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(16) "Compounding aseptic containment isolator" or "CACI" means a completely enclosed isolating cabinet that makes use of airtight glove ports designed to protect the user from exposure to airborne drugs and other agents during the compounding and material transfer processes.
A CACI also provides an aseptic environment for compounding sterile preparations.
(14) "Compounding" (sterile and nonsterile) 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.
(5) "Biological safety cabinet" or "BSC" means a containment unit suitable for the preparation of agents where there is a need for protection of the preparation, personnel, and environment, according to National Sanitation Foundation Standard 49.
Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a HEPA minimum, microbial retentive filter.A CAI is primarily used for nonhazardous drug preparations.(18) "Confidential information" means information maintained in a patient's records or which is communicated to a patient as part of patient counseling, which is privileged and may be released only to the patient, to those practitioners and pharmacists where, in the pharmacist's professional judgment, release is necessary to protect the patient's health and well-being, and to other persons or governmental agencies authorized by law to receive such confidential information.(22) "Designated pharmacist" means an individual currently licensed by the Board of Pharmacy in this State who certifies internship training.
(23) "Device" means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component part or accessory, which is required under federal law to bear the label: "Caution: Federal law restricts this device for sale by or on the order of a ___________", the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device; or "Federal law prohibits dispensing without prescription"; or any products deemed to be a public health threat after notice and public hearing as designated by the board.
For purposes of this chapter: (1) "Administer" means the direct application of a drug or device pursuant to a lawful order of a practitioner to the body of a patient by injection, inhalation, ingestion, topical application, or any other means.