Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-11 - PHARMACEUTICAL COMPOUNDING › Rule 480-11-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
(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.
(2) "Barrier
			 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
			 protection.
(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.
(7)
			 "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
			 "Rx Only."
(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.
(13) "Drug" means:
(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;
(b)
			 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;
			 and
(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.