For purposes of this Article, the following words and phrases have been defined to mean:

(a) Administer means the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion or any other means.

(b) Automated Pharmacy Systems include, but are not limited to, mechanical systems which perform operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing or distribution of medications, and which collect, control, and maintain all transaction information.

(c) Beyond-Use Date means a date determined by a pharmacist and placed on a prescription label at the time of dispensing that is intended to indicate to the patient or care giver a time beyond which the contents of the prescription are not recommended to be used.

(d) Board of Pharmacy or Board means the Guam Board of Examiners for Pharmacy.

(e) Collaborative Pharmacy Practice is that practice of pharmacy whereby a pharmacist has jointly agreed, on a voluntary basis, to work in conjunction with one or more practitioners under protocol whereby the pharmacist may perform certain patient care functions authorized by the practitioner or practitioners under certain specified conditions and/or limitations.

(f) Compounding means the preparation, mixing, assembling, packaging, or labeling of a drug or device:

(1) as the result of practitioner’s prescription drug order or initiative based on the

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practitioner/patient/pharmacist relationship in the course of professional practice, or

(2) for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

(g) Confidential Information means information accessed, maintained by or transmitted to the Pharmacist in the patient’s records, or which is communicated to the patient as part of patient counseling, which is privileged and may be released only to the patient or, as the patient directs, to those practitioners, other authorized health care professionals and other pharmacists where, in the pharmacist’s professional judgment, such release is necessary to protect the patient’s health and well being; and to such other persons or governmental agencies authorized by law to receive such confidential information, regardless of whether such information is in the form of paper, preserved on microfilm or is stored on electronic media.

(h) Deliver or Delivery means the actual, constructive, or attempted transfer of a drug or device from one (1) person to another, whether or not for a consideration.

(i) Device means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component part or accessory, which is required under Federal law to bear the label, ‘Caution: Federal or State law requires dispensing by or on the order of a physician.’

(j) Dispense or Dispensing means the interpretation, evaluation and implementation of a prescription drug order, including the preparation and delivery of a drug or device to a patient or patient’s agent in a suitable container appropriately labeled for subsequent Administration to, or use by, a patient.

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(k) Distribute means the delivery of a drug or device other than by administering or dispensing.

(l) Drug means:

(1) articles recognized as drugs in any official compendium, or supplement thereto, designated from time to time by the Board for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human or other animals;

(2) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in human or other animals;

(3) articles, other than food, intended to affect the structure or any function of the body of human or other animals; and

(4) articles intended for use as a component of any articles specified in clauses (1), (2) or (3) of this Subsection.

(m) Drug Regimen Review includes, but is not limited to, the following activities:

(1) evaluation of the prescription drug order(s) and patient record(s) for:

(A) known allergies;

(B) rational therapy-contraindications;

(C) reasonable dose and route of administration; and

(D) reasonable directions for use;

(2) evaluation of the prescription drug order(s) and patient record(s) for duplication of therapy;

(3) evaluation of the prescription drug order(s) and patient record(s) for interactions:
(A) drug-drug; (B) drug-food;

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(C) drug-disease; and

(D) adverse drug reactions.

(4) evaluation of the prescription drug order(s) and patient record(s) for proper utilization, including over- or under-utilization, and optimum therapeutic outcomes;

(n) Electronic Transmission means transmission of information in electronic form or the transmission of the exact visual image of a document by way of electronic equipment.

(o) Emergency Situations for the purposes of authorizing an oral prescription drug order or a Schedule II controlled substance, means those situations in which the prescribing practitioner determines:

(1) that immediate administration of the controlled substance is necessary for proper treatment of the patient;

(2) that no appropriate alternative treatment is available, including administration of a drug which is not a Schedule II controlled substance; and

(3) that it is not reasonably possible for the prescribing practitioner to provide a written or electronic prescription drug order to be presented to the person dispensing the substance, prior to the dispensing.

(p) Equivalent Drug Product means a drug product which has the same established name, active ingredient(s), strength or concentration, dosage form, and route of Administration and which is formulated to contain the same amount of active ingredient(s) in the same dosage form and to meet the same compendial or other applicable standards, (i.e. strength, quality, purity and identity,) but which may differ in characteristics such as shape, scoring, configuration, packaging, excipients (including colors, flavors, preservatives), and expiration time.

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(q) Home Infusion Pharmacy means a pharmacy which compounds solutions for direct administration to a patient in a private residence, long term care facility, or hospice setting by means of parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion.

(r) Intern means an individual who is:

(1) currently licensed by the Board to engage in the practice of pharmacy while under the personal supervision of a pharmacist and is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist; or

(2) a graduate of an approved college of pharmacy or a graduate who has established educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Committee (‘FPGEC’) Certificate, who is currently licensed by the Board of Pharmacy for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist; or

(3) a qualified applicant awaiting examination for licensure; or

(4) an individual participating in a residency or fellowship program.

(s) Labeling means the process of preparing and affixing a label to any drug container, exclusive, however, of the labeling by a manufacturer, packer or distributor of a non- prescription drug or commercially packaged legend drug or device. Any such label shall include all information required by Federal and state law or rule.

(t) Long Term Care Facility means a nursing home, retirement care, mental care, or other facility or institution which provides extended health care to resident patients.

(u) Manufacturer means a person engaged in the manufacture of drugs or devices.

(v) Manufacturing means the production, preparation, propagation, conversion, or processing of a drug or device,

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either directly or indirectly, by extraction from substances of natural origin, or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of the substance(s) or labeling or relabeling of its container, and the promotion and marketing of such drugs or devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners or other persons.

(w) Medical Order means a lawful order of a practitioner which may or may not include a prescription drug order.

(x) Non-Prescription Drug means a drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws and rules of Guam and the Federal government.

(y) Non-Resident Pharmacy means a pharmacy located outside Guam.

(z) Patient Counseling means the oral communication by the Pharmacist of information, as defined in the rules of the Board, to the patient or care giver, in order to ensure proper use of drugs and devices.

(aa) Person means an individual, corporation, partnership, association or any other legal entity including government.

(bb) Pharmaceutical Care is the provision of drug therapy and other patient care services intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient’s symptoms, or arresting or slowing of a disease process as defined in the rules of the Board.

(cc) Pharmacist means an individual currently licensed by the Board to engage in the practice of pharmacy.

(dd) Pharmacist-in-Charge means a pharmacist currently licensed in Guam who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy and the

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distribution of drugs, and who is personally in full and actual charge of such pharmacy and personnel.

(ee) Pharmacy means any place within Guam where drugs are dispensed and pharmaceutical care is provided and any place outside of Guam where drugs are dispensed and pharmaceutical care is provided to residents of Guam.

(ff) Pharmacy Technician means personnel who assist in the practice of pharmacy under the personal and direct supervision of a pharmacist, and are registered with the Board as defined in § 12614 of this Act.

(gg) Practice of Telepharmacy means the provision of pharmaceutical care through the use of telecommunications and information technologies to patients at a distance.

(hh) Practitioner means an individual currently licensed, registered, or otherwise authorized by the jurisdiction to prescribe and, administer drugs in the course of professional practice in Guam.

(ii) Preceptor means an individual who is currently licensed as a Pharmacist by the Board of Pharmacy, meets the qualifications as a preceptor under the rules of the Board, and participates in the instructional training of pharmacy Interns.

(jj) Prescription Drug or Legend Drug means a drug which is required under Federal law to be labeled with either of the following statements prior to being dispensed or delivered:

(A) ‘Caution: Federal law prohibits dispensing without prescription’; or

(B) ‘Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian’; or

(C) a drug which is required by any applicable Federal or state law or rule to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only.

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(kk) Prescription Drug Order means a lawful order of a practitioner for a drug or device for a specific patient, including orders derived from Collaborative Pharmacy Practice, that is communicated directly to a pharmacist in a licensed pharmacy.

(ll) Primary Care is the first level of contact of individuals, the family, and the community with the health care delivery system, bringing health care as close as possible to where people live and work, and constitutes the first element of a continuing health care process. Areas of Primary Care where pharmacists provide Pharmaceutical Care include, but are not limited to, the following: chronic disease management; smoking cessation; maternal and child health; immunizations; family planning; self-care consulting; drug selection under protocol; treatment of common diseases and injuries; nutrition; and general health education and promotion.

(mm) Prospective Drug Use Review means a review of the patient’s drug therapy and prescription drug order, as part of a drug regimen review, as defined in the rules of the Board, prior to dispensing the drug.

(nn) Significant Adverse Drug Reaction means any drug-related incident that may result in serious harm, injury or death to the patient.

(oo) Wholesale Distributor means any person engaged in wholesale distribution of drugs, including, but not limited to, manufacturers; repackagers; own label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers’ and distributors’ warehouses, chain drug warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.

SOURCE: Added by P.L. 16-123:24 (Dec. 28, 1982). Repealed and reenacted by P.L. 24-207:1 (May 13, 1998). Subsection (o) amended by P.L. 36-031:4 (June 11, 2021).

2013 NOTE: Pursuant to the authority granted by 1 Guam Code Ann. § 1606, numbers and/or letters in subsections (m)(1), (m)(3) and (jj) were altered to adhere to the Compiler’s alpha-numeric scheme.

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