SECTION 1. The legislature finds that in the interest of public health and safety, regulatory oversight is needed regarding the State's medical use of marijuana statutes. While the legislature affirmed the need of qualified patients to utilize this controlled substance for medical purposes, the lack of regulation regarding potency, dosage, quality control, and distribution leaves those same citizens lacking in effective care.

The purpose of this Act is to:

(1) Further define marijuana for medical use;

(2) Create standards for dosage and potency regarding

qualifying conditions; and

(3) Create licensing and operational regulations for

manufacturers and dispensaries for medical marijuana.

SECTION 2. Section 329-121, Hawaii Revised Statutes, is amended to read as follows:

"[[]PART IX.[]] MEDICAL USE OF MARIJUANA

§329-121 Definitions. As used in this part:

"Adequate supply" means an amount of marijuana jointly possessed between the qualifying patient and the primary caregiver that is not more than is reasonably necessary to assure the uninterrupted availability of marijuana for the purpose of alleviating the symptoms or effects of a qualifying patient's debilitating medical condition; provided that an "adequate supply" shall not exceed [~~seven marijuana plants, whether immature or mature, and~~] four ounces of usable marijuana at any given time.

"Debilitating medical condition" means:

(1) Cancer, glaucoma, positive status for human immunodeficiency virus, acquired immune deficiency syndrome, or the treatment of these conditions;

(2) A chronic or debilitating disease or medical condition or its treatment that produces one or more of the following:

(A) Cachexia or wasting syndrome;

(B) Severe pain;

(D) Seizures, including those characteristic of epilepsy; or

(E) Severe and persistent muscle spasms, including those characteristic of multiple sclerosis or Crohn's disease; or

(3) Any other medical condition approved by the department of health pursuant to administrative rules in response to a request from a physician or potentially qualifying patient.

"Dispensary" means an entity registered with the department of public safety and licensed by the department of health to dispense marijuana for medical use.

"Manufacturer" means an entity registered with the department of public safety and licensed by the department of health to cultivate, acquire, manufacture, possess, prepare, transfer, transport, or supply marijuana for medical use.

"Marijuana for medical use" or "medical marijuana" means any species of the genus cannabis plant, or any mixture or preparation of them, including whole plant extracts and resins, and is delivered in the form of:

(1) Liquid, including, but not limited to, oil;

(2) Pill;

(3) Vaporized delivery method with use of liquid or oil but which does not require the use of dried leaves or plant form; or

(4) Any other method, excluding smoking, as approved by the department of health.

[~~"Marijuana" shall have the same meaning as "marijuana" and "marijuana concentrate" as provided in sections 329-1 and 712-1240.~~]

["Medical use" means the acquisition, possession, cultivation, use, distribution, or transportation of marijuana or paraphernalia relating to the administration of marijuana to alleviate the symptoms or effects of a qualifying patient's debilitating medical condition. For the purposes of "medical use", the term distribution is limited to the transfer of marijuana and paraphernalia.]

"Physician" means a person who is licensed to practice under chapter 453 and is licensed with authority to prescribe drugs and is registered under section 329-32. "Physician" does not include physician's assistant or advanced practice registered nurse with prescriptive authority as described in section 453-5.3 or 457-8.6.

"Primary caregiver" means a person eighteen years of age or older, other than the qualifying patient and the qualifying patient's physician, who has agreed to undertake responsibility for managing the well-being of the qualifying patient with respect to the medical use of marijuana. In the case of a minor or an adult lacking legal capacity, the primary caregiver shall be a parent, guardian, or person having legal custody.

"Qualifying patient" means a person who has been diagnosed by a physician as having a debilitating medical condition.

["Usable marijuana" means the dried leaves and flowers of the plant Cannabis family Moraceae, and any mixture or preparation thereof, that are appropriate for the medical use of marijuana. "Usable marijuana" does not include the seeds, stalks, and roots of the plant.]

"Written certification" means the qualifying patient's medical records or a statement signed by a qualifying patient's physician, stating that in the physician's professional opinion, the qualifying patient has a debilitating medical condition and the potential benefits of the medical use of marijuana would likely outweigh the health risks for the qualifying patient. The department of health may require, through its rulemaking authority, that all written certifications comply with a designated form. "Written certifications" are valid for only one year from the time of signing."

SECTION 3. Chapter 329, Hawaii Revised Statutes, is amended by adding 4 new sections to be appropriately designated and to read as follows:

"§329-A Potency and Dosage. The department of health shall review and publicly report the medical and scientific findings regarding potency requirements, dosage recommendations, and chemical compositions of any plant of the genus cannabis that could be beneficial for each debilitating medical condition. The department shall submit its first report to the legislature no later than twenty days before the convening of the regular session of 2016. The information shall then be made available and distributed to qualifying patients, primary caregivers, physicians, dispensaries, and manufacturers by January 31, 2016. The information in this report shall be updated and distributed annually.

§329-B Manufacturer Licensing. (a) In accordance with sections 329-32 and 329-33, a manufacturer of marijuana for medical use must be registered with the department of public safety. Due to the nature of marijuana as a controlled substance, a manufacturer must also be licensed by the department of health. No more than two manufacturers shall be licensed at any one time in the State, and one manufacturer must be licensed prior to December 31, 2015. The department shall consider for licensing only those entities meeting, at a minimum, the following requirements:

(1) A manufacturer shall contract with a laboratory for purposes of testing its product for content, contamination, and consistency to verify that the marijuana fulfills the guidelines of the potency and dosage report as defined by section 329-A and distributed by the department of health. The cost of laboratory testing shall be paid by the manufacturer.

(2) A manufacturer must be able to consistently supply marijuana for medical use in the approved forms as defined in this section.

(3) A manufacturer is subject to sections 329-35, 329-36, 329-37, 329-38, and 329-39, and accordingly, must develop and maintain:

(A) Procedures for internal oversight;

(B) Procedures to ensure accurate record keeping;

(D) Procedures for the implementation of appropriate security measures to deter and prevent the theft of marijuana for medical use and unauthorized entrance into areas containing the controlled substance, including a fully operational security alarm system, facility access controls, perimeter intrusion detection systems, and a personnel identification system.

(4) A manufacturer shall not share office space with, refer patients to a physician, or have any financial relationship with a physician.

(5) A manufacturer may not employ any person who is under twenty-one years of age or who has been convicted of a felony offense under section 329, or part IV of chapter 712. Each employee must submit a completed criminal history record check consent form and a full set of classifiable fingerprints for submission to the department of health according to the criminal background check requirements of section 846-2.7. The department must conduct a Hawaii criminal history record check and is authorized to exchange the fingerprints with the Federal Bureau of Investigation to obtain the applicant's national criminal history record information.

(b) A manufacturer shall operate a single location for cultivation, harvesting, manufacturing, packaging, and processing of marijuana for medical use. The facility must be operational and begin distribution of marijuana for medical use by July 1, 2016.

(1) The amount, dosages, and chemical composition of marijuana for medical use that the manufacturer distributed; and

(2) The tracking number assigned to the marijuana for medical use that the manufacturer distributed.

(d) Each manufacturer shall be reviewed annually for license renewal by the department of health to ensure regulatory compliance.

(e) A manufacturer shall pay to the department of health fees of $5,000 for its initial licensing application and $2,500 per year thereafter to retain its license.

§329-C Dispensary Licensing. (a) In accordance with sections 329-32 and 329-33, a dispensary of marijuana for medical use must be registered with the department of public safety. Due to the nature of marijuana as a controlled substance, a dispensary must also be specially licensed as a dispenser of medical marijuana by the department of health. No more than three dispensaries shall be licensed per county at any one time, and no more than ten dispensaries licensed at any one time in the State. No less than two dispensaries must be licensed prior to December 31, 2015. The department shall consider for licensing only those entities meeting, at a minimum, the following requirements:

(1) A dispensary shall have functioned as a pharmacy in accordance with chapter 461, or as a clinic in accordance with section 329-31.5, for no less than five years.

(2) A dispensary shall have in their employ no more than four registered pharmacists to be listed in their license as authorized dispensers. No other employee of the dispensary is permitted to handle, process, dispense, or distribute marijuana for medical use.

(3) A dispensary may not employ a registered pharmacist who is under twenty-one years of age or who has been convicted of a felony offense under section 329, or part IV of chapter 712. Each pharmacist must submit a completed criminal history record check consent form and a full set of classifiable fingerprints for submission to the department of health according to the criminal background check requirements of section 846-2.7. The department must conduct a Hawaii criminal history record check and is authorized to exchange the fingerprints with the Federal Bureau of Investigation to obtain the applicant's national criminal history record information.

(4) A dispensary is subject to sections 329-35, 329-36, 329-37, 329-38, 329-39 and, in accordance, must show proof of:

(A) Procedures for internal oversight;

(B) Procedures to ensure accurate record keeping;

(b) A dispensary shall utilize the guidelines of the potency and dosage report as defined by section 329-A to determine the correct treatment for the qualifying patient according to the diagnosis of the physician.

(c) A dispensary shall only dispense marijuana for medical use to a registered qualifying patient or their registered primary caregiver.

(d) Each dispensary shall report to the department of health on a monthly basis:

(1) The amount, dosages, and chemical composition of marijuana for medical use dispensed; and

(2) The tracking number assigned to the marijuana for medical use dispensed.

(e) Each dispensary shall be reviewed annually for license renewal by the department of health to ensure compliance with all of the above regulations.

(f) A dispensary shall pay to the department of health fees of $2,500 for its initial licensing application and $1,000 per year thereafter to retain its license.

§329-D Intentional diversion; penalty. (a) Notwithstanding any law to the contrary, a manufacturer or dispensary, or any agent thereof, who intentionally sells, provides, dispenses, distributes, or otherwise transfers marijuana for medical use to any individual or entity other than a registered qualifying patient or primary caregiver, or licensed manufacturer or dispensary shall be guilty of a class C felony. The manufacturer or dispensary shall immediately lose its license with the department of health.

(b) Notwithstanding any law to the contrary, any qualifying patient, primary caregiver, or connected individual who intentionally sells, provides, dispenses, distributes, or otherwise transfers marijuana for medical use to any individual or entity other than a registered qualifying patient or primary caregiver shall be guilty of a class C felony. The connected patient's qualifying status will immediately be reviewed for possible revocation."

SECTION 4. The department of public safety and department of health shall adopt rules pursuant to chapter 91 to effectuate the purpose of this Act.

SECTION 5. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.

SECTION 6. This Act shall take effect on July 1, 2015; provided that the amendments made to section 329-121, Hawaii Revised Statutes, by section 2 of this Act shall take effect July 1, 2016.

INTRODUCED BY:	_____________________________

HOUSE OF REPRESENTATIVES	H.B. NO.	1485
TWENTY-EIGHTH LEGISLATURE, 2015
STATE OF HAWAII