(1) "Administer" or
"administration" means the provision of a unit dose and/or doses of medication
to an individual patient as a result of the order of an authorized practitioner
of the healing arts.
Isolator" means an isolator specifically designed for compounding
pharmaceutical ingredients or preparations in an aseptic environment.
(3) "Biological safety cabinet" means a
ventilated cabinet for personnel, product, and environmental protection having
an open front with inward airflow for personnel protection, downward HEPA
filtered laminar airflow for product protection, and
HEPA-filtered exhausted air for environmental
(4) "Board of Pharmacy"
or "Board" means the Georgia State Board of Pharmacy.
(5) "Class 100 Environment" or "ISO Class 5"
means an atmospheric environment which contains fewer than 100 particles 0.5
microns or larger in diameter per cubic meter of air.
(6) "Compounding" means the preparation,
mixing, assembling, packaging, or labeling of a drug or de vice as the result
of a practitioner's prescription drug order or initiative based on the
relationship between the practitioner, patient, and pharmacist in the course of
professional practice or 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 and regularly observed prescribing patterns.
Compounding does not include mixing, reconstituting, or similar acts that are
performed in accordance with the directions contained in approved labeling
provided by the product's manufacturer and other manufacturer directions
consistent with that labeling.
"Component" means any ingredient intended for use in the compounding of a drug
preparation, including those that may not appear in such preparation.
(8) "Cytotoxic" means a pharmaceutical that
has the capability of killing living cells.
(9) "Deliver" or "delivery" means the actual,
constructive, or attempted transfer of a drug or device from one person to
another, whether or not for a consideration.
(10) "Device" means an instrument, apparatus,
contrivance, 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" or
(11) "Dispense" or
"dispensing" means the preparation and delivery of a drug or device to a
patient, patient's caregiver, or patient's agent pursuant to a lawful order of
a practitioner in a suitable container appropriately labeled for subsequent
administration to, or use by a patient.
(12) "Distribute" means the delivery of a
drug or device other than by administering or dispensing.
(a) 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 humans or animals;
Articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in humans or animals;
(c) Articles, other than food, intended to
affect the structure or any function of the body of humans or animals;
(d) Articles intended for use
as a component of any articles specified in subparagraph (a), (b), or (c) of
this paragraph but does not include devices.
Drug regimen review includes but is not
limited to the following activities:
Evaluation of any prescription drug order and patient record for:
1. Known allergies;
Reasonable dose and route of administration; and
4. Reasonable directions for use.
(b) Evaluation of any prescription
drug order and patient record for duplication of therapy;
Evaluation of any prescription drug order
and patient record for the following interactions:
3. Drug-disease; and
4. Adverse drug reactions.
(d) Evaluation of any prescription
drug order and patient record for proper utilization, including over
utilization or under utilization, and optimum therapeutic outcomes.
(15) "Enteral" means within or by
way of the intestine.
means the United States Food and Drug Administration.
(17) "GDNA" means the Georgia Drugs and
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 nonprescription drug or commercially packaged legend drug or device. Any
such label shall include all information required by federal and state law or
(19) "Nonprescription drug"
means a drug which may be sold without a prescription drug order and which is
labeled for use by the consumer in accordance with the requirements of the laws
and rules of this state and/or the federal government.
(20) "Parenteral" means an injectable sterile
preparation of drugs for administration by any other means than through the
"Patient counseling" means the oral communication by the pharmacist of
information, as defined in the law and the rules of the Board, to the patient,
patient's caregiver, or patient's agent, in order to improve therapy by
ensuring proper use of drugs and devices.
(22) "Pharmaceutical" means a compound to be
used as a medicinal drug.
"Pharmacist" means an individual currently licensed by this state to engage in
the practice of pharmacy. This recognizes a pharmacist as a learned
professional who is authorized to provide patient services and pharmacy
(24) "Pharmacist in charge"
means a pharmacist currently licensed in this state who accepts responsibility
for the operation of a pharmacy in conformance with all laws and rules
pertinent to the practice of pharmacy and the distribution of drugs and who is
personally in full and actual charge of such pharmacy and personnel.
(25) "Pharmacy" means any place licensed in
accordance with the laws and rules of this state wherein the possessing,
displaying, compounding, dispensing, or selling of drugs may be conducted,
including any and all portions of the building or structure leased, used, or
controlled by the licensee in the conduct of the business or profession
licensed by the Board at the address for which the license was
(26) "Practitioner" or
"practitioner of the healing arts" means a physician, dentist, podiatrist, or
veterinarian and shall include any other person licensed under the laws of this
state to use, mix, prepare, dispense, prescribe, and administer drugs in
connection with medical treatment to the extent provided by the laws of this
(27) "Prescription drug
order" means a lawful order of a practitioner for a drug or device for a
drug use review" means a review of the patient's drug therapy and prescription
drug order, as defined in the law and the rules of the Board, prior to
dispensing the drug as part of a drug regimen review.
(29) "Sterile pharmaceutical" means any
dosage form devoid of viable microorganisms, or any other contaminant
including, but not limited to, parenterals, injectables, and
Preparations" are those as defined by USP 797.
(31) "USP-NF" means the United States
Pharmacopeia and National Formulary.