In addition to the definitions in 50-5-101 , MCA, the following definitions apply to this subchapter:

(1) "Antineoplastic" means a pharmaceutical that has the capability of killing malignant cells.

(2) "Biological safety cabinet" means a containment unit suitable for the preparation of low to moderate risk agents where there is a need, according to national sanitation foundation standard 49 for class II biohazard cabinetry, as revised May 1992, for protection of the product, personnel, and environment. The department hereby adopts and incorporates by reference national sanitation foundation standard 49 for class II biohazard cabinetry, as revised May 1992, promulgated by the National Sanitation Foundation International, 3475 Plymouth Road, P.O. Box 1468, Ann Arbor, MI 48113. A copy of national sanitation foundation standard 49 may be obtained from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(3) "Class 100 environment" means an atmospheric environment which contains less than 100 particles 0.5 microns in diameter per cubic foot of air.

(4) "Critical area" means an area where sterilized products or containers are exposed to the environment during aseptic preparation.

(5) "Enteral" means a preparation compounded in a class 100 environment and dispensed by a pharmacist and administered within or by way of the intestine.

(6) "Licensed health care professional" means a physician (M.D. or D.O.) , a physician assistant-certified, a nurse practitioner, or a registered nurse practicing within the scope of their license.

(7) "Parenteral" means a sterile preparation of drugs for injection through one or more layers of the skin with infusion administration time equal to or greater than 15 minutes.

(8) "Pharmacist" means a natural person licensed by the Montana department of labor and industry to prepare, compound, dispense, and sell drugs, medicines, chemicals, and poisons and who may affix to the person ' s name the term "R.Ph."

(9) "Pharmacist-in-charge" means a pharmacist licensed by the Montana department of labor and industry 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.

(10) "Pharmacy" means an established place registered by the Montana department of labor and industry in which prescriptions, drugs requiring a prescription, medicines, chemicals, and poisons are compounded, dispensed, vended, or sold.

(11) "Prescribing practitioner" means a practitioner authorized to prescribe by the jurisdiction in which he or she is licensed to practice the profession and acting with the scope of this authorization.

(12) "Sterile pharmaceutical or product" means a dosage form free from living micro-organisms (aseptic) .