(10) ‘Certified pharmacy technician’ means an individual who is a registered pharmacy technician and who has completed the requirements provided for in Section 404382(B). (511) ‘Chart order’ means a lawful order from a practitioner for a drug or device for patients of a hospital or extended care facility, or such an order prepared by another person and signed by a practitioner either immediately or at another time, issued for a legitimate medical purpose within the practitioner’s course of legitimate practice and including orders derived on behalf of a practitioner from a practitioner approved drug therapy management. (612) ‘Class 100 environment’ or ‘ISO 5’ means an atmospheric environment which contains less than one hundred particles 0.5 microns in diameter per cubic foot of air. (13) ‘Closedsystem transfer device’ or ‘CSTD’ means a closedsystem hazardous drug handling device comprising a number of interlocking parts for reconstituting, injecting, and administering doses of hazardous drugs. (14) ‘Colonyforming unit’ or ‘CFU’ means an estimate of cell quantity. (715) ‘Compounding’ means the preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, or the preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner’s prescription drug order or initiative based on the practitioner/patient/pharmacist relationship 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, regularly observed prescribing patterns. The term compounding does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling. (16) ‘Compounded sterile preparation’ or ‘CSP’ means a compounded biologic, diagnostic, drug, nutrient, or radiopharmaceutical that must be sterile when administered to a patient. Among other things, CSPs include: (a) aqueous bronchial and nasal inhalations; (b) baths and soaks for live organs and tissues;
to obtain health care services and shall not include those places where physicians, dentists, veterinarians, or other practitioners, who are duly licensed, engage in private practice. (2544) ‘Institutional pharmacy’ means the physical portion of an institutional facility that is engaged in the compounding, dispensing, and distribution of drugs, devices, and other materials, hereinafter referred to as ‘drugs’, used in the diagnosis and treatment of injury, illness, and disease and which is permitted by the State Board of Pharmacy. (2645) ‘Institutional consultant pharmacist’ means a pharmacist licensed in this State who acts as a consultant for institutional facilities. (2746) ‘Intern’ means an individual who is currently registered by certificate in this State 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. (47) ‘ISO’ means the International Organization for Standardization. (48) ‘ISO 5 environment’ means an atmospheric environment that contains fewer than 3,520 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 100. (49) ‘ISO 7 environment’ means an atmospheric environment that contains fewer than 352,000 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 10,000. (50) ‘ISO 8 environment’ means an atmospheric environment that contains fewer than 3,520,000 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 100,000. (51) ‘Isolator’ means a selfcontained primary engineering control defined by having fixed walls, a floor, and a ceiling, and includes barriers such as gloves, sleeves, and air locks that separate transfers of materials into and out of the environment. The use of an isolator can be an alternative to a buffer area for sterile preparations. (2852) ‘Labeling’ means the process of preparing and affixing a label which includes all information required by federal and state law to a drug container exclusive of the labeling by a manufacturer, packer, or distributor of a nonprescription drug or commercially packaged legend drug or device.