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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.(21) "Designated agent" means a person employed by an authorized practitioner to transmit, either orally or electronically, a prescription drug order on behalf of the authorized practitioner to the pharmacist.The authorized practitioner accepts the responsibility for the correct transmission of the prescription drug order.(12) "Closed-system transfer device" or "CSTD" means a closed-system hazardous drug handling device comprising a number of interlocking parts for reconstituting, injecting, and administering doses of hazardous drugs.(13) "Colony-forming unit" or "CFU" means an estimate of cell quantity.(7) "Brand name" means the proprietary or trade name placed upon a drug, its container, label, or wrapping at the time of packaging.(8) "Buffer area" means an area where the primary engineering control is physically located.
The purpose of this chapter is to promote, preserve, and protect the public health, safety, and welfare by and through the effective control and regulation of the practice of pharmacy; the licensure of pharmacists; the licensure, permitting, control, and regulation of all sites or persons, in or out of this State, that distribute, manufacture, possess, or sell drugs or devices within this State, as may be used in the diagnosis, treatment, and prevention of injury, illness, and disease of a patient or other individual. Except as otherwise provided in this chapter, it is unlawful for an individual to engage in the practice of pharmacy unless currently licensed pursuant to this chapter. An ante area precedes a buffer area, provided: (a) a buffer area must be separated by a wall from an ante area if high-risk preparations are compounded; and (b) if only low-risk and medium-risk preparations are compounded, separating an ante room from a buffer area is recommended.(15) "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; (c) injections, such as colloidal dispersions, emulsions, solutions, suspensions, among others; (d) irrigations for wounds and body cavities; (e) ophthalmic drops and ointments; and (f) tissue implants.(10) "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.
(11) "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.
A CAI is primarily used for nonhazardous drug preparations.