HB378

SECTION 1. Section 329-31.5, Hawaii Revised Statutes, is amended to read as follows:

"§329-31.5 Clinics. (a) Registration as a clinic is required when an out-patient medical facility maintains centralized ordering, storage, and record keeping of controlled substances to be administered and/or dispensed to patients. Registration of a clinic requires that:

(1) Each location where controlled substances are stocked be registered by name, location, and designated principal practitioner or affiliated pharmacy. The principal practitioner or affiliated pharmacy shall be responsible for the accurate maintenance of records which document all controlled substances ordered, received, administered, and dispensed within the clinic;

(2) Controlled substances stocked at a clinic under the clinic State of Hawaii and Drug Enforcement Administration registration numbers be administered to clinic patients by licensed or registered health care professionals under the supervision of the treating practitioner;

(3) Controlled substances stocked at a clinic under the clinic State of Hawaii and Drug Enforcement Administration registration numbers be dispensed to clinic patients only by the treating practitioner for emergency and urgent care, when a written prescription would not be practical;

(4) A centralized record signed and dated by the treating practitioner which indicates the patient, controlled substance, date and time of administration and/or dispensing be maintained and stored with the current controlled substance inventory, ordering, and receipt records. These records shall be maintained for five years; [~~and~~]

(5) A clinic practitioner who individually maintains a personal stock of controlled substances does so under the practitioner's individual State and Drug Enforcement Administration registration number. These controlled substances shall be kept separate from clinic stock and cannot be accessed by other practitioners[.]; and

(6) The clinic will be located at least seven hundred fifty feet away from any school.

(b) [~~The term "affiliated pharmacy" as~~] As used in this section:

"Affiliated pharmacy" means a licensed pharmacy which supplies and monitors the controlled substances stocked in a registered clinic.

[~~The term "clinic" as used in this section~~] "Clinic" means an out-patient medical facility owned and operated by a legal entity that employs individual practitioners for the treatment of patients and which may or may not provide after-hours emergency or urgent care.

[~~The term "principal physician"~~] "Principal physician" means the practitioner in a clinic whose signature appears on the clinic's State of Hawaii and Drug Enforcement Administration registrations, and who is responsible for the proper maintenance, storage, and record keeping of the controlled substances ordered and centrally stocked in the clinic using the clinic Drug Enforcement Administration registration number.

"School" shall have the same meaning as in section 712-1249.6."

SECTION 2. Section 329-32, Hawaii Revised Statutes, is amended to read as follows:

"§329-32 Registration requirements. (a) Every person who:

(1) Manufactures, distributes, prescribes, dispenses, or conducts reverse distribution with any controlled substance within this State;

(2) Proposes to engage in the manufacture, distribution, prescription, dispensing, or reverse distribution of any controlled substance within this State; or

(3) Dispenses or proposes to dispense any controlled substance for use in this State by shipping, mailing, or otherwise delivering the controlled substance from a location outside this State;

shall obtain a registration issued by the department [~~of public safety~~] in accordance with the department's rules. A licensed or registered health care professional who acts as the authorized agent of a practitioner and who administers controlled substances at the direction of the practitioner shall not be required to obtain a registration.

(b) Persons registered by the department [~~of public safety~~] under this chapter to manufacture, distribute, prescribe, dispense, store, conduct research, or conduct reverse distribution with controlled substances may possess, manufacture, distribute, prescribe, dispense, store, or conduct research with those substances to the extent authorized by their registration and in conformity with this part.

(c) Except as otherwise provided by law, the following persons shall not be required to register and may lawfully possess controlled substances under this chapter:

(1) An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance, if the agent or employee is acting in the usual course of the agent's or employee's business or employment;

(2) A common or contract carrier or warehouser, or an employee thereof, whose possession of any controlled substance is in the usual course of the person's business or employment; and

(3) An ultimate user or a person in possession of any controlled substance pursuant to a lawful order of a practitioner.

(d) The department [~~of public safety~~] may waive the registration or filing requirement for certain manufacturers, distributors, prescribers, or dispensers by rule if:

(1) It is consistent with the public health and safety; and

(2) The department [~~of public safety~~] states the specific reasons for the waiver and the time period for which the waiver is to be valid.

(e) A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, prescribes, dispenses, or conducts reverse distribution with controlled substances, except an office used by a practitioner (who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.

(f) The department [~~of law enforcement~~] may inspect the establishment of a registrant or applicant for registration in accordance with the department's rule.

(g) The department [~~of public safety~~] may require a registrant to submit documents or written statements of fact relevant to a registration that the department deems necessary to determine whether the registration should be granted or denied. The failure of the registrant to provide the documents or statements within a reasonable time after being requested to do so shall be deemed to be a waiver by the registrant of the opportunity to present the documents or statements for consideration by the department in granting or denying the registration.

(h) The failure to renew the controlled substance registration on a timely basis or to pay the applicable fees or payment with a check that is dishonored upon first deposit shall cause the registration to be automatically forfeited.

(i) No registration shall be issued or renewed under this section to any person, applicant, or registrant, and no registration shall be waived under subsection (d) for any person or applicant, for a methadone clinic or substance use disorder services clinic if the clinic is within seven hundred fifty feet of a school, as defined in section 712-1249.6."

SECTION 3. Section 329-33, Hawaii Revised Statutes, is amended to read as follows:

"§329-33 Registration. (a) The department [~~of public safety~~] shall register an applicant to manufacture, dispense, prescribe, distribute, or conduct reverse distribution with controlled substances included in sections 329-14, 329-16, 329-18, 329-20, and 329-22 unless [it] the department determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the department [~~of public safety~~] shall consider the following factors:

(1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific, or industrial channels;

(2) Compliance with applicable state and local [~~law;~~] laws;

(3) Any convictions of the applicant under any federal and state laws relating to any controlled substance;

(4) Past experience in the manufacture or distribution of controlled substances, and the existence in the applicant's establishment of effective controls against diversion;

(5) Furnishing by the applicant of false or fraudulent material in any application filed under this chapter;

(6) Suspension, revocation, or surrender of the applicant's federal registration to manufacture, distribute, prescribe, or dispense controlled substances as authorized by federal law; and

(7) Any other factor relevant to and consistent with the public health and safety.

(b) Registration under subsection (a) does not entitle a registrant to manufacture, dispense, prescribe, and distribute controlled substances in schedule I or II other than those specified in the registration.

(c) Practitioners shall be registered to dispense or to prescribe any controlled substances or to conduct research with controlled substances in schedules II through V if they are authorized to dispense or to prescribe or conduct research under the law of this State. The department [~~of public safety~~] need not require separate registration under this part for practitioners engaging in research with nonnarcotic controlled substances in schedules II through V where the registrant is already registered under this part in another capacity. Practitioners registered under federal law to conduct research with schedule I substances may conduct research with schedule I substances within this State upon furnishing the department of public safety evidence of that federal registration.

(d) Compliance by manufacturers and distributors with the provisions of the federal law respecting registration (excluding fees) entitles them to be registered under this chapter.

(e) No registration under this section shall be issued to any applicant for a methadone clinic or substance use disorder services clinic that will be located within seven hundred fifty feet of a school, as defined in section 712-1249.6."

SECTION 4. Section 329-34, Hawaii Revised Statutes, is amended to read as follows:

"§329-34 Revocation and suspension of registration. (a) A registration under section 329-33 to manufacture, distribute, dispense, or conduct reverse distribution with a controlled substance may be suspended or revoked by the department [~~of public safety~~] upon a finding that the registrant:

(1) Has furnished false or fraudulent material information in any application filed under this chapter;

(2) Has been convicted of a felony or has been granted a motion for the deferral of acceptance of a guilty plea or a nolo contendere plea to a felony, pursuant to chapter 853 and under any state or federal law relating to any controlled substance;

(3) Has had the registrant's federal registration suspended or revoked to manufacture, distribute, prescribe, dispense, or conduct reverse distribution with controlled substances; [or]

(4) Has had the registrant's state license to practice the registrant's profession suspended or revoked by the applicable governing state board[.]; or

(5) Is a registrant for a methadone clinic or substance use disorder services clinic that has located or relocated within seven hundred fifty feet of a school, as defined in section 712-1249.6.

(b) The department [~~of public safety~~] may limit revocation or suspension of a registration to the particular controlled substance with respect to which grounds for revocation or suspension exist.

(c) If the department [~~of public safety~~] suspends or revokes a registration, all controlled substances owned or possessed by the registrant at the time of suspension or the effective date of the revocation order may be placed under seal. No disposition may be made of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a court, upon application therefor, orders the sale of perishable substances and the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all controlled substances may be forfeited to the State.

(d) The department [~~of public safety~~] shall promptly notify the Bureau of all orders suspending or revoking registration and all forfeitures of controlled substances."

SECTION 5. Section 329-40, Hawaii Revised Statutes, is amended to read as follows:

"§329-40 Methadone treatment programs. (a) Notwithstanding any other provision of law to the contrary, methadone may be administered or dispensed or both as part of a state-registered and federal Substance Abuse and Mental Health Services Administration approved methadone treatment program by a practitioner who is licensed and registered under state and federal law to administer and dispense methadone for patients or by an agent of the practitioner, supervised by and under the order of the practitioner. The agent must be a pharmacist, registered nurse, or licensed practical nurse. The licensed practitioner shall be responsible for the amounts of methadone administered or dispensed in accordance with Substance Abuse and Mental Health Services Administration regulations and shall record, approve, and countersign all changes in dosage schedules.

(b) Registration of a methadone treatment program requires that:

(1) The methadone treatment program obtain a controlled substance registration from the State of Hawaii and the Drug Enforcement Administration;

(2) The medical director of a methadone treatment program obtain a controlled substance registration from the State of Hawaii and the Drug Enforcement Administration at the location of the program;

(3) Admission to a methadone treatment program be limited to the narcotic-dependent persons as defined in this chapter;

(4) Unless otherwise stated in this chapter, admission to a methadone treatment program be in accordance with Title 21 Code of Federal Regulations Part 291 and Title 42 Code of Federal Regulations Part 8;

(5) All medical orders including initial medication orders, all subsequent medication order changes, all changes in the frequency of take-home medication, and the prescription of additional take-home medication for emergency situations be authorized by a licensed registered physician employed by the program;

(6) Only the medical director or other designated program physician authorize a patient's admission for treatment in accordance with Title 21 Code of Federal Regulations Part 291 and Title 42 Code of Federal Regulations Part 8; [~~and~~]

(7) Take-home doses of methadone be dispensed to patients in accordance with Title 21 Code of Federal Regulations Part 291 and Title 42 Code of Federal Regulations Part 8, but shall not exceed a fourteen-day supply at any given time nor more than the maximum amount of take-homes for Levo-alphacetylmethadol (LAAM/Orlamm) that would allow a patient to be away from the clinic for dosing for more than two weeks unless authorized by the state authority[.

~~The term "methadone treatment program" as~~]; and

(8) The methadone treatment program be located at least seven hundred fifty feet away from a school.

"Methadone treatment program" means an organization or a person [(], including a private physician[~~) that~~], who administers or dispenses methadone to a narcotic-dependent person for maintenance or detoxification treatment and who provides the medical and rehabilitative services required by Title 21 Code of Federal Regulations Part 291 or Title 42 Code of Federal Regulations Part 8 and is approved to do so by the State and by the United States Substance Abuse and Mental Health Services Administration, and who holds a controlled substance registration as required by this chapter and the United States Drug Enforcement Administration to use methadone for the treatment of narcotic-dependent persons.

[~~The term "narcotic-dependent person" as used in this section~~] "Narcotic-dependent person" means an individual who physiologically needs heroin or a morphine-like drug to prevent the onset of signs of withdrawal.

[~~The term "state authority" as used in this section~~]

"School" shall have the same meaning as in section 712-1249.6.

"State authority" means the agency within the State which exercises the responsibility for governing the treatment of narcotic-dependent persons with the narcotic drug methadone."

SECTION 6. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.

SECTION 7. This Act shall take effect upon its approval; provided that any organization or person who was registered as a clinic under section 329-31.5, Hawaii Revised Statutes, or registered to manufacture, distribute, prescribe, dispense, or conduct reverse distribution with any controlled substance at a methadone clinic or substance use disorder services clinic prior to the effective date of this Act shall have one year from the effective date of this Act to comply with this Act.

INTRODUCED BY:	_____________________________

HOUSE OF REPRESENTATIVES	H.B. NO.	378
THIRTY-SECOND LEGISLATURE, 2023
STATE OF HAWAII