensing medical marijuana to
a patient or caregiver, the dispensary shall verify the
information in subsections (e) and (g) by consulting the
database established under section 301(1).
(g) Form of medical marijuana.--Medical marijuana dispensed
to a patient or caregiver by a dispensary shall conform to any
requirement or limitation set by the practitioner as to the form
of medical marijuana for the patient.
(h) Safety insert.--When a dispensary dispenses medical
marijuana to a patient or caregiver, the organization shall
provide to that patient or caregiver, as appropriate, a safety
insert. The insert shall be developed and approved by the
department. The insert shall provide the following information:
(1) Lawful methods for administering medical marijuana
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in individual doses.
(2) Any potential dangers stemming from the use of
medical marijuana.
(3) How to recognize what may be problematic usage of
medical marijuana and how to obtain appropriate services or
treatment for problematic usage.
(4) How to prevent or deter the misuse of medical
marijuana by minors or others.
(5) Any other information as determined by the
department.
(i) Sealed and labeled package.--Medical marijuana shall be
dispensed by a dispensary to a patient or caregiver in a sealed
and properly labeled package. The labeling shall contain the
following:
(1) The information required to be included in the
receipt provided to the patient or caregiver, as appropriate,
by the dispensary.
(2) The packaging date.
(3) Any applicable date by which the medical marijuana
should be used.
(4) A warning stating:
"This product is for medicinal use only. Women should not
consume during pregnancy or while breastfeeding except on the
advice of the practitioner who issued the certification and
in the case of breastfeeding, the infant's pediatrician. This
product might impair the ability to drive or operate heavy
machinery. Keep out of reach of children."
(5) The amount of individual doses contained within the
package and the species and percentage of
tetrahydrocannabinol and cannabidiol.
(6) A warning that the medical marijuana must be kept in
the original container in which it was dispensed.
(7) A warning that unauthorized use is unlawful and will
subject the person to criminal penalties.
(8) Any other information required by the department.
(j) Convictions prohibited.--The following individuals may
not hold volunteer positions or positions with remuneration in
or be affiliated with a medical marijuana organization in any
way if the individual has been convicted of any criminal offense
related to the sale or possession of illegal drugs, narcotics or
controlled substances:
(1) Financial backers.
(2) Principals.
(3) Employees.
Section 704. Pricing.
The following apply:
(1) Each sale of medical marijuana by a dispensary shall
not exceed the maximum price determined by the department
through regulation. A charge made or demanded for medical
marijuana by a dispensary which exceeds the maximum price
determined by the department is deemed to be a violation of
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the act of December 17, 1968 (P.L.1224, No.387), known as the
Unfair Trade Practices and Consumer Protection Law.
(2) The department shall set the maximum per-dose price
of each form of medical marijuana dispensed by a dispensary.
In setting the maximum per-dose price, the department shall
consider the fixed and variable costs of producing the form
of medical marijuana and any other factor the department
deems relevant to determine the maximum per-dose price.
(3) The department may set the maximum per-dose price of
each form of medical marijuana sold by a grower/processor to
a dispensary.
(4) A grower/processor shall make medical marijuana
available for sale to all dispensaries at the same per-dose
price.
(5) If a grower/processor changes the per-dose price on
any sale of any form of medical marijuana to a dispensary,
the grower/processor shall change the per-dose price for that
form of medical marijuana for all other dispensaries by the
same amount.
Section 705. Facility requirements.
(a) General rule.--The following apply:
(1) A grower/processor may only grow or process medical
marijuana in an indoor, enclosed, secure facility located
within this Commonwealth, as determined by the department.
The facility may include a greenhouse.
(2) A dispensary may only dispense medical marijuana in
an indoor, enclosed, secure facility located within this
Commonwealth, as determined by the department.
(3) A dispensary may not operate on the same site as a
facility used for growing and processing medical marijuana.
(b) Determination.--A grower/processor shall provide
documentation of the quality and safety of the medical marijuana
produced by the grower/processor to the department and to any
patient or caregiver to which the medical marijuana is
dispensed. The documentation shall include the test results
under section 702.
Section 706. Registration.
(a) Registration required.--Upon application, the department
may register the person as:
(1) Both a grower/processor and a dispensary or solely
as a grower/processor.
(2) Both a dispensary and a grower/processor or solely
as a dispensary.
(b) Separate registration.--Separate registration is
required for a grower/processor and for a dispensary, including
when:
(1) A dispensary is registered as a grower/processor.
(2) A grower/processor is registered as a dispensary.
(c) Records.--A grower/processor which is also registered as
a dispensary shall keep separate books and records.
(d) Department to establish regions.--The department shall
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establish no fewer than three regions within this Commonwealth
for the purpose of registering growers/processors and
dispensaries and providing for their locations. The department
shall implement this subsection in a manner which will supply an
adequate amount of medical marijuana to patients and caregivers
in each region. In determining the geographic boundaries of the
regions, the department shall consider the following:
(1) Population.
(2) The number of patients suffering from serious
medical conditions.
(3) The types of serious medical conditions.
(4) Access to public transportation.
(5) Any other factor the department deems relevant.
(e) Notice.--When the boundaries are established, the
department shall publish notice of the determination in the
Pennsylvania Bulletin. The department may adjust the boundaries
as necessary every two years. Notice of any adjustment to the
boundaries shall be published in the Pennsylvania Bulletin.
Section 707. Limitations on registrations.
The following limitations apply to registration of
grower/processors and dispensaries:
(1) The department may not initially register more than
25 growers/processors.
(2) The department may not initially register more than
50 dispensaries. Each dispensary may provide medical
marijuana at no more than three separate locations.
(3) The department may not permit a single person to
hold more than five individual dispensary registrations.
(4) The department may not permit a single person to
hold more than one grower/processor registration.
(5) No more than five grower/processors may be
registered as dispensaries. If the number of
growers/processors is increased pursuant to section 1108(4),
no more than 20% of the total number of growers/processors
may also be registered as dispensaries.
(6) A dispensary may only obtain medical marijuana from
a grower/processor holding a valid registration under this
act.
(7) A grower/processor may only provide medical
marijuana to a dispensary holding a valid registration under
this act.
(8) No medical marijuana may be dispensed from, obtained
from or transferred to a location outside of this
Commonwealth.
(8.1) In accordance with regulations promulgated by the
department:
(i) To initially grow medical marijuana, a
grower/processor may obtain seed and plant material from
outside this Commonwealth.
(ii) To grow medical marijuana, a grower/processor
may obtain seed and plant material from another
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grower/processor within this Commonwealth.
(9) A dispensary shall have a physician or a pharmacist
onsite at all times during the hours the dispensary is open
to receive patients and caregivers, except that if a
dispensary has more than one separate location, a physician
assistant or a certified registered nurse practitioner may be
onsite at the other location. A physician, a pharmacist, a
physician assistant or a certified registered nurse
practitioner shall, prior to assuming duties under this
paragraph, successfully complete the course established in
section 301(3). A physician may not certify patients to
receive medical marijuana or otherwise treat patients at the
dispensary.
(10) A dispensary may sell medical devices and
instruments which are needed to administer medical marijuana
under this act.
(11) A dispensary may sell services approved by the
department related to the use of medical marijuana.
Section 708. Application and issuance of registration.
(a) Application for initial registration.--The department is
authorized to register eligible applicants to grow and process
or dispense medical marijuana. The department shall develop a
standard application form, which shall be available upon
request. The department shall provide the application in
electronic form, which shall be available on the department's
publicly accessible Internet website.
(b) Contents of application.--An applicant shall provide the
following information:
(1) A description of the business activities in which
the applicant intends to engage as a medical marijuana
organization.
(2) A statement that the applicant:
(i) Is of good moral character. The applicant shall
submit Federal and Commonwealth criminal history record
information in order to support the assertion of good
moral character. For purposes of this subparagraph an
applicant shall include each financial backer and
principal of the medical marijuana organization.
(ii) Possesses or has the right to use sufficient
land, buildings and other premises and equipment to
properly carry on the activity described in the
application. The information shall be specified in the
application in sufficient detail to allow the department
to verify the information.
(iii) Is able to maintain effective security and
control to prevent diversion, abuse and other illegal
conduct relating to medical marijuana. The statement
shall include a provision which states that in the event
of any loss or theft of medical marijuana the medical
marijuana organization shall notify the Pennsylvania
State Police within 24 hours.
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(iv) Is able to comply with all applicable
Commonwealth laws and regulations relating to the
activities in which it intends to engage under the
registration.
(3) The name, address and title of each financial backer
and principal of the applicant. Residential addresses shall
be included for individuals. Each individual or
representative of an entity shall submit an affidavit with
the application setting forth:
(i) Any position of management or ownership during
the preceding 10 years of a controlling interest in any
other business, located inside or outside this
Commonwealth, manufacturing or distributing controlled
substances.
(ii) Whether the individual or entity has been
convicted of a criminal offense graded higher than a
summary offense.
(iii) Whether the individual or entity has had a
registration or license suspended or revoked in any
administrative or judicial proceeding.
(iv) Any other information the department may
require.
(c) Notice.--The application shall include notice that a
false statement made in the application is punishable under the
applicable provisions of 18 Pa.C.S. Ch. 49 (relating to
falsification and intimidation).
(d) Duty to report.--The applicant is under a continuing
duty to:
(1) Report to the department any change in facts or
circumstances reflected in the application or any newly
discovered or occurring fact or circumstance which is
required to be included in the application, including a
change in control of the medical marijuana organization.
(2) Report to the Pennsylvania State Police, within 24
hours, any loss or theft of medical marijuana from the
facility the applicant is operating.
(3) Submit to inspections, whether announced or
unannounced, by the department of the facilities for growing,
processing, dispensing or selling medical marijuana, or of
the books, papers and tracking or other systems required by
this act.
(e) Granting of registration.--The department shall grant a
registration or amendment to a registration under this section
if the department is satisfied that:
(1) The applicant will be able to maintain effective
control against diversion of medical marijuana.
(2) The applicant will be able to comply with all
applicable laws and regulations of this Commonwealth relating
to the activities in which it intends to engage under the
registration.
(3) The applicant is ready, willing and able to properly
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carry on the activity for which a registration is sought.
(4) The applicant possesses or has the right to use
sufficient land, buildings and equipment to properly carry on
the activity described in the application.
(5) It is in the public interest that the registration
be granted. In determining whether the granting of
registration is in the public interest, the department shall
consider whether the number of medical marijuana
organizations in an area will be adequate or excessive.
(6) The applicant and its principals and financial
backers are of good moral character.
(7) The applicant satisfies any other conditions as
determined by the department.
(f) Additional information.--If the department is not
satisfied that the applicant should be issued a registration,
the department shall notify the applicant in writing of the
factors for which further documentation is required. Within 30
days of the receipt of the notification, the applicant may
submit additional material to the department for consideration.
(g) Fees.--The following apply:
(1) For a grower/processor:
(i) An initial application fee in the amount of
$10,000 shall be paid. The fee is nonrefundable.
(ii) A fee for registration as a grower/processor in
the amount of $200,000 shall be paid. The period of
registration is one year. Applicants shall submit the
registration fee at the time of submission of the
application. The fee shall be returned if the
registration is not granted.
(iii) A renewal fee for registration as a
grower/processor in the amount of $10,000 shall be paid.
The renewal fee shall be returned if the renewal is not
granted.
(iv) Before the granting of the initial
registration, the department shall verify that the
applicant has $2,000,000 in capital, $500,000 of which
must be on deposit with a financial institution.
(v) An application to renew registration shall be
filed with the department not more than six months nor
less than four months prior to expiration.
(vi) All fees shall be paid by certified check or
money order.
(2) For a dispensary:
(i) An initial application fee in the amount of
$5,000 shall be paid. The fee is nonrefundable.
(ii) A fee for registration as a dispensary in the
amount of $30,000 shall be paid. The period of
registration is one year. An applicant shall submit the
registration fee at the time of submission of the
application. The fee shall be returned if the application
is not granted.
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(iii) A renewal fee for registration as a dispensary
in the amount of $5,000 shall be paid. The fee shall be
returned if the renewal is not granted.
(iv) There shall be no additional fee for operating
more than one location.
(v) Before the granting of the initial registration,
the department shall verify that the applicant has
$150,000 in capital, which must be on deposit with a
financial institution.
(vi) An application to renew registration shall be
filed with the department not more than six months nor
less than four months prior to expiration.
(vii) All fees shall be paid by certified check or
money order.
(3) A fee of $250 shall be required when amending the
application to indicate relocation within this Commonwealth
or the addition or deletion of approved activities by the
medical marijuana organization.
(4) Fees payable under this section shall be deposited
into the fund.
(h) Issuance.--A registration issued by the department to a
medical marijuana organization shall be effective only for that
organization and shall specify the following:
(1) The name and address of the medical marijuana
organization.
(2) The land, buildings and facilities that may be used
by the medical marijuana organization.
(3) Any other information the department requires to
assure compliance with this act.
(i) Relocation.--The department may approve an application
from a medical marijuana organization to relocate within this
Commonwealth or to add or delete activities or facilities. The
medical marijuana organization may not relocate or add or delete
activities or facilities unless approved by the department.
(j) Length of registration.--A registration issued by the
department shall be valid for one year from the date of
issuance, except that in order to facilitate registration
renewals, the department may, upon an initial application for
registration, issue registrations that are valid for not more
than one year and eleven months.
(k) Posting.--A dispensary shall post a copy of its
registration in a location within its facility such that it is
easily observable by patients, caregivers, law enforcement
officers and agents of the department.
Section 709. Registration renewals.
(a) The following apply to a renewal of registration:
(1) An applicant is under a continuing duty to report to
the department any change in facts or circumstances reflected
in the application or any newly discovered or occurring fact
or circumstance which is required to be included in the
application.
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(2) The application shall include the following
information, prepared in the manner and detail as the
department may require:
(i) Any material change in the information provided
by the medical marijuana organization in an application
or renewal of registration.
(ii) Every known charge or initiated investigation,
pending or concluded during the period of the
registration, by any governmental or administrative
agency with respect to:
(A) each incident or alleged incident involving
the theft, loss or possible diversion of medical
marijuana grown, processed or dispensed by the
applicant; and
(B) compliance by the applicant with the laws of
this Commonwealth with respect to any substance
listed in section 4 of the act of April 14, 1972
(P.L.233, No.64), known as The Controlled Substance,
Drug, Device and Cosmetic Act.
(b) Granting of renewal.--The department shall renew a
registration unless the department determines that:
(1) The applicant is unlikely to maintain or be able to
maintain effective control against diversion of medical
marijuana.
(2) The applicant is unlikely to comply with all laws of
this Commonwealth applicable to the activities in which it
may engage under the registration.
(c) Nonrenewal decision.--If the department is not satisfied
that the applicant is entitled to a renewal of the registration,
the department shall within a reasonable time serve upon the
applicant or the applicant's attorney of record by registered or
certified mail an order directing the applicant to show cause
why the application for renewal should not be denied. The order
shall specify in detail the way in which the applicant has not
satisfied the department's requirement for renewal. Within 30
days of the order, the applicant may submit additional material
to the department or demand a hearing, or both. If a hearing is
demanded, the department shall fix a date as soon as
practicable.
Section 710. Suspension or revocation of registration.
The department may suspend or revoke registration as a
medical marijuana organization if:
(1) The department has evidence that a medical marijuana
organization has failed to maintain effective control against
diversion of medical marijuana.
(2) The medical marijuana organization violates any
provision of this act or a regulation of the department.
(3) The medical marijuana organization has
intentionally, knowingly, recklessly or negligently failed to
comply with applicable laws of this Commonwealth relating to
the activities in which it engages under the registration.
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Section 711. Privilege not property right.
Registration of a medical marijuana organization gives a
medical marijuana organization a privilege to engage in the
specified activity, but registration does not give a property
right.
CHAPTER 9
TAX ON MEDICAL MARIJUANA
Section 901. Tax on medical marijuana.
(a) Tax imposed.--A tax is imposed on the gross receipts of
a grower/processor received from the sale of medical marijuana
by a grower/processor to a dispensary, to be paid by the
grower/processor, at the rate of 5%. The tax shall be charged
against and be paid by the grower/processor and shall not be
added as a separate charge or line item on any sales slip,
invoice, receipt or other statement or memorandum of the price
paid by a dispensary, patient or caregiver.
(b) Payment of tax and reports.--The tax imposed under
subsection (a) shall be administered in the same manner as the
tax imposed under Article XI of the act of March 4, 1971 (P.L.6,
No.2), known as the Tax Reform Code of 1971, except that
estimated tax payments under section 3003.2 of the Tax Reform
Code of 1971 shall not be required. A grower/processor shall
make quarterly payments under this section for each calendar
quarter at the rate prescribed in subsection (a) on the gross
receipts for the calendar quarter. The tax shall be due and
payable on the 20th day of January, April, July and October for
the preceding calendar quarter on a form prescribed by the
Department of Revenue.
(c) (Reserved).
(d) Deposit of proceeds.--All money received from the tax
imposed under subsection (a) shall be deposited in the fund.
(e) Exemption.--Medical marijuana shall not be subject to
the tax imposed under section 202 of the Tax Reform Code of
1971.
(f) Information.--A grower/processor that sells medical
marijuana shall provide to the Department of Revenue information
required by the department.
Section 902. Medical Marijuana Program Fund.
(a) Fund established.--The Medical Marijuana Program Fund is
established as a special fund in the State Treasury. Money in
the fund is appropriated as set forth in subsection (c). Any
amount unspent at the end of a fiscal year shall be appropriated
to the department for its operations.
(b) Source of funds.--Fees and taxes payable under this act
shall be deposited into the fund. The money deposited into the
fund may only be used for the purposes set forth in this
section. Any interest accrued shall be deposited into the fund.
(c) Use of proceeds.--After any repayment made under
subsection (d), money in the fund is appropriated in accordance
with the following percentages:
(1) To the department, for operations of the department,
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including outreach efforts under section 301(7), as required
by this act, 45% of the revenue in the fund. However, no more
than 15% of the amount under this paragraph may be expended
for:
(i) the cost of providing medical marijuana to
patients participating in the research program under
Chapter 19;
(ii) the cost of providing medical marijuana to
patients who demonstrate financial hardship under this
act; and
(iii) the cost associated with the waiver of fees
for identification cards under sections 505 (e) and
506(a)(6).
(2) To the Department of Drug and Alcohol Programs, for
drug abuse prevention and counseling and treatment services,
10% of the revenue in the fund.
(3) To the department, for further research related to
the safety and use of medical marijuana, including the
research program established under Chapter 19, 30% of the
revenue in the fund. Funding shall be provided for research
into the treatment of those serious medical conditions for
which medical marijuana is available for treatment within
this Commonwealth and for research into the use of medical
marijuana to treat other medical conditions for which medical
marijuana may have legitimate medicinal value.
(4) To the Pennsylvania Commission on Crime and
Delinquency, for distribution to local police departments
which demonstrate a need relating to the enforcement of this
act, as determined by the Pennsylvania Commission on Crime
and Delinquency, 10% of the revenue in the fund.
(5) To the Pennsylvania State Police to fulfill its
duties under this act, 5% of the revenue in the fund.
(d) Repayment of initial appropriation.--The department
shall repay from the fees, taxes and investment earnings of the
fund to the General Fund any money appropriated for the initial
planning, organization and administration by the department with
respect to the establishment of the program at the time of the
original enactment of this act. Repayment shall take place
within a 10-year period commencing one year after the date of
publication in the Pennsylvania Bulletin of the final
regulations described under section 1107.
CHAPTER 11
ADMINISTRATION
Section 1101. Governing practice and procedure.
The department's consideration and resolution of all
applications for registration under Chapter 7, the resolution of
applications for identification cards, the finding of violations
by the department and the imposition of civil penalties and
sanctions shall be conducted in accordance with 2 Pa.C.S.
(relating to administrative law and procedure).
Section 1102. Reports by medical marijuana organizations.
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(a) Report required.--A medical marijuana organization shall
periodically file reports related to its activities. The
department shall determine the information required in and the
frequency of filing the reports.
(b) Tracking systems.--Each medical marijuana organization
shall adopt and maintain security, tracking, recordkeeping,
record retention and surveillance systems relating to every
stage of acquiring, possessing, growing, manufacturing, selling,
delivering, transporting, distributing or dispensing medical
marijuana. The department shall specify the type and manner of
security, tracking, recordkeeping, record retention and
surveillance system required through regulation.
(c) Additional tracking and recall systems.--In addition to
other systems required by subsection (b), the department shall
require that a grower/processor or dispenser implement the
following:
(1) For a grower/processor and a dispensary, real time
inventory tracking.
(2) For a grower/processor, a seed-to-sale tracking
system that tracks medical marijuana from seed or immature
plant stage until the medical marijuana is sold to a
dispensary.
(3) For a dispensary, a system that tracks medical
marijuana from purchase from the grower/processor until the
medical marijuana is dispensed to a patient or caregiver.
(4) For a grower/processor and a dispensary, a daily log
of each day's beginning inventory, acquisitions, sales,
disbursements, disposals and ending inventory.
(5) For a grower/processor and a dispensary, a system
for recall of defective medical marijuana.
(6) For a grower/processor, a system to track the plant
waste resulting from the growth or processing of medical
marijuana.
Section 1103. Law enforcement notification.
Notwithstanding any law to the contrary, the department may
notify any appropriate law enforcement agency of information
relating to any violation or suspected violation of this act.
In addition, the department shall verify to law enforcement
personnel in an appropriate case whether a certification,
registration or an identification card is valid.
Section 1104. Evaluation.
The department may provide for an analysis and evaluation of
the implementation and effectiveness of this act, including
whether the intent and stated policy of the General Assembly
have been achieved. The department may enter into agreements
with one or more persons for the performance of an evaluation of
the implementation and effectiveness of this act.
Section 1105. Report.
(a) Report required.--The department shall submit a written
report under subsection (b) every two years, beginning two years
after the effective date of this section, to the following:
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(1) The Governor.
(2) The President pro tempore of the Senate.
(3) The Majority Leader and the Minority Leader of the
Senate.
(4) The Speaker of the House of Representatives.
(5) The Majority Leader and the Minority Leader of the
House of Representatives.
(6) The chairman and minority chairman of the Judiciary
Committee of the Senate.
(7) The chairman and minority chairman of the Public
Health and Welfare Committee of the Senate.
(8) The chairman and minority chairman of the Judiciary
Committee of the House of Representatives.
(9) The chairman and minority chairman of the Health
Committee of the House of Representatives.
(10) The Attorney General of the Commonwealth.
(b) Contents of report.--The following information shall be
included in the report:
(1) An assessment of the use of medical marijuana as a
result of the enactment of this act.
(2) An assessment of the benefits and risks to patients
using medical marijuana under this act, including adverse
events.
(3) Recommendations for amendments to this act for
reasons of patient safety or to aid the general welfare of
the citizens of this Commonwealth.
Section 1106. Advisory board.
(a) Establishment.--The Medical Marijuana Advisory Board is
established within the department. The advisory board shall
consist of the following members:
(1) The secretary or a designee.
(2) The Commissioner of the Pennsylvania State Police or
a designee.
(3) The chairman of the State Board of Pharmacy or a
designee.
(4) The Commissioner of Professional and Occupational
Affairs or a designee.
(5) The Physician General or a designee.
(6) The president of the Pennsylvania Chiefs of Police
Association or a designee.
(7) The president of the Pennsylvania District Attorneys
Association or a designee.
(8) One member to be appointed by each of the following,
which members shall be knowledgeable and experienced in
issues relating to care and treatment of individuals with a
serious medical condition, geriatric or pediatric medicine or
clinical research:
(i) The Governor.
(ii) The President pro tempore of the Senate.
(iii) The Majority Leader of the Senate.
(iv) The Minority Leader of the Senate.
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(v) The Speaker of the House of Representatives.
(vi) The Majority Leader of the House of
Representatives.
(vii) The Minority Leader of the House of
Representatives.
(9) One member appointed by the Governor, who shall be a
patient, a family or household member of a patient or a
patient advocate.
(b) Terms.--Except as provided under subsection (g), the
members appointed under subsection (a)(8) and (9) shall serve a
term of four years or until a successor has been appointed and
qualified, but no longer than six months beyond the four-year
period.
(c) Chair.--The secretary, or a designee, shall serve as
chair of the advisory board.
(d) Voting; quorum.--The members under subsections (1), (2),
(3), (4), (5), (6) and (7) shall serve ex officio and shall have
voting rights. A majority of the members shall constitute a
quorum for the purpose of organizing the advisory board,
conducting its business and fulfilling its duties. A vote of the
majority of the members present shall be sufficient for all
actions of the advisory board unless the bylaws require a
greater number.
(e) Attendance.--A member of the advisory board appointed
under subsection (a)(8) or (9) who fails to attend three
consecutive meetings shall forfeit his seat unless the
secretary, upon written request from the member, finds that the
member should be excused from a meeting for good cause. A member
who cannot be physically present may attend meetings via
electronic means, including video conference.
(f) Governance.--The advisory board shall have the power to
prescribe, amend and repeal bylaws, rules and regulations
governing the manner in which the business of the advisory board
is conducted and the manner in which the duties granted to it
are fulfilled. The advisory board may delegate supervision of
the administration of advisory board activities to an
administrative secretary and other employees of the department
as the secretary shall appoint.
(g) Initial terms.--The initial terms of members appointed
under subsection (a)(8) and (9) shall be for terms of one, two,
three or four years, the particular term of each member to be
designated by the secretary at the time of appointment. All
other members shall serve for a term of four years.
(h) Vacancy.--In the event that any member appointed under
subsection (a)(8) or (9) shall die or resign or otherwise become
disqualified during the member's term of office, a successor
shall be appointed in the same way and with the same
qualifications as set forth in this section and shall hold
office for the unexpired term. An appointed member of the
advisory board shall be eligible for reappointment.
(i) Expenses.--A member appointed under subsection (a)(8) or
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(9) shall receive the amount of reasonable travel, hotel and
other necessary expenses incurred in the performance of the
duties of the member in accordance with Commonwealth
regulations, but shall receive no other compensation for the
member's service on the board.
(j) Duties.--The advisory board shall have the following
duties:
(1) To examine and analyze the statutory and regulatory
law relating to medical marijuana within this Commonwealth.
(2) To examine and analyze the law and events in other
states and the nation with respect to medical marijuana.
(3) To accept and review written comments from
individuals and organizations about medical marijuana.
(4) To issue three years after the effective date of
this section a written report to the Governor, the Senate and
the House of Representatives.
(5) The written report under paragraph (4) shall include
recommendations and findings as to the following:
(i) Whether to change the types of medical
professionals who can issue certifications to patients.
(ii) Whether to change, add or reduce the types of
medical conditions which qualify as serious medical
conditions under this act.
(iii) Whether to change, add or reduce the form and
manner of consumption of medical marijuana permitted
under this act.
(iv) Whether to change, add or reduce the number of
growers/processors or dispensaries.
(v) How to ensure affordable patient access to
medical marijuana, including whether the department
should set a maximum per-dose price for medical
marijuana.
(vi) Whether to permit medical marijuana to be
dispensed in dry leaf or plant form, for administration
by vaporization.
(vii) Whether to permit an individual dose of
medical marijuana to contain a greater percentage of
tetrahydrocannabinol than 10%.
(6) The final written report under this section shall be
adopted at a public meeting. The report shall be a public
record under the act of February 14, 2008 (P.L.6, No.3),
known as the Right-to-Know Law.
Section 1107. Regulations.
In order to implement the provisions of this act, the
department shall promulgate regulations within 18 months of the
effective date of this section. The regulations shall provide
for the following:
(1) Restricting the advertising and marketing of medical
marijuana, which shall be consistent with the Federal
regulations governing prescription drug advertising and
marketing.
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(2) Growing of medical marijuana by grower/processors in
an indoor, enclosed facility. The regulations shall also
specify the manner and method of growing medical marijuana.
(3) The procedure for certification of patients.
(4) A procedure for review and approval of
certifications submitted by practitioners.
(5) A procedure to review the credentials of
practitioners who submit certifications.
(6) A procedure to review and approve applications for
identification cards.
(7) A procedure to review and approve applications to
become registered with the department as a medical marijuana
organization.
(8) A procedure to renew the registration of a medical
marijuana organization.
(9) The setting of a maximum per-dose price for medical
marijuana by a dispensary.
(10) Additional information required by the department
for certification of patients and applications to become
registered as a medical marijuana organization.
(11) The procedure for waiving or reducing application
fees to be paid by patients and caregivers in the case of
financial hardship.
(12) Additional requirements of identification cards for
patients or caregivers.
(13) The method of transporting, delivering, growing,
processing and selling medical marijuana by a
grower/processor and the method of dispensing of medical
marijuana by a dispensary, including the types of medical
devices, instruments and services, which may be sold by a
dispensary.
(14) The method for maintaining effective security and
control to prevent diversion and abuse of medical marijuana
by a medical marijuana organization, including specifying the
requirements of the tracking system required by section
1102(b) and (c).
(15) The contents and timing of reports which must be
filed with the department by medical marijuana organizations.
(16) The proper disposal of electronic information by
medical marijuana organizations.
(17) Information required for labeling of medical
marijuana by medical marijuana organizations.
(18) The procedure for practitioners registering with
the department.
(19) The frequency of filing reports by medical
marijuana organizations.
(20) The criteria for designating an appropriate
individual to be a caregiver for a patient under 18 years of
age.
(21) The procedure for obtaining photographs for
identification cards.
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(22) The procedure for reporting results of laboratory
testing of medical marijuana.
(23) The procedure for approving laboratories that seek
to test medical marijuana.
(24) The contents of the safety insert.
(25) The procedure for filing receipts generated by
dispensaries with the department.
(26) A schedule for inspections by the department of the
facilities for growing, processing, dispensing or selling
medical marijuana, or of the books, papers and tracking
systems of medical marijuana organizations required by this
act.
(27) Regulations that the department must promulgate
under section 1903(a), a procedure to select patients for the
research study and any other regulation the department deems
necessary to implement the research program under Chapter 19.
(28) Regulations which ensure a grower/processor only
provides medical marijuana to a dispensary holding a valid
registration and which ensure that a dispensary only procures
medical marijuana from a grower/processor holding a valid
registration, as set forth in section 707(6) and (7).
(29) The determination of the minimum number and the
types of medical marijuana to be produced by a
grower/processor and dispensed by a dispensary.
(30) Regulations which set forth the procedure for a
grower/processor to obtain seed and plant material:
(i) From outside this Commonwealth to initially grow
medical marijuana.
(ii) From another grower/processor within this
Commonwealth to grow medical marijuana.
(31) Any other regulation necessary to implement this
act, as determined by the department.
Section 1108. Regulations based on recommendations of advisory
board.
(a) Recommendations.--After receiving the report of the
advisory board under section 1106(j)(4), at the discretion of
the secretary, the department may promulgate regulations to
effectuate recommendations made by the advisory board. The
secretary shall issue notice in the Pennsylvania Bulletin within
12 months of the receipt of the report of the advisory board.
The notice shall include the recommendations of the advisory
board and shall state the specific reasons for the decision of
the secretary on whether or not to effectuate each
recommendation. The secretary shall consider whether to
promulgate regulations with respect to:
(1) Whether to change the types of medical professionals
who can issue certifications to patients with respect to the
use of medical marijuana under this act.
(2) Whether to change, add or reduce the types of
medical conditions which qualify as serious medical
conditions under this act.
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(3) Whether to change, add or reduce the form and manner
of consumption of medical marijuana permitted under this act.
(4) Whether to change, add or reduce the number of
growers/processors or dispensaries.
(5) Whether to permit medical marijuana to be dispensed
in dry leaf or plant form for administration by vaporization.
(6) Whether to permit an individual dose of medical
marijuana to contain a greater percentage of
tetrahydrocannabinol than 10%.
(b) Timing.--Any regulations promulgated under this
paragraph shall be promulgated within 12 months of the receipt
of the report of the advisory board.
Section 1109. Temporary regulations.
(a) Promulgation.--In order to facilitate the prompt
implementation of this act, regulations promulgated by the
department shall be deemed temporary regulations which shall
expire not later than 18 months following the publication of the
temporary regulation. The department may promulgate temporary
regulations not subject to:
(1) Sections 201, 202, 203, 204 and 205 of the act of
July 31, 1968 (P.L.769, No.240), referred to as the
Commonwealth Documents Law.
(2) The act of June 25, 1982 (P.L.633, No.181), known as
the Regulatory Review Act.
(3) Sections 204(b) and 301(10) of the act of October
15, 1980 (P.L.950, No.164), known as the Commonwealth
Attorneys Act.
(b) Expiration.--The department's authority to adopt
temporary regulations under subsection (a) shall expire 18
months after the effective date of this section. Regulations
adopted after this period shall be promulgated as provided by
law.
(c) Temporary regulations.--The department shall begin
publishing temporary regulations in the Pennsylvania Bulletin no
later than six months from the effective date of this section.
CHAPTER 13
OFFENSES RELATED TO MEDICAL MARIJUANA
Section 1301. Criminal diversion of medical marijuana by
practitioners.
In addition to any other penalty provided by law, a
practitioner commits a misdemeanor of the first degree if the
practitioner intentionally, knowingly or recklessly certifies a
person as being able to lawfully receive medical marijuana or
otherwise provides medical marijuana to a person who is not
lawfully permitted to receive medical marijuana.
Section 1302. Criminal diversion of medical marijuana by
medical marijuana organizations.
In addition to any other penalty provided by law, an employee
or principal of a medical marijuana organization commits a
misdemeanor of the first degree if the person intentionally,
knowingly or recklessly sells, dispenses, trades, delivers or
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otherwise provides medical marijuana to a person who is not
lawfully permitted to receive medical marijuana.
Section 1303. Criminal retention of medical marijuana.
In addition to any other penalty provided by law, a patient
or caregiver commits a misdemeanor of the third degree if the
patient or caregiver intentionally, knowingly or recklessly
possesses, stores or maintains an amount of medical marijuana in
excess of the amount legally permitted.
Section 1304. Criminal diversion of medical marijuana by
patient or caregiver.
(a) Offense defined.--In addition to any other penalty
provided by law, a patient or caregiver commits an offense if
the patient or caregiver intentionally, knowingly or recklessly
provides medical marijuana to a person who is not lawfully
permitted to receive medical marijuana.
(b) Grading.--A first offense under this section constitutes
a misdemeanor of the second degree. A second or subsequent
offense constitutes a misdemeanor of the first degree.
Section 1305. Falsification of identification cards.
(a) Offense defined.--In addition to any other penalty
provided by law, a person commits an offense if, knowing he is
not privileged to hold an identification card, the person:
(1) possesses an identification card and either attempts
to use the card to obtain medical marijuana or obtains
medical marijuana;
(2) possesses an identification card which falsely
identifies the person as being lawfully entitled to receive
medical marijuana and either attempts to use the card to
obtain medical marijuana or obtains medical marijuana; or
(3) possesses an identification card which contains any
false information on the card and the person either attempts
to use the card to obtain medical marijuana or obtains
medical marijuana.
(b) Grading.--A first offense under this section constitutes
a misdemeanor of the second degree. A second or subsequent
offense under this section constitutes a misdemeanor of the
first degree.
Section 1306. Adulteration of medical marijuana.
(a) General rule.--In addition to any other penalty provided
by law, a person commits an offense if the person adulterates,
fortifies, contaminates or changes the character or purity of
medical marijuana from that set forth on the patient's or
caregiver's identification card.
(b) Grading.--A first offense under this section constitutes
a misdemeanor of the second degree. A second or subsequent
offense under this section constitutes a misdemeanor of the
first degree.
Section 1307. Disclosure of information prohibited.
(a) Offense defined.--In addition to any other penalty
provided by law, an employee or principal of a medical marijuana
organization or an employee of the department commits a
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misdemeanor of the third degree if the person discloses, except
to authorized persons for official governmental or health care
purposes, any information related to the use of medical
marijuana.
(b) Exception.--Subsection (a) shall not apply where
disclosure is permitted or required by law or by court order.
Section 1308. Additional penalties.
(a) Criminal penalties.--In addition to any other penalty
provided by law, a practitioner, caregiver, patient or employee
or principal of any medical marijuana organization who violates
any of the provisions of this act, other than those specified in
section 1301, 1302, 1303, 1304, 1305, 1306 or 1307, or any
regulation promulgated under this act:
(1) For a first offense, commits a misdemeanor of the
third degree and shall, upon conviction, be sentenced to pay
a fine of not more than $5,000, or to imprisonment for not
more than six months.
(2) For a second or subsequent offense, commits a
misdemeanor of the third degree and shall, upon conviction,
be sentenced to pay a fine of not more than $10,000, or to
imprisonment for not less than six months or more than one
year, or both.
(b) Civil penalties.--In addition to any other remedy
available to the department, the department may assess a civil
penalty for a violation of this act, a regulation promulgated
under this act or an order issued under this act or regulation
as provided in this subsection. The following shall apply:
(1) The department may assess a penalty of not more than
$10,000 for each violation and an additional penalty of not
more than $1,000 for each day of a continuing violation. In
determining the amount of each penalty, the department shall
take the following factors into consideration:
(i) The gravity of the violation.
(ii) The potential harm resulting from the violation to
patients, caregivers or the general public.
(iii) The willfulness of the violation.
(iv) Previous violations, if any, by the person being
assessed.
(v) The economic benefit to the person being assessed
for failing to comply with the requirements of this act, a
regulation promulgated under this act or an order issued
under this act or regulation.
(2) If the department finds that the violation did not
threaten the safety or health of a patient, caregiver or the
general public and the violator took immediate action to
remedy the violation upon learning of it, the department may
issue a written warning in lieu of assessing a civil penalty.
(3) A person who aids, abets, counsels, induces,
procures or causes another person to violate this act, a
regulation promulgated under this act or an order issued
under this act or regulation shall be subject to the civil
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penalties provided under this subsection.
(c) Sanctions.--
(1) In addition to the penalties provided in subsection
(b) and any other penalty authorized by law, the department
may impose the following sanctions:
(i) Revoke or suspend the registration of a person
found to be in violation of this act, a regulation
promulgated under this act or an order issued under this
act or regulation.
(ii) Revoke or suspend the registration of a person
for conduct, activity or the occurrence of an event that
would have disqualified the person from receiving the
registration.
(iii) Revoke or suspend the registration of a person
for willfully and knowingly violating or attempting to
violate an order of the department directed to the
person.
(iv) Suspend a registration of a person pending the
outcome of a hearing in a case in which the registration
could be revoked.
(v) Order restitution of funds or property
unlawfully obtained or retained by a registrant.
(vi) Issue a cease and desist order.
(2) A person who aids, abets, counsels, induces,
procures or causes another person to violate this act shall
be subject to the sanctions provided under this subsection.
(d) Costs of action.--The department may assess against a
person determined to be in violation of this act the costs of
investigation of the violation.
(e) Minor violations.--Nothing in this section shall be
construed to require the assessment of a civil penalty or the
imposition of a sanction for a minor violation of this act if
the department determines that the public interest will be
adequately served under the circumstances by the issuance of a
written warning.
Section 1309. Other restrictions.
This act does not permit any person to engage in and does not
prevent the imposition of any civil, criminal or other penalty
for the following:
(1) Undertaking any task under the influence of medical
marijuana when doing so would constitute negligence,
professional malpractice or professional misconduct.
(2) Possessing or using medical marijuana in a State or
county correctional facility, including a facility owned or
operated or under contract with the Department of Corrections
or the county which houses inmates serving a portion of their
sentences on parole or other community correction program.
Nothing in this paragraph shall be construed to apply to
employees of the facilities set forth in this paragraph. The
Department of Corrections shall adopt a written policy no
later than 18 months from the effective date of this section
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regarding the possession and use of medical marijuana by
employees in State correctional facilities. The governing
authority of a county may adopt a resolution no later than 18
months from the effective date of this section regarding the
possession and use of medical marijuana by employees in a
county correctional facility.
(3) Possessing or using medical marijuana in a youth
detention center or other facility which houses children
adjudicated delinquent, including the separate, secure State-
owned facility or unit utilized for sexually violent
delinquent children under 42 Pa.C.S. § 6404 (relating to
duration of inpatient commitment and review). As used in this
paragraph, the term "sexually violent delinquent children"
shall have the meaning given to it in 42 Pa.C.S. § 6402
(relating to definitions). Nothing in this paragraph shall be
construed to apply to employees of the facilities set forth
in this paragraph.
CHAPTER 19
RESEARCH PROGRAM
Section 1901. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Health care medical marijuana organization." A vertically
integrated health system approved by the department to dispense
medical marijuana or grow and process medical marijuana, or
both, in accordance with a research study under this chapter.
"Vertically integrated health system." A health delivery
system licensed under the act of July 19, 1979 (P.L.130, No.48),
known as the Health Care Facilities Act, in which the complete
spectrum of care, including primary and specialty care,
hospitalization and pharmaceutical care, is provided within a
single organization.
Section 1902. Establishment of medical marijuana research
program.
(a) Program to be established.--The department shall
establish and develop a research program to study the impact of
medical marijuana on the treatment and symptom management of
serious medical conditions.
(b) Department duties.--The department shall:
(1) Review all serious medical conditions which are
cited by a practitioner upon the practitioner's certification
that a patient be granted an identification card.
(2) Create a database of all serious medical conditions,
including comorbidities, which are cited by practitioners in
the certifications of patients. The database shall also
include the form of medical marijuana certified to treat each
serious medical condition.
(3) When the database contains 25 or more patients with
the same serious medical condition, petition the United
States Food and Drug Administration and the United States
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Drug Enforcement Administration for approval to study the
condition and the impact of medical marijuana on the
condition.
(4) Concurrent with the request to the United States
Food and Drug Administration and United States Drug
Enforcement Administration, publicly announce the formation
of a research study to which a vertically integrated health
system and a university within this Commonwealth may submit a
request to participate.
(5) Upon approval of a research study by the United
States Food and Drug Administration and the United States
Drug Enforcement Administration, select a vertically
integrated health system or systems to conduct the research
study and designate the form or forms of medical marijuana
which will be used to treat the serious medical condition.
(6) Notify a patient who has been issued an
identification card:
(i) that the patient has been selected to
participate, at the patient's option, in a research study
to study medical marijuana as a treatment; and
(ii) where the patient may secure medical marijuana
through a health care medical marijuana organization at
no cost to the patient in accordance with subsection (c).
(7) If the United States Food and Drug Administration
and the United States Drug Enforcement Administration reject
the proposal for the research study, take all reasonable
steps to collect and collate data on the serious medical
condition and the use of medical marijuana as a treatment for
the serious medical condition and consider submitting an
additional request to the United States Food and Drug
Administration and United States Drug Enforcement
Administration for a research study on the same condition.
(c) Costs.--The cost of the medical marijuana which is
dispensed to patients in accordance with an approved research
study shall be paid for by the fund.
(d) Geographic accessibility.--The department shall take
into consideration the geographic location of the health care
medical marijuana organization when assigning a patient to a
health care medical marijuana organization. The department shall
make an effort to assign a patient to a health care medical
marijuana organization that is located within 50 miles of the
patient's residence.
(e) Data.--Data collected by the health care medical
marijuana organization shall be provided to the university
participating in the research study for analysis.
Section 1903. Medical marijuana research program
administration.
(a) General rule.--The department shall establish a research
study for each serious medical condition. The department shall
engage universities within this Commonwealth to participate in
the collection, collation, analysis and conclusive findings of
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the research studies. The department shall, by regulation,
establish the procedure to be used by health care medical
marijuana organizations with respect to:
(1) Real time inventory tracking.
(2) Real time tracking of the medical marijuana
dispensed.
(3) Recall of defective medical marijuana.
(b) Request for distributions.--The department shall
establish a form and procedure for universities selected to
participate in a research study to request distributions from
the fund to conduct research on medical marijuana, including
administrative costs. These distributions shall also be used to
pay for the cost of the medical marijuana so that it is not
borne by the patient participating in the research study. The
forms shall include, at a minimum, the following:
(1) The form or forms of medical marijuana to be
studied.
(2) The serious medical condition to be studied.
(c) Research reports.--
(1) A vertically integrated health system shall report
on the effectiveness of the use of medical marijuana for the
treatment of the serious medical condition studied and all
counterindications and noted side effects.
(2) The department shall notify the vertically
integrated health system and the university participating in
the research study of the data which is required to meet the
United States Food and Drug Administration's and the United
States Drug Enforcement Administration's approval for the
research study.
(3) The first report, including the data required under
paragraph (2), shall be submitted to the department and made
publicly available within 180 days of the initiation of a
research study for a specific serious medical condition.
(4) An annual report of the data required under
paragraph (2) shall be submitted to the department beginning
one year after the initiation of a research study for a
specific serious medical condition and each year thereafter.
Section 1904. Approval.
A vertically integrated health system located in this
Commonwealth may petition the department to participate in a
research study to study a serious medical condition under
section 1902. Approval of the vertically integrated health
system as a health care medical marijuana organization by the
department shall authorize access within a region under section
706(d) to medical marijuana for all patients included in an
approved research study.
Section 1905. Requirements.
(a) Dispensing.--A health care medical marijuana
organization that dispenses medical marijuana shall:
(1) Maintain licensure with the department as required
under the act of July 19, 1979 (P.L.130, No.48), known as the
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Health Care Facilities Act.
(2) Secure the medical marijuana within the associated
pharmacies of the health care medical marijuana organization
in a manner and method prescribed by the department.
(3) Keep a daily log of the medical marijuana dispensed
and the research study with which the patient and the medical
marijuana are associated. Reports shall be delivered to the
department and the university participating in the research
study on a weekly basis.
(4) Report to the Pennsylvania Health Care Cost
Containment Council the utilization rates of those patients
participating in the research of medical marijuana and
treatment options.
(5) Only dispense medical marijuana received from a
grower/processor or a health care medical marijuana
organization that is approved to grow and process medical
marijuana.
(6) Provide all patients or caregivers with the safety
insert, prepared by the department, which includes potential
dangers, recognition and correction of problematic dosage and
any other information required by the department or which the
department deems relevant for patient safety.
(b) Growing and processing.--A health care medical marijuana
organization that grows and processes medical marijuana shall:
(1) Maintain licensure with the department as required
under the Health Care Facilities Act.
(2) Only make available medical marijuana to health care
medical marijuana organizations that dispense medical
marijuana.
(3) Keep a daily log of medical marijuana intended for
ultimate use by patients participating in a research study.
Section 1906. Restrictions.
A health care medical marijuana organization may not
participate in a research study of any kind, including the
program established under this chapter, or dispense or grow and
process medical marijuana if it has violated its licensure
requirements under the Health Care Facilities Act.
Section 1907. Regulations.
The department shall, by regulation, establish the procedure
to be used by a health care medical marijuana organization that
grows and processes medical marijuana with respect to:
(1) Real time inventory tracking, including a seed-to-
dispensing tracking system that tracks medical marijuana from
seed or immature plant stage until the medical marijuana is
provided to a patient in a research study.
(2) Security, recordkeeping, record retention and
surveillance systems relating to every stage of growing and
processing medical marijuana.
(3) A daily log of each day's beginning inventory,
acquisitions, disbursements, disposals and ending inventory.
(4) A system to recall defective medical marijuana.
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(5) A system to track the plant waste resulting from the
growth of medical marijuana.
(6) Testing of medical marijuana by an independent
laboratory to test the medical marijuana produced by the
health care medical marijuana organization, including
requiring a test at harvest and a test at final processing.
(7) Any other procedure deemed necessary by the
department.
Section 1908. Nonentitlement.
Nothing in this chapter shall be construed to create an
entitlement or right of a patient to receive medical marijuana
or to participate in a research study.
CHAPTER 21
MISCELLANEOUS PROVISIONS
Section 2101. Conflict.
The growth, processing, manufacture, acquisition,
transportation, sale, dispensing, distribution, possession and
consumption of medical marijuana permitted under this act shall
not be deemed to be a violation of the act of April 14, 1972
(P.L.233, No.64), known as The Controlled Substance, Drug,
Device and Cosmetic Act. If a provision of the Controlled
Substance, Drug, Device and Cosmetic Act relating to marijuana
conflicts with a provision of this act, this act shall take
precedence.
Section 2102. Insurers.
Nothing in this act shall be construed to require an insurer
or a health plan, whether paid for by Commonwealth funds or
private funds, to provide coverage for medical marijuana.
Section 2103. Protections for patients and caregivers.
(a) Licensure.--No patient, caregiver, practitioner, medical
marijuana organization, health care medical marijuana
organization or university participating in a research study
under Chapter 19 or an employee, principal or financial backer
of a medical marijuana organization or employee of a health care
medical marijuana organization or an employee of a university
participating in a research study under Chapter 19 shall be
subject to arrest, prosecution or penalty in any manner, or
denied any right or privilege, including civil penalty or
disciplinary action by a Commonwealth licensing board or
commission, solely for lawful use of medical marijuana or
manufacture or sale or dispensing of medical marijuana, or for
any other action taken in accordance with this act.
(b) Employment.--
(1) No employer may discharge, threaten, refuse to hire
or otherwise discriminate or retaliate against an employee
regarding an employee's compensation, terms, conditions,
location or privileges solely on the basis of such employee's
status as an individual who is certified to use medical
marijuana.
(2) Nothing in this act shall require an employer to
make any accommodation of the use of medical marijuana on the
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property or premises of any place of employment. This act
shall in no way limit an employer's ability to discipline an
employee for being under the influence of medical marijuana
in the workplace or for working while under the influence of
medical marijuana when the employee's conduct falls below the
standard of care normally accepted for that position.
(3) Nothing in this act shall require an employer to
commit any act that would put the employer or any person
acting on its behalf in violation of Federal law.
(c) Custody determination.--The fact that an individual is
certified to use medical marijuana and acting in accordance with
this act shall not by itself be considered by a court in a
custody proceeding. In determining the best interest of a child
with respect to custody, the provisions of 23 Pa.C.S. Ch. 53
(relating to child custody) shall apply.
(d) Disclosure.--Data and information collected by the
department under this act, including copies of identification
cards and copies of certifications, shall be deemed exempt from
public disclosure under the act of February 14, 2008 (P.L.6,
No.3), known as the Right-to-Know Law. However, an application
to become a medical marijuana organization shall be a public
record under the Right-to-Know Law.
Section 2104. Schools.
The Department of Education shall promulgate regulations
within 18 months of the effective date of this section regarding
the following:
(1) Possession and use of medical marijuana by a student
on the grounds of a preschool, primary school and a secondary
school.
(2) Possession and use of medical marijuana by an
employee of a preschool, primary school and a secondary
school on the grounds of such school.
Section 2105. Day-care centers.
The Department of Human Services shall promulgate regulations
within 18 months of the effective date of this section regarding
the following:
(1) Possession and use of medical marijuana by a child
under the care of a child-care or social service center
licensed or operated by the Department of Human Services.
(2) Possession and use of medical marijuana by an
employee of a child-care or social service center licensed or
operated by the Department of Human Services.
(3) Possession and use of medical marijuana by employees
of a youth development center or other facility which houses
children adjudicated delinquent, including the separate,
secure State-owned facility or unit for sexually violent
children, as set forth in section 1309(3).
Section 2106. Medical marijuana from other states.
(a) General rule.--It is not a violation of this act or the
act of April 14, 1972 (P.L.233, No.64), known as The Controlled
Substance, Drug, Device and Cosmetic Act, if a parent or
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guardian of a minor under 18 years of age lawfully obtains
medical marijuana from another state, territory of the United
States or any other country to be administered to the minor.
(b) Expiration.--This section shall expire 730 days after
the effective date of this section.
Section 2107. Zoning.
The following apply:
(1) A grower/processor shall meet the same municipal
zoning and land use requirements as other manufacturing,
processing and production facilities that are located in the
same zoning district.
(2) A dispensary shall meet the same municipal zoning
and land use requirements as other commercial facilities that
are located in the same zoning district.
Section 2108. Notice.
Upon amendment of the Controlled Substances Act (Public Law
91-513, 84 Stat. 1236) removing marijuana from Schedule I of the
Controlled Substances Act, the department shall publish notice
of the effective date of the amendment in the Pennsylvania
Bulletin.
Section 2109. Applicability.
The provisions of this act with respect to dispensaries shall
not apply beginning 1,095 days from the effective date of an
amendment to the Controlled Substances Act (Public Law 91-513,
84 Stat. 1236) removing marijuana from Schedule I of the
Controlled Substances Act.
Section 2110. Effective date.
This act shall take effect as follows:
(1) The following provisions shall take effect
immediately:
(i) This section.
(ii) Chapter 1.
(iii) Chapter 3.
(iv) Section 704.
(v) Section 711.
(vi) Chapter 9.
(vii) Section 1101.
(viii) Section 1104.
(ix) Section 1105.
(x) Section 1106.
(xi) Section 1107.
(xii) Section 1108.
(xiii) Section 1109.
(xiv) Section 1309.
(xv) Chapter 19.
(xvi) Section 2101.
(xvii) Section 2102.
(xviii) Section 2103.
(xix) Section 2104.
(xx) Section 2105.
(xxi) Section 2106.
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(xxii) Section 2108.
(xxiii) Section 2109.
(2) The remainder of this act shall take effect upon the
issuance of temporary regulations by the department under
section 1109(a) or 18 months from the effective date of this
section, whichever is sooner.
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