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

(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:

(14) Drug regimen review includes but is not limited to the following activities:

(15) "Enteral" means within or by way of the intestine.

(16) "FDA" means the United States Food and Drug Administration.

(17) "GDNA" means the Georgia Drugs and Narcotics Agency.

(18) "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 nonprescription drug or commercially packaged legend drug or device. Any such label shall include all information required by federal and state law or rule.

(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 gastrointestinal tract.

(21) "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.

(23) "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 care.

(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 issued.

(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 state.

(27) "Prescription drug order" means a lawful order of a practitioner for a drug or device for a specific patient.

(28) "Prospective 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 ophthalmics.

(30) "Sterile Preparations" are those as defined by USP 797.

(31) "USP-NF" means the United States Pharmacopeia and National Formulary.