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;

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Terms Used In Hawaii Revised Statutes 329-31.5

  • Controlled substance: means a drug, substance, or immediate precursor in schedules I through V of part II. See Hawaii Revised Statutes 329-1
  • Drug: means :

    (1) Substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;
    (2) Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals;
    (3) Substances (other than food) intended to affect the structure or any function of the body of man or animals; and
    (4) Substances intended for use as a component of any article specified in clause (1), (2), or (3) of this subsection. See Hawaii Revised Statutes 329-1
  • Drug Enforcement Administration registration number: means the practitioner's Drug Enforcement Administration controlled substance registration number. See Hawaii Revised Statutes 329-1
  • Practitioner: means :

    (1) A physician, dentist, veterinarian, scientific investigator, or other person licensed and registered under § 329-32 to distribute, dispense, or conduct research with respect to a controlled substance in the course of professional practice or research in this State;
    (2) An advanced practice registered nurse with prescriptive authority licensed and registered under § 329-32 to prescribe and administer controlled substances in the course of professional practice in this State; and
    (3) A pharmacy, hospital, or other institution licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to or to administer a controlled substance in the course of professional practice or research in this State. See Hawaii Revised Statutes 329-1
  • Prescription: means an order for medication, which is dispensed to or for an ultimate user. See Hawaii Revised Statutes 329-1
  • State: when applied to a part of the United States, includes any state, district, commonwealth, territory, insular possession thereof, and any area subject to the legal authority of the United States of America. See Hawaii Revised Statutes 329-1
(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.

The term “affiliated pharmacy” as used in this section means a licensed pharmacy which supplies and monitors the controlled substances stocked in a registered clinic.

The term “clinic” as used in this section 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” 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.